Sample records for quality control protocols

  1. QUALITY CONTROL - VARIABILITY IN PROTOCOLS

    EPA Science Inventory

    The EPA Risk Reduction Engineering Laboratory’s Quality Assurance Office, which published the popular pocket guide Preparing Perfect Project Plans, is now introducing another quality assurance reference aid. The document Variability in Protocols (VIP) was initially designed as a ...

  2. Worldwide trends in volume and quality of published protocols of randomized controlled trials

    PubMed Central

    Alldinger, Ingo; Cieslak, Kasia P.; Wennink, Roos; Clarke, Mike; Ali, Usama Ahmed; Besselink, Marc G. H.

    2017-01-01

    Introduction Publishing protocols of randomized controlled trials (RCT) facilitates a more detailed description of study rational, design, and related ethical and safety issues, which should promote transparency. Little is known about how the practice of publishing protocols developed over time. Therefore, this study describes the worldwide trends in volume and methodological quality of published RCT protocols. Methods A systematic search was performed in PubMed and EMBASE, identifying RCT protocols published over a decade from 1 September 2001. Data were extracted on quality characteristics of RCT protocols. The primary outcome, methodological quality, was assessed by individual methodological characteristics (adequate generation of allocation, concealment of allocation and intention-to-treat analysis). A comparison was made by publication period (First, September 2001- December 2004; Second, January 2005-May 2008; Third, June 2008-September 2011), geographical region and medical specialty. Results The number of published RCT protocols increased from 69 in the first, to 390 in the third period (p<0.0001). Internal medicine and paediatrics were the most common specialty topics. Whereas most published RCT protocols in the first period originated from North America (n = 30, 44%), in the second and third period this was Europe (respectively, n = 65, 47% and n = 190, 48%, p = 0.02). Quality of RCT protocols was higher in Europe and Australasia, compared to North America (OR = 0.63, CI = 0.40–0.99, p = 0.04). Adequate generation of allocation improved with time (44%, 58%, 67%, p = 0.001), as did concealment of allocation (38%, 53%, 55%, p = 0.03). Surgical protocols had the highest quality among the three specialty topics used in this study (OR = 1.94, CI = 1.09–3.45, p = 0.02). Conclusion Publishing RCT protocols has become popular, with a five-fold increase in the past decade. The quality of published RCT protocols also improved, although variation between

  3. Application of QC_DR software for acceptance testing and routine quality control of direct digital radiography systems: initial experiences using the Italian Association of Physicist in Medicine quality control protocol.

    PubMed

    Nitrosi, Andrea; Bertolini, Marco; Borasi, Giovanni; Botti, Andrea; Barani, Adriana; Rivetti, Stefano; Pierotti, Luisa

    2009-12-01

    Ideally, medical x-ray imaging systems should be designed to deliver maximum image quality at an acceptable radiation risk to the patient. Quality assurance procedures are employed to ensure that these standards are maintained. A quality control protocol for direct digital radiography (DDR) systems is described and discussed. Software to automatically process and analyze the required images was developed. In this paper, the initial results obtained on equipment of different DDR manufacturers were reported. The protocol was developed to highlight even small discrepancies in standard operating performance.

  4. Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols

    PubMed Central

    Mhaskar, Rahul; Djulbegovic, Benjamin; Magazin, Anja; Soares, Heloisa P.; Kumar, Ambuj

    2011-01-01

    Objectives To assess whether reported methodological quality of randomized controlled trials (RCTs) reflect the actual methodological quality, and to evaluate the association of effect size (ES) and sample size with methodological quality. Study design Systematic review Setting Retrospective analysis of all consecutive phase III RCTs published by 8 National Cancer Institute Cooperative Groups until year 2006. Data were extracted from protocols (actual quality) and publications (reported quality) for each study. Results 429 RCTs met the inclusion criteria. Overall reporting of methodological quality was poor and did not reflect the actual high methodological quality of RCTs. The results showed no association between sample size and actual methodological quality of a trial. Poor reporting of allocation concealment and blinding exaggerated the ES by 6% (ratio of hazard ratio [RHR]: 0.94, 95%CI: 0.88, 0.99) and 24% (RHR: 1.24, 95%CI: 1.05, 1.43), respectively. However, actual quality assessment showed no association between ES and methodological quality. Conclusion The largest study to-date shows poor quality of reporting does not reflect the actual high methodological quality. Assessment of the impact of quality on the ES based on reported quality can produce misleading results. PMID:22424985

  5. Standardized protocols for quality control of MRM-based plasma proteomic workflows.

    PubMed

    Percy, Andrew J; Chambers, Andrew G; Smith, Derek S; Borchers, Christoph H

    2013-01-04

    Mass spectrometry (MS)-based proteomics is rapidly emerging as a viable technology for the identification and quantitation of biological samples, such as human plasma--the most complex yet commonly employed biofluid in clinical analyses. The transition from a qualitative to quantitative science is required if proteomics is going to successfully make the transition to a clinically useful technique. MS, however, has been criticized for a lack of reproducibility and interlaboratory transferability. Currently, the MS and plasma proteomics communities lack standardized protocols and reagents to ensure that high-quality quantitative data can be accurately and precisely reproduced by laboratories across the world using different MS technologies. Toward addressing this issue, we have developed standard protocols for multiple reaction monitoring (MRM)-based assays with customized isotopically labeled internal standards for quality control of the sample preparation workflow and the MS platform in quantitative plasma proteomic analyses. The development of reference standards and their application to a single MS platform is discussed herein, along with the results from intralaboratory tests. The tests highlighted the importance of the reference standards in assessing the efficiency and reproducibility of the entire bottom-up proteomic workflow and revealed errors related to the sample preparation and performance quality and deficits of the MS and LC systems. Such evaluations are necessary if MRM-based quantitative plasma proteomics is to be used in verifying and validating putative disease biomarkers across different research laboratories and eventually in clinical laboratories.

  6. Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols.

    PubMed

    Mhaskar, Rahul; Djulbegovic, Benjamin; Magazin, Anja; Soares, Heloisa P; Kumar, Ambuj

    2012-06-01

    To assess whether the reported methodological quality of randomized controlled trials (RCTs) reflects the actual methodological quality and to evaluate the association of effect size (ES) and sample size with methodological quality. Systematic review. This is a retrospective analysis of all consecutive phase III RCTs published by eight National Cancer Institute Cooperative Groups up to 2006. Data were extracted from protocols (actual quality) and publications (reported quality) for each study. Four hundred twenty-nine RCTs met the inclusion criteria. Overall reporting of methodological quality was poor and did not reflect the actual high methodological quality of RCTs. The results showed no association between sample size and actual methodological quality of a trial. Poor reporting of allocation concealment and blinding exaggerated the ES by 6% (ratio of hazard ratio [RHR]: 0.94; 95% confidence interval [CI]: 0.88, 0.99) and 24% (RHR: 1.24; 95% CI: 1.05, 1.43), respectively. However, actual quality assessment showed no association between ES and methodological quality. The largest study to date shows that poor quality of reporting does not reflect the actual high methodological quality. Assessment of the impact of quality on the ES based on reported quality can produce misleading results. Copyright © 2012 Elsevier Inc. All rights reserved.

  7. A New Dual-purpose Quality Control Dosimetry Protocol for Diagnostic Reference-level Determination in Computed Tomography.

    PubMed

    Sohrabi, Mehdi; Parsi, Masoumeh; Sina, Sedigheh

    2018-05-17

    A diagnostic reference level is an advisory dose level set by a regulatory authority in a country as an efficient criterion for protection of patients from unwanted medical exposure. In computed tomography, the direct dose measurement and data collection methods are commonly applied for determination of diagnostic reference levels. Recently, a new quality-control-based dose survey method was proposed by the authors to simplify the diagnostic reference-level determination using a retrospective quality control database usually available at a regulatory authority in a country. In line with such a development, a prospective dual-purpose quality control dosimetry protocol is proposed for determination of diagnostic reference levels in a country, which can be simply applied by quality control service providers. This new proposed method was applied to five computed tomography scanners in Shiraz, Iran, and diagnostic reference levels for head, abdomen/pelvis, sinus, chest, and lumbar spine examinations were determined. The results were compared to those obtained by the data collection and quality-control-based dose survey methods, carried out in parallel in this study, and were found to agree well within approximately 6%. This is highly acceptable for quality-control-based methods according to International Atomic Energy Agency tolerance levels (±20%).

  8. Principles and Practices for Quality Assurance and Quality Control

    USGS Publications Warehouse

    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.

  9. A novel protocol for dispatcher assisted CPR improves CPR quality and motivation among rescuers-A randomized controlled simulation study.

    PubMed

    Rasmussen, Stinne Eika; Nebsbjerg, Mette Amalie; Krogh, Lise Qvirin; Bjørnshave, Katrine; Krogh, Kristian; Povlsen, Jonas Agerlund; Riddervold, Ingunn Skogstad; Grøfte, Thorbjørn; Kirkegaard, Hans; Løfgren, Bo

    2017-01-01

    Emergency dispatchers use protocols to instruct bystanders in cardiopulmonary resuscitation (CPR). Studies changing one element in the dispatcher's protocol report improved CPR quality. Whether several changes interact is unknown and the effect of combining multiple changes previously reported to improve CPR quality into one protocol remains to be investigated. We hypothesize that a novel dispatch protocol, combining multiple beneficial elements improves CPR quality compared with a standard protocol. A novel dispatch protocol was designed including wording on chest compressions, using a metronome, regular encouragements and a 10-s rest each minute. In a simulated cardiac arrest scenario, laypersons were randomized to perform single-rescuer CPR guided with the novel or the standard protocol. a composite endpoint of time to first compression, hand position, compression depth and rate and hands-off time (maximum score: 22 points). Afterwards participants answered a questionnaire evaluating the dispatcher assistance. The novel protocol (n=61) improved CPR quality score compared with the standard protocol (n=64) (mean (SD): 18.6 (1.4)) points vs. 17.5 (1.7) points, p<0.001. The novel protocol resulted in deeper chest compressions (mean (SD): 58 (12)mm vs. 52 (13)mm, p=0.02) and improved rate of correct hand position (61% vs. 36%, p=0.01) compared with the standard protocol. In both protocols hands-off time was short. The novel protocol improved motivation among rescuers compared with the standard protocol (p=0.002). Participants guided with a standard dispatch protocol performed high quality CPR. A novel bundle of care protocol improved CPR quality score and motivation among rescuers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  10. 42 CFR 438.352 - External quality review protocols.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false External quality review protocols. 438.352 Section... SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS MANAGED CARE External Quality Review § 438.352 External quality review protocols. Each protocol must specify— (a) The data to be gathered; (b) The sources of the...

  11. Pilot studies for the North American Soil Geochemical Landscapes Project - Site selection, sampling protocols, analytical methods, and quality control protocols

    USGS Publications Warehouse

    Smith, D.B.; Woodruff, L.G.; O'Leary, R. M.; Cannon, W.F.; Garrett, R.G.; Kilburn, J.E.; Goldhaber, M.B.

    2009-01-01

    In 2004, the US Geological Survey (USGS) and the Geological Survey of Canada sampled and chemically analyzed soils along two transects across Canada and the USA in preparation for a planned soil geochemical survey of North America. This effort was a pilot study to test and refine sampling protocols, analytical methods, quality control protocols, and field logistics for the continental survey. A total of 220 sample sites were selected at approximately 40-km intervals along the two transects. The ideal sampling protocol at each site called for a sample from a depth of 0-5 cm and a composite of each of the O, A, and C horizons. The <2-mm fraction of each sample was analyzed for Al, Ca, Fe, K, Mg, Na, S, Ti, Ag, As, Ba, Be, Bi, Cd, Ce, Co, Cr, Cs, Cu, Ga, In, La, Li, Mn, Mo, Nb, Ni, P, Pb, Rb, Sb, Sc, Sn, Sr, Te, Th, Tl, U, V, W, Y, and Zn by inductively coupled plasma-mass spectrometry and inductively coupled plasma-atomic emission spectrometry following a near-total digestion in a mixture of HCl, HNO3, HClO4, and HF. Separate methods were used for Hg, Se, total C, and carbonate-C on this same size fraction. Only Ag, In, and Te had a large percentage of concentrations below the detection limit. Quality control (QC) of the analyses was monitored at three levels: the laboratory performing the analysis, the USGS QC officer, and the principal investigator for the study. This level of review resulted in an average of one QC sample for every 20 field samples, which proved to be minimally adequate for such a large-scale survey. Additional QC samples should be added to monitor within-batch quality to the extent that no more than 10 samples are analyzed between a QC sample. Only Cr (77%), Y (82%), and Sb (80%) fell outside the acceptable limits of accuracy (% recovery between 85 and 115%) because of likely residence in mineral phases resistant to the acid digestion. A separate sample of 0-5-cm material was collected at each site for determination of organic compounds. A subset

  12. [Development of external quality control protocol for CyberKnife beams dosimetry: preliminary tests multicentre].

    PubMed

    Guinement, L; Marchesi, V; Veres, A; Lacornerie, T; Buchheit, I; Peiffert, D

    2013-01-01

    To develop an external quality control procedure for CyberKnife(®) beams. This work conducted in Nancy, has included a test protocol initially drawn by the medical physicist of Nancy and Lille in collaboration with Equal-Estro Laboratory. A head and neck anthropomorphic phantom and a water-equivalent homogeneous cubic plastic test-object, so-called "MiniCube", have been used. Powder and solid thermoluminescent dosimeters as well as radiochromic films have been used to perform absolute and relative dose studies, respectively. The comparison between doses calculated by Multiplan treatment planning system and measured doses have been studied in absolute dose. The dose distributions measured with films and treatment planning system calculations have been compared via the gamma function, configured with different tolerance criteria. This work allowed, via solid thermoluminescent dosimeter measurements, verifying the beam reliability with a reproducibility of 1.7 %. The absolute dose measured in the phantom irradiated by the seven participating centres has shown an error inferior to the standard tolerance limits (± 5 %), for most of participating centres. The relative dose measurements performed at Nancy and by the Equal-Estro laboratory allowed defining the most adequate parameters for gamma index (5 %/2mm--with at least 95 % of pixels satisfying acceptability criteria: γ<1). These parameters should be independent of the film analysis software. This work allowed defining a dosimetric external quality control for CyberKnife(®) systems, based on a reproducible irradiation plan through measurements performed with thermoluminescent dosimeters and radiochromic films. This protocol should be validated by a new series of measurement and taking into account the lessons of this work. Copyright © 2013 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

  13. IDMA-Based MAC Protocol for Satellite Networks with Consideration on Channel Quality

    PubMed Central

    2014-01-01

    In order to overcome the shortcomings of existing medium access control (MAC) protocols based on TDMA or CDMA in satellite networks, interleave division multiple access (IDMA) technique is introduced into satellite communication networks. Therefore, a novel wide-band IDMA MAC protocol based on channel quality is proposed in this paper, consisting of a dynamic power allocation algorithm, a rate adaptation algorithm, and a call admission control (CAC) scheme. Firstly, the power allocation algorithm combining the technique of IDMA SINR-evolution and channel quality prediction is developed to guarantee high power efficiency even in terrible channel conditions. Secondly, the effective rate adaptation algorithm, based on accurate channel information per timeslot and by the means of rate degradation, can be realized. What is more, based on channel quality prediction, the CAC scheme, combining the new power allocation algorithm, rate scheduling, and buffering strategies together, is proposed for the emerging IDMA systems, which can support a variety of traffic types, and offering quality of service (QoS) requirements corresponding to different priority levels. Simulation results show that the new wide-band IDMA MAC protocol can make accurate estimation of available resource considering the effect of multiuser detection (MUD) and QoS requirements of multimedia traffic, leading to low outage probability as well as high overall system throughput. PMID:25126592

  14. National protocol for quality assurance in DXA-bone densitometry

    NASA Astrophysics Data System (ADS)

    Slavchev, A.; Avramova-Cholakova, S.; Vassileva, J.

    2008-01-01

    Osteoporosis becomes largely one of the most important socially significant and costly diseases. Modern techniques (DXA, US) are applied for bone densitometry. The paper presents a protocol for quality assurance especially of DXA-bone densitometers including quality control made in compliance with international standards (ISCD, IOF). The methodology has been tested in practice by measurements on site-functional assessment, entrance dose, radiation protection, calibration, in-vitro precision. It is expected to raise the quality of the diagnostic process in concert with the EU Medical Directive 97/43 particularly for population screening and sensitive groups. The protocol is an essential part of the National Program for constraining osteoporosis which has been elaborated at the Ministry of Health and at present under implementation throughout the country. It aims at reducing the risk, factors spreading, at diminishing the fracture risk the morbidity and the mortality from osteoporosis. An integral multidisciplinary approach to the problem solving is applied as well as training on three levels — doctors, patients, population, which effectively will contribute for obtaining real results in preventing osteoporosis.

  15. Framework and indicator testing protocol for developing and piloting quality indicators for the UK quality and outcomes framework.

    PubMed

    Campbell, Stephen M; Kontopantelis, Evangelos; Hannon, Kerin; Burke, Martyn; Barber, Annette; Lester, Helen E

    2011-08-10

    Quality measures should be subjected to a testing protocol before being used in practice using key attributes such as acceptability, feasibility and reliability, as well as identifying issues derived from actual implementation and unintended consequences. We describe the methodologies and results of an indicator testing protocol (ITP) using data from proposed quality indicators for the United Kingdom Quality and Outcomes Framework (QOF). The indicator testing protocol involved a multi-step and methodological process: 1) The RAND/UCLA Appropriateness Method, to test clarity and necessity, 2) data extraction from patients' medical records, to test technical feasibility and reliability, 3) diaries, to test workload, 4) cost-effectiveness modelling, and 5) semi-structured interviews, to test acceptability, implementation issues and unintended consequences. Testing was conducted in a sample of representative family practices in England. These methods were combined into an overall recommendation for each tested indicator. Using an indicator testing protocol as part of piloting was seen as a valuable way of testing potential indicators in 'real world' settings. Pilot 1 (October 2009-March 2010) involved thirteen indicators across six clinical domains and twelve indicators passed the indicator testing protocol. However, the indicator testing protocol identified a number of implementation issues and unintended consequences that can be rectified or removed prior to national roll out. A palliative care indicator is used as an exemplar of the value of piloting using a multiple attribute indicator testing protocol - while technically feasible and reliable, it was unacceptable to practice staff and raised concerns about potentially causing actual patient harm. This indicator testing protocol is one example of a protocol that may be useful in assessing potential quality indicators when adapted to specific country health care settings and may be of use to policy-makers and

  16. Robowell: An automated process for monitoring ground water quality using established sampling protocols

    USGS Publications Warehouse

    Granato, G.E.; Smith, K.P.

    1999-01-01

    Robowell is an automated process for monitoring selected ground water quality properties and constituents by pumping a well or multilevel sampler. Robowell was developed and tested to provide a cost-effective monitoring system that meets protocols expected for manual sampling. The process uses commercially available electronics, instrumentation, and hardware, so it can be configured to monitor ground water quality using the equipment, purge protocol, and monitoring well design most appropriate for the monitoring site and the contaminants of interest. A Robowell prototype was installed on a sewage treatment plant infiltration bed that overlies a well-studied unconfined sand and gravel aquifer at the Massachusetts Military Reservation, Cape Cod, Massachusetts, during a time when two distinct plumes of constituents were released. The prototype was operated from May 10 to November 13, 1996, and quality-assurance/quality-control measurements demonstrated that the data obtained by the automated method was equivalent to data obtained by manual sampling methods using the same sampling protocols. Water level, specific conductance, pH, water temperature, dissolved oxygen, and dissolved ammonium were monitored by the prototype as the wells were purged according to U.S Geological Survey (USGS) ground water sampling protocols. Remote access to the data record, via phone modem communications, indicated the arrival of each plume over a few days and the subsequent geochemical reactions over the following weeks. Real-time availability of the monitoring record provided the information needed to initiate manual sampling efforts in response to changes in measured ground water quality, which proved the method and characterized the screened portion of the plume in detail through time. The methods and the case study described are presented to document the process for future use.

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

    PubMed

    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

  18. Clinical Considerations of Adapted Drilling Protocol by Bone Quality Perception.

    PubMed

    Toia, Marco; Stocchero, Michele; Cecchinato, Francesca; Corrà, Enrico; Jimbo, Ryo; Cecchinato, Denis

    To evaluate insertion torque value (ITV) and marginal bone loss (MBL) of an implant system after a clinically perceived bone quality-adapted drilling. This multicenter retrospective study included patients treated with implants, conventionally loaded, in completely healed sites. Operators customized the osteotomy preparation according to radiographic assessment and their perception of bone quality. Drilling sequence, bone quality, and ITV were recorded at the time of surgery. Radiographs were taken at the time of implant placement and permanent restoration. MBL between implant placement and permanent restoration was calculated. The implant was used as the statistical unit. Demographic and implant characteristics were shown by means of descriptive statistics. Outcome values were compared using analysis of variance (ANOVA) and Kruskal-Wallis tests. Multiple regression models were used to test the effect of independent variables on ITV and MBL. One hundred eighty-eight implants placed in 87 patients were included in the analysis. The mean observation period was 144 ± 59 days. The mean ITV was 30.8 ± 15.1 Ncm. ITV differed significantly based on arches (mandible/maxilla) (P = .001), bone quality (P < .001), implant diameter (P = .032), and drilling protocol (P = .019). Median MBL was 0.05 mm (0.00; 0.24). A significant difference was found between the mandible and maxilla (P = .008) and between drilling protocols (P = .011). In particular, significantly higher MBL was found in the undersized drilling protocol. Multiple regression analysis showed that ITV was influenced by bone quality and implant diameter. MBL was influenced by bone quality, implant diameter, ITV, and the interaction between bone quality and ITV. It was estimated that MBL was greater with increased bone density and ITV. Excessive ITV in dense bone can cause negative marginal bone responses. A presurgical radiographic assessment and the perception of bone quality are necessary to select an optimal

  19. PA.NET International Quality Certification Protocol for blood pressure monitors.

    PubMed

    Omboni, Stefano; Costantini, Carlo; Pini, Claudio; Bulegato, Roberto; Manfellotto, Dario; Rizzoni, Damiano; Palatini, Paolo; O'brien, Eoin; Parati, Gianfranco

    2008-10-01

    Although standard validation protocols provide assurance of the accuracy of blood pressure monitors (BPMs), there is no guidance for the consumer as to the overall quality of a device. The PA.NET International Quality Certification Protocol, developed by the Association for Research and Development of Biomedical Technologies and for Continuing Medical Education (ARSMED), a nonprofit organization, with the support of the Italian Society of Hypertension-Italian Hypertension League, and the dabl Educational Trust denotes additional criteria of quality for BPMs that fulfilled basic validation criteria, published in full in peer-reviewed medical journals. The certification is characterized by three phases: (i) to determine that the device fulfilled standard validation criteria; (ii) to determine the technical and functional characteristics of the device (e.g. operativity, display dimension, accessory functions, memory availability, etc.) and (iii) to determine the commercial characteristics (e.g. price-quality ratio, after-sale service, guarantee, etc.). At the end of the certification process, ARSMED attributes a quality index to the device, based on a scale ranging from 1 to 100, and a quality seal with four different grades (bronze, silver, gold and diamond) according to the achieved score. The seal is identified by a unique alphanumeric code. The quality seal may be used on the packaging of the appliance or in advertising. A quality certification is released to the manufacturer and published on www.pressionearteriosa.net and www.dableducational.org. The PA.NET International Quality Certification Protocol represents the first attempt to provide health care personnel and consumers with an independent and objective assessment of BPMs based on their quality.

  20. Image quality and radiation reduction of 320-row area detector CT coronary angiography with optimal tube voltage selection and an automatic exposure control system: comparison with body mass index-adapted protocol.

    PubMed

    Lim, Jiyeon; Park, Eun-Ah; Lee, Whal; Shim, Hackjoon; Chung, Jin Wook

    2015-06-01

    To assess the image quality and radiation exposure of 320-row area detector computed tomography (320-ADCT) coronary angiography with optimal tube voltage selection with the guidance of an automatic exposure control system in comparison with a body mass index (BMI)-adapted protocol. Twenty-two patients (study group) underwent 320-ADCT coronary angiography using an automatic exposure control system with the target standard deviation value of 33 as the image quality index and the lowest possible tube voltage. For comparison, a sex- and BMI-matched group (control group, n = 22) using a BMI-adapted protocol was established. Images of both groups were reconstructed by an iterative reconstruction algorithm. For objective evaluation of the image quality, image noise, vessel density, signal to noise ratio (SNR), and contrast to noise ratio (CNR) were measured. Two blinded readers then subjectively graded the image quality using a four-point scale (1: nondiagnostic to 4: excellent). Radiation exposure was also measured. Although the study group tended to show higher image noise (14.1 ± 3.6 vs. 9.3 ± 2.2 HU, P = 0.111) and higher vessel density (665.5 ± 161 vs. 498 ± 143 HU, P = 0.430) than the control group, the differences were not significant. There was no significant difference between the two groups for SNR (52.5 ± 19.2 vs. 60.6 ± 21.8, P = 0.729), CNR (57.0 ± 19.8 vs. 67.8 ± 23.3, P = 0.531), or subjective image quality scores (3.47 ± 0.55 vs. 3.59 ± 0.56, P = 0.960). However, radiation exposure was significantly reduced by 42 % in the study group (1.9 ± 0.8 vs. 3.6 ± 0.4 mSv, P = 0.003). Optimal tube voltage selection with the guidance of an automatic exposure control system in 320-ADCT coronary angiography allows substantial radiation reduction without significant impairment of image quality, compared to the results obtained using a BMI-based protocol.

  1. Multifamily Quality Control Inspector Job/Task Analysis and Report: September 2013

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Owens, C. M.

    The development of job/task analyses (JTAs) is one of three components of the Guidelines for Home Energy Professionals project and will allow industry to develop training resources, quality assurance protocols, accredited training programs, and professional certifications. The Multifamily Quality Control Inspector JTA identifies and catalogs all of the tasks performed by multifamily quality control inspectors, as well as the knowledge, skills, and abilities (KSAs) needed to perform the identified tasks.

  2. Anthropometric standardisation and quality control protocols for the construction of new, international, fetal and newborn growth standards: the INTERGROWTH-21st Project.

    PubMed

    Cheikh Ismail, L; Knight, H E; Ohuma, E O; Hoch, L; Chumlea, W C

    2013-09-01

    The primary aim of the INTERGROWTH-21(st) Project is to construct new, prescriptive standards describing optimal fetal and preterm postnatal growth. The anthropometric measurements include the head circumference, recumbent length and weight of the infants, and the stature and weight of the parents. In such a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes in detail the anthropometric training, standardisation and quality control procedures used to collect data for these new standards. The initial standardisation session was in Nairobi, Kenya, using newborns, which was followed by similar sessions in the eight participating study sites in Brazil, China, India, Italy, Kenya, Oman, UK and USA. The intraobserver and inter-observer technical error of measurement values for head circumference range from 0.3 to 0.4 cm, and for recumbent length from 0.3 to 0.5 cm. These standardisation protocols implemented at each study site worldwide ensure that the anthropometric data collected are of the highest quality to construct international growth standards. © 2013 Royal College of Obstetricians and Gynaecologists.

  3. Methods for CT automatic exposure control protocol translation between scanner platforms.

    PubMed

    McKenney, Sarah E; Seibert, J Anthony; Lamba, Ramit; Boone, John M

    2014-03-01

    An imaging facility with a diverse fleet of CT scanners faces considerable challenges when propagating CT protocols with consistent image quality and patient dose across scanner makes and models. Although some protocol parameters can comfortably remain constant among scanners (eg, tube voltage, gantry rotation time), the automatic exposure control (AEC) parameter, which selects the overall mA level during tube current modulation, is difficult to match among scanners, especially from different CT manufacturers. Objective methods for converting tube current modulation protocols among CT scanners were developed. Three CT scanners were investigated, a GE LightSpeed 16 scanner, a GE VCT scanner, and a Siemens Definition AS+ scanner. Translation of the AEC parameters such as noise index and quality reference mAs across CT scanners was specifically investigated. A variable-diameter poly(methyl methacrylate) phantom was imaged on the 3 scanners using a range of AEC parameters for each scanner. The phantom consisted of 5 cylindrical sections with diameters of 13, 16, 20, 25, and 32 cm. The protocol translation scheme was based on matching either the volumetric CT dose index or image noise (in Hounsfield units) between two different CT scanners. A series of analytic fit functions, corresponding to different patient sizes (phantom diameters), were developed from the measured CT data. These functions relate the AEC metric of the reference scanner, the GE LightSpeed 16 in this case, to the AEC metric of a secondary scanner. When translating protocols between different models of CT scanners (from the GE LightSpeed 16 reference scanner to the GE VCT system), the translation functions were linear. However, a power-law function was necessary to convert the AEC functions of the GE LightSpeed 16 reference scanner to the Siemens Definition AS+ secondary scanner, because of differences in the AEC functionality designed by these two companies. Protocol translation on the basis of

  4. Online Error Reporting for Managing Quality Control Within Radiology.

    PubMed

    Golnari, Pedram; Forsberg, Daniel; Rosipko, Beverly; Sunshine, Jeffrey L

    2016-06-01

    Information technology systems within health care, such as picture archiving and communication system (PACS) in radiology, can have a positive impact on production but can also risk compromising quality. The widespread use of PACS has removed the previous feedback loop between radiologists and technologists. Instead of direct communication of quality discrepancies found for an examination, the radiologist submitted a paper-based quality-control report. A web-based issue-reporting tool can help restore some of the feedback loop and also provide possibilities for more detailed analysis of submitted errors. The purpose of this study was to evaluate the hypothesis that data from use of an online error reporting software for quality control can focus our efforts within our department. For the 372,258 radiologic examinations conducted during the 6-month period study, 930 errors (390 exam protocol, 390 exam validation, and 150 exam technique) were submitted, corresponding to an error rate of 0.25 %. Within the category exam protocol, technologist documentation had the highest number of submitted errors in ultrasonography (77 errors [44 %]), while imaging protocol errors were the highest subtype error for computed tomography modality (35 errors [18 %]). Positioning and incorrect accession had the highest errors in the exam technique and exam validation error category, respectively, for nearly all of the modalities. An error rate less than 1 % could signify a system with a very high quality; however, a more likely explanation is that not all errors were detected or reported. Furthermore, staff reception of the error reporting system could also affect the reporting rate.

  5. Analyzing the effect of routing protocols on media access control protocols in radio networks

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Barrett, C. L.; Drozda, M.; Marathe, A.

    2002-01-01

    We study the effect of routing protocols on the performance of media access control (MAC) protocols in wireless radio networks. Three well known MAC protocols: 802.11, CSMA, and MACA are considered. Similarly three recently proposed routing protocols: AODV, DSR and LAR scheme 1 are considered. The experimental analysis was carried out using GloMoSim: a tool for simulating wireless networks. The main focus of our experiments was to study how the routing protocols affect the performance of the MAC protocols when the underlying network and traffic parameters are varied. The performance of the protocols was measured w.r.t. five important parameters: (i)more » number of received packets, (ii) average latency of each packet, (iii) throughput (iv) long term fairness and (v) number of control packets at the MAC layer level. Our results show that combinations of routing and MAC protocols yield varying performance under varying network topology and traffic situations. The result has an important implication; no combination of routing protocol and MAC protocol is the best over all situations. Also, the performance analysis of protocols at a given level in the protocol stack needs to be studied not locally in isolation but as a part of the complete protocol stack. A novel aspect of our work is the use of statistical technique, ANOVA (Analysis of Variance) to characterize the effect of routing protocols on MAC protocols. This technique is of independent interest and can be utilized in several other simulation and empirical studies.« less

  6. Implementing clinical protocols in oncology: quality gaps and the learning curve phenomenon.

    PubMed

    Kedikoglou, Simos; Syrigos, Konstantinos; Skalkidis, Yannis; Ploiarchopoulou, Fani; Dessypris, Nick; Petridou, Eleni

    2005-08-01

    The quality improvement effort in clinical practice has focused mostly on 'performance quality', i.e. on the development of comprehensive, evidence-based guidelines. This study aimed to assess the 'conformance quality', i.e. the extent to which guidelines once developed are correctly and consistently applied. It also aimed to assess the existence of quality gaps in the treatment of certain patient segments as defined by age or gender and to investigate methods to improve overall conformance quality. A retrospective audit of clinical practice in a well-defined oncology setting was undertaken and the results compared to those obtained from prospectively applying an internally developed clinical protocol in the same setting and using specific tools to increase conformance quality. All indicators showed improvement after the implementation of the protocol that in many cases reached statistical significance, while in the entire cohort advanced age was associated (although not significantly) with sub-optimal delivery of care. A 'learning curve' phenomenon in the implementation of quality initiatives was detected, with all indicators improving substantially in the second part of the prospective study. Clinicians should pay separate attention to the implementation of chosen protocols and employ specific tools to increase conformance quality in patient care.

  7. Improving the quality of perinatal mental health: a health visitor-led protocol.

    PubMed

    Lewis, Anne; Ilot, Irene; Lekka, Chrysanthi; Oluboyede, Yemi

    2011-02-01

    The mental health of mothers is of significant concern to community practitioners. This paper reports on a case study exploring the success factors of a well established, health visitor-led protocol to identify and treat women with mild to moderate depression. Data were collected through interviews with a purposive sample of 12 community practitioners, a focus group of four health visitors and observation of a multidisciplinary steering group meeting. The protocol was described as an evidence-based tool and safety net that could be used flexibly to support clinical judgments and tailored to individual needs. Success factors included frontline clinician engagement and ownership, continuity of leadership to drive development and maintain momentum, comprehensive and on-going staff training, and strategic support for the protocol as a quality indicator at a time of organisational change. Quality and clinical leadership are continuing policy priorities. The protocol enabled frontline staff to lead a service innovation, providing a standardised multiprofessional approach to women's mental health needs through effective support, advice and treatment that can be measured and quality assured.

  8. NHEXAS PHASE I REGION 5 STUDY--STANDARD OPERATING PROCEDURE--HANDLING QUALITY CONTROL SAMPLES IN THE FIELD (RTI/ACS-AP-209-090)

    EPA Science Inventory

    This protocol describes how quality control samples should be handled in the field, and was designed as a quick reference source for the field staff. The protocol describes quality control samples for air-VOCs, air-particles, water samples, house dust, soil, urine, blood, hair, a...

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

    PubMed

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

    2018-05-15

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

  10. What is the quality of reporting on guideline, protocol or algorithm implementation in adult trauma centres? Protocol for a systematic review.

    PubMed

    Gotlib Conn, Lesley; Nathens, Avery B; Perrier, Laure; Haas, Barbara; Watamaniuk, Aaron; Daniel Pereira, Diego; Zwaiman, Ashley; da Luz, Luis Teodoro

    2018-05-09

    Quality improvement (QI) is mandatory in trauma centres but there is no prescription for doing successful QI. Considerable variation in implementation strategies and inconsistent use of evidence-based protocols therefore exist across centres. The quality of reporting on these strategies may limit the transferability of successful initiatives across centres. This systematic review will assess the quality of reporting on guideline, protocol or algorithm implementation within a trauma centre in terms of the Revised Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0). We will search for English language articles published after 2010 in EMBASE, MEDLINE, CINAHL electronic databases and the Cochrane Central Register of Controlled Trials. The database search will be supplemented by searching trial registries and grey literature online. Included studies will evaluate the effectiveness of guideline implementation in terms of change in clinical practice or improvement in patient outcomes. The primary outcome will be a global score reporting the proportion of studies respecting at least 80% of the SQUIRE 2.0 criteria and will be obtained based on the 18-items identified in the SQUIRE 2.0 guidelines. Secondary outcome will be the risk of bias assessed with the Risk Of Bias In Non-randomised Studies- of Interventions tool for observational cohort studies and with the Cochrane Collaboration tool for randomised controlled trials. Meta-analyses will be conducted in randomised controlled trials to estimate the effectiveness of guideline implementation if studies are not heterogeneous. If meta-analyses are conducted, we will combine studies according to the risk of bias (low, moderate or high/unclear) in subgroup analyses. All study titles, abstracts and full-text screening will be completed independently and in duplicate by the review team members. Data extraction and risk of bias assessment will also be done independently and in duplicate. Results will be

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

    PubMed Central

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

    2018-01-01

    Objective To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. Methods We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Results Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. Conclusions The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future. PMID:29872509

  12. Energy Efficient Medium Access Control Protocol for Clustered Wireless Sensor Networks with Adaptive Cross-Layer Scheduling.

    PubMed

    Sefuba, Maria; Walingo, Tom; Takawira, Fambirai

    2015-09-18

    This paper presents an Energy Efficient Medium Access Control (MAC) protocol for clustered wireless sensor networks that aims to improve energy efficiency and delay performance. The proposed protocol employs an adaptive cross-layer intra-cluster scheduling and an inter-cluster relay selection diversity. The scheduling is based on available data packets and remaining energy level of the source node (SN). This helps to minimize idle listening on nodes without data to transmit as well as reducing control packet overhead. The relay selection diversity is carried out between clusters, by the cluster head (CH), and the base station (BS). The diversity helps to improve network reliability and prolong the network lifetime. Relay selection is determined based on the communication distance, the remaining energy and the channel quality indicator (CQI) for the relay cluster head (RCH). An analytical framework for energy consumption and transmission delay for the proposed MAC protocol is presented in this work. The performance of the proposed MAC protocol is evaluated based on transmission delay, energy consumption, and network lifetime. The results obtained indicate that the proposed MAC protocol provides improved performance than traditional cluster based MAC protocols.

  13. Energy Efficient Medium Access Control Protocol for Clustered Wireless Sensor Networks with Adaptive Cross-Layer Scheduling

    PubMed Central

    Sefuba, Maria; Walingo, Tom; Takawira, Fambirai

    2015-01-01

    This paper presents an Energy Efficient Medium Access Control (MAC) protocol for clustered wireless sensor networks that aims to improve energy efficiency and delay performance. The proposed protocol employs an adaptive cross-layer intra-cluster scheduling and an inter-cluster relay selection diversity. The scheduling is based on available data packets and remaining energy level of the source node (SN). This helps to minimize idle listening on nodes without data to transmit as well as reducing control packet overhead. The relay selection diversity is carried out between clusters, by the cluster head (CH), and the base station (BS). The diversity helps to improve network reliability and prolong the network lifetime. Relay selection is determined based on the communication distance, the remaining energy and the channel quality indicator (CQI) for the relay cluster head (RCH). An analytical framework for energy consumption and transmission delay for the proposed MAC protocol is presented in this work. The performance of the proposed MAC protocol is evaluated based on transmission delay, energy consumption, and network lifetime. The results obtained indicate that the proposed MAC protocol provides improved performance than traditional cluster based MAC protocols. PMID:26393608

  14. The importance of quality control in validating concentrations ...

    EPA Pesticide Factsheets

    A national-scale survey of 247 contaminants of emerging concern (CECs), including organic and inorganic chemical compounds, and microbial contaminants, was conducted in source and treated drinking water samples from 25 treatment plants across the United States. Multiple methods were used to determine these CECs, including six analytical methods to measure 174 pharmaceuticals, personal care products, and pesticides. A three-component quality assurance/quality control (QA/QC) program was designed for the subset of 174 CECs which allowed us to assess and compare performances of the methods used. The three components included: 1) a common field QA/QC protocol and sample design, 2) individual investigator-developed method-specific QA/QC protocols, and 3) a suite of 46 method comparison analytes that were determined in two or more analytical methods. Overall method performance for the 174 organic chemical CECs was assessed by comparing spiked recoveries in reagent, source, and treated water over a two-year period. In addition to the 247 CECs reported in the larger drinking water study, another 48 pharmaceutical compounds measured did not consistently meet predetermined quality standards. Methodologies that did not seem suitable for these analytes are overviewed. The need to exclude analytes based on method performance demonstrates the importance of additional QA/QC protocols. This paper compares the method performance of six analytical methods used to measure 174 emer

  15. Quality Controlling CMIP datasets at GFDL

    NASA Astrophysics Data System (ADS)

    Horowitz, L. W.; Radhakrishnan, A.; Balaji, V.; Adcroft, A.; Krasting, J. P.; Nikonov, S.; Mason, E. E.; Schweitzer, R.; Nadeau, D.

    2017-12-01

    As GFDL makes the switch from model development to production in light of the Climate Model Intercomparison Project (CMIP), GFDL's efforts are shifted to testing and more importantly establishing guidelines and protocols for Quality Controlling and semi-automated data publishing. Every CMIP cycle introduces key challenges and the upcoming CMIP6 is no exception. The new CMIP experimental design comprises of multiple MIPs facilitating research in different focus areas. This paradigm has implications not only for the groups that develop the models and conduct the runs, but also for the groups that monitor, analyze and quality control the datasets before data publishing, before their knowledge makes its way into reports like the IPCC (Intergovernmental Panel on Climate Change) Assessment Reports. In this talk, we discuss some of the paths taken at GFDL to quality control the CMIP-ready datasets including: Jupyter notebooks, PrePARE, LAMP (Linux, Apache, MySQL, PHP/Python/Perl): technology-driven tracker system to monitor the status of experiments qualitatively and quantitatively, provide additional metadata and analysis services along with some in-built controlled-vocabulary validations in the workflow. In addition to this, we also discuss the integration of community-based model evaluation software (ESMValTool, PCMDI Metrics Package, and ILAMB) as part of our CMIP6 workflow.

  16. Quality: performance improvement, teamwork, information technology and protocols.

    PubMed

    Coleman, Nana E; Pon, Steven

    2013-04-01

    Using the Institute of Medicine framework that outlines the domains of quality, this article considers four key aspects of health care delivery which have the potential to significantly affect the quality of health care within the pediatric intensive care unit. The discussion covers: performance improvement and how existing methods for reporting, review, and analysis of medical error relate to patient care; team composition and workflow; and the impact of information technologies on clinical practice. Also considered is how protocol-driven and standardized practice affects both patients and the fiscal interests of the health care system.

  17. Stability and sensitivity of ABR flow control protocols

    NASA Astrophysics Data System (ADS)

    Tsai, Wie K.; Kim, Yuseok; Chiussi, Fabio; Toh, Chai-Keong

    1998-10-01

    This tutorial paper surveys the important issues in stability and sensitivity analysis of ABR flow control of ATM networks. THe stability and sensitivity issues are formulated in a systematic framework. Four main cause of instability in ABR flow control are identified: unstable control laws, temporal variations of available bandwidth with delayed feedback control, misbehaving components, and interactions between higher layer protocols and ABR flow control. Popular rate-based ABR flow control protocols are evaluated. Stability and sensitivity is shown to be the fundamental issues when the network has dynamically-varying bandwidth. Simulation result confirming the theoretical studies are provided. Open research problems are discussed.

  18. An intelligent case-adjustment algorithm for the automated design of population-based quality auditing protocols.

    PubMed

    Advani, Aneel; Jones, Neil; Shahar, Yuval; Goldstein, Mary K; Musen, Mark A

    2004-01-01

    We develop a method and algorithm for deciding the optimal approach to creating quality-auditing protocols for guideline-based clinical performance measures. An important element of the audit protocol design problem is deciding which guide-line elements to audit. Specifically, the problem is how and when to aggregate individual patient case-specific guideline elements into population-based quality measures. The key statistical issue involved is the trade-off between increased reliability with more general population-based quality measures versus increased validity from individually case-adjusted but more restricted measures done at a greater audit cost. Our intelligent algorithm for auditing protocol design is based on hierarchically modeling incrementally case-adjusted quality constraints. We select quality constraints to measure using an optimization criterion based on statistical generalizability coefficients. We present results of the approach from a deployed decision support system for a hypertension guideline.

  19. Using standard treatment protocols to manage costs and quality of hospital services.

    PubMed

    Meyer, J W; Feingold, M G

    1993-06-01

    The current health care environment has made it critically important that hospital costs and quality be managed in an integrated fashion. Promised health care reforms are expected to make cost reduction and quality enhancement only more important. Traditional methods of hospital cost and quality control have largely been replaced by such approaches as practice parameters, outcomes measurement, clinical indicators, clinical paths, benchmarking, patient-centered care, and a focus on patient selection criteria. This Special Report describes an integrated process for strategically managing costs and quality simultaneously, incorporating key elements of many important new quality and cost control tools. By using a multidisciplinary group process to develop standard treatment protocols, hospitals and their medical staffs address the most important services provided within major product lines. Using both clinical and financial data, groups of physicians, nurses, department managers, financial analysts, and administrators redesign key patterns of care within their hospital, incorporating the best practices of their own and other institutions. The outcome of this process is a new, standardized set of clinical guidelines that reduce unnecessary variation in care, eliminate redundant interventions, establish clear lines of communication for all caregivers, and reduce the cost of each stay. The hospital, medical staff, and patients benefit from the improved opportunities for managed care contracting, more efficient hospital systems, consensus-based quality measures, and reductions in the cost of care. STPs offer a workable and worthwhile approach to positioning the hospital of the 1990s for operational efficiency and cost and quality competitiveness.

  20. Fuzz Testing of Industrial Network Protocols in Programmable Logic Controllers

    DTIC Science & Technology

    2017-12-01

    PLCs) are vital components in these cyber-physical systems. The industrial network protocols used to communicate between nodes in a control network...AB/RA) MicroLogix 1100 PLC through its implementation of EtherNet/IP, Common Industrial Protocol (CIP), and Programmable Controller Communication ...Commands (PCCC) communication protocols. This research also examines whether cross-generational vulnerabilities exist in the more advanced AB/RA

  1. Kilovoltage cone-beam CT: Comparative dose and image quality evaluations in partial and full-angle scan protocols

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kim, Sangroh; Yoo, Sua; Yin Fangfang

    2010-07-15

    Purpose: To assess imaging dose of partial and full-angle kilovoltage CBCT scan protocols and to evaluate image quality for each protocol. Methods: The authors obtained the CT dose index (CTDI) of the kilovoltage CBCT protocols in an on-board imager by ion chamber (IC) measurements and Monte Carlo (MC) simulations. A total of six new CBCT scan protocols were evaluated: Standard-dose head (100 kVp, 151 mA s, partial-angle), low-dose head (100 kVp, 75 mA s, partial-angle), high-quality head (100 kVp, 754 mA s, partial-angle), pelvis (125 kVp, 706 mA s, full-angle), pelvis spotlight (125 kVp, 752 mA s, partial-angle), and low-dosemore » thorax (110 kVp, 271 mA s, full-angle). Using the point dose method, various CTDI values were calculated by (1) the conventional weighted CTDI (CTDI{sub w}) calculation and (2) Bakalyar's method (CTDI{sub wb}). The MC simulations were performed to obtain the CTDI{sub w} and CTDI{sub wb}, as well as from (3) central slice averaging (CTDI{sub 2D}) and (4) volume averaging (CTDI{sub 3D}) techniques. The CTDI values of the new protocols were compared to those of the old protocols (full-angle CBCT protocols). Image quality of the new protocols was evaluated following the CBCT image quality assurance (QA) protocol [S. Yoo et al., ''A quality assurance program for the on-board imager registered ,'' Med. Phys. 33(11), 4431-4447 (2006)] testing Hounsfield unit (HU) linearity, spatial linearity/resolution, contrast resolution, and HU uniformity. Results: The CTDI{sub w} were found as 6.0, 3.2, 29.0, 25.4, 23.8, and 7.7 mGy for the new protocols, respectively. The CTDI{sub w} and CTDI{sub wb} differed within +3% between IC measurements and MC simulations. Method (2) results were within {+-}12% of method (1). In MC simulations, the CTDI{sub w} and CTDI{sub wb} were comparable to the CTDI{sub 2D} and CTDI{sub 3D} with the differences ranging from -4.3% to 20.6%. The CTDI{sub 3D} were smallest among all the CTDI values. CTDI{sub w} of the new

  2. Quality control for quantitative multicenter whole-body PET/MR studies: A NEMA image quality phantom study with three current PET/MR systems

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Boellaard, Ronald, E-mail: r.boellaard@vumc.nl; European Association of Nuclear Medicine Research Ltd., Vienna 1060; European Association of Nuclear Medicine Physics Committee, Vienna 1060

    2015-10-15

    Purpose: Integrated positron emission tomography/magnetic resonance (PET/MR) systems derive the PET attenuation correction (AC) from dedicated MR sequences. While MR-AC performs reasonably well in clinical patient imaging, it may fail for phantom-based quality control (QC). The authors assess the applicability of different protocols for PET QC in multicenter PET/MR imaging. Methods: The National Electrical Manufacturers Association NU 2 2007 image quality phantom was imaged on three combined PET/MR systems: a Philips Ingenuity TF PET/MR, a Siemens Biograph mMR, and a GE SIGNA PET/MR (prototype) system. The phantom was filled according to the EANM FDG-PET/CT guideline 1.0 and scanned for 5more » min over 1 bed. Two MR-AC imaging protocols were tested: standard clinical procedures and a dedicated protocol for phantom tests. Depending on the system, the dedicated phantom protocol employs a two-class (water and air) segmentation of the MR data or a CT-based template. Differences in attenuation- and SUV recovery coefficients (RC) are reported. PET/CT-based simulations were performed to simulate the various artifacts seen in the AC maps (μ-map) and their impact on the accuracy of phantom-based QC. Results: Clinical MR-AC protocols caused substantial errors and artifacts in the AC maps, resulting in underestimations of the reconstructed PET activity of up to 27%, depending on the PET/MR system. Using dedicated phantom MR-AC protocols, PET bias was reduced to −8%. Mean and max SUV RC met EARL multicenter PET performance specifications for most contrast objects, but only when using the dedicated phantom protocol. Simulations confirmed the bias in experimental data to be caused by incorrect AC maps resulting from the use of clinical MR-AC protocols. Conclusions: Phantom-based quality control of PET/MR systems in a multicenter, multivendor setting may be performed with sufficient accuracy, but only when dedicated phantom acquisition and processing protocols are used for

  3. Controlled breathing protocols probe human autonomic cardiovascular rhythms

    NASA Technical Reports Server (NTRS)

    Cooke, W. H.; Cox, J. F.; Diedrich, A. M.; Taylor, J. A.; Beightol, L. A.; Ames, J. E. 4th; Hoag, J. B.; Seidel, H.; Eckberg, D. L.

    1998-01-01

    The purpose of this study was to determine how breathing protocols requiring varying degrees of control affect cardiovascular dynamics. We measured inspiratory volume, end-tidal CO2, R-R interval, and arterial pressure spectral power in 10 volunteers who followed the following 5 breathing protocols: 1) uncontrolled breathing for 5 min; 2) stepwise frequency breathing (at 0.3, 0.25, 0.2, 0.15, 0.1, and 0.05 Hz for 2 min each); 3) stepwise frequency breathing as above, but with prescribed tidal volumes; 4) random-frequency breathing (approximately 0.5-0.05 Hz) for 6 min; and 5) fixed-frequency breathing (0.25 Hz) for 5 min. During stepwise breathing, R-R interval and arterial pressure spectral power increased as breathing frequency decreased. Control of inspired volume reduced R-R interval spectral power during 0.1 Hz breathing (P < 0.05). Stepwise and random-breathing protocols yielded comparable coherence and transfer functions between respiration and R-R intervals and systolic pressure and R-R intervals. Random- and fixed-frequency breathing reduced end-tidal CO2 modestly (P < 0.05). Our data suggest that stringent tidal volume control attenuates low-frequency R-R interval oscillations and that fixed- and random-rate breathing may decrease CO2 chemoreceptor stimulation. We conclude that autonomic rhythms measured during different breathing protocols have much in common but that a stepwise protocol without stringent control of inspired volume may allow for the most efficient assessment of short-term respiratory-mediated autonomic oscillations.

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

    PubMed

    Gautier, Isabelle; Janiaud, Perrine; Rollet, Nelly; André, Nicolas; Tsimaratos, Michel; Cornu, Catherine; Malik, Salma; Gentile, Stéphanie; Kassaï, Behrouz

    2017-08-23

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

  5. Quality Control for Interviews to Obtain Dietary Recalls from Children for Research Studies

    PubMed Central

    SHAFFER, NICOLE M.; THOMPSON, WILLIAM O.; BAGLIO, MICHELLE L.; GUINN, CAROLINE H.; FRYE, FRANCESCA H. A.

    2005-01-01

    Quality control is an important aspect of a study because the quality of data collected provides a foundation for the conclusions drawn from the study. For studies that include interviews, establishing quality control for interviews is critical in ascertaining whether interviews are conducted according to protocol. Despite the importance of quality control for interviews, few studies adequately document the quality control procedures used during data collection. This article reviews quality control for interviews and describes methods and results of quality control for interviews from two of our studies regarding the accuracy of children's dietary recalls; the focus is on quality control regarding interviewer performance during the interview, and examples are provided from studies with children. For our two studies, every interview was audio recorded and transcribed. The audio recording and typed transcript from one interview conducted by each research dietitian either weekly or daily were randomly selected and reviewed by another research dietitian, who completed a standardized quality control for interviews checklist. Major strengths of the methods of quality control for interviews in our two studies include: (a) interviews obtained for data collection were randomly selected for quality control for interviews, and (b) quality control for interviews was assessed on a regular basis throughout data collection. The methods of quality control for interviews described may help researchers design appropriate methods of quality control for interviews for future studies. PMID:15389417

  6. Impact of two early treatment protocols for anterior dental crossbite on children's quality of life.

    PubMed

    Miamoto, Cristina Batista; Marques, Leandro Silva; Abreu, Lucas Guimarães; Paiva, Saul Martins

    2018-01-01

    To assess the impact of two early treatment protocols for anterior dental crossbite on children's quality of life. Thirty children, 8 to 10 years of age, with anterior dental crossbite, participated in this study. Individuals were divided into two groups: Group 1 - 15 children undergoing treatment with an upper removable appliance with digital springs; Group 2 - 15 children undergoing treatment with resin-reinforced glass ionomer cement bite pads on the lower first molars. Quality of life was evaluated using the Brazilian version of the Child Perceptions Questionnaire (CPQ8-10), which contains four subscales: oral symptoms (OS), functional limitations (FL), emotional well-being (EW), and social well-being (SW). A higher score denotes a greater negative impact on children's quality of life. Children answered the questionnaire before treatment (T1) and twelve months after orthodontic treatment onset (T2). Descriptive statistics, the Wilcoxon test and analysis of covariance (ANCOVA) were performed. Children's mean age was 9.07 ± 0.79 years in Group 1 and 9.00 ± 0.84 years in Group 2. For Group 1, the FL and EW subscale scores and the overall CPQ8-10 were significantly higher in T1 as compared to T2 (p= 0.004, p= 0.012 and p= 0.015, respectively). For Group 2, there were no statistically significant differences. The ANCOVA showed no significant difference regarding quality of life at T2 between groups, after controlling for quality of life measures at T1. The difference regarding the impact on quality of life between groups is not related to the protocol used.

  7. Water quality monitoring protocol for wadeable streams and rivers in the Northern Great Plains Network

    USGS Publications Warehouse

    Wilson, Marcia H.; Rowe, Barbara L.; Gitzen, Robert A.; Wilson, Stephen K.; Paintner-Green, Kara J.

    2014-01-01

    As recommended by Oakley et al. (2003), this protocol provides a narrative and the rationale for selection of streams and rivers within the NGPN that will be measured for water quality, including dissolved oxygen, pH, specific conductivity, and temperature. Standard operating procedures (SOPs) that detail the steps to collect, manage, and disseminate the NGPN water quality data are in an accompanying document. The sampling design documented in this protocol may be updated as monitoring information is collected and interpreted, and as refinement of methodologies develop through time. In addition, evaluation of data and refinement of the program may necessitate potential changes of program objectives. Changes to the NGPN water quality protocols and SOPs will be carefully documented in a revision history log.

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Driscoll, B.; Keller, H.; Jaffray, D.

    2013-08-15

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

  9. Dependency of image quality on acquisition protocol and image processing in chest tomosynthesis-a visual grading study based on clinical data.

    PubMed

    Jadidi, Masoud; Båth, Magnus; Nyrén, Sven

    2018-04-09

    quality than the vender-recommended protocol with acquisition time 12 s for several anatomical structures. Furthermore, the standard gradation processing  (the vendor-recommended post-processing for DTS), yields to some extent advantage over the gradation processing/multiobjective frequency processing/flexible noise control processing in terms of image quality for all classes of criteria. Advances in knowledge: The study proves that the image quality may be strongly affected by the selection of DTS protocol and that the vendor-recommended protocol may not always be the optimal choice.

  10. Quality of life and psychosocial and physical well-being among 1,023 women during their first assisted reproductive technology treatment: secondary outcome to a randomized controlled trial comparing gonadotropin-releasing hormone (GnRH) antagonist and GnRH agonist protocols.

    PubMed

    Toftager, Mette; Sylvest, Randi; Schmidt, Lone; Bogstad, Jeanette; Løssl, Kristine; Prætorius, Lisbeth; Zedeler, Anne; Bryndorf, Thue; Pinborg, Anja

    2018-01-01

    To compare self-reported quality of life, psychosocial well-being, and physical well-being during assisted reproductive technology (ART) treatment in 1,023 women allocated to either a short GnRH antagonist or long GnRH agonist protocol. Secondary outcome of a prospective phase 4, open-label, randomized controlled trial. Four times during treatment a questionnaire on self-reported physical well-being was completed. Further, a questionnaire on self-reported quality of life and psychosocial well-being was completed at the day of hCG testing. Fertility clinics at university hospitals. Women referred for their first ART treatment were randomized in a 1:1 ratio and started standardized ART protocols. Gonadotropin-releasing hormone analogue; 528 women allocated to a short GnRH antagonist protocol and 495 women allocated to a long GnRH agonist protocol. Self-reported quality of life, psychosocial well-being, and physical well-being based on questionnaires developed for women receiving ART treatment. Baseline characteristics were similar, and response rates were 79.4% and 74.3% in the GnRH antagonist and GnRH agonist groups, respectively. Self-reported quality of life during ART treatment was rated similar and slightly below normal in both groups. However, women in the GnRH antagonist group felt less emotional (adjusted odds ratio [AOR] 0.69), less limited in their everyday life (AOR 0.74), experienced less unexpected crying (AOR 0.71), and rated quality of sleep better (AOR 1.55). Further, women receiving GnRH agonist treatment felt worse physically. Women in a short GnRH antagonist protocol rated psychosocial and physical well-being during first ART treatment better than did women in a long GnRH agonist protocol. However, the one item on self-reported general quality of life was rated similarly. NCT00756028. Copyright © 2017 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

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

    PubMed

    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 < 50 cm 2 , total body surface area (TBSA) 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

  12. Evaluation of storage and filtration protocols for alpine/subalpine lake water quality samples

    Treesearch

    John L. Korfmacher; Robert C. Musselman

    2007-01-01

    Many government agencies and other organizations sample natural alpine and subalpine surface waters using varying protocols for sample storage and filtration. Simplification of protocols would be beneficial if it could be shown that sample quality is unaffected. In this study, samples collected from low ionic strength waters in alpine and subalpine lake inlets...

  13. Energy-efficient boarder node medium access control protocol for wireless sensor networks.

    PubMed

    Razaque, Abdul; Elleithy, Khaled M

    2014-03-12

    -synchronous feature with a low duty cycle, which is advantageous for reducing the latency and energy consumption for several WSN application areas to improve the throughput. BN-MAC uses a unique window slot size to enhance the contention resolution issue for improved throughput. BN-MAC also prefers to communicate within a one-hop destination using Anycast, which maintains load balancing to maintain network reliability. BN-MAC is introduced with the goal of supporting four major application areas: monitoring and behavioral areas, controlling natural disasters, human-centric applications, and tracking mobility and static home automation devices from remote places. These application areas require a congestion-free mobility-supported MAC protocol to guarantee reliable data delivery. BN-MAC was evaluated using network simulator-2 (ns2) and compared with other hybrid MAC protocols, such as Zebra medium access control (Z-MAC), advertisement-based MAC (A-MAC), Speck-MAC, adaptive duty cycle SMAC (ADC-SMAC), and low-power real-time medium access control (LPR-MAC). The simulation results indicate that BN-MAC is a robust and energy-efficient protocol that outperforms other hybrid MAC protocols in the context of quality of service (QoS) parameters, such as energy consumption, latency, throughput, channel access time, successful delivery rate, coverage efficiency, and average duty cycle.

  14. Energy-Efficient Boarder Node Medium Access Control Protocol for Wireless Sensor Networks

    PubMed Central

    Razaque, Abdul; Elleithy, Khaled M.

    2014-01-01

    -synchronous feature with a low duty cycle, which is advantageous for reducing the latency and energy consumption for several WSN application areas to improve the throughput. BN-MAC uses a unique window slot size to enhance the contention resolution issue for improved throughput. BN-MAC also prefers to communicate within a one-hop destination using Anycast, which maintains load balancing to maintain network reliability. BN-MAC is introduced with the goal of supporting four major application areas: monitoring and behavioral areas, controlling natural disasters, human-centric applications, and tracking mobility and static home automation devices from remote places. These application areas require a congestion-free mobility-supported MAC protocol to guarantee reliable data delivery. BN-MAC was evaluated using network simulator-2 (ns2) and compared with other hybrid MAC protocols, such as Zebra medium access control (Z-MAC), advertisement-based MAC (A-MAC), Speck-MAC, adaptive duty cycle SMAC (ADC-SMAC), and low-power real-time medium access control (LPR-MAC). The simulation results indicate that BN-MAC is a robust and energy-efficient protocol that outperforms other hybrid MAC protocols in the context of quality of service (QoS) parameters, such as energy consumption, latency, throughput, channel access time, successful delivery rate, coverage efficiency, and average duty cycle. PMID:24625737

  15. Evaluation of statistical protocols for quality control of ecosystem carbon dioxide fluxes

    Treesearch

    Jorge F. Perez-Quezada; Nicanor Z. Saliendra; William E. Emmerich; Emilio A. Laca

    2007-01-01

    The process of quality control of micrometeorological and carbon dioxide (CO2) flux data can be subjective and may lack repeatability, which would undermine the results of many studies. Multivariate statistical methods and time series analysis were used together and independently to detect and replace outliers in CO2 flux...

  16. Return of postural control to baseline after anaerobic and aerobic exercise protocols.

    PubMed

    Fox, Zachary G; Mihalik, Jason P; Blackburn, J Troy; Battaglini, Claudio L; Guskiewicz, Kevin M

    2008-01-01

    With regard to sideline concussion testing, the effect of fatigue associated with different types of exercise on postural control is unknown. To evaluate the effects of fatigue on postural control in healthy college-aged athletes performing anaerobic and aerobic exercise protocols and to establish an immediate recovery time course from each exercise protocol for postural control measures to return to baseline status. Counterbalanced, repeated measures. Research laboratory. Thirty-six collegiate athletes (18 males, 18 females; age = 19.00 +/- 1.01 years, height = 172.44 +/- 10.47 cm, mass = 69.72 +/- 12.84 kg). Participants completed 2 counterbalanced sessions within 7 days. Each session consisted of 1 exercise protocol followed by postexercise measures of postural control taken at 3-, 8-, 13-, and 18-minute time intervals. Baseline measures were established during the first session, before the specified exertion protocol was performed. Balance Error Scoring System (BESS) results, sway velocity, and elliptical sway area. We found a decrease in postural control after each exercise protocol for all dependent measures. An interaction was noted between exercise protocol and time for total BESS score (P = .002). For both exercise protocols, all measures of postural control returned to baseline within 13 minutes. Postural control was negatively affected after anaerobic and aerobic exercise protocols as measured by total BESS score, elliptical sway area, and sway velocity. The effect of exertion lasted up to 13 minutes after each exercise was completed. Certified athletic trainers and clinicians should be aware of these effects and their recovery time course when determining an appropriate time to administer sideline assessments of postural control after a suspected mild traumatic brain injury.

  17. Quality and Dose Optimized CT Trauma Protocol - Recommendation from a University Level-I Trauma Center.

    PubMed

    Kahn, Johannes; Kaul, David; Böning, Georg; Rotzinger, Roman; Freyhardt, Patrick; Schwabe, Philipp; Maurer, Martin H; Renz, Diane Miriam; Streitparth, Florian

    2017-09-01

    Purpose  As a supra-regional level-I trauma center, we evaluated computed tomography (CT) acquisitions of polytraumatized patients for quality and dose optimization purposes. Adapted statistical iterative reconstruction [(AS)IR] levels, tube voltage reduction as well as a split-bolus contrast agent (CA) protocol were applied. Materials and Methods  61 patients were split into 3 different groups that differed with respect to tube voltage (120 - 140 kVp) and level of applied ASIR reconstruction (ASIR 20 - 50 %). The CT protocol included a native acquisition of the head followed by a single contrast-enhanced acquisition of the whole body (64-MSCT). CA (350 mg/ml iodine) was administered as a split bolus injection of 100 ml (2 ml/s), 20 ml NaCl (1 ml/s), 60 ml (4 ml/s), 40 ml NaCl (4 ml/s) with a scan delay of 85 s to detect injuries of both the arterial system and parenchymal organs in a single acquisition. Both the quantitative (SNR/CNR) and qualitative (5-point Likert scale) image quality was evaluated in parenchymal organs that are often injured in trauma patients. Radiation exposure was assessed. Results  The use of IR combined with a reduction of tube voltage resulted in good qualitative and quantitative image quality and a significant reduction in radiation exposure of more than 40 % (DLP 1087 vs. 647 mGyxcm). Image quality could be improved due to a dedicated protocol that included different levels of IR adapted to different slice thicknesses, kernels and the examined area for the evaluation of head, lung, body and bone injury patterns. In synopsis of our results, we recommend the implementation of a polytrauma protocol with a tube voltage of 120 kVp and the following IR levels: cCT 5mm: ASIR 20; cCT 0.625 mm: ASIR 40; lung 2.5 mm: ASIR 30, body 5 mm: ASIR 40; body 1.25 mm: ASIR 50; body 0.625 mm: ASIR 0. Conclusion  A dedicated adaptation of the CT trauma protocol (level of reduction of tube voltage and of IR

  18. Human Connectome Project Informatics: quality control, database services, and data visualization

    PubMed Central

    Marcus, Daniel S.; Harms, Michael P.; Snyder, Abraham Z.; Jenkinson, Mark; Wilson, J Anthony; Glasser, Matthew F.; Barch, Deanna M.; Archie, Kevin A.; Burgess, Gregory C.; Ramaratnam, Mohana; Hodge, Michael; Horton, William; Herrick, Rick; Olsen, Timothy; McKay, Michael; House, Matthew; Hileman, Michael; Reid, Erin; Harwell, John; Coalson, Timothy; Schindler, Jon; Elam, Jennifer S.; Curtiss, Sandra W.; Van Essen, David C.

    2013-01-01

    The Human Connectome Project (HCP) has developed protocols, standard operating and quality control procedures, and a suite of informatics tools to enable high throughput data collection, data sharing, automated data processing and analysis, and data mining and visualization. Quality control procedures include methods to maintain data collection consistency over time, to measure head motion, and to establish quantitative modality-specific overall quality assessments. Database services developed as customizations of the XNAT imaging informatics platform support both internal daily operations and open access data sharing. The Connectome Workbench visualization environment enables user interaction with HCP data and is increasingly integrated with the HCP's database services. Here we describe the current state of these procedures and tools and their application in the ongoing HCP study. PMID:23707591

  19. Return of Postural Control to Baseline After Anaerobic and Aerobic Exercise Protocols

    PubMed Central

    Fox, Zachary G; Mihalik, Jason P; Blackburn, J Troy; Battaglini, Claudio L; Guskiewicz, Kevin M

    2008-01-01

    Context: With regard to sideline concussion testing, the effect of fatigue associated with different types of exercise on postural control is unknown. Objective: To evaluate the effects of fatigue on postural control in healthy college-aged athletes performing anaerobic and aerobic exercise protocols and to establish an immediate recovery time course from each exercise protocol for postural control measures to return to baseline status. Design: Counterbalanced, repeated measures. Setting: Research laboratory. Patients Or Other Participants: Thirty-six collegiate athletes (18 males, 18 females; age  =  19.00 ± 1.01 years, height  =  172.44 ± 10.47 cm, mass  =  69.72 ± 12.84 kg). Intervention(s): Participants completed 2 counterbalanced sessions within 7 days. Each session consisted of 1 exercise protocol followed by postexercise measures of postural control taken at 3-, 8-, 13-, and 18-minute time intervals. Baseline measures were established during the first session, before the specified exertion protocol was performed. Main Outcome Measure(s): Balance Error Scoring System (BESS) results, sway velocity, and elliptical sway area. Results: We found a decrease in postural control after each exercise protocol for all dependent measures. An interaction was noted between exercise protocol and time for total BESS score (P  =  .002). For both exercise protocols, all measures of postural control returned to baseline within 13 minutes. Conclusions: Postural control was negatively affected after anaerobic and aerobic exercise protocols as measured by total BESS score, elliptical sway area, and sway velocity. The effect of exertion lasted up to 13 minutes after each exercise was completed. Certified athletic trainers and clinicians should be aware of these effects and their recovery time course when determining an appropriate time to administer sideline assessments of postural control after a suspected mild traumatic brain injury. PMID:18833307

  20. Quality and Variability of Online Physical Therapy Protocols for Isolated Meniscal Repairs.

    PubMed

    Trofa, David P; Parisien, Robert L; Noticewala, Manish S; Noback, Peter C; Ahmad, Christopher S; Moutzouros, Vasilios; Makhni, Eric C

    2018-05-31

    The ideal meniscal repair postoperative rehabilitation protocol has yet to be determined. Further, patients are attempting to access health care content online at a precipitously increasing rate given the efficiency of modern search engines. The purpose of this investigation was to assess the quality and variability of meniscal repair rehabilitation protocols published online with the hypothesis that there would be a high degree of variability found across available protocols. To this end, Web-based meniscal repair physical therapy protocols from U.S. academic orthopaedic programs as well as the first 10 protocols identified by the Google search engine for the term "meniscal repair physical therapy protocol" were reviewed and assessed via a custom scoring rubric. Twenty protocols were identified from 155 U.S. academic orthopaedic programs for a total of 30 protocols. Twenty-six protocols (86.6%) recommended immediate postoperative bracing. Twelve (40.0%) protocols permitted immediate weight-bearing as tolerated (WBAT) postoperatively, while the remaining protocols permitted WBAT at an average of 4.0 (range, 1-7) weeks. There was considerable variation in range of motion (ROM) goals, with most protocols (73.3%) initiating immediate passive ROM to 90°. The types and timing of strength, proprioception, agility, and pivoting exercises advised were extremely diverse. Only five protocols (16.7%) employed functional testing as a marker for return to athletics. The results of this study indicate that only a minority of academic orthopaedic programs publish meniscal repair physical therapy protocols online and that within the most readily available online protocols there are significant disparities in regards to brace use, ROM, weight-bearing, and strengthening and proprioception exercises. These discrepancies reflect the fact that the best rehabilitation practices after a meniscal repair have yet to be elucidated. This represents a significant area for improved patient

  1. Evaluation of the clinical protocol quality for family planning services of people living with HIV/AIDS.

    PubMed

    Brasil, Raquel Ferreira Gomes; Silva, Maria Josefina da; Moura, Escolástica Rejane Ferreira

    2018-01-01

    To evaluate the quality of a clinical protocol for family planning care for people living with HIV/AIDS. An evaluative study based on the six domains of the Appraisal of Guidelines for Research & Evaluation II and on Pearson's Coefficient of Variation. The protocol reached between 88.8% and 100.0% quality in the domains of the Appraisal of Guidelines for Research & Evaluation II and 93.3% in the overall evaluation. The obtained Pearson's coefficient of variation was between zero and 18.6. Considering that a minimum percentage of 70.0% was adopted for the quality attributed by the evaluators, quality has been achieved for all domains of the Appraisal of Guidelines for Research & Evaluation II. As a coefficient for all domains was less than 25%, we can infer that the scores attributed by the evaluators were linear or homogeneous, meaning high agreement between them. The protocol was evaluated as a quality instrument, recommended for use by health professionals who deal with family planning for people living with HIV/AIDS.

  2. Design and Methodological Considerations of the Centers for Disease Control and Prevention Urologic and Renal Protocol for the Newborn and Young Child with Spina Bifida

    PubMed Central

    Routh, Jonathan C.; Cheng, Earl Y.; Austin, J. Christopher; Baum, Michelle A.; Gargollo, Patricio C.; Grady, Richard W.; Herron, Adrienne R.; Kim, Steven S.; King, Shelly J.; Koh, Chester J.; Paramsothy, Pangaja; Raman, Lisa; Schechter, Michael S.; Smith, Kathryn A.; Tanaka, Stacy T.; Thibadeau, Judy K.; Walker, William O.; Wallis, M. Chad; Wiener, John S.; Joseph, David B.

    2016-01-01

    Purpose Care of children with spina bifida has significantly advanced in the last half century, resulting in gains in longevity and quality of life for affected children and caregivers. Bladder dysfunction is the norm in patients with spina bifida and may result in infection, renal scarring and chronic kidney disease. However, the optimal urological management for spina bifida related bladder dysfunction is unknown. Materials and Methods In 2012 the Centers for Disease Control and Prevention convened a working group composed of pediatric urologists, nephrologists, epidemiologists, methodologists, community advocates and Centers for Disease Control and Prevention personnel to develop a protocol to optimize urological care of children with spina bifida from the newborn period through age 5 years. Results An iterative quality improvement protocol was selected. In this model participating institutions agree to prospectively treat all newborns with spina bifida using a single consensus based protocol. During the 5-year study period outcomes will be routinely assessed and the protocol adjusted as needed to optimize patient and process outcomes. Primary study outcomes include urinary tract infections, renal scarring, renal function and bladder characteristics. The protocol specifies the timing and use of testing (eg ultrasonography, urodynamics) and interventions (eg intermittent catheterization, prophylactic antibiotics, antimuscarinic medications). Starting in 2014 the Centers for Disease Control and Prevention began funding 9 study sites to implement and evaluate the protocol. Conclusions The Centers for Disease Control and Prevention Urologic and Renal Protocol for the Newborn and Young Child with Spina Bifida began accruing patients in 2015. Assessment in the first 5 years will focus on urinary tract infections, renal function, renal scarring and clinical process improvements. PMID:27475969

  3. Study protocol of a randomized controlled trial comparing integrative body-mind-spirit intervention and cognitive behavioral therapy in fostering quality of life of patients with lung cancer and their family caregivers.

    PubMed

    Lau, Bobo Hi-Po; Chow, Amy Y M; Wong, Daniel F K; Chan, Jessie S M; Chan, Celia H Y; Ho, Rainbow T H; So, Tsz-Him; Lam, Tai-Chung; Lee, Victor Ho-Fun; Lee, Anne W M; Chow, Sau Fong; Chan, Cecilia L W

    2018-01-01

    Compared to cancers at other sites, lung cancer often results in greater psychosocial distress to both the patients and their caregivers, due to the poor prognosis and survival rate, as well as the heavy symptom burden. In recent years, making protocols of proposed or on-going studies publicly available via clinical trial registries and/or peer-reviewed journals has benefited health sciences with timely communication of the latest research trends and improved transparency in reporting. However, such practice is yet to be a common sight in evidence-informed social work. Hence, this paper discusses the value of publishing protocols in social work research and presents the protocol of a randomized controlled trial that compares the effectiveness of integrative body-mind-spirit intervention with cognitive behavioral therapy for enhancing quality of life of patients with lung cancer and their family caregivers. The data collection process was still on-going at the time of manuscript submission.

  4. Head CT: Image quality improvement with ASIR-V using a reduced radiation dose protocol for children.

    PubMed

    Kim, Hyun Gi; Lee, Ho-Joon; Lee, Seung-Koo; Kim, Hyun Ji; Kim, Myung-Joon

    2017-09-01

    To investigate the quality of images reconstructed with adaptive statistical iterative reconstruction V (ASIR-V), using pediatric head CT protocols. A phantom was scanned at decreasing 20% mA intervals using our standard pediatric head CT protocols. Each study was then reconstructed at 10% ASIR-V intervals. After the phantom study, we reduced mA by 10% in the protocol for <3-year-old patients and applied 30% ASIR-V and by 30% in the protocol for 3- to 15-year-old patients and applied 40% ASIR-V. Increasing the percentage of ASIR-V resulted in lower noise and higher contrast-to-noise ratio (CNR) and preserved spatial resolution in the phantom study. Compared to a conventional-protocol, reduced-dose protocol with ASIR-V achieved 12.8% to 34.0% of dose reduction and showed images of lower noise (9.22 vs. 10.73, P = 0.043) and higher CNR in different levels (centrum semiovale, 2.14 vs. 1.52, P = 0.003; basal ganglia, 1.46 vs. 1.07, P = 0.001; and cerebellum, 2.18 vs. 1.33, P < 0.001). Qualitative analysis showed higher gray-white matter differentiation and sharpness and preserved overall diagnostic quality in the images with ASIR-V. Use of ASIR-V allowed a 12.8% to 34.0% dose reduction in each age group with potential to improve image quality. • It is possible to reduce radiation dose and improve image quality with ASIR-V. • We improved noise and CNR and decreased radiation dose. • Sharpness improved with ASIR-V. • Total radiation dose was decreased by 12.8% to 34.0%.

  5. Impact of two early treatment protocols for anterior dental crossbite on children’s quality of life

    PubMed Central

    Miamoto, Cristina Batista; Marques, Leandro Silva; Abreu, Lucas Guimarães; Paiva, Saul Martins

    2018-01-01

    ABSTRACT Objective: To assess the impact of two early treatment protocols for anterior dental crossbite on children’s quality of life. Methods: Thirty children, 8 to 10 years of age, with anterior dental crossbite, participated in this study. Individuals were divided into two groups: Group 1 - 15 children undergoing treatment with an upper removable appliance with digital springs; Group 2 - 15 children undergoing treatment with resin-reinforced glass ionomer cement bite pads on the lower first molars. Quality of life was evaluated using the Brazilian version of the Child Perceptions Questionnaire (CPQ8-10), which contains four subscales: oral symptoms (OS), functional limitations (FL), emotional well-being (EW), and social well-being (SW). A higher score denotes a greater negative impact on children’s quality of life. Children answered the questionnaire before treatment (T1) and twelve months after orthodontic treatment onset (T2). Descriptive statistics, the Wilcoxon test and analysis of covariance (ANCOVA) were performed. Results: Children’s mean age was 9.07 ± 0.79 years in Group 1 and 9.00 ± 0.84 years in Group 2. For Group 1, the FL and EW subscale scores and the overall CPQ8-10 were significantly higher in T1 as compared to T2 (p= 0.004, p= 0.012 and p= 0.015, respectively). For Group 2, there were no statistically significant differences. The ANCOVA showed no significant difference regarding quality of life at T2 between groups, after controlling for quality of life measures at T1. Conclusions: The difference regarding the impact on quality of life between groups is not related to the protocol used. PMID:29791690

  6. Quality control and conduct of genome-wide association meta-analyses

    PubMed Central

    Winkler, Thomas W; Day, Felix R; Croteau-Chonka, Damien C; Wood, Andrew R; Locke, Adam E; Mägi, Reedik; Ferreira, Teresa; Fall, Tove; Graff, Mariaelisa; Justice, Anne E; Luan, Jian'an; Gustafsson, Stefan; Randall, Joshua C; Vedantam, Sailaja; Workalemahu, Tsegaselassie; Kilpeläinen, Tuomas O; Scherag, André; Esko, Tonu; Kutalik, Zoltán; Heid, Iris M; Loos, Ruth JF

    2014-01-01

    Rigorous organization and quality control (QC) are necessary to facilitate successful genome-wide association meta-analyses (GWAMAs) of statistics aggregated across multiple genome-wide association studies. This protocol provides guidelines for [1] organizational aspects of GWAMAs, and for [2] QC at the study file level, the meta-level across studies, and the meta-analysis output level. Real–world examples highlight issues experienced and solutions developed by the GIANT Consortium that has conducted meta-analyses including data from 125 studies comprising more than 330,000 individuals. We provide a general protocol for conducting GWAMAs and carrying out QC to minimize errors and to guarantee maximum use of the data. We also include details for use of a powerful and flexible software package called EasyQC. For consortia of comparable size to the GIANT consortium, the present protocol takes a minimum of about 10 months to complete. PMID:24762786

  7. Quality assurance and quality control of geochemical data—A primer for the research scientist

    USGS Publications Warehouse

    Geboy, Nicholas J.; Engle, Mark A.

    2011-01-01

    Geochemistry is a constantly expanding science. More and more, scientists are employing geochemical tools to help answer questions about the Earth and earth system processes. Scientists may assume that the responsibility of examining and assessing the quality of the geochemical data they generate is not theirs but rather that of the analytical laboratories to which their samples have been submitted. This assumption may be partially based on knowledge about internal and external quality assurance and quality control (QA/QC) programs in which analytical laboratories typically participate. Or there may be a perceived lack of time or resources to adequately examine data quality. Regardless of the reason, the lack of QA/QC protocols can lead to the generation and publication of erroneous data. Because the interpretations drawn from the data are primary products to U.S. Geological Survey (USGS) stakeholders, the consequences of publishing erroneous results can be significant. The principal investigator of a scientific study ultimately is responsible for the quality and interpretation of the project's findings, and thus must also play a role in the understanding, implementation, and presentation of QA/QC information about the data. Although occasionally ignored, QA/QC protocols apply not only to procedures in the laboratory but also in the initial planning of a research study and throughout the life of the project. Many of the tenets of developing a sound QA/QC program or protocols also parallel the core concepts of developing a good study: What is the main objective of the study? Will the methods selected provide data of enough resolution to answer the hypothesis? How should samples be collected? Are there known or unknown artifacts or contamination sources in the sampling and analysis methods? Assessing data quality requires communication between the scientists responsible for designing the study and those collecting samples, analyzing samples, treating data, and

  8. Safety of a DVT chemoprophylaxis protocol following traumatic brain injury: a single center quality improvement initiative.

    PubMed

    Nickele, Christopher M; Kamps, Timothy K; Medow, Joshua E

    2013-04-01

    Venous thromboembolism (VTE) is a complication that affects approximately 30 % of moderate and severe traumatic brain injury (TBI) patients when pharmacologic prophylaxis is not used. Following TBI, specifically in the case of contusions, the safety and efficacy of pharmacologic thromboembolism prophylaxis (PTP) has been studied only in small sample sizes. In this study, we attempt to assess the safety and efficacy of a PTP protocol for TBI patients, as a quality improvement (QI) initiative, in the neuroscience intensive care unit (NSICU). Between January 1st and December 31st, 2009, consecutive patients discharged from the University of Wisconsin NSICU after >a 48 h minimum stay were evaluated as part of a QI project. A protocol for the initiation of PTP was designed and implemented for NSICU patients. The protocol did not vary based on type of intracranial injury. The rate of VTE was reported as was heparin-induced thrombocytopenia and PTP-related expansion of intracranial hemorrhage (IH) requiring reoperation. The number of patients receiving PTP and the timing of therapy were tracked. Patients were excluded for persistent coagulopathy, other organ system bleeding (such as the gastrointestinal tract), or pregnancy. Faculty could opt out of the protocol without reason. Using the same criteria, patients discharged during the preceding 6 months, from July 1st to December 31st, 2008, were evaluated as controls as the PTP protocol was not in effect during this time. During the control period, there were 48 head trauma admissions who met the inclusion criteria. In 22 patients (45.8 %), PTP was initiated at an average of 4.9 ± 5.4 days after admission. During the protocol period, there were 87 head trauma admissions taken from 1,143 total NSICU stays who met criteria. In 63 patients (72.4 %), the care team in the NSICU successfully initiated PTP, at an average of 3.4 ± 2.8 days after admission. All 87 trauma patients were analyzed, and the rate of clinically

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

    PubMed

    Thiele, Ines; Palsson, Bernhard Ø

    2010-01-01

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

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

    PubMed Central

    Thiele, Ines; Palsson, Bernhard Ø.

    2011-01-01

    Network reconstructions are a common denominator in systems biology. Bottom-up metabolic network reconstructions have developed over the past 10 years. These reconstructions represent structured knowledge-bases that abstract pertinent information on the biochemical transformations taking place within specific target organisms. The conversion of a reconstruction into a mathematical format facilitates myriad computational biological studies including evaluation of network content, hypothesis testing and generation, analysis of phenotypic characteristics, and metabolic engineering. To date, genome-scale metabolic reconstructions for more than 30 organisms have been published and this number is expected to increase rapidly. However, these reconstructions differ in quality and coverage that may minimize their predictive potential and use as knowledge-bases. Here, we present a comprehensive protocol describing each step necessary to build a high-quality genome-scale metabolic reconstruction as well as common trials and tribulations. Therefore, this protocol provides a helpful manual for all stages of the reconstruction process. PMID:20057383

  11. Clomiphene citrate 'stair-step' protocol vs. traditional protocol in patients with polycystic ovary syndrome: a randomized controlled trial.

    PubMed

    Deveci, Canan Dura; Demir, Berfu; Sengul, Ozlem; Dilbaz, Berna; Goktolga, Umit

    2015-01-01

    To evaluate the efficacy of the stair-step protocol using clomiphene citrate (CC) and to assess the uterine and systemic side effects in patients with polycystic ovary syndrome (PCOS). A total of 60 PCOS patients who failed to respond to 50 mg/day for 5 days of CC treatment within the cycle were randomly allocated to the control (traditional protocol) and study (stair-step protocol) groups. In the stair-step protocol,patients were treated with CC 50 mg/day for 5 days and then in nonresponsive patients, the dosage was increased to 100 mg/day for 5 days in the same cycle. Patients who failed the 50 mg/day CC treatment in the previous cycle were stimulated with 100 mg/day CC and were accepted as the control group. Ovulation and pregnancy rates, duration of treatment and uterine and systemic side effects were evaluated. Ovulation and pregnancy rates were similar between the stair-step and the control group (43.3 vs. 33.3 %, respectively) (16.7 vs. 10 %, respectively). The duration of treatment was significantly shorter in stair-step compared to traditional protocol (20.5 ± 2.0 vs. 48.6 ± 2.4 days, respectively). There were no significant differences in the systemic side effects between the groups. Uterine side effects were evaluated with endometrial thickness and uterine artery Doppler ultrasound; no significant differences were observed in stair-step compared to traditional protocol. The stair-step protocol was determined to have a significantly shorter treatment period without any detrimental effect on the ovulation and pregnancy rates.

  12. Mindcontrol: A web application for brain segmentation quality control.

    PubMed

    Keshavan, Anisha; Datta, Esha; M McDonough, Ian; Madan, Christopher R; Jordan, Kesshi; Henry, Roland G

    2018-04-15

    Tissue classification plays a crucial role in the investigation of normal neural development, brain-behavior relationships, and the disease mechanisms of many psychiatric and neurological illnesses. Ensuring the accuracy of tissue classification is important for quality research and, in particular, the translation of imaging biomarkers to clinical practice. Assessment with the human eye is vital to correct various errors inherent to all currently available segmentation algorithms. Manual quality assurance becomes methodologically difficult at a large scale - a problem of increasing importance as the number of data sets is on the rise. To make this process more efficient, we have developed Mindcontrol, an open-source web application for the collaborative quality control of neuroimaging processing outputs. The Mindcontrol platform consists of a dashboard to organize data, descriptive visualizations to explore the data, an imaging viewer, and an in-browser annotation and editing toolbox for data curation and quality control. Mindcontrol is flexible and can be configured for the outputs of any software package in any data organization structure. Example configurations for three large, open-source datasets are presented: the 1000 Functional Connectomes Project (FCP), the Consortium for Reliability and Reproducibility (CoRR), and the Autism Brain Imaging Data Exchange (ABIDE) Collection. These demo applications link descriptive quality control metrics, regional brain volumes, and thickness scalars to a 3D imaging viewer and editing module, resulting in an easy-to-implement quality control protocol that can be scaled for any size and complexity of study. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  13. A slotted access control protocol for metropolitan WDM ring networks

    NASA Astrophysics Data System (ADS)

    Baziana, P. A.; Pountourakis, I. E.

    2009-03-01

    In this study we focus on the serious scalability problems that many access protocols for WDM ring networks introduce due to the use of a dedicated wavelength per access node for either transmission or reception. We propose an efficient slotted MAC protocol suitable for WDM ring metropolitan area networks. The proposed network architecture employs a separate wavelength for control information exchange prior to the data packet transmission. Each access node is equipped with a pair of tunable transceivers for data communication and a pair of fixed tuned transceivers for control information exchange. Also, each access node includes a set of fixed delay lines for synchronization reasons; to keep the data packets, while the control information is processed. An efficient access algorithm is applied to avoid both the data wavelengths and the receiver collisions. In our protocol, each access node is capable of transmitting and receiving over any of the data wavelengths, facing the scalability issues. Two different slot reuse schemes are assumed: the source and the destination stripping schemes. For both schemes, performance measures evaluation is provided via an analytic model. The analytical results are validated by a discrete event simulation model that uses Poisson traffic sources. Simulation results show that the proposed protocol manages efficient bandwidth utilization, especially under high load. Also, comparative simulation results prove that our protocol achieves significant performance improvement as compared with other WDMA protocols which restrict transmission over a dedicated data wavelength. Finally, performance measures evaluation is explored for diverse numbers of buffer size, access nodes and data wavelengths.

  14. ? PID output-feedback control under event-triggered protocol

    NASA Astrophysics Data System (ADS)

    Zhao, Di; Wang, Zidong; Ding, Derui; Wei, Guoliang; Alsaadi, Fuad E.

    2018-07-01

    This paper is concerned with the ? proportional-integral-derivative (PID) output-feedback control problem for a class of linear discrete-time systems under event-triggered protocols. The controller and the actuators are connected through a communication network of limited bandwidth, and an event-triggered communication mechanism is adopted to decide when a certain control signal should be transmitted to the respective actuator. Furthermore, a novel PID output-feedback controller is designed where the accumulative sum-loop (the counterpart to the integral-loop in the continues-time setting) operates on a limited time-window with hope to mitigate the effect from the past measurement data. The main objective of the problem under consideration is to design a desired PID controller such that the closed-loop system is exponentially stable and the prescribed ? disturbance rejection attenuation level is guaranteed under event-triggered protocols. By means of the Lyapunov stability theory combined with the orthogonal decomposition, sufficient conditions are established under which the addressed PID controller design problem is recast into a linear convex optimization one that can be easily solved via available software packages. Finally, a simulation example is exploited to illustrate the usefulness and effectiveness of the established control scheme.

  15. Design and Methodological Considerations of the Centers for Disease Control and Prevention Urologic and Renal Protocol for the Newborn and Young Child with Spina Bifida.

    PubMed

    Routh, Jonathan C; Cheng, Earl Y; Austin, J Christopher; Baum, Michelle A; Gargollo, Patricio C; Grady, Richard W; Herron, Adrienne R; Kim, Steven S; King, Shelly J; Koh, Chester J; Paramsothy, Pangaja; Raman, Lisa; Schechter, Michael S; Smith, Kathryn A; Tanaka, Stacy T; Thibadeau, Judy K; Walker, William O; Wallis, M Chad; Wiener, John S; Joseph, David B

    2016-12-01

    Care of children with spina bifida has significantly advanced in the last half century, resulting in gains in longevity and quality of life for affected children and caregivers. Bladder dysfunction is the norm in patients with spina bifida and may result in infection, renal scarring and chronic kidney disease. However, the optimal urological management for spina bifida related bladder dysfunction is unknown. In 2012 the Centers for Disease Control and Prevention convened a working group composed of pediatric urologists, nephrologists, epidemiologists, methodologists, community advocates and Centers for Disease Control and Prevention personnel to develop a protocol to optimize urological care of children with spina bifida from the newborn period through age 5 years. An iterative quality improvement protocol was selected. In this model participating institutions agree to prospectively treat all newborns with spina bifida using a single consensus based protocol. During the 5-year study period outcomes will be routinely assessed and the protocol adjusted as needed to optimize patient and process outcomes. Primary study outcomes include urinary tract infections, renal scarring, renal function and bladder characteristics. The protocol specifies the timing and use of testing (eg ultrasonography, urodynamics) and interventions (eg intermittent catheterization, prophylactic antibiotics, antimuscarinic medications). Starting in 2014 the Centers for Disease Control and Prevention began funding 9 study sites to implement and evaluate the protocol. The Centers for Disease Control and Prevention Urologic and Renal Protocol for the Newborn and Young Child with Spina Bifida began accruing patients in 2015. Assessment in the first 5 years will focus on urinary tract infections, renal function, renal scarring and clinical process improvements. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  16. Characterizing urban areas with good sound quality: development of a research protocol.

    PubMed

    van Kempen, Elise; Devilee, Jeroen; Swart, Wim; van Kamp, Irene

    2014-01-01

    Due to rapid urbanization, the spatial variation between wanted and unwanted sounds will decrease or even disappear. Consequently, the characteristics of (urban) areas where people can temporarily withdraw themselves from urban stressors such as noise may change or become increasingly scarce. Hardly any research has been carried out into the positive health effects of spending time in areas with a good sound quality. One of the problems is that an overview of what aspects determines good sound quality in urban areas and how these are interrelated is lacking. This paper reviews the literature pertaining to the sound quality of urban areas. Aim is to summarize what is known about the influence of social, spatial, and physical aspects other than sounds, on peoples' perception of urban sound qualities. Literature from both conventional sound research and from the so-called soundscape field, published between 2000 and the beginning of 2013 in English or Dutch, was evaluated. Although a general set of validated indicators that can be directly applied, is not available yet, a set of indicators was derived from the literature. These form the basis of a study protocol that will be applied in "Towards a Sustainable acoustic Environment", a project that aims to describe sound qualities at a low-scale level. Key-elements of this study protocol, including a questionnaire and the systematic audit of neighborhoods, were presented in this paper.

  17. Quality control and conduct of genome-wide association meta-analyses.

    PubMed

    Winkler, Thomas W; Day, Felix R; Croteau-Chonka, Damien C; Wood, Andrew R; Locke, Adam E; Mägi, Reedik; Ferreira, Teresa; Fall, Tove; Graff, Mariaelisa; Justice, Anne E; Luan, Jian'an; Gustafsson, Stefan; Randall, Joshua C; Vedantam, Sailaja; Workalemahu, Tsegaselassie; Kilpeläinen, Tuomas O; Scherag, André; Esko, Tonu; Kutalik, Zoltán; Heid, Iris M; Loos, Ruth J F

    2014-05-01

    Rigorous organization and quality control (QC) are necessary to facilitate successful genome-wide association meta-analyses (GWAMAs) of statistics aggregated across multiple genome-wide association studies. This protocol provides guidelines for (i) organizational aspects of GWAMAs, and for (ii) QC at the study file level, the meta-level across studies and the meta-analysis output level. Real-world examples highlight issues experienced and solutions developed by the GIANT Consortium that has conducted meta-analyses including data from 125 studies comprising more than 330,000 individuals. We provide a general protocol for conducting GWAMAs and carrying out QC to minimize errors and to guarantee maximum use of the data. We also include details for the use of a powerful and flexible software package called EasyQC. Precise timings will be greatly influenced by consortium size. For consortia of comparable size to the GIANT Consortium, this protocol takes a minimum of about 10 months to complete.

  18. [Primary quality control in Israel Air Force clinics].

    PubMed

    Gilutz, H; Shamis, A; Ben-Amitay, D; Burger, A; Caine, Y G

    1994-05-15

    The practice of primary medicine within a military framework differs from that in the civilian environment in: accessibility, its consumers, obligations of the providers, involvement of the funder (the commanders), and ability to define and enforce professional guide lines. These differences influence the scope of medical service, as well as affect the methods and results of quality control. A system of quality control evaluation and feedback of military primary care in 16 Israel Air Force clinics was carried out by a team of experienced physicians using peer group review and according to a specially prepared protocol. Emphasis was placed on medical record assessment using obligatory markers of adequate medical evaluation and treatment. Identification of the population at risk, further medical training, and medical administration with a direct effect on the quality of medical treatment were also evaluated. 2 quality control surveys with feedback were carried out 6 months apart. The overall mean score was 81.66 +/- 7.16% at the first evaluation, increasing to 88.60 +/- 7.46% at the second (p < 0.01). The greatest improvements were in follow-up of population at risk (increasing from 68.4% to 86.4%, p < 0.025), training of medical teams, (from 75.7% to 87.5%, p < 0.05) and patient case management (from 79.4% to 85.1%, N.S.). Categories in which there was no improvement were medical records, recovery of old medical files and patient education. The categories in which there was improvement had a common denominator: "recognition of importance" and "provision of patterns" by headquarters. The quality control system was designed for routine use, and not as a research project.(ABSTRACT TRUNCATED AT 250 WORDS)

  19. FQC Dashboard: integrates FastQC results into a web-based, interactive, and extensible FASTQ quality control tool

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Brown, Joseph; Pirrung, Meg; McCue, Lee Ann

    FQC is software that facilitates large-scale quality control of FASTQ files by carrying out a QC protocol, parsing results, and aggregating quality metrics within and across experiments into an interactive dashboard. The dashboard utilizes human-readable configuration files to manipulate the pages and tabs, and is extensible with CSV data.

  20. 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.

    PubMed

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

    2015-02-18

    study (with 1:1 allocation ratio). The primary endpoint is number of quality indicators met in HealthPROMISE versus control arm. Secondary endpoints include decrease in number of emergency visits due to IBD, decrease in number of hospitalization due to IBD, change in generic QOL score from baseline, proportion of patients in each group who meet all eligible outpatient quality metrics, and proportion of patients in disease control in each group. In addition, we plan to conduct protocol analysis of intervention patients with adequate HealthPROMISE utilization (more than 6 log-ins with data entry from week 0 through week 52) achieving above mentioned primary and secondary endpoints. HealthPROMISE is a unique cloud-based patient-reported outcome (PRO) and decision support tool that empowers both patients and providers. Patients track their QOL and symptoms, and providers can use the visual data in real time (integrated with electronic health records [EHRs]) to provide better care to their entire patient population. Using pragmatic trial design, we hope to show that IBD patients who participate in their own care and share in decision making have appreciably improved outcomes when compared to patients who do not. ClinicalTrials.gov NCT02322307; https://clinicaltrials.gov/ct2/show/NCT02322307 (Archived by WebCite at http://www.webcitation.org/6W8PoYThr).

  1. New patient-controlled abdominal compression method in radiography: radiation dose and image quality.

    PubMed

    Piippo-Huotari, Oili; Norrman, Eva; Anderzén-Carlsson, Agneta; Geijer, Håkan

    2018-05-01

    The radiation dose for patients can be reduced with many methods and one way is to use abdominal compression. In this study, the radiation dose and image quality for a new patient-controlled compression device were compared with conventional compression and compression in the prone position . To compare radiation dose and image quality of patient-controlled compression compared with conventional and prone compression in general radiography. An experimental design with quantitative approach. After obtaining the approval of the ethics committee, a consecutive sample of 48 patients was examined with the standard clinical urography protocol. The radiation doses were measured as dose-area product and analyzed with a paired t-test. The image quality was evaluated by visual grading analysis. Four radiologists evaluated each image individually by scoring nine criteria modified from the European quality criteria for diagnostic radiographic images. There was no significant difference in radiation dose or image quality between conventional and patient-controlled compression. Prone position resulted in both higher dose and inferior image quality. Patient-controlled compression gave similar dose levels as conventional compression and lower than prone compression. Image quality was similar with both patient-controlled and conventional compression and was judged to be better than in the prone position.

  2. Control systems and coordination protocols of the secretory pathway.

    PubMed

    Luini, Alberto; Mavelli, Gabriella; Jung, Juan; Cancino, Jorge

    2014-01-01

    Like other cellular modules, the secretory pathway and the Golgi complex are likely to be supervised by control systems that support homeostasis and optimal functionality under all conditions, including external and internal perturbations. Moreover, the secretory apparatus must be functionally connected with other cellular modules, such as energy metabolism and protein degradation, via specific rules of interaction, or "coordination protocols". These regulatory devices are of fundamental importance for optimal function; however, they are generally "hidden" at steady state. The molecular components and the architecture of the control systems and coordination protocols of the secretory pathway are beginning to emerge through studies based on the use of controlled transport-specific perturbations aimed specifically at the detection and analysis of these internal regulatory devices.

  3. [Development of quality assurance/quality control web system in radiotherapy].

    PubMed

    Okamoto, Hiroyuki; Mochizuki, Toshihiko; Yokoyama, Kazutoshi; Wakita, Akihisa; Nakamura, Satoshi; Ueki, Heihachi; Shiozawa, Keiko; Sasaki, Koji; Fuse, Masashi; Abe, Yoshihisa; Itami, Jun

    2013-12-01

    Our purpose is to develop a QA/QC (quality assurance/quality control) web system using a server-side script language such as HTML (HyperText Markup Language) and PHP (Hypertext Preprocessor), which can be useful as a tool to share information about QA/QC in radiotherapy. The system proposed in this study can be easily built in one's own institute, because HTML can be easily handled. There are two desired functions in a QA/QC web system: (i) To review the results of QA/QC for a radiotherapy machine, manuals, and reports necessary for routinely performing radiotherapy through this system. By disclosing the results, transparency can be maintained, (ii) To reveal a protocol for QA/QC in one's own institute using pictures and movies relating to QA/QC for simplicity's sake, which can also be used as an educational tool for junior radiation technologists and medical physicists. By using this system, not only administrators, but also all staff involved in radiotherapy, can obtain information about the conditions and accuracy of treatment machines through the QA/QC web system.

  4. Accounting for patient size in the optimization of dose and image quality of pelvis cone beam CT protocols on the Varian OBI system

    PubMed Central

    Moore, Craig S; Horsfield, Carl J; Saunderson, John R; Beavis, Andrew W

    2015-01-01

    Objective: The purpose of this study was to develop size-based radiotherapy kilovoltage cone beam CT (CBCT) protocols for the pelvis. Methods: Image noise was measured in an elliptical phantom of varying size for a range of exposure factors. Based on a previously defined “small pelvis” reference patient and CBCT protocol, appropriate exposure factors for small, medium, large and extra-large patients were derived which approximate the image noise behaviour observed on a Philips CT scanner (Philips Medical Systems, Best, Netherlands) with automatic exposure control (AEC). Selection criteria, based on maximum tube current–time product per rotation selected during the radiotherapy treatment planning scan, were derived based on an audit of patient size. Results: It has been demonstrated that 110 kVp yields acceptable image noise for reduced patient dose in pelvic CBCT scans of small, medium and large patients, when compared with manufacturer's default settings (125 kVp). Conversely, extra-large patients require increased exposure factors to give acceptable images. 57% of patients in the local population now receive much lower radiation doses, whereas 13% require higher doses (but now yield acceptable images). Conclusion: The implementation of size-based exposure protocols has significantly reduced radiation dose to the majority of patients with no negative impact on image quality. Increased doses are required on the largest patients to give adequate image quality. Advances in knowledge: The development of size-based CBCT protocols that use the planning CT scan (with AEC) to determine which protocol is appropriate ensures adequate image quality whilst minimizing patient radiation dose. PMID:26419892

  5. Accounting for patient size in the optimization of dose and image quality of pelvis cone beam CT protocols on the Varian OBI system.

    PubMed

    Wood, Tim J; Moore, Craig S; Horsfield, Carl J; Saunderson, John R; Beavis, Andrew W

    2015-01-01

    The purpose of this study was to develop size-based radiotherapy kilovoltage cone beam CT (CBCT) protocols for the pelvis. Image noise was measured in an elliptical phantom of varying size for a range of exposure factors. Based on a previously defined "small pelvis" reference patient and CBCT protocol, appropriate exposure factors for small, medium, large and extra-large patients were derived which approximate the image noise behaviour observed on a Philips CT scanner (Philips Medical Systems, Best, Netherlands) with automatic exposure control (AEC). Selection criteria, based on maximum tube current-time product per rotation selected during the radiotherapy treatment planning scan, were derived based on an audit of patient size. It has been demonstrated that 110 kVp yields acceptable image noise for reduced patient dose in pelvic CBCT scans of small, medium and large patients, when compared with manufacturer's default settings (125 kVp). Conversely, extra-large patients require increased exposure factors to give acceptable images. 57% of patients in the local population now receive much lower radiation doses, whereas 13% require higher doses (but now yield acceptable images). The implementation of size-based exposure protocols has significantly reduced radiation dose to the majority of patients with no negative impact on image quality. Increased doses are required on the largest patients to give adequate image quality. The development of size-based CBCT protocols that use the planning CT scan (with AEC) to determine which protocol is appropriate ensures adequate image quality whilst minimizing patient radiation dose.

  6. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    PubMed

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

  7. Impact of peer-led quality improvement networks on quality of inpatient mental health care: study protocol for a cluster randomized controlled trial.

    PubMed

    Aimola, Lina; Jasim, Sarah; Tripathi, Neeraj; Tucker, Sarah; Worrall, Adrian; Quirk, Alan; Crawford, Mike J

    2016-09-21

    Quality improvement networks are peer-led programmes in which members of the network assess the quality of care colleagues provide according to agreed standards of practice. These networks aim to help members identify areas of service provision that could be improved and share good practice. Despite the widespread use of peer-led quality improvement networks, there is very little information about their impact. We are conducting a cluster randomized controlled trial of a quality improvement network for low-secure mental health wards to examine the impact of membership on the process and outcomes of care over a 12 month period. Standalone low secure units in England and Wales that expressed an interest in joining the quality improvement network were recruited for the study from 2012 to 2014. Thirty-eight units were randomly allocated to either the active intervention (participation in the network n = 18) or a control arm (delayed participation in the network n = 20). Using a 5 % significance level and 90 % power, it was calculated that a sample size of 60 wards was required taking into account a 10 % drop out. A total of 75 wards were assessed at baseline and 8 wards dropped out the study before the data collection at follow up. Researchers masked to the allocation status of the units assessed all study outcomes at baseline and follow-up 12 months later. The primary outcome is the quality of the physical environment and facilities on the wards. The secondary outcomes are: safety of the ward, patient-rated satisfaction with care and mental well-being, staff burnout, training and supervision. Relative to control wards, it is hypothesized that the quality of the physical environment and facilities will be higher on wards in the active arm of the trial 12 months after randomization. To our knowledge, this is the first randomized evaluation of a peer-led quality improvement network that has examined the impact of participation on both patient-level and

  8. Optimal early active mobilisation protocol after extensor tendon repairs in zones V and VI: A systematic review of literature.

    PubMed

    Collocott, Shirley Jf; Kelly, Edel; Ellis, Richard F

    2018-03-01

    Early mobilisation protocols after repair of extensor tendons in zone V and VI provide better outcomes than immobilisation protocols. This systematic review investigated different early active mobilisation protocols used after extensor tendon repair in zone V and VI. The purpose was to determine whether any one early active mobilisation protocol provides superior results. An extensive literature search was conducted to identify articles investigating the outcomes of early active mobilisation protocols after extensor tendon repair in zone V and VI. Databases searched were AMED, Embase, Medline, Cochrane and CINAHL. Studies were included if they involved participants with extensor tendon repairs in zone V and VI in digits 2-5 and described a post-operative rehabilitation protocol which allowed early active metacarpophalangeal joint extension. Study designs included were randomised controlled trials, observational studies, cohort studies and case series. The Structured Effectiveness Quality Evaluation Scale was used to evaluate the methodological quality of the included studies. Twelve articles met the inclusion criteria. Two types of early active mobilisation protocols were identified: controlled active motion protocols and relative motion extension splinting protocols. Articles describing relative motion extension splinting protocols were more recent but of lower methodological quality than those describing controlled active motion protocols. Participants treated with controlled active motion and relative motion extension splinting protocols had similar range of motion outcomes, but those in relative motion extension splinting groups returned to work earlier. The evidence reviewed suggested that relative motion extension splinting protocols may allow an earlier return to function than controlled active motion protocols without a greater risk of complication.

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

    PubMed

    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

  10. Efficacy of Multimodal Pain Control Protocol in the Setting of Total Hip Arthroplasty

    PubMed Central

    Lee, Kyung-Jae; Bae, Ki-Cheor; Cho, Chul-Hyun; Kwon, Doo-Hyun

    2009-01-01

    Background This study evaluated the benefits and safety of a multimodal pain control protocol, which included a periarticular injection of local anesthetics, in patients undergoing total hip arthroplasty. Methods Between March 2006 and March 2007, 60 patients undergoing unilateral total hip arthroplasty were randomized to undergo either a multimodal pain control protocol or a conventional pain control protocol. The following parameters were compared: the preoperative and postoperative visual analogue scales (VAS), hospital stay, operative time, postoperative rehabilitation, additional painkiller consumption, and complication rates. Results There was no difference between the groups in terms of diagnosis, age, gender, and BMI. Although both groups had similar VAS scores in the preoperative period and on the fifth postoperative day, there was a significant difference between the groups over the four-day period after surgery. There were no differences in the hospital stay, operative time, additional painkiller consumption, or complication rate between the groups. The average time for comfortable crutch ambulation was 2.8 days in the multimodal pain control protocol group and 5.3 days in the control group. Conclusions The multimodal pain control protocol can significantly reduce the level of postoperative pain and improve patients' satisfaction, with no apparent risks, after total hip arthroplasty. PMID:19885051

  11. Successful implementation of a perioperative glycemic control protocol in cardiac surgery: barrier analysis and intervention using lean six sigma.

    PubMed

    Martinez, Elizabeth A; Chavez-Valdez, Raul; Holt, Natalie F; Grogan, Kelly L; Khalifeh, Katherine W; Slater, Tammy; Winner, Laura E; Moyer, Jennifer; Lehmann, Christoph U

    2011-01-01

    Although the evidence strongly supports perioperative glycemic control among cardiac surgical patients, there is scant literature to describe the practical application of such a protocol in the complex ICU environment. This paper describes the use of the Lean Six Sigma methodology to implement a perioperative insulin protocol in a cardiac surgical intensive care unit (CSICU) in a large academic hospital. A preintervention chart audit revealed that fewer than 10% of patients were admitted to the CSICU with glucose <200 mg/dL, prompting the initiation of the quality improvement project. Following protocol implementation, more than 90% of patients were admitted with a glucose <200 mg/dL. Key elements to success include barrier analysis and intervention, provider education, and broadening the project scope to address the intraoperative period.

  12. Successful Implementation of a Perioperative Glycemic Control Protocol in Cardiac Surgery: Barrier Analysis and Intervention Using Lean Six Sigma

    PubMed Central

    Martinez, Elizabeth A.; Chavez-Valdez, Raul; Holt, Natalie F.; Grogan, Kelly L.; Khalifeh, Katherine W.; Slater, Tammy; Winner, Laura E.; Moyer, Jennifer; Lehmann, Christoph U.

    2011-01-01

    Although the evidence strongly supports perioperative glycemic control among cardiac surgical patients, there is scant literature to describe the practical application of such a protocol in the complex ICU environment. This paper describes the use of the Lean Six Sigma methodology to implement a perioperative insulin protocol in a cardiac surgical intensive care unit (CSICU) in a large academic hospital. A preintervention chart audit revealed that fewer than 10% of patients were admitted to the CSICU with glucose <200 mg/dL, prompting the initiation of the quality improvement project. Following protocol implementation, more than 90% of patients were admitted with a glucose <200 mg/dL. Key elements to success include barrier analysis and intervention, provider education, and broadening the project scope to address the intraoperative period. PMID:22091218

  13. Communication and protocol compliance and their relation to the quality of cardiopulmonary resuscitation (CPR): A mixed-methods study of simulated telephone-assisted CPR.

    PubMed

    Nord-Ljungquist, Helena; Brännström, Margareta; Bohm, Katarina

    2015-07-01

    In the event of a cardiac arrest, emergency medical dispatchers (EMDs) play a critical role by providing telephone-assisted cardiopulmonary resuscitation (T-CPR) to laypersons. The aim of our investigation was to describe compliance with the T-CPR protocol, the performance of the laypersons in a simulated T-CPR situation, and the communication between laypersons and EMDs during these actions. We conducted a retrospective observational study by analysing 20 recorded video and audio files. In a simulation, EMDs provided laypersons with instructions following T-CPR protocols. These were then analysed using a mixed method with convergent parallel design. If the EMDs complied with the T-CPR protocol, the laypersons performed the correct procedures in 71% of the actions. The single most challenging instruction of the T-CPR protocol, for both EMDs and laypersons, was airway control. Mean values for compression depth and frequency did not reach established guideline goals for CPR. Proper application of T-CPR protocols by EMDs resulted in better performance by laypersons in CPR. The most problematic task for EMDs as well for laypersons was airway management. The study results did not establish that the quality of communication between EMDs and laypersons performing CPR in a cardiac arrest situation led to statistically different outcomes, as measured by the quality and effectiveness of the CPR delivered. Copyright © 2014 Elsevier Ltd. All rights reserved.

  14. 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

    PubMed Central

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

    2015-01-01

    patients with IBD will be recruited into the study (with 1:1 allocation ratio). The primary endpoint is number of quality indicators met in HealthPROMISE versus control arm. Secondary endpoints include decrease in number of emergency visits due to IBD, decrease in number of hospitalization due to IBD, change in generic QOL score from baseline, proportion of patients in each group who meet all eligible outpatient quality metrics, and proportion of patients in disease control in each group. In addition, we plan to conduct protocol analysis of intervention patients with adequate HealthPROMISE utilization (more than 6 log-ins with data entry from week 0 through week 52) achieving above mentioned primary and secondary endpoints. Conclusions HealthPROMISE is a unique cloud-based patient-reported outcome (PRO) and decision support tool that empowers both patients and providers. Patients track their QOL and symptoms, and providers can use the visual data in real time (integrated with electronic health records [EHRs]) to provide better care to their entire patient population. Using pragmatic trial design, we hope to show that IBD patients who participate in their own care and share in decision making have appreciably improved outcomes when compared to patients who do not. Trial Registration ClinicalTrials.gov NCT02322307; https://clinicaltrials.gov/ct2/show/NCT02322307 (Archived by WebCite at http://www.webcitation.org/6W8PoYThr). PMID:25693610

  15. Streetlight Control System Based on Wireless Communication over DALI Protocol

    PubMed Central

    Bellido-Outeiriño, Francisco José; Quiles-Latorre, Francisco Javier; Moreno-Moreno, Carlos Diego; Flores-Arias, José María; Moreno-García, Isabel; Ortiz-López, Manuel

    2016-01-01

    Public lighting represents a large part of the energy consumption of towns and cities. Efficient management of public lighting can entail significant energy savings. This work presents a smart system for managing public lighting networks based on wireless communication and the DALI protocol. Wireless communication entails significant economic savings, as there is no need to install new wiring and visual impacts and damage to the facades of historical buildings in city centers are avoided. The DALI protocol uses bidirectional communication with the ballast, which allows its status to be controlled and monitored at all times. The novelty of this work is that it tackles all aspects related to the management of public lighting: a standard protocol, DALI, was selected to control the ballast, a wireless node based on the IEEE 802.15.4 standard with a DALI interface was designed, a network layer that considers the topology of the lighting network has been developed, and lastly, some user-friendly applications for the control and maintenance of the system by the technical crews of the different towns and cities have been developed. PMID:27128923

  16. Post-trial follow-up methodology in large randomized controlled trials: a systematic review protocol.

    PubMed

    Llewellyn-Bennett, Rebecca; Bowman, Louise; Bulbulia, Richard

    2016-12-15

    Clinical trials typically have a relatively short follow-up period, and may both underestimate potential benefits of treatments investigated, and fail to detect hazards, which can take much longer to emerge. Prolonged follow-up of trial participants after the end of the scheduled trial period can provide important information on both efficacy and safety outcomes. This protocol describes a systematic review to qualitatively compare methods of post-trial follow-up used in large randomized controlled trials. A systematic search of electronic databases and clinical trial registries will use a predefined search strategy. All large (more than 1000 adult participants) randomized controlled trials will be evaluated. Two reviewers will screen and extract data according to this protocol with the aim of 95% concordance of papers checked and discrepancies will be resolved by a third reviewer. Trial methods, participant retention rates and prevalence of missing data will be recorded and compared. The potential for bias will be evaluated using the Cochrane Risk of Bias tool (applied to the methods used during the in-trial period) with the aim of investigating whether the quality of the post-trial follow-up methodology might be predicted by the quality of the methods used for the original trial. Post-trial follow-up can provide valuable information about the long-term benefits and hazards of medical interventions. However, it can be logistically challenging and costly. The aim of this systematic review is to describe how trial participants have been followed-up post-trial in order to inform future post-trial follow-up designs. Not applicable for PROSPERO registration.

  17. Resource use and costs of type 2 diabetes patients receiving managed or protocolized primary care: a controlled clinical trial.

    PubMed

    van der Heijden, Amber A W A; de Bruijne, Martine C; Feenstra, Talitha L; Dekker, Jacqueline M; Baan, Caroline A; Bosmans, Judith E; Bot, Sandra D M; Donker, Gé A; Nijpels, Giel

    2014-06-25

    The increasing prevalence of diabetes is associated with increased health care use and costs. Innovations to improve the quality of care, manage the increasing demand for health care and control the growth of health care costs are needed. The aim of this study is to evaluate the care process and costs of managed, protocolized and usual care for type 2 diabetes patients from a societal perspective. In two distinct regions of the Netherlands, both managed and protocolized diabetes care were implemented. Managed care was characterized by centralized organization, coordination, responsibility and centralized annual assessment. Protocolized care had a partly centralized organizational structure. Usual care was characterized by a decentralized organizational structure. Using a quasi-experimental control group pretest-posttest design, the care process (guideline adherence) and costs were compared between managed (n = 253), protocolized (n = 197), and usual care (n = 333). We made a distinction between direct health care costs, direct non-health care costs and indirect costs. Multivariate regression models were used to estimate differences in costs adjusted for confounding factors. Because of the skewed distribution of the costs, bootstrapping methods (5000 replications) with a bias-corrected and accelerated approach were used to estimate 95% confidence intervals (CI) around the differences in costs. Compared to usual and protocolized care, in managed care more patients were treated according to diabetes guidelines. Secondary health care use was higher in patients under usual care compared to managed and protocolized care. Compared to usual care, direct costs were significantly lower in managed care (€-1.181 (95% CI: -2.597 to -334)) while indirect costs were higher (€ 758 (95% CI: -353 to 2.701), although not significant. Direct, indirect and total costs were lower in protocolized care compared to usual care (though not significantly). Compared to usual care, managed

  18. Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol.

    PubMed

    Furberg, Robert D; Ortiz, Alexa M; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

    2016-06-27

    Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care-related infections were reviewed to develop the infection control protocol to support tablet maintenance. This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings.

  19. Activity for Diabetic Polyneuropathy (ADAPT): Study Design and Protocol for a 2-Site Randomized Controlled Trial.

    PubMed

    Kluding, Patricia M; Singleton, J Robinson; Pasnoor, Mamatha; Dimachkie, Mazen M; Barohn, Richard J; Smith, A Gordon; Marcus, Robin L

    2017-01-01

    Half of all patients with diabetes develop diabetic peripheral neuropathy (DPN), a complication leading to reduced mobility and quality of life. Although there are no proven pharmacologic approaches to reduce DPN risk or slow its progression, evidence suggests that physical activity may improve symptoms and enhance peripheral nerve regeneration. The aim of the study will be to determine the impact of an intense lifestyle intervention on neuropathy progression and quality of life in individuals with DPN. The study will be a randomized controlled trial. The study will be conducted at 2 academic medical centers. The participants will be 140 individuals with type 2 diabetes and mild to moderate DPN. The intervention group will receive 18 months of supervised exercise training, actigraphy-based counseling to reduce sedentary behavior, and individualized dietary counseling. Control group participants will receive diet and activity counseling at baseline and at 9 months. The primary outcomes are neuropathy progression as measured by intraepidermal nerve fiber density in a distal thigh skin biopsy and the Norfolk Quality of Life-Diabetic Neuropathy score. Secondary outcomes include pain, gait, balance, and mobility measures. Due to the combined intervention approach, this protocol will not be able to determine which intervention components influence outcomes. There also may be difficulty with participant attrition during the 18-month study intervention. The Activity for Diabetic Polyneuropathy (ADAPT) protocol resulted from a collaboration between physical therapists and neurologist researchers that includes as primary outcomes both a quality-of-life measure (NQOL-DN) and a physiologic biomarker (IENFD). It has the potential to demonstrate that an intensive lifestyle intervention may be a sustainable, clinically effective approach for people with DPN that improves patient outcomes and can have an immediate impact on patient care and future clinical trials. © 2017 American

  20. An Ultra-low-power Medium Access Control Protocol for Body Sensor Network.

    PubMed

    Li, Huaming; Tan, Jindong

    2005-01-01

    In this paper, a medium access control (MAC) protocol designed for Body Sensor Network (BSN-MAC) is proposed. BSN-MAC is an adaptive, feedback-based and IEEE 802.15.4-compatible MAC protocol. Due to the traffic coupling and sensor diversity characteristics of BSNs, common MAC protocols can not satisfy the unique requirements of the biomedical sensors in BSN. BSN-MAC exploits the feedback information from the deployed sensors to form a closed-loop control of the MAC parameters. A control algorithm is proposed to enable the BSN coordinator to adjust parameters of the IEEE 802.15.4 superframe to achieve both energy efficiency and low latency on energy critical nodes. We evaluate the performance of BSN-MAC using energy efficiency as the primary metric.

  1. Incorporating Quality Control Information in the Sensor Web

    NASA Astrophysics Data System (ADS)

    Devaraju, Anusuriya; Kunkel, Ralf; Bogena, Heye

    2013-04-01

    The rapid development of sensing technologies had led to the creation of large amounts of heterogeneous environmental observations. The Sensor Web provides a wider access to sensors and observations via common protocols and specifications. Observations typically go through several levels of quality control, and aggregation before they are made available to end-users. Raw data are usually inspected, and related quality flags are assigned. Data are gap-filled, and errors are removed. New data series may also be derived from one or more corrected data sets. Until now, it is unclear how these kinds of information can be captured in the Sensor Web Enablement (SWE) framework. Apart from the quality measures (e.g., accuracy, precision, tolerance, or confidence), the levels of observational series, the changes applied, and the methods involved must be specified. It is important that this kind of quality control information is well described and communicated to end-users to allow for a better usage and interpretation of data products. In this paper, we describe how quality control information can be incorporated into the SWE framework. Concerning this, first, we introduce the TERENO (TERrestrial ENvironmental Observatories), an initiative funded by the large research infrastructure program of the Helmholtz Association in Germany. The main goal of the initiative is to facilitate the study of long-term effects of climate and land use changes. The TERENO Online Data RepOsitORry (TEODOOR) is a software infrastructure that supports acquisition, provision, and management of observations within TERENO via SWE specifications and several other OGC web services. Next, we specify changes made to the existing observational data model to incorporate quality control information. Here, we describe the underlying TERENO data policy in terms of provision and maintenance issues. We present data levels, and their implementation within TEODOOR. The data levels are adapted from those used by

  2. A cross-platform survey of CT image quality and dose from routine abdomen protocols and a method to systematically standardize image quality

    PubMed Central

    Favazza, Christopher P.; Duan, Xinhui; Zhang, Yi; Yu, Lifeng; Leng, Shuai; Kofler, James M.; Bruesewitz, Michael R.; McCollough, Cynthia H.

    2015-01-01

    Through this investigation we developed a methodology to evaluate and standardize CT image quality from routine abdomen protocols across different manufacturers and models. The influence of manufacturer-specific automated exposure control systems on image quality was directly assessed to standardize performance across a range of patient sizes. We evaluated 16 CT scanners across our health system, including Siemens, GE, and Toshiba models. Using each practice’s routine abdomen protocol, we measured spatial resolution, image noise, and scanner radiation output (CTDIvol). Axial and in-plane spatial resolutions were assessed through slice sensitivity profile (SSP) and modulation transfer function (MTF) measurements, respectively. Image noise and CTDIvol values were obtained for three different phantom sizes. SSP measurements demonstrated a bimodal distribution in slice widths: an average of 6.2 ± 0.2 mm using GE’s “Plus” mode reconstruction setting and 5.0 ± 0.1 mm for all other scanners. MTF curves were similar for all scanners. Average spatial frequencies at 50%, 10%, and 2% MTF values were 3.24 ± 0.37, 6.20 ± 0.34, and 7.84 ± 0.70 lp/cm, respectively. For all phantom sizes, image noise and CTDIvol varied considerably: 6.5–13.3 HU (noise) and 4.8–13.3 mGy (CTDIvol) for the smallest phantom; 9.1–18.4 HU and 9.3–28.8 mGy for the medium phantom; and 7.8–23.4 HU and 16.0–48.1 mGy for the largest phantom. Using these measurements and benchmark SSP, MTF, and image noise targets, CT image quality can be standardized across a range of patient sizes. PMID:26459751

  3. Distributed reservation control protocols for random access broadcasting channels

    NASA Technical Reports Server (NTRS)

    Greene, E. P.; Ephremides, A.

    1981-01-01

    Attention is given to a communication network consisting of an arbitrary number of nodes which can communicate with each other via a time-division multiple access (TDMA) broadcast channel. The reported investigation is concerned with the development of efficient distributed multiple access protocols for traffic consisting primarily of single packet messages in a datagram mode of operation. The motivation for the design of the protocols came from the consideration of efficient multiple access utilization of moderate to high bandwidth (4-40 Mbit/s capacity) communication satellite channels used for the transmission of short (1000-10,000 bits) fixed length packets. Under these circumstances, the ratio of roundtrip propagation time to packet transmission time is between 100 to 10,000. It is shown how a TDMA channel can be adaptively shared by datagram traffic and constant bandwidth users such as in digital voice applications. The distributed reservation control protocols described are a hybrid between contention and reservation protocols.

  4. A new communication protocol family for a distributed spacecraft control system

    NASA Technical Reports Server (NTRS)

    Baldi, Andrea; Pace, Marco

    1994-01-01

    In this paper we describe the concepts behind and architecture of a communication protocol family, which was designed to fulfill the communication requirements of ESOC's new distributed spacecraft control system SCOS 2. A distributed spacecraft control system needs a data delivery subsystem to be used for telemetry (TLM) distribution, telecommand (TLC) dispatch and inter-application communication, characterized by the following properties: reliability, so that any operational workstation is guaranteed to receive the data it needs to accomplish its role; efficiency, so that the telemetry distribution, even for missions with high telemetry rates, does not cause a degradation of the overall control system performance; scalability, so that the network is not the bottleneck both in terms of bandwidth and reconfiguration; flexibility, so that it can be efficiently used in many different situations. The new protocol family which satisfies the above requirements is built on top of widely used communication protocols (UDP and TCP), provides reliable point-to-point and broadcast communication (UDP+) and is implemented in C++. Reliability is achieved using a retransmission mechanism based on a sequence numbering scheme. Such a scheme allows to have cost-effective performances compared to the traditional protocols, because retransmission is only triggered by applications which explicitly need reliability. This flexibility enables applications with different profiles to take advantage of the available protocols, so that the best rate between sped and reliability can be achieved case by case.

  5. Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol

    PubMed Central

    Furberg, Robert D; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

    2016-01-01

    Background Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Objective Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. Methods The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care–related infections were reviewed to develop the infection control protocol to support tablet maintenance. Results This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. Conclusions These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings. PMID:27350013

  6. Medium Access Control Protocols for Cognitive Radio Ad Hoc Networks: A Survey

    PubMed Central

    Islam, A. K. M. Muzahidul; Baharun, Sabariah; Mansoor, Nafees

    2017-01-01

    New wireless network paradigms will demand higher spectrum use and availability to cope with emerging data-hungry devices. Traditional static spectrum allocation policies cause spectrum scarcity, and new paradigms such as Cognitive Radio (CR) and new protocols and techniques need to be developed in order to have efficient spectrum usage. Medium Access Control (MAC) protocols are accountable for recognizing free spectrum, scheduling available resources and coordinating the coexistence of heterogeneous systems and users. This paper provides an ample review of the state-of-the-art MAC protocols, which mainly focuses on Cognitive Radio Ad Hoc Networks (CRAHN). First, a description of the cognitive radio fundamental functions is presented. Next, MAC protocols are divided into three groups, which are based on their channel access mechanism, namely time-slotted protocol, random access protocol and hybrid protocol. In each group, a detailed and comprehensive explanation of the latest MAC protocols is presented, as well as the pros and cons of each protocol. A discussion on future challenges for CRAHN MAC protocols is included with a comparison of the protocols from a functional perspective. PMID:28926952

  7. The costs and cost-effectiveness of an integrated sepsis treatment protocol.

    PubMed

    Talmor, Daniel; Greenberg, Dan; Howell, Michael D; Lisbon, Alan; Novack, Victor; Shapiro, Nathan

    2008-04-01

    Sepsis is associated with high mortality and treatment costs. International guidelines recommend the implementation of integrated sepsis protocols; however, the true cost and cost-effectiveness of these are unknown. To assess the cost-effectiveness of an integrated sepsis protocol, as compared with conventional care. Prospective cohort study of consecutive patients presenting with septic shock and enrolled in the institution's integrated sepsis protocol. Clinical and economic outcomes were compared with a historical control cohort. Beth Israel Deaconess Medical Center. Overall, 79 patients presenting to the emergency department with septic shock in the treatment cohort and 51 patients in the control group. An integrated sepsis treatment protocol incorporating empirical antibiotics, early goal-directed therapy, intensive insulin therapy, lung-protective ventilation, and consideration for drotrecogin alfa and steroid therapy. In-hospital treatment costs were collected using the hospital's detailed accounting system. The cost-effectiveness analysis was performed from the perspective of the healthcare system using a lifetime horizon. The primary end point for the cost-effectiveness analysis was the incremental cost per quality-adjusted life year gained. Mortality in the treatment group was 20.3% vs. 29.4% in the control group (p = .23). Implementing an integrated sepsis protocol resulted in a mean increase in cost of approximately $8,800 per patient, largely driven by increased intensive care unit length of stay. Life expectancy and quality-adjusted life years were higher in the treatment group; 0.78 and 0.54, respectively. The protocol was associated with an incremental cost of $11,274 per life-year saved and a cost of $16,309 per quality-adjusted life year gained. In patients with septic shock, an integrated sepsis protocol, although not cost-saving, appears to be cost-effective and compares very favorably to other commonly delivered acute care interventions.

  8. Description of the Protocols for Randomized Controlled Trials on Cancer Drugs Conducted in Spain (1999–2003)

    PubMed Central

    Bonfill, Xavier; Ballesteros, Mónica; Gich, Ignasi; Serrano, María Antonia; García López, Fernando; Urrútia, Gerard

    2013-01-01

    Objective To describe the characteristics of randomized controlled clinical trials (RCT) on cancer drugs conducted in Spain between 1999 and 2003 based on their protocols. Methods We conducted an observational retrospective cohort study to identify the protocols of RCTs on cancer drugs authorized by the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) (Spanish Agency for Medicines and Medical Devices) during 1999-2003. A descriptive analysis was completed and the association between variables based on the study setting and sponsorship were assessed. Results We identified a total of 303 protocols, which included 176,835 potentially eligible patients. Three-quarter of the studies were internationally-based, 61.7% were phase III, and 76.2% were sponsored by pharmaceutical companies. The most frequently assessed outcomes were response rate (24.7%), overall survival (20.7%), and progression-free survival (14.5%). Of all protocols, 10.6% intended to include more than 1000 patients (mean: 2442, SD: 2724). Compared with their national counterparts, internationally-based studies were significantly larger (p<0.001) and were more likely to implement centralized randomization (p<0.001), blinding of the intervention (p<0.001), and survival as primary outcome (p<0.001). Additionally, most internationally-based studies were sponsored by pharmaceutical companies (p<0.01). In a high percentage of protocols, the available information was not explicit enough to assess the validity of each trial. Compared to other European countries, the proportion of Spanish cancer drugs protocols registered at www.clinicaltrials.gov (7%) was lower. Conclusion RCTs on cancer drugs conducted in Spain between 1999 and 2003 were more likely to be promoted by pharmaceutical companies rather than by non-profit national groups. The former were more often part of international studies, which generally had better methodological quality than national ones. There are some worldwide on

  9. Quality Risk Management: Putting GMP Controls First.

    PubMed

    O'Donnell, Kevin; Greene, Anne; Zwitkovits, Michael; Calnan, Nuala

    2012-01-01

    This paper presents a practical way in which current approaches to quality risk management (QRM) may be improved, such that they better support qualification, validation programs, and change control proposals at manufacturing sites. The paper is focused on the treatment of good manufacturing practice (GMP) controls during QRM exercises. It specifically addresses why it is important to evaluate and classify such controls in terms of how they affect the severity, probability of occurrence, and detection ratings that may be assigned to potential failure modes or negative events. It also presents a QRM process that is designed to directly link the outputs of risk assessments and risk control activities with qualification and validation protocols in the GMP environment. This paper concerns the need for improvement in the use of risk-based principles and tools when working to ensure that the manufacturing processes used to produce medicines, and their related equipment, are appropriate. Manufacturing processes need to be validated (or proven) to demonstrate that they can produce a medicine of the required quality. The items of equipment used in such processes need to be qualified, in order to prove that they are fit for their intended use. Quality risk management (QRM) tools can be used to support such qualification and validation activities, but their use should be science-based and subject to as little subjectivity and uncertainty as possible. When changes are proposed to manufacturing processes, equipment, or related activities, they also need careful evaluation to ensure that any risks present are managed effectively. This paper presents a practical approach to how QRM may be improved so that it better supports qualification, validation programs, and change control proposals in a more scientific way. This improved approach is based on the treatment of what are called good manufacturing process (GMP) controls during those QRM exercises. A GMP control can be considered

  10. FQC Dashboard: integrates FastQC results into a web-based, interactive, and extensible FASTQ quality control tool

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Brown, Joseph; Pirrung, Meg; McCue, Lee Ann

    FQC is software that facilitates quality control of FASTQ files by carrying out a QC protocol using FastQC, parsing results, and aggregating quality metrics into an interactive dashboard designed to richly summarize individual sequencing runs. The dashboard groups samples in dropdowns for navigation among the data sets, utilizes human-readable configuration files to manipulate the pages and tabs, and is extensible with CSV data.

  11. FQC Dashboard: integrates FastQC results into a web-based, interactive, and extensible FASTQ quality control tool

    DOE PAGES

    Brown, Joseph; Pirrung, Meg; McCue, Lee Ann

    2017-06-09

    FQC is software that facilitates quality control of FASTQ files by carrying out a QC protocol using FastQC, parsing results, and aggregating quality metrics into an interactive dashboard designed to richly summarize individual sequencing runs. The dashboard groups samples in dropdowns for navigation among the data sets, utilizes human-readable configuration files to manipulate the pages and tabs, and is extensible with CSV data.

  12. Appearance Investment, Quality of Life, and Metabolic Control Among Women with Type 1 Diabetes.

    PubMed

    Gawlik, Nicola R; Elias, Anna J; Bond, Malcolm J

    2016-06-01

    Concomitants of Type 1 diabetes management include weight gain and dietary restraint. Body image concerns, particularly among women, are therefore common. The study evaluated associations between the appearance investment component of body image, age, quality of life and self-reported metabolic control were examined, along with the practice of insulin restriction as a weight control strategy. A questionnaire comprising demographic and diabetes-related information, the Appearance Schemas Inventory, and Diabetes Quality of Life Brief Clinical Inventory was completed by Australian women diagnosed with type 1 diabetes (N = 177). Self-evaluative salience was higher among younger participants, those with a lower quality of life, and those with better metabolic control of their diabetes, with the relationships between metabolic control and all of age, quality of life, and self-evaluative salience noted to be non-linear. Among participants who reported restricting insulin for weight control, self-evaluative salience was particularly relevant. Motivational salience was not related to other study variables. Clinically, the provision of information regarding appearance changes that might arise in order to mitigate later body image difficulties is a potentially beneficial adjunct to standard diabetes management protocols that may lead to more successful disease adjustment.

  13. A cross-platform survey of CT image quality and dose from routine abdomen protocols and a method to systematically standardize image quality.

    PubMed

    Favazza, Christopher P; Duan, Xinhui; Zhang, Yi; Yu, Lifeng; Leng, Shuai; Kofler, James M; Bruesewitz, Michael R; McCollough, Cynthia H

    2015-11-07

    Through this investigation we developed a methodology to evaluate and standardize CT image quality from routine abdomen protocols across different manufacturers and models. The influence of manufacturer-specific automated exposure control systems on image quality was directly assessed to standardize performance across a range of patient sizes. We evaluated 16 CT scanners across our health system, including Siemens, GE, and Toshiba models. Using each practice's routine abdomen protocol, we measured spatial resolution, image noise, and scanner radiation output (CTDIvol). Axial and in-plane spatial resolutions were assessed through slice sensitivity profile (SSP) and modulation transfer function (MTF) measurements, respectively. Image noise and CTDIvol values were obtained for three different phantom sizes. SSP measurements demonstrated a bimodal distribution in slice widths: an average of 6.2  ±  0.2 mm using GE's 'Plus' mode reconstruction setting and 5.0  ±  0.1 mm for all other scanners. MTF curves were similar for all scanners. Average spatial frequencies at 50%, 10%, and 2% MTF values were 3.24  ±  0.37, 6.20  ±  0.34, and 7.84  ±  0.70 lp cm(-1), respectively. For all phantom sizes, image noise and CTDIvol varied considerably: 6.5-13.3 HU (noise) and 4.8-13.3 mGy (CTDIvol) for the smallest phantom; 9.1-18.4 HU and 9.3-28.8 mGy for the medium phantom; and 7.8-23.4 HU and 16.0-48.1 mGy for the largest phantom. Using these measurements and benchmark SSP, MTF, and image noise targets, CT image quality can be standardized across a range of patient sizes.

  14. Quality Leadership and Quality Control

    PubMed Central

    Badrick, Tony

    2003-01-01

    Different quality control rules detect different analytical errors with varying levels of efficiency depending on the type of error present, its prevalence and the number of observations. The efficiency of a rule can be gauged by inspection of a power function graph. Control rules are only part of a process and not an end in itself; just as important are the trouble-shooting systems employed when a failure occurs. 'Average of patient normals' may develop as a usual adjunct to conventional quality control serum based programmes. Acceptable error can be based on various criteria; biological variation is probably the most sensible. Once determined, acceptable error can be used as limits in quality control rule systems. A key aspect of an organisation is leadership, which links the various components of the quality system. Leadership is difficult to characterise but its key aspects include trust, setting an example, developing staff and critically setting the vision for the organisation. Organisations also have internal characteristics such as the degree of formalisation, centralisation, and complexity. Medical organisations can have internal tensions because of the dichotomy between the bureaucratic and the shadow medical structures. PMID:18568046

  15. Employing quality control and feedback to the EQ-5D-5L valuation protocol to improve the quality of data collection.

    PubMed

    Purba, Fredrick Dermawan; Hunfeld, Joke A M; Iskandarsyah, Aulia; Fitriana, Titi Sahidah; Sadarjoen, Sawitri S; Passchier, Jan; Busschbach, Jan J V

    2017-05-01

    In valuing health states using generic questionnaires such as EQ-5D, there are unrevealed issues with the quality of the data collection. The aims were to describe the problems encountered during valuation and to evaluate a quality control report and subsequent retraining of interviewers in improving this valuation. Data from the first 266 respondents in an EQ-5D-5L valuation study were used. Interviewers were trained and answered questions regarding problems during these initial interviews. Thematic analysis was used, and individual feedback was provided. After completion of 98 interviews, a first quantitative quality control (QC) report was generated, followed by a 1-day retraining program. Subsequently individual feedback was also given on the basis of follow-up QCs. The Wilcoxon signed-rank test was used to assess improvements based on 7 indicators of quality as identified in the first QC and the QC conducted after a further 168 interviews. Interviewers encountered problems in recruiting respondents. Solutions provided were: optimization of the time of interview, the use of broader networks and the use of different scripts to explain the project's goals to respondents. For problems in interviewing process, solutions applied were: developing the technical and personal skills of the interviewers and stimulating the respondents' thought processes. There were also technical problems related to hardware, software and internet connections. There was an improvement in all 7 indicators of quality after the second QC. Training before and during a study, and individual feedback on the basis of a quantitative QC, can increase the validity of values obtained from generic questionnaires.

  16. Resource use and costs of type 2 diabetes patients receiving managed or protocolized primary care: a controlled clinical trial

    PubMed Central

    2014-01-01

    Background The increasing prevalence of diabetes is associated with increased health care use and costs. Innovations to improve the quality of care, manage the increasing demand for health care and control the growth of health care costs are needed. The aim of this study is to evaluate the care process and costs of managed, protocolized and usual care for type 2 diabetes patients from a societal perspective. Methods In two distinct regions of the Netherlands, both managed and protocolized diabetes care were implemented. Managed care was characterized by centralized organization, coordination, responsibility and centralized annual assessment. Protocolized care had a partly centralized organizational structure. Usual care was characterized by a decentralized organizational structure. Using a quasi-experimental control group pretest-posttest design, the care process (guideline adherence) and costs were compared between managed (n = 253), protocolized (n = 197), and usual care (n = 333). We made a distinction between direct health care costs, direct non-health care costs and indirect costs. Multivariate regression models were used to estimate differences in costs adjusted for confounding factors. Because of the skewed distribution of the costs, bootstrapping methods (5000 replications) with a bias-corrected and accelerated approach were used to estimate 95% confidence intervals (CI) around the differences in costs. Results Compared to usual and protocolized care, in managed care more patients were treated according to diabetes guidelines. Secondary health care use was higher in patients under usual care compared to managed and protocolized care. Compared to usual care, direct costs were significantly lower in managed care (€-1.181 (95% CI: -2.597 to -334)) while indirect costs were higher (€758 (95% CI: -353 to 2.701), although not significant. Direct, indirect and total costs were lower in protocolized care compared to usual care (though not

  17. Music therapy in Huntington's disease: a protocol for a multi-center randomized controlled trial.

    PubMed

    van Bruggen-Rufi, Monique; Vink, Annemieke; Achterberg, Wilco; Roos, Raymund

    2016-07-26

    Huntington's disease is a progressive, neurodegenerative disease with autosomal dominant inheritance, characterized by motor disturbances, cognitive decline and behavioral and psychological symptoms. Since there is no cure, all treatment is aimed at improving quality of life. Music therapy is a non-pharmacological intervention, aiming to improve the quality of life, but its use and efficacy in patients with Huntington's disease has hardly been studied. In this article, a protocol is described to study the effects of music therapy in comparison with a control intervention to improve quality of life through stimulating expressive and communicative skills. By targeting these skills we assume that the social-cognitive functioning will improve, leading to a reduction in behavioral problems, resulting in an overall improvement of the quality of life in patients with Huntington's disease. The study is designed as a multi-center single-blind randomised controlled intervention trial. Sixty patients will be randomised using centre-stratified block-permuted randomisation. Patients will be recruited from four long-term care facilities specialized in Huntington's disease-care in The Netherlands. The outcome measure to assess changes in expressive and communication skills is the Behaviour Observation Scale Huntington and changes in behavior will be assessed by the Problem Behaviour Assesment-short version and by the BOSH. Measurements take place at baseline, then 8, 16 (end of intervention) and 12 weeks after the last intervention (follow-up). This randomized controlled study will provide greater insight into the effectiveness of music therapy on activities of daily living, social-cognitive functioning and behavior problems by improving expressive and communication skills, thus leading to a better quality of life for patients with Huntington's disease. Netherlands Trial Register: NTR4904 , registration date Nov. 15, 2014.

  18. Owner perceptions of their cat's quality of life when treated with a modified University of Wisconsin-Madison protocol for lymphoma.

    PubMed

    Thornton, Laura A; Cave, Nicholas; Bridges, Janis P; Stell, Anneliese J

    2018-04-01

    Objectives The objectives of this study were to assess owner perceptions of their cat's quality of life during treatment for lymphoma with a doxorubicin-containing multi-agent chemotherapy protocol, whether various health-related parameters correlated with quality of life scores, and to assess owner satisfaction with the protocol. Methods A postal questionnaire was sent to the owners of 33 treated cats. Owners retrospectively assessed their cat's quality of life using a Likert scale (1-10) before lymphoma was diagnosed, at diagnosis and during chemotherapy. Owners assigned scores to various health-related parameters previously reported to affect quality of life at the three time points, and correlations with quality of life scores were sought. Owners were asked to rate the importance of these health-related parameters. Satisfaction with the protocol was investigated. Results Twenty questionnaires were completed (61% response rate). The median quality of life score before diagnosis (10, range 5-10) was higher than at diagnosis (3, range 1-9) ( P <0.05). The median quality of life score during chemotherapy (7, range 3-9) was lower than before diagnosis ( P <0.05) and higher than at diagnosis, but this was not statistically significant. Quality of life scores did not correlate with individual health-related parameter scores consistently; however, quality of life scores did correlate with appetite scores during chemotherapy. Appetite, vomiting and diarrhoea were parameters perceived as important in affecting quality of life. Most owners (75%) were happy they had treated their cat. Conclusions and relevance The quality of life scores observed were comparable to a previous study using cyclophosphamide, vincristine and prednisolone, employing the same scoring system. Although quality of life scores during chemotherapy were not significantly improved at diagnosis, owner satisfaction with the protocol was high. The factors perceived by owners to determine quality of life in

  19. A randomized controlled clinical trial evaluating quality of life when using a simple acupressure protocol in women with primary dysmenorrhea.

    PubMed

    Bazarganipour, Fatemeh; Taghavi, Seyed-Abdolvahab; Allan, Helen; Hosseini, Nazafarin; Khosravi, Ahmad; Asadi, Rahimeh; Salari, Shohreh; Dehghani, Raziyeh; Jamshidi, Zahra; Rezaei, Marziyeh; Saberian, Mansoreh; Javedan, Fatemeh; Salari, Zahra; Miri, Fahimeh

    2017-10-01

    To evaluate a simple acupressure protocol in LIV3 and LI4 acupoints in women with primary dysmenorrhea. This paper reports a randomized, single blinded clinical trial. 90 young women with dysmenorrhea were recruited to three groups to receive 20min acupressure every day in either LIV3 or LI4, or placebo points. Acupressure was timed five days before menstruation for three successive menstrual cycles. On menstruation, each participant completed the Wong Baker faces pain scale, and the quality of life short form -12 (QOL SF-12). Intensity and duration of pain between the three groups in the second and third cycles during the intervention (p<0.05) differed significantly. Significant differences were seen in all domains of QOL except for mental health (p=0.4), general health (p=0.7) and mental subscale component (p=0.12) in the second cycle, and mental health (p=0.9), and mental subscale component (p=0.14) in the third cycle. Performing the simple acupressure protocol is an effective method to decrease the intensity and duration of dysmenorrhea, and improve the QOL. Registration ID in IRCT: IRCT2016052428038N1. Copyright © 2017. Published by Elsevier Ltd.

  20. Performance of Stochastic Targeted Blood Glucose Control Protocol by virtual trials in the Malaysian intensive care unit.

    PubMed

    Jamaludin, Ummu K; M Suhaimi, Fatanah; Abdul Razak, Normy Norfiza; Md Ralib, Azrina; Mat Nor, Mohd Basri; Pretty, Christopher G; Humaidi, Luqman

    2018-08-01

    Blood glucose variability is common in healthcare and it is not related or influenced by diabetes mellitus. To minimise the risk of high blood glucose in critically ill patients, Stochastic Targeted Blood Glucose Control Protocol is used in intensive care unit at hospitals worldwide. Thus, this study focuses on the performance of stochastic modelling protocol in comparison to the current blood glucose management protocols in the Malaysian intensive care unit. Also, this study is to assess the effectiveness of Stochastic Targeted Blood Glucose Control Protocol when it is applied to a cohort of diabetic patients. Retrospective data from 210 patients were obtained from a general hospital in Malaysia from May 2014 until June 2015, where 123 patients were having comorbid diabetes mellitus. The comparison of blood glucose control protocol performance between both protocol simulations was conducted through blood glucose fitted with physiological modelling on top of virtual trial simulations, mean calculation of simulation error and several graphical comparisons using stochastic modelling. Stochastic Targeted Blood Glucose Control Protocol reduces hyperglycaemia by 16% in diabetic and 9% in nondiabetic cohorts. The protocol helps to control blood glucose level in the targeted range of 4.0-10.0 mmol/L for 71.8% in diabetic and 82.7% in nondiabetic cohorts, besides minimising the treatment hour up to 71 h for 123 diabetic patients and 39 h for 87 nondiabetic patients. It is concluded that Stochastic Targeted Blood Glucose Control Protocol is good in reducing hyperglycaemia as compared to the current blood glucose management protocol in the Malaysian intensive care unit. Hence, the current Malaysian intensive care unit protocols need to be modified to enhance their performance, especially in the integration of insulin and nutrition intervention in decreasing the hyperglycaemia incidences. Improvement in Stochastic Targeted Blood Glucose Control Protocol in terms of u en

  1. Difficult‐to‐control asthma management through the use of a specific protocol

    PubMed Central

    Giavina‐Bianchi, Pedro; Aun, Marcelo Vivolo; Bisaccioni, Carla; Agondi, Rosana; Kalil, Jorge

    2010-01-01

    The present study is a critical review of difficult‐to‐control asthma, highlighting the characteristics and severity of the disease. It also presents a protocol for the management of patients with this asthma phenotype. The protocol, which was based on relevant studies in the literature, is described and analyzed. PMID:21049219

  2. Improvement in quality of life and sexual functioning in a comorbid sample after the unified protocol transdiagnostic group treatment.

    PubMed

    de Ornelas Maia, Ana Claudia Corrêa; Sanford, Jenny; Boettcher, Hannah; Nardi, Antonio E; Barlow, David

    2017-10-01

    Patients with multiple mental disorders often experience sexual dysfunction and reduced quality of life. The unified protocol (UP) is a transdiagnostic treatment for emotional disorders that has the potential to improve quality of life and sexual functioning via improved emotion management. The present study evaluates changes in quality of life and sexual functioning in a highly comorbid sample treated with the UP in a group format. Forty-eight patients were randomly assigned to either a UP active-treatment group or a medication-only control group. Treatment was delivered in 14 sessions over the course of 4 months. Symptoms of anxiety and depression were assessed using the Beck Anxiety Inventory and Beck Depression Inventory. Sexual functioning was assessed by the Arizona Sexual Experience Scale (ASEX), and quality of life was assessed by the World Health Organization Quality of Life-BREF scale (WHOQOL-BREF). Quality of life, anxiety and depression all significantly improved among participants treated with the UP. Some improvement in sexual functioning was also noted. The results support the efficacy of the UP in improving quality of life and sexual functioning in comorbid patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. [Applying back massage protocol to promote an intensive care unit patient's quality of sleep].

    PubMed

    Fang, Chiu-Shu; Liu, Chin-Fang

    2006-12-01

    This case report concerns the nursing experience of applying back massage to a patient in an intensive care unit (ICU) from 10 May, 2005, in order to improve the patient's quality of sleep. In order to collect information about his quality of sleep of the patient, the author used observation, interview and a Richards-Campbell sleep questionnaire (RCSQ). It was observed that, before massage, the patient's sleep quality was poor, which wa why the protocol with back massage was proposed. The results after back massage was applied that heart beat, respiration. oxygen saturation and blood pressure were not significantly improved. This was probably related to the patient's worry about having his endotracheal tube removed. The patient's perception of sleep, indeed, was obviously improved, a result which may have been related to his/her perception of comfort and care from the nurse. Applying back massage to an ICU patient may therefore be regarded as helpful improving the patient's sleep quality. It is hoped that this case report may serve as a positive reference for health care providers so that it may help patients to recover fully through rest and sleep. Since this report concerned only one patient, however, to understand the real outcome of how back massage could improve the quality of sleep of ICU patients, research is planned on the use of back massage protocol on a large number os such patients.

  4. Tongue pressure profile training for dysphagia post stroke (TPPT): study protocol for an exploratory randomized controlled trial.

    PubMed

    Steele, Catriona M; Bayley, Mark A; Péladeau-Pigeon, Melanie; Stokely, Shauna L

    2013-05-07

    It is estimated that approximately 50% of stroke survivors will experience swallowing difficulty, or dysphagia. The associated sequelae of dysphagia include dehydration, malnutrition, and aspiration pneumonia, all of which have can have serious medical consequences. To improve swallowing safety and efficiency, alternative nutritional intake methods (for example, a feeding tube) or a modified diet texture (such as pureed foods or thickened liquids) may be recommended but these modifications may negatively affect quality of life. An alternative approach to treating dysphagia has emerged over the past few years, targeting stronger lingual muscles through maximal isometric pressure tasks. Although these studies have shown promising results, thin-liquid bolus control continues to be challenging for patients with dysphagia. Previous work investigating lingual pressures when healthy participants swallow has suggested that greater task specificity in lingual exercises may yield improved results with thin liquids. This is a small, exploratory randomized clinical trial being conducted with post-stroke patients 4 to 20 weeks after onset of dysphagia secondary to impaired lingual control. At enrollment, participants are randomly assigned to one of two treatment protocols, either tongue pressure profile training (TPPT) or the control treatment, tongue pressure strength-and-accuracy training (TPSAT). Each treatment protocol consists of 24 sessions of treatment over 8 to 12 weeks with monitoring of tongue pressure as well as a baseline and outcome videofluoroscopic swallowing study. Tongue pressure measures, videofluoroscopic measures, and functional outcome measures will be obtained following training of 60 participants (30 in each condition), to determine whether TPPT yields better outcomes. This study will continue to explore options beyond tube feeding and modified diets for people with neurogenic dysphagia following stroke. Should the novel protocol, TPPT, prove to be more

  5. Incentive spirometry combined with expiratory positive airway pressure improves asthma control and quality of life in asthma: a randomised controlled trial.

    PubMed

    Rondinel, Tatiana Zacarias; Corrêa, Isadora Faraco; Hoscheidt, Luíza Machado; Bueno, Mirelle Hugo; Da Silva, Luciano Muller Corrêa; Reppold, Caroline Tozzi; Dal Lago, Pedro

    2015-03-01

    The use of the incentive spirometer (IS) and expiratory positive airway pressure (EPAP) provides several benefits in patients with respiratory disorders. However, the effects of the use of these devices coupled (IS + EPAP) are still unknown in asthmatic patients. The aim of this study was to evaluate the effect of IS associated with EPAP on exercise tolerance (six-minute walk test - 6MWT), lung function (by spirometry), asthma control (Asthma Control Questionnaire - ACQ) and quality of life (Asthma Quality of Life Questionnaire - AQLQ) in patients with severe asthma. Patients were randomised into two groups: IS + EPAP (n = 8) and control (n = 6). The IS + EPAP group performed breathing exercises at home, twice daily for 20 min, over a period of 5 weeks. There was no significant difference in spirometric variables and in the distance walked in the 6MWT in both groups. However, the IS + EPAP group showed an improvement in asthma control (p = 0.002) and quality of life (p = 0.02). These findings demonstrate that the IS + EPAP protocol, when performed at home, provides an improvement in asthma control and quality of life for patients with severe asthma when evaluated by ACQ and AQLQ, respectively.

  6. Strategies to improve the quality of life of persons post-stroke: protocol of a systematic review.

    PubMed

    Munce, Sarah E P; Perrier, Laure; Shin, Saeha; Adhihetty, Chamila; Pitzul, Kristen; Nelson, Michelle L A; Bayley, Mark T

    2017-09-07

    While many outcomes post-stroke (e.g., depression) have been previously investigated, there is no complete data on the impact of a variety of quality improvement strategies on the quality of life and physical and psychological well-being of individuals post-stroke. The current paper outlines a systematic review protocol on the impact of quality improvement strategies on quality of life as well as physical and psychological well-being of individuals with stroke. MEDLINE, CINAHL, EMBASE, and PsycINFO databases will be searched. Two independent reviewers will conduct all levels of screening, data abstraction, and quality appraisal. Only randomized controlled trials that report on the impact of quality improvement strategies on quality of life outcomes in people with stroke will be included. The secondary outcomes will be physical and psychological well-being. Quality improvement strategies include audit and feedback, case management, team changes, electronic patient registries, clinician education, clinical reminders, facilitated relay of clinical information to clinicians, patient education, (promotion of) self-management, patient reminder systems, and continuous quality improvement. Studies published since 2000 will be included to increase the relevancy of findings. Results will be grouped according to the target group of the varying quality improvement strategies (i.e., health system, health care professionals, or patients) and/or by any other noteworthy grouping variables, such as etiology of stroke or by sex. This systematic review will identify those quality improvement strategies aimed at the health system, health care professionals, and patients that impact the quality of life of individuals with stroke. Improving awareness and utilization of such strategies may enhance uptake of stroke best practices and reduce inappropriate health care utilization costs. PROSPERO, CRD42017064141.

  7. Reliable multicast protocol specifications flow control and NACK policy

    NASA Technical Reports Server (NTRS)

    Callahan, John R.; Montgomery, Todd L.; Whetten, Brian

    1995-01-01

    This appendix presents the flow and congestion control schemes recommended for RMP and a NACK policy based on the whiteboard tool. Because RMP uses a primarily NACK based error detection scheme, there is no direct feedback path through which receivers can signal losses through low buffer space or congestion. Reliable multicast protocols also suffer from the fact that throughput for a multicast group must be divided among the members of the group. This division is usually very dynamic in nature and therefore does not lend itself well to a priori determination. These facts have led the flow and congestion control schemes of RMP to be made completely orthogonal to the protocol specification. This allows several differing schemes to be used in different environments to produce the best results. As a default, a modified sliding window scheme based on previous algorithms are suggested and described below.

  8. Choosing GnRH Antagonist Protocol Shows Improved Oocyte and Embryo Quality, Coherent with the Perifollicular Vascularity (PFV) in Assisted Reproductive Techniques

    PubMed Central

    Ramachandran, Amar; Kumar, Pratap

    2015-01-01

    Introduction The parent oocyte from which the embryo is derived, determines its quality and the perifollicular vascularity (PFV) determines the micro-environment of the developing ovum. The PFV correlates well with the follicular oxygenation, oocyte maturation and embryo viability. PFV is imaged with Power Doppler Ultrasound. Aim To study and compare the association of the PFV of follicles with the quality of the oocytes and embryos in agonist and antagonist protocol, employed in Assisted Reproductive techniques (ART). Study Design A prospective observational study was conducted on 75 patients, who were recruited for ART cycles, out of which 25 were given the Agonist protocol and the remaining 50 received the Antagonist protocol. Materials and Methods The patients underwent the stimulation protocol. The PFV of preovulatory follicles were studied with Transvaginal Power Doppler and graded. Each oocyte retrieved carried the same label of its parent follicle. Embryos were cultured. The embryologist was blinded. The oocyte and embryo quality were assessed and compared with the PFV of parent follicle. Results Follicles with grade 1 and 2 PFV were predominantly observed. The yield of oocytes was independent of PFV. The mean yield of good quality embryos in conjunction with the PFV of the parent follicle was found to be highly significant in both the groups. The antagonist group had statistically significant yield of mature oocytes and embryos, compared to the agonist group. Conclusion Antagonist protocol had favourable outcomes compared with the agonist protocol. The retrieval of oocytes, even the mature ones and the yield of high grade embryos were found higher. As the PFV increased, the yield and overall pregnancy rates were higher. PFV as assessed by Power Doppler is a useful non-invasive biomarker of embryo quality and can be employed in conjunction with other biomarkers in ART to predict successful outcome. PMID:26674932

  9. SU-F-18C-01: Minimum Detectability Analysis for Comprehensive Sized Based Optimization of Image Quality and Radiation Dose Across CT Protocols

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Smitherman, C; Chen, B; Samei, E

    2014-06-15

    Purpose: This work involved a comprehensive modeling of task-based performance of CT across a wide range of protocols. The approach was used for optimization and consistency of dose and image quality within a large multi-vendor clinical facility. Methods: 150 adult protocols from the Duke University Medical Center were grouped into sub-protocols with similar acquisition characteristics. A size based image quality phantom (Duke Mercury Phantom) was imaged using these sub-protocols for a range of clinically relevant doses on two CT manufacturer platforms (Siemens, GE). The images were analyzed to extract task-based image quality metrics such as the Task Transfer Function (TTF),more » Noise Power Spectrum, and Az based on designer nodule task functions. The data were analyzed in terms of the detectability of a lesion size/contrast as a function of dose, patient size, and protocol. A graphical user interface (GUI) was developed to predict image quality and dose to achieve a minimum level of detectability. Results: Image quality trends with variations in dose, patient size, and lesion contrast/size were evaluated and calculated data behaved as predicted. The GUI proved effective to predict the Az values representing radiologist confidence for a targeted lesion, patient size, and dose. As an example, an abdomen pelvis exam for the GE scanner, with a task size/contrast of 5-mm/50-HU, and an Az of 0.9 requires a dose of 4.0, 8.9, and 16.9 mGy for patient diameters of 25, 30, and 35 cm, respectively. For a constant patient diameter of 30 cm, the minimum detected lesion size at those dose levels would be 8.4, 5, and 3.9 mm, respectively. Conclusion: The designed CT protocol optimization platform can be used to evaluate minimum detectability across dose levels and patient diameters. The method can be used to improve individual protocols as well as to improve protocol consistency across CT scanners.« less

  10. Two new Controlled not Gate Based Quantum Secret Sharing Protocols without Entanglement Attenuation

    NASA Astrophysics Data System (ADS)

    Zhu, Zhen-Chao; Hu, Ai-Qun; Fu, An-Min

    2016-05-01

    In this paper, we propose two new controlled not gate based quantum secret sharing protocols. In these two protocols, each photon only travels once, which guarantees the agents located in long distance can be able to derive the dealer's secret without suffering entanglement attenuation problem. The protocols are secure against trojan horse attack, intercept-resend attack, entangle-measure attack and entanglement-swapping attack. The theoretical efficiency for qubits of these two protocols can approach 100 %, except those used for eavesdropping checking, all entangled states can be used for final secret sharing.

  11. Semi-quantum communication: protocols for key agreement, controlled secure direct communication and dialogue

    NASA Astrophysics Data System (ADS)

    Shukla, Chitra; Thapliyal, Kishore; Pathak, Anirban

    2017-12-01

    Semi-quantum protocols that allow some of the users to remain classical are proposed for a large class of problems associated with secure communication and secure multiparty computation. Specifically, first-time semi-quantum protocols are proposed for key agreement, controlled deterministic secure communication and dialogue, and it is shown that the semi-quantum protocols for controlled deterministic secure communication and dialogue can be reduced to semi-quantum protocols for e-commerce and private comparison (socialist millionaire problem), respectively. Complementing with the earlier proposed semi-quantum schemes for key distribution, secret sharing and deterministic secure communication, set of schemes proposed here and subsequent discussions have established that almost every secure communication and computation tasks that can be performed using fully quantum protocols can also be performed in semi-quantum manner. Some of the proposed schemes are completely orthogonal-state-based, and thus, fundamentally different from the existing semi-quantum schemes that are conjugate coding-based. Security, efficiency and applicability of the proposed schemes have been discussed with appropriate importance.

  12. Implementation of Quality Assurance and Quality Control Measures in the National Phenology Database

    NASA Astrophysics Data System (ADS)

    Gerst, K.; Rosemartin, A.; Denny, E. G.; Marsh, L.; Barnett, L.

    2015-12-01

    The USA National Phenology Network (USA-NPN; www.usanpn.org) serves science and society by promoting a broad understanding of plant and animal phenology and the relationships among phenological patterns and environmental change. The National Phenology Database has over 5.5 million observation records for plants and animals for the period 1954-2015. These data have been used in a number of science, conservation and resource management applications, including national assessments of historical and potential future trends in phenology, regional assessments of spatio-temporal variation in organismal activity, and local monitoring for invasive species detection. Customizable data downloads are freely available, and data are accompanied by FGDC-compliant metadata, data-use and data-attribution policies, and vetted documented methodologies and protocols. The USA-NPN has implemented a number of measures to ensure both quality assurance and quality control. Here we describe the resources that have been developed so that incoming data submitted by both citizen and professional scientists are reliable; these include training materials, such as a botanical primer and species profiles. We also describe a number of automated quality control processes applied to incoming data streams to optimize data output quality. Existing and planned quality control measures for output of raw and derived data include: (1) Validation of site locations, including latitude, longitude, and elevation; (2) Flagging of records that conflict for a given date for an individual plant; (3) Flagging where species occur outside known ranges; (4) Flagging of records when phenophases occur outside of the plausible order for a species; (5) Flagging of records when intensity measures do not follow a plausible progression for a phenophase; (6) Flagging of records when a phenophase occurs outside of the plausible season, and (7) Quantification of precision and uncertainty for estimation of phenological metrics

  13. Optimizing preservation protocols to extract high-quality RNA from different tissues of echinoderms for next-generation sequencing.

    PubMed

    Pérez-Portela, Rocío; Riesgo, Ana

    2013-09-01

    Transcriptomic information provides fundamental insights into biological processes. Extraction of quality RNA is a challenging step, and preservation and extraction protocols need to be adjusted in many cases. Our objectives were to optimize preservation protocols for isolation of high-quality RNA from diverse echinoderm tissues and to compare the utility of parameters as absorbance ratios and RIN values to assess RNA quality. Three different tissues (gonad, oesophagus and coelomocytes) were selected from the sea urchin Arbacia lixula. Solid tissues were flash-frozen and stored at -80 °C until processed. Four preservation treatments were applied to coelomocytes: flash freezing and storage at -80 °C, RNAlater and storage at -20 °C, preservation in TRIzol reagent and storage at -80 °C and direct extraction with TRIzol from fresh cells. Extractions of total RNA were performed with a modified TRIzol protocol for all tissues. Our results showed high values of RNA quantity and quality for all tissues, showing nonsignificant differences among them. However, while flash freezing was effective for solid tissues, it was inadequate for coelomocytes because of the low quality of the RNA extractions. Coelomocytes preserved in RNAlater displayed large variability in RNA integrity and insufficient RNA amount for further isolation of mRNA. TRIzol was the most efficient system for stabilizing RNA which resulted on high RNA quality and quantity. We did not detect correlation between absorbance ratios and RNA integrity. The best strategies for assessing RNA integrity was the visualization of 18S rRNA and 28S rRNA bands in agarose gels and estimation of RIN values with Agilent Bioanalyzer chips. © 2013 John Wiley & Sons Ltd.

  14. QUALITY CONTROLS FOR PCR

    EPA Science Inventory

    The purpose of this presentation is to present an overview of the quality control (QC) sections of a draft EPA document entitled, "Quality Assurance/Quality Control Guidance for Laboratories Performing PCR Analyses on Environmental Samples." This document has been prepared by th...

  15. Remote control of the industry processes. POWERLINK protocol application

    NASA Astrophysics Data System (ADS)

    Wóbel, A.; Paruzel, D.; Paszkiewicz, B.

    2017-08-01

    The present technological development enables the use of solutions characterized by a lower failure rate, and work with greater precision. This allows you to obtain the most efficient production, high speed production and reliability of individual components. The main scope of this article was POWERLINK protocol application for communication with the controller B & R through communication Ethernet for recording process parameters. This enables control of run production cycle using an internal network connected to the PC industry. Knowledge of the most important parameters of the production in real time allows detecting of a failure immediately after occurrence. For this purpose, the position of diagnostic use driver X20CP1301 B&R to record measurement data such as pressure, temperature valve between the parties and the torque required to change the valve setting was made. The use of POWERLINK protocol allows for the transmission of information on the status of every 200 μs.

  16. On shaky ground - A study of security vulnerabilities in control protocols

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Byres, E. J.; Huffman, D.; Kube, N.

    2006-07-01

    The recent introduction of information technologies such as Ethernet R into nuclear industry control devices has resulted in significantly less isolation from the outside world. This raises the question of whether these systems could be attacked by malware, network hackers or professional criminals to cause disruption to critical operations in a manner similar to the impacts now felt in the business world. To help answer this question, a study was undertaken to test a representative control protocol to determine if it had vulnerabilities that could be exploited. A framework was created in which a test could express a large numbermore » of test cases in very compact formal language. This in turn, allowed for the economical automation of both the generation of selectively malformed protocol traffic and the measurement of device under test's (DUT) behavior in response to this traffic. Approximately 5000 protocol conformance tests were run against two major brands of industrial controller. More than 60 categories of errors were discovered, the majority of which were in the form of incorrect error responses to malformed traffic. Several malformed packets however, caused the device to respond or communicate in inappropriate ways. These would be relatively simple for an attacker to inject into a system and could result in the plant operator losing complete view or control of the control device. Based on this relatively small set of devices, we believe that the nuclear industry urgently needs to adopt better security robustness testing of control devices as standard practice. (authors)« less

  17. Combined Protocol for Acute Malnutrition Study (ComPAS) in rural South Sudan and urban Kenya: study protocol for a randomized controlled trial.

    PubMed

    Bailey, Jeanette; Lelijveld, Natasha; Marron, Bethany; Onyoo, Pamela; Ho, Lara S; Manary, Mark; Briend, André; Opondo, Charles; Kerac, Marko

    2018-04-24

    Acute malnutrition is a continuum condition, but severe and moderate forms are treated separately, with different protocols and therapeutic products, managed by separate United Nations agencies. The Combined Protocol for Acute Malnutrition Study (ComPAS) aims to simplify and unify the treatment of uncomplicated severe and moderate acute malnutrition (SAM and MAM) for children 6-59 months into one protocol in order to improve the global coverage, quality, continuity of care and cost-effectiveness of acute malnutrition treatment in resource-constrained settings. This study is a multi-site, cluster randomized non-inferiority trial with 12 clusters in Kenya and 12 clusters in South Sudan. Participants are 3600 children aged 6-59 months with uncomplicated acute malnutrition. This study will evaluate the impact of a simplified and combined protocol for the treatment of SAM and MAM compared to the standard protocol, which is the national treatment protocol in each country. We will assess recovery rate as a primary outcome and coverage, defaulting, death, length of stay, average weekly weight gain and average weekly mid-upper arm circumference (MUAC) gain as secondary outcomes. Recovery rate is defined across both treatment arms as MUAC ≥125 mm and no oedema for two consecutive visits. Per-protocol and intention-to-treat analyses will be conducted. If the combined protocol is shown to be non-inferior to the standard protocol, updating guidelines to use the combined protocol would eliminate the need for separate products, resources and procedures for MAM treatment. This would likely be more cost-effective, increase availability of services, enable earlier case finding and treatment before deterioration of MAM into SAM, promote better continuity of care and improve community perceptions of the programme. ISRCTN, ISRCTN30393230 . Registered on 16 March 2017.

  18. Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial.

    PubMed

    Padwal, Raj; McAlister, Finlay Aleck; Wood, Peter William; Boulanger, Pierre; Fradette, Miriam; Klarenbach, Scott; Edwards, Alun L; Holroyd-Leduc, Jayna M; Alagiakrishnan, Kannayiram; Rabi, Doreen; Majumdar, Sumit Ranjan

    2016-06-24

    Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving "optimal BP control" (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring-the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management. To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with "enhanced usual care" in community-dwelling seniors with diabetes and hypertension. A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors' residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management. Outcomes will be ascertained at 6 and 12 months. Within-study-arm change

  19. A BMI-adjusted ultra-low-dose CT angiography protocol for the peripheral arteries-Image quality, diagnostic accuracy and radiation exposure.

    PubMed

    Schreiner, Markus M; Platzgummer, Hannes; Unterhumer, Sylvia; Weber, Michael; Mistelbauer, Gabriel; Loewe, Christian; Schernthaner, Ruediger E

    2017-08-01

    To investigate radiation exposure, objective image quality, and the diagnostic accuracy of a BMI-adjusted ultra-low-dose CT angiography (CTA) protocol for the assessment of peripheral arterial disease (PAD), with digital subtraction angiography (DSA) as the standard of reference. In this prospective, IRB-approved study, 40 PAD patients (30 male, mean age 72 years) underwent CTA on a dual-source CT scanner at 80kV tube voltage. The reference amplitude for tube current modulation was personalized based on the body mass index (BMI) with 120 mAs for [BMI≤25] or 150 mAs for [2570%) was assessed by two readers independently and compared to subsequent DSA. Radiation exposure was assessed with the computed tomography dose index (CTDIvol) and the dosis-length product (DLP). Objective image quality was assessed via contrast- and signal-to-noise ratio (CNR and SNR) measurements. Radiation exposure and image quality were compared between the BMI groups and between the BMI-adjusted ultra-low-dose protocol and the low-dose institutional standard protocol (ISP). The BMI-adjusted ultra-low-dose protocol reached high diagnostic accuracy values of 94% for Reader 1 and 93% for Reader 2. Moreover, in comparison to the ISP, it showed significantly (p<0.001) lower CTDIvol (1.97±0.55mGy vs. 4.18±0.62 mGy) and DLP (256±81mGy x cm vs. 544±83mGy x cm) but similar image quality (p=0.37 for CNR). Furthermore, image quality was similar between BMI groups (p=0.86 for CNR). A CT protocol that incorporates low kV settings with a personalized (BMI-adjusted) reference amplitude for tube current modulation and iterative reconstruction enables very low radiation exposure CTA, while maintaining good image quality and high diagnostic accuracy in the assessment of PAD. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. Quality of Mobile Phone and Tablet Mobile Apps for Speech Sound Disorders: Protocol for an Evidence-Based Appraisal.

    PubMed

    Furlong, Lisa M; Morris, Meg E; Erickson, Shane; Serry, Tanya A

    2016-11-29

    Although mobile apps are readily available for speech sound disorders (SSD), their validity has not been systematically evaluated. This evidence-based appraisal will critically review and synthesize current evidence on available therapy apps for use by children with SSD. The main aims are to (1) identify the types of apps currently available for Android and iOS mobile phones and tablets, and (2) to critique their design features and content using a structured quality appraisal tool. This protocol paper presents and justifies the methods used for a systematic review of mobile apps that provide intervention for use by children with SSD. The primary outcomes of interest are (1) engagement, (2) functionality, (3) aesthetics, (4) information quality, (5) subjective quality, and (6) perceived impact. Quality will be assessed by 2 certified practicing speech-language pathologists using a structured quality appraisal tool. Two app stores will be searched from the 2 largest operating platforms, Android and iOS. Systematic methods of knowledge synthesis shall include searching the app stores using a defined procedure, data extraction, and quality analysis. This search strategy shall enable us to determine how many SSD apps are available for Android and for iOS compatible mobile phones and tablets. It shall also identify the regions of the world responsible for the apps' development, the content and the quality of offerings. Recommendations will be made for speech-language pathologists seeking to use mobile apps in their clinical practice. This protocol provides a structured process for locating apps and appraising the quality, as the basis for evaluating their use in speech pathology for children in English-speaking nations. ©Lisa M Furlong, Meg E Morris, Shane Erickson, Tanya A Serry. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.11.2016.

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

    PubMed

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

    2014-02-01

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

  2. Controlling for confounding variables in MS-omics protocol: why modularity matters.

    PubMed

    Smith, Rob; Ventura, Dan; Prince, John T

    2014-09-01

    As the field of bioinformatics research continues to grow, more and more novel techniques are proposed to meet new challenges and improvements upon solutions to long-standing problems. These include data processing techniques and wet lab protocol techniques. Although the literature is consistently thorough in experimental detail and variable-controlling rigor for wet lab protocol techniques, bioinformatics techniques tend to be less described and less controlled. As the validation or rejection of hypotheses rests on the experiment's ability to isolate and measure a variable of interest, we urge the importance of reducing confounding variables in bioinformatics techniques during mass spectrometry experimentation. © The Author 2013. Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.

  3. Performance Evaluation of a SLA Negotiation Control Protocol for Grid Networks

    NASA Astrophysics Data System (ADS)

    Cergol, Igor; Mirchandani, Vinod; Verchere, Dominique

    A framework for an autonomous negotiation control protocol for service delivery is crucial to enable the support of heterogeneous service level agreements (SLAs) that will exist in distributed environments. We have first given a gist of our augmented service negotiation protocol to support distinct service elements. The augmentations also encompass related composition of the services and negotiation with several service providers simultaneously. All the incorporated augmentations will enable to consolidate the service negotiation operations for telecom networks, which are evolving towards Grid networks. Furthermore, our autonomous negotiation protocol is based on a distributed multi-agent framework to create an open market for Grid services. Second, we have concisely presented key simulation results of our work in progress. The results exhibit the usefulness of our negotiation protocol for realistic scenarios that involves different background traffic loading, message sizes and traffic flow asymmetry between background and negotiation traffics.

  4. Multimodal Pain Management Protocol Versus Patient Controlled Narcotic Analgesia for Postoperative Pain Control after Shoulder Arthroplasty.

    PubMed

    Nicholson, Thema; Maltenfort, Mitchell; Getz, Charles; Lazarus, Mark; Williams, Gerald; Namdari, Surena

    2018-05-01

    Our institution's traditional pain management strategy after shoulder arthroplasty has involved the utilization of postoperative patient-controlled narcotic analgesia. More recently, we have implemented a protocol (TLC) that utilizes a multimodal approach. The purpose of this study was to determine whether this change has improved pain control and decreased narcotic utilization. Patients undergoing primary total shoulder or reverse arthroplasty were retrospectively studied. All patients underwent interscalene brachial plexus blockade. "Traditional" patients were provided a patient-controlled analgesic pump postoperatively. TLC patients were given preoperative and postoperative multimodal, non-narcotic analgesic medications and breakthrough narcotics. Morphine equivalent units (MEU) consumed and Visual Analog Scale (VAS) scores for pain (0, 8, 16, and 24 hours) were considered. There were 108 patients in each group. Total postoperative narcotic consumption in the first 24 postoperative hours was 38.5 +/- 81.1 MEU in the "Traditional group" compared to 59.3 +/- 59.1 MEU in the TLC group ( P<0.001 ). Of patients in the TLC group, 88% utilized breakthrough narcotics. VAS pain was significantly higher in the "Traditional group" at 16 hours (4.1 +/- 2.9 vs 3.2 +/- 2.7, P=0.020 ) and 24 hours (4.8 +/- 2.7 vs 3.7 +/- 2.6, P=0.004 ). Those treated with the TLC protocol had greater narcotic utilization but better VAS pain scores at 24 hours after surgery. Both groups experienced rebound pain. While the TLC protocol led to an improved pain experience, further modification of the currently protocol may be necessary to reduce overall narcotic utilization.

  5. Dynamic Postural Control in Female Athletes and Nonathletes After a Whole-Body Fatigue Protocol.

    PubMed

    Baghbani, Fatemeh; Woodhouse, Linda J; Gaeini, Abbas A

    2016-07-01

    Baghbani, F, Woodhouse, LJ, and Gaeini, AA. Dynamic postural control in female athletes and nonathletes after a whole-body fatigue protocol. J Strength Cond Res 30(7): 1942-1947, 2016-Postural control is a crucial element in regular training of athletes, development of complex technical movement, and injury prevention; however, distributing factor of the postural control such as fatigue has been neglected by athletic trainers in novice and inexperienced athletes. The objective of this study was to compare changes in dynamic postural control of young female athletes and nonathletes after a fatigue protocol. Thirty females (15 athletes and 15 nonathletes) with no orthopedic problems were recruited to participate in this study. All participants completed the pre-SEBT (star excursion balance test) in 8 directions at baseline; then, they performed a 20-minute fatigue protocol after which post-SEBT was measured. Rating of perceived exertion was measured using the Borg scale immediately before, mid-way through (i.e., after the third station), and after performing the fatigue protocol (i.e., immediately before the post-SEBT). Female nonathlete groups had significant differences in dynamic balance performance after fatigue in the medial, posteromedial, and posterior directions (p < 0.01) measured by SEBT. Athletes, however, showed no significant changes after the fatigue protocol. Our results indicates the importance of evaluation and monitoring of dynamic postural control of the novice with progressing the exercise time. Our findings could also help coaches to develop trainings focused on the 3 directions of medial, posteromedial, and posterior directions and aimed at exercises increasing fatigue resistance.

  6. Who's really hypertensive?--Quality control issues in the assessment of blood pressure for randomized trials.

    PubMed

    Reid, Christopher M; Ryan, Philip; Miles, Helen; Willson, Kristyn; Beilin, Laurence J; Brown, Mark A; Jennings, Garry L; Johnston, Colin I; Macdonald, Graham J; Marley, John E; McNeil, John J; Morgan, Trefor O; West, Malcolm J; Wing, Lindon M H

    2005-01-01

    The characterization of blood pressure in treatment trials assessing the benefits of blood pressure lowering regimens is a critical factor for the appropriate interpretation of study results. With numerous operators involved in the measurement of blood pressure in many thousands of patients being screened for entry into clinical trials, it is essential that operators follow pre-defined measurement protocols involving multiple measurements and standardized techniques. Blood pressure measurement protocols have been developed by international societies and emphasize the importance of appropriate choice of cuff size, identification of Korotkoff sounds, and digit preference. Training of operators and auditing of blood pressure measurement may assist in reducing the operator-related errors in measurement. This paper describes the quality control activities adopted for the screening stage of the 2nd Australian National Blood Pressure Study (ANBP2). ANBP2 is cardiovascular outcome trial of the treatment of hypertension in the elderly that was conducted entirely in general practices in Australia. A total of 54 288 subjects were screened; 3688 previously untreated subjects were identified as having blood pressure >140/90 mmHg at the initial screening visit, 898 (24%) were not eligible for study entry after two further visits due to the elevated reading not being sustained. For both systolic and diastolic blood pressure recording, observed digit preference fell within 7 percentage points of the expected frequency. Protocol adherence, in terms of the required minimum blood pressure difference between the last two successive recordings, was 99.8%. These data suggest that adherence to blood pressure recording protocols and elimination of digit preferences can be achieved through appropriate training programs and quality control activities in large multi-centre community-based trials in general practice. Repeated blood pressure measurement prior to initial diagnosis and study

  7. Writing standard operating procedures (SOPs) for cryostorage protocols: using shoot meristem cryopreservation as an example.

    PubMed

    Harding, Keith; Benson, Erica E

    2015-01-01

    Standard operating procedures are a systematic way of making sure that biopreservation processes, tasks, protocols, and operations are correctly and consistently performed. They are the basic documents of biorepository quality management systems and are used in quality assurance, control, and improvement. Methodologies for constructing workflows and writing standard operating procedures and work instructions are described using a plant cryopreservation protocol as an example. This chapter is pertinent to other biopreservation sectors because how methods are written, interpreted, and implemented can affect the quality of storage outcomes.

  8. Serial Interface through Stream Protocol on EPICS Platform for Distributed Control and Monitoring

    NASA Astrophysics Data System (ADS)

    Das Gupta, Arnab; Srivastava, Amit K.; Sunil, S.; Khan, Ziauddin

    2017-04-01

    Remote operation of any equipment or device is implemented in distributed systems in order to control and proper monitoring of process values. For such remote operations, Experimental Physics and Industrial Control System (EPICS) is used as one of the important software tool for control and monitoring of a wide range of scientific parameters. A hardware interface is developed for implementation of EPICS software so that different equipment such as data converters, power supplies, pump controllers etc. could be remotely operated through stream protocol. EPICS base was setup on windows as well as Linux operating system for control and monitoring while EPICS modules such as asyn and stream device were used to interface the equipment with standard RS-232/RS-485 protocol. Stream Device protocol communicates with the serial line with an interface to asyn drivers. Graphical user interface and alarm handling were implemented with Motif Editor and Display Manager (MEDM) and Alarm Handler (ALH) command line channel access utility tools. This paper will describe the developed application which was tested with different equipment and devices serially interfaced to the PCs on a distributed network.

  9. [Quality control in anesthesiology].

    PubMed

    Muñoz-Ramón, J M

    1995-03-01

    The process of quality control and auditing of anesthesiology allows us to evaluate care given by a service and solve problems that are detected. Quality control is a basic element of care giving and is only secondarily an area of academic research; it is therefore a meaningless effort if the information does not serve to improve departmental procedures. Quality assurance procedures assume certain infrastructural requirements and an initial period of implementation and adjustment. The main objectives of quality control are the reduction of morbidity and mortality due to anesthesia, assurance of the availability and proper management of resources and, finally, the well-being and safety of the patient.

  10. Analytical Models of Cross-Layer Protocol Optimization in Real-Time Wireless Sensor Ad Hoc Networks

    NASA Astrophysics Data System (ADS)

    Hortos, William S.

    The real-time interactions among the nodes of a wireless sensor network (WSN) to cooperatively process data from multiple sensors are modeled. Quality-of-service (QoS) metrics are associated with the quality of fused information: throughput, delay, packet error rate, etc. Multivariate point process (MVPP) models of discrete random events in WSNs establish stochastic characteristics of optimal cross-layer protocols. Discrete-event, cross-layer interactions in mobile ad hoc network (MANET) protocols have been modeled using a set of concatenated design parameters and associated resource levels by the MVPPs. Characterization of the "best" cross-layer designs for a MANET is formulated by applying the general theory of martingale representations to controlled MVPPs. Performance is described in terms of concatenated protocol parameters and controlled through conditional rates of the MVPPs. Modeling limitations to determination of closed-form solutions versus explicit iterative solutions for ad hoc WSN controls are examined.

  11. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial.

    PubMed

    Veldhuis, Lydian; Struijk, Mirjam K; Kroeze, Willemieke; Oenema, Anke; Renders, Carry M; Bulk-Bunschoten, Anneke Mw; Hirasing, Remy A; Raat, Hein

    2009-06-08

    The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children. A cluster randomised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams randomised within 9 Municipal Health Services. The teams are randomly allocated to the intervention or control group. The teams measure the weight and height of all children. When a child in the intervention group is detected with overweight according to the international age and gender specific cut-off points of BMI, the prevention protocol is applied. According to this protocol parents of overweight children are invited for up to three counselling sessions during which they receive personal advice about a healthy lifestyle, and are motivated for and assisted in behavioural change.The primary outcome measures are Body Mass Index and waist circumference of the children. Parents will complete questionnaires to assess secondary outcome measures: levels of overweight inducing/reducing behaviours (i.e. being physically active, having breakfast, drinking sweet beverages and watching television/playing computer games), parenting styles, parenting practices, and attitudes of parents regarding these behaviours, health-related quality of life of the children, and possible negative side effects of the prevention protocol. Data will be collected at baseline (when the children are aged 5 years), and after 12 and 24 months of follow-up. Additionally, a process and a cost-effectiveness evaluation will be conducted. In this study called 'Be active, eat right' we evaluate an overweight prevention protocol for use in the setting of Youth Health Care. It is hypothesized that the use of this protocol will result in a healthier lifestyle of the

  12. Study protocol for a randomized controlled trial: tongue strengthening exercises in head and neck cancer patients, does exercise load matter?

    PubMed

    Van Nuffelen, Gwen; Van den Steen, Leen; Vanderveken, Olivier; Specenier, Pol; Van Laer, Carl; Van Rompaey, Diane; Guns, Cindy; Mariën, Steven; Peeters, Marc; Van de Heyning, Paul; Vanderwegen, Jan; De Bodt, Marc

    2015-09-04

    Reduced tongue strength is an important factor contributing to early and late dysphagia in head and neck cancer patients previously treated with chemoradiotherapy. The evidence is growing that tongue strengthening exercises can improve tongue strength and swallowing function in both healthy and dysphagic subjects. However, little is known about the impact of specific features of an exercise protocol for tongue strength on the actual outcome (strength or swallowing function). Previous research originating in the fields of sports medicine and physical rehabilitation shows that the degree of exercise load is an influential factor for increasing muscle strength in the limb skeletal muscles. Since the tongue is considered a muscular hydrostat, it remains to be proven whether the same concepts will apply. This ongoing randomized controlled trial in chemoradiotherapy-treated patients with head and neck cancer investigates the effect of three tongue strengthening exercise protocols, with different degrees of exercise load, on tongue strength and swallowing. At enrollment, 51 patients whose dysphagia is primarily related to reduced tongue strength are randomly assigned to a training schedule of 60, 80, or 100% of their maximal tongue strength. Patients are treated three times a week for 8 weeks, executing 120 repetitions of the assigned exercise once per training day. Exercise load is progressively adjusted every 2 weeks. Patients are evaluated before, during and after treatment by means of tongue strength measurements, fiber-optic endoscopic evaluation of swallowing and quality-of-life questionnaires. This randomized controlled trial is the first to systematically investigate the effect of different exercise loads in tongue strengthening exercise protocols. The results will allow the development of more efficacious protocols. Current Controlled Trials ISRCTN14447678.

  13. Developing quality indicators and auditing protocols from formal guideline models: knowledge representation and transformations.

    PubMed

    Advani, Aneel; Goldstein, Mary; Shahar, Yuval; Musen, Mark A

    2003-01-01

    Automated quality assessment of clinician actions and patient outcomes is a central problem in guideline- or standards-based medical care. In this paper we describe a model representation and algorithm for deriving structured quality indicators and auditing protocols from formalized specifications of guidelines used in decision support systems. We apply the model and algorithm to the assessment of physician concordance with a guideline knowledge model for hypertension used in a decision-support system. The properties of our solution include the ability to derive automatically context-specific and case-mix-adjusted quality indicators that can model global or local levels of detail about the guideline parameterized by defining the reliability of each indicator or element of the guideline.

  14. Protocol Coordinator | Center for Cancer Research

    Cancer.gov

    blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases.  CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive clinical and administrative support to the National Cancer Institute’s Center for Cancer Research’s (CCR), Office of Regulatory Affairs for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration. KEY ROLES/RESPONSIBILITIES - THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Protocol Coordinator II: Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials Provides deployment of clinical support services for clinical research Streamlines protocol development timeline Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities Provides administrative coordination and general logistical support for regulatory activities Ensures the provision of training for investigators and associate staff to reinforce and enhance a GCP culture Provides quality assurance and quality control oversight Performs regulatory review of clinical protocols, informed consent and other clinical documents Tracks and facilitates a portfolio of protocols through each process step (IRB, RAC, DSMB, Office of Protocol Services) Assists clinical investigators in preparing clinical research protocols, including writing and formatting protocol documents and consent forms Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with

  15. ANDRO-IVF: a novel protocol for poor responders to IVF controlled ovarian stimulation

    PubMed Central

    Bercaire, Ludmila; Nogueira, Sara MB; Lima, Priscila CM; Alves, Vanessa R; Donadio, Nilka; Dzik, Artur; Cavagna, Mario; Fanchin, Renato

    2018-01-01

    Objective This study aimed to assess a novel protocol designed to improve poor ovarian response through intra-ovarian androgenization. The endpoints were: number of oocytes and mature oocytes retrieved, fertilization, cancellation and pregnancy rates. Methods This prospective crossover study enrolled poor responders from previous ovarian stimulation cycles submitted to a novel protocol called ANDRO-IVF. The protocol included pretreatment with transdermal AndroGel(r) (Besins) 25 mg, oral letrozole 2.5 mg and subcutaneous hCG 2500 IU; cycle control was performed with estradiol valerate and micronized progesterone; ovarian stimulation was attained with gonadotropins FSH/LH 450 IU, GnRH antagonist and hCG 5000 IU. Results Fourteen poor responders were enrolled. One patient did not meet the inclusion criteria. Thirteen patients previously summited to the standard protocol were offered the ANDRO-IVF Protocol.-Standard Protocol: Mean age: 35.30 years; cancellation rate: 61.53%; mean number of MII oocytes retrieved per patient: 1.8; fertilization rate: 33.33%. Only two patients had embryo transfers, and none got pregnant.-ANDRO-IVF Protocol: Mean age: 35.83 years; cancellation rate: 7.69%; mean number of oocytes retrieved per patient: 5.58, MII oocytes: 3.91. ICSI was performed in 84.61% of the patients and a mean of 1.5 embryos were transferred per patient. Fertilization rate: 62.5%; cumulative pregnancy rate: 16.66%; mean duration of stimulation: 9.77 days. Conclusion ANDRO-IVF allows intra-ovarian androgenization by increasing serum and intra-follicular androgen levels and preventing androgen aromatization. This protocol apparently improved clinical outcomes of poor responders in parameters such as number of oocytes retrieved and clinical pregnancy rates. Further randomized controlled trials are needed to confirm these findings. PMID:29303236

  16. Straight Talk About Birth Control: A Contraceptive Education Protocol for Home Care.

    PubMed

    Schoenberg, Leslie

    Home healthcare providers play a critical role in the prevention of unintended pregnancies by providing evidence-based contraception education during home visits. This article describes an innovative and comprehensive contraception protocol that was developed for Nurse-Family Partnership to improve contraception education for home healthcare patients. The protocol focused on increasing uptake of long-acting reversible contraception (LARC) for high-risk prenatal and postpartum home healthcare patients. The protocol was designed to reduce early subsequent pregnancies and thereby improve outcomes for mothers and their infants. An evidence-based translation project was designed and piloted in three California counties. The protocol consisted of a contraception education module for nurses and a patient education toolkit. The toolkit included an interactive patient education workbook emphasizing LARC methods for nurses to complete with their patients along with other teaching tools. The project was evaluated using pre- and posttest surveys that measured changes in nurses' knowledge, attitudes, and practice before, after, and 2 months after implementation. Outcomes revealed the following statistically significant results: (a) nurses' knowledge doubled at the first posttest and persisted at 2 months, (b) nurses' attitudes improved on two of the three measures, and (c) there was a 17.7% increase in the frequency of LARC birth control education 2 months after implementation. An evidence-based contraception protocol can promote acceptance of LARC methods and improve home healthcare clinician comfort with and frequency of birth control education.

  17. An extended smart utilization medium access control (ESU-MAC) protocol for ad hoc wireless systems

    NASA Astrophysics Data System (ADS)

    Vashishtha, Jyoti; Sinha, Aakash

    2006-05-01

    The demand for spontaneous setup of a wireless communication system has increased in recent years for areas like battlefield, disaster relief operations etc., where a pre-deployment of network infrastructure is difficult or unavailable. A mobile ad-hoc network (MANET) is a promising solution, but poses a lot of challenges for all the design layers, specifically medium access control (MAC) layer. Recent existing works have used the concepts of multi-channel and power control in designing MAC layer protocols. SU-MAC developed by the same authors, efficiently uses the 'available' data and control bandwidth to send control information and results in increased throughput via decreasing contention on the control channel. However, SU-MAC protocol was limited for static ad-hoc network and also faced the busy-receiver node problem. We present the Extended SU-MAC (ESU-MAC) protocol which works mobile nodes. Also, we significantly improve the scheme of control information exchange in ESU-MAC to overcome the busy-receiver node problem and thus, further avoid the blockage of control channel for longer periods of time. A power control scheme is used as before to reduce interference and to effectively re-use the available bandwidth. Simulation results show that ESU-MAC protocol is promising for mobile, ad-hoc network in terms of reduced contention at the control channel and improved throughput because of channel re-use. Results show a considerable increase in throughput compared to SU-MAC which could be attributed to increased accessibility of control channel and improved utilization of data channels due to superior control information exchange scheme.

  18. Protocol Coordinator | Center for Cancer Research

    Cancer.gov

    blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive clinical and administrative support to the National Cancer Institute’s Center for Cancer Research’s (CCR) Protocol Support Office (PSO) for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration. KEY ROLES/RESPONSIBILITIES The Protocol Coordinator III: Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials. Provides deployment of clinical support services for clinical research. Streamlines the protocol development timeline. Provides data and documents collection and compilation for regulatory filing with the U.S. Food and Drug Administration (FDA) and other regulatory authorities.. Provides technical review and report preparation. Provides administrative coordination and general logistical support for regulatory activities. Ensures the provision of training for investigators and associate staff to reinforce and enhance a Good Clinical Practices (GCP) culture. Oversees quality assurance and quality control, performs regulatory review of clinical protocols, informed consent and other clinical documents. Tracks and facilitates a portfolio of protocols through each process step (Institutional Review Board [IRB], Regulatory Affairs Compliance [RAC], Data Safety Monitoring Board [DSMB], Office of Protocol Services). Assists clinical investigators in preparing clinical research protocols, including writing and formatting consent

  19. Commercial jet fuel quality control

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    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.

  20. Engagement, Alignment, and Rigor as Vital Signs of High-Quality Instruction: A Classroom Visit Protocol for Instructional Improvement and Research

    ERIC Educational Resources Information Center

    Early, Diane M.; Rogge, Ronald D.; Deci, Edward L.

    2014-01-01

    This paper investigates engagement (E), alignment (A), and rigor (R) as vital signs of high-quality teacher instruction as measured by the EAR Classroom Visit Protocol, designed by the Institute for Research and Reform in Education (IRRE). Findings indicated that both school leaders and outside raters could learn to score the protocol with…

  1. Effect of aquatic physical therapy on pain perception, functional capacity and quality of life in older people with knee osteoarthritis: study protocol for a randomized controlled trial.

    PubMed

    Alcalde, Guilherme Eleutério; Fonseca, Ana Carolina; Bôscoa, Thais Fernanda; Gonçalves, Mirella Regina; Bernardo, Gabriele Candido; Pianna, Bruna; Carnavale, Bianca Ferdin; Gimenes, Camila; Barrile, Silvia Regina; Arca, Eduardo Aguilar

    2017-07-11

    Aquatic therapy promotes short-term benefits for patients with knee osteoarthritis (OA), and it may be the first therapeutic option for this pathological condition. The objective of this study was to investigate the effects of an aquatic therapy program on pain intensity, functional ability, and quality of life in older people with knee OA. This is a parallel, two-arm, open, randomized controlled clinical trial with older people with knee OA. Volunteers will be allocated to an aquatic intervention group (WG), subjected to the intervention, or to a control group, not be subjected to any kind of intervention. Data collection pre- and postintervention will be composed of the evaluation of the perception of pain by visual analogue scale with application of nociceptive stimuli in four anatomical points of the knee, functional fitness tests, and application of the World Health Organization Quality of Life Scale abbreviated version and Western Ontario and McMaster Universities Osteoarthritis Index. The program will last 12 weeks, consisting of aerobic and functional exercises in the form of circuit training. The objective of this clinical trial is to evaluate the effect of aquatic therapy in elderly patients with knee OA. The study is guided by practice-based scientific evidence for the use of aquatic rehabilitation exercises. It is expected that the WG volunteers will show reduced pain intensity, increased flexibility, and improved functional capacity and quality of life. It is believed that the desired results can be attributed to physical and physiological effects of immersion in warm water associated with the exercise protocol proposed. The data will be published after completion of the study. Brazilian Registry of Clinical Trials (ReBEC) registration number: RBR-78h48d . Registered on 19 August 2015.

  2. Simulation improves procedural protocol adherence during central venous catheter placement: a randomized-controlled trial

    PubMed Central

    Peltan, Ithan D.; Shiga, Takashi; Gordon, James A.; Currier, Paul F.

    2015-01-01

    Background Simulation training may improve proficiency at and reduces complications from central venous catheter (CVC) placement, but the scope of simulation’s effect remains unclear. This randomized controlled trial evaluated the effects of a pragmatic CVC simulation program on procedural protocol adherence, technical skill, and patient outcomes. Methods Internal medicine interns were randomized to standard training for CVC insertion or standard training plus simulation-based mastery training. Standard training involved a lecture, a video-based online module, and instruction by the supervising physician during actual CVC insertions. Intervention-group subjects additionally underwent supervised training on a venous access simulator until they demonstrated procedural competence. Raters evaluated interns’ performance during internal jugular CVC placement on actual patients in the medical intensive care unit. Generalized estimating equations were used to account for outcome clustering within trainees. Results We observed 52 interns place 87 CVCs. Simulation-trained interns exhibited better adherence to prescribed procedural technique than interns who received only standard training (p=0.024). There were no significant differences detected in first-attempt or overall cannulation success rates, mean needle passes, global assessment scores or complication rates. Conclusions Simulation training added to standard training improved protocol adherence during CVC insertion by novice practitioners. This study may have been too small to detect meaningful differences in venous cannulation proficiency and other clinical outcomes, highlighting the difficulty of patient-centered simulation research in settings where poor outcomes are rare. For high-performing systems, where protocol deviations may provide an important proxy for rare procedural complications, simulation may improve CVC insertion quality and safety. PMID:26154250

  3. Hospital protocols for targeted glycemic control: Development, implementation, and models for cost justification.

    PubMed

    Magee, Michelle F

    2007-05-15

    Evolving elements of best practices for providing targeted glycemic control in the hospital setting, clinical performance measurement, basal-bolus plus correction-dose insulin regimens, components of standardized subcutaneous (s.c.) insulin order sets, and strategies for implementation and cost justification of glycemic control initiatives are discussed. Best practices for targeted glycemic control should address accurate documentation of hyperglycemia, initial patient assessment, management plan, target blood glucose range, blood glucose monitoring frequency, maintenance of glycemic control, criteria for glucose management consultations, and standardized insulin order sets and protocols. Establishing clinical performance measures, including desirable processes and outcomes, can help ensure the success of targeted hospital glycemic control initiatives. The basal-bolus plus correction-dose regimen for insulin administration will be used to mimic the normal physiologic pattern of endogenous insulin secretion. Standardized insulin order sets and protocols are being used to minimize the risk of error in insulin therapy. Components of standardized s.c. insulin order sets include specification of the hyperglycemia diagnosis, finger stick blood glucose monitoring frequency and timing, target blood glucose concentration range, cutoff values for excessively high or low blood glucose concentrations that warrant alerting the physician, basal and prandial or nutritional (i.e., bolus) insulin, correction doses, hypoglycemia treatment, and perioperative or procedural dosage adjustments. The endorsement of hospital administrators and key physician and nursing leaders is needed for glycemic control initiatives. Initiatives may be cost justified on the basis of the billings for clinical diabetes management services and/or the return- on-investment accrued to reductions in hospital length of stay, readmissions, and accurate documentation and coding of unrecognized or uncontrolled

  4. Quality of randomised controlled trials in medical education reported between 2012 and 2013: a systematic review protocol.

    PubMed

    Tolsgaard, Martin G; Ku, Cheryl; Woods, Nicole N; Kulasegaram, Kulamakan Mahan; Brydges, Ryan; Ringsted, Charlotte

    2014-07-30

    Research in medical education has increased in volume over the past decades but concerns have been raised regarding the quality of trials conducted within this field. Randomised controlled trials (RCTs) involving educational interventions that are reported in biomedical journals have been criticised for their insufficient conceptual, theoretical framework. RCTs published in journals dedicated to medical education, on the other hand, have been questioned regarding their methodological rigour. The aim of this study is therefore to assess the quality of RCTs of educational interventions reported in 2012 and 2013 in journals dedicated to medical education compared to biomedical journals with respect to objective quality criteria. RCTs published between 1 January 2012 and 31 December 2013 in English are included. The search strategy is developed with the help of experienced librarians to search online databases for key terms. All of the identified RCTs are screened based on their titles and abstracts individually by the authors and then compared in pairs to assess agreement. Data are extracted from the included RCTs by independently scoring each RCT using a data collection form. The data collection form consists of four steps. Step 1 includes confirmation of RCT eligibility; step 2 consists of the CONSORT checklist; step 3 consists of the Medical Education Research Study Quality Instrument framework; step 4 consists of a Medical Education Extension (MEdEx) to the CONSORT checklist. The MEdEx includes the following elements: Description of scientific background, explanation of rationale, quality of research questions and hypotheses, clarity in the description of the use of the intervention and control as well as interpretation of results. This review is the first to systematically examine the quality of RCTs conducted in medical education. We plan to disseminate the results through publications and presentation at relevant conferences. Ethical approval is not sought for

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

    PubMed

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

    2018-02-01

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

  6. Developing Quality Indicators and Auditing Protocols from Formal Guideline Models: Knowledge Representation and Transformations

    PubMed Central

    Advani, Aneel; Goldstein, Mary; Shahar, Yuval; Musen, Mark A.

    2003-01-01

    Automated quality assessment of clinician actions and patient outcomes is a central problem in guideline- or standards-based medical care. In this paper we describe a model representation and algorithm for deriving structured quality indicators and auditing protocols from formalized specifications of guidelines used in decision support systems. We apply the model and algorithm to the assessment of physician concordance with a guideline knowledge model for hypertension used in a decision-support system. The properties of our solution include the ability to derive automatically (1) context-specific and (2) case-mix-adjusted quality indicators that (3) can model global or local levels of detail about the guideline (4) parameterized by defining the reliability of each indicator or element of the guideline. PMID:14728124

  7. SU-F-I-46: Optimizing Dose Reduction in Adult Head CT Protocols While Maintaining Image Quality in Postmortem Head Scans

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lipnharski, I; Carranza, C; Quails, N

    Purpose: To optimize adult head CT protocol by reducing dose to an appropriate level while providing CT images of diagnostic quality. Methods: Five cadavers were scanned from the skull base to the vertex using a routine adult head CT protocol (120 kVp, 270 mA, 0.75 s rotation, 0.5 mm × 32 detectors, 70.8 mGy CTDIvol) followed by seven reduced-dose protocols with varying combinations of reduced tube current, reduced rotation time, and increased detectors with CTDIvol ranging from 38.2 to 65.6 mGy. Organ doses were directly measured with 21 OSL dosimeters placed on the surface and implanted in the head bymore » a neurosurgeon. Two neuroradiologists assessed grey-white matter differentiation, fluid space, ventricular size, midline shift, brain mass, edema, ischemia, and skull fractures on a three point scale: (1) Unacceptable, (2) Borderline Acceptable, and (3) Acceptable. Results: For the standard scan, doses to the skin, lens of the eye, salivary glands, thyroid, and brain were 37.55 mGy, 49.65 mGy, 40.67 mGy, 4.63 mGy, and 27.33 mGy, respectively. Two cadavers had cerebral edema due to changing dynamics of postmortem effects, causing the grey-white matter differentiation to appear less distinct. Two cadavers with preserved grey-white matter received acceptable scores for all image quality features for the protocol with a CTDIvol of 57.3 mGy, allowing organ dose savings ranging from 34% to 45%. One cadaver allowed for greater dose reduction for the protocol with a CTDIvol of 42 mGy. Conclusion: Efforts to optimize scan protocol should consider both dose and clinical image quality. This is made possible with postmortem subjects, whose brains are similar to patients, allowing for an investigation of ideal scan parameters. Radiologists at our institution accepted scan protocols acquired with lower scan parameters, with CTDIvol values closer to the American College of Radiology’s (ACR) Achievable Dose level of 57 mGy.« less

  8. Soft chelating irrigation protocol optimizes bonding quality of Resilon/Epiphany root fillings.

    PubMed

    De-Deus, Gustavo; Namen, Fátima; Galan, João; Zehnder, Matthias

    2008-06-01

    This study was designed to test the impact of either a strong (MTAD) or a soft (1-hydroxyethylidene-1, 1-bisphosphonate [HEPB]) chelating solution on the bond strength of Resilon/Epiphany root fillings. Both 17% EDTA and the omission of a chelator in the irrigation protocol were used as reference treatments. Forty extracted human upper lateral incisors were prepared using different irrigation protocols (n = 10): G1: NaOCl, G2: NaOCl + 17% EDTA, G3: NaOCl + BioPure MTAD (Dentsply/Tulsa, Tulsa, OK), and G4: NaOCl + 18% HEPB. The teeth were obturated and then prepared for micropush-out assessment using root slices of 1 mm thickness. Loading was performed on a universal testing machine at a speed of 0.5 mm/min. One-way analysis of variance and Tukey multiple comparisons were used to compare the results among the experimental groups. EDTA- and MTAD-treated samples revealed intermediate bond strength (0.3-3.6 MPa). The lowest bond strengths were achieved in NaOCl-treated samples (0.3-1.2 MPa, p < 0.05). The highest bond strength was reached in the HEBP-treated samples (3.1-6.1 MPa, p < 0.05). Under the present in vitro conditions, the soft chelating irrigation protocol (18% HEBP) optimized the bonding quality of Resilon/Epiphany (Resilon Research LLC, Madison, CT) root fillings.

  9. Developing the protocol for the evaluation of the health foundation's 'engaging with quality initiative' – an emergent approach

    PubMed Central

    Soper, Bryony; Buxton, Martin; Hanney, Stephen; Oortwijn, Wija; Scoggins, Amanda; Steel, Nick; Ling, Tom

    2008-01-01

    In 2004 a UK charity, The Health Foundation, established the 'Engaging with Quality Initiative' to explore and evaluate the benefits of engaging clinicians in quality improvement in healthcare. Eight projects run by professional bodies or specialist societies were commissioned in various areas of acute care. A developmental approach to the initiative was adopted, accompanied by a two level evaluation: eight project self-evaluations and a related external evaluation. This paper describes how the protocol for the external evaluation was developed. The challenges faced included large variation between and within the projects (in approach, scope and context, and in understanding of quality improvement), the need to support the project teams in their self-evaluations while retaining a necessary objectivity, and the difficulty of evaluating the moving target created by the developmental approach adopted in the initiative. An initial period to develop the evaluation protocol proved invaluable in helping us to explore these issues. PMID:18973650

  10. 40 CFR 75.21 - Quality assurance and quality control requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Quality assurance and quality control... PROGRAMS (CONTINUED) CONTINUOUS EMISSION MONITORING Operation and Maintenance Requirements § 75.21 Quality assurance and quality control requirements. (a) Continuous emission monitoring systems. The owner or...

  11. Quality, efficiency, and cost of a physician-assistant-protocol system for managment of diabetes and hypertension.

    PubMed

    Komaroff, A L; Flatley, M; Browne, C; Sherman, H; Fineberg, S E; Knopp, R H

    1976-04-01

    Briefly trained physicians assistants using protocols (clinical algorithms) for diabetes, hypertension, and related chronic arteriosclerotic and hypertensive heart disease abstrated information from the medical record and obtained history and physical examination data on every patient-visit to a city hospital chronic disease clinic over a 18-month period. The care rendered by the protocol system was compared with care rendered by a "traditional" system in the same clinic in which physicians delegated few clinical tasks. Increased thoroughness in collecting clinical data in the protocol system led to an increase in the recognition of new pathology. Outcome criteria reflected equivalent quality of care in both groups. Efficiency time-motion studies demonstrated a 20 per cent saving in physician time with the protocol system. Coct estimates, based on the time spent with patients by various providers and on the laboratory-test-ordering patterns, demonstrated equivalent costs of the two systems, given optimal staffing patterns. Laboratory tests were a major element of the cost of patient care,and the clinical yield per unit cost of different tests varied widely.

  12. 40 CFR 51.359 - Quality control.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 2 2013-07-01 2013-07-01 false Quality control. 51.359 Section 51.359....359 Quality control. Quality control measures shall insure that emission testing equipment is calibrated and maintained properly, and that inspection, calibration records, and control charts are...

  13. 40 CFR 51.359 - Quality control.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 2 2010-07-01 2010-07-01 false Quality control. 51.359 Section 51.359....359 Quality control. Quality control measures shall insure that emission testing equipment is calibrated and maintained properly, and that inspection, calibration records, and control charts are...

  14. 40 CFR 51.359 - Quality control.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 2 2011-07-01 2011-07-01 false Quality control. 51.359 Section 51.359....359 Quality control. Quality control measures shall insure that emission testing equipment is calibrated and maintained properly, and that inspection, calibration records, and control charts are...

  15. 40 CFR 51.359 - Quality control.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 2 2012-07-01 2012-07-01 false Quality control. 51.359 Section 51.359....359 Quality control. Quality control measures shall insure that emission testing equipment is calibrated and maintained properly, and that inspection, calibration records, and control charts are...

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

    PubMed

    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.

  17. An optimized immunohistochemistry protocol for detecting the guidance cue Netrin-1 in neural tissue.

    PubMed

    Salameh, Samer; Nouel, Dominique; Flores, Cecilia; Hoops, Daniel

    2018-01-01

    Netrin-1, an axon guidance protein, is difficult to detect using immunohistochemistry. We performed a multi-step, blinded, and controlled protocol optimization procedure to establish an efficient and effective fluorescent immunohistochemistry protocol for characterizing Netrin-1 expression. Coronal mouse brain sections were used to test numerous antigen retrieval methods and combinations thereof in order to optimize the stain quality of a commercially available Netrin-1 antibody. Stain quality was evaluated by experienced neuroanatomists for two criteria: signal intensity and signal-to-noise ratio. After five rounds of testing protocol variants, we established a modified immunohistochemistry protocol that produced a Netrin-1 signal with good signal intensity and a high signal-to-noise ratio. The key protocol modifications are as follows: •Use phosphate buffer (PB) as the blocking solution solvent.•Use 1% sodium dodecyl sulfate (SDS) treatment for antigen retrieval. The original protocol was optimized for use with the Netrin-1 antibody produced by Novus Biologicals. However, we subsequently further modified the protocol to work with the antibody produced by Abcam. The Abcam protocol uses PBS as the blocking solution solvent and adds a citrate buffer antigen retrieval step.

  18. Quality control in gastrointestinal surgery.

    PubMed

    Ramírez-Barba, Ector Jaime; Arenas-Moya, Diego; Vázquez-Guerrero, Arturo

    2011-01-01

    We analyzed the Mexican legal framework, identifying the vectors that characterize quality and control in gastrointestinal surgery. Quality is contemplated in the health protection rights determined according to the Mexican Constitution, established in the general health law and included as a specific goal in the actual National Development Plan and Health Sector Plan. Quality control implies planning, verification and application of corrective measures. Mexico has implemented several quality strategies such as certification of hospitals and regulatory agreements by the General Salubrity Council, creation of the National Health Quality Committee, generation of Clinical Practice Guidelines and the Certification of Medical Specialties, among others. Quality control in gastrointestinal surgery must begin at the time of medical education and continue during professional activities of surgeons, encouraging multidisciplinary teamwork, knowledge, abilities, attitudes, values and skills that promote homogeneous, safe and quality health services for the Mexican population.

  19. The effect of personalized versus standard patient protocols for radiostereometric analysis (RSA).

    PubMed

    Muharemovic, O; Troelsen, A; Thomsen, M G; Kallemose, T; Gosvig, K K

    2018-05-01

    Increasing pressure in the clinic requires a more standardized approach to radiostereometric analysis (RSA) imaging. The aim of this study was to investigate whether implementation of personalized RSA patient protocols could increase image quality and decrease examination time and the number of exposure repetitions. Forty patients undergoing primary total hip arthroplasty were equally randomized to either a case or a control group. Radiographers in the case group were assisted by personalized patient protocols containing information about each patient's post-operative RSA imaging. Radiographers in the control group used a standard RSA protocol. At three months, radiographers in the case group significantly reduced (p < 0.001) the number of exposures by 1.6, examination time with 19.2 min, and distance between centrum of prosthesis and centrum of calibration field with 34.1 mm when compared to post-operative (baseline) results. At twelve months, the case group significantly reduced (p < 0.001) number of exposures by two, examination time with 22.5 min, and centrum of prosthesis to centrum of calibration field distance with 43.1 mm when compared to baseline results. No significant improvements were found in the control group at any time point. There is strong evidence that personalized RSA patient protocols have a positive effect on image quality and radiation dose savings. Implementation of personal patient protocols as a RSA standard will contribute to the reduction of examination time, thus ensuring a cost benefit for department and patient safety. Copyright © 2017 The College of Radiographers. Published by Elsevier Ltd. All rights reserved.

  20. A Routing Protocol Based on Energy and Link Quality for Internet of Things Applications

    PubMed Central

    Machado, Kassio; Rosário, Denis; Cerqueira, Eduardo; Loureiro, Antonio A. F.; Neto, Augusto; de Souza, José Neuman

    2013-01-01

    The Internet of Things (IoT) is attracting considerable attention from the universities, industries, citizens and governments for applications, such as healthcare,environmental monitoring and smart buildings. IoT enables network connectivity between smart devices at all times, everywhere, and about everything. In this context, Wireless Sensor Networks (WSNs) play an important role in increasing the ubiquity of networks with smart devices that are low-cost and easy to deploy. However, sensor nodes are restricted in terms of energy, processing and memory. Additionally, low-power radios are very sensitive to noise, interference and multipath distortions. In this context, this article proposes a routing protocol based on Routing by Energy and Link quality (REL) for IoT applications. To increase reliability and energy-efficiency, REL selects routes on the basis of a proposed end-to-end link quality estimator mechanism, residual energy and hop count. Furthermore, REL proposes an event-driven mechanism to provide load balancing and avoid the premature energy depletion of nodes/networks. Performance evaluations were carried out using simulation and testbed experiments to show the impact and benefits of REL in small and large-scale networks. The results show that REL increases the network lifetime and services availability, as well as the quality of service of IoT applications. It also provides an even distribution of scarce network resources and reduces the packet loss rate, compared with the performance of well-known protocols. PMID:23385410

  1. A routing protocol based on energy and link quality for Internet of Things applications.

    PubMed

    Machado, Kássio; Rosário, Denis; Cerqueira, Eduardo; Loureiro, Antonio A F; Neto, Augusto; Souza, José Neuman de

    2013-02-04

    The Internet of Things (IoT) is attracting considerable attention from the universities, industries, citizens and governments for applications, such as healthcare, environmental monitoring and smart buildings. IoT enables network connectivity between smart devices at all times, everywhere, and about everything. In this context, Wireless Sensor Networks (WSNs) play an important role in increasing the ubiquity of networks with smart devices that are low-cost and easy to deploy. However, sensor nodes are restricted in terms of energy, processing and memory. Additionally, low-power radios are very sensitive to noise, interference and multipath distortions. In this context, this article proposes a routing protocol based on Routing by Energy and Link quality (REL) for IoT applications. To increase reliability and energy-efficiency, REL selects routes on the basis of a proposed end-to-end link quality estimator mechanism, residual energy and hop count. Furthermore, REL proposes an event-driven mechanism to provide load balancing and avoid the premature energy depletion of nodes/networks. Performance evaluations were carried out using simulation and testbed experiments to show the impact and benefits of REL in small and large-scale networks. The results show that REL increases the network lifetime and services availability, as well as the quality of service of IoT applications. It also provides an even distribution of scarce network resources and reduces the packet loss rate, compared with the performance of well-known protocols.

  2. Efficacy of the unified protocol for the treatment of emotional disorders in the Spanish public mental health system using a group format: study protocol for a multicenter, randomized, non-inferiority controlled trial.

    PubMed

    Osma, Jorge; Suso-Ribera, Carlos; García-Palacios, Azucena; Crespo-Delgado, Elena; Robert-Flor, Cristina; Sánchez-Guerrero, Ana; Ferreres-Galan, Vanesa; Pérez-Ayerra, Luisa; Malea-Fernández, Amparo; Torres-Alfosea, Mª Ángeles

    2018-03-12

    Emotional disorders, which include both anxiety and depressive disorders, are the most prevalent psychological disorders according to recent epidemiological studies. Consequently, public costs associated with their treatment have become a matter of concern for public health systems, which face long waiting lists. Because of their high prevalence in the population, finding an effective treatment for emotional disorders has become a key goal of today's clinical psychology. The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders might serve the aforementioned purpose, as it can be applied to a variety of disorders simultaneously and it can be easily performed in a group format. The study is a multicenter, randomized, non-inferiority controlled clinical trial. Participants will be 220 individuals with emotional disorders, who are randomized to either a treatment as usual (individual cognitive behavioral therapy) or to a Unified Protocol condition in group format. Depression, anxiety, and diagnostic criteria are the primary outcome measures. Secondary measures include the assessment of positive and negative affect, anxiety control, personality traits, overall adjustment, and quality of life. An analysis of treatment satisfaction is also conducted. Assessment points include baseline, post-treatment, and three follow-ups at 3, 6, and 12 months. To control for missing data and possible biases, intention-to-treat and per-protocol analyses will be performed. This is the first randomized, controlled clinical trial to test the effectiveness of a transdiagnostic intervention in a group format for the treatment of emotional disorders in public settings in Spain. Results obtained from this study may have important clinical, social, and economic implications for public mental health settings in Spain. Retrospectively registered at https://clinicaltrials.gov/ . Trial NCT03064477 (March 10, 2017). The trial is active and recruitment is ongoing. Recruitment

  3. Biplane interventional pediatric system with cone-beam CT: dose and image quality characterization for the default protocols.

    PubMed

    Corredoira, Eva; Vañó, Eliseo; Alejo, Luis; Ubeda, Carlos; Gutiérrez-Larraya, Federico; Garayoa, Julia

    2016-07-08

    The aim of this study was to assess image quality and radiation dose of a biplane angiographic system with cone-beam CT (CBCT) capability tuned for pediatric cardiac procedures. The results of this study can be used to explore dose reduction techniques. For pulsed fluoroscopy and cine modes, polymethyl methacrylate phantoms of various thicknesses and a Leeds TOR 18-FG test object were employed. Various fields of view (FOV) were selected. For CBCT, the study employed head and body dose phantoms, Catphan 504, and an anthropomorphic cardiology phantom. The study also compared two 3D rotational angiography protocols. The entrance surface air kerma per frame increases by a factor of 3-12 when comparing cine and fluoroscopy frames. The biggest difference in the signal-to- noise ratio between fluoroscopy and cine modes occurs at FOV 32 cm because fluoroscopy is acquired at a 1440 × 1440 pixel matrix size and in unbinned mode, whereas cine is acquired at 720 × 720 pixels and in binned mode. The high-contrast spatial resolution of cine is better than that of fluoroscopy, except for FOV 32 cm, because fluoroscopy mode with 32 cm FOV is unbinned. Acquiring CBCT series with a 16 cm head phantom using the standard dose protocol results in a threefold dose increase compared with the low-dose protocol. Although the amount of noise present in the images acquired with the low-dose protocol is much higher than that obtained with the standard mode, the images present better spatial resolution. A 1 mm diameter rod with 250 Hounsfield units can be distinguished in reconstructed images with an 8 mm slice width. Pediatric-specific protocols provide lower doses while maintaining sufficient image quality. The system offers a novel 3D imaging mode. The acquisition of CBCT images results in increased doses administered to the patients, but also provides further diagnostic information contained in the volumetric images. The assessed CBCT protocols provide images that are noisy, but with

  4. General aviation fuel quality control

    NASA Technical Reports Server (NTRS)

    Poitz, H.

    1983-01-01

    Quality control measures for aviation gasoline, and some of the differences between quality control on avgas and mogas are discussed. One thing to keep in mind is that with motor gasoline you can always pull off to the side of the road. It's not so easy to do in an airplane. Consequently, there are reasons for having the tight specifications and the tight quality control measures on avgas as compared to motor gasoline.

  5. SU-F-207-02: Use of Postmortem Subjects for Subjective Image Quality Assessment in Abdominal CT Protocols with Iterative Reconstruction

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Mench, A; Lipnharski, I; Carranza, C

    Purpose: New radiation dose reduction technologies are emerging constantly in the medical imaging field. The latest of these technologies, iterative reconstruction (IR) in CT, presents the ability to reduce dose significantly and hence provides great opportunity for CT protocol optimization. However, without effective analysis of image quality, the reduction in radiation exposure becomes irrelevant. This work explores the use of postmortem subjects as an image quality assessment medium for protocol optimizations in abdominal CT. Methods: Three female postmortem subjects were scanned using the Abdomen-Pelvis (AP) protocol at reduced minimum tube current and target noise index (SD) settings of 12.5, 17.5,more » 20.0, and 25.0. Images were reconstructed using two strengths of iterative reconstruction. Radiologists and radiology residents from several subspecialties were asked to evaluate 8 AP image sets including the current facility default scan protocol and 7 scans with the parameters varied as listed above. Images were viewed in the soft tissue window and scored on a 3-point scale as acceptable, borderline acceptable, and unacceptable for diagnosis. The facility default AP scan was identified to the reviewer while the 7 remaining AP scans were randomized and de-identified of acquisition and reconstruction details. The observers were also asked to comment on the subjective image quality criteria they used for scoring images. This included visibility of specific anatomical structures and tissue textures. Results: Radiologists scored images as acceptable or borderline acceptable for target noise index settings of up to 20. Due to the postmortem subjects’ close representation of living human anatomy, readers were able to evaluate images as they would those of actual patients. Conclusion: Postmortem subjects have already been proven useful for direct CT organ dose measurements. This work illustrates the validity of their use for the crucial evaluation of image

  6. Network-based production quality control

    NASA Astrophysics Data System (ADS)

    Kwon, Yongjin; Tseng, Bill; Chiou, Richard

    2007-09-01

    This study investigates the feasibility of remote quality control using a host of advanced automation equipment with Internet accessibility. Recent emphasis on product quality and reduction of waste stems from the dynamic, globalized and customer-driven market, which brings opportunities and threats to companies, depending on the response speed and production strategies. The current trends in industry also include a wide spread of distributed manufacturing systems, where design, production, and management facilities are geographically dispersed. This situation mandates not only the accessibility to remotely located production equipment for monitoring and control, but efficient means of responding to changing environment to counter process variations and diverse customer demands. To compete under such an environment, companies are striving to achieve 100%, sensor-based, automated inspection for zero-defect manufacturing. In this study, the Internet-based quality control scheme is referred to as "E-Quality for Manufacturing" or "EQM" for short. By its definition, EQM refers to a holistic approach to design and to embed efficient quality control functions in the context of network integrated manufacturing systems. Such system let designers located far away from the production facility to monitor, control and adjust the quality inspection processes as production design evolves.

  7. A Telerehabilitation Approach to Enhance Quality of Life Through Exercise Among Adults With Paraplegia: Study Protocol.

    PubMed

    Sweet, Shane Norman; Rocchi, Meredith; Arbour-Nicitopoulos, Kelly; Kairy, Dahlia; Fillion, Brigitte

    2017-10-19

    assessment, participants will be randomly assigned to the intervention or control group. Participants in the intervention group will participate in 8 weekly, 1-hour video-based telerehabilitation sessions with a trained physical activity counselor, while participants in the control group will be asked to continue with their regular routine. We expect higher ratings of the basic psychological needs and autonomous motivation and lower scores for controlled motivation for the intervention group compared to the control group (Objective 1). We also expect that our video-based intervention will have moderate effects on exercise participation, as well as small-to-moderate positive effects on the quality of life‒related variables (Objective 2). Finally, we expect the intervention to have a small positive effect on psychosocial predictors of physical activity and well-being (Objective 3). We anticipate that the results will show that the intervention is appropriate for adults with paraplegia and feasible to test in a full-scale RCT. ClinicalTrials.gov NCT02833935; https://clinicaltrials.gov/ct2/show/NCT02833935 (Archived by WebCite at http://www.webcitation.org/6u8U9x2yt). ©Shane Norman Sweet, Meredith Rocchi, Kelly Arbour-Nicitopoulos, Dahlia Kairy, Brigitte Fillion. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.10.2017.

  8. Quality and Variability of Online Available Physical Therapy Protocols From Academic Orthopaedic Surgery Programs for Anterior Cruciate Ligament Reconstruction.

    PubMed

    Makhni, Eric C; Crump, Erica K; Steinhaus, Michael E; Verma, Nikhil N; Ahmad, Christopher S; Cole, Brian J; Bach, Bernard R

    2016-08-01

    To assess the quality and variability found across anterior cruciate ligament (ACL) rehabilitation protocols published online by academic orthopaedic programs. Web-based ACL physical therapy protocols from United States academic orthopaedic programs available online were included for review. Main exclusion criteria included concomitant meniscus repair, protocols aimed at pediatric patients, and failure to provide time points for the commencement or recommended completion of any protocol components. A comprehensive, custom scoring rubric was created that was used to assess each protocol for the presence or absence of various rehabilitation components, as well as when those activities were allowed to be initiated in each protocol. Forty-two protocols were included for review from 155 U.S. academic orthopaedic programs. Only 13 protocols (31%) recommended a prehabilitation program. Five protocols (12%) recommended continuous passive motion postoperatively. Eleven protocols (26%) recommended routine partial or non-weight bearing immediately postoperatively. Ten protocols (24%) mentioned utilization of a secondary/functional brace. There was considerable variation in range of desired full-weight-bearing initiation (9 weeks), as well as in the types of strength and proprioception exercises specifically recommended. Only 8 different protocols (19%) recommended return to sport after achieving certain strength and activity criteria. Many ACL rehabilitation protocols recommend treatment modalities not supported by current reports. Moreover, high variability in the composition and time ranges of rehabilitation components may lead to confusion among patients and therapists. Level II. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  9. Difficulties in controlling mobilization pain using a standardized patient-controlled analgesia protocol in burns.

    PubMed

    Nilsson, Andreas; Kalman, Sigga; Sonesson, Lena Karin; Arvidsson, Anders; Sjöberg, Folke

    2011-01-01

    The aim of this study was to evaluate pain relief for patients with burns during rest and mobilization with morphine according to a standard protocol for patient-controlled analgesia (PCA). Eighteen patients with a mean (SD) burned TBSA% of 26 (20) were studied for 10 days. Using a numeric rating scale (NRS, 0 = no pain and 10 = unbearable pain), patients were asked to estimate their acceptable and worst experienced pain by specifying a number on a scale and at what point they would like additional analgesics. Patients were allowed free access to morphine with a PCA pump device. Bolus doses were set according to age, (100 - age)/24 = bolus dose (mg), and 6 minutes lockout time. Degrees of pain, morphine requirements, doses delivered and demanded, oral intake of food, and antiemetics given were used as endpoints. Acceptable pain (mean [SD]) was estimated to be 3.8 (1.3) on the NRS, and additional treatment was considered necessary at scores of 4.3 (1.6) or more. NRS at rest was 2.7 (2.2) and during mobilization 4.7 (2.6). Required mean morphine per day was 81 (15) mg, and the number of doses requested increased during the first 6 days after the burn. The authors found no correlation between dose of morphine required and any other variables. Background pain can be controlled adequately with a standard PCA protocol. During mobilization, the pain experienced was too intense, despite having the already high doses of morphine increased. The present protocol must be refined further to provide analgesia adequate to cover mobilization as well.

  10. A modified laboratory canning protocol for quality evaluation of dry bean (Phaseolus vulgaris L).

    PubMed

    Balasubramanian, Parthiba; Slinkard, Alfred; Tyler, Robert; Vandenberg, Albert

    2000-05-01

    The effects of calcium (Ca 2+ ) level in the soak water, blanch water and brine, blanching temperature, and total seed solids on dry bean canning quality were investigated to optimise a laboratory canning protocol. A linear increase in the Ca 2+ level of soak water, blanch water and brine resulted in a linear decrease in hydration coefficient and percent washed drained weight but a linear increase in texture. Low Ca 2+ level (10 mg kg -1 ) reduced the hydration time for dry bean seed from 14 to 1 h. Blanching temperatures of 50, 70 and 88 °C had non-significant effects on canning quality traits. Blanching for 30 min at 70 °C for black bean or at 88 °C for navy bean and pinto bean resulted in percent washed drained weight ≥ 60, as required by the Canada Agricultural Products Standards Act. Seed solids levels of 95-97 g per 300 × 407 (14 fl oz) can were sufficient to attain a percent washed drained weight of 60. It was confirmed that the thermal processing conditions (115.6 °C retort temperature, 45 min) used in this study were sufficient to achieve commercial sterility. The optimised lab protocol for evaluation of the canning quality of dry bean breeding lines is as follows. Seed containing 95 g of solids for pinto bean, 96 g for navy bean and 97 g for black bean is soaked in water for 30 min at 20 °C and blanched for 30 min at 70 °C for black bean and 88 °C for navy bean and pinto bean in water containing 10 mg kg -1 of Ca 2+ . The seed is then transferred to a 300 × 407 can, filled with brine containing 10 mg kg -1 of Ca 2+ , 1.3% (w/v) of NaCl and 1.6% (w/v) of sugar. The can is then sealed, processed in steam at 115.6 °C for 45 min and cooled at 20 °C for 20 min. Cans are stored for at least 2 weeks prior to quality evaluation of the canned product. Canning of dry bean seed according to this protocol results in precise estimation of canning quality traits, particularly percent

  11. 40 CFR 51.359 - Quality control.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 2 2014-07-01 2014-07-01 false Quality control. 51.359 Section 51.359 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS REQUIREMENTS FOR... to assure test accuracy. Computer control of quality assurance checks and quality control charts...

  12. Quality control of positron emission tomography radiopharmaceuticals: An institutional experience.

    PubMed

    Shukla, Jaya; Vatsa, Rakhee; Garg, Nitasha; Bhusari, Priya; Watts, Ankit; Mittal, Bhagwant R

    2013-10-01

    To study quality control parameters of routinely prepared positron emission tomography (PET) radiopharmaceuticals. Three PET radiopharmaceuticals fluorine-18 fluorodeoxyglucose (F-18 FDG), N-13 ammonia (N-13 NH3), and Ga-68 DOTATATE (n = 25 each), prepared by standardized protocols were used. The radionuclide purity, radiochemical purity, residual solvents, pH, endotoxins, and sterility of these radiopharmaceuticals were determined. The physical half-life of radionuclide in radiopharmaceuticals, determined by both graphical and formula method, demonstrated purity of radionuclides used. pH of all PET radiopharmaceuticals used was in the range of 5-6.5. No microbial growth was observed in radiopharmaceutical preparations. The residual solvents, chemical impurity, and pyrogens were within the permissible limits. All three PET radiopharmaceuticals were safe for intravenous administration.

  13. Satellite-Friendly Protocols and Standards

    NASA Astrophysics Data System (ADS)

    Koudelka, O.; Schmidt, M.; Ebert, J.; Schlemmer, H.; Kastner, S.; Riedler, W.

    2002-01-01

    We are currently observing a development unprecedented with other services, the enormous growth of the Internet. Video, voice and data applications can be supported via this network in high quality. Multi-media applications require high bandwidth which may not be available in many areas. When making proper use of the broadcast feature of a communications satellite, the performance of the satellite-based system can compare favourably to terrestrial solutions. Internet applications are in many cases highly asymmetric, making them very well suited to applications using small and inexpensive terminals. Data from one source may be used simultaneously by a large number of users. The Internet protocol suite has become the de-facto standard. But this protocol family in its original form has not been designed to support guaranteed quality of service, a prerequisite for real-time, high quality traffic. The Internet Protocol has to be adapted for the satellite environment, because long roundtrip delays and the error behaviour of the channel could make it inefficient over a GEO satellite. Another requirement is to utilise the satellite bandwidth as efficiently as possible. This can be achieved by adapting the access system to the nature of IP frames, which are variable in length. In the framework of ESA's ARTES project a novel satellite multimedia system was developed which utilises Multi-Frequency TDMA in a meshed network topology. The system supports Quality of Service (QoS) by reserving capacity with different QoS requirements. The system is centrally controlled by a master station with the implementation of a demand assignment (DAMA) system. A lean internal signalling system has been adopted. Network management is based on the SNMP protocol and industry-standard network management platforms, making interfaces to standard accounting and billing systems easy. Modern communication systems will have to be compliant to different standards in a very flexible manner. The

  14. Protocols for pressure ulcer prevention: are they evidence-based?

    PubMed

    Chaves, Lidice M; Grypdonck, Mieke H F; Defloor, Tom

    2010-03-01

    This study is a report of a study to determine the quality of protocols for pressure ulcer prevention in home care in the Netherlands. If pressure ulcer prevention protocols are evidence-based and practitioners use them correctly in practice, this will result a reduction in pressure ulcers. Very little is known about the evidence-based content and quality of the pressure ulcer prevention protocols. In 2008, current pressure ulcer prevention protocols from 24 home-care agencies in the Netherlands were evaluated. A checklist developed and validated by two pressure ulcer prevention experts was used to assess the quality of the protocols, and weighted and unweighted quality scores were computed and analysed using descriptive statistics. The 24 pressure ulcer prevention protocols had a mean weighted quality score of 63.38 points out of a maximum of 100 (sd 5). The importance of observing the skin at the pressure points at least once a day was emphasized in 75% of the protocols. Only 42% correctly warned against the use of materials that were 'less effective or that could potentially cause harm'. Pressure ulcer prevention commands a reasonable amount of attention in home care, but the incidence of pressure ulcers and lack of a consistent, standardized document for use in actual practice indicate a need for systematic implementation of national pressure ulcer prevention standards in the Netherlands to ensure adherence to the established protocols.

  15. 7 CFR 981.42 - Quality control.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 8 2012-01-01 2012-01-01 false Quality control. 981.42 Section 981.42 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Regulating Handling Quality Control § 981.42 Quality control. (a) Incoming. Except as provided in this...

  16. 7 CFR 981.42 - Quality control.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 8 2013-01-01 2013-01-01 false Quality control. 981.42 Section 981.42 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS... Regulating Handling Quality Control § 981.42 Quality control. (a) Incoming. Except as provided in this...

  17. 7 CFR 981.42 - Quality control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Quality control. 981.42 Section 981.42 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Regulating Handling Quality Control § 981.42 Quality control. (a) Incoming. Except as provided in this...

  18. 7 CFR 981.42 - Quality control.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Quality control. 981.42 Section 981.42 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Regulating Handling Quality Control § 981.42 Quality control. (a) Incoming. Except as provided in this...

  19. The importance of quality control in validating concentrations of contaminants of emerging concern in source and treated drinking water samples.

    PubMed

    Batt, Angela L; Furlong, Edward T; Mash, Heath E; Glassmeyer, Susan T; Kolpin, Dana W

    2017-02-01

    A national-scale survey of 247 contaminants of emerging concern (CECs), including organic and inorganic chemical compounds, and microbial contaminants, was conducted in source and treated drinking water samples from 25 treatment plants across the United States. Multiple methods were used to determine these CECs, including six analytical methods to measure 174 pharmaceuticals, personal care products, and pesticides. A three-component quality assurance/quality control (QA/QC) program was designed for the subset of 174 CECs which allowed us to assess and compare performances of the methods used. The three components included: 1) a common field QA/QC protocol and sample design, 2) individual investigator-developed method-specific QA/QC protocols, and 3) a suite of 46 method comparison analytes that were determined in two or more analytical methods. Overall method performance for the 174 organic chemical CECs was assessed by comparing spiked recoveries in reagent, source, and treated water over a two-year period. In addition to the 247 CECs reported in the larger drinking water study, another 48 pharmaceutical compounds measured did not consistently meet predetermined quality standards. Methodologies that did not seem suitable for these analytes are overviewed. The need to exclude analytes based on method performance demonstrates the importance of additional QA/QC protocols. Published by Elsevier B.V.

  20. Evaluating the Process of Generating a Clinical Trial Protocol

    PubMed Central

    Franciosi, Lui G.; Butterfield, Noam N.; MacLeod, Bernard A.

    2002-01-01

    The research protocol is the principal document in the conduct of a clinical trial. Its generation requires knowledge about the research problem, the potential experimental confounders, and the relevant Good Clinical Practices for conducting the trial. However, such information is not always available to authors during the writing process. A checklist of over 80 items has been developed to better understand the considerations made by authors in generating a protocol. It is based on the most cited requirements for designing and implementing the randomised controlled trial. Items are categorised according to the trial's research question, experimental design, statistics, ethics, and standard operating procedures. This quality assessment tool evaluates the extent that a generated protocol deviates from the best-planned clinical trial.

  1. 7 CFR 930.44 - Quality control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Quality control. 930.44 Section 930.44 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of the...

  2. 7 CFR 930.44 - Quality control.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Quality control. 930.44 Section 930.44 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of the...

  3. 7 CFR 930.44 - Quality control.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 8 2012-01-01 2012-01-01 false Quality control. 930.44 Section 930.44 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of the...

  4. 7 CFR 930.44 - Quality control.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 8 2013-01-01 2013-01-01 false Quality control. 930.44 Section 930.44 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS... Control § 930.44 Quality control. (a) Quality standards. The Board may establish, with the approval of the...

  5. A low power medium access control protocol for wireless medical sensor networks.

    PubMed

    Lamprinos, I; Prentza, A; Sakka, E; Koutsouris, D

    2004-01-01

    The concept of a wireless integrated network of sensors, already applied in several sectors of our everyday life, such as security, transportation and environment monitoring, can as well provide an advanced monitor and control resource for healthcare services. By networking medical sensors wirelessly, attaching them in patient's body, we create the appropriate infrastructure for continuous and real-time monitoring of patient without discomforting him. This infrastructure can improve healthcare by providing the means for flexible acquisition of vital signs, while at the same time it provides more convenience to the patient. Given the type of wireless network, traditional medium access control (MAC) protocols cannot take advantage of the application specific requirements and information characteristics occurring in medical sensor networks, such as the demand for low power consumption and the rather limited and asymmetric data traffic. In this paper, we present the architecture of a low power MAC protocol, designated to support wireless networks of medical sensors. This protocol aims to improve energy efficiency by exploiting the inherent application features and requirements. It is oriented towards the avoidance of main energy wastage sources, such as idle listening, collision and power outspending.

  6. Quantitative image feature variability amongst CT scanners with a controlled scan protocol

    NASA Astrophysics Data System (ADS)

    Ger, Rachel B.; Zhou, Shouhao; Chi, Pai-Chun Melinda; Goff, David L.; Zhang, Lifei; Lee, Hannah J.; Fuller, Clifton D.; Howell, Rebecca M.; Li, Heng; Stafford, R. Jason; Court, Laurence E.; Mackin, Dennis S.

    2018-02-01

    Radiomics studies often analyze patient computed tomography (CT) images acquired from different CT scanners. This may result in differences in imaging parameters, e.g. different manufacturers, different acquisition protocols, etc. However, quantifiable differences in radiomics features can occur based on acquisition parameters. A controlled protocol may allow for minimization of these effects, thus allowing for larger patient cohorts from many different CT scanners. In order to test radiomics feature variability across different CT scanners a radiomics phantom was developed with six different cartridges encased in high density polystyrene. A harmonized protocol was developed to control for tube voltage, tube current, scan type, pitch, CTDIvol, convolution kernel, display field of view, and slice thickness across different manufacturers. The radiomics phantom was imaged on 18 scanners using the control protocol. A linear mixed effects model was created to assess the impact of inter-scanner variability with decomposition of feature variation between scanners and cartridge materials. The inter-scanner variability was compared to the residual variability (the unexplained variability) and to the inter-patient variability using two different patient cohorts. The patient cohorts consisted of 20 non-small cell lung cancer (NSCLC) and 30 head and neck squamous cell carcinoma (HNSCC) patients. The inter-scanner standard deviation was at least half of the residual standard deviation for 36 of 49 quantitative image features. The ratio of inter-scanner to patient coefficient of variation was above 0.2 for 22 and 28 of the 49 features for NSCLC and HNSCC patients, respectively. Inter-scanner variability was a significant factor compared to patient variation in this small study for many of the features. Further analysis with a larger cohort will allow more thorough analysis with additional variables in the model to truly isolate the interscanner difference.

  7. Development of quality control and instrumentation performance metrics for diffuse optical spectroscopic imaging instruments in the multi-center clinical environment

    NASA Astrophysics Data System (ADS)

    Keene, Samuel T.; Cerussi, Albert E.; Warren, Robert V.; Hill, Brian; Roblyer, Darren; Leproux, AnaÑ--s.; Durkin, Amanda F.; O'Sullivan, Thomas D.; Haghany, Hosain; Mantulin, William W.; Tromberg, Bruce J.

    2013-03-01

    Instrument equivalence and quality control are critical elements of multi-center clinical trials. We currently have five identical Diffuse Optical Spectroscopic Imaging (DOSI) instruments enrolled in the American College of Radiology Imaging Network (ACRIN, #6691) trial located at five academic clinical research sites in the US. The goal of the study is to predict the response of breast tumors to neoadjuvant chemotherapy in 60 patients. In order to reliably compare DOSI measurements across different instruments, operators and sites, we must be confident that the data quality is comparable. We require objective and reliable methods for identifying, correcting, and rejecting low quality data. To achieve this goal, we developed and tested an automated quality control algorithm that rejects data points below the instrument noise floor, improves tissue optical property recovery, and outputs a detailed data quality report. Using a new protocol for obtaining dark-noise data, we applied the algorithm to ACRIN patient data and successfully improved the quality of recovered physiological data in some cases.

  8. An Argument Approach to Observation Protocol Validity

    ERIC Educational Resources Information Center

    Bell, Courtney A.; Gitomer, Drew H.; McCaffrey, Daniel F.; Hamre, Bridget K.; Pianta, Robert C.; Qi, Yi

    2012-01-01

    This article develops a validity argument approach for use on observation protocols currently used to assess teacher quality for high-stakes personnel and professional development decisions. After defining the teaching quality domain, we articulate an interpretive argument for observation protocols. To illustrate the types of evidence that might…

  9. Automating PACS quality control with the Vanderbilt image processing enterprise resource

    NASA Astrophysics Data System (ADS)

    Esparza, Michael L.; Welch, E. Brian; Landman, Bennett A.

    2012-02-01

    Precise image acquisition is an integral part of modern patient care and medical imaging research. Periodic quality control using standardized protocols and phantoms ensures that scanners are operating according to specifications, yet such procedures do not ensure that individual datasets are free from corruption; for example due to patient motion, transient interference, or physiological variability. If unacceptable artifacts are noticed during scanning, a technologist can repeat a procedure. Yet, substantial delays may be incurred if a problematic scan is not noticed until a radiologist reads the scans or an automated algorithm fails. Given scores of slices in typical three-dimensional scans and widevariety of potential use cases, a technologist cannot practically be expected inspect all images. In large-scale research, automated pipeline systems have had great success in achieving high throughput. However, clinical and institutional workflows are largely based on DICOM and PACS technologies; these systems are not readily compatible with research systems due to security and privacy restrictions. Hence, quantitative quality control has been relegated to individual investigators and too often neglected. Herein, we propose a scalable system, the Vanderbilt Image Processing Enterprise Resource (VIPER) to integrate modular quality control and image analysis routines with a standard PACS configuration. This server unifies image processing routines across an institutional level and provides a simple interface so that investigators can collaborate to deploy new analysis technologies. VIPER integrates with high performance computing environments has successfully analyzed all standard scans from our institutional research center over the course of the last 18 months.

  10. Effectiveness of Aquatic Therapy vs Land-based Therapy for Balance and Pain in Women with Fibromyalgia: a study protocol for a randomised controlled trial.

    PubMed

    Rivas Neira, Sabela; Pasqual Marques, Amélia; Pegito Pérez, Irene; Fernández Cervantes, Ramón; Vivas Costa, Jamile

    2017-01-19

    Fibromyalgia is a disease with an increasing incidence. It impairs the quality of life of patients and decreases their functional capacity. Aquatic therapy has already been used for managing the symptoms of this syndrome. However, aquatic therapy has only recently been introduced as a treatment modality for improving proprioception in fibromyalgia. The main objective of this study is to determine the effectiveness of two physiotherapy protocols, one in and one out of water, for improving balance and decreasing pain in women with fibromyalgia. The study protocol will be a single-blind randomised controlled trial. Forty women diagnosed with fibromyalgia will be randomly assigned into 2 groups: Aquatic Therapy (n = 20) or Land-based Therapy (n = 20). Both interventions include 60-min therapy sessions, structured into 4 sections: Warm-up, Proprioceptive Exercises, Stretching and Relaxation. These sessions will be carried out 3 times a week for 3 months. Primary outcomes are balance (static and dynamic) and pain (intensity and threshold). Secondary outcomes include functional balance, quality of life, quality of sleep, fatigue, self-confidence in balance and physical ability. Outcome measures will be evaluated at baseline, at the end of the 3-month intervention period, and 6-weeks post-treatment. Statistical analysis will be carried out using the SPSS 21.0 program for Windows and a significance level of p ≤ 0.05 will be used for all tests. This study protocol details two physiotherapy interventions in women with fibromyalgia to improve balance and decrease pain: aquatic therapy and land-based therapy. In current literature there is a lack of methodological rigour and a limited number of studies that describe physiotherapy protocols to manage fibromyalgia symptoms. High-quality scientific works are required to highlight physiotherapy as one of the most recommended treatment options for this syndrome. Date of publication in ClinicalTrials.gov: 18

  11. 14 CFR 21.139 - Quality control.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Quality control. 21.139 Section 21.139... PROCEDURES FOR PRODUCTS AND PARTS Production Certificates § 21.139 Quality control. The applicant must show that he has established and can maintain a quality control system for any product, for which he...

  12. 33 CFR 385.21 - Quality control.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 3 2011-07-01 2011-07-01 false Quality control. 385.21 Section... Processes § 385.21 Quality control. (a) The Corps of Engineers and the non-Federal sponsor shall prepare a quality control plan, in accordance with applicable Corps of Engineers regulations, for each product that...

  13. 14 CFR 21.139 - Quality control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Quality control. 21.139 Section 21.139... PROCEDURES FOR PRODUCTS AND PARTS Production Certificates § 21.139 Quality control. The applicant must show that he has established and can maintain a quality control system for any product, for which he...

  14. 33 CFR 385.21 - Quality control.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 33 Navigation and Navigable Waters 3 2013-07-01 2013-07-01 false Quality control. 385.21 Section... Processes § 385.21 Quality control. (a) The Corps of Engineers and the non-Federal sponsor shall prepare a quality control plan, in accordance with applicable Corps of Engineers regulations, for each product that...

  15. 33 CFR 385.21 - Quality control.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 3 2010-07-01 2010-07-01 false Quality control. 385.21 Section... Processes § 385.21 Quality control. (a) The Corps of Engineers and the non-Federal sponsor shall prepare a quality control plan, in accordance with applicable Corps of Engineers regulations, for each product that...

  16. 40 CFR 136.7 - Quality assurance and quality control.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... quality control elements, where applicable, into the laboratory's documented standard operating procedure... quality control elements must be clearly documented in the written standard operating procedure for each... Methods contains QA/QC procedures in the Part 1000 section of the Standard Methods Compendium. The...

  17. 40 CFR 136.7 - Quality assurance and quality control.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... quality control elements, where applicable, into the laboratory's documented standard operating procedure... quality control elements must be clearly documented in the written standard operating procedure for each... Methods contains QA/QC procedures in the Part 1000 section of the Standard Methods Compendium. The...

  18. 40 CFR 136.7 - Quality assurance and quality control.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... quality control elements, where applicable, into the laboratory's documented standard operating procedure... quality control elements must be clearly documented in the written standard operating procedure for each... Methods contains QA/QC procedures in the Part 1000 section of the Standard Methods Compendium. The...

  19. RNA-SeQC: RNA-seq metrics for quality control and process optimization.

    PubMed

    DeLuca, David S; Levin, Joshua Z; Sivachenko, Andrey; Fennell, Timothy; Nazaire, Marc-Danie; Williams, Chris; Reich, Michael; Winckler, Wendy; Getz, Gad

    2012-06-01

    RNA-seq, the application of next-generation sequencing to RNA, provides transcriptome-wide characterization of cellular activity. Assessment of sequencing performance and library quality is critical to the interpretation of RNA-seq data, yet few tools exist to address this issue. We introduce RNA-SeQC, a program which provides key measures of data quality. These metrics include yield, alignment and duplication rates; GC bias, rRNA content, regions of alignment (exon, intron and intragenic), continuity of coverage, 3'/5' bias and count of detectable transcripts, among others. The software provides multi-sample evaluation of library construction protocols, input materials and other experimental parameters. The modularity of the software enables pipeline integration and the routine monitoring of key measures of data quality such as the number of alignable reads, duplication rates and rRNA contamination. RNA-SeQC allows investigators to make informed decisions about sample inclusion in downstream analysis. In summary, RNA-SeQC provides quality control measures critical to experiment design, process optimization and downstream computational analysis. See www.genepattern.org to run online, or www.broadinstitute.org/rna-seqc/ for a command line tool.

  20. The Deployment of Routing Protocols in Distributed Control Plane of SDN

    PubMed Central

    Jingjing, Zhou; Di, Cheng; Weiming, Wang; Rong, Jin; Xiaochun, Wu

    2014-01-01

    Software defined network (SDN) provides a programmable network through decoupling the data plane, control plane, and application plane from the original closed system, thus revolutionizing the existing network architecture to improve the performance and scalability. In this paper, we learned about the distributed characteristics of Kandoo architecture and, meanwhile, improved and optimized Kandoo's two levels of controllers based on ideological inspiration of RCP (routing control platform). Finally, we analyzed the deployment strategies of BGP and OSPF protocol in a distributed control plane of SDN. The simulation results show that our deployment strategies are superior to the traditional routing strategies. PMID:25250395

  1. The deployment of routing protocols in distributed control plane of SDN.

    PubMed

    Jingjing, Zhou; Di, Cheng; Weiming, Wang; Rong, Jin; Xiaochun, Wu

    2014-01-01

    Software defined network (SDN) provides a programmable network through decoupling the data plane, control plane, and application plane from the original closed system, thus revolutionizing the existing network architecture to improve the performance and scalability. In this paper, we learned about the distributed characteristics of Kandoo architecture and, meanwhile, improved and optimized Kandoo's two levels of controllers based on ideological inspiration of RCP (routing control platform). Finally, we analyzed the deployment strategies of BGP and OSPF protocol in a distributed control plane of SDN. The simulation results show that our deployment strategies are superior to the traditional routing strategies.

  2. Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial

    PubMed Central

    McAlister, Finlay Aleck; Wood, Peter William; Boulanger, Pierre; Fradette, Miriam; Klarenbach, Scott; Edwards, Alun L; Holroyd-Leduc, Jayna M; Alagiakrishnan, Kannayiram; Rabi, Doreen; Majumdar, Sumit Ranjan

    2016-01-01

    Background Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving “optimal BP control” (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring—the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management. Objective To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with “enhanced usual care” in community-dwelling seniors with diabetes and hypertension. Methods A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors’ residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management. Results Outcomes will be

  3. Establishment of a rapid, inexpensive protocol for extraction of high quality RNA from small amounts of strawberry plant tissues and other recalcitrant fruit crops.

    PubMed

    Christou, Anastasis; Georgiadou, Egli C; Filippou, Panagiota; Manganaris, George A; Fotopoulos, Vasileios

    2014-03-01

    Strawberry plant tissues and particularly fruit material are rich in polysaccharides and polyphenolic compounds, thus rendering the isolation of nucleic acids a difficult task. This work describes the successful modification of a total RNA extraction protocol, which enables the isolation of high quantity and quality of total RNA from small amounts of strawberry leaf, root and fruit tissues. Reverse-transcription polymerase chain reaction (RT-PCR) amplification of GAPDH housekeeping gene from isolated RNA further supports the proposed protocol efficiency and its use for downstream molecular applications. This novel procedure was also successfully followed using other fruit tissues, such as olive and kiwifruit. In addition, optional treatment with RNase A following initial nucleic acid extraction can provide sufficient quality and quality of genomic DNA for subsequent PCR analyses, as evidenced from PCR amplification of housekeeping genes using extracted genomic DNA as template. Overall, this optimized protocol allows easy, rapid and economic isolation of high quality RNA from small amounts of an important fruit crop, such as strawberry, with extended applicability to other recalcitrant fruit crops. Copyright © 2013 Elsevier B.V. All rights reserved.

  4. Acute Pain Service and multimodal therapy for postsurgical pain control: evaluation of protocol efficacy.

    PubMed

    Moizo, E; Berti, M; Marchetti, C; Deni, F; Albertin, A; Muzzolon, F; Antonino, A

    2004-11-01

    The institution of a postoperative Acute Pain Control Service is mandatory to improve the control of pain induced by surgical injury. Treatment of postoperative pain may be achieved using a combination of analgesic agents and techniques, reducing the incidence of side effects owing to the lower doses of the individual drugs. In 1997 we established an Acute Pain Service (APS) at the San Raffaele Hospital in Milan. The aim of this study was to assess the efficacy and safety of our APS both in terms of treatment protocols and organisational issues. In this prospective observational study we included 592 patients undergoing abdominal, gynecological, or orthopedic surgery with severe expected pain. According to general guidelines on pain treatment, the patients were assigned to different treatment protocols based on the kind of operation. All protocols were based on the multimodal therapy, with the association of nonsteroidal anti-inflammatory drugs (NSAIDS), opioids and regional anesthesia techniques. During the first 48 h of the postoperative period we recorded vital signs, level of pain and occurrence of any side effect. Our analgesic protocols proved to be effective and safe (low incidence of side effects) for every surgery. The incidence of postoperative nausea and vomiting was higher in patients receiving patient-controlled morphine than that with continuous epidural or nerve block. After lower abdominal surgery, pain at movement at 24 h was significantly lower in the epidural group than in the Patient Control Analgesia group. Nausea and vomiting, numbness and paresthesias at the lower limbs were higher in gynecological patients. A larger percentage of orthopedic patients in the epidural group reported numbness and paresthesias at the lower limbs in comparison with patients receiving continuous peripheral nerve block. In agreement with previous literature, this study confirmed that a multimodal approach to pain treatment provides an adequate control of

  5. Dose specification and quality assurance of RTOG protocol 95-17; a cooperative group study of 192Ir breast implants as sole therapy

    PubMed Central

    Ibbott, Geoffrey S.; Hanson, W.F.; Martin, Elizabeth; Kuske, Robert R.; Arthur, Douglas; Rabinovitch, Rachel; White, Julia; Wilenzick, Raymond M.; Harris, Irene; Tailor, Ramesh C.

    2007-01-01

    Purpose RTOG protocol 95-17 was a phase I/II trial to evaluate multi-catheter brachytherapy as the sole method of adjuvant breast radiotherapy for stage I/II breast carcinoma following breast conserving surgery. Low or high dose rate sources were allowed. Dose prescription and treatment evaluation were based on recommendations in ICRU Report 58, and included the parameters mean central dose (MCD), average peripheral dose, dose homogeneity index (DHI), and the dimensions of the low and high dose regions. Methods and Materials Three levels of quality assurance were implemented: (1) Credentialing of institutions was required prior to entering patients onto the study. (2) Rapid review of each treatment plan was conducted prior to treatment, and (3) Retrospective review was performed by the Radiological Physics Center in conjunction with the study chairman and RTOG dosimetry staff. Results Credentialing focused on the accuracy of dose calculation algorithm and compliance with protocol guidelines. Rapid review was designed to identify and correct deviations from the protocol prior to treatment. The retrospective review involved recalculation of dosimetry parameters and review of dose distributions to evaluate the treatment. Specifying both central and peripheral doses resulted in uniform dose distributions, with a mean dose homogeneity index of 0.83 ±0.06. Conclusions Vigorous quality assurance resulted in a high-quality study with few deviations; only 4 of 100 patients were judged as minor variations from protocol and no patient was judged a major deviation. This study should be considered a model for quality assurance of future trials. PMID:18035213

  6. The effects of pulmonary rehabilitation in patients with non-cystic fibrosis bronchiectasis: protocol for a randomised controlled trial.

    PubMed

    Lee, Annemarie L; Cecins, Nola; Hill, Catherine J; Holland, Anne E; Rautela, Linda; Stirling, Robert G; Thompson, Phillip J; McDonald, Christine F; Jenkins, Sue

    2010-02-02

    Non-cystic fibrosis bronchiectasis is characterised by sputum production, exercise limitation and recurrent infections. Although pulmonary rehabilitation is advocated for this patient group, its effects are unclear. The aims of this study are to determine the short and long term effects of pulmonary rehabilitation on exercise capacity, cough, quality of life and the incidence of acute pulmonary exacerbations. This randomised controlled trial aims to recruit 64 patients with bronchiectasis from three tertiary institutions. Participants will be randomly allocated to the intervention group (supervised, twice weekly exercise training with regular review of airway clearance therapy) or a control group (twice weekly telephone support). Measurements will be taken at baseline, immediately following the intervention and at six and 12 months following the intervention period by a blinded assessor. Exercise capacity will be measured using the incremental shuttle walk test and the six-minute walk test. Quality of life and health status will be measured using the Chronic Respiratory Questionnaire, Leicester Cough Questionnaire, Assessment of Quality of Life Questionnaire and the Hospital Anxiety and Depression Scale. The rate of hospitalisation will be captured as well as the incidence of acute pulmonary exacerbations using a daily symptom diary. Results from this study will help to determine the efficacy of supervised twice-weekly pulmonary rehabilitation upon exercise capacity and quality of life in patients with bronchiectasis and will contribute to clinical practice guidelines for physiotherapists in the management of this population. This study protocol is registered with ClinicalTrials.gov (NCT00885521).

  7. Comparing clinical quality indicators for asthma management in children with outcome measures used in randomised controlled trials: a protocol.

    PubMed

    Choong, Miew Keen; Tsafnat, Guy; Hibbert, Peter; Runciman, William B; Coiera, Enrico

    2015-09-08

    Clinical quality indicators are necessary to monitor the performance of healthcare services. The development of indicators should, wherever possible, be based on research evidence to minimise the risk of bias which may be introduced during their development, because of logistic, ethical or financial constraints alone. The development of automated methods to identify the evidence base for candidate indicators should improve the process of indicator development. The objective of this study is to explore the relationship between clinical quality indicators for asthma management in children with outcome and process measurements extracted from randomised controlled clinical trial reports. National-level indicators for asthma management in children will be extracted from the National Quality Measures Clearinghouse (NQMC) database and the National Institute for Health and Care Excellence (NICE) quality standards. Outcome measures will be extracted from published English language randomised controlled trial (RCT) reports for asthma management in children aged below 12 years. The two sets of measures will be compared to assess any overlap. The study will provide insights into the relationship between clinical quality indicators and measurements in RCTs. This study will also yield a list of measurements used in RCTs for asthma management in children, and will find RCT evidence for indicators used in practice. Ethical approval is not necessary because this study will not include patient data. Findings will be disseminated through peer-reviewed publications. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  8. A quality improvement plan for hypertension control: the INCOTECA Project (INterventions for COntrol of hyperTEnsion in CAtalonia)

    PubMed Central

    Vallès-Fernandez, Roser; Rosell-Murphy, Magdalena; Correcher-Aventin, Olga; Mengual-Martínez, Lucas; Aznar-Martínez, Núria; Prieto-De Lamo, Gemma; Franzi-Sisó, Alícia; Puig-Manresa, Jordi; Ma Bonet-Simó, Josep

    2009-01-01

    . Significance level (α) will be set at < 0.05. Outcomes will be analysed on an intention-to-treat basis. Discussion The implementation of a quality improvement plan might benefit the coordination of different professionals of PHCTs and may also improve blood pressure control. Trial Registration This protocol has been registered at clinicaltrials.gov with the ID number MS: 1998275938244441. PMID:19321009

  9. The Marburg-Münster Affective Disorders Cohort Study (MACS): A quality assurance protocol for MR neuroimaging data.

    PubMed

    Vogelbacher, Christoph; Möbius, Thomas W D; Sommer, Jens; Schuster, Verena; Dannlowski, Udo; Kircher, Tilo; Dempfle, Astrid; Jansen, Andreas; Bopp, Miriam H A

    2018-05-15

    Large, longitudinal, multi-center MR neuroimaging studies require comprehensive quality assurance (QA) protocols for assessing the general quality of the compiled data, indicating potential malfunctions in the scanning equipment, and evaluating inter-site differences that need to be accounted for in subsequent analyses. We describe the implementation of a QA protocol for functional magnet resonance imaging (fMRI) data based on the regular measurement of an MRI phantom and an extensive variety of currently published QA statistics. The protocol is implemented in the MACS (Marburg-Münster Affective Disorders Cohort Study, http://for2107.de/), a two-center research consortium studying the neurobiological foundations of affective disorders. Between February 2015 and October 2016, 1214 phantom measurements have been acquired using a standard fMRI protocol. Using 444 healthy control subjects which have been measured between 2014 and 2016 in the cohort, we investigate the extent of between-site differences in contrast to the dependence on subject-specific covariates (age and sex) for structural MRI, fMRI, and diffusion tensor imaging (DTI) data. We show that most of the presented QA statistics differ severely not only between the two scanners used for the cohort but also between experimental settings (e.g. hardware and software changes), demonstrate that some of these statistics depend on external variables (e.g. time of day, temperature), highlight their strong dependence on proper handling of the MRI phantom, and show how the use of a phantom holder may balance this dependence. Site effects, however, do not only exist for the phantom data, but also for human MRI data. Using T1-weighted structural images, we show that total intracranial (TIV), grey matter (GMV), and white matter (WMV) volumes significantly differ between the MR scanners, showing large effect sizes. Voxel-based morphometry (VBM) analyses show that these structural differences observed between scanners are

  10. Biplane interventional pediatric system with cone‐beam CT: dose and image quality characterization for the default protocols

    PubMed Central

    Vañó, Eliseo; Alejo, Luis; Ubeda, Carlos; Gutiérrez‐Larraya, Federico; Garayoa, Julia

    2016-01-01

    The aim of this study was to assess image quality and radiation dose of a biplane angiographic system with cone‐beam CT (CBCT) capability tuned for pediatric cardiac procedures. The results of this study can be used to explore dose reduction techniques. For pulsed fluoroscopy and cine modes, polymethyl methacrylate phantoms of various thicknesses and a Leeds TOR 18‐FG test object were employed. Various fields of view (FOV) were selected. For CBCT, the study employed head and body dose phantoms, Catphan 504, and an anthropomorphic cardiology phantom. The study also compared two 3D rotational angiography protocols. The entrance surface air kerma per frame increases by a factor of 3–12 when comparing cine and fluoroscopy frames. The biggest difference in the signal‐to‐noise ratio between fluoroscopy and cine modes occurs at FOV 32 cm because fluoroscopy is acquired at a 1440×1440 pixel matrix size and in unbinned mode, whereas cine is acquired at 720×720 pixels and in binned mode. The high‐contrast spatial resolution of cine is better than that of fluoroscopy, except for FOV 32 cm, because fluoroscopy mode with 32 cm FOV is unbinned. Acquiring CBCT series with a 16 cm head phantom using the standard dose protocol results in a threefold dose increase compared with the low‐dose protocol. Although the amount of noise present in the images acquired with the low‐dose protocol is much higher than that obtained with the standard mode, the images present better spatial resolution. A 1 mm diameter rod with 250 Hounsfield units can be distinguished in reconstructed images with an 8 mm slice width. Pediatric‐specific protocols provide lower doses while maintaining sufficient image quality. The system offers a novel 3D imaging mode. The acquisition of CBCT images results in increased doses administered to the patients, but also provides further diagnostic information contained in the volumetric images. The assessed CBCT protocols provide images that are noisy

  11. A Modified Protocol for High-Quality RNA Extraction from Oleoresin-Producing Adult Pines.

    PubMed

    de Lima, Júlio César; Füller, Thanise Nogueira; de Costa, Fernanda; Rodrigues-Corrêa, Kelly C S; Fett-Neto, Arthur G

    2016-01-01

    RNA extraction resulting in good yields and quality is a fundamental step for the analyses of transcriptomes through high-throughput sequencing technologies, microarray, and also northern blots, RT-PCR, and RTqPCR. Even though many specific protocols designed for plants with high content of secondary metabolites have been developed, these are often expensive, time consuming, and not suitable for a wide range of tissues. Here we present a modification of the method previously described using the commercially available Concert™ Plant RNA Reagent (Invitrogen) buffer for field-grown adult pine trees with high oleoresin content.

  12. Quality of Mobile Phone and Tablet Mobile Apps for Speech Sound Disorders: Protocol for an Evidence-Based Appraisal

    PubMed Central

    Morris, Meg E; Erickson, Shane; Serry, Tanya A

    2016-01-01

    Background Although mobile apps are readily available for speech sound disorders (SSD), their validity has not been systematically evaluated. This evidence-based appraisal will critically review and synthesize current evidence on available therapy apps for use by children with SSD. Objective The main aims are to (1) identify the types of apps currently available for Android and iOS mobile phones and tablets, and (2) to critique their design features and content using a structured quality appraisal tool. Methods This protocol paper presents and justifies the methods used for a systematic review of mobile apps that provide intervention for use by children with SSD. The primary outcomes of interest are (1) engagement, (2) functionality, (3) aesthetics, (4) information quality, (5) subjective quality, and (6) perceived impact. Quality will be assessed by 2 certified practicing speech-language pathologists using a structured quality appraisal tool. Two app stores will be searched from the 2 largest operating platforms, Android and iOS. Systematic methods of knowledge synthesis shall include searching the app stores using a defined procedure, data extraction, and quality analysis. Results This search strategy shall enable us to determine how many SSD apps are available for Android and for iOS compatible mobile phones and tablets. It shall also identify the regions of the world responsible for the apps’ development, the content and the quality of offerings. Recommendations will be made for speech-language pathologists seeking to use mobile apps in their clinical practice. Conclusions This protocol provides a structured process for locating apps and appraising the quality, as the basis for evaluating their use in speech pathology for children in English-speaking nations. PMID:27899341

  13. Inter-laboratory quality control for hormone-dependent gene expression in human breast tumors using real-time reverse transcription-polymerase chain reaction.

    PubMed

    de Cremoux, P; Bieche, I; Tran-Perennou, C; Vignaud, S; Boudou, E; Asselain, B; Lidereau, R; Magdelénat, H; Becette, V; Sigal-Zafrani, B; Spyratos, F

    2004-09-01

    Quantitative reverse transcription-polymerase chain reaction (RT-PCR) used to detect minor changes in specific mRNA concentrations may be associated with poor reproducibility. Stringent quality control is therefore essential at each step of the protocol, including the PCR procedure. We performed inter-laboratory quality control of quantitative PCR between two independent laboratories, using in-house RT-PCR assays on a series of hormone-related target genes in a retrospective consecutive series of 79 breast tumors. Total RNA was reverse transcribed in a single center. Calibration curves were performed for five target genes (estrogen receptor (ER)alpha, ERbeta, progesterone receptor (PR), CYP19 (aromatase) and Ki 67) and for two reference genes (human acidic ribosomal phosphoprotein PO (RPLPO) and TATA box-binding protein (TBP)). Amplification efficiencies of the calibrator were determined for each run and used to calculate mRNA expression. Correlation coefficients were evaluated for each target and each reference gene. A good correlation was observed for all target and reference genes in both centers using their own protocols and kits (P < 0.0001). The correlation coefficients ranged from 0.90 to 0.98 for the various target genes in the two centers. A good correlation was observed between the level of expression of the ERalpha and the PR transcripts (P < 0.001). A weak inverse correlation was observed in both centers between ERalpha and ERbeta levels, but only when TBP was the reference gene. No other correlation was observed with other parameters. Real-time PCR assays allow convenient quantification of target mRNA transcripts and quantification of target-derived nucleic acids in clinical specimens. This study addresses the importance of inter-laboratory quality controls for the use of a panel of real-time PCR assays devoted to clinical samples and protocols and to ensure their appropriate accuracy. This can also facilitate exchanges and multicenter comparison of

  14. QUALITY CONTROL OF PHARMACEUTICALS.

    PubMed

    LEVI, L; WALKER, G C; PUGSLEY, L I

    1964-10-10

    Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. Requirements governing the quality control of pharmaceuticals in accordance with the Canadian Food and Drugs Act are cited and discussed.

  15. Complementary religious and spiritual interventions in physical health and quality of life: A systematic review of randomized controlled clinical trials

    PubMed Central

    Lucchetti, Giancarlo; Menezes, Paulo Rossi; Vallada, Homero

    2017-01-01

    Objective To examine whether religious and spiritual interventions (RSIs) can promote physical health and quality of life in individuals. Methods 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. Results 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

  16. 7 CFR 58.928 - Quality control tests.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to inspection for quality and condition throughout each processing operation. Quality control tests shall be...

  17. Expert database system for quality control

    NASA Astrophysics Data System (ADS)

    Wang, Anne J.; Li, Zhi-Cheng

    1993-09-01

    There are more competitors today. Markets are not homogeneous they are fragmented into increasingly focused niches requiring greater flexibility in the product mix shorter manufacturing production runs and above allhigher quality. In this paper the author identified a real-time expert system as a way to improve plantwide quality management. The quality control expert database system (QCEDS) by integrating knowledge of experts in operations quality management and computer systems use all information relevant to quality managementfacts as well as rulesto determine if a product meets quality standards. Keywords: expert system quality control data base

  18. 7 CFR 58.335 - Quality control tests.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Quality control tests. 58.335 Section 58.335... Procedures § 58.335 Quality control tests. All milk, cream and related products are subject to inspection for quality and condition throughout each processing operation. Quality control tests shall be made on flow...

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

    PubMed

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

    2018-01-01

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

  20. Emergency department-initiated palliative care for advanced cancer patients: protocol for a pilot randomized controlled trial.

    PubMed

    Kandarian, Brandon; Morrison, R Sean; Richardson, Lynne D; Ortiz, Joanna; Grudzen, Corita R

    2014-06-25

    For patients with advanced cancer, visits to the emergency department (ED) are common. Such patients present to the ED with a specific profile of palliative care needs, including burdensome symptoms such as pain, dyspnea, or vomiting that cannot be controlled in other settings and a lack of well-defined goals of care. The goals of this study are: i) to test the feasibility of recruiting, enrolling, and randomizing patients with serious illness in the ED; and ii) to evaluate the impact of ED-initiated palliative care on health care utilization, quality of life, and survival. This is a protocol for a single center parallel, two-arm randomized controlled trial in ED patients with metastatic solid tumors comparing ED-initiated palliative care referral to a control group receiving usual care. We plan to enroll 125 to 150 ED-advanced cancer patients at Mount Sinai Hospital in New York, USA, who meet the following criteria: i) pass a brief cognitive screen; ii) speak fluent English or Spanish; and iii) have never been seen by palliative care. We will use balanced block randomization in groups of 50 to assign patients to the intervention or control group after completion of a baseline questionnaire. All research staff performing assessment or analysis will be blinded to patient assignment. We will measure the impact of the palliative care intervention on the following outcomes: i) timing and rate of palliative care consultation; ii) quality of life and depression at 12 weeks, measured using the FACT-G and PHQ-9; iii) health care utilization; and iv) length of survival. The primary analysis will be based on intention-to-treat. This pilot randomized controlled trial will test the feasibility of recruiting, enrolling, and randomizing patients with advanced cancer in the ED, and provide a preliminary estimate of the impact of palliative care referral on health care utilization, quality of life, and survival. Clinical Trials.gov identifier: NCT01358110 (Entered 5/19/2011).

  1. FQC Dashboard: integrates FastQC results into a web-based, interactive, and extensible FASTQ quality control tool.

    PubMed

    Brown, Joseph; Pirrung, Meg; McCue, Lee Ann

    2017-06-09

    FQC is software that facilitates quality control of FASTQ files by carrying out a QC protocol using FastQC, parsing results, and aggregating quality metrics into an interactive dashboard designed to richly summarize individual sequencing runs. The dashboard groups samples in dropdowns for navigation among the data sets, utilizes human-readable configuration files to manipulate the pages and tabs, and is extensible with CSV data. FQC is implemented in Python 3 and Javascript, and is maintained under an MIT license. Documentation and source code is available at: https://github.com/pnnl/fqc . joseph.brown@pnnl.gov. © The Author(s) 2017. Published by Oxford University Press.

  2. Promoting psychosocial well-being following stroke: study protocol for a randomized, controlled trial.

    PubMed

    Kirkevold, Marit; Kildal Bragstad, Line; Bronken, Berit A; Kvigne, Kari; Martinsen, Randi; Gabrielsen Hjelle, Ellen; Kitzmüller, Gabriele; Mangset, Margrete; Angel, Sanne; Aadal, Lena; Eriksen, Siren; Wyller, Torgeir B; Sveen, Unni

    2018-04-03

    Stroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia. The study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15-20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity. The intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex

  3. Screening for plant viruses by next generation sequencing using a modified double strand RNA extraction protocol with an internal amplification control.

    PubMed

    Kesanakurti, Prasad; Belton, Mark; Saeed, Hanaa; Rast, Heidi; Boyes, Ian; Rott, Michael

    2016-10-01

    The majority of plant viruses contain RNA genomes. Detection of viral RNA genomes in infected plant material by next generation sequencing (NGS) is possible through the extraction and sequencing of total RNA, total RNA devoid of ribosomal RNA, small RNA interference (RNAi) molecules, or double stranded RNA (dsRNA). Plants do not typically produce high molecular weight dsRNA, therefore the presence of dsRNA makes it an attractive target for plant virus diagnostics. The sensitivity of NGS as a diagnostic method demands an effective dsRNA protocol that is both representative of the sample and minimizes sample cross contamination. We have developed a modified dsRNA extraction protocol that is more efficient compared to traditional protocols, requiring reduced amounts of starting material, that is less prone to sample cross contamination. This was accomplished by using bead based homogenization of plant material in closed, disposable 50ml tubes. To assess the quality of extraction, we also developed an internal control by designing a real-time (quantitative) PCR (qPCR) assay that targets endornaviruses present in Phaseolus vulgaris cultivar Black Turtle Soup (BTS). Crown Copyright © 2016. Published by Elsevier B.V. All rights reserved.

  4. Quality Control of Pharmaceuticals

    PubMed Central

    Levi, Leo; Walker, George C.; Pugsley, L. I.

    1964-01-01

    Quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. Requirements governing the quality control of pharmaceuticals in accordance with the Canadian Food and Drugs Act are cited and discussed. PMID:14199105

  5. Dose reduction for abdominal and pelvic MDCT after change to graduated weight-based protocol for selecting quality reference tube current, peak kilovoltage, and slice collimation.

    PubMed

    Herts, Brian R; Baker, Mark E; Obuchowski, Nancy; Primak, Andrew; Schneider, Erika; Rhana, Harpreet; Dong, Frank

    2013-06-01

    The purpose of this article is to determine the decrease in volume CT dose index (CTDI(vol)) and dose-length product (DLP) achieved by switching from fixed quality reference tube current protocols with automatic tube current modulation to protocols adjusting the quality reference tube current, slice collimation, and peak kilovoltage according to patient weight. All adult patients who underwent CT examinations of the abdomen or abdomen and pelvis during 2010 using weight-based protocols who also underwent a CT examination in 2008 or 2009 using fixed quality reference tube current protocols were identified from the radiology information system. Protocol pages were electronically retrieved, and the CT model, examination date, scan protocol, CTDI(vol), and DLP were extracted from the DICOM header or by optical character recognition. There were 15,779 scans with dose records for 2700 patients. Changes in CTDI(vol) and DLP were compared only between examinations of the same patient and same CT system model for examinations performed in 2008 or 2009 and those performed in 2010. The final analysis consisted of 1117 comparisons in 1057 patients, and 1209 comparisons in 988 patients for CTDI(vol) and DLP, respectively. The change to a weight-based protocol resulted in a statistically significant reduction in CTDI(vol) and DLP on three MDCT system models (p < 0.001). The largest average CTDI(vol) decrease was 13.9%, and the largest average DLP decrease was 16.1% on a 64-MDCT system. Both the CTDI(vol) and DLP decreased the most for patients who weighed less than 250 lb (112.5 kg). Adjusting the CT protocol by selecting parameters according to patient weight is a viable method for reducing CT radiation dose. The largest reductions occurred in the patients weighing less than 250 lb.

  6. From assessment to improvement of elderly care in general practice using decision support to increase adherence to ACOVE quality indicators: study protocol for randomized control trial

    PubMed Central

    2014-01-01

    Background Previous efforts such as Assessing Care of Vulnerable Elders (ACOVE) provide quality indicators for assessing the care of elderly patients, but thus far little has been done to leverage this knowledge to improve care for these patients. We describe a clinical decision support system to improve general practitioner (GP) adherence to ACOVE quality indicators and a protocol for investigating impact on GPs’ adherence to the rules. Design We propose two randomized controlled trials among a group of Dutch GP teams on adherence to ACOVE quality indicators. In both trials a clinical decision support system provides un-intrusive feedback appearing as a color-coded, dynamically updated, list of items needing attention. The first trial pertains to real-time automatically verifiable rules. The second trial concerns non-automatically verifiable rules (adherence cannot be established by the clinical decision support system itself, but the GPs report whether they will adhere to the rules). In both trials we will randomize teams of GPs caring for the same patients into two groups, A and B. For the automatically verifiable rules, group A GPs receive support only for a specific inter-related subset of rules, and group B GPs receive support only for the remainder of the rules. For non-automatically verifiable rules, group A GPs receive feedback framed as actions with positive consequences, and group B GPs receive feedback framed as inaction with negative consequences. GPs indicate whether they adhere to non-automatically verifiable rules. In both trials, the main outcome measure is mean adherence, automatically derived or self-reported, to the rules. Discussion We relied on active end-user involvement in selecting the rules to support, and on a model for providing feedback displayed as color-coded real-time messages concerning the patient visiting the GP at that time, without interrupting the GP’s workflow with pop-ups. While these aspects are believed to increase

  7. 30 CFR 28.31 - Quality control plans; contents.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality control plans; contents. 28.31 Section... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.31 Quality control plans; contents. (a) Each quality control plan shall contain provisions for the management of quality, including: (1...

  8. Satellite Communications Using Commercial Protocols

    NASA Technical Reports Server (NTRS)

    Ivancic, William D.; Griner, James H.; Dimond, Robert; Frantz, Brian D.; Kachmar, Brian; Shell, Dan

    2000-01-01

    NASA Glenn Research Center has been working with industry, academia, and other government agencies in assessing commercial communications protocols for satellite and space-based applications. In addition, NASA Glenn has been developing and advocating new satellite-friendly modifications to existing communications protocol standards. This paper summarizes recent research into the applicability of various commercial standard protocols for use over satellite and space- based communications networks as well as expectations for future protocol development. It serves as a reference point from which the detailed work can be readily accessed. Areas that will be addressed include asynchronous-transfer-mode quality of service; completed and ongoing work of the Internet Engineering Task Force; data-link-layer protocol development for unidirectional link routing; and protocols for aeronautical applications, including mobile Internet protocol routing for wireless/mobile hosts and the aeronautical telecommunications network protocol.

  9. [Highly quality-controlled radiation therapy].

    PubMed

    Shirato, Hiroki

    2005-04-01

    Advanced radiation therapy for intracranial disease has focused on set-up accuracy for the past 15 years. However, quality control in the prescribed dose is actually as important as the tumor set-up in radiation therapy. Because of the complexity of the three-dimensional radiation treatment planning system in recent years, the highly quality-controlled prescription of the dose has now been reappraised as the mainstream to improve the treatment outcome of radiation therapy for intracranial disease. The Japanese Committee for Quality Control of Radiation Therapy has developed fundamental requirements such as a QC committee in each hospital, a medical physicist, dosimetrists (QC members), and an external audit.

  10. Control by quality: proposition of a typology.

    PubMed

    Pujo, P; Pillet, M

    The application of Quality tools and methods in industrial management has always had a fundamental impact on the control of production. It influences the behavior of the actors concerned, while introducing the necessary notions and formalizations, especially for production systems with little or no automation, which constitute a large part of the industrial activity. Several quality approaches are applied in the workshop and are implemented at the level of the control. In this paper, the authors present a typology of the various approaches that have successively influenced control, such as statistical process control, quality assurance, and continuous improvement. First the authors present a parallel between production control and quality organizational structure. They note the duality between control, which is aimed at increasing productivity, and quality, which aims to satisfy the needs of the customer. They also note the hierarchical organizational structure of these two systems of management with, at each level, the notion of a feedback loop. This notion is fundamental to any kind of decision making. The paper is organized around the operational, tactical, and strategic levels, by describing for each level the main methods and tools for control by quality. The overview of these tools and methods starts at the operational level, with the Statistical Process Control, the Taguchi technique, and the "six sigma" approach. On the tactical level, we find a quality system approach, with a documented description of the procedures introduced in the firm. The management system can refer here to Quality Assurance, Total Productive Maintenance, or Management by Total Quality. The formalization through procedures of the rules of decision governing the process control enhances the validity of these rules. This leads to the enhancement of their reliability and to their consolidation. All this counterbalances the human, intrinsically fluctuating, behavior of the control

  11. Mindfulness-based intervention for teenagers with cancer: study protocol for a randomized controlled trial.

    PubMed

    Malboeuf-Hurtubise, Catherine; Achille, Marie; Sultan, Serge; Vadnais, Majorie

    2013-05-10

    Individuals living with cancer must learn to face not only the physical symptoms of their condition, but also the anxiety and uncertainty related to the progression of the disease, the anticipation of physical and emotional pain related to illness and treatment, the significant changes implied in living with cancer, as well as the fear of recurrence after remission. Mindfulness-based meditation constitutes a promising option to alleviate these manifestations. This article presents the rationale and protocol development for a research project aimed at evaluating the effects of a mindfulness-based meditation intervention on quality of life, sleep, and mood in adolescents with cancer compared to a control group. A prospective, longitudinal, experimental design involving three time points (baseline, post-intervention, and follow-up) and two groups (experimental and control) was developed for this project. Participants will be assigned randomly to either group. Eligible participants are adolescents aged 11 to 18 years with a diagnosis of cancer, with no specific selection/exclusion based on type, stage, or trajectory of cancer. A final sample size of 28 participants is targeted. Adolescents in the experimental group will be completing the mindfulness meditation intervention, taught by two trained therapists. The intervention will comprise of eight weekly sessions, lasting 90 min each. Once the follow-up assessment is completed by the experimental group, wait-list controls will be offered to complete the mindfulness-based program. Intra-group analyses will serve to evaluate the impact of the mindfulness-based meditation intervention on quality of life, sleep, and mood pre-post intervention, as well as follow-up. Analyses will also be used to carry out inter-group comparisons between the experimental group and the wait-list controls. Voluntary participation, risk of attrition, and the small sample size are potential limitations of this project. In spite of possible

  12. Mindfulness-based intervention for teenagers with cancer: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Individuals living with cancer must learn to face not only the physical symptoms of their condition, but also the anxiety and uncertainty related to the progression of the disease, the anticipation of physical and emotional pain related to illness and treatment, the significant changes implied in living with cancer, as well as the fear of recurrence after remission. Mindfulness-based meditation constitutes a promising option to alleviate these manifestations. Methods/Design This article presents the rationale and protocol development for a research project aimed at evaluating the effects of a mindfulness-based meditation intervention on quality of life, sleep, and mood in adolescents with cancer compared to a control group. A prospective, longitudinal, experimental design involving three time points (baseline, post-intervention, and follow-up) and two groups (experimental and control) was developed for this project. Participants will be assigned randomly to either group. Eligible participants are adolescents aged 11 to 18 years with a diagnosis of cancer, with no specific selection/exclusion based on type, stage, or trajectory of cancer. A final sample size of 28 participants is targeted. Adolescents in the experimental group will be completing the mindfulness meditation intervention, taught by two trained therapists. The intervention will comprise of eight weekly sessions, lasting 90 min each. Once the follow-up assessment is completed by the experimental group, wait-list controls will be offered to complete the mindfulness-based program. Intra-group analyses will serve to evaluate the impact of the mindfulness-based meditation intervention on quality of life, sleep, and mood pre-post intervention, as well as follow-up. Analyses will also be used to carry out inter-group comparisons between the experimental group and the wait-list controls. Voluntary participation, risk of attrition, and the small sample size are potential limitations of this project

  13. Protocol of a Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for laypeople (MANI-CPR)

    PubMed Central

    Contri, Enrico; Burkart, Roman; Borrelli, Paola; Ferraro, Ottavia Eleonora; Tonani, Michela; Cutuli, Amedeo; Bertaia, Daniele; Iozzo, Pasquale; Tinguely, Caroline; Lopez, Daniel; Boldarin, Susi; Deiuri, Claudio; Dénéréaz, Sandrine; Dénéréaz, Yves; Terrapon, Michael; Tami, Christian; Cereda, Cinzia; Somaschini, Alberto; Cornara, Stefano; Cortegiani, Andrea

    2018-01-01

    Introduction Out-of-hospital cardiac arrest is one of the leading causes of death in industrialised countries. Survival depends on prompt identification of cardiac arrest and on the quality and timing of cardiopulmonary resuscitation (CPR) and defibrillation. For laypeople, there has been a growing interest on hands-only CPR, meaning continuous chest compression without interruption to perform ventilations. It has been demonstrated that intentional interruptions in hands-only CPR can increase its quality. The aim of this randomised trial is to compare three CPR protocols performed with different intentional interruptions with hands-only CPR. Methods and analysis This is a prospective randomised trial performed in eight training centres. Laypeople who passed a basic life support course will be randomised to one of the four CPR protocols in an 8 min simulated cardiac arrest scenario on a manikin: (1) 30 compressions and 2 s pause; (2) 50 compressions and 5 s pause; (3) 100 compressions and 10 s pause; (4) hands-only. The calculated sample size is 552 people. The primary outcome is the percentage of chest compression performed with correct depth evaluated by a computerised feedback system (Laerdal QCPR). Ethics and dissemination Due to the nature of the study, we obtained a waiver from the Ethics Committee (IRCCS Policlinico San Matteo, Pavia, Italy). All participants will sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journal. The data collected will also be made available in a public data repository. Trial registration number NCT02632500. PMID:29674365

  14. Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial

    PubMed Central

    Goldberg, Andrew J; Zaidi, Razi; Thomson, Claire; Doré, Caroline J; Cro, Suzie; Round, Jeff; Molloy, Andrew; Davies, Mark; Karski, Michael; Kim, Louise; Cooke, Paul

    2016-01-01

    Introduction Total ankle replacement (TAR) or ankle arthrodesis (fusion) is the main surgical treatments for end-stage ankle osteoarthritis (OA). The popularity of ankle replacement is increasing while ankle fusion rates remain static. Both treatments have efficacy but to date all studies comparing the 2 have been observational without randomisation, and there are no published guidelines as to the most appropriate management. The TAR versus arthrodesis (TARVA) trial aims to compare the clinical and cost-effectiveness of TAR against ankle arthrodesis in the treatment of end-stage ankle OA in patients aged 50–85 years. Methods and analysis TARVA is a multicentre randomised controlled trial that will randomise 328 patients aged 50–85 years with end-stage ankle arthritis. The 2 arms of the study will be TAR or ankle arthrodesis with 164 patients in each group. Up to 16 UK centres will participate. Patients will have clinical assessments and complete questionnaires before their operation and at 6, 12, 26 and 52 weeks after surgery. The primary clinical outcome of the study is a validated patient-reported outcome measure, the Manchester Oxford foot questionnaire, captured preoperatively and 12 months after surgery. Secondary outcomes include quality-of-life scores, complications, revision, reoperation and a health economic analysis. Ethics and dissemination The protocol has been approved by the National Research Ethics Service Committee (London, Bloomsbury 14/LO/0807). This manuscript is based on V.5.0 of the protocol. The trial findings will be disseminated through peer-reviewed publications and conference presentations. Trial registration number NCT02128555. PMID:27601503

  15. RNA-seq mixology: designing realistic control experiments to compare protocols and analysis methods

    PubMed Central

    Holik, Aliaksei Z.; Law, Charity W.; Liu, Ruijie; Wang, Zeya; Wang, Wenyi; Ahn, Jaeil; Asselin-Labat, Marie-Liesse; Smyth, Gordon K.

    2017-01-01

    Abstract Carefully designed control experiments provide a gold standard for benchmarking different genomics research tools. A shortcoming of many gene expression control studies is that replication involves profiling the same reference RNA sample multiple times. This leads to low, pure technical noise that is atypical of regular studies. To achieve a more realistic noise structure, we generated a RNA-sequencing mixture experiment using two cell lines of the same cancer type. Variability was added by extracting RNA from independent cell cultures and degrading particular samples. The systematic gene expression changes induced by this design allowed benchmarking of different library preparation kits (standard poly-A versus total RNA with Ribozero depletion) and analysis pipelines. Data generated using the total RNA kit had more signal for introns and various RNA classes (ncRNA, snRNA, snoRNA) and less variability after degradation. For differential expression analysis, voom with quality weights marginally outperformed other popular methods, while for differential splicing, DEXSeq was simultaneously the most sensitive and the most inconsistent method. For sample deconvolution analysis, DeMix outperformed IsoPure convincingly. Our RNA-sequencing data set provides a valuable resource for benchmarking different protocols and data pre-processing workflows. The extra noise mimics routine lab experiments more closely, ensuring any conclusions are widely applicable. PMID:27899618

  16. Effects of Adding an Internet-Based Pain Coping Skills Training Protocol to a Standardized Education and Exercise Program for People With Persistent Hip Pain (HOPE Trial): Randomized Controlled Trial Protocol

    PubMed Central

    Rini, Christine; Keefe, Francis; French, Simon; Nelligan, Rachel; Kasza, Jessica; Forbes, Andrew; Dobson, Fiona; Haxby Abbott, J.; Dalwood, Andrew; Vicenzino, Bill; Harris, Anthony; Hinman, Rana S.

    2015-01-01

    Background Persistent hip pain in older people is usually due to hip osteoarthritis (OA), a major cause of pain, disability, and psychological dysfunction. Objective The purpose of this study is to evaluate whether adding an Internet-based pain coping skills training (PCST) protocol to a standardized intervention of education followed by physical therapist–instructed home exercise leads to greater reductions in pain and improvements in function. Design An assessor-, therapist-, and participant-blinded randomized controlled trial will be conducted. Setting The study will be conducted in a community setting. Participants The participants will be 142 people over 50 years of age with self-reported hip pain consistent with hip OA. Intervention Participants will be randomly allocated to: (1) a control group receiving a 24-week standardized intervention comprising an 8-week Internet-based education package followed by 5 individual physical therapy exercise sessions plus home exercises (3 times weekly) or (2) a PCST group receiving an 8-week Internet-based PCST protocol in addition to the control intervention. Measurements Outcomes will be measured at baseline and 8, 24, and 52 weeks, with the primary time point at 24 weeks. Primary outcomes are hip pain on walking and self-reported physical function. Secondary outcomes include health-related quality-of-life, participant-perceived treatment response, self-efficacy for pain management and function, pain coping attempts, pain catastrophizing, and physical activity. Measurements of adherence, adverse events, use of health services, and process measures will be collected at 24 and 52 weeks. Cost-effectiveness will be assessed at 52 weeks. Limitations A self-reported diagnosis of persistent hip pain will be used. Conclusions The findings will help determine whether adding an Internet-based PCST protocol to standardized education and physical therapist–instructed home exercise is more effective than education and exercise

  17. Effects of Adding an Internet-Based Pain Coping Skills Training Protocol to a Standardized Education and Exercise Program for People With Persistent Hip Pain (HOPE Trial): Randomized Controlled Trial Protocol.

    PubMed

    Bennell, Kim L; Rini, Christine; Keefe, Francis; French, Simon; Nelligan, Rachel; Kasza, Jessica; Forbes, Andrew; Dobson, Fiona; Abbott, J Haxby; Dalwood, Andrew; Vicenzino, Bill; Harris, Anthony; Hinman, Rana S

    2015-10-01

    Persistent hip pain in older people is usually due to hip osteoarthritis (OA), a major cause of pain, disability, and psychological dysfunction. The purpose of this study is to evaluate whether adding an Internet-based pain coping skills training (PCST) protocol to a standardized intervention of education followed by physical therapist-instructed home exercise leads to greater reductions in pain and improvements in function. An assessor-, therapist-, and participant-blinded randomized controlled trial will be conducted. The study will be conducted in a community setting. The participants will be 142 people over 50 years of age with self-reported hip pain consistent with hip OA. Participants will be randomly allocated to: (1) a control group receiving a 24-week standardized intervention comprising an 8-week Internet-based education package followed by 5 individual physical therapy exercise sessions plus home exercises (3 times weekly) or (2) a PCST group receiving an 8-week Internet-based PCST protocol in addition to the control intervention. Outcomes will be measured at baseline and 8, 24, and 52 weeks, with the primary time point at 24 weeks. Primary outcomes are hip pain on walking and self-reported physical function. Secondary outcomes include health-related quality-of-life, participant-perceived treatment response, self-efficacy for pain management and function, pain coping attempts, pain catastrophizing, and physical activity. Measurements of adherence, adverse events, use of health services, and process measures will be collected at 24 and 52 weeks. Cost-effectiveness will be assessed at 52 weeks. A self-reported diagnosis of persistent hip pain will be used. The findings will help determine whether adding an Internet-based PCST protocol to standardized education and physical therapist-instructed home exercise is more effective than education and exercise alone for persistent hip pain. This study has the potential to guide clinical practice toward innovative

  18. Augmented Quadruple-Phase Contrast Media Administration and Triphasic Scan Protocol Increases Image Quality at Reduced Radiation Dose During Computed Tomography Urography.

    PubMed

    Saade, Charbel; Mohamad, May; Kerek, Racha; Hamieh, Nadine; Alsheikh Deeb, Ibrahim; El-Achkar, Bassam; Tamim, Hani; Abdul Razzak, Farah; Haddad, Maurice; Abi-Ghanem, Alain S; El-Merhi, Fadi

    The aim of this article was to investigate the opacification of the renal vasculature and the urogenital system during computed tomography urography by using a quadruple-phase contrast media in a triphasic scan protocol. A total of 200 patients with possible urinary tract abnormalities were equally divided between 2 protocols. Protocol A used the conventional single bolus and quadruple-phase scan protocol (pre, arterial, venous, and delayed), retrospectively. Protocol B included a quadruple-phase contrast media injection with a triphasic scan protocol (pre, arterial and combined venous, and delayed), prospectively. Each protocol used 100 mL contrast and saline at a flow rate of 4.5 mL. Attenuation profiles and contrast-to-noise ratio of the renal arteries, veins, and urogenital tract were measured. Effective radiation dose calculation, data analysis by independent sample t test, receiver operating characteristic, and visual grading characteristic analyses were performed. In arterial circulation, only the inferior interlobular arteries in both protocols showed a statistical significance (P < 0.05). Venously, the inferior vena cava, proximal and distal renal veins demonstrated a significant opacification reduction in protocol B than in protocol A (P < 0.001). Protocol B showed a significantly higher mean contrast-to-noise ratio than protocol A (protocol B: 22.68 ± 13.72; protocol A: 14.75 ± 5.76; P < 0.001). Radiation dose was significantly reduced in protocol B (7.38 ± 2.22 mSv) than in protocol A (12.28 ± 2.72 mSv) (P < 0.001). Visual grading characteristic (P < 0.027) and receiver operating characteristic (P < 0.0001) analyses demonstrated a significant preference for protocol B. In computed tomography urography, augmented quadruple-phase contrast media and triphasic scan protocol usage increases the image quality at a reduced radiation dose.

  19. 30 CFR 74.6 - Quality control.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality control. 74.6 Section 74.6 Mineral... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and... DUST SAMPLING DEVICES Approval Requirements for Coal Mine Dust Personal Sampler Unit § 74.6 Quality...

  20. The Effects of Respondents' Consent to Be Recorded on Interview Length and Data Quality in a National Panel Study

    ERIC Educational Resources Information Center

    McGonagle, Katherine A.; Brown, Charles; Schoeni, Robert F.

    2015-01-01

    Recording interviews is a key feature of quality control protocols for most survey organizations. We examine the effects on interview length and data quality of a new protocol adopted by a national panel study. The protocol recorded a randomly chosen one-third of all interviews digitally, although all respondents were asked for permission to…

  1. 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

    PubMed Central

    2011-01-01

    Background 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. Methods 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. Discussion 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

  2. 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.

    PubMed

    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

  3. A phase II trial for the efficacy of physiotherapy intervention for early-onset hip osteoarthritis: study protocol for a randomised controlled trial.

    PubMed

    Kemp, Joanne L; Moore, Kate; Fransen, Marlene; Russell, Trevor G; Crossley, Kay M

    2015-01-27

    Early-onset hip osteoarthritis is commonly seen in people undergoing hip arthroscopy and is associated with increased pain, reduced ability to participate in physical activity, reduced quality of life and reduced range of motion and muscle strength. Despite this, the efficacy of non-surgical interventions such as exercise therapies remains unknown. The primary aim is to establish the feasibility of a phase III randomised controlled trial investigating a targeted physiotherapy intervention for people with early-onset hip osteoarthritis. The secondary aims are to determine the size of treatment effects of a physiotherapy intervention, targeted to improve hip joint range and hip-related symptoms in early-onset hip osteoarthritis following hip arthroscopy, compared to a health-education control. This protocol describes a randomised, assessor- and participant-blind, controlled clinical trial. We will include 20 participants who are (i) aged between 18 and 50 years; (ii) have undergone hip arthroscopy during the past six to 12 months; (iii) have early-onset hip osteoarthritis (defined as chondrolabral pathology) at the time of hip arthroscopy; and (iv) experience hip-related pain during activities. Primary outcome will be the feasibility of a phase III clinical trial. Secondary outcomes will be (i) perceived global change score; (ii) hip-related symptoms (measured using the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale, activity subscale, and sport and recreation subscale); (iii) hip quality of life (measured using the HOOS quality of life subscale and International Hip Outcome tool; (iv) hip muscle strength and (v) hip range of motion. The physiotherapy intervention is semi-standardised, including joint and soft tissue mobilisation and stretching, hip and trunk muscle retraining and functional and activity-specific retraining and education. The control intervention encompasses individualised health education, with the same frequency and duration

  4. Promoting physical activity in sedentary elderly Malays with type 2 diabetes: a protocol for randomised controlled trial.

    PubMed

    Sazlina, Shariff-Ghazali; Browning, Colette Joy; Yasin, Shajahan

    2012-01-01

    Like many countries Malaysia is facing an increase in the number of people with type 2 diabetes mellitus diabetes (T2DM) and modifiable lifestyle factors such as sedentary behaviour are important drivers of this increase. The level of physical activity is low among elderly Malay people. In Malaysia, strategies to promote physical activity in elderly Malay people with T2DM are not well documented in the research literature. This paper discusses an intervention to increase physical activity in elderly Malay people with T2DM. The aim of our study was to evaluate the effectiveness of personalised feedback alone and in combination with peer support in promoting and maintaining physical activity in comparison with usual care. A three-arm randomised controlled trial will be conducted among sedentary Malay adults aged 60 years and above with T2DM attending an urban primary healthcare clinic in Malaysia. The participants will be randomised into three groups for a 12-week intervention with a follow-up at 24 and 36 weeks to assess adherence. The primary outcome of this study is pedometer-determined physical activity. Glycaemic and blood pressure control, body composition, cardiorespiratory fitness, balance, lipid profile, health-related quality of life, psychological well-being, social support and self-efficacy for exercise are the secondary measures. Linear mixed models will be used to determine the effect of the intervention over time and between groups. ETHICAL AND DISSEMINATION: The Monash University Human Research Ethics Committee and the Malaysian Ministry of Health's Medical Research Ethics Committee approved this protocol. The findings of this study will be presented at international conferences and published in peer-reviewed journals. This study protocol has been registered with the Malaysian National Medical Research Registry and with the Current Controlled Trial Ltd (http://www.controlled-trials.com/ISRCTN71447000/).

  5. [Quality control in herbal supplements].

    PubMed

    Oelker, Luisa

    2005-01-01

    Quality and safety of food and herbal supplements are the result of a whole of different elements as good manufacturing practice and process control. The process control must be active and able to individuate and correct all possible hazards. The main and most utilized instrument is the hazard analysis critical control point (HACCP) system the correct application of which can guarantee the safety of the product. Herbal supplements need, in addition to standard quality control, a set of checks to assure the harmlessness and safety of the plants used.

  6. Distributed sensor architecture for intelligent control that supports quality of control and quality of service.

    PubMed

    Poza-Lujan, Jose-Luis; Posadas-Yagüe, Juan-Luis; Simó-Ten, José-Enrique; Simarro, Raúl; Benet, Ginés

    2015-02-25

    This paper is part of a study of intelligent architectures for distributed control and communications systems. The study focuses on optimizing control systems by evaluating the performance of middleware through quality of service (QoS) parameters and the optimization of control using Quality of Control (QoC) parameters. The main aim of this work is to study, design, develop, and evaluate a distributed control architecture based on the Data-Distribution Service for Real-Time Systems (DDS) communication standard as proposed by the Object Management Group (OMG). As a result of the study, an architecture called Frame-Sensor-Adapter to Control (FSACtrl) has been developed. FSACtrl provides a model to implement an intelligent distributed Event-Based Control (EBC) system with support to measure QoS and QoC parameters. The novelty consists of using, simultaneously, the measured QoS and QoC parameters to make decisions about the control action with a new method called Event Based Quality Integral Cycle. To validate the architecture, the first five Braitenberg vehicles have been implemented using the FSACtrl architecture. The experimental outcomes, demonstrate the convenience of using jointly QoS and QoC parameters in distributed control systems.

  7. Distributed Sensor Architecture for Intelligent Control that Supports Quality of Control and Quality of Service

    PubMed Central

    Poza-Lujan, Jose-Luis; Posadas-Yagüe, Juan-Luis; Simó-Ten, José-Enrique; Simarro, Raúl; Benet, Ginés

    2015-01-01

    This paper is part of a study of intelligent architectures for distributed control and communications systems. The study focuses on optimizing control systems by evaluating the performance of middleware through quality of service (QoS) parameters and the optimization of control using Quality of Control (QoC) parameters. The main aim of this work is to study, design, develop, and evaluate a distributed control architecture based on the Data-Distribution Service for Real-Time Systems (DDS) communication standard as proposed by the Object Management Group (OMG). As a result of the study, an architecture called Frame-Sensor-Adapter to Control (FSACtrl) has been developed. FSACtrl provides a model to implement an intelligent distributed Event-Based Control (EBC) system with support to measure QoS and QoC parameters. The novelty consists of using, simultaneously, the measured QoS and QoC parameters to make decisions about the control action with a new method called Event Based Quality Integral Cycle. To validate the architecture, the first five Braitenberg vehicles have been implemented using the FSACtrl architecture. The experimental outcomes, demonstrate the convenience of using jointly QoS and QoC parameters in distributed control systems. PMID:25723145

  8. Quality control education in the community college

    NASA Technical Reports Server (NTRS)

    Greene, J. Griffen; Wilson, Steve

    1966-01-01

    This paper describes the Quality Control Program at Daytona Beach Junior College, including course descriptions. The program in quality control required communication between the college and the American Society for Quality Control (ASQC). The college has machinery established for certification of the learning process, and the society has the source of teachers who are competent in the technical field and who are the employers of the educational products. The associate degree for quality control does not have a fixed program, which can serve all needs, any more than all engineering degrees have identical programs. The main ideas which would be common to all quality control programs are the concept of economic control of a repetitive process and the concept of developing individual potentialities into individuals who are needed and productive.

  9. An Improved Protocol for Controlled Deterministic Secure Quantum Communication Using Five-Qubit Entangled State

    NASA Astrophysics Data System (ADS)

    Kao, Shih-Hung; Lin, Jason; Tsai, Chia-Wei; Hwang, Tzonelih

    2018-03-01

    In early 2009, Xiu et al. (Opt. Commun. 282(2) 333-337 2009) presented a controlled deterministic secure quantum communication (CDSQC) protocol via a newly constructed five-qubit entangled quantum state. Later, Qin et al. (Opt. Commun. 282(13), 2656-2658 2009) pointed out two security loopholes in Xiu et al.'s protocol: (1) A correlation-elicitation (CE) attack can reveal the entire secret message; (2) A leakage of partial information for the receiver is noticed. Then, Xiu et al. (Opt. Commun. 283(2), 344-347 2010) presented a revised CDSQC protocol to remedy the CE attack problem. However, the information leakage problem still remains open. This work proposes a new CDSQC protocol using the same five-qubit entangled state which can work without the above mentioned security problems. Moreover, the Trojan Horse attacks can be automatically avoided without using detecting devices in the new CDSQC.

  10. An Improved Protocol for Controlled Deterministic Secure Quantum Communication Using Five-Qubit Entangled State

    NASA Astrophysics Data System (ADS)

    Kao, Shih-Hung; Lin, Jason; Tsai, Chia-Wei; Hwang, Tzonelih

    2018-06-01

    In early 2009, Xiu et al. (Opt. Commun. 282(2) 333-337 2009) presented a controlled deterministic secure quantum communication (CDSQC) protocol via a newly constructed five-qubit entangled quantum state. Later, Qin et al. (Opt. Commun. 282(13), 2656-2658 2009) pointed out two security loopholes in Xiu et al.'s protocol: (1) A correlation-elicitation (CE) attack can reveal the entire secret message; (2) A leakage of partial information for the receiver is noticed. Then, Xiu et al. (Opt. Commun. 283(2), 344-347 2010) presented a revised CDSQC protocol to remedy the CE attack problem. However, the information leakage problem still remains open. This work proposes a new CDSQC protocol using the same five-qubit entangled state which can work without the above mentioned security problems. Moreover, the Trojan Horse attacks can be automatically avoided without using detecting devices in the new CDSQC.

  11. The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial protocol: detailed statistical analysis plan.

    PubMed

    Lawlor, Debbie A; Peters, Tim J; Howe, Laura D; Noble, Sian M; Kipping, Ruth R; Jago, Russell

    2013-07-24

    The Active For Life Year 5 (AFLY5) randomised controlled trial protocol was published in this journal in 2011. It provided a summary analysis plan. This publication is an update of that protocol and provides a detailed analysis plan. This update provides a detailed analysis plan of the effectiveness and cost-effectiveness of the AFLY5 intervention. The plan includes details of how variables will be quality control checked and the criteria used to define derived variables. Details of four key analyses are provided: (a) effectiveness analysis 1 (the effect of the AFLY5 intervention on primary and secondary outcomes at the end of the school year in which the intervention is delivered); (b) mediation analyses (secondary analyses examining the extent to which any effects of the intervention are mediated via self-efficacy, parental support and knowledge, through which the intervention is theoretically believed to act); (c) effectiveness analysis 2 (the effect of the AFLY5 intervention on primary and secondary outcomes 12 months after the end of the intervention) and (d) cost effectiveness analysis (the cost-effectiveness of the AFLY5 intervention). The details include how the intention to treat and per-protocol analyses were defined and planned sensitivity analyses for dealing with missing data. A set of dummy tables are provided in Additional file 1. This detailed analysis plan was written prior to any analyst having access to any data and was approved by the AFLY5 Trial Steering Committee. Its publication will ensure that analyses are in accordance with an a priori plan related to the trial objectives and not driven by knowledge of the data. ISRCTN50133740.

  12. Optimizing radiation exposure in screening of body packing: image quality and diagnostic acceptability of an 80 kVp protocol with automated tube current modulation.

    PubMed

    Aissa, Joel; Boos, Johannes; Rubbert, Christian; Caspers, Julian; Schleich, Christoph; Thomas, Christoph; Kröpil, Patric; Antoch, Gerald; Miese, Falk

    2017-06-01

    The aim of this study was to evaluate the objective and subjective image quality of a novel computed tomography (CT) protocol with reduced radiation dose for body packing with 80 kVp and automated tube current modulation (ATCM) compared to a standard body packing CT protocol. 80 individuals who were examined between March 2012 and July 2015 in suspicion of ingested drug packets were retrospectively included in this study. Thirty-one CT examinations were performed using ATCM and a fixed tube voltage of 80 kVp (group A). Forty-nine CT examinations were performed using a standard protocol with a tube voltage of 120 kVp and a fixed tube current time product of 40 mAs (group B). Subjective and objective image quality and visibility of drug packets were assessed. Radiation exposure of both protocols was compared. Contrast-to-noise ratio (group A: 0.56 ± 0.36; group B: 1.13 ± 0.91) and Signal-to-noise ratio (group A: 3.69 ± 0.98; group B: 7.08 ± 2.67) were significantly lower for group A compared to group B (p < 0.001). Subjectively, image quality was decreased for group A compared to group B (2.5 ± 0.8 vs. 1.2 ± 0.4; p < 0.001). Attenuation of body packets was higher with the new protocol (group A: 362.2 ± 70.3 Hounsfield Units (HU); group B: 210.6 ± 60.2 HU; p = 0.005). Volumetric Computed Tomography Dose Index (CTDIvol) and Dose Length Product (DLP) were significantly lower in group A (CTDIvol 2.2 ± 0.9 mGy, DLP 105.7 ± 52.3 mGycm) as compared to group B (CTDIvol 2.7 ± 0.1 mGy, DLP 126.0 ± 9.7 mGycm, p = 0.002 and p = 0.01). The novel 80 kVp CT protocol with ATCM leads to a significant dose reduction compared to a standard CT body packing protocol. The novel protocol led to a diagnostic image quality and cocaine body packets were reliably detected due to the high attenuation.

  13. Voice over Internet Protocol (VoIP) Technology as a Global Learning Tool: Information Systems Success and Control Belief Perspectives

    ERIC Educational Resources Information Center

    Chen, Charlie C.; Vannoy, Sandra

    2013-01-01

    Voice over Internet Protocol- (VoIP) enabled online learning service providers struggling with high attrition rates and low customer loyalty issues despite VoIP's high degree of system fit for online global learning applications. Effective solutions to this prevalent problem rely on the understanding of system quality, information quality, and…

  14. 23 CFR 1340.8 - Quality control.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... OBSERVATIONAL SURVEYS OF SEAT BELT USE Survey Design Requirements § 1340.8 Quality control. (a) Quality control... control monitors involved in seat belt use surveys shall have received training in data collection...) Statistical review. Survey results shall be reviewed and approved by a survey statistician, i.e., a person...

  15. 23 CFR 1340.8 - Quality control.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... OBSERVATIONAL SURVEYS OF SEAT BELT USE Survey Design Requirements § 1340.8 Quality control. (a) Quality control... control monitors involved in seat belt use surveys shall have received training in data collection...) Statistical review. Survey results shall be reviewed and approved by a survey statistician, i.e., a person...

  16. 23 CFR 1340.8 - Quality control.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... OBSERVATIONAL SURVEYS OF SEAT BELT USE Survey Design Requirements § 1340.8 Quality control. (a) Quality control... control monitors involved in seat belt use surveys shall have received training in data collection...) Statistical review. Survey results shall be reviewed and approved by a survey statistician, i.e., a person...

  17. [Donation protocol following controlled cardiac death (Maastricht type III donation). First experience].

    PubMed

    Rubio-Muñoz, J J; Pérez-Redondo, M; Alcántara-Carmona, S; Lipperheide-Vallhonrat, I; Fernández-Simón, I; Valdivia-de la Fuente, M; Villanueva-Fernández, H; Balandín-Moreno, B; Ortega-López, A; Romera-Ortega, M A; Galdos-Anuncibay, P

    2014-03-01

    To present our experience with the implementation of a donation protocol following controlled cardiac death (Maastricht type III donation). A retrospective descriptive and observational study was made. Intensive Care Unit of a third-level university hospital. Eight patients in an irreversible state, in which withdrawal of all life support had been agreed, were evaluated as potential donors. Application of the adopted protocol. Clinical data of donors, evaluation of a donation protocol following cardiac death, warm ischemia times, and short-term outcome of the recipients. Eight patients were evaluated. In one case donation was not possible because no cardiac arrest developed in the 120 minutes after extubation. The 7 remaining patients were effective kidney donors. Warm ischemia times were less than 23 minutes in all cases. Although 7 of the 14 recipients suffered delayed graft function, all of them achieved good renal function. Donation after cardiac death in patients in an overwhelming and irreversible state represents a potential source of donors not previously considered in this country. The prior development of a consensus-based protocol can help increase the number of organs in combination with those obtained after brain death. In our experience, the results of kidney transplants obtained from donors after cardiac death are good, and the success of these types of protocols could be extended to other organs such as the liver and lungs. Copyright © 2012 Elsevier España, S.L. and SEMICYUC. All rights reserved.

  18. Compliance with AAPM Practice Guideline 1.a: CT Protocol Management and Review — from the perspective of a university hospital

    PubMed Central

    Bour, Robert K.; Pozniak, Myron; Ranallo, Frank N.

    2015-01-01

    The purpose of this paper is to describe our experience with the AAPM Medical Physics Practice Guideline 1.a: “CT Protocol Management and Review Practice Guideline”. Specifically, we will share how our institution's quality management system addresses the suggestions within the AAPM practice report. We feel this paper is needed as it was beyond the scope of the AAPM practice guideline to provide specific details on fulfilling individual guidelines. Our hope is that other institutions will be able to emulate some of our practices and that this article would encourage other types of centers (e.g., community hospitals) to share their methodology for approaching CT protocol optimization and quality control. Our institution had a functioning CT protocol optimization process, albeit informal, since we began using CT. Recently, we made our protocol development and validation process compliant with a number of the ISO 9001:2008 clauses and this required us to formalize the roles of the members of our CT protocol optimization team. We rely heavily on PACS‐based IT solutions for acquiring radiologist feedback on the performance of our CT protocols and the performance of our CT scanners in terms of dose (scanner output) and the function of the automatic tube current modulation. Specific details on our quality management system covering both quality control and ongoing optimization have been provided. The roles of each CT protocol team member have been defined, and the critical role that IT solutions provides for the management of files and the monitoring of CT protocols has been reviewed. In addition, the invaluable role management provides by being a champion for the project has been explained; lack of a project champion will mitigate the efforts of a CT protocol optimization team. Meeting the guidelines set forth in the AAPM practice guideline was not inherently difficult, but did, in our case, require the cooperation of radiologists, technologists, physicists, IT

  19. 42 CFR 84.41 - Quality control plans; contents.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Quality control plans; contents. 84.41 Section 84... AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality Control § 84.41 Quality control plans; contents. (a) Each quality control plan shall contain provisions for the...

  20. 42 CFR 84.41 - Quality control plans; contents.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Quality control plans; contents. 84.41 Section 84... AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality Control § 84.41 Quality control plans; contents. (a) Each quality control plan shall contain provisions for the...

  1. 42 CFR 84.41 - Quality control plans; contents.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Quality control plans; contents. 84.41 Section 84... AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality Control § 84.41 Quality control plans; contents. (a) Each quality control plan shall contain provisions for the...

  2. 42 CFR 84.41 - Quality control plans; contents.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Quality control plans; contents. 84.41 Section 84... AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality Control § 84.41 Quality control plans; contents. (a) Each quality control plan shall contain provisions for the...

  3. 42 CFR 84.41 - Quality control plans; contents.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Quality control plans; contents. 84.41 Section 84... AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Quality Control § 84.41 Quality control plans; contents. (a) Each quality control plan shall contain provisions for the...

  4. Instrument Quality Control.

    PubMed

    Jayakody, Chatura; Hull-Ryde, Emily A

    2016-01-01

    Well-defined quality control (QC) processes are used to determine whether a certain procedure or action conforms to a widely accepted standard and/or set of guidelines, and are important components of any laboratory quality assurance program (Popa-Burke et al., J Biomol Screen 14: 1017-1030, 2009). In this chapter, we describe QC procedures useful for monitoring the accuracy and precision of laboratory instrumentation, most notably automated liquid dispensers. Two techniques, gravimetric QC and photometric QC, are highlighted in this chapter. When used together, these simple techniques provide a robust process for evaluating liquid handler accuracy and precision, and critically underpin high-quality research programs.

  5. 14 CFR 145.211 - Quality control system.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Quality control system. 145.211 Section 145...) SCHOOLS AND OTHER CERTIFICATED AGENCIES REPAIR STATIONS Operating Rules § 145.211 Quality control system. (a) A certificated repair station must establish and maintain a quality control system acceptable to...

  6. 18 CFR 12.40 - Quality control programs.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Quality control... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.40 Quality control programs. (a... meeting any requirements or standards set by the Regional Engineer. If a quality control program is...

  7. 18 CFR 12.40 - Quality control programs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Quality control... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.40 Quality control programs. (a... meeting any requirements or standards set by the Regional Engineer. If a quality control program is...

  8. 14 CFR 145.211 - Quality control system.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Quality control system. 145.211 Section 145...) SCHOOLS AND OTHER CERTIFICATED AGENCIES REPAIR STATIONS Operating Rules § 145.211 Quality control system. (a) A certificated repair station must establish and maintain a quality control system acceptable to...

  9. Engineering platform and experimental protocol for design and evaluation of a neurally-controlled powered transfemoral prosthesis.

    PubMed

    Zhang, Fan; Liu, Ming; Harper, Stephen; Lee, Michael; Huang, He

    2014-07-22

    To enable intuitive operation of powered artificial legs, an interface between user and prosthesis that can recognize the user's movement intent is desired. A novel neural-machine interface (NMI) based on neuromuscular-mechanical fusion developed in our previous study has demonstrated a great potential to accurately identify the intended movement of transfemoral amputees. However, this interface has not yet been integrated with a powered prosthetic leg for true neural control. This study aimed to report (1) a flexible platform to implement and optimize neural control of powered lower limb prosthesis and (2) an experimental setup and protocol to evaluate neural prosthesis control on patients with lower limb amputations. First a platform based on a PC and a visual programming environment were developed to implement the prosthesis control algorithms, including NMI training algorithm, NMI online testing algorithm, and intrinsic control algorithm. To demonstrate the function of this platform, in this study the NMI based on neuromuscular-mechanical fusion was hierarchically integrated with intrinsic control of a prototypical transfemoral prosthesis. One patient with a unilateral transfemoral amputation was recruited to evaluate our implemented neural controller when performing activities, such as standing, level-ground walking, ramp ascent, and ramp descent continuously in the laboratory. A novel experimental setup and protocol were developed in order to test the new prosthesis control safely and efficiently. The presented proof-of-concept platform and experimental setup and protocol could aid the future development and application of neurally-controlled powered artificial legs.

  10. Quality Control in construction.

    DTIC Science & Technology

    1984-01-01

    behavioral scientists. In 1962, Dr. Kaoru Ishikawa gave shape to the form of training which featured intradepartmental groups of ten or so workers seated...and Japanese circles bears closer scrutiny. 4.3.1 Japanese Ingredients of Quality The founder of quality circles, Dr. Kaoru Ishikawa , gives six...around 51 a table; hence the name Quality Control Circle. 4 Dr. 0 Ishikawa was an engineering professor at Tokyo University, and the circles were

  11. A proposed protocol for acceptance and constancy control of computed tomography systems: a Nordic Association for Clinical Physics (NACP) work group report.

    PubMed

    Kuttner, Samuel; Bujila, Robert; Kortesniemi, Mika; Andersson, Henrik; Kull, Love; Østerås, Bjørn Helge; Thygesen, Jesper; Tarp, Ivanka Sojat

    2013-03-01

    Quality assurance (QA) of computed tomography (CT) systems is one of the routine tasks for medical physicists in the Nordic countries. However, standardized QA protocols do not yet exist and the QA methods, as well as the applied tolerance levels, vary in scope and extent at different hospitals. To propose a standardized protocol for acceptance and constancy testing of CT scanners in the Nordic Region. Following a Nordic Association for Clinical Physics (NACP) initiative, a group of medical physicists, with representatives from four Nordic countries, was formed. Based on international literature and practical experience within the group, a comprehensive standardized test protocol was developed. The proposed protocol includes tests related to the mechanical functionality, X-ray tube, detector, and image quality for CT scanners. For each test, recommendations regarding the purpose, equipment needed, an outline of the test method, the measured parameter, tolerance levels, and the testing frequency are stated. In addition, a number of optional tests are briefly discussed that may provide further information about the CT system. Based on international references and medical physicists' practical experiences, a comprehensive QA protocol for CT systems is proposed, including both acceptance and constancy tests. The protocol may serve as a reference for medical physicists in the Nordic countries.

  12. Pterodon pubescens oil: characterisation, certification of origin and quality control via mass spectrometry fingerprinting analysis.

    PubMed

    Cabral, E C; Sevart, L; Spindola, H M; Coelho, M B; Sousa, I M O; Queiroz, N C A; Foglio, M A; Eberlin, M N; Riveros, J M

    2013-02-01

    The oil obtained from Pterodon pubescens (Leguminosae) seeds are known to display anti-cancer, anti-dermatogenic and anti-nociceptive activitiy. Phytochemical studies have demonstrated that its main constituents are diterpenoids with voucapan skeletons. Considering the potential biological activities of the oil, rapid and efficient methods for assessing its quality would facilitate certification and quality control. To develop a direct mass spectrometric fingerprinting method for the P. pubescens seed oil that would focus on the major diterpenoids constituents, enabling quality control, origin certification and recognition of marker species in commercially available products. Two techniques were used: (i) direct infusion electrospray ionisation (ESI) mass spectrometry after solvent extraction and dilution and (ii) ambient desorption/ionisation via easy ambient sonic-spray ionisation, EASI(+)-MS, performed directly on the seed surface or at a paper surface imprinted with the oil. From a combination of ESI-MS, HRESI-MS and ESI-MS/MS data, 12 diterpenes were characterised, and typical profiles were obtained for the oil extract or the crude oil via both ESI-MS and EASI-MS. These techniques require no or very simple sample preparation protocols and the whole analytical processes with spectra acquisition take just a few minutes. Both techniques, but particularly EASI-MS, provide simple, fast and efficient MS fingerprinting methodologies to characterise the P. pubescens oil with typical (di)terpene profiles being applicable to quality control and certification of authenticity and origin. Copyright © 2012 John Wiley & Sons, Ltd.

  13. Quality of Care and Job Satisfaction in the European Home Care Setting: Research Protocol

    PubMed Central

    van der Roest, Henriëtte; van Hout, Hein; Declercq, Anja

    2016-01-01

    Introduction: Since the European population is ageing, a growing number of elderly will need home care. Consequently, high quality home care for the elderly remains an important challenge. Job satisfaction among care professionals is regarded as an important aspect of the quality of home care. Aim: This paper describes a research protocol to identify elements that have an impact on job satisfaction among care professionals and on quality of care for older people in the home care setting of six European countries. Methods: Data on elements at the macro-level (policy), meso-level (care organisations) and micro-level (clients) are of importance in determining job satisfaction and quality of care. Macro-level indicators will be identified in a previously published literature review. At meso- and micro-level, data will be collected by means of two questionnaires utilsed with both care organisations and care professionals, and by means of interRAI Home Care assessments of clients. The client assessments will be used to calculate quality of care indicators. Subsequently, data will be analysed by means of linear and stepwise multiple regression analyses, correlations and multilevel techniques. Conclusions and Discussion: These results can guide health care policy makers in their decision making process in order to increase the quality of home care in their organisation, in their country or in Europe. PMID:28435423

  14. 30 CFR 74.6 - Quality control.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

  15. 30 CFR 74.6 - Quality control.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

  16. 30 CFR 74.6 - Quality control.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Quality control. 74.6 Section 74.6 Mineral... control. The applicant shall describe the way in which each lot of components will be sampled and tested... of the CMDPSU will be maintained in production through adequate quality control procedures, MSHA and...

  17. Image quality comparison between single energy and dual energy CT protocols for hepatic imaging

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Yao, Yuan, E-mail: yuanyao@stanford.edu; Pelc, Nor

    Purpose: Multi-detector computed tomography (MDCT) enables volumetric scans in a single breath hold and is clinically useful for hepatic imaging. For simple tasks, conventional single energy (SE) computed tomography (CT) images acquired at the optimal tube potential are known to have better quality than dual energy (DE) blended images. However, liver imaging is complex and often requires imaging of both structures containing iodinated contrast media, where atomic number differences are the primary contrast mechanism, and other structures, where density differences are the primary contrast mechanism. Hence it is conceivable that the broad spectrum used in a dual energy acquisition maymore » be an advantage. In this work we are interested in comparing these two imaging strategies at equal-dose and more complex settings. Methods: We developed numerical anthropomorphic phantoms to mimic realistic clinical CT scans for medium size and large size patients. MDCT images based on the defined phantoms were simulated using various SE and DE protocols at pre- and post-contrast stages. For SE CT, images from 60 kVp through 140 with 10 kVp steps were considered; for DE CT, both 80/140 and 100/140 kVp scans were simulated and linearly blended at the optimal weights. To make a fair comparison, the mAs of each scan was adjusted to match the reference radiation dose (120 kVp, 200 mAs for medium size patients and 140 kVp, 400 mAs for large size patients). Contrast-to-noise ratio (CNR) of liver against other soft tissues was used to evaluate and compare the SE and DE protocols, and multiple pre- and post-contrasted liver-tissue pairs were used to define a composite CNR. To help validate the simulation results, we conducted a small clinical study. Eighty-five 120 kVp images and 81 blended 80/140 kVp images were collected and compared through both quantitative image quality analysis and an observer study. Results: In the simulation study, we found that the CNR of pre-contrast SE image

  18. Quality Assurance and Quality Control, Part 2.

    PubMed

    Akers, Michael J

    2015-01-01

    The tragedy surrounding the New England Compounding Center and contaminated steroid syringe preparations clearly points out what can happen if quality-assurance and quality-control procedures are not strictly practiced in the compounding of sterile preparations. This article is part 2 of a two-part article on requirements to comply with United States Pharmacopeia general chapters <797> and <1163> with respect to quality assurance of compounded sterile preparations. Part 1 covered documentation requirements, inspection procedures, compounding accuracy checks, and part of a discussion on bacterial endotoxin testing. Part 2 covers sterility testing, the completion from part 1 on bacterial endotoxin testing, a brief dicussion of United States Pharmacopeia <1163>, and advances in pharmaceutical quality systems.

  19. Guidance for Efficient Small Animal Imaging Quality Control.

    PubMed

    Osborne, Dustin R; Kuntner, Claudia; Berr, Stuart; Stout, David

    2017-08-01

    Routine quality control is a critical aspect of properly maintaining high-performance small animal imaging instrumentation. A robust quality control program helps produce more reliable data both for academic purposes and as proof of system performance for contract imaging work. For preclinical imaging laboratories, the combination of costs and available resources often limits their ability to produce efficient and effective quality control programs. This work presents a series of simplified quality control procedures that are accessible to a wide range of preclinical imaging laboratories. Our intent is to provide minimum guidelines for routine quality control that can assist preclinical imaging specialists in setting up an appropriate quality control program for their facility.

  20. 42 CFR 84.256 - Quality control requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Quality control requirements. 84.256 Section 84.256... § 84.256 Quality control requirements. (a) In addition to the construction and performance requirements specified in §§ 84.251, 84.252, 84.253, 84.254, and 84.255, the quality control requirements in paragraphs...

  1. 42 CFR 84.256 - Quality control requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Quality control requirements. 84.256 Section 84.256... § 84.256 Quality control requirements. (a) In addition to the construction and performance requirements specified in §§ 84.251, 84.252, 84.253, 84.254, and 84.255, the quality control requirements in paragraphs...

  2. 42 CFR 84.256 - Quality control requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Quality control requirements. 84.256 Section 84.256... § 84.256 Quality control requirements. (a) In addition to the construction and performance requirements specified in §§ 84.251, 84.252, 84.253, 84.254, and 84.255, the quality control requirements in paragraphs...

  3. 42 CFR 84.256 - Quality control requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Quality control requirements. 84.256 Section 84.256... § 84.256 Quality control requirements. (a) In addition to the construction and performance requirements specified in §§ 84.251, 84.252, 84.253, 84.254, and 84.255, the quality control requirements in paragraphs...

  4. 42 CFR 84.256 - Quality control requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Quality control requirements. 84.256 Section 84.256... § 84.256 Quality control requirements. (a) In addition to the construction and performance requirements specified in §§ 84.251, 84.252, 84.253, 84.254, and 84.255, the quality control requirements in paragraphs...

  5. Data exploration, quality control and statistical analysis of ChIP-exo/nexus experiments

    PubMed Central

    Welch, Rene; Chung, Dongjun; Grass, Jeffrey; Landick, Robert

    2017-01-01

    Abstract ChIP-exo/nexus experiments rely on innovative modifications of the commonly used ChIP-seq protocol for high resolution mapping of transcription factor binding sites. Although many aspects of the ChIP-exo data analysis are similar to those of ChIP-seq, these high throughput experiments pose a number of unique quality control and analysis challenges. We develop a novel statistical quality control pipeline and accompanying R/Bioconductor package, ChIPexoQual, to enable exploration and analysis of ChIP-exo and related experiments. ChIPexoQual evaluates a number of key issues including strand imbalance, library complexity, and signal enrichment of data. Assessment of these features are facilitated through diagnostic plots and summary statistics computed over regions of the genome with varying levels of coverage. We evaluated our QC pipeline with both large collections of public ChIP-exo/nexus data and multiple, new ChIP-exo datasets from Escherichia coli. ChIPexoQual analysis of these datasets resulted in guidelines for using these QC metrics across a wide range of sequencing depths and provided further insights for modelling ChIP-exo data. PMID:28911122

  6. Inexpensive metagenomic DNA extraction protocol with high quality from marine sediments contaminated by petroleum hydrocarbons.

    PubMed

    García-Bautista, I; Toledano-Thompson, T; Dantán-González, E; González-Montilla, J; Valdez-Ojeda, R

    2017-09-21

    Marine environments are a reservoir of relevant information on dangerous contaminants such as hydrocarbons, as well as microbial communities with probable degradation skills. However, to access microbial diversity, it is necessary to obtain high-quality DNA. An inexpensive, reliable, and effective metagenomic DNA (mgDNA) extraction protocol from marine sediments contaminated with petroleum hydrocarbons was established in this study from modifications to Zhou's protocol. The optimization included pretreatment of sediment with saline solutions for the removal of contaminants, a second precipitation and enzymatic degradation of RNA, followed by purification of mgDNA extracted by electroelution. The results obtained indicated that the modifications applied to 12 sediments with total petroleum hydrocarbon (TPH) concentrations from 22.6-174.3 (µg/g dry sediment) yielded 20.3-321.3 ng/µL mgDNA with A 260 /A 280 and A 260 /A 230 ratios of 1.75 ± 0.08 and 1.19 ± 0.22, respectively. The 16S rRNA amplification confirmed the purity of the mgDNA. The suitability of this mgDNA extraction protocol lies in the fact that all chemical solutions utilized are common in all molecular biology laboratories, and the use of dialysis membrane does not require any sophisticated or expensive equipment, only an electrophoretic chamber.

  7. An ultra low-power and traffic-adaptive medium access control protocol for wireless body area network.

    PubMed

    Ullah, Sana; Kwak, Kyung Sup

    2012-06-01

    Wireless Body Area Network (WBAN) consists of low-power, miniaturized, and autonomous wireless sensor nodes that enable physicians to remotely monitor vital signs of patients and provide real-time feedback with medical diagnosis and consultations. It is the most reliable and cheaper way to take care of patients suffering from chronic diseases such as asthma, diabetes and cardiovascular diseases. Some of the most important attributes of WBAN is low-power consumption and delay. This can be achieved by introducing flexible duty cycling techniques on the energy constraint sensor nodes. Stated otherwise, low duty cycle nodes should not receive frequent synchronization and control packets if they have no data to send/receive. In this paper, we introduce a Traffic-adaptive MAC protocol (TaMAC) by taking into account the traffic information of the sensor nodes. The protocol dynamically adjusts the duty cycle of the sensor nodes according to their traffic-patterns, thus solving the idle listening and overhearing problems. The traffic-patterns of all sensor nodes are organized and maintained by the coordinator. The TaMAC protocol is supported by a wakeup radio that is used to accommodate emergency and on-demand events in a reliable manner. The wakeup radio uses a separate control channel along with the data channel and therefore it has considerably low power consumption requirements. Analytical expressions are derived to analyze and compare the performance of the TaMAC protocol with the well-known beacon-enabled IEEE 802.15.4 MAC, WiseMAC, and SMAC protocols. The analytical derivations are further validated by simulation results. It is shown that the TaMAC protocol outperforms all other protocols in terms of power consumption and delay.

  8. Chapter 3: Commercial and Industrial Lighting Controls Evaluation Protocol. The Uniform Methods Project: Methods for Determining Energy Efficiency Savings for Specific Measures

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kurnik, Charles W.; Carlson, Stephen

    This Commercial and Industrial Lighting Controls Evaluation Protocol (the protocol) describes methods to account for energy savings resulting from programmatic installation of lighting control equipment in large populations of commercial, industrial, government, institutional, and other nonresidential facilities. This protocol does not address savings resulting from changes in codes and standards, or from education and training activities. When lighting controls are installed in conjunction with a lighting retrofit project, the lighting control savings must be calculated parametrically with the lighting retrofit project so savings are not double counted.

  9. Study protocol for a randomised controlled trial examining the association between physical activity and sleep quality in children with autism spectrum disorder based on the melatonin-mediated mechanism model.

    PubMed

    Tse, Andy C Y; Lee, Paul H; Zhang, Jihui; Lai, Elvis W H

    2018-04-13

    Sleep disturbance is commonly observed in children with autism spectrum disorders (ASD). Disturbed sleep may exacerbate the core symptoms of ASD. Behavioural interventions and supplemental melatonin medication are traditionally used to improve sleep quality, but poor sustainability of behavioural intervention effects and use of other medications that metabolise melatonin may degrade the effectiveness of these interventions. However, several studies have suggested that physical activity may provide an effective intervention for treating sleep disturbance in typically developing children. Thus, we designed a study to examine whether such an intervention is also effective in children with ASD. We present a protocol (4 December 2017) for a jogging intervention with a parallel and two-group randomised controlled trial design using objective actigraphic assessment and 6-sulfatoxymelatonin measurement to determine whether a 12-week physical activity intervention elicits changes in sleep quality or melatonin levels. All eligible participants will be randomly allocated to either a jogging intervention group or a control group receiving standard care. Changes in sleep quality will be monitored through actigraphic assessment and parental sleep logs. All participants will also be instructed to collect a 24-hour urine sample. 6-sulfatoxymelatonin, a creatinine-adjusted morning urinary melatonin representative of the participant's melatonin levels, will be measured from the sample. All assessments will be carried out before the intervention (T1), immediately after the 12-week intervention or regular treatment (T2), 6 weeks after the intervention (T3) and 12 weeks after the intervention (T4) to examine the sustainability of the intervention effects. The first enrolment began in February 2018. Ethical approval was obtained through the Human Research Ethics Committee, Education University of Hong Kong. The results of this trial will be submitted for publication in peer

  10. Association between progression-free survival and health-related quality of life in oncology: a systematic review protocol.

    PubMed

    Kovic, Bruno; Guyatt, Gordon; Brundage, Michael; Thabane, Lehana; Bhatnagar, Neera; Xie, Feng

    2016-09-02

    There is an increasing number of new oncology drugs being studied, approved and put into clinical practice based on improvement in progression-free survival, when no overall survival benefits exist. In oncology, the association between progression-free survival and health-related quality of life is currently unknown, despite its importance for patients with cancer, and the unverified assumption that longer progression-free survival indicates improved health-related quality of life. Thus far, only 1 study has investigated this association, providing insufficient evidence and inconclusive results. The objective of this study protocol is to provide increased transparency in supporting a systematic summary of the evidence bearing on this association in oncology. Using the OVID platform in MEDLINE, Embase and Cochrane databases, we will conduct a systematic review of randomised controlled human trials addressing oncology issues published starting in 2000. A team of reviewers will, in pairs, independently screen and abstract data using standardised, pilot-tested forms. We will employ numerical integration to calculate mean incremental area under the curve between treatment groups in studies for health-related quality of life, along with total related error estimates, and a 95% CI around incremental area. To describe the progression-free survival to health-related quality of life association, we will construct a scatterplot for incremental health-related quality of life versus incremental progression-free survival. To estimate the association, we will use a weighted simple regression approach, comparing mean incremental health-related quality of life with either median incremental progression-free survival time or the progression-free survival HR, in the absence of overall survival benefit. Identifying direction and magnitude of association between progression-free survival and health-related quality of life is critically important in interpreting results of oncology

  11. Association between progression-free survival and health-related quality of life in oncology: a systematic review protocol

    PubMed Central

    Kovic, Bruno; Guyatt, Gordon; Brundage, Michael; Thabane, Lehana; Bhatnagar, Neera; Xie, Feng

    2016-01-01

    Introduction There is an increasing number of new oncology drugs being studied, approved and put into clinical practice based on improvement in progression-free survival, when no overall survival benefits exist. In oncology, the association between progression-free survival and health-related quality of life is currently unknown, despite its importance for patients with cancer, and the unverified assumption that longer progression-free survival indicates improved health-related quality of life. Thus far, only 1 study has investigated this association, providing insufficient evidence and inconclusive results. The objective of this study protocol is to provide increased transparency in supporting a systematic summary of the evidence bearing on this association in oncology. Methods and analysis Using the OVID platform in MEDLINE, Embase and Cochrane databases, we will conduct a systematic review of randomised controlled human trials addressing oncology issues published starting in 2000. A team of reviewers will, in pairs, independently screen and abstract data using standardised, pilot-tested forms. We will employ numerical integration to calculate mean incremental area under the curve between treatment groups in studies for health-related quality of life, along with total related error estimates, and a 95% CI around incremental area. To describe the progression-free survival to health-related quality of life association, we will construct a scatterplot for incremental health-related quality of life versus incremental progression-free survival. To estimate the association, we will use a weighted simple regression approach, comparing mean incremental health-related quality of life with either median incremental progression-free survival time or the progression-free survival HR, in the absence of overall survival benefit. Discussion Identifying direction and magnitude of association between progression-free survival and health-related quality of life is critically

  12. TH-C-18A-08: A Management Tool for CT Dose Monitoring, Analysis, and Protocol Review

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Wang, J; Chan, F; Newman, B

    2014-06-15

    Purpose: To develop a customizable tool for enterprise-wide managing of CT protocols and analyzing radiation dose information of CT exams for a variety of quality control applications Methods: All clinical CT protocols implemented on the 11 CT scanners at our institution were extracted in digital format. The original protocols had been preset by our CT management team. A commercial CT dose tracking software (DoseWatch,GE healthcare,WI) was used to collect exam information (exam date, patient age etc.), scanning parameters, and radiation doses for all CT exams. We developed a Matlab-based program (MathWorks,MA) with graphic user interface which allows to analyze themore » scanning protocols with the actual dose estimates, and compare the data to national (ACR,AAPM) and internal reference values for CT quality control. Results: The CT protocol review portion of our tool allows the user to look up the scanning and image reconstruction parameters of any protocol on any of the installed CT systems among about 120 protocols per scanner. In the dose analysis tool, dose information of all CT exams (from 05/2013 to 02/2014) was stratified on a protocol level, and within a protocol down to series level, i.e. each individual exposure event. This allows numerical and graphical review of dose information of any combination of scanner models, protocols and series. The key functions of the tool include: statistics of CTDI, DLP and SSDE, dose monitoring using user-set CTDI/DLP/SSDE thresholds, look-up of any CT exam dose data, and CT protocol review. Conclusion: our inhouse CT management tool provides radiologists, technologists and administration a first-hand near real-time enterprise-wide knowledge on CT dose levels of different exam types. Medical physicists use this tool to manage CT protocols, compare and optimize dose levels across different scanner models. It provides technologists feedback on CT scanning operation, and knowledge on important dose baselines and thresholds.« less

  13. Kinesio Taping for pain control during labor: Protocol of a randomized, controlled trial.

    PubMed

    Miquelutti, Maria Amelia; Cecatti, José Guilherme

    2017-03-01

    This study protocol will evaluate the effectiveness and safety during labor and delivery of the Kinesio Taping bandage for pain sensation, satisfaction of patients, and obstetric and neonatal outcomes. A randomized controlled trial with 60 participants divided into two groups will be conducted. The intervention group will receive bandage application on the vertebral regions corresponding to uterine dermatomes - from T10 to L1 and from S2 to S4. The control group will receive bandage application away from uterine dermatomes, from T1 to T4. The primary endpoint is pain during labor. Secondary endpoints are perinatal outcomes and patient satisfaction with the bandage and with her labor. Pain levels will be evaluated on an hourly basis during labor, and intention-to-treat analysis will be performed. Risk ratios and 95% confidence intervals will be calculated. Findings on effectiveness of pain control with no adverse effects to both the mother and neonate are the first step in evaluating the systematic use of Kinesio Taping during labor. Since self-control may affect birthing experience satisfaction, discovering new alternatives for pain control may allow for a better experience. © 2017 John Wiley & Sons Australia, Ltd.

  14. Plan delivery quality assurance for CyberKnife: Statistical process control analysis of 350 film-based patient-specific QAs.

    PubMed

    Bellec, J; Delaby, N; Jouyaux, F; Perdrieux, M; Bouvier, J; Sorel, S; Henry, O; Lafond, C

    2017-07-01

    Robotic radiosurgery requires plan delivery quality assurance (DQA) but there has never been a published comprehensive analysis of a patient-specific DQA process in a clinic. We proposed to evaluate 350 consecutive film-based patient-specific DQAs using statistical process control. We evaluated the performance of the process to propose achievable tolerance criteria for DQA validation and we sought to identify suboptimal DQA using control charts. DQAs were performed on a CyberKnife-M6 using Gafchromic-EBT3 films. The signal-to-dose conversion was performed using a multichannel-correction and a scanning protocol that combined measurement and calibration in a single scan. The DQA analysis comprised a gamma-index analysis at 3%/1.5mm and a separate evaluation of spatial and dosimetric accuracy of the plan delivery. Each parameter was plotted on a control chart and control limits were calculated. A capability index (Cpm) was calculated to evaluate the ability of the process to produce results within specifications. The analysis of capability showed that a gamma pass rate of 85% at 3%/1.5mm was highly achievable as acceptance criteria for DQA validation using a film-based protocol (Cpm>1.33). 3.4% of DQA were outside a control limit of 88% for gamma pass-rate. The analysis of the out-of-control DQA helped identify a dosimetric error in our institute for a specific treatment type. We have defined initial tolerance criteria for DQA validations. We have shown that the implementation of a film-based patient-specific DQA protocol with the use of control charts is an effective method to improve patient treatment safety on CyberKnife. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

  15. Dual sensory loss: development of a dual sensory loss protocol and design of a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Dual sensory loss (DSL) has a negative impact on health and wellbeing and its prevalence is expected to increase due to demographic aging. However, specialized care or rehabilitation programs for DSL are scarce. Until now, low vision rehabilitation does not sufficiently target concurrent impairments in vision and hearing. This study aims to 1) develop a DSL protocol (for occupational therapists working in low vision rehabilitation) which focuses on optimal use of the senses and teaches DSL patients and their communication partners to use effective communication strategies, and 2) describe the multicenter parallel randomized controlled trial (RCT) designed to test the effectiveness and cost-effectiveness of the DSL protocol. Methods/design To develop a DSL protocol, literature was reviewed and content was discussed with professionals in eye/ear care (interviews/focus groups) and DSL patients (interviews). A pilot study was conducted to test and confirm the DSL protocol. In addition, a two-armed international multi-center RCT will evaluate the effectiveness and cost-effectiveness of the DSL protocol compared to waiting list controls, in 124 patients in low vision rehabilitation centers in the Netherlands and Belgium. Discussion This study provides a treatment protocol for rehabilitation of DSL within low vision rehabilitation, which aims to be a valuable addition to the general low vision rehabilitation care. Trial registration Netherlands Trial Register (NTR) identifier: NTR2843 PMID:23941667

  16. Efficacy of a Sleep Quality Intervention in People With Low Back Pain: Protocol for a Feasibility Randomized Co-Twin Controlled Trial.

    PubMed

    Pinheiro, Marina B; Ho, Kevin K; Ferreira, Manuela L; Refshauge, Kathryn M; Grunstein, Ron; Hopper, John L; Maher, Christopher G; Koes, Bart W; Ordoñana, Juan R; Ferreira, Paulo H

    2016-10-01

    Poor sleep quality is highly prevalent in patients with low back pain (LBP) and is associated with high levels of pain, psychological distress, and physical disability. Studies have reported a bidirectional relationship between sleep problems and intensity of LBP. Accordingly, effective management of LBP should address sleep quality. In addition, genetics has been found to significantly affect the prevalence of both LBP and insomnia. Our study aims to establish the feasibility of a trial exploring the efficacy of a web-based sleep quality intervention in people with LBP, with the genetic influences being controlled for. 30 twins (15 complete pairs) with subacute or chronic LBP (>6 weeks) will be recruited from the Australian Twin Registry. Participants will be randomly assigned to one of the two groups with each twin within a pair receiving either an interactive web-based sleep intervention based on cognitive behavioral therapy principles (intervention) or a web-based education program (control) for 6 weeks. The feasibility of the trial will be investigated with regard to recruitment rate, feasibility of data collection and outcome measure completion, contamination of intervention, acceptability and experience of intervention, and sample size requirement for the full trial. Patient outcomes will be collected electronically at baseline, immediately post-treatment, and at 3-months' follow-up post-randomization. This trial employs a robust design that will effectively control for the influence of genetics on treatment effect. Additionally, this study addresses sleep quality, a significant but under-explored issue in LBP. Results will inform the design and implementation of the definitive trial.

  17. The effectiveness of mindfulness-based stress reduction (MBSR) for survivors of breast cancer: study protocol for a randomized controlled trial.

    PubMed

    Huang, Jiayan; Shi, Lu

    2016-04-22

    After treatment completion, breast cancer (BC) survivors frequently experience residual symptoms of pain, fatigue, high levels of psychological stress, anxiety, depression, fear of recurrence, and metastasis. Post-treatment stress, in particular, can adversely affect health-related quality of life, which, in turn, induces onset or recurrence of chronic diseases. Effective interventions that target these psychological symptoms and their physiological consequences are needed, especially for economically disadvantaged patients. However, in China, few evidence-based intervention strategies have been established among BC survivors. This study will formally adapt, develop, and evaluate an intensive mindfulness-based stress reduction (MBSR) intervention protocol to improve mental health, quality of life, and compliance with medication among Chinese BC survivors. A randomized, waitlist-controlled clinical trial will be conducted. Based on our power calculation, 418 BC survivors will be recruited from 10 low-income communities in Shanghai. All subjects will be randomly assigned either to the MBSR program or to a waitlisted usual care regimen that will offer the MBSR program after the completion of the other trial arm (after 6 months follow-up). Our 8-week MBSR intervention program will provide systematic training to promote stress reduction by self-regulating arousal to stress. Assessments will be made at baseline, 4 weeks (in the middle of the first MBSR intervention), 8 weeks (at the end of the first MBSR intervention), 6 months, and 12 months, and will include measures of psychological symptoms (depression, anxiety, and perceived stress), quality of life, and medication adherence. The expected outcome will be the improvement in psychological symptoms, quality of life, and medication compliance in the MBSR intervention group. This study will help develop an affordable, self-care psychological intervention protocol to help Chinese BC survivors improve their quality of

  18. 21 CFR 1301.18 - Research protocols.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 9 2014-04-01 2014-04-01 false Research protocols. 1301.18 Section 1301.18 Food..., DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES Registration § 1301.18 Research protocols. (a) A protocol to conduct research with controlled substances listed in Schedule I shall be in the following form...

  19. 21 CFR 1301.18 - Research protocols.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Research protocols. 1301.18 Section 1301.18 Food..., DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES Registration § 1301.18 Research protocols. (a) A protocol to conduct research with controlled substances listed in Schedule I shall be in the following form...

  20. 21 CFR 1301.18 - Research protocols.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Research protocols. 1301.18 Section 1301.18 Food..., DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES Registration § 1301.18 Research protocols. (a) A protocol to conduct research with controlled substances listed in Schedule I shall be in the following form...

  1. 21 CFR 1301.18 - Research protocols.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Research protocols. 1301.18 Section 1301.18 Food..., DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES Registration § 1301.18 Research protocols. (a) A protocol to conduct research with controlled substances listed in Schedule I shall be in the following form...

  2. 21 CFR 1301.18 - Research protocols.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Research protocols. 1301.18 Section 1301.18 Food..., DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES Registration § 1301.18 Research protocols. (a) A protocol to conduct research with controlled substances listed in Schedule I shall be in the following form...

  3. Technical assessment of a cone-beam CT scanner for otolaryngology imaging: image quality, dose, and technique protocols.

    PubMed

    Xu, J; Reh, D D; Carey, J P; Mahesh, M; Siewerdsen, J H

    2012-08-01

    As cone-beam CT (CBCT) systems dedicated to various imaging specialties proliferate, technical assessment grounded in imaging physics is important to ensuring that image quality and radiation dose are quantified, understood, and justified. This paper involves technical assessment of a new CBCT scanner (CS 9300, Carestream Health, Rochester, NY) dedicated to imaging of the ear and sinuses for applications in otolaryngology-head and neck surgery (OHNS). The results guided evaluation of technique protocols to minimize radiation dose in a manner sufficient for OHNS imaging tasks. The technical assessment focused on the imaging performance and radiation dose for each of seven technique protocols recommended by the manufacturer: three sinus protocols and four ear (temporal bone) protocols. Absolute dose was measured using techniques adapted from AAPM Task Group Report No. 111, involving three stacked 16 cm diameter acrylic cylinders (CTDI phantoms) and a 0.6 cm(3) Farmer ionization chamber to measure central and peripheral dose. The central dose (D(o)) was also measured as a function of longitudinal position (z) within and beyond the primary radiation field to assess, for example, out-of-field dose to the neck. Signal-difference-to-noise ratio (SDNR) and Hounsfield unit (HU) accuracy were assessed in a commercially available quality assurance phantom (CATPHAN module CTP404, The Phantom Laboratory, Greenwich, NY) and a custom phantom with soft-tissue-simulating plastic inserts (Gammex RMI, Madison, WI). Spatial resolution was assessed both qualitatively (a line-pair pattern, CATPHAN module CTP528) and quantitatively (modulation transfer function, MTF, measured with a wire phantom). Imaging performance pertinent to various OHNS imaging tasks was qualitatively assessed using an anthropomorphic phantom as evaluated by two experienced OHNS specialists. The technical assessment motivated a variety of modifications to the manufacturer-specified protocols to provide reduced

  4. Clinical pathways for acute coronary syndromes in China: protocol for a hospital quality improvement initiative.

    PubMed

    Rong, Ye; Turnbull, Fiona; Patel, Anushka; Du, Xin; Wu, Yangfeng; Gao, Runlin

    2010-09-01

    Clinical pathways have been shown to be effective in improving quality of care for patients admitted to hospital for acute coronary syndromes (ACS) in high-income countries. However, their utility has not formally been evaluated in low- or middle-income countries. The Clinical Pathways for Acute Coronary Syndromes in China program is a 7-year study with the overall goal of reducing evidence-practice gaps in the management of patients admitted to hospitals in China with suspected ACS. The program comprises 2 phases: a prospective survey of current management of ACS patients to identify the areas that evidence-based patient care can be potentially improved, and a quality care initiative to maximize the use of evidence-based investigations and treatments for ACS patients in China. In this article, we outline the details of the study protocol, including key aspects of the development, implementation, and evaluation of the quality improvement initiative (clinical pathway) for management of patients with suspected ACS.

  5. Guidelines for quality assurance and quality control of fish taxonomic data collected as part of the National Water-Quality Assessment Program

    USGS Publications Warehouse

    Walsh, Stephen Joseph; Meador, Michael R.

    1998-01-01

    Fish community structure is characterized by the U.S. Geological Survey's National Water-Quality Assessment (NAWQA) Program as part of a perennial, multidisciplinary approach to evaluating the physical, chemical, and biological conditions of the Nation's water resources. The objective of quality assurance and quality control of fish taxonomic data that are collected as part of the NAWQA Program is to establish uniform guidelines and protocols for the identification, processing, and archiving of fish specimens to ensure that accurate and reliable data are collected. Study unit biologists, collaborating with regional biologists and fish taxonomic specialists, prepare a pre-sampling study plan that includes a preliminary faunal list and identification of an ichthyological curation center for receiving preserved fish specimens. Problematic taxonomic issues and protected taxa also are identified in the study plan, and collecting permits are obtained in advance of sampling activities. Taxonomic specialists are selected to identify fish specimens in the field and to assist in determining what fish specimens should be sacrificed, fixed, and preserved for laboratory identification, independent taxonomic verification, and long-term storage in reference or voucher collections. Quantitative and qualitative sampling of fishes follows standard methods previously established for the NAWQA Program. Common ichthyological techniques are used to process samples in the field and prepare fish specimens to be returned to the laboratory or sent to an institutional repository. Taxonomic identifications are reported by using a standardized list of scientific names that provides nomenclatural consistency and uniformity across study units.

  6. Effect of low-level laser therapy on pain, quality of life and sleep in patients with fibromyalgia: study protocol for a double-blinded randomized controlled trial.

    PubMed

    de Carvalho, Paulo de Tarso Camillo; Leal-Junior, Ernesto Cesar Pinto; Alves, Ana Carolina Araruna; Rambo, Caroline Sobral de Melo; Sampaio, Luciana Maria Malosa; Oliveira, Claudia Santos; Albertini, Regiane; de Oliveira, Luis Vicente Franco

    2012-11-21

    Low-level laser therapy (LLLT) has been widely used as adjuvant strategy for treatment of musculoskeletal disorders. The light-tissue interaction (photobiostimulation) promotes analgesic and anti-inflammatory effects and improves tissue healing, which could justify the recommendation of this therapy for patients with fibromyalgia, leading to an improvement in pain and possibly minimizing social impact related to this disease. The present study proposes to evaluate the effect of LLLT on tender points in patients with fibromyalgia, correlating this outcome with quality of life and sleep. One hundred and twenty patients with fibromyalgia will be treated at the Integrated Health Center and the Sleep Laboratory of the Post Graduate Program in Rehabilitation Sciences of the Nove de Julho University located in the city of Sao Paulo, Brazil. After fulfilling the eligibility criteria, a clinical evaluation and assessments of pain and sleep quality will be carried out and self-administered quality of life questionnaires will be applied. The 120 volunteers will be randomly allocated to an intervention group (LLLT, n = 60) or control group (CLLLT, n = 60). Patients from both groups will be treated three times per week for four weeks, totaling twelve sessions. However, only the LLLT group will receive an energy dose of 6 J per tender point. A standardized 50-minute exercise program will be performed after the laser application. The patients will be evaluated regarding the primary outcome (pain) using the following instruments: visual analog scale, McGill Pain Questionnaire and pressure algometry. The secondary outcome (quality of life and sleep) will be assessed with the following instruments: Medical Outcomes Study 36-item Short-Form Health Survey, Fibromyalgia Impact Questionnaire, Berlin Questionnaire, Epworth Sleepiness Scale and polysomnography. ANOVA test with repeated measurements for the time factor will be performed to test between-groups differences (followed by the

  7. Effect of low-level laser therapy on pain, quality of life and sleep in patients with fibromyalgia: study protocol for a double-blinded randomized controlled trial

    PubMed Central

    2012-01-01

    Background Low-level laser therapy (LLLT) has been widely used as adjuvant strategy for treatment of musculoskeletal disorders. The light-tissue interaction (photobiostimulation) promotes analgesic and anti-inflammatory effects and improves tissue healing, which could justify the recommendation of this therapy for patients with fibromyalgia, leading to an improvement in pain and possibly minimizing social impact related to this disease. The present study proposes to evaluate the effect of LLLT on tender points in patients with fibromyalgia, correlating this outcome with quality of life and sleep. Methods/design One hundred and twenty patients with fibromyalgia will be treated at the Integrated Health Center and the Sleep Laboratory of the Post Graduate Program in Rehabilitation Sciences of the Nove de Julho University located in the city of Sao Paulo, Brazil. After fulfilling the eligibility criteria, a clinical evaluation and assessments of pain and sleep quality will be carried out and self-administered quality of life questionnaires will be applied. The 120 volunteers will be randomly allocated to an intervention group (LLLT, n = 60) or control group (CLLLT, n = 60). Patients from both groups will be treated three times per week for four weeks, totaling twelve sessions. However, only the LLLT group will receive an energy dose of 6 J per tender point. A standardized 50-minute exercise program will be performed after the laser application. The patients will be evaluated regarding the primary outcome (pain) using the following instruments: visual analog scale, McGill Pain Questionnaire and pressure algometry. The secondary outcome (quality of life and sleep) will be assessed with the following instruments: Medical Outcomes Study 36-item Short-Form Health Survey, Fibromyalgia Impact Questionnaire, Berlin Questionnaire, Epworth Sleepiness Scale and polysomnography. ANOVA test with repeated measurements for the time factor will be performed to test between

  8. Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial.

    PubMed

    Cerritelli, Francesco; Cicchitti, Luca; Martelli, Marta; Barlafante, Gina; Renzetti, Cinzia; Pizzolorusso, Gianfranco; Lupacchini, Mariacristina; D'Orazio, Marianna; Marinelli, Benedetta; Cozzolino, Vincenzo; Fusilli, Paola; D'Incecco, Carmine

    2015-03-08

    Recent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in reducing pain in a sample of preterms. A three-armed single blinded placebo-control randomised controlled trial protocol has been designed to primarily evaluate the extent to which OMT is effective in reducing pain in preterms. One hundred and twenty newborns will be enrolled from one tertiary neonatal intensive care unit in central Italy and randomised in three groups: study, sham and control. The study group will be further prospectively randomised in two subgroups: experienced osteopaths and students. All preterms will receive standard medical care. Osteopathic treatment will be applied to the study group only whilst 'soft touch' will be administer to the sham group only. Newborns will undergo manual sessions once a week for the entire period of hospitalisation. Blinding will be assured for neonatal staff and outcome assessor. Primary outcome will be the mean difference in baseline score changes of PIPP questionnaire between discharge and entry among the three groups. Secondary outcomes will be: mean difference in length of stay and costs between groups. Statistical analyses will use per-protocol analysis method. Missing data will be handled using last observation carried forward imputation technique. The present single blinded randomised controlled trial has been designed to explore potential advantages of OMT in the management of newborns' pain. Currently, based on a patient-centred need-based approach, this research will be looking at the benefit of osteopathic care rather than the efficacy

  9. 7 CFR 58.928 - Quality control tests.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... quality test shall be made to determine product stability. ... 7 Agriculture 3 2013-01-01 2013-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to...

  10. 7 CFR 58.928 - Quality control tests.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... quality test shall be made to determine product stability. ... 7 Agriculture 3 2012-01-01 2012-01-01 false Quality control tests. 58.928 Section 58.928... Procedures § 58.928 Quality control tests. All dairy products and other ingredients shall be subject to...

  11. Demographic and quality control parameters of Anastrepha Fraterculus (Diptera: Tephritidae) maintained under artificial rearing

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Vera, T.; Abraham, S.; Oviedo, A.

    The integration of the sterile insect technique (SIT) in the management of the South American fruit fly Anastrepha fraterculus (Wiedemann) (Diptera: Tephritidae) is a promising alternative to chemically-based control in those areas where it is sympatric with Ceratitis capitata (Wiedemann) (Diptera: Tephritidae) or other tephritid species for which the SIT is being used. Implementation of the SIT requires the development of a cost effective mass-rearing protocol. In this work, we present demographic and quality control parameters for the A. fraterculus strain reared at the Estacion Experimental Agroindustrial Obispo Colombres, Tucuman, Argentina. Considering the rearing cage as the reproduction unit, wemore » observed that fecundity is optimal during the first 3 weeks after the onset of oviposition. Fertility was constant during this period. During 2003 and 2004, some improvements were made to the existing rearing protocol, which resulted in increased larval viability, pupal weight, and adult emergence. Current weekly egg production is 1 million per week. These eggs are used to maintain the colony and to assess quality parameters. Finally, research needs leading to improved yields and fly quality are discussed. (author) [Spanish] La integracion de la Tecnica del Insecto Esteril (TIE) en el combate integrado de la mosca Sudamericana de la fruta, Anastrepha fraterculus (Wiedemann) (Diptera: Tephritidae), es una alternativa interesante para reemplazar al control quimico en aquellas zonas donde esta especie es simpatrica con Ceratitis capitata (Wiedemann) (Diptera: Tephritidae) u otros tefritidos para los que ya se utiliza la TIE. La implementacion de la TIE requiere del desarrollo de un protocolo de cria masiva que sea costo-efectivo. En este trabajo presentamos parametros demograficos y de control de calidad de la cepa criada en la Estacion Experimental Agroindustrial Obispo Colombres, Tucuman, Argentina. Considerando a la jaula de cria como unidad reproductiva, se

  12. Internet Protocol Display Sharing Solution for Mission Control Center Video System

    NASA Technical Reports Server (NTRS)

    Brown, Michael A.

    2009-01-01

    With the advent of broadcast television as a constant source of information throughout the NASA manned space flight Mission Control Center (MCC) at the Johnson Space Center (JSC), the current Video Transport System (VTS) characteristics provides the ability to visually enhance real-time applications as a broadcast channel that decision making flight controllers come to rely on, but can be difficult to maintain and costly. The Operations Technology Facility (OTF) of the Mission Operations Facility Division (MOFD) has been tasked to provide insight to new innovative technological solutions for the MCC environment focusing on alternative architectures for a VTS. New technology will be provided to enable sharing of all imagery from one specific computer display, better known as Display Sharing (DS), to other computer displays and display systems such as; large projector systems, flight control rooms, and back supporting rooms throughout the facilities and other offsite centers using IP networks. It has been stated that Internet Protocol (IP) applications are easily readied to substitute for the current visual architecture, but quality and speed may need to be forfeited for reducing cost and maintainability. Although the IP infrastructure can support many technologies, the simple task of sharing ones computer display can be rather clumsy and difficult to configure and manage to the many operators and products. The DS process shall invest in collectively automating the sharing of images while focusing on such characteristics as; managing bandwidth, encrypting security measures, synchronizing disconnections from loss of signal / loss of acquisitions, performance latency, and provide functions like, scalability, multi-sharing, ease of initial integration / sustained configuration, integration with video adjustments packages, collaborative tools, host / recipient controllability, and the utmost paramount priority, an enterprise solution that provides ownership to the whole

  13. Proteomics Quality Control: Quality Control Software for MaxQuant Results.

    PubMed

    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 .

  14. Coping with Pain in the Motivational Context of Values: Comparison between an Acceptance-Based and a Cognitive Control-Based Protocol

    ERIC Educational Resources Information Center

    Paez-Blarrina, Marisa; Luciano, Carmen; Gutierrez-Martinez, Olga; Valdivia, Sonsoles; Rodriguez-Valverde, Miguel; Ortega, Jose

    2008-01-01

    This study compares the effect of an acceptance-based protocol (ACT) and a cognitive control-based (CONT) protocol on three measures of pain coping: tolerance, self-report, and believability. Specific methodological controls were employed to further isolate the role of the value of participating in a pain task, compared to previous investigations…

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

    PubMed Central

    2012-01-01

    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, cytokine levels in

  16. The United States Department Of Agriculture Northeast Area-wide Tick Control Project: history and protocol.

    PubMed

    Pound, Joe Mathews; Miller, John Allen; George, John E; Fish, Durland

    2009-08-01

    The Northeast Area-wide Tick Control Project (NEATCP) was funded by the United States Department of Agriculture (USDA) as a large-scale cooperative demonstration project of the USDA-Agricultural Research Service (ARS)-patented 4-Poster tick control technology (Pound et al. 1994) involving the USDA-ARS and a consortium of universities, state agencies, and a consulting firm at research locations in the five states of Connecticut (CT), Maryland (MD), New Jersey (NJ), New York (NY), and Rhode Island (RI). The stated objective of the project was "A community-based field trial of ARS-patented tick control technology designed to reduce the risk of Lyme disease in northeastern states." Here we relate the rationale and history of the technology, a chronological listing of events leading to implementation of the project, the original protocol for selecting treatment, and control sites, and protocols for deployment of treatments, sampling, assays, data analyses, and estimates of efficacy.

  17. Performance assessment of a glucose control protocol in septic patients with an automated intermittent plasma glucose monitoring device.

    PubMed

    Umbrello, M; Salice, V; Spanu, P; Formenti, P; Barassi, A; Melzi d'Eril, G V; Iapichino, G

    2014-10-01

    The optimal level and modality of glucose control in critically ill patients is still debated. A protocolized approach and the use of nearly-continuous technologies are recommended to manage hyperglycemia, hypoglycemia and glycemic variability. We recently proposed a pato-physiology-based glucose control protocol which takes into account patient glucose/carbohydrate intake and insulin resistance. Aim of the present investigation was to assess the performance of our protocol with an automated intermittent plasma glucose monitoring device (OptiScanner™ 5000). OptiScanner™ was used in 6 septic patients, providing glucose measurement every 15' from a side-port of an indwelling central venous catheter. Target level of glucose was 80-150 mg/dL. Insulin infusion and kcal with nutritional support were also recorded. 6 septic patients were studied for 319 h (1277 measurements); 58 [45-65] hours for each patient (measurements/patient: 231 [172-265]). Blood glucose was at target for 93 [90-98]% of study time. Mean plasma glucose was 126 ± 11 mg/dL. Only 3 hypoglycemic episodes (78, 78, 69 mg/dL) were recorded. Glucose variability was limited: plasma glucose coefficient of variation was 11.7 ± 4.0% and plasma glucose standard deviation was 14.3 ± 5.5 mg/dL. The local glucose control protocol achieved satisfactory glucose control in septic patients along with a high degree of safeness. Automated intermittent plasma glucose monitoring seemed useful to assess the performance of the protocol. Copyright © 2013 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  18. 7 CFR 981.442 - Quality control.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 8 2012-01-01 2012-01-01 false Quality control. 981.442 Section 981.442 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Administrative Rules and Regulations § 981.442 Quality control. (a) Incoming. Pursuant to § 981.42(a), the...

  19. 7 CFR 981.442 - Quality control.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 8 2013-01-01 2013-01-01 false Quality control. 981.442 Section 981.442 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (MARKETING AGREEMENTS... Administrative Rules and Regulations § 981.442 Quality control. (a) Incoming. Pursuant to § 981.42(a), the...

  20. 7 CFR 981.442 - Quality control.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 8 2011-01-01 2011-01-01 false Quality control. 981.442 Section 981.442 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Administrative Rules and Regulations § 981.442 Quality control. (a) Incoming. Pursuant to § 981.42(a), the...

  1. Simple and economic colloidal centrifugation protocols may be incorporated into the clinical equine sperm processing procedure.

    PubMed

    Gutiérrez-Cepeda, L; Fernández, A; Crespo, F; Gosálvez, J; Serres, C

    2011-03-01

    For many years in human assisted-reproduction procedures there have been special protocols to prepare and improve sperm quality. Colloidal centrifugation (CC) is a useful technique that has been proved to enhance semen quality by selection of the best spermatozoa for different species. Its use is recommended to improve fertility of subfertile stallions but current CC protocols are clinically complicated in the equine sperm processing technique due to economic and technical difficulties. The aim of this study was to determine the optimal processing procedures to adapt the use of a CC product (EquiPure™) in the equine reproduction industry. A total of nineteen ejaculates were collected from 10 Purebred Spanish Horses (P.R.E horses) using a Missouri artificial vagina. Gel-free semen aliquots were analyzed prior to treatment (control). Semen was subjected to one of six CC protocols with EquiPure™ and centrifuged samples were statistically evaluated by ANOVA and Duncan tests (p<0.05) for sperm quality and recovery rate. We obtained higher values by colloidal centrifugation in LIN, STR and BCF variables and DNA fragmentation index trended to be lower in most of the CC protocols. The studied protocols were shown to be as efficient in improving equine sperm quality as the current commercial EquiPure™, with the added advantage of being much more economical and simple to use. According to these results it seems to be possible to incorporate single layer and or high colloidal centrifugation volume protocols what would make them simple, economic and clinically viable for the equine sperm processing procedure. Copyright © 2011 Elsevier B.V. All rights reserved.

  2. SU-E-T-776: Use of Quality Metrics for a New Hypo-Fractionated Pre-Surgical Mesothelioma Protocol

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Richardson, S; Mehta, V

    Purpose: The “SMART” (Surgery for Mesothelioma After Radiation Therapy) approach involves hypo-fractionated radiotherapy of the lung pleura to 25Gy over 5 days followed by surgical resection within 7. Early clinical results suggest that this approach is very promising, but also logistically challenging due to the multidisciplinary involvement. Due to the compressed schedule, high dose, and shortened planning time, the delivery of the planned doses were monitored for safety with quality metric software. Methods: Hypo-fractionated IMRT treatment plans were developed for all patients and exported to Quality Reports™ software. Plan quality metrics or PQMs™ were created to calculate an objective scoringmore » function for each plan. This allows for an objective assessment of the quality of the plan and a benchmark for plan improvement for subsequent patients. The priorities of various components were incorporated based on similar hypo-fractionated protocols such as lung SBRT treatments. Results: Five patients have been treated at our institution using this approach. The plans were developed, QA performed, and ready within 5 days of simulation. Plan Quality metrics utilized in scoring included doses to OAR and target coverage. All patients tolerated treatment well and proceeded to surgery as scheduled. Reported toxicity included grade 1 nausea (n=1), grade 1 esophagitis (n=1), grade 2 fatigue (n=3). One patient had recurrent fluid accumulation following surgery. No patients experienced any pulmonary toxicity prior to surgery. Conclusion: An accelerated course of pre-operative high dose radiation for mesothelioma is an innovative and promising new protocol. Without historical data, one must proceed cautiously and monitor the data carefully. The development of quality metrics and scoring functions for these treatments allows us to benchmark our plans and monitor improvement. If subsequent toxicities occur, these will be easy to investigate and incorporate into

  3. Protocol of a Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for laypeople (MANI-CPR).

    PubMed

    Baldi, Enrico; Contri, Enrico; Burkart, Roman; Borrelli, Paola; Ferraro, Ottavia Eleonora; Tonani, Michela; Cutuli, Amedeo; Bertaia, Daniele; Iozzo, Pasquale; Tinguely, Caroline; Lopez, Daniel; Boldarin, Susi; Deiuri, Claudio; Dénéréaz, Sandrine; Dénéréaz, Yves; Terrapon, Michael; Tami, Christian; Cereda, Cinzia; Somaschini, Alberto; Cornara, Stefano; Cortegiani, Andrea

    2018-04-19

    Out-of-hospital cardiac arrest is one of the leading causes of death in industrialised countries. Survival depends on prompt identification of cardiac arrest and on the quality and timing of cardiopulmonary resuscitation (CPR) and defibrillation. For laypeople, there has been a growing interest on hands-only CPR, meaning continuous chest compression without interruption to perform ventilations. It has been demonstrated that intentional interruptions in hands-only CPR can increase its quality. The aim of this randomised trial is to compare three CPR protocols performed with different intentional interruptions with hands-only CPR. This is a prospective randomised trial performed in eight training centres. Laypeople who passed a basic life support course will be randomised to one of the four CPR protocols in an 8 min simulated cardiac arrest scenario on a manikin: (1) 30 compressions and 2 s pause; (2) 50 compressions and 5 s pause; (3) 100 compressions and 10 s pause; (4) hands-only. The calculated sample size is 552 people. The primary outcome is the percentage of chest compression performed with correct depth evaluated by a computerised feedback system (Laerdal QCPR). ETHICS AND DISSEMINATION: . Due to the nature of the study, we obtained a waiver from the Ethics Committee (IRCCS Policlinico San Matteo, Pavia, Italy). All participants will sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journal. The data collected will also be made available in a public data repository. NCT02632500. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  4. The Effects of Respondents’ Consent to be Recorded on Interview Length and Data Quality in a National Panel Study

    PubMed Central

    McGonagle, Katherine A.; Brown, Charles; Schoeni, Robert F.

    2014-01-01

    Recording interviews is a key feature of quality control protocols for most survey organizations. We examine the effects on interview length and data quality of a new protocol adopted by a national panel study. The protocol recorded a randomly chosen one-third of all interviews digitally, although all respondents were asked for permission to record their interview, and interviewers were blind to whether or not interviews were recorded. We find that the recording software slowed the interview slightly. Interviewer knowledge that the interview may be recorded improved data quality, but this knowledge also increased the length of the interview. Interviewers with higher education and performance ratings were less reactive to the new recording protocol. Survey managers may face a trade-off between higher data quality and longer interviews when determining recording protocols. PMID:26550000

  5. Contributions of CCLM to advances in quality control.

    PubMed

    Kazmierczak, Steven C

    2013-01-01

    Abstract The discipline of laboratory medicine is relatively young when considered in the context of the history of medicine itself. The history of quality control, within the context of laboratory medicine, also enjoys a relatively brief, but rich history. Laboratory quality control continues to evolve along with advances in automation, measurement techniques and information technology. Clinical Chemistry and Laboratory Medicine (CCLM) has played a key role in helping disseminate information about the proper use and utility of quality control. Publication of important advances in quality control techniques and dissemination of guidelines concerned with laboratory quality control has undoubtedly helped readers of this journal keep up to date on the most recent developments in this field.

  6. A review of rate control in atrial fibrillation, and the rationale and protocol for the RATE-AF trial

    PubMed Central

    Deeks, Jonathan J; Griffith, Michael; Lip, Gregory YH; Mehta, Samir; Slinn, Gemma; Stanbury, Mary; Steeds, Richard P; Townend, Jonathan N

    2017-01-01

    Background and objective Atrial fibrillation (AF) is common and causes impaired quality of life, an increased risk of stroke and death as well as frequent hospital admissions. The majority of patients with AF require control of heart rate. In this article, we summarise the limited evidence from clinical trials that guides prescription, and present the rationale and protocol for a new randomised trial. As rate control has not yet been shown to reduce mortality, there is a clear need to compare the impact of therapy on quality of life, cardiac function and exercise capacity. Such a trial should concentrate on the long-term effects of treatment in the largest proportion of patients with AF, those with symptomatic permanent AF, with the aim of improving patient well-being. Design and intervention The RAte control Therapy Evaluation in permanent Atrial Fibrillation (RATE-AF) trial will enrol 160 participants with a prospective, randomised, open-label, blinded end point design comparing initial rate control with digoxin or bisoprolol. This will be the first head-to-head randomised trial of digoxin and beta-blockers in AF. Participants Recruited patients will be aged ≥60 years with permanent AF and symptoms of breathlessness (equivalent to New York Heart Association class II or above), with few exclusion criteria to maximise generalisability to routine clinical practice. Outcome measures The primary outcome is patient-reported quality of life, with secondary outcomes including echocardiographic ventricular function, exercise capacity and biomarkers of cellular and clinical response. Follow-up will occur at 6 and 12 months, with feasibility components to inform the design of a future trial powered to detect a difference in hospital admission. The RATE-AF trial will underpin an integrated approach to management including biomarkers, functions and symptoms that will guide future research into optimal, personalised rate control in patients with AF. Ethics and dissemination

  7. A neural networks-based hybrid routing protocol for wireless mesh networks.

    PubMed

    Kojić, Nenad; Reljin, Irini; Reljin, Branimir

    2012-01-01

    The networking infrastructure of wireless mesh networks (WMNs) is decentralized and relatively simple, but they can display reliable functioning performance while having good redundancy. WMNs provide Internet access for fixed and mobile wireless devices. Both in urban and rural areas they provide users with high-bandwidth networks over a specific coverage area. The main problems affecting these networks are changes in network topology and link quality. In order to provide regular functioning, the routing protocol has the main influence in WMN implementations. In this paper we suggest a new routing protocol for WMN, based on good results of a proactive and reactive routing protocol, and for that reason it can be classified as a hybrid routing protocol. The proposed solution should avoid flooding and creating the new routing metric. We suggest the use of artificial logic-i.e., neural networks (NNs). This protocol is based on mobile agent technologies controlled by a Hopfield neural network. In addition to this, our new routing metric is based on multicriteria optimization in order to minimize delay and blocking probability (rejected packets or their retransmission). The routing protocol observes real network parameters and real network environments. As a result of artificial logic intelligence, the proposed routing protocol should maximize usage of network resources and optimize network performance.

  8. A Neural Networks-Based Hybrid Routing Protocol for Wireless Mesh Networks

    PubMed Central

    Kojić, Nenad; Reljin, Irini; Reljin, Branimir

    2012-01-01

    The networking infrastructure of wireless mesh networks (WMNs) is decentralized and relatively simple, but they can display reliable functioning performance while having good redundancy. WMNs provide Internet access for fixed and mobile wireless devices. Both in urban and rural areas they provide users with high-bandwidth networks over a specific coverage area. The main problems affecting these networks are changes in network topology and link quality. In order to provide regular functioning, the routing protocol has the main influence in WMN implementations. In this paper we suggest a new routing protocol for WMN, based on good results of a proactive and reactive routing protocol, and for that reason it can be classified as a hybrid routing protocol. The proposed solution should avoid flooding and creating the new routing metric. We suggest the use of artificial logic—i.e., neural networks (NNs). This protocol is based on mobile agent technologies controlled by a Hopfield neural network. In addition to this, our new routing metric is based on multicriteria optimization in order to minimize delay and blocking probability (rejected packets or their retransmission). The routing protocol observes real network parameters and real network environments. As a result of artificial logic intelligence, the proposed routing protocol should maximize usage of network resources and optimize network performance. PMID:22969360

  9. 7 CFR 58.733 - Quality control tests.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Quality control tests. 58.733 Section 58.733... Procedures § 58.733 Quality control tests. (a) Chemical analyses. The following chemical analyses shall be... pasteurization by means of the phosphatase test, as well as any other tests necessary to assure good quality...

  10. 7 CFR 58.733 - Quality control tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Quality control tests. 58.733 Section 58.733... Procedures § 58.733 Quality control tests. (a) Chemical analyses. The following chemical analyses shall be... pasteurization by means of the phosphatase test, as well as any other tests necessary to assure good quality...

  11. SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

    PubMed

    Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

    2015-12-01

    The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

  12. SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

    PubMed Central

    Chan, An-Wen; Tetzlaff, Jennifer M.; Altman, Douglas G.; Laupacis, Andreas; Gøtzsche, Peter C.; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A.; Doré, Caroline J.; Parulekar, Wendy R.; Summerskill, William S.M.; Groves, Trish; Schulz, Kenneth F.; Sox, Harold C.; Rockhold, Frank W.; Rennie, Drummond; Moher, David

    2016-01-01

    The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders. PMID:23295957

  13. SPIRIT 2013 statement: defining standard protocol items for clinical trials.

    PubMed

    Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Doré, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

    2013-02-05

    The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

  14. Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial

    PubMed Central

    Cai, Yiyi; Ouyang, Wenwei; Li, Jianmin; Nong, Wenheng; Zhang, Anthony Lin

    2018-01-01

    Introduction Spasticity is a common complication of stroke. Current therapies for poststroke spasticity (PSS) have been reported to be associated with high costs, lack of long-term benefit and unwanted adverse events (AEs). Electroacupuncture (EA) has been used for PSS, however, its efficacy and safety is yet to be confirmed by high-quality clinical studies. This study is designed to evaluate the add-on effects and safety profile of EA when used in combination with usual care (UC). Methods and analysis This study is a parallel group randomised controlled trial. A total of 136 participants will be included and randomly assigned to either the treatment group (EA plus UC) or the control group (UC alone). Prior to the main trial, a pilot study involving 30 participants will be conducted to assess the feasibility of the trial protocol. EA will be administered by registered acupuncturists for 20min to 30 min, three times per week for 4 weeks. The primary outcome measure (Modified Ashworth Scale) and secondary outcome measures (Fugl-Meyer Assessment and Barthel Index) will be evaluated at baseline, the end of treatment (week 4) and the end of follow-up (week 8). AEs will be monitored, recorded and reported, and their causality will be explored. Ethics and dissemination Ethics approval was obtained from the ethics committees of Guangdong Provincial Hospital of Chinese Medicine and RMIT University in December 2016. The results will be disseminated in a peer-reviewed journal, and PhD theses and might be presented at international conferences. Trial registration number ChiCTR-IOR-16010283; Pre-results. PMID:29487073

  15. Quality-control design for surface-water sampling in the National Water-Quality Network

    USGS Publications Warehouse

    Riskin, Melissa L.; Reutter, David C.; Martin, Jeffrey D.; Mueller, David K.

    2018-04-10

    The data-quality objectives for samples collected at surface-water sites in the National Water-Quality Network include estimating the extent to which contamination, matrix effects, and measurement variability affect interpretation of environmental conditions. Quality-control samples provide insight into how well the samples collected at surface-water sites represent the true environmental conditions. Quality-control samples used in this program include field blanks, replicates, and field matrix spikes. This report describes the design for collection of these quality-control samples and the data management needed to properly identify these samples in the U.S. Geological Survey’s national database.

  16. Advanced strategies for quality control of Chinese medicines.

    PubMed

    Zhao, Jing; Ma, Shuang-Cheng; Li, Shao-Ping

    2018-01-05

    Quality control is always the critical issue for Chinese medicines (CMs) with their worldwide increasing use. Different from western medicine, CMs are usually considered that multiple constituents are responsible for the therapeutic effects. Therefore, quality control of CMs is a challenge. In 2011, the strategies for quantification, related to the markers, reference compounds and approaches, in quality control of CMs were reviewed (Li, et al., J. Pharm. Biomed. Anal., 2011, 55, 802-809). Since then, some new strategies have been proposed in these fields. Therefore, the review on the strategies for quality control of CMs should be updated to improve the safety and efficacy of CMs. Herein, novel strategies related to quality marker discovery, reference compound development and advanced approaches (focused on glyco-analysis) for quality control, during 2011-2016, were summarized and discussed. Copyright © 2017 Elsevier B.V. All rights reserved.

  17. STANDARD MEASUREMENT PROTOCOLS - FLORIDA RADON RESEARCH PROGRAM

    EPA Science Inventory

    The manual, in support of the Florida Radon Research Program, contains standard protocols for key measurements where data quality is vital to the program. t contains two sections. he first section, soil measurements, contains field sampling protocols for soil gas permeability and...

  18. 30 CFR 28.30 - Quality control plans; filing requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Quality control plans; filing requirements. 28... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.30 Quality control plans; filing... part, each applicant shall file with MSHA a proposed quality control plan which shall be designed to...

  19. 30 CFR 28.30 - Quality control plans; filing requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality control plans; filing requirements. 28... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.30 Quality control plans; filing... part, each applicant shall file with MSHA a proposed quality control plan which shall be designed to...

  20. 30 CFR 28.30 - Quality control plans; filing requirements.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.30 Quality control plans; filing... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Quality control plans; filing requirements. 28... part, each applicant shall file with MSHA a proposed quality control plan which shall be designed to...

  1. 30 CFR 28.30 - Quality control plans; filing requirements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.30 Quality control plans; filing... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Quality control plans; filing requirements. 28... part, each applicant shall file with MSHA a proposed quality control plan which shall be designed to...

  2. 30 CFR 28.30 - Quality control plans; filing requirements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... PROTECTION FOR TRAILING CABLES IN COAL MINES Quality Control § 28.30 Quality control plans; filing... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality control plans; filing requirements. 28... part, each applicant shall file with MSHA a proposed quality control plan which shall be designed to...

  3. 21 CFR 864.8625 - Hematology quality control mixture.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hematology quality control mixture. 864.8625 Section 864.8625 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... quality control mixture. (a) Identification. A hematology quality control mixture is a device used to...

  4. Quality assurance and quality control in mammography: a review of available guidance worldwide.

    PubMed

    Reis, Cláudia; Pascoal, Ana; Sakellaris, Taxiarchis; Koutalonis, Manthos

    2013-10-01

    Review available guidance for quality assurance (QA) in mammography and discuss its contribution to harmonise practices worldwide. Literature search was performed on different sources to identify guidance documents for QA in mammography available worldwide in international bodies, healthcare providers, professional/scientific associations. The guidance documents identified were reviewed and a selection was compared for type of guidance (clinical/technical), technology and proposed QA methodologies focusing on dose and image quality (IQ) performance assessment. Fourteen protocols (targeted at conventional and digital mammography) were reviewed. All included recommendations for testing acquisition, processing and display systems associated with mammographic equipment. All guidance reviewed highlighted the importance of dose assessment and testing the Automatic Exposure Control (AEC) system. Recommended tests for assessment of IQ showed variations in the proposed methodologies. Recommended testing focused on assessment of low-contrast detection, spatial resolution and noise. QC of image display is recommended following the American Association of Physicists in Medicine guidelines. The existing QA guidance for mammography is derived from key documents (American College of Radiology and European Union guidelines) and proposes similar tests despite the variations in detail and methodologies. Studies reported on QA data should provide detail on experimental technique to allow robust data comparison. Countries aiming to implement a mammography/QA program may select/prioritise the tests depending on available technology and resources. •An effective QA program should be practical to implement in a clinical setting. •QA should address the various stages of the imaging chain: acquisition, processing and display. •AEC system QC testing is simple to implement and provides information on equipment performance.

  5. Barriers and enablers to implementing clinical treatment protocols for fever, hyperglycaemia, and swallowing dysfunction in the Quality in Acute Stroke Care (QASC) Project--a mixed methods study.

    PubMed

    Dale, Simeon; Levi, Christopher; Ward, Jeanette; Grimshaw, Jeremy M; Jammali-Blasi, Asmara; D'Este, Catherine; Griffiths, Rhonda; Quinn, Clare; Evans, Malcolm; Cadilhac, Dominique; Cheung, N Wah; Middleton, Sandy

    2015-02-01

    The Quality in Acute Stroke Care (QASC) trial evaluated systematic implementation of clinical treatment protocols to manage fever, sugar, and swallow (FeSS protocols) in acute stroke care. This cluster-randomised controlled trial was conducted in 19 stroke units in Australia. To describe perceived barriers and enablers preimplementation to the introduction of the FeSS protocols and, postimplementation, to determine which of these barriers eventuated as actual barriers. Preimplementation: Workshops were held at the intervention stroke units (n = 10). The first workshop involved senior clinicians who identified perceived barriers and enablers to implementation of the protocols, the second workshop involved bedside clinicians. Postimplementation, an online survey with stroke champions from intervention sites was conducted. A total of 111 clinicians attended the preimplementation workshops, identifying 22 barriers covering four main themes: (a) need for new policies, (b) limited workforce (capacity), (c) lack of equipment, and (d) education and logistics of training staff. Preimplementation enablers identified were: support by clinical champions, medical staff, nursing management and allied health staff; easy adaptation of current protocols, care-plans, and local policies; and presence of specialist stroke unit staff. Postimplementation, only five of the 22 barriers identified preimplementation were reported as actual barriers to adoption of the FeSS protocols, namely, no previous use of insulin infusions; hyperglycaemic protocols could not be commenced without written orders; medical staff reluctance to use the ASSIST swallowing screening tool; poor level of engagement of medical staff; and doctors' unawareness of the trial. The process of identifying barriers and enablers preimplementation allowed staff to take ownership and to address barriers and plan for change. As only five of the 22 barriers identified preimplementation were reported to be actual barriers at

  6. An audit of a hospital-based Doppler ultrasound quality control protocol using a commercial string Doppler phantom.

    PubMed

    Cournane, S; Fagan, A J; Browne, J E

    2014-05-01

    Results from a four-year audit of a Doppler quality assurance (QA) program using a commercially available Doppler string phantom are presented. The suitability of the phantom was firstly determined and modifications were made to improve the reliability and quality of the measurements. QA of Doppler ultrasound equipment is very important as data obtained from these systems is used in patient management. It was found that if the braided-silk filament of the Doppler phantom was exchanged with an O-ring rubber filament and the velocity range below 50 cm/s was avoided for Doppler quality control (QC) measurements, then the maximum velocity accuracy (MVA) error and intrinsic spectral broadening (ISB) results obtained using this device had a repeatability of 18 ± 3.3% and 19 ± 3.5%, respectively. A consistent overestimation of the MVA of between 12% and 56% was found for each of the tested ultrasound systems. Of more concern was the variation of the overestimation within each respective transducer category: MVA errors of the linear, curvilinear and phased array probes were in the range 12.3-20.8%, 32.3-53.8% and 27-40.7%, respectively. There is a dearth of QA data for Doppler ultrasound; it would be beneficial if a multicentre longitudinal study was carried out using the same Doppler ultrasound test object to evaluate sensitivity to deterioration in performance measurements. Copyright © 2013 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

  7. Cellular Strategies of Protein Quality Control

    PubMed Central

    Chen, Bryan; Retzlaff, Marco; Roos, Thomas; Frydman, Judith

    2011-01-01

    Eukaryotic cells must contend with a continuous stream of misfolded proteins that compromise the cellular protein homeostasis balance and jeopardize cell viability. An elaborate network of molecular chaperones and protein degradation factors continually monitor and maintain the integrity of the proteome. Cellular protein quality control relies on three distinct yet interconnected strategies whereby misfolded proteins can either be refolded, degraded, or delivered to distinct quality control compartments that sequester potentially harmful misfolded species. Molecular chaperones play a critical role in determining the fate of misfolded proteins in the cell. Here, we discuss the spatial and temporal organization of cellular quality control strategies and their implications for human diseases linked to protein misfolding and aggregation. PMID:21746797

  8. 21 CFR 211.22 - Responsibilities of quality control unit.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Responsibilities of quality control unit. 211.22... Personnel § 211.22 Responsibilities of quality control unit. (a) There shall be a quality control unit that... have been fully investigated. The quality control unit shall be responsible for approving or rejecting...

  9. 21 CFR 211.22 - Responsibilities of quality control unit.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Responsibilities of quality control unit. 211.22... Personnel § 211.22 Responsibilities of quality control unit. (a) There shall be a quality control unit that... have been fully investigated. The quality control unit shall be responsible for approving or rejecting...

  10. 40 CFR 81.112 - Charleston Intrastate Air Quality Control Region.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Quality Control Regions § 81.112 Charleston Intrastate Air Quality Control Region. The Charleston Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... Quality Control Region: Region 1. 81.107Greenwood Intrastate Air Quality Control Region: Region 2. 81...

  11. 40 CFR 81.112 - Charleston Intrastate Air Quality Control Region.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Quality Control Regions § 81.112 Charleston Intrastate Air Quality Control Region. The Charleston Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... Quality Control Region: Region 1. 81.107Greenwood Intrastate Air Quality Control Region: Region 2. 81...

  12. Internet Protocol Transition Workbook

    DTIC Science & Technology

    1982-03-01

    U N C-* INTERNET PROTOCOL TRANSITION WORKBOOK March 1982 Network Information Canter SRI International Menlo Park, CA 94025 t tv l...Feinler Network Information Center SRI International Menlo Park. California 94025 (415) 859-3695 FEINLEROSRI-NIC (Online mail) [Page ii] I.7 Internet ...31 Postel. J., " Internet Control Message Protocol - DARPA Internet Program Protocol Specification." RFC 792, USC/ Information Sciences Institute

  13. 7 CFR 275.21 - Quality control review reports.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 4 2011-01-01 2011-01-01 false Quality control review reports. 275.21 Section 275.21... Reporting on Program Performance § 275.21 Quality control review reports. (a) General. Each State agency shall submit reports on the performance of quality control reviews in accordance with the requirements...

  14. Land-based versus aquatic resistance therapeutic exercises for older women with sarcopenic obesity: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Sarcopenic obesity is a health condition that combines excess adipose tissue and loss of muscle mass and strength. Sarcopenic obesity predisposes to more functional disabilities than obesity or sarcopenia alone. Progressive resistance exercises are recommended for older people as a potential treatment for sarcopenia and also for obesity. However, there is a lack of evidence indicating which programmes are best applied to older people, and no studies have investigated their effects on sarcopenic obese people. The aims of this protocol study are to investigate and compare the efficacy of land-based and aquatic resistance exercise programmes on improving muscle performance, functional capacity and quality of life of older women with sarcopenic obesity. Methods/Design This is a protocol study for a parallel randomised controlled clinical trial. Eligible participants are older women (≥65 years) with a body mass index ≥30 kg/m 2 and hand grip strength ≤21 kg force. A total sample of 36 participants will be randomly allocated to one of the intervention groups in blocks of three: land-based, aquatic or control. Each intervention group will undergo 2-week sessions of a 10-week therapeutic exercise programme for strength, power and endurance training of the lower-limb muscles. Participants in the control group will not participate in any strengthening activity for lower limbs and will receive telephone calls once a week. Baseline and final evaluation of outcomes will encompass muscle performance of the lower limbs assessed by an isokinetic dynamometer; functional tests of usual walking speed, maximal walking speed (shuttle walking test), stair speed and the Short Physical Performance Battery; and health-related quality of life (Medical Outcomes Study Short Form Questionnaire – SF-36). Data collectors will be blinded to randomisation and will not be in touch with participants during the interventions. Discussion This study is the first randomised controlled

  15. Effect of a preoperative protocol of aerobic physical therapy on the quality of life of patients with adolescent idiopathic scoliosis: a randomized clinical study.

    PubMed

    dos Santos Alves, Vera Lucia; Alves da Silva, Renato Jose Azevedo Leite; Avanzi, Osmar

    2014-06-01

    Patients with adolescent idiopathic scoliosis (AIS) have lower potential for physical activity because of lung dysfunction and lower muscle strength, which can be reversed by the cardiorespiratory and musculoskeletal conditioning provided by standardized physical activities. We conducted a study to determine if a preoperative protocol of aerobic exercise would improve quality of life (QoL) both before and after training and if there would be any differences between patients who received the therapy and those who did not. Patients with the indication of surgical correction of AIS were randomized to receive or not receive a 4-month preoperative course of aerobic physical training. At baseline and after 4 months, they were evaluated with the Short Form-36 questionnaire (SF-36). QoL scores improved for the study group but did not change for the control group. In all QoL domains, the study group's mean score increased significantly between baseline and 4 months. We concluded that the proposed preoperative physical therapy protocol improved the QoL of patients with AIS.

  16. Data exploration, quality control and statistical analysis of ChIP-exo/nexus experiments.

    PubMed

    Welch, Rene; Chung, Dongjun; Grass, Jeffrey; Landick, Robert; Keles, Sündüz

    2017-09-06

    ChIP-exo/nexus experiments rely on innovative modifications of the commonly used ChIP-seq protocol for high resolution mapping of transcription factor binding sites. Although many aspects of the ChIP-exo data analysis are similar to those of ChIP-seq, these high throughput experiments pose a number of unique quality control and analysis challenges. We develop a novel statistical quality control pipeline and accompanying R/Bioconductor package, ChIPexoQual, to enable exploration and analysis of ChIP-exo and related experiments. ChIPexoQual evaluates a number of key issues including strand imbalance, library complexity, and signal enrichment of data. Assessment of these features are facilitated through diagnostic plots and summary statistics computed over regions of the genome with varying levels of coverage. We evaluated our QC pipeline with both large collections of public ChIP-exo/nexus data and multiple, new ChIP-exo datasets from Escherichia coli. ChIPexoQual analysis of these datasets resulted in guidelines for using these QC metrics across a wide range of sequencing depths and provided further insights for modelling ChIP-exo data. © The Author(s) 2017. Published by Oxford University Press on behalf of Nucleic Acids Research.

  17. 40 CFR 81.88 - Billings Intrastate Air Quality Control Region.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Quality Control Regions § 81.88 Billings Intrastate Air Quality Control Region. The Metropolitan Billings Intrastate Air Quality Control Region (Montana) has been renamed the Billings Intrastate Air Quality Control... to by Montana authorities as follows: Sec. 481.168Great Falls Intrastate Air Quality Control Region...

  18. 40 CFR 81.88 - Billings Intrastate Air Quality Control Region.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Quality Control Regions § 81.88 Billings Intrastate Air Quality Control Region. The Metropolitan Billings Intrastate Air Quality Control Region (Montana) has been renamed the Billings Intrastate Air Quality Control... to by Montana authorities as follows: Sec. 481.168Great Falls Intrastate Air Quality Control Region...

  19. Effect of Rebound Exercises and Circuit Training on Complications Associated with Type 2 Diabetes: Protocol for a Randomized Controlled Trial.

    PubMed

    Kaka, Bashir; Maharaj, Sonill Sooknunan

    2018-05-07

    such as exercise and dietary and lifestyle modifications exist for the control of type 2 diabetes, they are mostly applied for the control of glucose level. No strategies have been identified for the control of complications associated with diabetes such as musculoskeletal pain, depression, and reduction in quality of life. Clinicaltrials.gov NCT03200795; https://clinicaltrials.gov/ct2/show/NCT03200795 (Archived by WebCite at http://www.webcitation.org/6mBgcj6z7). ©Bashir Kaka, Sonill Sooknunan Maharaj. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.05.2018.

  20. A multi-level system quality improvement intervention to reduce racial disparities in hypertension care and control: study protocol

    PubMed Central

    2013-01-01

    Background Racial disparities in blood pressure control have been well documented in the United States. Research suggests that many factors contribute to this disparity, including barriers to care at patient, clinician, healthcare system, and community levels. To date, few interventions aimed at reducing hypertension disparities have addressed factors at all of these levels. This paper describes the design of Project ReD CHiP (Reducing Disparities and Controlling Hypertension in Primary Care), a multi-level system quality improvement project. By intervening on multiple levels, this project aims to reduce disparities in blood pressure control and improve guideline concordant hypertension care. Methods Using a pragmatic trial design, we are implementing three complementary multi-level interventions designed to improve blood pressure measurement, provide patient care management services and offer expanded provider education resources in six primary care clinics in Baltimore, Maryland. We are staggering the introduction of the interventions and will use Statistical Process Control (SPC) charting to determine if there are changes in outcomes at each clinic after implementation of each intervention. The main hypothesis is that each intervention will have an additive effect on improvements in guideline concordant care and reductions in hypertension disparities, but the combination of all three interventions will result in the greatest impact, followed by blood pressure measurement with care management support, blood pressure measurement with provider education, and blood pressure measurement only. This study also examines how organizational functioning and cultural competence affect the success of the interventions. Discussion As a quality improvement project, Project ReD CHiP employs a novel study design that specifically targets multi-level factors known to contribute to hypertension disparities. To facilitate its implementation and improve its sustainability, we have

  1. The German Quality Network Sepsis: study protocol for the evaluation of a quality collaborative on decreasing sepsis-related mortality in a quasi-experimental difference-in-differences design.

    PubMed

    Schwarzkopf, Daniel; Rüddel, Hendrik; Gründling, Matthias; Putensen, Christian; Reinhart, Konrad

    2018-01-18

    While sepsis-related mortality decreased substantially in other developed countries, mortality of severe sepsis remained as high as 44% in Germany. A recent German cluster randomized trial was not able to improve guideline adherence and decrease sepsis-related mortality within the participating hospitals, partly based on lacking support by hospital management and lacking resources for documentation of prospective data. Thus, more pragmatic approaches are needed to improve quality of sepsis care in Germany. The primary objective of the study is to decrease sepsis-related hospital mortality within a quality collaborative relying on claims data. The German Quality Network Sepsis (GQNS) is a quality collaborative involving 75 hospitals. This study protocol describes the conduction and evaluation of the start-up period of the GQNS running from March 2016 to August 2018. Democratic structures assure participatory action, a study coordination bureau provides central support and resources, and local interdisciplinary quality improvement teams implement changes within the participating hospitals. Quarterly quality reports focusing on risk-adjusted hospital mortality in cases with sepsis based on claims data are provided. Hospitals committed to publish their individual risk-adjusted mortality compared to the German average. A complex risk-model is used to control for differences in patient-related risk factors. Hospitals are encouraged to implement a bundle of interventions, e.g., interdisciplinary case analyses, external peer-reviews, hospital-wide staff education, and implementation of rapid response teams. The effectiveness of the GQNS is evaluated in a quasi-experimental difference-in-differences design by comparing the change of hospital mortality of cases with sepsis with organ dysfunction from a retrospective baseline period (January 2014 to December 2015) and the intervention period (April 2016 to March 2018) between the participating hospitals and all other German

  2. Effects of scapulohumeral rehabilitation protocol on trunk control recovery in patients with subacute stroke: A pilot randomized controlled trial.

    PubMed

    Dell'Uomo, Daniela; Morone, Giovanni; Centrella, Antonio; Paolucci, Stefano; Caltagirone, Carlo; Grasso, Maria Grazia; Traballesi, Marco; Iosa, Marco

    2017-01-01

    Despite upper limb rehabilitation is widely investigated in patients with stroke, the effects of scapulohumeral rehabilitation on trunk stabillization are mainly unknown. To test the effects of scapulohumeral rehabilitation protocol on trunk control recovery in patients with subacute stroke. A pilot randomized controlled trial with two groups of 14 patients each one performing 20 minutes per day, 5 days a week, for 6 weeks in add on to standard therapy. Experimental group performed a specific scapulohumeral rehabilitation protocol aiming to improve trunk competencies whereas control group performed conventional arm rehabilitation. Clinical scale tests and accelerometric evaluations were performed pre- and post-treatment. Experimental groups showed better scores at discharge at Trunk impairment Scale (p < 0.001), Barthel Index (p = 0.024), Trunk Control Test (p = 0.002), Sitting Balance Scale (p = 0.002), but neither at Fugl-Meyer Scale (p = 0.194) nor Modified Ashworth Scale (p = 0.114). Accelerometric analysis showed higher stability of trunk for experimental group especially during static and dynamic items. The recovery of scapulohumeral functions also acts on trunk stabilization post-stroke.

  3. The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer, but randomized controlled trials in surgery are often difficult to conduct. The ROMIO (Randomized Open or Minimally Invasive Oesophagectomy) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer. Methods/Design A pilot randomized controlled trial (RCT), in two centers (University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study. Interventions will include esophagectomy by: (1) open gastric mobilization and right thoracotomy, (2) laparoscopic gastric mobilization and right thoracotomy, and (3) totally minimally invasive surgery (in the Bristol center only). The primary outcomes of the feasibility study will be measures of recruitment, successful development of methods to monitor quality of surgery and fidelity to a surgical protocol, and development of a core outcome set to evaluate esophageal cancer surgery. The study will test patient-reported outcomes measures to assess recovery, methods to blind participants, assessments of surgical morbidity, and methods to capture cost and resource use. ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons, nurses, and patients to provide feedback for recruiting staff. Discussion The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer. Trial registration The pilot trial has Current Controlled Trials registration number ISRCTN59036820(25/02/2013) at http://www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of

  4. 7 CFR 58.141 - Alternate quality control program.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Alternate quality control program. 58.141 Section 58... Service 1 Quality Specifications for Raw Milk § 58.141 Alternate quality control program. When a plant has in operation an acceptable quality program, at the producer level, which is approved by the...

  5. 21 CFR 111.105 - What must quality control personnel do?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What must quality control personnel do? 111.105... for Quality Control § 111.105 What must quality control personnel do? Quality control personnel must... manufacturing record. To do so, quality control personnel must perform operations that include: (a) Approving or...

  6. Theoretical approach to society-wide environmental quality control

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Ayano, K.

    1982-01-01

    The study outlines the basis for a theory of societal control of environmental quality in the US based on the concepts and philosophy of company-wide quality control which has developed in Japan as a cross-disciplinary approach to problem-solving in the industrial realm. The basic concepts are: 1) every member of society, as a producer of environmental products and services for future generations, in principle has the responsibility to control the quality of his output; 2) environment quality is the quality of life, or the fitness of use of environment for humans; and 3) societal control is any activity necessary formore » quality production of environmental products and services continuously or in the long run. A motivator-hygiene theory of environmental quality is identified, and a proposal is made that the policy provision must be formulated differently between those aimed at hygiene factors of environmental quality and those aimed at motivators, the former in a collectivistic manner, the latter as an individual problem. The concept of societal cost of environmental quality is introduced. Based on the motivator-hygiene theory of environmental quality, the collectivistic and individual approaches are differentiated and discussed.« less

  7. Normalization of cortical thickness measurements across different T1 magnetic resonance imaging protocols by novel W-Score standardization.

    PubMed

    Chung, Jinyong; Yoo, Kwangsun; Lee, Peter; Kim, Chan Mi; Roh, Jee Hoon; Park, Ji Eun; Kim, Sang Joon; Seo, Sang Won; Shin, Jeong-Hyeon; Seong, Joon-Kyung; Jeong, Yong

    2017-10-01

    The use of different 3D T1-weighted magnetic resonance (T1 MR) imaging protocols induces image incompatibility across multicenter studies, negating the many advantages of multicenter studies. A few methods have been developed to address this problem, but significant image incompatibility still remains. Thus, we developed a novel and convenient method to improve image compatibility. W-score standardization creates quality reference values by using a healthy group to obtain normalized disease values. We developed a protocol-specific w-score standardization to control the protocol effect, which is applied to each protocol separately. We used three data sets. In dataset 1, brain T1 MR images of normal controls (NC) and patients with Alzheimer's disease (AD) from two centers, acquired with different T1 MR protocols, were used (Protocol 1 and 2, n = 45/group). In dataset 2, data from six subjects, who underwent MRI with two different protocols (Protocol 1 and 2), were used with different repetition times, echo times, and slice thicknesses. In dataset 3, T1 MR images from a large number of healthy normal controls (Protocol 1: n = 148, Protocol 2: n = 343) were collected for w-score standardization. The protocol effect and disease effect on subjects' cortical thickness were analyzed before and after the application of protocol-specific w-score standardization. As expected, different protocols resulted in differing cortical thickness measurements in both NC and AD subjects. Different measurements were obtained for the same subject when imaged with different protocols. Multivariate pattern difference between measurements was observed between the protocols. Classification accuracy between two protocols was nearly 90%. After applying protocol-specific w-score standardization, the differences between the protocols substantially decreased. Most importantly, protocol-specific w-score standardization reduced both univariate and multivariate differences in the images while

  8. Quantum-key-distribution protocol with pseudorandom bases

    NASA Astrophysics Data System (ADS)

    Trushechkin, A. S.; Tregubov, P. A.; Kiktenko, E. O.; Kurochkin, Y. V.; Fedorov, A. K.

    2018-01-01

    Quantum key distribution (QKD) offers a way for establishing information-theoretical secure communications. An important part of QKD technology is a high-quality random number generator for the quantum-state preparation and for post-processing procedures. In this work, we consider a class of prepare-and-measure QKD protocols, utilizing additional pseudorandomness in the preparation of quantum states. We study one of such protocols and analyze its security against the intercept-resend attack. We demonstrate that, for single-photon sources, the considered protocol gives better secret key rates than the BB84 and the asymmetric BB84 protocols. However, the protocol strongly requires single-photon sources.

  9. The effect of an information and communication technology (ICT) on older adults' quality of life: study protocol for a randomized control trial.

    PubMed

    Gustafson, David H; McTavish, Fiona; Gustafson, David H; Mahoney, Jane E; Johnson, Roberta A; Lee, John D; Quanbeck, Andrew; Atwood, Amy K; Isham, Andrew; Veeramani, Raj; Clemson, Lindy; Shah, Dhavan

    2015-04-25

    This study investigates the use of an information and communication technology (Elder Tree) designed for older adults and their informal caregivers to improve older adult quality of life and address challenges older adults face in maintaining their independence (for example, loneliness and isolation, falling, managing medications, driving and transportation). This study, an unblinded randomized controlled trial, will evaluate the effectiveness and cost of Elder Tree. Older adults who are at risk for losing their independence - along with their informal caregivers, if they name them - are randomized to two groups. The intervention group has access to their usual sources of information and communication as well as to Elder Tree for 18 months while the control group uses only their usual sources of information and communication. The primary outcome of the study is older adult quality of life. Secondary outcomes are cost per Quality-Adjusted Life Year and the impact of the technology on independence, loneliness, falls, medication management, driving and transportation, and caregiver appraisal and mastery. We will also examine the mediating effect of self-determination theory. We will evaluate the effectiveness of Elder Tree by comparing intervention- and control-group participants at baseline and months 6, 12, and 18. We will use mixed-effect models to evaluate the primary and secondary outcomes, where pretest score functions as a covariate, treatment condition is a between-subjects factor, and the multivariate outcome reflects scores for a given assessment at the three time points. Separate analyses will be conducted for each outcome. Cost per Quality-Adjusted Life Year will be compared between the intervention and control groups. Additional analyses will examine the mediating effect of self-determination theory on each outcome. Elder Tree is a multifaceted intervention, making it a challenge to assess which services or combinations of services account for outcomes in

  10. Minimizing variance in Care of Pediatric Blunt Solid Organ Injury through Utilization of a hemodynamic-driven protocol: a multi-institution study.

    PubMed

    Cunningham, Aaron J; Lofberg, Katrine M; Krishnaswami, Sanjay; Butler, Marilyn W; Azarow, Kenneth S; Hamilton, Nicholas A; Fialkowski, Elizabeth A; Bilyeu, Pamela; Ohm, Erika; Burns, Erin C; Hendrickson, Margo; Krishnan, Preetha; Gingalewski, Cynthia; Jafri, Mubeen A

    2017-12-01

    An expedited recovery protocol for management of pediatric blunt solid organ injury (spleen, liver, and kidney) was instituted across two Level 1 Trauma Centers, managed by nine pediatric surgeons within three hospital systems. Data were collected for 18months on consecutive patients after protocol implementation. Patient demographics (including grade of injury), surgeon compliance, National Surgical Quality Improvement Program (NSQIP) complications, direct hospital cost, length of stay, time in the ICU, phlebotomy, and re-admission were compared to an 18-month control period immediately preceding study initiation. A total of 106 patients were treated (control=55, protocol=51). Demographics were similar among groups, and compliance was 78%. Hospital stay (4.6 vs. 3.5days, p=0.04), ICU stay (1.9 vs. 1.0days, p=0.02), and total phlebotomy (7.7 vs. 5.3 draws, p=0.007) were significantly less in the protocol group. A decrease in direct hospital costs was also observed ($11,965 vs. $8795, p=0.09). Complication rates (1.8% vs. 3.9%, p=0.86, no deaths) were similar. An expedited, hemodynamic-driven, pediatric solid organ injury protocol is achievable across hospital systems and surgeons. Through implementation we maintained quality while impacting length of stay, ICU utilization, phlebotomy, and cost. Future protocols should work to further limit resource utilization. Retrospective cohort study. Level II. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. Validation of the Tensoval Duo Control II blood pressure monitor for clinic use and self-measurement according to the British Hypertension Society protocol and the European Society of Hypertension International Protocol Revision 2010.

    PubMed

    de Greeff, Annemarie; Shennan, Andrew H

    2013-06-01

    The Tensoval Duo Control II is an automated upper arm device that uses a combination of oscillometric and auscultatory technology to determine blood pressure noninvasively. The accuracy of this device was assessed according to the British Hypertension Society (BHS) protocol and the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) in an adult population. Ethical approval was obtained. Eighty-five and 33 adult individuals, respectively, were recruited to fulfil the requirements of each protocol. Trained observers took nine sequential same-arm measurements alternating between a mercury sphygmomanometer and the device. The device had to achieve at least a B grade for both systolic and diastolic pressures to pass the BHS protocol and had to fulfil the criteria of all three phases of the ESH-IP2 protocol to receive recommendation. The device achieved an A/A grading for the BHS protocol and passed all three phases of the ESH-IP2 protocol. The mean difference±SD for the BHS/ESH protocols, respectively, was -1.8±6.5/-0.7±5.7 mmHg for systolic pressure and 1.9±5.1/2.4±4.5 mmHg for diastolic pressure. The device maintained its A/A grading throughout the low-pressure, medium-pressure and high-pressure ranges. The Tensoval Duo Control II device is recommended for clinical and home use according to both the BHS and the ESH-IP2 standard.

  12. RITPBC: B-cell depleting therapy (rituximab) as a treatment for fatigue in primary biliary cirrhosis: study protocol for a randomised controlled trial

    PubMed Central

    Jopson, Laura; Newton, Julia L; Palmer, Jeremy; Floudas, Achilleas; Isaacs, John; Qian, Jessica; Wilkinson, Jennifer; Trenell, Mike; Blamire, Andrew; Howel, Denise; Jones, David E

    2015-01-01

    Introduction Primary biliary cirrhosis (PBC) is an autoimmune liver disease with approximately 50% of patients experiencing fatigue. This can be a particularly debilitating symptom, affecting quality of life and resulting in social isolation. Fatigue is highlighted by patients as a priority for research and patient support groups were involved in designing this trial. This is the first randomised controlled trial to investigate a treatment for fatigue in PBC. The trial protocol is innovative as it utilises novel magnetic resonance spectroscopy (MRS) techniques as an outcome measure. The protocol will be valuable to research groups planning clinical trials targeting fatigue in PBC and also transferrable to other conditions associated with fatigue. Methods and analysis RITPBC is a Medical Research Council (MRC) and National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation Programme (EME)-funded project. It is a phase II, single-centre, randomised controlled, double-blinded trial comparing rituximab with placebo in fatigued PBC patients. 78 patients with PBC and moderate to severe fatigue will be randomised to receive two infusions of rituximab or placebo. The study aims to assess whether rituximab improves fatigue in patients with PBC, the safety, and tolerability of rituximab in PBC and the sustainability of any beneficial actions. The primary outcome will be an improvement in fatigue domain score of the PBC-40, a disease-specific quality of life measure, evaluated at 12-week assessment. Secondary outcome measures include novel MRS techniques assessing muscle bioenergetic function, physical activity, anaerobic threshold and symptom, and quality of life measures. The trial started recruiting in October 2012 and recruitment is ongoing. Ethics and dissemination The trial has ethical approval from the NRES Committee North East, has Clinical Trial Authorisation from MHRA and local R&D approval. Trial results will be communicated to participants

  13. RITPBC: B-cell depleting therapy (rituximab) as a treatment for fatigue in primary biliary cirrhosis: study protocol for a randomised controlled trial.

    PubMed

    Jopson, Laura; Newton, Julia L; Palmer, Jeremy; Floudas, Achilleas; Isaacs, John; Qian, Jessica; Wilkinson, Jennifer; Trenell, Mike; Blamire, Andrew; Howel, Denise; Jones, David E

    2015-08-20

    Primary biliary cirrhosis (PBC) is an autoimmune liver disease with approximately 50% of patients experiencing fatigue. This can be a particularly debilitating symptom, affecting quality of life and resulting in social isolation. Fatigue is highlighted by patients as a priority for research and patient support groups were involved in designing this trial. This is the first randomised controlled trial to investigate a treatment for fatigue in PBC. The trial protocol is innovative as it utilises novel magnetic resonance spectroscopy (MRS) techniques as an outcome measure. The protocol will be valuable to research groups planning clinical trials targeting fatigue in PBC and also transferrable to other conditions associated with fatigue. RITPBC is a Medical Research Council (MRC) and National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation Programme (EME)-funded project. It is a phase II, single-centre, randomised controlled, double-blinded trial comparing rituximab with placebo in fatigued PBC patients. 78 patients with PBC and moderate to severe fatigue will be randomised to receive two infusions of rituximab or placebo. The study aims to assess whether rituximab improves fatigue in patients with PBC, the safety, and tolerability of rituximab in PBC and the sustainability of any beneficial actions. The primary outcome will be an improvement in fatigue domain score of the PBC-40, a disease-specific quality of life measure, evaluated at 12-week assessment. Secondary outcome measures include novel MRS techniques assessing muscle bioenergetic function, physical activity, anaerobic threshold and symptom, and quality of life measures. The trial started recruiting in October 2012 and recruitment is ongoing. The trial has ethical approval from the NRES Committee North East, has Clinical Trial Authorisation from MHRA and local R&D approval. Trial results will be communicated to participants, presented at national and international meetings and published

  14. Quality Control in Higher Education.

    ERIC Educational Resources Information Center

    Hogarth, Charles P.

    The status of quality control in U.S. higher education is discussed with an overview of the functions and structure of public and private colleges and universities. The book is divided into seven chapters: (1) outside controls (accrediting groups, governmental groups and other groups); (2) structure (board of control, president, organization); (3)…

  15. Evaluation of Quality Assessment Protocols for High Throughput Genome Resequencing Data

    PubMed Central

    Chiara, Matteo; Pavesi, Giulio

    2017-01-01

    Large-scale initiatives aiming to recover the complete sequence of thousands of human genomes are currently being undertaken worldwide, concurring to the generation of a comprehensive catalog of human genetic variation. The ultimate and most ambitious goal of human population scale genomics is the characterization of the so-called human “variome,” through the identification of causal mutations or haplotypes. Several research institutions worldwide currently use genotyping assays based on Next-Generation Sequencing (NGS) for diagnostics and clinical screenings, and the widespread application of such technologies promises major revolutions in medical science. Bioinformatic analysis of human resequencing data is one of the main factors limiting the effectiveness and general applicability of NGS for clinical studies. The requirement for multiple tools, to be combined in dedicated protocols in order to accommodate different types of data (gene panels, exomes, or whole genomes) and the high variability of the data makes difficult the establishment of a ultimate strategy of general use. While there already exist several studies comparing sensitivity and accuracy of bioinformatic pipelines for the identification of single nucleotide variants from resequencing data, little is known about the impact of quality assessment and reads pre-processing strategies. In this work we discuss major strengths and limitations of the various genome resequencing protocols are currently used in molecular diagnostics and for the discovery of novel disease-causing mutations. By taking advantage of publicly available data we devise and suggest a series of best practices for the pre-processing of the data that consistently improve the outcome of genotyping with minimal impacts on computational costs. PMID:28736571

  16. PUREAIR protocol: randomized controlled trial of intensive pulmonary rehabilitation versus standard care in patients undergoing surgical resection for lung cancer.

    PubMed

    Fugazzaro, Stefania; Costi, Stefania; Mainini, Carlotta; Kopliku, Besa; Rapicetta, Cristian; Piro, Roberto; Bardelli, Roberta; Rebelo, Patricia Filipa Sobral; Galeone, Carla; Sgarbi, Giorgio; Lococo, Filippo; Paci, Massimiliano; Ricchetti, Tommaso; Cavuto, Silvio; Merlo, Domenico Franco; Tenconi, Sara

    2017-07-31

    Non-small cell lung cancer is the most common type of lung cancer. Surgery is proven to be the most effective treatment in early stages, despite its potential impact on quality of life. Pulmonary rehabilitation, either before or after surgery, is associated with reduced morbidity related symptoms and improved exercise capacity, lung function and quality of life. We describe the study protocol for the open-label randomized controlled trial we are conducting on patients affected by primary lung cancer (stages I-II) eligible for surgical treatment. The control group receives standard care consisting in one educational session before surgery and early inpatient postoperative physiotherapy. The treatment group receives, in addition to standard care, intensive rehabilitation involving 14 preoperative sessions (6 outpatient and 8 home-based) and 39 postoperative sessions (15 outpatient and 24 home-based) with aerobic, resistance and respiratory training, as well as scar massage and group bodyweight exercise training. Assessments are performed at baseline, the day before surgery and one month and six months after surgery. The main outcome is the long-term exercise capacity measured with the Six-Minute Walk Test; short-term exercise capacity, lung function, postoperative morbidity, length of hospital stay, quality of life (Short Form 12), mood disturbances (Hospital Anxiety and Depression Scale) and pain (Numeric Rating Scale) are also recorded and analysed. Patient compliance and treatment-related side effects are also collected. Statistical analyses will be performed according to the intention-to-treat approach. T-test for independent samples will be used for continuous variables after assessment of normality of distribution. Chi-square test will be used for categorical variables. Expecting a 10% dropout rate, assuming α of 5% and power of 80%, we planned to enrol 140 patients to demonstrate a statistically significant difference of 25 m at Six-Minute Walk Test

  17. Quality Control Technician.

    ERIC Educational Resources Information Center

    Ohio State Univ., Columbus. Center on Education and Training for Employment.

    This document contains 18 units to consider for use in a tech prep competency profile for the occupation of quality control technician. All the units listed will not necessarily apply to every situation or tech prep consortium, nor will all the competencies within each unit be appropriate. Several units appear within each specific occupation and…

  18. Controlled quantum secure communication protocol with single photons in both polarization and spatial-mode degrees of freedom

    NASA Astrophysics Data System (ADS)

    Wang, Lili; Ma, Wenping

    2016-02-01

    In this paper, we propose a new controlled quantum secure direct communication (CQSDC) protocol with single photons in both polarization and spatial-mode degrees of freedom. Based on the defined local collective unitary operations, the sender’s secret messages can be transmitted directly to the receiver through encoding secret messages on the particles. Only with the help of the third side, the receiver can reconstruct the secret messages. Each single photon in two degrees of freedom can carry two bits of information, so the cost of our protocol is less than others using entangled qubits. Moreover, the security of our QSDC network protocol is discussed comprehensively. It is shown that our new CQSDC protocol cannot only defend the outsider eavesdroppers’ several sorts of attacks but also the inside attacks. Besides, our protocol is feasible since the preparation and the measurement of single photon quantum states in both the polarization and the spatial-mode degrees of freedom are available with current quantum techniques.

  19. 40 CFR 81.77 - Puerto Rico Air Quality Control Region.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Puerto Rico Air Quality Control Region... PROGRAMS (CONTINUED) DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES Designation of Air Quality Control Regions § 81.77 Puerto Rico Air Quality Control Region. The Puerto Rico Air Quality Control Region...

  20. 40 CFR 81.77 - Puerto Rico Air Quality Control Region.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Puerto Rico Air Quality Control Region... PROGRAMS (CONTINUED) DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES Designation of Air Quality Control Regions § 81.77 Puerto Rico Air Quality Control Region. The Puerto Rico Air Quality Control Region...

  1. 40 CFR 81.77 - Puerto Rico Air Quality Control Region.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 18 2012-07-01 2012-07-01 false Puerto Rico Air Quality Control Region... PROGRAMS (CONTINUED) DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES Designation of Air Quality Control Regions § 81.77 Puerto Rico Air Quality Control Region. The Puerto Rico Air Quality Control Region...

  2. 40 CFR 81.77 - Puerto Rico Air Quality Control Region.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 18 2013-07-01 2013-07-01 false Puerto Rico Air Quality Control Region... PROGRAMS (CONTINUED) DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES Designation of Air Quality Control Regions § 81.77 Puerto Rico Air Quality Control Region. The Puerto Rico Air Quality Control Region...

  3. SU-E-P-49: Evaluation of Image Quality and Radiation Dose of Various Unenhanced Head CT Protocols

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Chen, L; Khan, M; Alapati, K

    2015-06-15

    Purpose: To evaluate the diagnostic value of various unenhanced head CT protocols and predicate acceptable radiation dose level for head CT exam. Methods: Our retrospective analysis included 3 groups, 20 patients per group, who underwent clinical routine unenhanced adult head CT examination. All exams were performed axially with 120 kVp. Three protocols, 380 mAs without iterative reconstruction and automAs, 340 mAs with iterative reconstruction without automAs, 340 mAs with iterative reconstruction and automAs, were applied on each group patients respectively. The images were reconstructed with H30, J30 for brain window and H60, J70 for bone window. Images acquired with threemore » protocols were randomized and blindly reviewed by three radiologists. A 5 point scale was used to rate each exam The percentage of exam score above 3 and average scores of each protocol were calculated for each reviewer and tissue types. Results: For protocols without automAs, the average scores of bone window with iterative reconstruction were higher than those without iterative reconstruction for each reviewer although the radiation dose was 10 percentage lower. 100 percentage exams were scored 3 or higher and the average scores were above 4 for both brain and bone reconstructions. The CTDIvols are 64.4 and 57.8 mGy of 380 and 340 mAs, respectively. With automAs, the radiation dose varied with head size, resulting in 47.5 mGy average CTDIvol between 39.5 and 56.5 mGy. 93 and 98 percentage exams were scored great than 3 for brain and bone windows, respectively. The diagnostic confidence level and image quality of exams with AutomAs were less than those without AutomAs for each reviewer. Conclusion: According to these results, the mAs was reduced to 300 with automAs OFF for head CT exam. The radiation dose was 20 percentage lower than the original protocol and the CTDIvol was reduced to 51.2 mGy.« less

  4. Population-based cancer survival in the United States: Data, quality control, and statistical methods.

    PubMed

    Allemani, Claudia; Harewood, Rhea; Johnson, Christopher J; Carreira, Helena; Spika, Devon; Bonaventure, Audrey; Ward, Kevin; Weir, Hannah K; Coleman, Michel P

    2017-12-15

    Robust comparisons of population-based cancer survival estimates require tight adherence to the study protocol, standardized quality control, appropriate life tables of background mortality, and centralized analysis. The CONCORD program established worldwide surveillance of population-based cancer survival in 2015, analyzing individual data on 26 million patients (including 10 million US patients) diagnosed between 1995 and 2009 with 1 of 10 common malignancies. In this Cancer supplement, we analyzed data from 37 state cancer registries that participated in the second cycle of the CONCORD program (CONCORD-2), covering approximately 80% of the US population. Data quality checks were performed in 3 consecutive phases: protocol adherence, exclusions, and editorial checks. One-, 3-, and 5-year age-standardized net survival was estimated using the Pohar Perme estimator and state- and race-specific life tables of all-cause mortality for each year. The cohort approach was adopted for patients diagnosed between 2001 and 2003, and the complete approach for patients diagnosed between 2004 and 2009. Articles in this supplement report population coverage, data quality indicators, and age-standardized 5-year net survival by state, race, and stage at diagnosis. Examples of tables, bar charts, and funnel plots are provided in this article. Population-based cancer survival is a key measure of the overall effectiveness of services in providing equitable health care. The high quality of US cancer registry data, 80% population coverage, and use of an unbiased net survival estimator ensure that the survival trends reported in this supplement are robustly comparable by race and state. The results can be used by policymakers to identify and address inequities in cancer survival in each state and for the United States nationally. Cancer 2017;123:4982-93. Published 2017. This article is a U.S. Government work and is in the public domain in the USA. Published 2017. This article is a U

  5. 21 CFR 111.105 - What must quality control personnel do?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What must quality control personnel do? 111.105..., LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for Quality Control § 111.105 What must quality control personnel do? Quality control personnel must...

  6. [Methodological quality of an article on the treatment of gastric cancer adopted as protocol by some Chilean hospitals].

    PubMed

    Manterola, Carlos; Torres, Rodrigo; Burgos, Luis; Vial, Manuel; Pineda, Viviana

    2006-07-01

    Surgery is a curative treatment for gastric cancer (GC). As relapse is frequent, adjuvant therapies such as postoperative chemo radiotherapy have been tried. In Chile, some hospitals adopted Macdonald's study as a protocol for the treatment of GC. To determine methodological quality and internal and external validity of the Macdonald study. Three instruments were applied that assess methodological quality. A critical appraisal was done and the internal and external validity of the methodological quality was analyzed with two scales: MINCIR (Methodology and Research in Surgery), valid for therapy studies and CONSORT (Consolidated Standards of Reporting Trials), valid for randomized controlled trials (RCT). Guides and scales were applied by 5 researchers with training in clinical epidemiology. The reader's guide verified that the Macdonald study was not directed to answer a clearly defined question. There was random assignment, but the method used is not described and the patients were not considered until the end of the study (36% of the group with surgery plus chemo radiotherapy did not complete treatment). MINCIR scale confirmed a multicentric RCT, not blinded, with an unclear randomized sequence, erroneous sample size estimation, vague objectives and no exclusion criteria. CONSORT system proved the lack of working hypothesis and specific objectives as well as an absence of exclusion criteria and identification of the primary variable, an imprecise estimation of sample size, ambiguities in the randomization process, no blinding, an absence of statistical adjustment and the omission of a subgroup analysis. The instruments applied demonstrated methodological shortcomings that compromise the internal and external validity of the.

  7. [Effect of a multidisciplinar protocol on the clinical results obtained after bariatric surgery].

    PubMed

    Cánovas Gaillemin, B; Sastre Martos, J; Moreno Segura, G; Llamazares Iglesias, O; Familiar Casado, C; Abad de Castro, S; López Pardo, R; Sánchez-Cabezudo Muñoz, M A

    2011-01-01

    Bariatric surgery has been shown to be an effective therapy for weight loss in patients with severe obesity, and the implementation of a multidisciplinar management protocol is recommended. To assess the usefulness of the implementation of a management protocol in obesity surgery based on the Spanish Consensus Document of the SEEDO. Retrospective comparative study of the outcomes in patients previously operated (51 patients) and after the implementation of the protocol (66 patients). The following data were gathered: anthropometry, pre-and post-surgery comorbidities, post-surgical nutritional and surgical complications, validated Quality of Life questionnaire, and dietary habits. Withdrawals (l7.6%) and alcoholism (5.8%) were higher in patients pre- versus post-implementation of the protocol (4.5% vs. 3%, respectively), the differences being statistically significant. The mortality rate was 2% in the pre-protocol group and 0% in the postprotocol group. The dietary habits were better in the post-protocol group, the pre-protocol group presenting a higher percentage of feeding-behavior disorders (5.1%) although not reaching a statistical significance. The improvement in quality of life was higher in the post-protocol group for all items, but only reaching statistical significance in sexual activity (p = 0.004). In the pre-protocol group, 70.5% of the patients had more than one nutritional complication vs. 32.8% in the post-protocol group (p < 0.05). There were no differences regarding the percentage of weight in excess lost at two years (> 50% in 81.3% in the pre-protocol group vs. 74.8% in the pos-protocol group) or the comorbidities. Bariatric surgery achieves excellent outcomes in weight loss, comorbidities, and quality of life, but presents nutritional, surgical, and psychiatric complications that require a protocol-based and multidisciplinary approach. Our protocol improves the outcomes regarding the withdrawal rates, feeding-behavior disorders, dietary habits

  8. Protocol for the evaluation of a quality-based pay for performance scheme in Liberia.

    PubMed

    Bawo, Luke; Leonard, Kenneth L; Mohammed, Rianna

    2015-01-13

    Improving the quality of care at hospitals is a key next step in rebuilding Liberia's health system. In order to improve the efficiency, effectiveness, and quality of care at the secondary hospital level, the country is developing a system to upgrade health worker skills and competencies, and shifting towards improved provider accountability for results, including a Graduate Medical Residency Program (GMRP) and provider accountability for improvements in quality through performance-based financing (PBF) at the hospital level. This document outlines the protocol for the impact evaluation of the hospital improvement program. The evaluation will provide an estimate of the impact of the project and investigate the mechanism for success in a way that can provide general lessons about the quality of health care in low-income countries. The evaluation aims 1) to provide the best possible estimate of program impact and 2) to quantitatively describe the changes that took place within facilities as a result of the program. In particular, the impact evaluation focuses on the changes in human resources within the hospitals. As such, we use a three-period intensive evaluation of treated and matched comparison hospitals to see how services change in treated hospitals as well as a continuous data collection effort to track the activities of individual health workers within treated hospitals. We are particularly interested in understanding how facilities met quality targets. Did they bring in new health workers with higher qualifications? Did they improve the knowledge or competence of their existing staff? Did they improve the availability of medicines and equipment so that the capacities of existing health workers were improved? Did they address the motivation of health workers so that individuals with the same competence and capacity were able to provide higher quality? And, if they did improve quality, did patients notice?

  9. Dry needling in a manual physiotherapy and therapeutic exercise protocol for patients with chronic mechanical shoulder pain of unspecific origin: a protocol for a randomized control trial.

    PubMed

    Tejera-Falcón, Emma; Toledo-Martel, Nuria Del Carmen; Sosa-Medina, Francisco Manuel; Santana-González, Fátima; Quintana-de la Fe, Miriam Del Pino; Gallego-Izquierdo, Tomás; Pecos-Martín, Daniel

    2017-09-18

    Shoulder pain of musculoskeletal origin is the main cause of upper limb pain of non-traumatic origin. Despite being one of the most common reasons for consultation, there is no established protocol for treatment due to the complexity of its etiology. However, it has been shown that the presence of myofascial trigger points on the shoulder muscles is a common condition associated with patients suffering from shoulder pain. This protocol has been created which describes the design of a randomized controlled trial to evaluate the effectiveness of the inclusion of dry needling (DN) within a protocol of manual physiotherapy and therapeutic exercise in the treatment of chronic shoulder pain of unspecific origin. Thirty-six participants aged 18-65 years will be recruited having mechanical chronic shoulder pain on unspecific origin and meeting the inclusion criteria. These will be randomized to one of two interventions, (i) DN, manual physiotherapy and therapeutic exercise or (ii) sham DN, manual physiotherapy and therapeutic exercise. The protocol will cover 6 weeks of treatment, with a 6-month follow-up. Our main outcome measure will be the Visual Analogue Scale for pain. This is the first study to combine the use of DN, manual physiotherapy and an exercise program with a 6-month follow-up, thus becoming a new contribution to the treatment of chronic shoulder pain, while new lines of research may be established to help determine the effects of DN on chronic shoulder pain and the frequency and proper dosage. International Standard Randomized Controlled Trial Number Register: ISRCTN30604244 ( http://www.controlled-trials.com ) 29 June 2016.

  10. Spinal versus general anaesthesia in surgery for inguinodynia (SPINASIA trial): study protocol for a randomised controlled trial.

    PubMed

    Zwaans, Willem A R; le Mair, Léon H P M; Scheltinga, Marc R M; Roumen, Rudi M H

    2017-01-14

    Chronic inguinodynia (groin pain) is a common complication following open inguinal hernia repair or a Pfannenstiel incision but may also be experienced after other types of (groin) surgery. If conservative treatments are to no avail, tailored remedial surgery, including a neurectomy and/or a (partial) meshectomy, may be considered. Retrospective studies in patients with chronic inguinodynia suggested that spinal anaesthesia is superior compared to general anaesthesia in terms of pain relief following remedial operations. This randomised controlled trial is designed to study the effect of type of anaesthesia (spinal or general) on pain relief following remedial surgery for inguinodynia. A total of 190 adult patients who suffer from unacceptable chronic (more than 3 months) inguinodynia, as subjectively judged by the patients themselves, are included. Only patients scheduled to undergo a neurectomy and/or a meshectomy by an open approach are considered for inclusion and randomised to spinal or general anaesthesia. Patients are excluded if pain is attributable to abdominal causes or if any contraindications for either type of anaesthesia are present. Primary outcome is effect of type of anaesthesia on pain relief. Secondary outcomes include patient satisfaction, quality of life, use of analgesics and (in)direct medical costs. Patient follow-up period is one year. The first patient was included in January 2016. The expected trial deadline is December 2019. Potential effects are deemed related to the entire setting of type of anaesthesia. Since any setting is multifactorial, all of these factors may influence the outcome measures. This is the first large randomised controlled trial comparing the two most frequently used anaesthetic techniques in remedial surgery for groin pain. There is a definite need for evidence-based strategies to optimise results of these types of surgery. Besides pain relief, other important patient-related outcome measures are assessed to

  11. A Total Quality-Control Plan with Right-Sized Statistical Quality-Control.

    PubMed

    Westgard, James O

    2017-03-01

    A new Clinical Laboratory Improvement Amendments option for risk-based quality-control (QC) plans became effective in January, 2016. Called an Individualized QC Plan, this option requires the laboratory to perform a risk assessment, develop a QC plan, and implement a QC program to monitor ongoing performance of the QC plan. Difficulties in performing a risk assessment may limit validity of an Individualized QC Plan. A better alternative is to develop a Total QC Plan including a right-sized statistical QC procedure to detect medically important errors. Westgard Sigma Rules provides a simple way to select the right control rules and the right number of control measurements. Copyright © 2016 Elsevier Inc. All rights reserved.

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Li, Nan; Carmona, Ruben; Sirak, Igor

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

  13. Comparison of results of cycles treated with modified mild protocol and short protocol for ovarian stimulation.

    PubMed

    Coelho, F; Aguiar, L F; Cunha, G S P; Cardinot, N; Lucena, E

    2014-01-01

    The ovarian stimulation has been applied in order to increase the number of oocytes to compensate for the poor results of in vitro fertilization, allowing the selection of one or more embryos to be transferred. Our aim is to compare the results obtained in IVF/ICSI cycles using the short protocol for controlled ovarian stimulation to the results from the modified mild protocol used in our department. A total of 240 cycles were conducted from January 2010 to December 2011. When comparing both protocols, it could be observed that there was a significant difference in the quantity of gonadotropins doses in the mild protocol and in the short protocol. No significant difference was observed regarding pregnancy rates per cycle, 22% and 26.2%, in short and mild protocols, respectively. The protocols of controlled ovarian stimulation are often associated with high risk of complications such as ovarian hyperstimulation syndrome, excessive emotional stress, high rates of treatment dropouts, and abdominal discomfort. With the data obtained in this study, one can conclude that there are less risks and complications for the patient when using the mild stimulation protocol. It was also observed that in this group there was a slightly higher rate.

  14. A Message Exchange Protocol in Command and Control Systems Integration, using the JC3IEDM

    DTIC Science & Technology

    2014-06-01

    19TH International Command and Control Research and Technology Symposium C2 Agility: Lessons Learned from Research and Operations. A Message...distribution unlimited 13. SUPPLEMENTARY NOTES Presented at the 18th International Command & Control Research & Technology Symposium (ICCRTS) held 16...presents approaches of integration, compares their technologies , points out their advantages, proposes requirements, and provides the design of a protocol

  15. 18 CFR 12.40 - Quality control programs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.40 Quality control programs. (a) General rule. During any construction, repair, or modification of project works, including any corrective... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Quality control...

  16. 18 CFR 12.40 - Quality control programs.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.40 Quality control programs. (a) General rule. During any construction, repair, or modification of project works, including any corrective... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Quality control...

  17. 18 CFR 12.40 - Quality control programs.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... PROJECT WORKS Other Responsibilities of Applicant or Licensee § 12.40 Quality control programs. (a) General rule. During any construction, repair, or modification of project works, including any corrective... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Quality control...

  18. 46 CFR 164.019-13 - Production quality control requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 6 2011-10-01 2011-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

  19. 46 CFR 164.019-13 - Production quality control requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 6 2012-10-01 2012-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

  20. 46 CFR 164.019-13 - Production quality control requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

  1. 46 CFR 164.019-13 - Production quality control requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 6 2014-10-01 2014-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

  2. 46 CFR 164.019-13 - Production quality control requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 6 2013-10-01 2013-10-01 false Production quality control requirements. 164.019-13....019-13 Production quality control requirements. (a) General. Each component manufacturer shall establish procedures for maintaining quality control of the materials used in production, manufacturing...

  3. Coronary CT angiography with single-source and dual-source CT: comparison of image quality and radiation dose between prospective ECG-triggered and retrospective ECG-gated protocols.

    PubMed

    Sabarudin, Akmal; Sun, Zhonghua; Yusof, Ahmad Khairuddin Md

    2013-09-30

    This study is conducted to investigate and compare image quality and radiation dose between prospective ECG-triggered and retrospective ECG-gated coronary CT angiography (CCTA) with the use of single-source CT (SSCT) and dual-source CT (DSCT). A total of 209 patients who underwent CCTA with suspected coronary artery disease scanned with SSCT (n=95) and DSCT (n=114) scanners using prospective ECG-triggered and retrospective ECG-gated protocols were recruited from two institutions. The image was assessed by two experienced observers, while quantitative assessment was performed by measuring the image noise, the signal-to-noise ratio (SNR) and the contrast-to-noise ratio (CNR). Effective dose was calculated using the latest published conversion coefficient factor. A total of 2087 out of 2880 coronary artery segments were assessable, with 98.0% classified as of sufficient and 2.0% as of insufficient image quality for clinical diagnosis. There was no significant difference in overall image quality between prospective ECG-triggered and retrospective gated protocols, whether it was performed with DSCT or SSCT scanners. Prospective ECG-triggered protocol was compared in terms of radiation dose calculation between DSCT (6.5 ± 2.9 mSv) and SSCT (6.2 ± 1.0 mSv) scanners and no significant difference was noted (p=0.99). However, the effective dose was significantly lower with DSCT (18.2 ± 8.3 mSv) than with SSCT (28.3 ± 7.0 mSv) in the retrospective gated protocol. Prospective ECG-triggered CCTA reduces radiation dose significantly compared to retrospective ECG-gated CCTA, while maintaining good image quality. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  4. Accuracy of prehospital triage protocols in selecting severely injured patients: A systematic review.

    PubMed

    van Rein, Eveline A J; Houwert, R Marijn; Gunning, Amy C; Lichtveld, Rob A; Leenen, Luke P H; van Heijl, Mark

    2017-08-01

    Prehospital trauma triage ensures proper transport of patients at risk of severe injury to hospitals with an appropriate corresponding level of trauma care. Incorrect triage results in undertriage and overtriage. The American College of Surgeons Committee on Trauma recommends an undertriage rate below 5% and an overtriage rate below 50% for prehospital trauma triage protocols. To find the most accurate prehospital trauma triage protocol, a clear overview of all currently available protocols and corresponding outcomes is necessary. The aim of this systematic review was to evaluate the current literature on all available prehospital trauma triage protocols and determine accuracy of protocol-based triage quality in terms of sensitivity and specificity. A search of Pubmed, Embase, and Cochrane Library databases was performed to identify all studies describing prehospital trauma triage protocols before November 2016. The search terms included "trauma," "trauma center," or "trauma system" combined with "triage," "undertriage," or "overtriage." All studies describing protocol-based triage quality were reviewed. To assess the quality of these type of studies, a new critical appraisal tool was developed. In this review, 21 articles were included with numbers of patients ranging from 130 to over 1 million. Significant predictors for severe injury were: vital signs, suspicion of certain anatomic injuries, mechanism of injury, and age. Sensitivity ranged from 10% to 100%; specificity from 9% to 100%. Nearly all protocols had a low sensitivity, thereby failing to identify severely injured patients. Additionally, the critical appraisal showed poor quality of the majority of included studies. This systematic review shows that nearly all protocols are incapable of identifying severely injured patients. Future studies of high methodological quality should be performed to improve prehospital trauma triage protocols. Systematic review, level III.

  5. PACS quality control and automatic problem notifier

    NASA Astrophysics Data System (ADS)

    Honeyman-Buck, Janice C.; Jones, Douglas; Frost, Meryll M.; Staab, Edward V.

    1997-05-01

    One side effect of installing a clinical PACS Is that users become dependent upon the technology and in some cases it can be very difficult to revert back to a film based system if components fail. The nature of system failures range from slow deterioration of function as seen in the loss of monitor luminance through sudden catastrophic loss of the entire PACS networks. This paper describes the quality control procedures in place at the University of Florida and the automatic notification system that alerts PACS personnel when a failure has happened or is anticipated. The goal is to recover from a failure with a minimum of downtime and no data loss. Routine quality control is practiced on all aspects of PACS, from acquisition, through network routing, through display, and including archiving. Whenever possible, the system components perform self and between platform checks for active processes, file system status, errors in log files, and system uptime. When an error is detected or a exception occurs, an automatic page is sent to a pager with a diagnostic code. Documentation on each code, trouble shooting procedures, and repairs are kept on an intranet server accessible only to people involved in maintaining the PACS. In addition to the automatic paging system for error conditions, acquisition is assured by an automatic fax report sent on a daily basis to all technologists acquiring PACS images to be used as a cross check that all studies are archived prior to being removed from the acquisition systems. Daily quality control is preformed to assure that studies can be moved from each acquisition and contrast adjustment. The results of selected quality control reports will be presented. The intranet documentation server will be described with the automatic pager system. Monitor quality control reports will be described and the cost of quality control will be quantified. As PACS is accepted as a clinical tool, the same standards of quality control must be established

  6. A multicentre non-blinded randomised controlled trial to assess the impact of regular early specialist symptom control treatment on quality of life in malignant mesothelioma (RESPECT-MESO): study protocol for a randomised controlled trial.

    PubMed

    Gunatilake, Samal; Brims, Fraser J H; Fogg, Carole; Lawrie, Iain; Maskell, Nick; Forbes, Karen; Rahman, Najib; Morris, Steve; Ogollah, Reuben; Gerry, Stephen; Peake, Mick; Darlison, Liz; Chauhan, Anoop J

    2014-09-19

    Malignant pleural mesothelioma is an incurable cancer caused by exposure to asbestos. The United Kingdom has the highest death rate from mesothelioma in the world and this figure is increasing. Median survival is 8 to 12 months, and most patients have symptoms at diagnosis. The fittest patients may be offered chemotherapy with palliative intent. For patients not fit for systemic anticancer treatment, best supportive care remains the mainstay of management. A study from the United States examining advanced lung cancer showed that early specialist palliative care input improved patient health related quality of life and depression symptoms 12 weeks after diagnosis. While mesothelioma and advanced lung cancer share many symptoms and have a poor prognosis, oncology and palliative care services in the United Kingdom, and many other countries, vary considerably compared to the United States. The aim of this trial is to assess whether regular early symptom control treatment provided by palliative care specialists can improve health related quality of life in patients newly diagnosed with mesothelioma. This multicentre study is an non-blinded, randomised controlled, parallel group trial. A total of 174 patients with a new diagnosis of malignant pleural mesothelioma will be minimised with a random element in a 1:1 ratio to receive either 4 weekly regular early specialist symptom control care, or standard care. The primary outcome is health related quality of life for patients at 12 weeks. Secondary outcomes include health related quality of life for patients at 24 weeks, carer health related quality of life at 12 and 24 weeks, patient and carer mood at 12 and 24 weeks, overall survival and analysis of healthcare utilisation and cost. Current practice in the United Kingdom is to involve specialist palliative care towards the final weeks or months of a life-limiting illness. This study aims to investigate whether early, regular specialist care input can result in significant

  7. Quality by control: Towards model predictive control of mammalian cell culture bioprocesses.

    PubMed

    Sommeregger, Wolfgang; Sissolak, Bernhard; Kandra, Kulwant; von Stosch, Moritz; Mayer, Martin; Striedner, Gerald

    2017-07-01

    The industrial production of complex biopharmaceuticals using recombinant mammalian cell lines is still mainly built on a quality by testing approach, which is represented by fixed process conditions and extensive testing of the end-product. In 2004 the FDA launched the process analytical technology initiative, aiming to guide the industry towards advanced process monitoring and better understanding of how critical process parameters affect the critical quality attributes. Implementation of process analytical technology into the bio-production process enables moving from the quality by testing to a more flexible quality by design approach. The application of advanced sensor systems in combination with mathematical modelling techniques offers enhanced process understanding, allows on-line prediction of critical quality attributes and subsequently real-time product quality control. In this review opportunities and unsolved issues on the road to a successful quality by design and dynamic control implementation are discussed. A major focus is directed on the preconditions for the application of model predictive control for mammalian cell culture bioprocesses. Design of experiments providing information about the process dynamics upon parameter change, dynamic process models, on-line process state predictions and powerful software environments seem to be a prerequisite for quality by control realization. © 2017 The Authors. Biotechnology Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  8. Analytical approaches to quality assurance and quality control in rangeland monitoring data

    USDA-ARS?s Scientific Manuscript database

    Producing quality data to support land management decisions is the goal of every rangeland monitoring program. However, the results of quality assurance (QA) and quality control (QC) efforts to improve data quality are rarely reported. The purpose of QA and QC is to prevent and describe non-sampling...

  9. Professional Development for Water Quality Control Personnel.

    ERIC Educational Resources Information Center

    Shepard, Clinton Lewis

    This study investigated the availability of professional development opportunities for water quality control personnel in the midwest. The major objective of the study was to establish a listing of educational opportunities for the professional development of water quality control personnel and to compare these with the opportunities technicians…

  10. An exercise protocol designed to control energy expenditure for long-term space missions.

    PubMed

    Matsuo, Tomoaki; Ohkawara, Kazunori; Seino, Satoshi; Shimojo, Nobutake; Yamada, Shin; Ohshima, Hiroshi; Tanaka, Kiyoji; Mukai, Chiaki

    2012-08-01

    Astronauts experience weight loss during spaceflight. Future space missions require a more efficient exercise program not only to maintain work efficiency, but also to control increased energy expenditure (EE). When discussing issues concerning EE incurred through exercise, excess post-exercise energy expenditure (EPEE) must also be considered. The aim of this study was to compare the total EE, including EPEE, induced by two types of interval cycling protocols with the total EE of a traditional, continuous cycling protocol. There were 10 healthy men, ages 20 to 31 yr, who completed 3 exercise sessions: sprint interval training (SIT) consisting of 7 sets of 30-s cycling at 120% VO2max with a 15-s rest between each bout; high-intensity interval aerobic training (HIAT) consisting of 3 sets of 3-min cycling at 80-90% VO2max with a 2-min active rest at 50% VO2max; and continuous aerobic training (CAT) consisting of 40 min of cycling at 60-65% VO2max. During each session, resting metabolic rate, exercise EE, and a 180-min post-exercise EE were measured. The EPEEs during the SIT, HIAT, and CAT averaged 32 +/- 19, 21 +/- 16, and 13 +/- 13 kcal, and the total EE for an entire exercise/ rest session averaged 109 +/- 20, 182 +/- 17, and 363 +/- 45 kcal, respectively. While the EPEE after the CAT was significantly less than after the SIT, the total EE with the CAT was the greatest of the three. The SIT and HIAT would be potential protocols to control energy expenditure for long space missions.

  11. IoT real time data acquisition using MQTT protocol

    NASA Astrophysics Data System (ADS)

    Atmoko, R. A.; Riantini, R.; Hasin, M. K.

    2017-05-01

    The Internet of Things (IoT) provides ease to monitor and to gain sensor data through the Internet [1]. The need of high quality data is increasing to the extent that data monitoring and acquisition system in real time is required, such as smart city or telediagnostic in medical areas [2]. Therefore, an appropriate communication protocol is required to resolve these problems. Lately, researchers have developed a lot of communication protocols for IoT, of which each has advantages and disadvantages. This study proposes the utilization of MQTT as a communication protocol, which is one of data communication protocols for IoT. This study used temperature and humidity sensors because the physical parameters are often needed as parameters of environment condition [3]. Data acquisition was done in real-time and stored in MySQL database. This study is also completed by interface web-based and mobile for online monitoring. This result of this study is the enhancement of data quality and reliability using MQTT protocol.

  12. Assessment of Active Video Gaming Using Adapted Controllers by Individuals With Physical Disabilities: A Protocol.

    PubMed

    Malone, Laurie A; Padalabalanarayanan, Sangeetha; McCroskey, Justin; Thirumalai, Mohanraj

    2017-06-16

    collected during an initial 20-minute baseline, followed by 40 minutes of game play. The controller (balance board or gaming mat) played was randomly selected. A set of games was played for 10 minutes, followed by 5 minutes of rest, and then another set of games was played for 10 minutes, followed by rest. Quality of game play was observed and documented for each set. During rest, the participant completed questions regarding enjoyment. Following the same procedures, the participant then played the two sets of games using the other version (off-the-shelf or adapted) of the controller. The entire procedure was repeated during Visit 3 with the controller that was not played. Enrollment began in February 2016 and ended in September 2016. Study results will be reported in late 2017. We hypothesized that the adapted versions of the Wii Fit balance board and gaming mat would produce greater quality of game play, enjoyment, and energy expenditure in persons with mobility impairments compared to off-the-shelf versions. ClinicalTrials.gov NCT02994199; https://clinicaltrials.gov/ct2/show/NCT02994199 (Archived by WebCite at http://www.webcitation.org/6qpPszPJ7). ©Laurie A Malone, Sangeetha Padalabalanarayanan, Justin McCroskey, Mohanraj Thirumalai. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.06.2017.

  13. A case against justified non-voluntary active euthanasia (the Groningen Protocol).

    PubMed

    Jotkowitz, Alan; Glick, S; Gesundheit, B

    2008-11-01

    The Groningen Protocol allows active euthanasia of severely ill newborns with unbearable suffering. Defenders of the protocol insist that the protocol refers to terminally ill infants and that quality of life should not be a factor in the decision to euthanize an infant. They also argue that there should be no ethical difference between active and passive euthanasia of these infants. However, nowhere in the protocol does it refer to terminally ill infants; on the contrary, the developers of the protocol take into account the future quality of life of the infant. We also note how the Nazi Euthanasie Programm started with the premise that there is some life not worthy of living. Therefore, in our opinion, the protocol violates the traditional ethical codes of physicians and the moral values of the overwhelming majority of the citizens of the world.

  14. Standards for Environmental Measurement Using GIS: Toward a Protocol for Protocols.

    PubMed

    Forsyth, Ann; Schmitz, Kathryn H; Oakes, Michael; Zimmerman, Jason; Koepp, Joel

    2006-02-01

    Interdisciplinary research regarding how the built environment influences physical activity has recently increased. Many research projects conducted jointly by public health and environmental design professionals are using geographic information systems (GIS) to objectively measure the built environment. Numerous methodological issues remain, however, and environmental measurements have not been well documented with accepted, common definitions of valid, reliable variables. This paper proposes how to create and document standardized definitions for measures of environmental variables using GIS with the ultimate goal of developing reliable, valid measures. Inherent problems with software and data that hamper environmental measurement can be offset by protocols combining clear conceptual bases with detailed measurement instructions. Examples demonstrate how protocols can more clearly translate concepts into specific measurement. This paper provides a model for developing protocols to allow high quality comparative research on relationships between the environment and physical activity and other outcomes of public health interest.

  15. A Validated Method for the Quality Control of Andrographis paniculata Preparations.

    PubMed

    Karioti, Anastasia; Timoteo, Patricia; Bergonzi, Maria Camilla; Bilia, Anna Rita

    2017-10-01

    Andrographis paniculata is a herbal drug of Asian traditional medicine largely employed for the treatment of several diseases. Recently, it has been introduced in Europe for the prophylactic and symptomatic treatment of common cold and as an ingredient of dietary supplements. The active principles are diterpenes with andrographolide as the main representative. In the present study, an analytical protocol was developed for the determination of the main constituents in the herb and preparations of A. paniculata . Three different extraction protocols (methanol extraction using a modified Soxhlet procedure, maceration under ultrasonication, and decoction) were tested. Ultrasonication achieved the highest content of analytes. HPLC conditions were optimized in terms of solvent mixtures, time course, and temperature. A reversed phase C18 column eluted with a gradient system consisting of acetonitrile and acidified water and including an isocratic step at 30 °C was used. The HPLC method was validated for linearity, limits of quantitation and detection, repeatability, precision, and accuracy. The overall method was validated for precision and accuracy over at least three different concentration levels. Relative standard deviation was less than 1.13%, whereas recovery was between 95.50% and 97.19%. The method also proved to be suitable for the determination of a large number of commercial samples and was proposed to the European Pharmacopoeia for the quality control of Andrographidis herba. Georg Thieme Verlag KG Stuttgart · New York.

  16. Ride quality sensitivity to SAS control law and to handling quality variations

    NASA Technical Reports Server (NTRS)

    Roberts, P. A.; Schmidt, D. K.; Swaim, R. L.

    1976-01-01

    The RQ trends which large flexible aircraft exhibit under various parameterizations of control laws and handling qualities are discussed. A summary of the assumptions and solution technique, a control law parameterization review, a discussion of ride sensitivity to handling qualities, and the RQ effects generated by implementing relaxed static stability configurations are included.

  17. 14 CFR 21.147 - Changes in quality control system.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Changes in quality control system. 21.147 Section 21.147 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION... quality control system. After the issue of a production certificate, each change to the quality control...

  18. 14 CFR 21.147 - Changes in quality control system.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Changes in quality control system. 21.147 Section 21.147 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION... quality control system. After the issue of a production certificate, each change to the quality control...

  19. Building a protocol expressway: the case of Mayo Clinic Cancer Center.

    PubMed

    McJoynt, Terre A; Hirzallah, Muhanad A; Satele, Daniel V; Pitzen, Jason H; Alberts, Steven R; Rajkumar, S Vincent

    2009-08-10

    Inconsistencies and errors resulting from nonstandard processes, together with redundancies, rework, and excess workload, lead to extended time frames for clinical trial protocol development. This results in dissatisfaction among sponsors, investigators, and staff and restricts the availability of novel treatment options for patients. A team of experts from Mayo Clinic formed, including Protocol Development Unit staff and management from the three Mayo Clinic campuses (Florida, Minnesota, and Arizona), a systems and procedures analyst, a quality office analyst, and two physician members to address the identified deficiencies. The current-state process was intensively reviewed, and improvement steps were taken to accelerate the development and approval of cancer-related clinical trials. The primary goal was to decrease the time from receipt of a new protocol through submission to an approving authority, such as the National Cancer Institute or institutional review board. Using the Define, Measure, Analyze, Improve, Control (DMAIC) framework infused with Lean waste-reduction methodologies, areas were identified for improvement, including enhancing first-time quality and processing new studies on a first-in/first-out basis. The project was successful in improving the mean turnaround time for internally authored protocols (P < .001) from 25.00 weeks (n = 41; range, 3.43 to 94.14 weeks) to 10.15 weeks (n = 14; range, 4.00 to 22.14 weeks). The mean turnaround time for externally authored protocols was improved (P < .001) from 20.61 weeks (n = 85; range, 3.29 to 108.57 weeks) to 7.79 weeks (n = 50; range, 2.00 to 20.86 weeks). DMAIC framework combined with Lean methodologies is an effective tool to structure the definition, planning, analysis, and implementation of significant process changes.

  20. A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: Study protocol for a randomised controlled trial

    PubMed Central

    2012-01-01

    Background Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person’s quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. Methods/design This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to four months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session. Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries), satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood information is also being collected. The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect), age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence intervals will be presented

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

    PubMed

    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.

  2. A review of rate control in atrial fibrillation, and the rationale and protocol for the RATE-AF trial.

    PubMed

    Kotecha, Dipak; Calvert, Melanie; Deeks, Jonathan J; Griffith, Michael; Kirchhof, Paulus; Lip, Gregory Yh; Mehta, Samir; Slinn, Gemma; Stanbury, Mary; Steeds, Richard P; Townend, Jonathan N

    2017-07-20

    Atrial fibrillation (AF) is common and causes impaired quality of life, an increased risk of stroke and death as well as frequent hospital admissions. The majority of patients with AF require control of heart rate. In this article , we summarise the limited evidence from clinical trials that guides prescription, and present the rationale and protocol for a new randomised trial. As rate control has not yet been shown to reduce mortality, there is a clear need to compare the impact of therapy on quality of life, cardiac function and exercise capacity. Such a trial should concentrate on the long-term effects of treatment in the largest proportion of patients with AF, those with symptomatic permanent AF, with the aim of improving patient well-being. The RAte control Therapy Evaluation in permanent Atrial Fibrillation (RATE-AF) trial will enrol 160 participants with a prospective, randomised, open-label, blinded end point design comparing initial rate control with digoxin or bisoprolol. This will be the first head-to-head randomised trial of digoxin and beta-blockers in AF. Recruited patients will be aged ≥60 years with permanent AF and symptoms of breathlessness (equivalent to New York Heart Association class II or above), with few exclusion criteria to maximise generalisability to routine clinical practice. The primary outcome is patient-reported quality of life, with secondary outcomes including echocardiographic ventricular function, exercise capacity and biomarkers of cellular and clinical response. Follow-up will occur at 6 and 12 months, with feasibility components to inform the design of a future trial powered to detect a difference in hospital admission. The RATE-AF trial will underpin an integrated approach to management including biomarkers, functions and symptoms that will guide future research into optimal, personalised rate control in patients with AF. East Midlands-Derby Research Ethics Committee (16/EM/0178); peer-reviewed publications

  3. 21 CFR 111.117 - What quality control operations are required for equipment, instruments, and controls?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What quality control operations are required for equipment, instruments, and controls? 111.117 Section 111.117 Food and Drugs FOOD AND DRUG ADMINISTRATION... and Process Control System: Requirements for Quality Control § 111.117 What quality control operations...

  4. A status review of photovoltaic power conversion equipment reliability, safety, and quality assurance protocols

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Hacke, Peter; Lokanath, Sumanth; Williams, Paul

    Data indicate that the inverter is the element of the photovoltaic plant that has the highest number of service calls and the greatest operation and maintenance cost burden. This paper describes the projects and relevant background needed in developing design qualification standards that would serve to establish a minimum level of reliability, along with a review of photovoltaic inverter quality and safety standards, most of which are in their infancy. We compare stresses and levels for accelerated testing of inverters proposed in the standard drafts, and those proposed by manufacturers and purchasers of inverters. We also review bases for themore » methods, stress types, and stress levels for durability testing of key inverter components. Many of the test protocols appear to need more comprehensive inclusion of stress factors existing in the natural environment such as wind driven rain, dust, and grid disturbances. Further understanding of how temperature, humidity ingress, and voltage bias affect the inverters and their components is also required. We provide data indicating inconsistent quality of the inverters and the durability of components leading to greater cost for the photovoltaic plant operator. Accordingly, the recommendation for data collection within quality standards for obtaining cost of ownership metrics is made. Design validation testing using realistic operation, environmental, and connection conditions, including under end-use field conditions with feedback for continuous improvement is recommended for inclusion within a quality standard.« less

  5. A status review of photovoltaic power conversion equipment reliability, safety, and quality assurance protocols

    DOE PAGES

    Hacke, Peter; Lokanath, Sumanth; Williams, Paul; ...

    2017-10-10

    Data indicate that the inverter is the element of the photovoltaic plant that has the highest number of service calls and the greatest operation and maintenance cost burden. This paper describes the projects and relevant background needed in developing design qualification standards that would serve to establish a minimum level of reliability, along with a review of photovoltaic inverter quality and safety standards, most of which are in their infancy. We compare stresses and levels for accelerated testing of inverters proposed in the standard drafts, and those proposed by manufacturers and purchasers of inverters. We also review bases for themore » methods, stress types, and stress levels for durability testing of key inverter components. Many of the test protocols appear to need more comprehensive inclusion of stress factors existing in the natural environment such as wind driven rain, dust, and grid disturbances. Further understanding of how temperature, humidity ingress, and voltage bias affect the inverters and their components is also required. We provide data indicating inconsistent quality of the inverters and the durability of components leading to greater cost for the photovoltaic plant operator. Accordingly, the recommendation for data collection within quality standards for obtaining cost of ownership metrics is made. Design validation testing using realistic operation, environmental, and connection conditions, including under end-use field conditions with feedback for continuous improvement is recommended for inclusion within a quality standard.« less

  6. Effectiveness of Chinese massage therapy (Tui Na) for chronic low back pain: study protocol for a randomized controlled trial.

    PubMed

    Yang, Mingxiao; Feng, Yue; Pei, Hong; Deng, Shufang; Wang, Minyu; Xiao, Xianjun; Zheng, Hui; Lai, Zhenhong; Chen, Jiao; Li, Xiang; He, Xiaoguo; Liang, Fanrong

    2014-10-29

    Low back pain is a common, disabling musculoskeletal disorder in both developing and developed countries. Although often recommended, the potential efficacy of massage therapy in general, and Chinese massage (tuina) in particular, for relief of chronic low back pain (CLBP) has not been fully established due to inadequate sample sizes, low methodological quality, and subclinical dosing regimens of trials to date. Thus, the purpose of this randomized controlled trial (RCT) is to evaluate the comparative effectiveness of tuina massage therapy versus conventional analgesics for CLBP. The present study is a single center, two-arm, open-label RCT. A total of 150 eligible CLBP patients will be randomly assigned to either a tuina treatment group or a conventional drug control group in a 1:1 ratio. Patients in the tuina group receive a 20 minutes, 4-step treatment protocol which includes both structural and relaxation massage, administered in 20 sessions over a period of 4 weeks. Patients in the conventional drug control group are instructed to take a specific daily dose of ibuprofen. The primary outcome measure is the change from baseline back pain and function, measured by Roland-Morris Disability Questionnaire, at two months. Secondary outcome measures include the visual analogue scale, Japanese orthopedic association score (JOAS), and McGill pain questionnaire. The design and methodological rigor of this trial will allow for collection of valuable data to evaluate the efficacy of a specific tuina protocol for treating CLBP. This trial will therefore contribute to providing a solid foundation for clinical treatment of CLBP, as well as future research in massage therapy. This trial was registered with ClinicalTrials.gov of the National Institute of Health on 22 October 2013 (http://NCT01973010).

  7. Image processing and Quality Control for the first 10,000 brain imaging datasets from UK Biobank.

    PubMed

    Alfaro-Almagro, Fidel; Jenkinson, Mark; Bangerter, Neal K; Andersson, Jesper L R; Griffanti, Ludovica; Douaud, Gwenaëlle; Sotiropoulos, Stamatios N; Jbabdi, Saad; Hernandez-Fernandez, Moises; Vallee, Emmanuel; Vidaurre, Diego; Webster, Matthew; McCarthy, Paul; Rorden, Christopher; Daducci, Alessandro; Alexander, Daniel C; Zhang, Hui; Dragonu, Iulius; Matthews, Paul M; Miller, Karla L; Smith, Stephen M

    2018-02-01

    UK Biobank is a large-scale prospective epidemiological study with all data accessible to researchers worldwide. It is currently in the process of bringing back 100,000 of the original participants for brain, heart and body MRI, carotid ultrasound and low-dose bone/fat x-ray. The brain imaging component covers 6 modalities (T1, T2 FLAIR, susceptibility weighted MRI, Resting fMRI, Task fMRI and Diffusion MRI). Raw and processed data from the first 10,000 imaged subjects has recently been released for general research access. To help convert this data into useful summary information we have developed an automated processing and QC (Quality Control) pipeline that is available for use by other researchers. In this paper we describe the pipeline in detail, following a brief overview of UK Biobank brain imaging and the acquisition protocol. We also describe several quantitative investigations carried out as part of the development of both the imaging protocol and the processing pipeline. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  8. Colorado Air Quality Control Regulations and Ambient Air Quality Standards.

    ERIC Educational Resources Information Center

    Colorado State Dept. of Health, Denver. Div. of Air Pollution Control.

    Regulations and standards relative to air quality control in Colorado are defined in this publication. Presented first are definitions of terms, a statement of intent, and general provisions applicable to all emission control regulations adopted by the Colorado Air Pollution Control Commission. Following this, three regulations are enumerated: (1)…

  9. The Spanish Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: Study Protocol for a Cluster Randomized Controlled Trial.

    PubMed

    García-Escalera, Julia; Valiente, Rosa M; Chorot, Paloma; Ehrenreich-May, Jill; Kennedy, Sarah M; Sandín, Bonifacio

    2017-08-21

    Anxiety and depression are common, impairing conditions that evidence high comorbidity rates in adolescence. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) is one of the few existing resources aimed at applying transdiagnostic treatment principles to target core dysfunctions associated with both anxiety and depression within a single protocol. To our knowledge, this is the first study examining the efficacy of the UP-A adapted as a universal preventive intervention program. The primary aim of this study is to examine whether the Spanish version of the UP-A is more effective than a waitlist (WL) control group in reducing and preventing symptoms of anxiety and depression when employed as a universal, classroom-based preventive intervention. The secondary aim is to investigate changes in a broad range of secondary outcome measures, including negative and positive affect, anxiety sensitivity, emotional avoidance, top problems ratings, school grades, depression and anxiety-related interference, self-esteem, life satisfaction, quality of life, conduct problems, hyperactivity/inattention symptoms, peer problems, prosocial behavior, school adjustment, and discipline problems. Other aims are to assess a range of possible predictors of intervention effects and to examine the feasibility and the acceptability of implementing UP-A in a prevention group format and in a school setting. A cluster, randomized, WL, controlled trial design with classroom as the unit of randomization was used in this study. Five classes including a total of 152 adolescents were randomized to the experimental or WL control groups. Participants in the experimental group received 9 55-minute sessions delivered by advanced doctoral and masters students in clinical psychology. The WL control group will receive the intervention once the 3-month follow-up assessment is completed. We have recruited participants to the cluster randomized controlled trial (RCT

  10. 46 CFR 164.120-11 - Production quality control requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 6 2014-10-01 2014-10-01 false Production quality control requirements. 164.120-11... Rescue Boats § 164.120-11 Production quality control requirements. The resin manufacturer must institute a quality control procedure to ensure that all Coast Guard-accepted resin is produced to the same...

  11. 46 CFR 164.120-11 - Production quality control requirements.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 6 2012-10-01 2012-10-01 false Production quality control requirements. 164.120-11... Rescue Boats § 164.120-11 Production quality control requirements. The resin manufacturer must institute a quality control procedure to ensure that all Coast Guard-accepted resin is produced to the same...

  12. 46 CFR 164.120-11 - Production quality control requirements.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 6 2013-10-01 2013-10-01 false Production quality control requirements. 164.120-11... Rescue Boats § 164.120-11 Production quality control requirements. The resin manufacturer must institute a quality control procedure to ensure that all Coast Guard-accepted resin is produced to the same...

  13. 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.

    PubMed

    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.

  14. Chapter 19: HVAC Controls (DDC/EMS/BAS) Evaluation Protocol. The Uniform Methods Project: Methods for Determining Energy Efficiency Savings for Specific Measures

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kurnik, Charles W.; Romberger, Jeff

    The HVAC Controls Evaluation Protocol is designed to address evaluation issues for direct digital controls/energy management systems/building automation systems (DDC/EMS/BAS) that are installed to control heating, ventilation, and air-conditioning (HVAC) equipment in commercial and institutional buildings. (This chapter refers to the DDC/EMS/BAS measure as HVAC controls.) This protocol may also be applicable to industrial facilities such as clean rooms and labs, which have either significant HVAC equipment or spaces requiring special environmental conditions.

  15. Development of a data entry auditing protocol and quality assurance for a tissue bank database.

    PubMed

    Khushi, Matloob; Carpenter, Jane E; Balleine, Rosemary L; Clarke, Christine L

    2012-03-01

    Human transcription error is an acknowledged risk when extracting information from paper records for entry into a database. For a tissue bank, it is critical that accurate data are provided to researchers with approved access to tissue bank material. The challenges of tissue bank data collection include manual extraction of data from complex medical reports that are accessed from a number of sources and that differ in style and layout. As a quality assurance measure, the Breast Cancer Tissue Bank (http:\\\\www.abctb.org.au) has implemented an auditing protocol and in order to efficiently execute the process, has developed an open source database plug-in tool (eAuditor) to assist in auditing of data held in our tissue bank database. Using eAuditor, we have identified that human entry errors range from 0.01% when entering donor's clinical follow-up details, to 0.53% when entering pathological details, highlighting the importance of an audit protocol tool such as eAuditor in a tissue bank database. eAuditor was developed and tested on the Caisis open source clinical-research database; however, it can be integrated in other databases where similar functionality is required.

  16. Quality of life and myelomeningocele: an ethical and evidence-based analysis of the Groningen Protocol.

    PubMed

    Barry, Sean

    2010-01-01

    In 2005, a group of pediatricians at the University Medical Center in Groningen, The Netherlands, published the Groningen Protocol (GP) for Euthanasia in Newborns. This protocol is a set of guidelines devised in 2001 to clarify and facilitate the assessment of clinically stable neonates deemed to be in unbearable suffering for whom the prognosis is felt to be hopeless. At the time of publication, the GP had been in use for 7 years, and 22 patients, all with diagnosed myelomeningocele (MMC), had met the selection criteria for euthanasia by lethal injection. MMC is the most common neurological congenital anomaly, affecting approximately 300,000 newborns yearly worldwide. Neurosurgeons have a unique perspective on this disease and therefore an important voice, given the significant role they have in caring for these patients at all stages of their lives. This paper reviews the principal ethical arguments presented to date in the literature regarding the GP. It also provides an evidence-based critique of the GP in light of quality-of-life studies addressing adults with MMC, and ascertains whether or not the GP meets the criteria for an evidence-based guideline. Copyright © 2011 S. Karger AG, Basel.

  17. Quality Control Technician Curriculum. An Elusive Butterfly.

    ERIC Educational Resources Information Center

    Holler, Michael

    Defining and developing a quality control technician curriculum for an associate degree program is a difficult and puzzling job. There are as many definitions of quality control and curriculum ideas as there are educators asked. However, one could start by dividing the field into its major areas--heavy manufacturing, maintenance, research, and…

  18. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

    PubMed Central

    Tetzlaff, Jennifer M; Gøtzsche, Peter C; Altman, Douglas G; Mann, Howard; Berlin, Jesse A; Dickersin, Kay; Hróbjartsson, Asbjørn; Schulz, Kenneth F; Parulekar, Wendy R; Krleža-Jerić, Karmela; Laupacis, Andreas; Moher, David

    2013-01-01

    High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders. PMID:23303884

  19. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.

    PubMed

    Chan, An-Wen; Tetzlaff, Jennifer M; Gøtzsche, Peter C; Altman, Douglas G; Mann, Howard; Berlin, Jesse A; Dickersin, Kay; Hróbjartsson, Asbjørn; Schulz, Kenneth F; Parulekar, Wendy R; Krleza-Jeric, Karmela; Laupacis, Andreas; Moher, David

    2013-01-08

    High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.

  20. Rehabilitation for the management of knee osteoarthritis using comprehensive traditional Chinese medicine in community health centers: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background It is becoming increasingly necessary for community health centers to make rehabilitation services available to patients with osteoarthritis of the knee. However, for a number of reasons, including a lack of expertise, the small size of community health centers and the availability of only simple medical equipment, conventional rehabilitation therapy has not been widely used in China. Consequently, most patients with knee osteoarthritis seek treatment in high-grade hospitals. However, many patients cannot manage the techniques that they were taught in the hospital. Methods such as acupuncture, tuina, Chinese medical herb fumigation-washing and t’ai chi are easy to do and have been reported to have curative effects in those with knee osteoarthritis. To date, there have been no randomized controlled trials validating comprehensive traditional Chinese medicine for the rehabilitation of knee osteoarthritis in a community health center. Furthermore, there is no standard rehabilitation protocol using traditional Chinese medicine for knee osteoarthritis. The aim of the current study is to develop a comprehensive rehabilitation protocol using traditional Chinese medicine for the management of knee osteoarthritis in a community health center. Method/design This will be a randomized controlled clinical trial with blinded assessment. There will be a 4-week intervention utilizing rehabilitation protocols from traditional Chinese medicine and conventional therapy. Follow-up will be conducted for a period of 12 weeks. A total of 722 participants with knee osteoarthritis will be recruited. Participants will be randomly divided into two groups: experimental and control. Primary outcomes will include range of motion, girth measurement, the visual analogue scale, and results from the manual muscle, six-minute walking and stair-climbing tests. Secondary outcomes will include average daily consumption of pain medication, ability to perform daily tasks and health

  1. Rehabilitation for the management of knee osteoarthritis using comprehensive traditional Chinese medicine in community health centers: study protocol for a randomized controlled trial.

    PubMed

    Yan, Hu; Su, Youxin; Chen, Lidian; Zheng, Guohua; Lin, Xueyi; Chen, Baojun; Zhou, Bihong; Zhang, Qing

    2013-11-04

    It is becoming increasingly necessary for community health centers to make rehabilitation services available to patients with osteoarthritis of the knee. However, for a number of reasons, including a lack of expertise, the small size of community health centers and the availability of only simple medical equipment, conventional rehabilitation therapy has not been widely used in China. Consequently, most patients with knee osteoarthritis seek treatment in high-grade hospitals. However, many patients cannot manage the techniques that they were taught in the hospital. Methods such as acupuncture, tuina, Chinese medical herb fumigation-washing and t'ai chi are easy to do and have been reported to have curative effects in those with knee osteoarthritis. To date, there have been no randomized controlled trials validating comprehensive traditional Chinese medicine for the rehabilitation of knee osteoarthritis in a community health center. Furthermore, there is no standard rehabilitation protocol using traditional Chinese medicine for knee osteoarthritis. The aim of the current study is to develop a comprehensive rehabilitation protocol using traditional Chinese medicine for the management of knee osteoarthritis in a community health center. This will be a randomized controlled clinical trial with blinded assessment. There will be a 4-week intervention utilizing rehabilitation protocols from traditional Chinese medicine and conventional therapy. Follow-up will be conducted for a period of 12 weeks. A total of 722 participants with knee osteoarthritis will be recruited. Participants will be randomly divided into two groups: experimental and control. Primary outcomes will include range of motion, girth measurement, the visual analogue scale, and results from the manual muscle, six-minute walking and stair-climbing tests. Secondary outcomes will include average daily consumption of pain medication, ability to perform daily tasks and health-related quality-of-life assessments

  2. The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial.

    PubMed

    Huang, Jia; Lin, Zhengkun; Wang, Qin; Liu, Feiwen; Liu, Jiao; Fang, Yunhua; Chen, Shanjia; Zhou, Xiaoxuan; Hong, Wenjun; Wu, Jinsong; Madrigal-Mora, Natalia; Zheng, Guohua; Yang, Shanli; Tao, Jing; Chen, Lidian

    2015-06-16

    Post-stroke cognitive impairment (PSCI) lessens quality of life, restricts the rehabilitation of stroke, and increases the social and economic burden stroke imposes on patients and their families. Therefore effective treatment is of paramount importance. However, the treatment of PSCI is very limited. The primary aim of this protocol is to propose a lower cost and more effective therapy, and to confirm the long-term effectiveness of a therapeutic regimen of Traditional Chinese Medicine (TCM) rehabilitation for PSCI. A prospective, multicenter, large sample, randomized controlled trial will be conducted. A total of 416 eligible patients will be recruited from seven inpatient and outpatient stroke rehabilitation units and randomly allocated into a therapeutic regimen of TCM rehabilitation group or cognitive training (CT) control group. The intervention period of both groups will last 12 weeks (30 minutes per day, five days per week). Primary and secondary outcomes will be measured at baseline, 12 weeks (at the end of the intervention), and 36 weeks (after the 24-week follow-up period). This protocol presents an objective design of a multicenter, large sample, randomized controlled trial that aims to put forward a lower cost and more effective therapy, and confirm the long-term effectiveness of a therapeutic regimen of TCM rehabilitation for PSCI through subjective and objective assessments, as well as highlight its economic advantages. This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-14004872 ) on 23 June 2014.

  3. Angioplasty and stenting for patients with symptomatic intracranial atherosclerosis: study protocol of a randomised controlled trial

    PubMed Central

    Cui, Xiao-Ping; Lin, Min; Mu, Jun-Shan; Ye, Jian-Xin; He, Wen-Qing; Fu, Mao-Lin; Li, Hua; Fang, Jia-Yang; Shen, Feng-Feng; Lin, Hang

    2016-01-01

    Introduction Whether adding percutaneous transluminal angioplasty and stenting (PTAS) to background medical treatment is effective for decreasing the incidence of stroke or death in patients with symptomatic intracranial atherosclerosis (ICAS) is still controversial. We perform a randomised controlled trial to examine the effectiveness and safety of an improved PTAS procedure for patients with ICAS. Methods and analysis A randomised controlled trial will be conducted in three hospitals in China. Eligible patients with ICAS will be randomly assigned to receive medication treatment (MT) plus PTAS or MT alone. The MT will be initiated immediately after randomisation, while the PTAS will be performed when patients report relief of alarm symptoms defined as sudden weakness or numbness. All patients will be followed up at 30 days, 3 and 12 months after randomisation. The primary end point will be the incidence of stroke or death at 30 days after randomisation. Secondary outcomes will be the incidence of ischaemic stroke in the territory of stenosis arteries, the incidence of in-stent restenosis, the Chinese version of the modified Rankin Scale and the Chinese version of the Stroke-Specific Quality of Life (CSQoL). Ethics and dissemination The study protocol is approved by institutional review boards in participating hospitals (reference number FZ20160003, 180PLA20160101 and 476PLA2016007). The results of this study will be disseminated to patients, physicians and policymakers through publication in a peer-reviewed journal or presentations in conferences. It is anticipated that the results of this study will improve the quality of the current PTAS procedure and guide clinical decision-making for patients with ICAS. Trial registration number NCT02689037 PMID:27852711

  4. Comparing five simple vascular storage protocols.

    PubMed

    van Doormaal, Tristan P C; Sluijs, Jurren H; Vink, Aryan; Tulleken, Cornelis A F; van der Zwan, Albert

    2014-11-01

    We aim to find a storage protocol for vessels that preserves their dimensional, histologic, and mechanical characteristics to facilitate reproducible anastomosis experiments and microsurgical training with constant quality. We compared stored rabbit aortas, harvested in a slaughterhouse, using five different protocols with fresh controls. Aortas were preserved for 125 d in (1) NaCl 0.9% at -18°C, (2) Roswell Park Memorial Institute 1640 90% with 10% dimethyl sulfoxide (RPMI/DMSO) at -18°C, (3) RPMI/DMSO at -70°C, (4) glycerol 85% at 4°C, and (5) glycerol in stepwise increased concentrations until 85% at 4°C. After preservation, we measured vessel diameter, wall thickness, and Young's Modulus indicating stiffness. Neurosurgeons compared stored vessels with fresh vessels, blinded for preservation subgroup. We performed histologic assessment blinded for preservation subgroup. Fresh rabbit aortas showed a mean diameter of 2.65 ± 0.14 mm, a mean wall thickness of 126 ± 22 μm, and a Young's Modulus of 11.4 ± 2.4 N/mm(2). NaCl 0.9%-preserved aortas showed a significantly increased vessel diameter and decreased stiffness. RPMI/DMSO-preserved aortas showed no significant differences from fresh aortas in dimensions and mechanical characteristics. Glycerol-preserved tissue showed a significant increase in wall thickness, a related significant decrease in diameter, and increase in stiffness. Neurosurgeons regarded RPMI/DMSO tissue as most comparable with fresh tissue. Histologic assessment revealed no differences between the different protocols and fresh control group. Storage of rabbit aortas in RPMI/DMSO most adequately preserves their dimensional and mechanical properties. Copyright © 2014 Elsevier Inc. All rights reserved.

  5. Data Quality Control for Vessel Mounted Acoustic Doppler Current Profiler. Application for the Western Mediterranean Sea

    NASA Technical Reports Server (NTRS)

    Garcia-Gorriz, E.; Front, J.; Candela, J.

    1997-01-01

    A systematic Data Quality Checking Protocol for vessel Mounted Acoustic Doppler Current Profiler observations is proposed. Previous-to-acquisition conditions are considered along with simultaneous ones.

  6. Comparison of Results of Cycles Treated with Modified Mild Protocol and Short Protocol for Ovarian Stimulation

    PubMed Central

    Aguiar, L. F.; Cunha, G. S. P.; Cardinot, N.; Lucena, E.

    2014-01-01

    The ovarian stimulation has been applied in order to increase the number of oocytes to compensate for the poor results of in vitro fertilization, allowing the selection of one or more embryos to be transferred. Our aim is to compare the results obtained in IVF/ICSI cycles using the short protocol for controlled ovarian stimulation to the results from the modified mild protocol used in our department. A total of 240 cycles were conducted from January 2010 to December 2011. When comparing both protocols, it could be observed that there was a significant difference in the quantity of gonadotropins doses in the mild protocol and in the short protocol. No significant difference was observed regarding pregnancy rates per cycle, 22% and 26.2%, in short and mild protocols, respectively. The protocols of controlled ovarian stimulation are often associated with high risk of complications such as ovarian hyperstimulation syndrome, excessive emotional stress, high rates of treatment dropouts, and abdominal discomfort. With the data obtained in this study, one can conclude that there are less risks and complications for the patient when using the mild stimulation protocol. It was also observed that in this group there was a slightly higher rate. PMID:25763398

  7. A multiple objective optimization approach to quality control

    NASA Technical Reports Server (NTRS)

    Seaman, Christopher Michael

    1991-01-01

    The use of product quality as the performance criteria for manufacturing system control is explored. The goal in manufacturing, for economic reasons, is to optimize product quality. The problem is that since quality is a rather nebulous product characteristic, there is seldom an analytic function that can be used as a measure. Therefore standard control approaches, such as optimal control, cannot readily be applied. A second problem with optimizing product quality is that it is typically measured along many dimensions: there are many apsects of quality which must be optimized simultaneously. Very often these different aspects are incommensurate and competing. The concept of optimality must now include accepting tradeoffs among the different quality characteristics. These problems are addressed using multiple objective optimization. It is shown that the quality control problem can be defined as a multiple objective optimization problem. A controller structure is defined using this as the basis. Then, an algorithm is presented which can be used by an operator to interactively find the best operating point. Essentially, the algorithm uses process data to provide the operator with two pieces of information: (1) if it is possible to simultaneously improve all quality criteria, then determine what changes to the process input or controller parameters should be made to do this; and (2) if it is not possible to improve all criteria, and the current operating point is not a desirable one, select a criteria in which a tradeoff should be made, and make input changes to improve all other criteria. The process is not operating at an optimal point in any sense if no tradeoff has to be made to move to a new operating point. This algorithm ensures that operating points are optimal in some sense and provides the operator with information about tradeoffs when seeking the best operating point. The multiobjective algorithm was implemented in two different injection molding scenarios

  8. 7 CFR 58.523 - Laboratory and quality control tests.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 3 2014-01-01 2014-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

  9. 7 CFR 58.523 - Laboratory and quality control tests.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

  10. 7 CFR 58.523 - Laboratory and quality control tests.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 3 2013-01-01 2013-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

  11. 7 CFR 58.523 - Laboratory and quality control tests.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 3 2011-01-01 2011-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

  12. 7 CFR 58.523 - Laboratory and quality control tests.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 3 2012-01-01 2012-01-01 false Laboratory and quality control tests. 58.523 Section... Service 1 Operations and Operating Procedures § 58.523 Laboratory and quality control tests. (a) Quality control tests shall be made on samples as often as necessary to determine the shelf-life and stability of...

  13. 21 CFR 640.56 - Quality control test for potency.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... quality control test for potency may be performed by a clinical laboratory which meets the standards of... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Quality control test for potency. 640.56 Section...) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Cryoprecipitate § 640.56 Quality control...

  14. Web quality control for lectures: Supercourse and Amazon.com.

    PubMed

    Linkov, Faina; LaPorte, Ronald; Lovalekar, Mita; Dodani, Sunita

    2005-12-01

    Peer review has been at the corner stone of quality control of the biomedical journals in the past 300 years. With the emergency of the Internet, new models of quality control and peer review are emerging. However, such models are poorly investigated. We would argue that the popular system of quality control used in Amazon.com offers a way to ensure continuous quality improvement in the area of research communications on the Internet. Such system is providing an interesting alternative to the traditional peer review approaches used in the biomedical journals and challenges the traditional paradigms of scientific publishing. This idea is being explored in the context of Supercourse, a library of 2,350 prevention lectures, shared for free by faculty members from over 150 countries. Supercourse is successfully utilizing quality control approaches that are similar to Amazon.com model. Clearly, the existing approaches and emerging alternatives for quality control in scientific communications needs to be assessed scientifically. Rapid explosion of internet technologies could be leveraged to produce better, more cost effective systems for quality control in the biomedical publications and across all sciences.

  15. 40 CFR 81.107 - Greenwood Intrastate Air Quality Control Region.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Quality Control Regions § 81.107 Greenwood Intrastate Air Quality Control Region. The Greenwood Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Greenwood Intrastate Air Quality...

  16. 40 CFR 81.108 - Columbia Intrastate Air Quality Control Region.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Quality Control Regions § 81.108 Columbia Intrastate Air Quality Control Region. The Columbia Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Columbia Intrastate Air Quality...

  17. 40 CFR 81.108 - Columbia Intrastate Air Quality Control Region.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Quality Control Regions § 81.108 Columbia Intrastate Air Quality Control Region. The Columbia Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Columbia Intrastate Air Quality...

  18. 40 CFR 81.111 - Georgetown Intrastate Air Quality Control Region.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Quality Control Regions § 81.111 Georgetown Intrastate Air Quality Control Region. The Georgetown Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Georgetown Intrastate Air Quality...

  19. 40 CFR 81.109 - Florence Intrastate Air Quality Control Region.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Quality Control Regions § 81.109 Florence Intrastate Air Quality Control Region. The Florence Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Florence Intrastate Air Quality...

  20. 40 CFR 81.111 - Georgetown Intrastate Air Quality Control Region.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Quality Control Regions § 81.111 Georgetown Intrastate Air Quality Control Region. The Georgetown Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Georgetown Intrastate Air Quality...

  1. 40 CFR 81.109 - Florence Intrastate Air Quality Control Region.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Quality Control Regions § 81.109 Florence Intrastate Air Quality Control Region. The Florence Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Florence Intrastate Air Quality...

  2. 40 CFR 81.107 - Greenwood Intrastate Air Quality Control Region.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Quality Control Regions § 81.107 Greenwood Intrastate Air Quality Control Region. The Greenwood Intrastate Air Quality Control Region (South Carolina) consists of the territorial area encompassed by the... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Greenwood Intrastate Air Quality...

  3. Analytical approach to cross-layer protocol optimization in wireless sensor networks

    NASA Astrophysics Data System (ADS)

    Hortos, William S.

    2008-04-01

    In the distributed operations of route discovery and maintenance, strong interaction occurs across mobile ad hoc network (MANET) protocol layers. Quality of service (QoS) requirements of multimedia service classes must be satisfied by the cross-layer protocol, along with minimization of the distributed power consumption at nodes and along routes to battery-limited energy constraints. In previous work by the author, cross-layer interactions in the MANET protocol are modeled in terms of a set of concatenated design parameters and associated resource levels by multivariate point processes (MVPPs). Determination of the "best" cross-layer design is carried out using the optimal control of martingale representations of the MVPPs. In contrast to the competitive interaction among nodes in a MANET for multimedia services using limited resources, the interaction among the nodes of a wireless sensor network (WSN) is distributed and collaborative, based on the processing of data from a variety of sensors at nodes to satisfy common mission objectives. Sensor data originates at the nodes at the periphery of the WSN, is successively transported to other nodes for aggregation based on information-theoretic measures of correlation and ultimately sent as information to one or more destination (decision) nodes. The "multimedia services" in the MANET model are replaced by multiple types of sensors, e.g., audio, seismic, imaging, thermal, etc., at the nodes; the QoS metrics associated with MANETs become those associated with the quality of fused information flow, i.e., throughput, delay, packet error rate, data correlation, etc. Significantly, the essential analytical approach to MANET cross-layer optimization, now based on the MVPPs for discrete random events occurring in the WSN, can be applied to develop the stochastic characteristics and optimality conditions for cross-layer designs of sensor network protocols. Functional dependencies of WSN performance metrics are described in

  4. Contractor Performed Quality Control on KyTC Projects.

    DOT National Transportation Integrated Search

    2002-08-01

    This report addresses issues related to transferring the responsibility for quality control from the Kentucky Transportation Cabinet (KyTC) to construction contractors. : Several key topics related to Contractor Performed Quality Control (CPQC) are p...

  5. Whole body vibration exercise for chronic low back pain: study protocol for a single-blind randomized controlled trial.

    PubMed

    Wang, Xue-Qiang; Pi, Yan-Lin; Chen, Pei-Jie; Chen, Bin-Lin; Liang, Lei-Chao; Li, Xin; Wang, Xiao; Zhang, Juan

    2014-04-02

    Low back pain affects approximately 80% of people at some stage in their lives. Exercise therapy is the most widely used nonsurgical intervention for low back pain in practice guidelines. Whole body vibration exercise is becoming increasingly popular for relieving musculoskeletal pain and improving health-related quality of life. However, the efficacy of whole body vibration exercise for low back pain is not without dispute. This study aims to estimate the effect of whole body vibration exercise for chronic low back pain. We will conduct a prospective, single-blind, randomized controlled trial of 120 patients with chronic low back pain. Patients will be randomly assigned into an intervention group and a control group. The intervention group will participate in whole body vibration exercise twice a week for 3 months. The control group will receive general exercise twice a week for 3 months. Primary outcome measures will be the visual analog scale for pain, the Oswestry Disability Index and adverse events. The secondary outcome measures will include muscle strength and endurance of spine, trunk proprioception, transversus abdominis activation capacity, and quality of life. We will conduct intention-to-treat analysis if any participants withdraw from the trial. Important features of this study include the randomization procedures, single-blind, large sample size, and a standardized protocol for whole body vibration in chronic low back pain. This study aims to determine whether whole body vibration exercise produces more beneficial effects than general exercise for chronic low back pain. Therefore, our results will be useful for patients with chronic low back pain as well as for medical staff and health-care decision makers. Chinese Clinical Trial Registry: ChiCTR-TRC-13003708.

  6. [Pharmaceutical product quality control and good manufacturing practices].

    PubMed

    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.

  7. Low-Contrast and Low-Radiation Dose Protocol in Cardiac Computed Tomography: Usefulness of Low Tube Voltage and Knowledge-Based Iterative Model Reconstruction Algorithm.

    PubMed

    Iyama, Yuji; Nakaura, Takeshi; Yokoyama, Koichi; Kidoh, Masafumi; Harada, Kazunori; Oda, Seitaro; Tokuyasu, Shinichi; Yamashita, Yasuyuki

    This study aimed to evaluate the feasibility of a low contrast, low-radiation dose protocol of 80-peak kilovoltage (kVp) with prospective electrocardiography-gated cardiac computed tomography (CT) using knowledge-based iterative model reconstruction (IMR). Thirty patients underwent an 80-kVp prospective electrocardiography-gated cardiac CT with low-contrast agent (222-mg iodine per kilogram of body weight) dose. We also enrolled 30 consecutive patients who were scanned with a 120-kVp cardiac CT with filtered back projection using the standard contrast agent dose (370-mg iodine per kilogram of body weight) as a historical control group. We evaluated the radiation dose for the 2 groups. The 80-kVp images were reconstructed with filtered back projection (protocol A), hybrid iterative reconstruction (HIR, protocol B), and IMR (protocol C). We compared CT numbers, image noise, and contrast-to-noise ratio among 120-kVp protocol, protocol A, protocol B, and protocol C. In addition, we compared the noise reduction rate between HIR and IMR. Two independent readers compared image contrast, image noise, image sharpness, unfamiliar image texture, and overall image quality among the 4 protocols. The estimated effective dose (ED) of the 80-kVp protocol was 74% lower than that of the 120-kVp protocol (1.4 vs 5.4 mSv). The contrast-to-noise ratio of protocol C was significantly higher than that of protocol A. The noise reduction rate of IMR was significantly higher than that of HIR (P < 0.01). There was no significant difference in almost all qualitative image quality between 120-kVp protocol and protocol C except for image contrast. A 80-kVp protocol with IMR yields higher image quality with 74% decreased radiation dose and 40% decreased contrast agent dose as compared with a 120-kVp protocol, while decreasing more image noise compared with the 80-kVp protocol with HIR.

  8. A Brief Survey of Media Access Control, Data Link Layer, and Protocol Technologies for Lunar Surface Communications

    NASA Technical Reports Server (NTRS)

    Wallett, Thomas M.

    2009-01-01

    This paper surveys and describes some of the existing media access control and data link layer technologies for possible application in lunar surface communications and the advanced wideband Direct Sequence Code Division Multiple Access (DSCDMA) conceptual systems utilizing phased-array technology that will evolve in the next decade. Time Domain Multiple Access (TDMA) and Code Division Multiple Access (CDMA) are standard Media Access Control (MAC) techniques that can be incorporated into lunar surface communications architectures. Another novel hybrid technique that is recently being developed for use with smart antenna technology combines the advantages of CDMA with those of TDMA. The relatively new and sundry wireless LAN data link layer protocols that are continually under development offer distinct advantages for lunar surface applications over the legacy protocols which are not wireless. Also several communication transport and routing protocols can be chosen with characteristics commensurate with smart antenna systems to provide spacecraft communications for links exhibiting high capacity on the surface of the Moon. The proper choices depend on the specific communication requirements.

  9. Protocol Coordinator | Center for Cancer Research

    Cancer.gov

    PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood

  10. 21 CFR 862.1660 - Quality control material (assayed and unassayed).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Quality control material (assayed and unassayed... Test Systems § 862.1660 Quality control material (assayed and unassayed). (a) Identification. A quality... that may arise from reagent or analytical instrument variation. A quality control material (assayed and...

  11. Traditional Chinese medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trial.

    PubMed

    Zhang, Zhe; Zhang, Fan; Wang, Yang; Du, Yi; Zhang, Huiyong; Kong, Dezhao; Liu, Yue; Yang, Guanlin

    2014-10-30

    Stable angina pectoris is experienced as trans-sternal or retro-sternal pressure or pain that may radiate to the left arm, neck or back. Although available evidence relating to its effectiveness and mechanism are weak, traditional Chinese medicine is used as an alternative therapy for stable angina pectoris. We report a protocol of a randomized controlled trial using traditional Chinese medicine to investigate the effectiveness, mechanism and safety for patients with stable angina pectoris. This is a north-east Chinese, multi-center, multi-blinded, placebo-controlled and superiority randomized trail. A total of 240 patients with stable angina pectoris will be randomly assigned to three groups: two treatment groups and a control group. The treatment groups will receive Chinese herbal medicine consisting of Yi-Qi-Jian-Pi and Qu-Tan-Hua-Zhuo granule and Yi-Qi-Jian-Pi and Qu-Tan-Hua-Yu granule, respectively, and conventional medicine. The control group will receive placebo medicine in addition to conventional medicine. All 3 groups will undergo a 12-week treatment and 2-week follow-up. Four visits in sum will be scheduled for each subject: 1 visit each in week 0, week 4, week 12 and week 14. The primary outcomes include: the frequency of angina pectoris attack; the dosage of nitroglycerin; body limited dimension of Seattle Angina Questionnaire. The secondary outcomes include: except for the body limited dimension of SAQ, traditional Chinese medicine pattern questionnaire and so on. Therapeutic mechanism outcomes, safety outcomes and endpoint outcomes will be also assessed. The primary aim of this trial is to develop a standard protocol to utilize high-quality EBM evidence for assessing the effectiveness and safety of SAP via TCM pattern differentiation as well as exploring the efficacy mechanism and regulation with the molecular biology and systems biology. ChiCTR-TRC-13003608, registered 18 June 2013.

  12. Channel MAC Protocol for Opportunistic Communication in Ad Hoc Wireless Networks

    NASA Astrophysics Data System (ADS)

    Ashraf, Manzur; Jayasuriya, Aruna; Perreau, Sylvie

    2008-12-01

    Despite significant research effort, the performance of distributed medium access control methods has failed to meet theoretical expectations. This paper proposes a protocol named "Channel MAC" performing a fully distributed medium access control based on opportunistic communication principles. In this protocol, nodes access the channel when the channel quality increases beyond a threshold, while neighbouring nodes are deemed to be silent. Once a node starts transmitting, it will keep transmitting until the channel becomes "bad." We derive an analytical throughput limit for Channel MAC in a shared multiple access environment. Furthermore, three performance metrics of Channel MAC—throughput, fairness, and delay—are analysed in single hop and multihop scenarios using NS2 simulations. The simulation results show throughput performance improvement of up to 130% with Channel MAC over IEEE 802.11. We also show that the severe resource starvation problem (unfairness) of IEEE 802.11 in some network scenarios is reduced by the Channel MAC mechanism.

  13. QUALITY ASSURANCE AND QUALITY CONTROL FOR WASTE CONTAINMENT FACILITIES. Project Summary

    EPA Science Inventory

    It is generally agreed that both quality assurance (QA) and quality control (QC) are essential to the proper installation and eventual performance of environmentally safe and secure waste containment systems. Even further, there are both manufacturing and construction aspects to...

  14. Internet-Based Acceptance and Commitment Therapy for Psychological Distress Experienced by People With Hearing Problems: Study Protocol for a Randomized Controlled Trial.

    PubMed

    Molander, Peter; Hesser, Hugo; Weineland, Sandra; Bergwall, Kajsa; Buck, Sonia; Hansson-Malmlöf, Johan; Lantz, Henning; Lunner, Thomas; Andersson, Gerhard

    2015-09-01

    Psychological distress and psychiatric symptoms are prevalent among people with hearing loss or other audiological conditions, but psychological interventions for these groups are rare. This article describes the study protocol for a randomized controlled trial for evaluating the effect of a psychological treatment delivered over the Internet for individuals with hearing problems and concurrent psychological distress. Participants who are significantly distressed will be randomized to either an 8-week Internet-delivered acceptance-based cognitive behavioral therapy (i.e., acceptance and commitment therapy [ACT]), or wa it-list control. We aim to include measures of distress associated with hearing difficulties, anxiety, and depression. In addition, we aim to measure acceptance associated with hearing difficulties as well as quality of life. The results of the trial may further our understanding of how to best treat people who present problems with both psychological distress and hearing in using the Internet.

  15. Cryotherapy for acute ankle sprains: a randomised controlled study of two different icing protocols.

    PubMed

    Bleakley, C M; McDonough, S M; MacAuley, D C; Bjordal, J

    2006-08-01

    The use of cryotherapy in the management of acute soft tissue injury is largely based on anecdotal evidence. Preliminary evidence suggests that intermittent cryotherapy applications are most effective at reducing tissue temperature to optimal therapeutic levels. However, its efficacy in treating injured human subjects is not yet known. To compare the efficacy of an intermittent cryotherapy treatment protocol with a standard cryotherapy treatment protocol in the management of acute ankle sprains. Sportsmen (n = 44) and members of the general public (n = 45) with mild/moderate acute ankle sprains. Subjects were randomly allocated, under strictly controlled double blind conditions, to one of two treatment groups: standard ice application (n = 46) or intermittent ice application (n = 43). The mode of cryotherapy was standardised across groups and consisted of melting iced water (0 degrees C) in a standardised pack. Function, pain, and swelling were recorded at baseline and one, two, three, four, and six weeks after injury. Subjects treated with the intermittent protocol had significantly (p<0.05) less ankle pain on activity than those using a standard 20 minute protocol; however, one week after ankle injury, there were no significant differences between groups in terms of function, swelling, or pain at rest. Intermittent applications may enhance the therapeutic effect of ice in pain relief after acute soft tissue injury.

  16. The development of the cell cryopreservation protocol with controlled rate thawing.

    PubMed

    Gurina, Tatyana M; Pakhomov, Alexandr V; Polyakova, Anna L; Legach, Evgeniy I; Bozhok, Galyna A

    2016-06-01

    Thawing in the water bath is often considered as a standard procedure. The thermal history of samples thawed in this way is poorly controlled, but cryopreservation and banking of cell-based products require standardization, automation and safety of all the technological stages including thawing. The programmable freezers allow implementation of the controlled cooling as well as the controlled thawing. As the cell damage occurs during the phase transformation that takes place in the cryoprotectant medium in the process of freezing-thawing, the choice of warming rates within the temperature intervals of transformations is very important. The goal of the study was to investigate the influence of warming rates within the intervals of the phase transformations in the DMSO-based cryoprotectant medium on the cell recovery and to develop a cryopreservation protocol with controlled cooling and warming rates. The temperature intervals of phase transformations such as melting of the eutectic mixture of the cryoprotectant solution (MEMCS), melting of the eutectic salt solution (MESS), melting of the main ice mass (MMIM), recrystallization before MEMCS, recrystallization before MESS and recrystallization before MMIM were determined by thermo-mechanical analysis. The biological experiments were performed on the rat testicular interstitial cells (TIC). The highest levels of the cell recovery and metabolic activity after cryopreservation were obtained using the protocol with the high (20 °C/min) warming rate in the temperature intervals of crystallization of the eutectics as well as recrystallizations and the low (1 °C/min) warming rate in the temperature intervals of melting of the eutectics as well as MMIM. The total cell recovery was 65.3 ± 2.1 %, the recovery of the 3-beta-HSD-positive (Leydig) cells was 82.9 ± 1.8 %, the MTT staining was 32.5 ± 0.9 % versus 42.1 ± 1.7 %; 57.4 ± 2.1 % and 24.0 ± 1.1 % respectively, when compared to the thawing in

  17. Effectiveness of muscle strengthening and description of protocols for preventing falls in the elderly: a systematic review

    PubMed Central

    Ishigaki, Erika Y.; Ramos, Lidiane G.; Carvalho, Elisa S.; Lunardi, Adriana C.

    2014-01-01

    Background Falls are a geriatric syndrome that is considered a significant public health problem in terms of morbidity and mortality because they lead to a decline in functional capacity and an impaired quality of life in the elderly. Lower limb muscle strengthening seems to be an effective intervention for preventing falls; however, there is no consensus regarding the best method for increasing lower limb muscle strength. Objectives To analyze the effectiveness of lower limb muscle strengthening and to investigate and describe the protocols used for preventing falls in elderly subjects. Method We performed a systematic review of randomized and controlled clinical trials published between 2002 and 2012 in the databases PubMed, EMBASE, Scopus, Web of Science, and PEDro that cited some type of lower limb muscle strengthening protocol and that evaluated the incidence of falls as the primary outcome exclusively in elderly subjects. Twelve studies met the inclusion criteria. Qualitative analysis was performed by independent reviewers applying the PEDro scale. Results The data obtained from the selected studies showed lower fall rates in the intervention groups compared to controls. Six studies described the lower limb muscle strengthening protocol in detail. High methodological quality was found in 6 studies (PEDro score ≥7/10 points). Conclusions The methodological quality of the studies in this area appears to leave little doubt regarding the effectiveness of lower limb strengthening exercises for preventing falls in elderly subjects, however the interventions in these studies were poorly reported. PMID:24760166

  18. [Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

    PubMed

    Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

    2015-06-01

    The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

  19. Automated Data Quality Assurance using OGC Sensor Web Enablement Frameworks for Marine Observatories

    NASA Astrophysics Data System (ADS)

    Toma, Daniel; Bghiel, Ikram; del Rio, Joaquin; Hidalgo, Alberto; Carreras, Normandino; Manuel, Antoni

    2014-05-01

    Over the past years, environmental sensors have continuously improved by becoming smaller, cheaper, and more intelligent. Therefore, many sensor networks are increasingly deployed to monitor our environment. But due to the large number of sensor manufacturers, accompanying protocols and data encoding, automated integration and data quality assurance of diverse sensors in an observing systems is not straightforward, requiring development of data management code and manual tedious configuration. However, over the past few years it has been demonstrated that Open-Geospatial Consortium (OGC) frameworks can enable web services with fully-described sensor systems, including data processing, sensor characteristics and quality control tests and results. So far, the SWE framework does not describe how to integrate sensors on-the-fly with minimal human intervention. The data management software which enables access to sensors, data processing and quality control tests has to be implemented and the results have to be manually mapped to the SWE models. In this contribution, we describe a Sensor Plug & Play infrastructure for the Sensor Web by combining (1) OGC PUCK protocol - a simple standard embedded instrument protocol to store and retrieve directly from the devices the declarative description of sensor characteristics and quality control tests, (2) an automatic mechanism for data processing and quality control tests underlying the Sensor Web - the Sensor Interface Descriptor (SID) concept, as well as (3) a model for the declarative description of sensor which serves as a generic data management mechanism - designed as a profile and extension of OGC SWE's SensorML standard. We implement and evaluate our approach by applying it to the OBSEA Observatory, and can be used to demonstrate the ability to assess data quality for temperature, salinity, air pressure and wind speed and direction observations off the coast of Garraf, in the north-eastern Spain.

  20. Advance care planning in patients with incurable cancer: study protocol for a randomised controlled trial

    PubMed Central

    Clayton, Josephine; Butow, Phyllis N; Silvester, William; Detering, Karen; Hall, Jane; Kiely, Belinda E; Cebon, Jonathon; Clarke, Stephen; Bell, Melanie L; Stockler, Martin; Beale, Phillip; Tattersall, Martin H N

    2016-01-01

    Introduction There is limited evidence documenting the effectiveness of Advance Care Planning (ACP) in cancer care. The present randomised trial is designed to evaluate whether the administration of formal ACP improves compliance with patients' end-of-life (EOL) wishes and patient and family satisfaction with care. Methods and analysis A randomised control trial in eight oncology centres across New South Wales and Victoria, Australia, is designed to assess the efficacy of a formal ACP intervention for patients with cancer. Patients with incurable cancer and an expected survival of 3–12 months, plus a nominated family member or friend will be randomised to receive either standard care or standard care plus a formal ACP intervention. The project sample size is 210 patient–family/friend dyads. The primary outcome measure is family/friend-reported: (1) discussion with the patient about their EOL wishes and (2) perception that the patient's EOL wishes were met. Secondary outcome measures include: documentation of and compliance with patient preferences for medical intervention at the EOL; the family/friend's perception of the quality of the patient's EOL care; the impact of death on surviving family; patient–family and patient–healthcare provider communication about EOL care; patient and family/friend satisfaction with care; quality of life of patient and family/friend subsequent to trial entry, the patient's strength of preferences for quality of life and length of life; the costs of care subsequent to trial entry and place of death. Ethics and dissemination Ethical approval was received from the Sydney Local Health District (RPA Zone) Human Research Ethical Committee, Australia (Protocol number X13-0064). Study results will be submitted for publication in peer-reviewed journals and presented at national and international conferences. Trial registration number Pre-results; ACTRN12613001288718. PMID:27909034