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.

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

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.

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.

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.

Tuning of automatic exposure control strength in lumbar spine CT.

PubMed

D'Hondt, A; Cornil, A; Bohy, P; De Maertelaer, V; Gevenois, P A; Tack, D

2014-05-01

To investigate the impact of tuning the automatic exposure control (AEC) strength curve (specific to Care Dose 4D®; Siemens Healthcare, Forchheim, Germany) from "average" to "strong" on image quality, radiation dose and operator dependency during lumbar spine CT examinations. Two hospitals (H1, H2), both using the same scanners, were considered for two time periods (P1 and P2). During P1, the AEC curve was "average" and radiographers had to select one of two protocols according to the body mass index (BMI): "standard" if BMI <30.0 kg m(-2) (120 kV-330 mAs) or "large" if BMI >30.0 kg m(-2) (140 kV-280 mAs). During P2, the AEC curve was changed to "strong", and all acquisitions were obtained with one protocol (120 kV and 270 mAs). Image quality was scored and patients' diameters calculated for both periods. 497 examinations were analysed. There was no significant difference in mean diameters according to hospitals and periods (p > 0.801) and in quality scores between periods (p > 0.172). There was a significant difference between hospitals regarding how often the "large" protocol was assigned [13 (10%)/132 patients in H1 vs 37 (28%)/133 in H2] (p < 0.001). During P1, volume CT dose index (CTDIvol) was higher in H2 (+13%; p = 0.050). In both hospitals, CTDIvol was reduced between periods (-19.2% in H1 and -29.4% in H2; p < 0.001). An operator dependency in protocol selection, unexplained by patient diameters or highlighted by image quality scores, has been observed. Tuning the AEC curve from average to strong enables suppression of the operator dependency in protocol selection and related dose increase, while preserving image quality. CT acquisition protocols based on weight are responsible for biases in protocol selection. Using an appropriate AEC strength curve reduces the number of protocols to one. Operator dependency of protocol selection is thereby eliminated.

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.

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, administrative staff, and hospital management. Some of the IT solutions presented in this paper are novel and currently unique to our institution. PACS number: 87.57.Q PMID:26103176

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.

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

SU-F-J-16: Planar KV Imaging Dose Reduction Study

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

Gershkevitsh, E; Zolotuhhin, D

Purpose: IGRT has become an indispensable tool in modern radiotherapy with kV imaging used in many departments due to superior image quality and lower dose when compared to MV imaging. Many departments use manufacturer supplied protocols for imaging which are not always optimised between image quality and radiation dose (ALARA). Methods: Whole body phantom PBU-50 (Kyoto Kagaku ltd., Japan) for imaging in radiology has been imaged on Varian iX accelerator (Varian Medical Systems, USA) with OBI 1.5 system. Manufacturer’s default protocols were adapted by modifying kV and mAs values when imaging different anatomical regions of the phantom (head, thorax, abdomen,more » pelvis, extremities). Images with different settings were independently reviewed by two persons and their suitability for IGRT set-up correction protocols were evaluated. The suitable images with the lowest mAs were then selected. The entrance surface dose (ESD) for manufacturer’s default protocols and modified protocols were measured with RTI Black Piranha (RTI Group, Sweden) and compared. Image quality was also measured with kVQC phantom (Standard Imaging, USA) for different protocols. The modified protocols have been applied for clinical work. Results: For most cases optimized protocols reduced the ESD on average by a factor of 3(range 0.9–8.5). Further reduction in ESD has been observed by applying bow-tie filter designed for CBCT. The largest reduction in dose (12.2 times) was observed for Thorax lateral protocol. The dose was slightly increased (by 10%) for large pelvis AP protocol. Conclusion: Manufacturer’s default IGRT protocols could be optimised to reduce the ESD to the patient without losing the necessary image quality for patient set-up correction. For patient set-up with planar kV imaging the bony anatomy is mostly used and optimization should focus on this aspect. Therefore, the current approach with anthropomorphic phantom is more advantageous in optimization over standard kV quality control phantoms and SNR metrics.« less

Stochastic Characterization of Communication Network Latency for Wide Area Grid Control Applications.

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

Ameme, Dan Selorm Kwami; Guttromson, Ross

This report characterizes communications network latency under various network topologies and qualities of service (QoS). The characterizations are probabilistic in nature, allowing deeper analysis of stability for Internet Protocol (IP) based feedback control systems used in grid applications. The work involves the use of Raspberry Pi computers as a proxy for a controlled resource, and an ns-3 network simulator on a Linux server to create an experimental platform (testbed) that can be used to model wide-area grid control network communications in smart grid. Modbus protocol is used for information transport, and Routing Information Protocol is used for dynamic route selectionmore » within the simulated network.« less

Minimizing variance in pediatric gastrostomy: does standardized perioperative feeding plan decrease cost and improve outcomes?

PubMed

Sunstrom, Rachel; Hamilton, Nicholas; Fialkowski, Elizabeth; Lofberg, Katrine; McKee, Julie; Sims, Thomas; Krishnaswami, Sanjay; Azarow, Kenneth

2016-05-01

A protocol for laparoscopic gastrostomy placement was implemented which specified perioperative antibiotics, feeding regimens, and discharge criteria. Our hypothesis was that hospital cost could be decreased, whereas at the same time improving or maintaining patient outcomes. Data were collected on consecutive patients beginning 6 months after implementation of our protocol. We recorded surgeon compliance, patient outcomes (as defined by 30-day NSQIP complication rates), and cost of initial hospitalization, which was then compare to a 6-month historical control period. Our control group n = 26 and protocol group n = 39. Length of stay was shorter in the protocol group (P ≤ .05 by nonparametric analysis). The complication rate was similar in both groups (23% control vs 15% protocol, P = .43). Initial hospital costs were not different. Surgeon compliance to protocol was 82%. A standard protocol is achievable for gastrostomy tube management. After implementation of our protocol, we were able to show a significant decrease in length of stay, whereas maintaining quality. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

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...

Improving Sleep for Hospitalized Antepartum Patients: A Non-Randomized Controlled Pilot Study.

PubMed

Lee, Kathryn A; Gay, Caryl L

2017-12-15

To evaluate feasibility and efficacy of a hospital-based protocol for improving sleep in high- risk antepartum patients. Sleep measures were compared during 1 week of hospitalization before and after implementing a Sleep Improvement Protocol for Antepartum Patients (SIP-AP). A non-randomized convenience sample of usual care controls was compared to a subsequent intervention sample after the protocol was implemented. Women were eligible if they spoke English, were medically stable, pregnant for at least 20 weeks, and hospitalized at least 24 hours; 25 pregnant women had sufficient data for analyses (11 controls, 14 intervention). Sleep was assessed in 3 ways: the Pittsburgh Sleep Quality Index was completed after obtaining consent to estimate sleep quality prior to hospital admission; sleep diary completed each hospital day; and General Sleep Disturbance Scale completed at 7 days or prior to hospital discharge. Symptoms that could affect sleep were assessed with the Memorial Symptom Assessment Scale. Both groups recorded similar sleep duration (7 hours) but the intervention group had fewer symptoms and significantly ( P = .015) lower sleep disturbance scores (53.1 ± 14.5) than controls (71.9 ± 18.8). Participant feedback about the intervention was positive, although adherence to components of the intervention protocol was variable. This pilot study provides evidence of the feasibility and preliminary efficacy of the SIP-AP intervention for reducing symptoms and improving sleep of antepartum patients during hospitalization. Further detailed evaluation of specific components of this protocol is warranted, and other types of hospitalized patients may benefit from unit-based modifications to this SIP-AP protocol. © 2017 American Academy of Sleep Medicine

Dedicated dental volumetric and total body multislice computed tomography: a comparison of image quality and radiation dose

NASA Astrophysics Data System (ADS)

Strocchi, Sabina; Colli, Vittoria; Novario, Raffaele; Carrafiello, Gianpaolo; Giorgianni, Andrea; Macchi, Aldo; Fugazzola, Carlo; Conte, Leopoldo

2007-03-01

Aim of this work is to compare the performances of a Xoran Technologies i-CAT Cone Beam CT for dental applications with those of a standard total body multislice CT (Toshiba Aquilion 64 multislice) used for dental examinations. Image quality and doses to patients have been compared for the three main i-CAT protocols, the Toshiba standard protocol and a Toshiba modified protocol. Images of two phantoms have been acquired: a standard CT quality control phantom and an Alderson Rando ® anthropomorphic phantom. Image noise, Signal to Noise Ratio (SNR), Contrast to Noise Ratio (CNR) and geometric accuracy have been considered. Clinical image quality was assessed. Effective dose and doses to main head and neck organs were evaluated by means of thermo-luminescent dosimeters (TLD-100) placed in the anthropomorphic phantom. A Quality Index (QI), defined as the ratio of squared CNR to effective dose, has been evaluated. The evaluated effective doses range from 0.06 mSv (i-CAT 10 s protocol) to 2.37 mSv (Toshiba standard protocol). The Toshiba modified protocol (halved tube current, higher pitch value) imparts lower effective dose (0.99 mSv). The conventional CT device provides lower image noise and better SNR, but clinical effectiveness similar to that of dedicated dental CT (comparable CNR and clinical judgment). Consequently, QI values are much higher for this second CT scanner. No geometric distortion has been observed with both devices. As a conclusion, dental volumetric CT supplies adequate image quality to clinical purposes, at doses that are really lower than those imparted by a conventional CT device.

QA/QC in the laboratory

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

Hood, F.C.

1992-05-01

Quality assurance and quality control (QA/QC) of analytical chemistry laboratory activities are essential to the validity and usefulness of resultant data. However, in themselves, conventional QA/QC measures will not always ensure that fraudulent data are not generated. Conventional QA/QC measures are based on the assumption that work will be done in good faith; to assure against fraudulent practices, QA/QC measures must be tailored to specific analyses protocols in anticipation of intentional misapplication of those protocols. Application of specific QA/QC measures to ensure against fraudulent practices result in an increased administrative burden being placed on the analytical process; accordingly, in keepingmore » with graded QA philosophy, data quality objectives must be used to identify specific points of concern for special control to minimize the administrative impact.« less

QA/QC in the laboratory. Session F

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

Hood, F.C.

1992-05-01

Quality assurance and quality control (QA/QC) of analytical chemistry laboratory activities are essential to the validity and usefulness of resultant data. However, in themselves, conventional QA/QC measures will not always ensure that fraudulent data are not generated. Conventional QA/QC measures are based on the assumption that work will be done in good faith; to assure against fraudulent practices, QA/QC measures must be tailored to specific analyses protocols in anticipation of intentional misapplication of those protocols. Application of specific QA/QC measures to ensure against fraudulent practices result in an increased administrative burden being placed on the analytical process; accordingly, in keepingmore » with graded QA philosophy, data quality objectives must be used to identify specific points of concern for special control to minimize the administrative impact.« less

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.

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.

Standardized quality-assessment system to evaluate pressure ulcer care in the nursing home.

PubMed

Bates-Jensen, Barbara M; Cadogan, Mary; Jorge, Jennifer; Schnelle, John F

2003-09-01

To demonstrate reliability and feasibility of a standardized protocol to assess and score quality indicators relevant to pressure ulcer (PU) care processes in nursing homes (NHs). Descriptive. Eight NHs. One hundred ninety-one NH residents for whom the PU Resident Assessment Protocol of the Minimum Data Set was initiated. Nine quality indicators (two related to screening and prevention of PU, two focused on assessment, and five addressing management) were scored using medical record data, direct human observation, and wireless thigh monitor observation data. Feasibility and reliability of medical record, observation, and thigh monitor protocols were determined. The percentage of participants who passed each of the indicators, indicating care consistent with practice guidelines, ranged from 0% to 98% across all indicators. In general, participants in NHs passed fewer indicators and had more problems with medical record accuracy before a PU was detected (screening/prevention indicators) than they did once an ulcer was documented (assessment and management indicators). Reliability of the medical record protocol showed kappa statistics ranging from 0.689 to 1.00 and percentage agreement from 80% to 100%. Direct observation protocols yielded kappa statistics of 0.979 and 0.928. Thigh monitor protocols showed kappa statistics ranging from 0.609 to 0.842. Training was variable, with the observation protocol requiring 1 to 2 hours, medical records requiring joint review of 20 charts with average time to complete the review of 20 minutes, and the thigh monitor data requiring 1 week for training in data preparation and interpretation. The standardized quality assessment system generated scores for nine PU quality indicators with good reliability and provided explicit scoring rules that permit reproducible conclusions about PU care. The focus of the indicators on care processes that are under the control of NH staff made the protocol useful for external survey and internal quality improvement purposes, and the thigh monitor observational technology provided a method for monitoring repositioning care processes that were otherwise difficult to monitor and manage.

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.

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.

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

40 CFR 266.103 - Interim status standards for burners.

Code of Federal Regulations, 2014 CFR

2014-07-01

... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

40 CFR 266.103 - Interim status standards for burners.

Code of Federal Regulations, 2011 CFR

2011-07-01

... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

40 CFR 266.103 - Interim status standards for burners.

Code of Federal Regulations, 2010 CFR

2010-07-01

... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

40 CFR 266.103 - Interim status standards for burners.

Code of Federal Regulations, 2012 CFR

2012-07-01

... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

40 CFR 266.103 - Interim status standards for burners.

Code of Federal Regulations, 2013 CFR

2013-07-01

... complying with the CO controls of § 266.104(c), the CO limit is established based on the compliance test... testing planned, including a complete copy of the test protocol and Quality Assurance/Quality Control (QA...; (vi) In subpart G (Closure and post-closure), §§ 265.111-265.115; (vii) In subpart H (Financial...

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.

Psychological treatment of Comorbid Asthma and Panic Disorder: A Pilot Study

PubMed Central

Lehrer, Paul M.; Karavidas, Maria Katsamanis; Lu, Shou-En; Feldman, Jonathan; Kranitz, Linda; Abraham, Smrithy; Sanderson, William; Reynolds, Russ

2008-01-01

We evaluated two protocols for treating adults with comorbid asthma and panic disorder. The protocols included elements of Barlow’s “panic control therapy” and several asthma education programs, as well as modules designed to teach participants how to differentiate asthma and panic symptoms, and how to apply specific home management strategies for each. Fifty percent of subjects dropped out of a 14-session protocol by the eighth session; however, 83% of patients were retained in an eight-session protocol. Clinical results were mostly equivalent: significant decreases of >50% in panic symptoms, clinically significant decreases in asthma symptoms, improvement in asthma quality of life, and maintenance of clinical stability in asthma. Albuterol use decreased significantly in the 14-session protocol and at a borderline level in the 8-session protocol, while pulmonary function was maintained. A controlled evaluation of this procedure is warranted. PMID:17693054

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.

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.

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.

Multicenter Cell Processing for Cardiovascular Regenerative Medicine Applications - The Cardiovascular Cell Therapy Research Network (CCTRN) Experience

PubMed Central

Gee, Adrian P.; Richman, Sara; Durett, April; McKenna, David; Traverse, Jay; Henry, Timothy; Fisk, Diann; Pepine, Carl; Bloom, Jeannette; Willerson, James; Prater, Karen; Zhao, David; Koç, Jane Reese; Ellis, Steven; Taylor, Doris; Cogle, Christopher; Moyé, Lemuel; Simari, Robert; Skarlatos, Sonia

2013-01-01

Background Aims Multi-center cellular therapy clinical trials require the establishment and implementation of standardized cell processing protocols and associated quality control mechanisms. The aims here were to develop such an infrastructure in support of the Cardiovascular Cell Therapy Research Network (CCTRN) and to report on the results of processing for the first 60 patients. Methods Standardized cell preparations, consisting of autologous bone marrow mononuclear cells, prepared using the Sepax device were manufactured at each of the five processing facilities that supported the clinical treatment centers. Processing staff underwent centralized training that included proficiency evaluation. Quality was subsequently monitored by a central quality control program that included product evaluation by the CCTRN biorepositories. Results Data from the first 60 procedures demonstrate that uniform products, that met all release criteria, could be manufactured at all five sites within 7 hours of receipt of the bone marrow. Uniformity was facilitated by use of the automated systems (the Sepax for processing and the Endosafe device for endotoxin testing), standardized procedures and centralized quality control. Conclusions Complex multicenter cell therapy and regenerative medicine protocols can, where necessary, successfully utilize local processing facilities once an effective infrastructure is in place to provide training, and quality control. PMID:20524773

Effects of exercise with or without light exposure on sleep quality and hormone reponses

PubMed Central

Lee, Hayan; Kim, Sunho; Kim, Donghee

2014-01-01

[Purpose] The objectives of the present study were to determine the effect of sun exposure and aerobic exercise on quality of sleep and investigate sleep-related hormonal responses in college-aged males. [Methods] In this study, the cross-over design was utilized. The subjects (N = 10) without any physical problems or sleep disorders participated in the experimental performed 4 protocols in only sun exposure (for 30 minutes, EG1) protocol, only aerobic exercise (walking and jogging for 30 minutes, EG2) protocol, aerobic exercise with sun exposure (EG3) protocol, and control (no exercise and no sun exposure, EG4) protocol. Each protocol was 5 times per week with one-week break (wash-out period) between protocols to prevent the effects of the previous protocol. Total test period was should be 7 weeks (one week of protocol and one week of break). Before and after each aerobic exercise session, the subjects completed stretching to warm up for 5 to 10 minutes. Surveys consisting of (bedtime, wake-up time, sleep onset latency, and (Pittsburgh Sleep Quality Index (PSQI) were obtained before the test and after each protocol. After each protocol, the following sleep-related hormonal responses were measured: blood concentrations of melatonin, cortisol, epinephrine, and norepinephrine. One-way ANOVA was used to determine differences between protocols. Statistical significance was set at p < 0.05. [Results] Bedtime of EG4 was significantly later than that of the EG1 or EG3. Wake-up time in the EG4 was significantly later than that of the EG1 or the EG3. Sleep onset latency in the EG4 was longer than that of the EG3. The quality of sleep in the EG4 was lower than that of the EG3. Sleep cycle in the EG4 was significantly shorter than that of the EG1. Blood melatonin concentrations of the EG3 was significantly higher than that of the EG4. There were no significant differences in blood concentrations of cortisol, epinephrine, or norepinephrine among protocols, with the order from the lowest to the highest values of EG1 < EG2 < EG3 < EG4. [Conclusion] The present data found that EG1 and EG3 showed positive sleep-related hormonal responses, sleep habits, and quality of sleep, indicating that sun exposure or exercise with sun exposure may improve the physical status and quality of life. PMID:25566466

Manipulation of follicle development to ensure optimal oocyte quality and conception rates in cattle.

PubMed

Baruselli, P S; Sá Filho, M F; Ferreira, R M; Sales, J N S; Gimenes, L U; Vieira, L M; Mendanha, M F; Bó, G A

2012-08-01

Over the last several decades, a number of therapies have been developed that manipulate ovarian follicle growth to improve oocyte quality and conception rates in cattle. Various strategies have been proposed to improve the responses to reproductive biotechnologies following timed artificial insemination (TAI), superovulation (SOV) or ovum pickup (OPU) programmes. During TAI protocols, final follicular growth and size of the ovulatory follicle are key factors that may significantly influence oocyte quality, ovulation, the uterine environment and consequently pregnancy outcomes. Progesterone concentrations during SOV protocols influence follicular growth, oocyte quality and embryo quality; therefore, several adjustments to SOV protocols have been proposed depending on the animal category and breed. In addition, the success of in vitro embryo production is directly related to the number and quality of cumulus oocyte complexes harvested by OPU. Control of follicle development has a significant impact on the OPU outcome. This article discusses a number of key points related to the manipulation of ovarian follicular growth to maximize oocyte quality and improve conception rates following TAI and embryo transfer of in vivo- and in vitro-derived embryos in cattle. © 2012 Blackwell Verlag GmbH.

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.

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

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.

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

Design of the frame structure for a multiservice interactive system using ATM-PON

NASA Astrophysics Data System (ADS)

Nam, Jae-Hyun; Jang, Jongwook; Lee, Jung-Tae

1998-10-01

The MAC (Medium Access Control) protocol controls B-NT1s' (Optical Network Unit) access to the shared capacity on the PON, this protocol is very important if TDMA (Time Division Multiple Access) multiplexing is used on the upstream. To control the upstream traffic some kind of access protocol has to be implemented. There are roughly two different approaches to use request cells: in a collision free way or such that collisions in a request slot are allowed. It is the objective of this paper to describe a MAC-protocol structure that supports both approaches and hybrids of it. In our paper we grantee the QoS (Quality of Service) of each B-NT1 through LOC, LOV, LOA field that are the length field of the transmitted cell at each B-NT1. Each B-NT1 transmits its status of request on request cell.

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.

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

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.

VERIFYING THE VOC CONTROL PERFORMANCE OF BIOREACTORS

EPA Science Inventory

The paper describes the verification testing approach used to collect high-quality, peer-reviewed data on the performance of bioreaction-based technologies for the control of volatile organic compounds (VOCs). The verification protocol that describes the approach for these tests ...

Technical Note: Independent component analysis for quality assurance in functional MRI.

PubMed

Astrakas, Loukas G; Kallistis, Nikolaos S; Kalef-Ezra, John A

2016-02-01

Independent component analysis (ICA) is an established method of analyzing human functional MRI (fMRI) data. Here, an ICA-based fMRI quality control (QC) tool was developed and used. ICA-based fMRI QC tool to be used with a commercial phantom was developed. In an attempt to assess the performance of the tool relative to preexisting alternative tools, it was used seven weeks before and eight weeks after repair of a faulty gradient amplifier of a non-state-of-the-art MRI unit. More specifically, its performance was compared with the AAPM 100 acceptance testing and quality assurance protocol and two fMRI QC protocols, proposed by Freidman et al. ["Report on a multicenter fMRI quality assurance protocol," J. Magn. Reson. Imaging 23, 827-839 (2006)] and Stocker et al. ["Automated quality assurance routines for fMRI data applied to a multicenter study," Hum. Brain Mapp. 25, 237-246 (2005)], respectively. The easily developed and applied ICA-based QC protocol provided fMRI QC indices and maps equally sensitive to fMRI instabilities with the indices and maps of other established protocols. The ICA fMRI QC indices were highly correlated with indices of other fMRI QC protocols and in some cases theoretically related to them. Three or four independent components with slow varying time series are detected under normal conditions. ICA applied on phantom measurements is an easy and efficient tool for fMRI QC. Additionally, it can protect against misinterpretations of artifact components as human brain activations. Evaluating fMRI QC indices in the central region of a phantom is not always the optimal choice.

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.

Use of cardiocerebral resuscitation or AHA/ERC 2005 Guidelines is associated with improved survival from out-of-hospital cardiac arrest: a systematic review and meta-analysis.

PubMed

Salmen, Marcus; Ewy, Gordon A; Sasson, Comilla

2012-01-01

To determine whether the use of cardiocerebral resuscitation (CCR) or AHA/ERC 2005 Resuscitation Guidelines improved patient outcomes from out-of-hospital cardiac arrest (OHCA) compared to older guidelines. Systematic review and meta-analysis. MEDLINE, EMBASE, Web of Science and the Cochrane Library databases. We also hand-searched study references and consulted experts. Design: randomised controlled trials and observational studies. OHCA patients, age >17 years. 'Control' protocol versus 'Study' protocol. 'Control' protocol defined as AHA/ERC 2000 Guidelines for cardiopulmonary resuscitation (CPR). 'Study' protocol defined as AHA/ERC 2005 Guidelines for CPR, or a CCR protocol. Survival to hospital discharge. High-quality or medium-quality studies, as measured by the Newcastle Ottawa Scale using predefined categories. Twelve observational studies met inclusion criteria. All the three studies using CCR demonstrated significantly improved survival compared to use of AHA 2000 Guidelines, as did five of the nine studies using AHA/ERC 2005 Guidelines. Pooled data demonstrate that use of a CCR protocol has an unadjusted OR of 2.26 (95% CI 1.64 to 3.12) for survival to hospital discharge among all cardiac arrest patients. Among witnessed ventricular fibrillation/ventricular tachycardia (VF/VT) patients, CCR increased survival by an OR of 2.98 (95% CI 1.92 to 4.62). Studies using AHA/ERC 2005 Guidelines showed an overall trend towards increased survival, but significant heterogeneity existed among these studies. We demonstrate an association with improved survival from OHCA when CCR protocols or AHA/ERC 2005 Guidelines are compared to use of older guidelines. In the subgroup of patients with witnessed VF/VT, there was a threefold increase in OHCA survival when CCR was used. CCR appears to be a promising resuscitation protocol for Emergency Medical Services providers in increasing survival from OHCA. Future research will need to be conducted to directly compare AHA/ERC 2010 Guidelines with the CCR approach.

Development and validation of a protocol for optimizing the use of paraffin blocks in molecular epidemiological studies: The example from the HPV-AHEAD study.

PubMed

Mena, Marisa; Lloveras, Belen; Tous, Sara; Bogers, Johannes; Maffini, Fausto; Gangane, Nitin; Kumar, Rekha Vijay; Somanathan, Thara; Lucas, Eric; Anantharaman, Devasena; Gheit, Tarik; Castellsagué, Xavier; Pawlita, Michael; de Sanjosé, Silvia; Alemany, Laia; Tommasino, Massimo

2017-01-01

Worldwide use of formalin-fixed paraffin-embedded blocks (FFPE) is extensive in diagnosis and research. Yet, there is a lack of optimized/standardized protocols to process the blocks and verify the quality and presence of the targeted tissue. In the context of an international study on head and neck cancer (HNC)-HPV-AHEAD, a standardized protocol for optimizing the use of FFPEs in molecular epidemiology was developed and validated. First, a protocol for sectioning the FFPE was developed to prevent cross-contamination and distributed between participating centers. Before processing blocks, all sectioning centers underwent a quality control to guarantee a satisfactory training process. The first and last sections of the FFPEs were used for histopathological assessment. A consensus histopathology evaluation form was developed by an international panel of pathologists and evaluated for four indicators in a pilot analysis in order to validate it: 1) presence/type of tumor tissue, 2) identification of other tissue components that could affect the molecular diagnosis and 3) quality of the tissue. No HPV DNA was found in sections from empty FFPE generated in any histology laboratories of HPV-AHEAD consortium and all centers passed quality assurance for processing after quality control. The pilot analysis to validate the histopathology form included 355 HNC cases. The form was filled by six pathologists and each case was randomly assigned to two of them. Most samples (86%) were considered satisfactory. Presence of >50% of invasive carcinoma was observed in all sections of 66% of cases. Substantial necrosis (>50%) was present in <2% of samples. The concordance for the indicators targeted to validate the histopathology form was very high (kappa > 0.85) between first and last sections and fair to high between pathologists (kappa/pabak 0.21-0.72). The protocol allowed to correctly process without signs of contamination all FFPE of the study. The histopathology evaluation of the cases assured the presence of the targeted tissue, identified the presence of other tissues that could disturb the molecular diagnosis and allowed the assessment of tissue quality.

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

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.

Bandwidth Management in Resource Constrained Networks

DTIC Science & Technology

2012-03-01

Postgraduate School OSI Open Systems Interconnection QoS Quality of Service TCP Transmission Control Protocol/Internet Protocol TCP/IP Transmission...filtering. B. NORMAL TCP/IP COMMUNICATIONS The Internet is a “complex network WAN that connects LANs and clients around the globe” (Dean, 2009...of the Open Systems Interconnection ( OSI ) model allowing them to route traffic based on MAC address (Kurose & Ross, 2009). While switching

An adaptive toolkit for image quality evaluation in system performance test of digital breast tomosynthesis

NASA Astrophysics Data System (ADS)

Zhang, Guozhi; Petrov, Dimitar; Marshall, Nicholas; Bosmans, Hilde

2017-03-01

Digital breast tomosynthesis (DBT) is a relatively new diagnostic imaging modality for women. Currently, various models of DBT systems are available on the market and the number of installations is rapidly increasing. EUREF, the European Reference Organization for Quality Assured Breast Screening and Diagnostic Services, has proposed a preliminary Guideline - protocol for the quality control of the physical and technical aspects of digital breast tomosynthesis systems, with an ultimate aim of providing limiting values guaranteeing proper performance for different applications of DBT. In this work, we introduce an adaptive toolkit developed in accordance with this guideline to facilitate the process of image quality evaluation in DBT performance test. This toolkit implements robust algorithms to quantify various technical parameters of DBT images and provides a convenient user interface in practice. Each test is built into a separate module with configurations set corresponding to the European guideline, which can be easily adapted to different settings and extended with additional tests. This toolkit largely improves the efficiency for image quality evaluation of DBT. It is also going to evolve with the development of protocols in quality control of DBT systems.

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.

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

Oral medications including clomiphene citrate or aromatase inhibitors with gonadotropins for controlled ovarian stimulation in women undergoing in vitro fertilisation.

PubMed

Kamath, Mohan S; Maheshwari, Abha; Bhattacharya, Siladitya; Lor, Kar Yee; Gibreel, Ahmed

2017-11-02

Gonadotropins are the most commonly used medications for controlled ovarian stimulation in in vitro fertilisation (IVF). However, they are expensive and invasive, and are associated with the risk of ovarian hyperstimulation syndrome (OHSS). Recent calls for more patient-friendly regimens have led to growing interest in the use of clomiphene citrate (CC) and aromatase inhibitors with or without gonadotropins to reduce the burden of hormonal injections. It is currently unknown whether regimens using CC or aromatase inhibitors such as letrozole (Ltz) are as effective as gonadotropins alone. To determine the effectiveness and safety of regimens including oral induction medication (such as clomiphene citrate or letrozole) versus gonadotropin-only regimens for controlled ovarian stimulation in IVF or intracytoplasmic sperm injection (ICSI) treatment. We searched the following databases: Cochrane Gynaecology and Fertility Group Specialised Register (searched January 2017), the Cochrane Central Register of Controlled Trials (CENTRAL CRSO), MEDLINE (1946 to January 2017), Embase (1980 to January 2017), and reference lists of relevant articles. We also searched trials registries ClinicalTrials.gov (clinicaltrials.gov/) and the World Health Organization International Clinical Trials Registry Platform (www.who.int/trialsearch/Default.aspx). We handsearched relevant conference proceedings. We included randomized controlled trials (RCTs). The primary outcomes were live-birth rate (LBR) and OHSS. Three review authors independently assessed trial eligibility and risk of bias. We calculated risk ratios (RR) and Peto odds ratio (OR) with 95% confidence intervals (CIs) for dichotomous outcomes and mean differences (MD) for continuous outcomes. We analyzed the general population of women undergoing IVF treatment and (as a separate analysis) women identified as poor responders. We assessed the overall quality of the evidence using the GRADE approach. We included 27 studies in the updated review. Most of the new trials in the updated review included poor responders and evaluated Ltz protocols. We could perform meta-analysis with data from 22 studies including a total of 3599 participants. The quality of the evidence for different comparisons ranged from low to moderate. The main limitations in the quality of the evidence were risk of bias associated with poor reporting of study methods, and imprecision.In the general population of women undergoing IVF, it is unclear whether CC or Ltz used with or without gonadotropins compared to use of gonadotropins along with gonadotropin-releasing hormone (GnRH) agonists or antagonists resulted in a difference in live birth (RR 0.92, 95% CI 0.66 to 1.27, 4 RCTs, n = 493, I 2 = 0%, low-quality evidence) or clinical pregnancy rate (RR 1.00, 95% CI 0.86 to 1.16, 12 RCTs, n = 1998, I 2 = 3%, moderate-quality evidence). This means that for a typical clinic with 23% LBR using a GnRH agonist regimen, switching to CC or Ltz protocols would be expected to result in LBRs between 15% and 30%. Clomiphene citrate or Ltz protocols were associated with a reduction in the incidence of OHSS (Peto OR 0.21, 95% CI 0.11 to 0.41, 5 RCTs, n = 1067, I 2 = 0%, low-quality evidence). This means that for a typical clinic with 6% prevalence of OHSS associated with a GnRH regimen, switching to CC or Ltz protocols would be expected to reduce the incidence to between 0.5% and 2.5%. We found evidence of an increase in cycle cancellation rate with the CC protocol compared to gonadotropins in GnRH protocols (RR 1.87, 95% CI 1.43 to 2.45, 9 RCTs, n = 1784, I 2 = 61%, low-quality evidence). There was moderate quality evidence of a decrease in the mean number of ampoules used,) and mean number of oocytes collected with CC with or without gonadotropins compared to the gonadotropins in GnRH agonist protocols, though data were too heterogeneous to pool.Similarly, in the poor-responder population, it is unclear whether there was any difference in rates of live birth (RR 1.16, 95% CI 0.49 to 2.79, 2 RCTs, n = 357, I 2 = 38%, low-quality evidence) or clinical pregnancy (RR 0.85, 95% CI 0.64 to 1.12, 8 RCTs, n = 1462, I 2 = 0%, low-quality evidence) following CC or Ltz with or without gonadotropin versus gonadotropin and GnRH protocol. This means that for a typical clinic with a 5% LBR in the poor responders using a GnRH protocol, switching to CC or Ltz protocols would be expected to yield LBRs between 2% to 14%. There was low quality evidence that the CC or Ltz protocols were associated with an increase in the cycle cancellation rate (RR 1.46, 95% CI 1.18 to 1.81, 10 RCTs, n = 1601, I 2 = 64%) and moderate quality evidence of a decrease in the mean number of gonadotropin ampoules used and the mean number of oocytes collected, though data were too heterogeneous to pool. The adverse effects of these protocols were poorly reported. In addition, data on foetal abnormalities following use of CC or Ltz protocols are lacking. We found no conclusive evidence indicating that clomiphene citrate or letrozole with or without gonadotropins differed from gonadotropins in GnRH agonist or antagonist protocols with respect to their effects on live-birth or pregnancy rates, either in the general population of women undergoing IVF treatment or in women who were poor responders. Use of clomiphene or letrozole led to a reduction in the amount of gonadotropins required and the incidence of OHSS. However, use of clomiphene citrate or letrozole may be associated with a significant increase in the incidence of cycle cancellations, as well as reductions in the mean number of oocytes retrieved in both the general IVF population and the poor responders. Larger, high-quality randomized trials are needed to reach a firm conclusion before they are adopted into routine clinical practice.

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.

Short-Term Health-Related Quality of Life of Critically Ill Children Following Daily Sedation Interruption.

PubMed

Vet, Nienke J; de Wildt, Saskia N; Verlaat, Carin W M; Mooij, Miriam G; Tibboel, Dick; de Hoog, Matthijs; Buysse, Corinne M P

2016-11-01

Our earlier pediatric daily sedation interruption trial showed that daily sedation interruption in addition to protocolized sedation in critically ill children does not reduce duration of mechanical ventilation, length of stay, or amounts of sedative drugs administered when compared with protocolized sedation only, but undersedation was more frequent in the daily sedation interruption + protocolized sedation group. We now report the preplanned analysis comparing short-term health-related quality of life and posttraumatic stress symptoms between the two groups. Preplanned prospective part of a randomized controlled trial. Two tertiary medical-surgical PICUs in the Netherlands. Critically ill children requiring mechanical ventilation. None. Eight weeks after a child's discharge from the PICU, health-related quality of life was assessed with the validated Child Health Questionnaire and, only for children above 4 years old, posttraumatic stress was assessed with the Dutch Children's Responses to Trauma Inventory. Additionally, health-related quality of life of all study patients was compared with Dutch normative data. Of the 113 patients from two participating centers in the original study, 96 patients were eligible for follow-up and 64 patients were included (response rate, 67%). No difference was found with respect to health-related quality of life between the two study groups. None of the eight children more than 4 years old showed posttraumatic stress symptoms. Daily sedation interruption in addition to protocolized sedation for critically ill children did not seem to have an effect on short-term health-related quality of life. Also in view of the earlier found absence of effect on clinical outcome, we cannot recommend the use of daily sedation interruption + protocolized sedation.

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

To compare the quality of images obtained with two different protocols with different acquisition time and the influence from image post processing in a chest digital tomosynthesis (DTS) system. 20 patients with suspected lung cancer were imaged with a chest X-ray equipment with tomosynthesis option. Two examination protocols with different acquisition times (6.3 and 12 s) were performed on each patient. Both protocols were presented with two different image post-processing (standard DTS processing and more advanced processing optimised for chest radiography). Thus, 4 series from each patient, altogether 80 series, were presented anonymously and in a random order. Five observers rated the quality of the reconstructed section images according to predefined quality criteria in three different classes. Visual grading characteristics (VGC) was used to analyse the data and the area under the VGC curve (AUC VGC ) was used as figure-of-merit. The 12 s protocol and the standard DTS processing were used as references in the analyses. The protocol with 6.3 s acquisition time had a statistically significant advantage over the vendor-recommended protocol with 12 s acquisition time for the classes of criteria, Demarcation (AUC VGC = 0.56, p = 0.009) and Disturbance (AUC VGC = 0.58, p < 0.001). A similar value of AUC VGC was found also for the class Structure (definition of bone structures in the spine) (0.56) but it could not be statistically separated from 0.5 (p = 0.21). For the image processing, the VGC analysis showed a small but statistically significant advantage for the standard DTS processing over the more advanced processing for the classes of criteria Demarcation (AUC VGC = 0.45, p = 0.017) and Disturbance (AUC VGC = 0.43, p = 0.005). A similar value of AUC VGC was found also for the class Structure (0.46), but it could not be statistically separated from 0.5 (p = 0.31). The study indicates that the protocol with 6.3 s acquisition time yields slightly better image 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.

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...

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.

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

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.

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.

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 quantitative metrics (volumetric CT dose index or measured image noise) is feasible. Protocol translation has a dependency on patient size, especially between the GE and Siemens systems. Translation schemes that preserve dose levels may not produce identical image quality. Copyright © 2014 American College of Radiology. Published by Elsevier Inc. All rights reserved.

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

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: 18/02/2016. ClinicalTrials.gov Identifier: NCT02695875 .

Does bone debris in anterior cruciate ligament reconstruction really matter? A cohort study of a protocol for bone debris debridement

PubMed Central

Imam, Mohamed A.; Abdelkafy, Ashraf; Dinah, Feroz; Adhikari, Ajeya

2015-01-01

Background: The purpose of the current study was to determine whether a systematic five-step protocol for debridement and evacuation of bone debris during anterior cruciate ligament reconstruction (ACLR) reduces the presence of such debris on post-operative radiographs. Methods: A five-step protocol for removal of bone debris during arthroscopic assisted ACLR was designed. It was applied to 60 patients undergoing ACLR (Group 1), and high-quality digital radiographs were taken post-operatively in each case to assess for the presence of intra-articular bone debris. A control group of 60 consecutive patients in whom no specific bone debris protocol was applied (Group 2) and their post-operative radiographs were also checked for the presence of intra-articular bone debris. Results: In Group 1, only 15% of post-operative radiographs showed residual bone debris, compared to 69% in Group 2 (p < 0.001). Conclusion: A five-step systematic protocol for bone debris removal during arthroscopic assisted ACLR resulted in a significant decrease in residual bone debris seen on high-quality post-operative radiographs. PMID:27163060

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.

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 disseminated through scientific publication and conferences. CRD42018084273. © 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.

Industrial-scale radio frequency treatments for insect control in lentils

USDA-ARS?s Scientific Manuscript database

Radio frequency (RF) treatments are considered to be a potential postharvest technology for disinfesting legumes of internal seed pests such as the cowpea weevil. After treatment protocols are shown to control postharvest insects without significant quality degradation, it is important to scale-up l...

Fast-track surgery for uncomplicated appendicitis in children: a matched case-control study.

PubMed

Cundy, Thomas P; Sierakowski, Kyra; Manna, Alexandra; Cooper, Celia M; Burgoyne, Laura L; Khurana, Sanjeev

2017-04-01

Standardized post-operative protocols reduce variation and enhance efficiency in patient care. Patients may benefit from these initiatives by improved quality of care. This matched case-control study investigates the effect of a multidisciplinary criteria-led discharge protocol for uncomplicated appendicitis in children. Key protocol components included limiting post-operative antibiotics to two intravenous doses, avoidance of intravenous opioid analgesia, prompt resumption of diet, active encouragement of early ambulation and nursing staff autonomy to discharge patients that met assigned criteria. The study period was from August 2015 to February 2016. Outcomes were compared with a historical control group matched for operative approach. Outcomes for 83 patients enrolled to our protocol were compared with those of 83 controls. There was a 29.2% reduction in median post-operative length of stay in our protocol-based care group (19.6 versus 27.7 h; P < 0.001). The rate of discharges within 24 h improved from 12 to 42%. There was no significant difference in complication rate (4.8 versus 7.2%; P = 0.51). Mean oral morphine dose equivalent per kilogram requirement was less than half (46%) that of control group patients (P < 0.001). Mean number of ondansetron doses was also significantly lower. Projected annual direct cost savings following protocol implementation was AUD$77 057. Implementation of a criteria-led discharge protocol at our hospital decreased length of stay, reduced variation in care, preserved existing low morbidity, incurred substantial cost savings, and safely rationalized opioid and antiemetic medication. These protocols are inexpensive and offer tangible benefits that are accessible to all health care settings. © 2016 Royal Australasian College of Surgeons.

Results of drug screening from a producer's view.

PubMed

Adams, J B

1994-07-01

The dairy industry is faced with increasing governmental and public concern about the safety of the nation's milk supply. New regulations under the Grade A Pasteurized Milk Ordinance require that prescription drugs be properly labeled and that all tanker loads of milk be tested for beta-lactam antimicrobial residues. Concern over the use of animal drugs in an extralabel manner has prompted the National Milk Producers Federation and the American Veterinary Medical Association to develop a quality assurance program for on-farm residue prevention known as the Dairy Quality Assurance 10-Point Milk and Dairy Beef Residue Prevention Protocol. The program promotes the concept of Hazard Analysis Critical Control Points, applied to a pre-harvest farm environment. Screening limitations at point of milk receipt necessitates widespread adoption of the Dairy Quality Assurance protocol to address controlled use of all animal medications under a valid relationship among veterinarian, client, and animals, thus minimizing the potential for violative residues in the milk and meat supply.

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

Implementing the Free Water Protocol does not Result in Aspiration Pneumonia in Carefully Selected Patients with Dysphagia: A Systematic Review.

PubMed

Gillman, Anna; Winkler, Renata; Taylor, Nicholas F

2017-06-01

The Frazier Free Water Protocol was developed with the aim of providing patients with dysphagia an option to consume thin (i.e. unthickened) water in-between mealtimes. A systematic review was conducted of research published in peer-reviewed journals. An electronic search of the EMBASE, CINAHL and MEDLINE databases was completed up to July 2016. A total of 8 studies were identified for inclusion: 5 randomised controlled trials, 2 cohort studies with matched cases and 1 single group pre-post intervention prospective study. A total of 215 rehabilitation inpatients and 30 acute patients with oropharyngeal dysphagia who required thickened fluids or were to remain 'nil by mouth', as determined by bedside swallow assessment and/or videofluoroscopy/fiberoptic endoscopic evaluation of swallowing, were included. Meta-analyses of the data from the rehabilitation studies revealed (1) low-quality evidence that implementing the protocol did not result in increased odds of having lung complications and (2) low-quality evidence that fluid intake may increase. Patients' perceptions of swallow-related quality of life appeared to improve. This review has found that when the protocol is closely adhered to and patients are carefully selected using strict exclusion criteria, including an evaluation of their cognition and mobility, adult rehabilitation inpatients with dysphagia to thin fluids can be offered the choice of implementing the Free Water Protocol. Further research is required to determine if the Free Water Protocol can be implemented in settings other than inpatient rehabilitation.

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.

Scalable Lunar Surface Networks and Adaptive Orbit Access

NASA Technical Reports Server (NTRS)

Wang, Xudong

2015-01-01

Teranovi Technologies, Inc., has developed innovative network architecture, protocols, and algorithms for both lunar surface and orbit access networks. A key component of the overall architecture is a medium access control (MAC) protocol that includes a novel mechanism of overlaying time division multiple access (TDMA) and carrier sense multiple access with collision avoidance (CSMA/CA), ensuring scalable throughput and quality of service. The new MAC protocol is compatible with legacy Institute of Electrical and Electronics Engineers (IEEE) 802.11 networks. Advanced features include efficiency power management, adaptive channel width adjustment, and error control capability. A hybrid routing protocol combines the advantages of ad hoc on-demand distance vector (AODV) routing and disruption/delay-tolerant network (DTN) routing. Performance is significantly better than AODV or DTN and will be particularly effective for wireless networks with intermittent links, such as lunar and planetary surface networks and orbit access networks.

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 maintaining the AD disease effect. Compared to conventional regression methods, our method showed the best performance for in terms of controlling the protocol effect while preserving disease information. Protocol-specific w-score standardization effectively resolved the concerns of conventional regression methods. It showed the best performance for improving the compatibility of a T1 MR post-processed feature, cortical thickness. Copyright © 2017 Elsevier Inc. All rights reserved.

TH-C-18A-06: Combined CT Image Quality and Radiation Dose Monitoring Program Based On Patient Data to Assess Consistency of Clinical Imaging Across Scanner Models

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

Christianson, O; Winslow, J; Samei, E

2014-06-15

Purpose: One of the principal challenges of clinical imaging is to achieve an ideal balance between image quality and radiation dose across multiple CT models. The number of scanners and protocols at large medical centers necessitates an automated quality assurance program to facilitate this objective. Therefore, the goal of this work was to implement an automated CT image quality and radiation dose monitoring program based on actual patient data and to use this program to assess consistency of protocols across CT scanner models. Methods: Patient CT scans are routed to a HIPPA compliant quality assurance server. CTDI, extracted using opticalmore » character recognition, and patient size, measured from the localizers, are used to calculate SSDE. A previously validated noise measurement algorithm determines the noise in uniform areas of the image across the scanned anatomy to generate a global noise level (GNL). Using this program, 2358 abdominopelvic scans acquired on three commercial CT scanners were analyzed. Median SSDE and GNL were compared across scanner models and trends in SSDE and GNL with patient size were used to determine the impact of differing automatic exposure control (AEC) algorithms. Results: There was a significant difference in both SSDE and GNL across scanner models (9–33% and 15–35% for SSDE and GNL, respectively). Adjusting all protocols to achieve the same image noise would reduce patient dose by 27–45% depending on scanner model. Additionally, differences in AEC methodologies across vendors resulted in disparate relationships of SSDE and GNL with patient size. Conclusion: The difference in noise across scanner models indicates that protocols are not optimally matched to achieve consistent image quality. Our results indicated substantial possibility for dose reduction while achieving more consistent image appearance. Finally, the difference in AEC methodologies suggests the need for size-specific CT protocols to minimize variability in image quality across CT vendors.« less

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 cardiac measures and satisfaction with the protocols, revealed no evidence for RSIs. Regarding the quality of the selected articles according to the Cochrane Back Review Group Scale, the average score was 6.83 (SD = 9.08) on a scale of 11, demonstrating robustness in the studies. Conclusion Clinical trials on RSIs demonstrated that they had small benefits compared with other complementary health therapies by reducing pain and weight, improving quality of life and promoting health behaviors. The lack of clinical trials that included biological outcomes and the diversity of approaches indicate a need for more studies to understand the possible mechanisms of action of RSIs and their roles in health care. PMID:29049421

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.

Optimal molecular profiling of tissue and tissue components: defining the best processing and microdissection methods for biomedical applications.

PubMed

Bova, G Steven; Eltoum, Isam A; Kiernan, John A; Siegal, Gene P; Frost, Andra R; Best, Carolyn J M; Gillespie, John W; Su, Gloria H; Emmert-Buck, Michael R

2005-02-01

Isolation of well-preserved pure cell populations is a prerequisite for sound studies of the molecular basis of any tissue-based biological phenomenon. This article reviews current methods for obtaining anatomically specific signals from molecules isolated from tissues, a basic requirement for productive linking of phenotype and genotype. The quality of samples isolated from tissue and used for molecular analysis is often glossed over or omitted from publications, making interpretation and replication of data difficult or impossible. Fortunately, recently developed techniques allow life scientists to better document and control the quality of samples used for a given assay, creating a foundation for improvement in this area. Tissue processing for molecular studies usually involves some or all of the following steps: tissue collection, gross dissection/identification, fixation, processing/embedding, storage/archiving, sectioning, staining, microdissection/annotation, and pure analyte labeling/identification and quantification. We provide a detailed comparison of some current tissue microdissection technologies, and provide detailed example protocols for tissue component handling upstream and downstream from microdissection. We also discuss some of the physical and chemical issues related to optimal tissue processing, and include methods specific to cytology specimens. We encourage each laboratory to use these as a starting point for optimization of their overall process of moving from collected tissue to high quality, appropriately anatomically tagged scientific results. In optimized protocols is a source of inefficiency in current life science research. Improvement in this area will significantly increase life science quality and productivity. The article is divided into introduction, materials, protocols, and notes sections. Because many protocols are covered in each of these sections, information relating to a single protocol is not contiguous. To get the greatest benefit from this article, readers are advised to read through the entire article first, identify protocols appropriate to their laboratory for each step in their workflow, and then reread entries in each section pertaining to each of these single protocols.

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 data.

Procedures of Laboratory Fumigation for Pest Control with Nitric Oxide Gas.

PubMed

Liu, Yong-Biao; Yang, Xiangbing; Masuda, Tiffany

2017-11-24

Nitric oxide (NO) is a newly discovered fumigant for postharvest pest control. This paper provides detailed protocols for conducting NO fumigation on fresh products and procedures for residue analysis and product quality evaluation. An airtight fumigation chamber containing fresh fruit and vegetables is first flushed with nitrogen (N2) to establish an ultralow oxygen (ULO) environment followed by injection of NO. The fumigation chamber is then kept at a low temperature of 2 - 5 °C for a specified time period necessary to kill a target pest to complete a fumigation treatment. At the end of a fumigation treatment, the fumigation chamber is flushed with N2 to dilute NO prior to opening the chamber to ambient air to prevent the reaction between NO and O2, which produces NO2 and may damage delicate fresh products. At different times after NO fumigation, NO2 in headspace and nitrate and nitrite in liquid samples were measured as residues. Product quality was evaluated after 2 weeks of post-treatment cold storage to determine effects of NO fumigation on product quality. Keeping O2 from reacting with NO is critical to NO fumigation and is an important part of the protocols. Measuring NO levels is challenging and a practical solution is provided. Possible protocol modifications are also suggested for measuring NO levels in the fumigation chambers as well as residues. NO fumigation has the potential to be a practical alternative to methyl bromide fumigation for postharvest pest control on fresh and stored products. This publication is intended to assist other researchers in conducting NO fumigation research for postharvest pest control and accelerating the development of NO fumigation for practical applications.

Procedures of Laboratory Fumigation for Pest Control with Nitric Oxide Gas

PubMed Central

Liu, Yong-Biao; Yang, Xiangbing; Masuda, Tiffany

2017-01-01

Nitric oxide (NO) is a newly discovered fumigant for postharvest pest control. This paper provides detailed protocols for conducting NO fumigation on fresh products and procedures for residue analysis and product quality evaluation. An airtight fumigation chamber containing fresh fruit and vegetables is first flushed with nitrogen (N2) to establish an ultralow oxygen (ULO) environment followed by injection of NO. The fumigation chamber is then kept at a low temperature of 2 - 5 °C for a specified time period necessary to kill a target pest to complete a fumigation treatment. At the end of a fumigation treatment, the fumigation chamber is flushed with N2 to dilute NO prior to opening the chamber to ambient air to prevent the reaction between NO and O2, which produces NO2 and may damage delicate fresh products. At different times after NO fumigation, NO2 in headspace and nitrate and nitrite in liquid samples were measured as residues. Product quality was evaluated after 2 weeks of post-treatment cold storage to determine effects of NO fumigation on product quality. Keeping O2 from reacting with NO is critical to NO fumigation and is an important part of the protocols. Measuring NO levels is challenging and a practical solution is provided. Possible protocol modifications are also suggested for measuring NO levels in the fumigation chambers as well as residues. NO fumigation has the potential to be a practical alternative to methyl bromide fumigation for postharvest pest control on fresh and stored products. This publication is intended to assist other researchers in conducting NO fumigation research for postharvest pest control and accelerating the development of NO fumigation for practical applications. PMID:29286372

Presentation of a quality management program in off-pump coronary bypass surgery.

PubMed

Bougioukakis, Petros; Kluegl, Stefan J; Babin-Ebell, Joerg; Tagarakis, Giorgios I; Mandewirth, Martin; Zacher, Michael; Diegeler, Anno

2014-01-01

To increase the number of off-pump coronary procedures at our institution, a new surgical team was formed. The first 3 years of "learning period" were accompanied by a quality management program aimed to control and adjust the surgical process and to ensure the safety and quality of the procedure. All patients were operated on by the same surgeon between January 2004 and December 2006; all procedures were performed under the following quality management protocol. First, a flow chart regulated surgical and anesthetic details. Second, an online file, named "disturbance file," was used to report work flow interruption, disturbance, and intraoperative events, that is, myocardial ischemia, hypotension, conversion to cardiopulmonary bypass, and any violation of the protocol. Each event was coded with 1 point and added to a score (the higher the score is, the greater the disturbance). Outcome parameters known as major events-major cardiac and cerebral events: mortality within 30 days/myocardial infarction confirmed by electrocardiogram or significantly high levels of total creatine kinase-myocardial muscle creatine kinase/reintervention within 30 days/stroke--and new-onset dialysis were also measured. Success was defined as freedom from any of those events and depicted in a cumulative sum control (CUSUM) chart. Outcome data and CUSUM were correlated with the intraoperative Disturbance Index. In total, 490 off-pump coronary bypass operations were performed by the named surgeon during the study period. The 30-day mortality was reduced from 4.0% to 1.9%. Disturbance Index score of greater than 1 declined from 41.6% to 23.3%. All major cardiac and cerebral events declined. The CUSUM chart showed two critical periods during the learning period, which made an adjustment of the protocol necessary. Quality management control is efficient in improving the postoperative results of a surgical procedure. A learning period is of cardinal importance for any new team wishing to engage in a novel surgical technique.

Validation of high-quality potato seed production protocol under controlled conditions (CETS System) in cultivated potato species (Solanum tuberosum L.)

USDA-ARS?s Scientific Manuscript database

Low potato yield in Peru and other countries in the region are attributed to the use of low quality seeds and tuber recycling. Therefore, there is consensus on the need of incorporating seed production technologies that are effective and efficient but also consistent with the reality of potato in La...

Selection and application of microbial source tracking tools for water-quality investigations

USGS Publications Warehouse

Stoeckel, Donald M.

2005-01-01

Microbial source tracking (MST) is a complex process that includes many decision-making steps. Once a contamination problem has been defined, the potential user of MST tools must thoroughly consider study objectives before deciding upon a source identifier, a detection method, and an analytical approach to apply to the problem. Regardless of which MST protocol is chosen, underlying assumptions can affect the results and interpretation. It is crucial to incorporate tests of those assumptions in the study quality-control plan to help validate results and facilitate interpretation. Detailed descriptions of MST objectives, protocols, and assumptions are provided in this report to assist in selection and application of MST tools for water-quality investigations. Several case studies illustrate real-world applications of MST protocols over a range of settings, spatial scales, and types of contamination. Technical details of many available source identifiers and detection methods are included as appendixes. By use of this information, researchers should be able to formulate realistic expectations for the information that MST tools can provide and, where possible, successfully execute investigations to characterize sources of fecal contamination to resource waters.

Creative musical expression as a catalyst for quality-of-life improvement in inner-city adolescents placed in a court-referred residential treatment program.

PubMed

Bittman, Barry; Dickson, Larry; Coddington, Kim

2009-01-01

Obstacles to effectively rehabilitate inner-city adolescents in staff-secure residential treatment centers should not be underestimated. Effective evidence-based protocols are lacking to help juveniles who are often angry, detached, frustrated, and in direct conflict with their peers. Facing a myriad of issues ranging from youth delinquency offenses to trauma, abuse, drug/alcohol use, peer pressure/gang-related activities, lack of structure in home environments, mental health diagnoses, and cognitive functioning difficulties, these adolescents present extraordinary challenges to an over-stressed juvenile justice system. A randomized controlled crossover study is utilized to comprehensively evaluate the effectiveness of a novel creative musical expression protocol as a catalyst for nonverbal and verbal disclosure leading to improvements in quality of life for inner-city youth in a court-referred residential treatment program. A total of 52 (30 females and 22 males) African-American, Asian, Caucasian, and Puerto Rican subjects ranging in age from 12 to 18 (mean age 14.5) completed the study. Dependent variable measures included the Child and Adolescent Functional Assessment Scale (CAFAS), the Adolescent Psychopathology Scale (APS), the Adolescent Anger Rating Scale (AARS), the Reynolds Adolescent Depression Scale, 2nd edition (RADS 2), and the Adolescent Visual-Analog Recreational Music Making Assessment (A-VARMMA). Statistically significant (experimental vs control) improvements in multiple parameters include school/work role performance, total depression, anhedonia/negative affect, negative self-evaluation, and instrumental anger. In addition, extended impact (experimental vs control) is characterized by statistically significant improvements 6 weeks after completion of the protocol, for school/work role performance, behavior toward others, anhedonia/negative affect, total anger, instrumental anger, anger, and interpersonal problems. The primary limitations of this study include an extended follow-up period of only 6 weeks post completion of the protocol, and the inability to blind the counselors performing standardized assessments. This study is the first of its kind to test a replicable creative musical expression protocol as a catalyst for nonverbal and verbal disclosure leading to improved quality of life for inner-city youth in a court-referred residential treatment program. With substantial potential for widespread dissemination, this innovative protocol for adolescents can be readily utilized by behavioral health professionals without prior musical experience.

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

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.

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.

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.

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.

Biobanking of CSF: international standardization to optimize biomarker development.

PubMed

Teunissen, Charlotte E; Tumani, Hayrettin; Engelborghs, Sebastiaan; Mollenhauer, Brit

2014-03-01

Cerebrospinal fluid (CSF) reflects pathophysiological aspects of neurological diseases, where neuroprotective strategies and biomarkers are urgently needed. Therefore, biobanking is very relevant for biomarker discovery and evaluation of neurological diseases. Important and unique features of CSF biobanking are intensive collaboration in international networks and the tight application of standardized protocols. The current adoption of standardized protocols for CSF and blood collection as presented in this review enables biomarker studies in large cohorts of patients and controls. Another topic of this review is the selection of control groups, which influences the outcome of biomarker investigations. Control groups in CSF biobanks mainly consist of different disease controls. This is in part due to the fact that lumbar punctures are mostly performed for clinical indications and rarely for research purposes only, as it is a relatively invasive procedure. Moreover, there is a lack of homogenous criteria and definition of control groups. We therefore propose uniform consensus definitions for such control groups in biomarker research, i.e. Healthy controls (HC), Spinal anesthesia subjects (SAS), Symptomatic controls (SC), Inflammatory Neurological Disease Controls (CINDC), Peripheral Inflammatory Neurological Disease Controls (PINDC) and Non-inflammatory Neurological Disease Controls (NINDC). Another important aspect of CSF biobanking is quality control. Systematic studies to address effects of pre-analytical and storage variation on a broad range of CSF proteins are needed. In conclusion, biomarker research in neurodegenerative diseases has entered a new era due to the collaborative and multicenter efforts of many groups. The streamlining of biobanking procedures, including quality control, and the selection of optimal control groups for investigating biomarkers are important improvements to perform high quality biomarker studies. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

ICP-Forests (International Co-operative Programme on Assessment and Monitoring of Air Pollution Effects on Forests): Quality Assurance procedure in plant diversity monitoring.

PubMed

Allegrini, Maria-Cristina; Canullo, Roberto; Campetella, Giandiego

2009-04-01

Knowledge of accuracy and precision rates is particularly important for long-term studies. Vegetation assessments include many sources of error related to overlooking and misidentification, that are usually influenced by some factors, such as cover estimate subjectivity, observer biased species lists and experience of the botanist. The vegetation assessment protocol adopted in the Italian forest monitoring programme (CONECOFOR) contains a Quality Assurance programme. The paper presents the different phases of QA, separates the 5 main critical points of the whole protocol as sources of random or systematic errors. Examples of Measurement Quality Objectives (MQOs) expressed as Data Quality Limits (DQLs) are given for vascular plant cover estimates, in order to establish the reproducibility of the data. Quality control activities were used to determine the "distance" between the surveyor teams and the control team. Selected data were acquired during the training and inter-calibration courses. In particular, an index of average cover by species groups was used to evaluate the random error (CV 4%) as the dispersion around the "true values" of the control team. The systematic error in the evaluation of species composition, caused by overlooking or misidentification of species, was calculated following the pseudo-turnover rate; detailed species censuses on smaller sampling units were accepted as the pseudo-turnover which always fell below the 25% established threshold; species density scores recorded at community level (100 m(2) surface) rarely exceeded that limit.

Colwater fish in rivers

EPA Science Inventory

A standard sampling protocol to assess the fish assemblages and abundances in large, coldwater rivers is most accurate and precise if consistent gears and levels of effort are used at each site. This requires thorough crew training, quality control audits, and replicate sampling...

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 entry is essential to appropriately characterize hypertension in these elderly patients.

Association of physical activity with cognition, metacognition and academic performance in children and adolescents: a protocol for systematic review and meta-analysis.

PubMed

Álvarez-Bueno, Celia; Pesce, Caterina; Cavero-Redondo, Iván; Sánchez-López, Mairena; Pardo-Guijarro, María Jesús; Martínez-Vizcaíno, Vicente

2016-06-28

Schools provide a relevant context for improving children's and adolescents' physical and mental health by increasing physical activity during school hours and/or beyond. The interest in the relationship between physical activity programmes and cognition during development has recently increased, with evidence suggesting a positive association. We present a protocol of systematic reviews and meta-analysis of intervention studies that, by determining the effects of chronic physical exercise on children's and adolescents' cognitive and metacognitive functions, cognitive life skills, academic behaviours and achievement, aims to ensure procedural objectivity and transparency, and maximise the extraction of relevant information to inform policy development. This protocol is guided by Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) and by the Cochrane Collaboration Handbook. Databases to be utilised for a thorough selection of the pertinent literature are MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Web of Science, PsycINFO and ERIC. Selection is proposed to encompass an international and a national publication level, with inclusion of experimental studies written in English or in Spanish, respectively. Also, relevant references included in the selected studies will be considered suitable for review as supplemental sources.We present an integrated approach to the methodological quality assessment of the selected studies, including the Jadad Scale for the assessment of the quality of randomised controlled trials and the Quality Assessment Tool for Quantitative Studies for pre-post studies and non-randomised controlled trials. The pre-post interventions mean differences will be the primary indicator of the intervention outcome. A subgroup analysis is proposed based on cognitive functions and their neural correlates, metacognitive functions and cognitive life skills, academic achievement areas and academic behaviours. PROSPERO CRD42015029913. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Effects of a single-session assertiveness music therapy role playing protocol for psychiatric inpatients.

PubMed

Silverman, Michael J

2011-01-01

The purpose of this study was to implement and measure the effectiveness of a single-session assertiveness music therapy role playing protocol for psychiatric inpatients. Participants (N=133) were randomly assigned by group to one of three conditions: (a) Assertiveness Music Therapy, (b) No Music Assertiveness, or (c) Music No Assertiveness. Participants in both assertiveness conditions role played a number of different commonly occurring scenarios at an inpatient psychiatric facility and in the community. There were no significant between-group differences in posttest quality of life, locus of control, or other subscales. However, participants in both assertiveness conditions tended to have slightly higher internal locus of control and overall quality of life scores than participants in the music no assertiveness condition. Additionally, the assertiveness music therapy condition had higher attendance rates than the other conditions. A higher percentage of participants from both the assertiveness music therapy and music no assertiveness conditions indicated they thought their session was the most helpful/therapeutic group therapy session in which they had participated; this was not the case for the assertiveness no music condition. Future research is warranted to measure the effects of protocols that can help psychiatric patients generalize skills learned in treatment.

A practical method to standardise and optimise the Philips DoseRight 2.0 CT automatic exposure control system.

PubMed

Wood, T J; Moore, C S; Stephens, A; Saunderson, J R; Beavis, A W

2015-09-01

Given the increasing use of computed tomography (CT) in the UK over the last 30 years, it is essential to ensure that all imaging protocols are optimised to keep radiation doses as low as reasonably practicable, consistent with the intended clinical task. However, the complexity of modern CT equipment can make this task difficult to achieve in practice. Recent results of local patient dose audits have shown discrepancies between two Philips CT scanners that use the DoseRight 2.0 automatic exposure control (AEC) system in the 'automatic' mode of operation. The use of this system can result in drifting dose and image quality performance over time as it is designed to evolve based on operator technique. The purpose of this study was to develop a practical technique for configuring examination protocols on four CT scanners that use the DoseRight 2.0 AEC system in the 'manual' mode of operation. This method used a uniform phantom to generate reference images which form the basis for how the AEC system calculates exposure factors for any given patient. The results of this study have demonstrated excellent agreement in the configuration of the CT scanners in terms of average patient dose and image quality when using this technique. This work highlights the importance of CT protocol harmonisation in a modern Radiology department to ensure both consistent image quality and radiation dose. Following this study, the average radiation dose for a range of CT examinations has been reduced without any negative impact on clinical image quality.

Low-dose computed tomography scans with automatic exposure control for patients of different ages undergoing cardiac PET/CT and SPECT/CT.

PubMed

Yang, Ching-Ching; Yang, Bang-Hung; Tu, Chun-Yuan; Wu, Tung-Hsin; Liu, Shu-Hsin

2017-06-01

This study aimed to evaluate the efficacy of automatic exposure control (AEC) in order to optimize low-dose computed tomography (CT) protocols for patients of different ages undergoing cardiac PET/CT and single-photon emission computed tomography/computed tomography (SPECT/CT). One PET/CT and one SPECT/CT were used to acquire CT images for four anthropomorphic phantoms representative of 1-year-old, 5-year-old and 10-year-old children and an adult. For the hybrid systems investigated in this study, the radiation dose and image quality of cardiac CT scans performed with AEC activated depend mainly on the selection of a predefined image quality index. Multiple linear regression methods were used to analyse image data from anthropomorphic phantom studies to investigate the effects of body size and predefined image quality index on CT radiation dose in cardiac PET/CT and SPECT/CT scans. The regression relationships have a coefficient of determination larger than 0.9, indicating a good fit to the data. According to the regression models, low-dose protocols using the AEC technique were optimized for patients of different ages. In comparison with the standard protocol with AEC activated for adult cardiac examinations used in our clinical routine practice, the optimized paediatric protocols in PET/CT allow 32.2, 63.7 and 79.2% CT dose reductions for anthropomorphic phantoms simulating 10-year-old, 5-year-old and 1-year-old children, respectively. The corresponding results for cardiac SPECT/CT are 8.4, 51.5 and 72.7%. AEC is a practical way to reduce CT radiation dose in cardiac PET/CT and SPECT/CT, but the AEC settings should be determined properly for optimal effect. Our results show that AEC does not eliminate the need for paediatric protocols and CT examinations using the AEC technique should be optimized for paediatric patients to reduce the radiation dose as low as reasonably achievable.

Improvements in the order, isotropy and electron density of glypican-1 crystals by controlled dehydration.

PubMed

Awad, Wael; Svensson Birkedal, Gabriel; Thunnissen, Marjolein M G M; Mani, Katrin; Logan, Derek T

2013-12-01

The use of controlled dehydration for improvement of protein crystal diffraction quality is increasing in popularity, although there are still relatively few documented examples of success. A study has been carried out to establish whether controlled dehydration could be used to improve the anisotropy of crystals of the core protein of the human proteoglycan glypican-1. Crystals were subjected to controlled dehydration using the HC1 device. The optimal protocol for dehydration was developed by careful investigation of the following parameters: dehydration rate, final relative humidity and total incubation time Tinc. Of these, the most important was shown to be Tinc. After dehydration using the optimal protocol the crystals showed significantly reduced anisotropy and improved electron density, allowing the building of previously disordered parts of the structure.

Application of enhanced recovery after gastric cancer surgery: An updated meta-analysis

PubMed Central

Wang, Liu-Hua; Zhu, Ren-Fei; Gao, Cheng; Wang, Shou-Lin; Shen, Li-Zong

2018-01-01

AIM To provide an updated assessment of the safety and efficacy of enhanced recovery after surgery (ERAS) protocols in elective gastric cancer (GC) surgery. METHODS PubMed, Medline, EMBASE, World Health Organization International Trial Register, and Cochrane Library were searched up to June 2017 for all available randomized controlled trials (RCTs) comparing ERAS protocols and standard care (SC) in GC surgery. Thirteen RCTs, with a total of 1092 participants, were analyzed in this study, of whom 545 underwent ERAS protocols and 547 received SC treatment. RESULTS No significant difference was observed between ERAS and control groups regarding total complications (P = 0.88), mortality (P = 0.50) and reoperation (P = 0.49). The incidence of pulmonary infection was significantly reduced (P = 0.03) following gastrectomy. However, the readmission rate after GC surgery nearly tripled under ERAS (P = 0.009). ERAS protocols significantly decreased the length of postoperative hospital stay (P < 0.00001) and medical costs (P < 0.00001), and accelerated bowel function recovery, as measured by earlier time to the first flatus (P = 0.0004) and the first defecation (P < 0.0001). Moreover, ERAS protocols were associated with a lower level of serum inflammatory response, higher serum albumin, and superior short-term quality of life (QOL). CONCLUSION Collectively, ERAS results in accelerated convalescence, reduction of surgical stress and medical costs, improved nutritional status, and better QOL for GC patients. However, high-quality multicenter RCTs with large samples and long-term follow-up are needed to more precisely evaluate ERAS in radical gastrectomy. PMID:29662294

Diagnostic accuracy of 256-row multidetector CT coronary angiography with prospective ECG-gating combined with fourth-generation iterative reconstruction algorithm in the assessment of coronary artery bypass: evaluation of dose reduction and image quality.

PubMed

Ippolito, Davide; Fior, Davide; Franzesi, Cammillo Talei; Riva, Luca; Casiraghi, Alessandra; Sironi, Sandro

2017-12-01

Effective radiation dose in coronary CT angiography (CTCA) for coronary artery bypass graft (CABG) evaluation is remarkably high because of long scan lengths. Prospective electrocardiographic gating with iterative reconstruction can reduce effective radiation dose. To evaluate the diagnostic performance of low-kV CT angiography protocol with prospective ecg-gating technique and iterative reconstruction (IR) algorithm in follow-up of CABG patients compared with standard retrospective protocol. Seventy-four non-obese patients with known coronary disease treated with artery bypass grafting were prospectively enrolled. All the patients underwent 256 MDCT (Brilliance iCT, Philips) CTCA using low-dose protocol (100 kV; 800 mAs; rotation time: 0.275 s) combined with prospective ECG-triggering acquisition and fourth-generation IR technique (iDose 4 ; Philips); all the lengths of the bypass graft were included in the evaluation. A control group of 42 similar patients was evaluated with a standard retrospective ECG-gated CTCA (100 kV; 800 mAs).On both CT examinations, ROIs were placed to calculate standard deviation of pixel values and intra-vessel density. Diagnostic quality was also evaluated using a 4-point quality scale. Despite the statistically significant reduction of radiation dose evaluated with DLP (study group mean DLP: 274 mGy cm; control group mean DLP: 1224 mGy cm; P value < 0.001). No statistical differences were found between PGA group and RGH group regarding intra-vessel density absolute values and SNR. Qualitative analysis, evaluated by two radiologists in "double blind", did not reveal any significant difference in diagnostic quality of the two groups. The development of high-speed MDCT scans combined with modern IR allows an accurate evaluation of CABG with prospective ECG-gating protocols in a single breath hold, obtaining a significant reduction in radiation dose.

Data Acceptance Criteria for Standardized Human-Associated Fecal Source Identification Quantitative Real-Time PCR Methods.

PubMed

Shanks, Orin C; Kelty, Catherine A; Oshiro, Robin; Haugland, Richard A; Madi, Tania; Brooks, Lauren; Field, Katharine G; Sivaganesan, Mano

2016-05-01

There is growing interest in the application of human-associated fecal source identification quantitative real-time PCR (qPCR) technologies for water quality management. The transition from a research tool to a standardized protocol requires a high degree of confidence in data quality across laboratories. Data quality is typically determined through a series of specifications that ensure good experimental practice and the absence of bias in the results due to DNA isolation and amplification interferences. However, there is currently a lack of consensus on how best to evaluate and interpret human fecal source identification qPCR experiments. This is, in part, due to the lack of standardized protocols and information on interlaboratory variability under conditions for data acceptance. The aim of this study is to provide users and reviewers with a complete series of conditions for data acceptance derived from a multiple laboratory data set using standardized procedures. To establish these benchmarks, data from HF183/BacR287 and HumM2 human-associated qPCR methods were generated across 14 laboratories. Each laboratory followed a standardized protocol utilizing the same lot of reference DNA materials, DNA isolation kits, amplification reagents, and test samples to generate comparable data. After removal of outliers, a nested analysis of variance (ANOVA) was used to establish proficiency metrics that include lab-to-lab, replicate testing within a lab, and random error for amplification inhibition and sample processing controls. Other data acceptance measurements included extraneous DNA contamination assessments (no-template and extraction blank controls) and calibration model performance (correlation coefficient, amplification efficiency, and lower limit of quantification). To demonstrate the implementation of the proposed standardized protocols and data acceptance criteria, comparable data from two additional laboratories were reviewed. The data acceptance criteria proposed in this study should help scientists, managers, reviewers, and the public evaluate the technical quality of future findings against an established benchmark. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

ATM QoS Experiments Using TCP Applications: Performance of TCP/IP Over ATM in a Variety of Errored Links

NASA Technical Reports Server (NTRS)

Frantz, Brian D.; Ivancic, William D.

2001-01-01

Asynchronous Transfer Mode (ATM) Quality of Service (QoS) experiments using the Transmission Control Protocol/Internet Protocol (TCP/IP) were performed for various link delays. The link delay was set to emulate a Wide Area Network (WAN) and a Satellite Link. The purpose of these experiments was to evaluate the ATM QoS requirements for applications that utilize advance TCP/IP protocols implemented with large windows and Selective ACKnowledgements (SACK). The effects of cell error, cell loss, and random bit errors on throughput were reported. The detailed test plan and test results are presented herein.

Characterizing SWCNT Dispersion in Polymer Composites

NASA Technical Reports Server (NTRS)

Lillehei, Peter T.; Kim, Jae-Woo; Gibbons, Luke; Park, Cheol

2007-01-01

The new wave of single wall carbon nanotube (SWCNT) infused composites will yield structurally sound multifunctional nanomaterials. The SWCNT network requires thorough dispersion within the polymer matrix in order to maximize the benefits of the nanomaterial. However, before any nanomaterials can be used in aerospace applications a means of quality assurance and quality control must be certified. Quality control certification requires a means of quantification, however, the measurement protocol mandates a method of seeing the dispersion first. We describe here the new tools that we have developed and implemented to first be able to see carbon nanotubes in polymers and second to measure or quantify the dispersion of the nanotubes.

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.

Optimal molecular profiling of tissue and tissue components: defining the best processing and microdissection methods for biomedical applications.

PubMed

Rodriguez-Canales, Jaime; Hanson, Jeffrey C; Hipp, Jason D; Balis, Ulysses J; Tangrea, Michael A; Emmert-Buck, Michael R; Bova, G Steven

2013-01-01

Isolation of well-preserved pure cell populations is a prerequisite for sound studies of the molecular basis of any tissue-based biological phenomenon. This updated chapter reviews current methods for obtaining anatomically specific signals from molecules isolated from tissues, a basic requirement for productive linking of phenotype and genotype. The quality of samples isolated from tissue and used for molecular analysis is often glossed over or omitted from publications, making interpretation and replication of data difficult or impossible. Fortunately, recently developed techniques allow life scientists to better document and control the quality of samples used for a given assay, creating a foundation for improvement in this area. Tissue processing for molecular studies usually involves some or all of the following steps: tissue collection, gross dissection/identification, fixation, processing/embedding, storage/archiving, sectioning, staining, microdissection/annotation, and pure analyte labeling/identification and quantification. We provide a detailed comparison of some current tissue microdissection technologies and provide detailed example protocols for tissue component handling upstream and downstream from microdissection. We also discuss some of the physical and chemical issues related to optimal tissue processing and include methods specific to cytology specimens. We encourage each laboratory to use these as a starting point for optimization of their overall process of moving from collected tissue to high-quality, appropriately anatomically tagged scientific results. Improvement in this area will significantly increase life science quality and productivity. The chapter is divided into introduction, materials, protocols, and notes subheadings. Because many protocols are covered in each of these sections, information relating to a single protocol is not contiguous. To get the greatest benefit from this chapter, readers are advised to read through the entire chapter first, identify protocols appropriate to their laboratory for each step in their workflow, and then reread entries in each section pertaining to each of these single protocols.

Quality-assurance plan for the analysis of fluvial sediment by laboratories of the U.S. Geological Survey

USGS Publications Warehouse

Matthes, Wilbur J.; Sholar, Clyde J.; George, John R.

1992-01-01

This report describes procedures used by the Iowa District sediment laboratory of the U.S. Geological Survey to assure the quality of sediment-laboratory data. These procedures can be used by other U.S. Geological Survey laboratories regardless of size and type of operation for quality assurance and quality control of specific sediment-laboratory processes. Also described are the equipment, specifications, calibration and maintenance, and the protocol for methods used in the analyses of fluvial sediment for concentration or particle size.

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-going initiatives that aim to increase the transparency and quality of future research. PMID:24236154

Dual-layer DECT for multiphasic hepatic CT with 50 percent iodine load: a matched-pair comparison with a 120 kVp protocol.

PubMed

Nagayama, Yasunori; Nakaura, Takeshi; Oda, Seitaro; Utsunomiya, Daisuke; Funama, Yoshinori; Iyama, Yuji; Taguchi, Narumi; Namimoto, Tomohiro; Yuki, Hideaki; Kidoh, Masafumi; Hirata, Kenichiro; Nakagawa, Masataka; Yamashita, Yasuyuki

2018-04-01

To evaluate the image quality and lesion conspicuity of virtual-monochromatic-imaging (VMI) with dual-layer DECT (DL-DECT) for reduced-iodine-load multiphasic-hepatic CT. Forty-five adults with renal dysfunction who had undergone hepatic DL-DECT with 300-mgI/kg were included. VMI (40-70-keV, DL-DECT-VMI) was generated at each enhancement phase. As controls, 45 matched patients undergoing standard 120-kVp protocol (120-kVp, 600-mgI/kg, and iterative reconstruction) were included. We compared the size-specific dose estimate (SSDE), image noise, CT attenuation, and contrast-to-noise ratio (CNR) between protocols. Two radiologists scored the image quality and lesion conspicuity. SSDE was significantly lower in DL-DECT group (p < 0.01). Image noise of DL-DECT-VMI was almost constant at each keV (differences of ≤15%) and equivalent to or lower than of 120-kVp. As the energy decreased, CT attenuation and CNR gradually increased; the values of 55-60 keV images were almost equivalent to those of standard 120-kVp. The highest scores for overall quality and lesion conspicuity were assigned at 40-keV followed by 45 to 55-keV, all of which were similar to or better than of 120-kVp. For multiphasic-hepatic CT with 50% iodine-load, DL-DECT-VMI at 40- to 55-keV provides equivalent or better image quality and lesion conspicuity without increasing radiation dose compared with standard 120-kVp protocol. • 40-55-keV yields optimal image quality for half-iodine-load multiphasic-hepatic CT with DL-DECT. • DL-DECT protocol decreases radiation exposure compared with 120-kVp scans with iterative reconstruction. • 40-keV images maximise conspicuity of hepatocellular carcinoma especially at hepatic-arterial phase.

Comparison of Radiation Dose and Image Quality of Triple-Rule-Out Computed Tomography Angiography Between Conventional Helical Scanning and a Strategy Incorporating Sequential Scanning

PubMed Central

Manheimer, Eric D.; Peters, M. Robert; Wolff, Steven D.; Qureshi, Mehreen A.; Atluri, Prashanth; Pearson, Gregory D.N.; Einstein, Andrew J.

2011-01-01

Triple-rule-out computed tomography angiography (TRO CTA), performed to evaluate the coronary arteries, pulmonary arteries, and thoracic aorta, has been associated with high radiation exposure. Utilization of sequential scanning for coronary computed tomography angiography (CCTA) reduces radiation dose. The application of sequential scanning to TRO CTA is much less well defined. We analyzed radiation dose and image quality from TRO CTA performed in a single outpatient center, comparing scans from a period during which helical scanning with electrocardiographically controlled tube current modulation was used for all patients (n=35) and after adoption of a strategy incorporating sequential scanning whenever appropriate (n=35). Sequential scanning was able to be employed in 86% of cases. The sequential-if-appropriate strategy, compared to the helical-only strategy, was associated with a 61.6% dose decrease (mean dose-length product [DLP] of 439 mGy×cm vs 1144 mGy×cm and mean effective dose of 7.5 mSv vs 19.4 mSv, respectively, p<0.0001). Similarly, there was a 71.5% dose reduction among 30 patients scanned with the sequential protocol compared to 40 patients scanned with the helical protocol under either strategy (326 mGy×cm vs 1141 mGy×cm and 5.5 mSv vs 19.4 mSv, respectively, p<0.0001). Although image quality did not differ between strategies, there was a non-statistically significant trend towards better quality in the sequential protocol compared to the helical protocol. In conclusion, approaching TRO CTA with a diagnostic strategy of sequential scanning as appropriate offers a marked reduction in radiation dose while maintaining image quality. PMID:21306693

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.

Isolation of high-quality total RNA from leaves of Myrciaria dubia "CAMU CAMU".

PubMed

Gómez, Juan Carlos Castro; Reátegui, Alina Del Carmen Egoavil; Flores, Julián Torres; Saavedra, Roberson Ramírez; Ruiz, Marianela Cobos; Correa, Sixto Alfredo Imán

2013-01-01

Myrciaria dubia is a main source of vitamin C for people in the Amazon region. Molecular studies of M. dubia require high-quality total RNA from different tissues. So far, no protocols have been reported for total RNA isolation from leaves of this species. The objective of this research was to develop protocols for extracting high-quality total RNA from leaves of M. dubia. Total RNA was purified following two modified protocols developed for leaves of other species (by Zeng and Yang, and by Reid et al.) and one modified protocol developed for fruits of the studied species (by Silva). Quantity and quality of purified total RNA were assessed by spectrophotometric and electrophoretic analysis. Additionally, quality of total RNA was evaluated with reverse-transcription polymerase chain reaction (RT-PCR). With these three modified protocols we were able to isolate high-quality RNA (A260nm/A280nm >1.9 and A260nm/A230nm >2.0). Highest yield was produced with the Zeng and Yang modified protocol (384±46µg ARN/g fresh weight). Furthermore, electrophoretic analysis showed the integrity of isolated RNA and the absence of DNA. Another proof of the high quality of our purified RNA was the successful cDNA synthesis and amplification of a segment of the M. dubia actin 1 gene. We report three modified protocols for isolation total RNA from leaves of M. dubia. The modified protocols are easy, rapid, low in cost, and effective for high-quality and quantity total RNA isolation suitable for cDNA synthesis and polymerase chain reaction.

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.

BATHING BEACH MONITORING PROTOCOLS/COMMUNICATING SWIMMING ACTIVITY RISK TO THE PUBLIC

EPA Science Inventory

Current Environmental Protection Agency (EPA) recommended monitoring practices for bathing beach water quality were suggested in 1968, as a part of the fecal coliform guideline developed by the Federal Water Pollution Control Administration. The guideline stated that five water ...

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.

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.

Natural Language Processing-Enabled and Conventional Data Capture Methods for Input to Electronic Health Records: A Comparative Usability Study.

PubMed

Kaufman, David R; Sheehan, Barbara; Stetson, Peter; Bhatt, Ashish R; Field, Adele I; Patel, Chirag; Maisel, James Mark

2016-10-28

The process of documentation in electronic health records (EHRs) is known to be time consuming, inefficient, and cumbersome. The use of dictation coupled with manual transcription has become an increasingly common practice. In recent years, natural language processing (NLP)-enabled data capture has become a viable alternative for data entry. It enables the clinician to maintain control of the process and potentially reduce the documentation burden. The question remains how this NLP-enabled workflow will impact EHR usability and whether it can meet the structured data and other EHR requirements while enhancing the user's experience. The objective of this study is evaluate the comparative effectiveness of an NLP-enabled data capture method using dictation and data extraction from transcribed documents (NLP Entry) in terms of documentation time, documentation quality, and usability versus standard EHR keyboard-and-mouse data entry. This formative study investigated the results of using 4 combinations of NLP Entry and Standard Entry methods ("protocols") of EHR data capture. We compared a novel dictation-based protocol using MediSapien NLP (NLP-NLP) for structured data capture against a standard structured data capture protocol (Standard-Standard) as well as 2 novel hybrid protocols (NLP-Standard and Standard-NLP). The 31 participants included neurologists, cardiologists, and nephrologists. Participants generated 4 consultation or admission notes using 4 documentation protocols. We recorded the time on task, documentation quality (using the Physician Documentation Quality Instrument, PDQI-9), and usability of the documentation processes. A total of 118 notes were documented across the 3 subject areas. The NLP-NLP protocol required a median of 5.2 minutes per cardiology note, 7.3 minutes per nephrology note, and 8.5 minutes per neurology note compared with 16.9, 20.7, and 21.2 minutes, respectively, using the Standard-Standard protocol and 13.8, 21.3, and 18.7 minutes using the Standard-NLP protocol (1 of 2 hybrid methods). Using 8 out of 9 characteristics measured by the PDQI-9 instrument, the NLP-NLP protocol received a median quality score sum of 24.5; the Standard-Standard protocol received a median sum of 29; and the Standard-NLP protocol received a median sum of 29.5. The mean total score of the usability measure was 36.7 when the participants used the NLP-NLP protocol compared with 30.3 when they used the Standard-Standard protocol. In this study, the feasibility of an approach to EHR data capture involving the application of NLP to transcribed dictation was demonstrated. This novel dictation-based approach has the potential to reduce the time required for documentation and improve usability while maintaining documentation quality. Future research will evaluate the NLP-based EHR data capture approach in a clinical setting. It is reasonable to assert that EHRs will increasingly use NLP-enabled data entry tools such as MediSapien NLP because they hold promise for enhancing the documentation process and end-user experience. ©David R. Kaufman, Barbara Sheehan, Peter Stetson, Ashish R. Bhatt, Adele I. Field, Chirag Patel, James Mark Maisel. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 28.10.2016.

Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol for a controlled clinical trial developed by consensus of an international study group. Part two: design of the study.

PubMed

Bauhofer, A; Lorenz, W; Stinner, B; Rothmund, M; Koller, M; Sitter, H; Celik, I; Farndon, J R; Fingerhut, A; Hay, J M; Lefering, R; Lorijn, R; Nyström, P O; Schäfer, H; Schein, M; Solomkin, J; Troidl, H; Volk, H D; Wittmann, D H; Wyatt, J

2001-04-01

Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). This part describes the design of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). The trial design includes the following elements for a prototype protocol: * The study population is restricted to patients with colorectal cancer, including a left sided resection and an increased perioperative risk (ASA 3 and 4). * Patients are allocated by random to the control or treatment group. * The double blinding strategy of the trial is assessed by psychometric indices. * An endpoint construct with quality of life (EORTC QLQ-C30) and a recovery index (modified Mc Peek index) are used as primary endpoints. Qualitative analysis of clinical relevance of the endpoints is performed by both patients and doctors. * Statistical analysis uses an area under the curve (AUC) model for improvement of quality of life on leaving hospital and two and six months after operation. A confirmatory statistical model with quality of life as the first primary endpoint in the hierarchic test procedure is used. Expectations of patients and surgeons and the negative affect are analysed by social psychological scales. This study design differs from other trials on preoperative prophylaxis and postoperative recovery, and has been developed to try a new concept and avoid previous failures.

[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.

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 protocols were found as {approx}14 times lower for standard head scan and 1.8 times lower for standard body scan than the old protocols, respectively. In the image quality QA tests, all the protocols except low-dose head and low-dose thorax protocols were within the tolerance in the HU verification test. The HU value for the two protocols was always higher than the nominal value. All the protocols passed the spatial linearity/resolution and HU uniformity tests. In the contrast resolution test, only high-quality head and pelvis scan protocols were within the tolerance. In addition, crescent effect was found in the partial-angle scan protocols. Conclusions: The authors found that CTDI{sub w} of the new CBCT protocols has been significantly reduced compared to the old protocols with acceptable image quality. The CTDI{sub w} values in the point dose method were close to the volume averaging method within 9%-21% for all the CBCT scan protocols. The Bakalyar's method produced more accurate dose estimation within 14%. The HU inaccuracy from low-dose head and low-dose thorax protocols can render incorrect dose results in the treatment planning system. When high soft-tissue contrast data are desired, high-quality head or pelvis scan protocol is recommended depending on the imaging area. The point dose method can be applicable to estimate CBCT dose with reasonable accuracy in the clinical environment.« less

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 Physical Therapy Association

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 interpreting results. This primer has been developed to provide basic information and guidance about developing QA/QC protocols for geochemical studies. It is not intended to be a comprehensive guide but rather an introduction to key concepts tied to a list of relevant references for further reading. The guidelines are presented in stepwise order beginning with presampling considerations and continuing through final data interpretation. The goal of this primer is to outline basic QA/QC practices that scientists can use before, during, and after chemical analysis to ensure the validity of the data they collect with the goal of providing defendable results and conclusions.

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 significant deep venous thrombosis (DVT) was 6.9 % (6 of 87). Three protocol patients (3.45 %) went to the operating room for surgery after the initiation of PTP; none of these patients had a measurable change in hemorrhage size on head CT. The change in percentage of patients receiving PTP was significantly increased by the protocol (p < 0.0001); while the average days to first PTP dose trended down with institution of the protocol, this change was not statistically significant. A PTP protocol in the NSICU is useful in controlling the number of complications from DVT and pulmonary embolism while avoiding additional IH. This protocol, based on a published body of literature, allowed for VTE rates similar to published rates, while having no PTP-related hemorrhage expansion. The protocol significantly changed physician behavior, increasing the percentage of patients receiving PTP during their hospitalization; whether long-term patient outcomes are affected is a potential goal for future study.

Accuracy and reliability of Chile's National Air Quality Information System for measuring particulate matter: Beta attenuation monitoring issue.

PubMed

Toro A, Richard; Campos, Claudia; Molina, Carolina; Morales S, Raul G E; Leiva-Guzmán, Manuel A

2015-09-01

A critical analysis of Chile's National Air Quality Information System (NAQIS) is presented, focusing on particulate matter (PM) measurement. This paper examines the complexity, availability and reliability of monitoring station information, the implementation of control systems, the quality assurance protocols of the monitoring station data and the reliability of the measurement systems in areas highly polluted by particulate matter. From information available on the NAQIS website, it is possible to confirm that the PM2.5 (PM10) data available on the site correspond to 30.8% (69.2%) of the total information available from the monitoring stations. There is a lack of information regarding the measurement systems used to quantify air pollutants, most of the available data registers contain gaps, almost all of the information is categorized as "preliminary information" and neither standard operating procedures (operational and validation) nor assurance audits or quality control of the measurements are reported. In contrast, events that cause saturation of the monitoring detectors located in northern and southern Chile have been observed using beta attenuation monitoring. In these cases, it can only be concluded that the PM content is equal to or greater than the saturation concentration registered by the monitors and that the air quality indexes obtained from these measurements are underestimated. This occurrence has been observed in 12 (20) public and private stations where PM2.5 (PM10) is measured. The shortcomings of the NAQIS data have important repercussions for the conclusions obtained from the data and for how the data are used. However, these issues represent opportunities for improving the system to widen its use, incorporate comparison protocols between equipment, install new stations and standardize the control system and quality assurance. Copyright © 2015 Elsevier Ltd. All rights reserved.

Evaluation of mailed pediatric buccal cytobrushes for use in a case-control study of birth defects.

PubMed

Gallagher, Margaret L; Sturchio, Cynthia; Smith, Ashley; Koontz, Deborah; Jenkins, Mary M; Honein, Margaret A; Rasmussen, Sonja A

2011-07-01

Buccal cell collection is a convenient DNA collection method; however, little attention has been given to the quality of DNA obtained from pediatric populations. The purpose of this study was to determine the effect of a modified cytobrush collection method on the yield and quality of infant buccal DNA collected as part of a population-based case-control study of birth defects. METHODS Cytobrushes were collected from infants, mothers, and fathers using a standard collection method in 1997 to 2003 and a modified protocol that allows air-drying of the cytobrushes after collection from 2003 to the present. Yield and quality of DNA from 1057 cytobrushes was assessed by quantitative PCR and short tandem repeat (STR) genotyping, respectively. RESULTS Air-dried cytobrushes from infants had higher median DNA yields (1300 ng) and STR completion rates (99.5%) than standard collection method cytobrushes (60 ng and 59.5%, respectively). A subset of DNA aliquots was genotyped for six single nucleotide polymorphisms (SNPs). Aliquots from both collection methods that passed the quality protocol (DNA concentration >1 ng/μl, and successful amplification of ≥1 STR) had high genotype completion rates (99-100%). The median DNA yield following whole genome amplification was more than twofold higher for air-dried than standard collection specimens (p < 0.001). CONCLUSION Yield and quality of buccal DNA collected from infants are improved by using a method that incorporates air-drying; however, DNA collected by both methods is suitable for genotyping if stringent quality control procedures are instituted. These findings may be helpful for future epidemiologic studies of birth defects and other adverse pediatric outcomes. Copyright © 2011 Wiley-Liss, Inc.

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 researchers worldwide to test the likely effect of implementing indicators prior to roll out. It builds on and codifies existing literature and other testing protocols to create a field testing methodology that can be used to produce country specific quality indicators for pay-for-performance or quality improvement schemes.

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.

Technical standards and guidelines: prenatal screening for Down syndrome that includes first-trimester biochemistry and/or ultrasound measurements.

PubMed

Palomaki, Glenn E; Lee, Jo Ellen S; Canick, Jacob A; McDowell, Geraldine A; Donnenfeld, Alan E

2009-09-01

This statement is intended to augment the current general ACMG Standards and Guidelines for Clinical Genetics Laboratories and to address guidelines specific to first-trimester screening for Down syndrome. The aim is to provide the laboratory the necessary information to ensure accurate and reliable Down syndrome screening results given a screening protocol (e.g., combined first trimester and integrated testing). Information about various test combinations and their expected performance are provided, but other issues such as availability of reagents, patient interest in early test results, access to open neural tube defect screening, and availability of chorionic villus sampling are all contextual factors in deciding which screening protocol(s) will be selected by individual health care providers. Individual laboratories are responsible for meeting the quality assurance standards described by the Clinical Laboratory Improvement Act, the College of American Pathologists, and other regulatory agencies, with respect to appropriate sample documentation, assay validation, general proficiency, and quality control measures. These guidelines address first-trimester screening that includes ultrasound measurement and interpretation of nuchal translucency thickness and protocols that combine markers from both the first and second trimesters. Laboratories can use their professional judgment to make modification or additions.

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.

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 original versus KBP{sub FINAL} plans across the 35-patient validation set. Paired t tests were used to test differences between planning sets. Results: KBP{sub FINAL} plans outperformed manual planning across the validation set in all protocol-specific DVH cutpoints. The mean normal tissue complication probability for gastrointestinal toxicity was lower for KBP{sub FINAL} versus validation-set plans (48.7% vs 53.8%, P<.001). Similarly, the estimated mean white blood cell count nadir was higher (2.77 vs 2.49 k/mL, P<.001) with KBP{sub FINAL} plans, indicating lowered probability of hematologic toxicity. Conclusions: This work demonstrates that a KBP system can be efficiently trained and refined for use in radiation therapy clinical trials with minimal effort. This patient-specific plan quality control resulted in improvements on protocol-specific dosimetric endpoints.« less

Automatic spectral imaging protocol selection and iterative reconstruction in abdominal CT with reduced contrast agent dose: initial experience.

PubMed

Lv, Peijie; Liu, Jie; Chai, Yaru; Yan, Xiaopeng; Gao, Jianbo; Dong, Junqiang

2017-01-01

To evaluate the feasibility, image quality, and radiation dose of automatic spectral imaging protocol selection (ASIS) and adaptive statistical iterative reconstruction (ASIR) with reduced contrast agent dose in abdominal multiphase CT. One hundred and sixty patients were randomly divided into two scan protocols (n = 80 each; protocol A, 120 kVp/450 mgI/kg, filtered back projection algorithm (FBP); protocol B, spectral CT imaging with ASIS and 40 to 70 keV monochromatic images generated per 300 mgI/kg, ASIR algorithm. Quantitative parameters (image noise and contrast-to-noise ratios [CNRs]) and qualitative visual parameters (image noise, small structures, organ enhancement, and overall image quality) were compared. Monochromatic images at 50 keV and 60 keV provided similar or lower image noise, but higher contrast and overall image quality as compared with 120-kVp images. Despite the higher image noise, 40-keV images showed similar overall image quality compared to 120-kVp images. Radiation dose did not differ between the two protocols, while contrast agent dose in protocol B was reduced by 33 %. Application of ASIR and ASIS to monochromatic imaging from 40 to 60 keV allowed contrast agent dose reduction with adequate image quality and without increasing radiation dose compared to 120 kVp with FBP. • Automatic spectral imaging protocol selection provides appropriate scan protocols. • Abdominal CT is feasible using spectral imaging and 300 mgI/kg contrast agent. • 50-keV monochromatic images with 50 % ASIR provide optimal image quality.

Intervention quality is not routinely assessed in Cochrane systematic reviews of radiation therapy interventions.

PubMed

Abdul Rahim, Mohamad R; James, Melissa L; Hickey, Brigid E

2017-10-01

The aim of this study was to maximise the benefits from clinical trials involving technological interventions such as radiation therapy. High compliance to the quality assurance protocols is crucial. We assessed whether the quality of radiation therapy intervention was evaluated in Cochrane systematic reviews. We searched 416 published Cochrane systematic reviews and identified 67 Cochrane systematic reviews that investigated radiation therapy or radiotherapy as an intervention. For each systematic review, either quality assurance or quality control for the intervention was identified by a description of such processes in the published systematic reviews. Of the 67 Cochrane systematic reviews studied, only two mentioned quality assurance or quality control. Our findings revealed that 65 of 67 (97%) Cochrane systematic reviews of radiation therapy interventions failed to consider the quality of the intervention. We suggest that advice about the evaluation of intervention quality be added to author support materials. © 2017 The Royal Australian and New Zealand College of Radiologists.

Primary path reservation using enhanced slot assignment in TDMA for session admission.

PubMed

Koneri Chandrasekaran, Suresh; Savarimuthu, Prakash; Andi Elumalai, Priya; Ayyaswamy, Kathirvel

2015-01-01

Mobile ad hoc networks (MANET) is a self-organized collection of nodes that communicates without any infrastructure. Providing quality of service (QoS) in such networks is a competitive task due to unreliable wireless link, mobility, lack of centralized coordination, and channel contention. The success of many real time applications is purely based on the QoS, which can be achieved by quality aware routing (QAR) and admission control (AC). Recently proposed QoS mechanisms do focus completely on either reservation or admission control but are not better enough. In MANET, high mobility causes frequent path break due to the fact that every time the source node must find the route. In such cases the QoS session is affected. To admit a QoS session, admission control protocols must ensure the bandwidth of the relaying path before transmission starts; reservation of such bandwidth noticeably improves the admission control performance. Many TDMA based reservation mechanisms are proposed but need some improvement over slot reservation procedures. In order to overcome this specific issue, we propose a framework-PRAC (primary path reservation admission control protocol), which achieves improved QoS by making use of backup route combined with resource reservation. A network topology has been simulated and our approach proves to be a mechanism that admits the session effectively.

Natural Language Processing–Enabled and Conventional Data Capture Methods for Input to Electronic Health Records: A Comparative Usability Study

PubMed Central

Sheehan, Barbara; Stetson, Peter; Bhatt, Ashish R; Field, Adele I; Patel, Chirag; Maisel, James Mark

2016-01-01

Background The process of documentation in electronic health records (EHRs) is known to be time consuming, inefficient, and cumbersome. The use of dictation coupled with manual transcription has become an increasingly common practice. In recent years, natural language processing (NLP)–enabled data capture has become a viable alternative for data entry. It enables the clinician to maintain control of the process and potentially reduce the documentation burden. The question remains how this NLP-enabled workflow will impact EHR usability and whether it can meet the structured data and other EHR requirements while enhancing the user’s experience. Objective The objective of this study is evaluate the comparative effectiveness of an NLP-enabled data capture method using dictation and data extraction from transcribed documents (NLP Entry) in terms of documentation time, documentation quality, and usability versus standard EHR keyboard-and-mouse data entry. Methods This formative study investigated the results of using 4 combinations of NLP Entry and Standard Entry methods (“protocols”) of EHR data capture. We compared a novel dictation-based protocol using MediSapien NLP (NLP-NLP) for structured data capture against a standard structured data capture protocol (Standard-Standard) as well as 2 novel hybrid protocols (NLP-Standard and Standard-NLP). The 31 participants included neurologists, cardiologists, and nephrologists. Participants generated 4 consultation or admission notes using 4 documentation protocols. We recorded the time on task, documentation quality (using the Physician Documentation Quality Instrument, PDQI-9), and usability of the documentation processes. Results A total of 118 notes were documented across the 3 subject areas. The NLP-NLP protocol required a median of 5.2 minutes per cardiology note, 7.3 minutes per nephrology note, and 8.5 minutes per neurology note compared with 16.9, 20.7, and 21.2 minutes, respectively, using the Standard-Standard protocol and 13.8, 21.3, and 18.7 minutes using the Standard-NLP protocol (1 of 2 hybrid methods). Using 8 out of 9 characteristics measured by the PDQI-9 instrument, the NLP-NLP protocol received a median quality score sum of 24.5; the Standard-Standard protocol received a median sum of 29; and the Standard-NLP protocol received a median sum of 29.5. The mean total score of the usability measure was 36.7 when the participants used the NLP-NLP protocol compared with 30.3 when they used the Standard-Standard protocol. Conclusions In this study, the feasibility of an approach to EHR data capture involving the application of NLP to transcribed dictation was demonstrated. This novel dictation-based approach has the potential to reduce the time required for documentation and improve usability while maintaining documentation quality. Future research will evaluate the NLP-based EHR data capture approach in a clinical setting. It is reasonable to assert that EHRs will increasingly use NLP-enabled data entry tools such as MediSapien NLP because they hold promise for enhancing the documentation process and end-user experience. PMID:27793791

76 FR 9025 - Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-16

... consumer protection, the Agency issued GLP regulations. The regulations specify minimum standards for the proper conduct of safety testing and contain sections on facilities, personnel, equipment, standard operating procedures (SOPs), test and control articles, quality assurance, protocol and conduct of a safety...

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.

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.

Use of cardiocerebral resuscitation or AHA/ERC 2005 Guidelines is associated with improved survival from out-of-hospital cardiac arrest: a systematic review and meta-analysis

PubMed Central

Salmen, Marcus; Ewy, Gordon A; Sasson, Comilla

2012-01-01

Objective To determine whether the use of cardiocerebral resuscitation (CCR) or AHA/ERC 2005 Resuscitation Guidelines improved patient outcomes from out-of-hospital cardiac arrest (OHCA) compared to older guidelines. Design Systematic review and meta-analysis. Data sources MEDLINE, EMBASE, Web of Science and the Cochrane Library databases. We also hand-searched study references and consulted experts. Study selection Design: randomised controlled trials and observational studies. Population OHCA patients, age >17 years. Comparators ‘Control’ protocol versus ‘Study’ protocol. ‘Control’ protocol defined as AHA/ERC 2000 Guidelines for cardiopulmonary resuscitation (CPR). ‘Study’ protocol defined as AHA/ERC 2005 Guidelines for CPR, or a CCR protocol. Outcome Survival to hospital discharge. Quality High-quality or medium-quality studies, as measured by the Newcastle Ottawa Scale using predefined categories. Results Twelve observational studies met inclusion criteria. All the three studies using CCR demonstrated significantly improved survival compared to use of AHA 2000 Guidelines, as did five of the nine studies using AHA/ERC 2005 Guidelines. Pooled data demonstrate that use of a CCR protocol has an unadjusted OR of 2.26 (95% CI 1.64 to 3.12) for survival to hospital discharge among all cardiac arrest patients. Among witnessed ventricular fibrillation/ventricular tachycardia (VF/VT) patients, CCR increased survival by an OR of 2.98 (95% CI 1.92 to 4.62). Studies using AHA/ERC 2005 Guidelines showed an overall trend towards increased survival, but significant heterogeneity existed among these studies. Conclusions We demonstrate an association with improved survival from OHCA when CCR protocols or AHA/ERC 2005 Guidelines are compared to use of older guidelines. In the subgroup of patients with witnessed VF/VT, there was a threefold increase in OHCA survival when CCR was used. CCR appears to be a promising resuscitation protocol for Emergency Medical Services providers in increasing survival from OHCA. Future research will need to be conducted to directly compare AHA/ERC 2010 Guidelines with the CCR approach. PMID:23036985

A two-step dilution tris-egg yolk extender containing Equex STM significantly improves sperm cryopreservation in the African wild dog (Lycaon pictus).

PubMed

Van den Berghe, Femke; Paris, Monique Christina Johanna; Briggs, Michael Brent; Farstad, Wenche Kristin; Paris, Damien Boyd Bertrand Paul

2018-02-01

Conservation management of endangered African wild dogs (AWD; Lycaon pictus) can benefit greatly from development of sperm freezing and artificial insemination. Previous freezing attempts yielded nearly 0% motile sperm within 2 h of thawing. In this study, two canine freezing protocols were tested: Protocol 1: a one-step dilution in TRIS-20% egg yolk containing 8% glycerol; and Protocol 2: a two-step dilution in TRIS-20% egg yolk containing a final extender concentration of 5% glycerol and 0.5% Equex STM, coupled with a TRIS-citrate-fructose thawing solution. Semen was collected by electroejaculation from n = 24 AWDs, of which eight ejaculates of sufficient quality (four good quality with initial sperm motility of 75.0 ± 4.4% and four poor quality; showing rapid decrease in sperm motility to 3.3 ± 3.3% prior to freezing) were frozen. For good quality samples, motility and sperm motility index persisted for up to 8 h for Protocol 2, and was higher between 2 and 6 h after thawing with a decrease from 4 h of incubation. Motility dropped to nearly 0% after 2 h incubation for Protocol 1. Viability was higher for Protocol 2 throughout the 8 h of incubation, with a decrease after 6 h, compared to 4 h for Protocol 1. Acrosome integrity was higher for Protocol 2 throughout post-thaw incubation, with a decrease after 2 h for both protocols. Protocols did not differ in normal sperm morphology or DNA integrity. Poor quality samples yielded similar results, except for acrosome integrity, which declined for Protocol 2. In conclusion, a two-step dilution in TRIS-egg yolk-glycerol extender containing Equex STM yields significantly improved post-thaw quality and longevity of AWD spermatozoa, making it suitable for sperm banking and artificial insemination initiatives. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

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 life, and could be helpful in further developing affordable disease management plans for patients of other chronic diseases. ChiCTR-IOR-14005390 (10/27/2014).

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.

An ICT-Based Platform to Monitor Protocols in the Healthcare Environment.

PubMed

Rorís, Víctor M Alonso; Gago, Juan M Santos; Sabucedo, Luis Álvarez; Merino, Mateo Ramos; Valero, Javier Sanz

2016-10-01

Procedures from the healthcare domain involve highly critical actions as they may pose a risk for patients' life. Therefore, a large effort is devoted to the standardization in clinical praxis and to the control of quality for these protocols in order to minimize hazards. In this line, this work is compelled to provide an ICT-based support to carry out these controls in a simple and effective manner. Using a methodology based on HACCP and taking advantage of Semantic tools, a holistic platform of services for traceability and control of processes has been designed and implemented. The applied paradigm is based on the use of Control Points as singular points to generate traces using observations and measures relevant for the processes considered. Based on those, it is possible to offer services for advanced querying and knowledge inference. The local deployment just requires regular mobile phones or tablets making this solution cost-effective and easily replicable.

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

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 care was significantly associated with better process in terms of diabetes care, fewer secondary care consultations and lower health care costs. The same trends were seen for protocolized care, however they were not statistically significant. Current Controlled trials: ISRCTN66124817.

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 significantly). Conclusions Compared to usual care, managed care was significantly associated with better process in terms of diabetes care, fewer secondary care consultations and lower health care costs. The same trends were seen for protocolized care, however they were not statistically significant. Trial registration Current Controlled trials: ISRCTN66124817. PMID:24966055

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 of 73 of these samples was analyzed for a suite of 19 organochlorine pesticides by gas chromatography. Only three of these samples had detectable pesticide concentrations. A separate sample of A-horizon soil was collected for microbial characterization by phospholipid fatty acid analysis (PLFA), soil enzyme assays, and determination of selected human and agricultural pathogens. Collection, preservation and analysis of samples for both organic compounds and microbial characterization add a great degree of complication to the sampling and preservation protocols and a significant increase to the cost for a continental-scale survey. Both these issues must be considered carefully prior to adopting these parameters as part of the soil geochemical survey of North America.

76 FR 39434 - Notice of Utah's Resource Advisory Council (RAC)

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-06

... wildlife, livestock water quality, and recreational opportunities of ``time control'' grazing. A... protocol. The conference call with Director Abbey will take place from 1-1:45 p.m. (Mountain Time). A half.... All meetings are open to the public; however, transportation, lodging, and meals are the...

Data analysis protocol for using resistivity array as an early-warning wastewater pond leak detector

USDA-ARS?s Scientific Manuscript database

Typically, holding ponds are used to control runoff from concentrated animal feeding operations. The integrity of these holding ponds has come under increased scrutiny since subsurface leakage has the potential to affect soil and groundwater quality. Traditionally, ponds are monitored by installin...

Developing Ubiquitous Sensor Network Platform Using Internet of Things: Application in Precision Agriculture.

PubMed

Ferrández-Pastor, Francisco Javier; García-Chamizo, Juan Manuel; Nieto-Hidalgo, Mario; Mora-Pascual, Jerónimo; Mora-Martínez, José

2016-07-22

The application of Information Technologies into Precision Agriculture methods has clear benefits. Precision Agriculture optimises production efficiency, increases quality, minimises environmental impact and reduces the use of resources (energy, water); however, there are different barriers that have delayed its wide development. Some of these main barriers are expensive equipment, the difficulty to operate and maintain and the standard for sensor networks are still under development. Nowadays, new technological development in embedded devices (hardware and communication protocols), the evolution of Internet technologies (Internet of Things) and ubiquitous computing (Ubiquitous Sensor Networks) allow developing less expensive systems, easier to control, install and maintain, using standard protocols with low-power consumption. This work develops and test a low-cost sensor/actuator network platform, based in Internet of Things, integrating machine-to-machine and human-machine-interface protocols. Edge computing uses this multi-protocol approach to develop control processes on Precision Agriculture scenarios. A greenhouse with hydroponic crop production was developed and tested using Ubiquitous Sensor Network monitoring and edge control on Internet of Things paradigm. The experimental results showed that the Internet technologies and Smart Object Communication Patterns can be combined to encourage development of Precision Agriculture. They demonstrated added benefits (cost, energy, smart developing, acceptance by agricultural specialists) when a project is launched.

Developing Ubiquitous Sensor Network Platform Using Internet of Things: Application in Precision Agriculture

PubMed Central

Ferrández-Pastor, Francisco Javier; García-Chamizo, Juan Manuel; Nieto-Hidalgo, Mario; Mora-Pascual, Jerónimo; Mora-Martínez, José

2016-01-01

The application of Information Technologies into Precision Agriculture methods has clear benefits. Precision Agriculture optimises production efficiency, increases quality, minimises environmental impact and reduces the use of resources (energy, water); however, there are different barriers that have delayed its wide development. Some of these main barriers are expensive equipment, the difficulty to operate and maintain and the standard for sensor networks are still under development. Nowadays, new technological development in embedded devices (hardware and communication protocols), the evolution of Internet technologies (Internet of Things) and ubiquitous computing (Ubiquitous Sensor Networks) allow developing less expensive systems, easier to control, install and maintain, using standard protocols with low-power consumption. This work develops and test a low-cost sensor/actuator network platform, based in Internet of Things, integrating machine-to-machine and human-machine-interface protocols. Edge computing uses this multi-protocol approach to develop control processes on Precision Agriculture scenarios. A greenhouse with hydroponic crop production was developed and tested using Ubiquitous Sensor Network monitoring and edge control on Internet of Things paradigm. The experimental results showed that the Internet technologies and Smart Object Communication Patterns can be combined to encourage development of Precision Agriculture. They demonstrated added benefits (cost, energy, smart developing, acceptance by agricultural specialists) when a project is launched. PMID:27455265

First intention IVF protocol for polycystic ovaries: does oral contraceptive pill pretreatment influence COH outcome?

PubMed

Decanter, Christine; Robin, Geoffroy; Thomas, Patricia; Leroy, Maryse; Lefebvre, Catherine; Soudan, Benoit; Lefebvre-Khalil, Valerie; Leroy-Martin, Brigitte; Dewailly, Didier

2013-06-19

Morphological aspect of polycystic ovaries (PCO) is a very common finding in an IVF center population: this includes PCOS patients identified in 18-25% of the couples presenting with infertility and so called "sonographic PCO only" the prevalence of which has been estimated as high as 33% in asymptomatic patients. Finding the optimal first intention IVF protocol for polycystic ovaries patients is still challenging in order to improve the controlled ovarian hyperstimulation (COH) outcome while avoiding ovarian hyperstimulation syndrome (OHSS). It has been suggested that women with PCO would benefit from a longer period of pituitary down-regulation. The purpose of this study was to compare an extended duration of OCP pretreatment with a classic GnRH agonist protocol. A single center prospective non-randomized study was performed from January 2009 to December 2010 in the Lille University Hospital including 113 women diagnosed with PCO(S) according to the Rotterdam ultrasonographic criteria and undergoing their first IVF attempt. Comprehensive hormonal and ultra-sonographic assessments were collected during COH in these patients. LH and androgen suppression and dynamics of follicular growth were compared between the two protocols as well as the COH outcome in terms of oocyte/embryo number and quality, implantation and pregnancy rates. No significant difference was observed between the two groups concerning dynamics of follicular growth and hormonal values. Clinical and ongoing pregnancy rates were significantly lower in the OCP group despite same oocyte and embryo quality. Nevertheless, the cumulative pregnancy rate did not differ between the two groups. The incidence of OHSS was not statistically significant. Extended duration of OCP pretreatment, as a first intention IVF protocol for PCO patients, does not improve the pattern of follicular growth nor the oocyte and embryo quality.

High dose microCT does not contribute towards improved microPET/CT image quantitative accuracy and can limit longitudinal scanning of small animals

NASA Astrophysics Data System (ADS)

McDougald, Wendy A.; Collins, Richard; Green, Mark; Tavares, Adriana A. S.

2017-10-01

Obtaining accurate quantitative measurements in preclinical Positron Emission Tomography/Computed Tomography (PET/CT) imaging is of paramount importance in biomedical research and helps supporting efficient translation of preclinical results to the clinic. The purpose of this study was two-fold: (1) to investigate the effects of different CT acquisition protocols on PET/CT image quality and data quantification; and (2) to evaluate the absorbed dose associated with varying CT parameters. Methods: An air/water quality control CT phantom, tissue equivalent material phantom, an in-house 3D printed phantom and an image quality PET/CT phantom were imaged using a Mediso nanoPET/CT scanner. Collected data was analyzed using PMOD software, VivoQuant software and National Electric Manufactures Association (NEMA) software implemented by Mediso. Measured Hounsfield Unit (HU) in collected CT images were compared to the known HU values and image noise was quantified. PET recovery coefficients (RC), uniformity and quantitative bias were also measured. Results: Only less than 2% and 1% of CT acquisition protocols yielded water HU values < -80 and air HU values < -840, respectively. Four out of eleven CT protocols resulted in more than 100 mGy absorbed dose. Different CT protocols did not impact PET uniformity and RC, and resulted in <4% overall bias relative to expected radioactive concentration. Conclusion: Preclinical CT protocols with increased exposure times can result in high absorbed doses to the small animals. These should be avoided, as they do not contributed towards improved microPET/CT image quantitative accuracy and could limit longitudinal scanning of small animals.

A parameterization method and application in breast tomosynthesis dosimetry

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

Li, Xinhua; Zhang, Da; Liu, Bob

2013-09-15

Purpose: To present a parameterization method based on singular value decomposition (SVD), and to provide analytical parameterization of the mean glandular dose (MGD) conversion factors from eight references for evaluating breast tomosynthesis dose in the Mammography Quality Standards Act (MQSA) protocol and in the UK, European, and IAEA dosimetry protocols.Methods: MGD conversion factor is usually listed in lookup tables for the factors such as beam quality, breast thickness, breast glandularity, and projection angle. The authors analyzed multiple sets of MGD conversion factors from the Hologic Selenia Dimensions quality control manual and seven previous papers. Each data set was parameterized usingmore » a one- to three-dimensional polynomial function of 2–16 terms. Variable substitution was used to improve accuracy. A least-squares fit was conducted using the SVD.Results: The differences between the originally tabulated MGD conversion factors and the results computed using the parameterization algorithms were (a) 0.08%–0.18% on average and 1.31% maximum for the Selenia Dimensions quality control manual, (b) 0.09%–0.66% on average and 2.97% maximum for the published data by Dance et al. [Phys. Med. Biol. 35, 1211–1219 (1990); ibid. 45, 3225–3240 (2000); ibid. 54, 4361–4372 (2009); ibid. 56, 453–471 (2011)], (c) 0.74%–0.99% on average and 3.94% maximum for the published data by Sechopoulos et al. [Med. Phys. 34, 221–232 (2007); J. Appl. Clin. Med. Phys. 9, 161–171 (2008)], and (d) 0.66%–1.33% on average and 2.72% maximum for the published data by Feng and Sechopoulos [Radiology 263, 35–42 (2012)], excluding one sample in (d) that does not follow the trends in the published data table.Conclusions: A flexible parameterization method is presented in this paper, and was applied to breast tomosynthesis dosimetry. The resultant data offer easy and accurate computations of MGD conversion factors for evaluating mean glandular breast dose in the MQSA protocol and in the UK, European, and IAEA dosimetry protocols. Microsoft Excel™ spreadsheets are provided for the convenience of readers.« less

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 consecutive audits. The DQMIS was successful, despite an increase from 20 to 130 data collectors. In the absence of widely disseminated data quality methods and standards for large RCT interventions in limited-resource settings, we developed an integrated DQA system, combining auditing, rapid data feedback, and supportive supervision, which ensured high-quality data and could serve as a model for future health systems research trials. Future efforts should focus on standardization of DQA processes for health systems research. ClinicalTrials.gov identifier, NCT02148952 . Registered on 13 February 2014.

Ensuring Quality in AFRINEST and SATT

PubMed Central

2013-01-01

Background: Three randomized open-label clinical trials [Simplified Antibiotic Therapy Trial (SATT) Bangladesh, SATT Pakistan and African Neonatal Sepsis Trial (AFRINEST)] were developed to test the equivalence of simplified antibiotic regimens compared with the standard regimen of 7 days of parenteral antibiotics. These trials were originally conceived and designed separately; subsequently, significant efforts were made to develop and implement a common protocol and approach. Previous articles in this supplement briefly describe the specific quality control methods used in the individual trials; this article presents additional information about the systematic approaches used to minimize threats to validity and ensure quality across the trials. Methods: A critical component of quality control for AFRINEST and SATT was striving to eliminate variation in clinical assessments and decisions regarding eligibility, enrollment and treatment outcomes. Ensuring appropriate and consistent clinical judgment was accomplished through standardized approaches applied across the trials, including training, assessment of clinical skills and refresher training. Standardized monitoring procedures were also applied across the trials, including routine (day-to-day) internal monitoring of performance and adherence to protocols, systematic external monitoring by funding agencies and external monitoring by experienced, independent trial monitors. A group of independent experts (Technical Steering Committee/Technical Advisory Group) provided regular monitoring and technical oversight for the trials. Conclusions: Harmonization of AFRINEST and SATT have helped to ensure consistency and quality of implementation, both internally and across the trials as a whole, thereby minimizing potential threats to the validity of the trials’ results. PMID:23945575

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.

Quality assurance of data collection in the multi-site community randomized trial and prevalence survey of the children's healthy living program.

PubMed

Yamanaka, Ashley; Fialkowski, Marie Kainoa; Wilkens, Lynne; Li, Fenfang; Ettienne, Reynolette; Fleming, Travis; Power, Julianne; Deenik, Jonathan; Coleman, Patricia; Leon Guerrero, Rachael; Novotny, Rachel

2016-09-02

Quality assurance plays an important role in research by assuring data integrity, and thus, valid study results. We aim to describe and share the results of the quality assurance process used to guide the data collection process in a multi-site childhood obesity prevalence study and intervention trial across the US Affiliated Pacific Region. Quality assurance assessments following a standardized protocol were conducted by one assessor in every participating site. Results were summarized to examine and align the implementation of protocol procedures across diverse settings. Data collection protocols focused on food and physical activity were adhered to closely; however, protocols for handling completed forms and ensuring data security showed more variability. Quality assurance protocols are common in the clinical literature but are limited in multi-site community-based studies, especially in underserved populations. The reduction in the number of QA problems found in the second as compared to the first data collection periods for the intervention study attest to the value of this assessment. This paper can serve as a reference for similar studies wishing to implement quality assurance protocols of the data collection process to preserve data integrity and enhance the validity of study findings. NIH clinical trial #NCT01881373.

Nonpharmacologic, nonherbal management of menopause-associated vasomotor symptoms: an umbrella systematic review (protocol).

PubMed

Goldstein, Karen M; McDuffie, Jennifer R; Shepherd-Banigan, Megan; Befus, Deanna; Coeytaux, Remy R; Van Noord, Megan G; Goode, Adam P; Masilamani, Varsha; Adam, Soheir; Nagi, Avishek; Williams, John W

2016-04-07

Vasomotor symptoms such as hot flashes and night sweats are a common concern of perimenopausal and postmenopausal women and are associated with a decreased quality of life. These symptoms can be effectively managed with hormone therapy, but safety concerns limit its use. Thus, understanding the effectiveness of nonpharmacologic therapies such as acupuncture or yoga is critical to managing these common symptoms in older women. Our review seeks to address the following question: In women with menopause-associated vasomotor symptoms, what are the effects on health-related quality of life, vasomotor symptoms, and adverse events of the following nonpharmacologic, nonherbal interventions as compared with any inactive control or active comparator: (a) acupuncture, (b) yoga, tai chi, and qigong, (c) structured exercise, and (d) meditation, mindfulness-based practices, and relaxation? We describe a protocol for an umbrella review approach, supplemented by evaluating randomized controlled trials (RCTs) published after the most recent good-quality systematic review for each of the eligible interventions. Specific interventions were chosen based on current literature and with input from a technical expert panel and organizational stakeholders. We will conduct a thorough literature search and perform a quality assessment of potentially included systematic reviews and RCTs. Our umbrella review, supplemented by an additional search for eligible RCTs, aims to synthesize existing evidence on the use of nonpharmacologic, nonherbal interventions to manage bothersome vasomotor symptoms in perimenopausal and postmenopausal women. PROSPERO CRD42016029335.

Implementation research to improve quality of maternal and newborn health care, Malawi.

PubMed

Brenner, Stephan; Wilhelm, Danielle; Lohmann, Julia; Kambala, Christabel; Chinkhumba, Jobiba; Muula, Adamson S; De Allegri, Manuela

2017-07-01

To evaluate the impact of a performance-based financing scheme on maternal and neonatal health service quality in Malawi. We conducted a non-randomized controlled before and after study to evaluate the effects of district- and facility-level performance incentives for health workers and management teams. We assessed changes in the facilities' essential drug stocks, equipment maintenance and clinical obstetric care processes. Difference-in-difference regression models were used to analyse effects of the scheme on adherence to obstetric care treatment protocols and provision of essential drugs, supplies and equipment. We observed 33 health facilities, 23 intervention facilities and 10 control facilities and 401 pregnant women across four districts. The scheme improved the availability of both functional equipment and essential drug stocks in the intervention facilities. We observed positive effects in respect to drug procurement and clinical care activities at non-intervention facilities, likely in response to improved district management performance. Birth assistants' adherence to clinical protocols improved across all studied facilities as district health managers supervised and coached clinical staff more actively. Despite nation-wide stock-outs and extreme health worker shortages, facilities in the study districts managed to improve maternal and neonatal health service quality by overcoming bottlenecks related to supply procurement, equipment maintenance and clinical performance. To strengthen and reform health management structures, performance-based financing may be a promising approach to sustainable improvements in quality of health care.

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…

Knowledge translation interventions for critically ill patients: a systematic review*.

PubMed

Sinuff, Tasnim; Muscedere, John; Adhikari, Neill K J; Stelfox, Henry T; Dodek, Peter; Heyland, Daren K; Rubenfeld, Gordon D; Cook, Deborah J; Pinto, Ruxandra; Manoharan, Venika; Currie, Jan; Cahill, Naomi; Friedrich, Jan O; Amaral, Andre; Piquette, Dominique; Scales, Damon C; Dhanani, Sonny; Garland, Allan

2013-11-01

We systematically reviewed ICU-based knowledge translation studies to assess the impact of knowledge translation interventions on processes and outcomes of care. We searched electronic databases (to July, 2010) without language restrictions and hand-searched reference lists of relevant studies and reviews. Two reviewers independently identified randomized controlled trials and observational studies comparing any ICU-based knowledge translation intervention (e.g., protocols, guidelines, and audit and feedback) to management without a knowledge translation intervention. We focused on clinical topics that were addressed in greater than or equal to five studies. Pairs of reviewers abstracted data on the clinical topic, knowledge translation intervention(s), process of care measures, and patient outcomes. For each individual or combination of knowledge translation intervention(s) addressed in greater than or equal to three studies, we summarized each study using median risk ratio for dichotomous and standardized mean difference for continuous process measures. We used random-effects models. Anticipating a small number of randomized controlled trials, our primary meta-analyses included randomized controlled trials and observational studies. In separate sensitivity analyses, we excluded randomized controlled trials and collapsed protocols, guidelines, and bundles into one category of intervention. We conducted meta-analyses for clinical outcomes (ICU and hospital mortality, ventilator-associated pneumonia, duration of mechanical ventilation, and ICU length of stay) related to interventions that were associated with improvements in processes of care. From 11,742 publications, we included 119 investigations (seven randomized controlled trials, 112 observational studies) on nine clinical topics. Interventions that included protocols with or without education improved continuous process measures (seven observational studies and one randomized controlled trial; standardized mean difference [95% CI]: 0.26 [0.1, 0.42]; p = 0.001 and four observational studies and one randomized controlled trial; 0.83 [0.37, 1.29]; p = 0.0004, respectively). Heterogeneity among studies within topics ranged from low to extreme. The exclusion of randomized controlled trials did not change our results. Single-intervention and lower-quality studies had higher standardized mean differences compared to multiple-intervention and higher-quality studies (p = 0.013 and 0.016, respectively). There were no associated improvements in clinical outcomes. Knowledge translation interventions in the ICU that include protocols with or without education are associated with the greatest improvements in processes of critical care.

Building high-quality assay libraries for targeted analysis of SWATH MS data.

PubMed

Schubert, Olga T; Gillet, Ludovic C; Collins, Ben C; Navarro, Pedro; Rosenberger, George; Wolski, Witold E; Lam, Henry; Amodei, Dario; Mallick, Parag; MacLean, Brendan; Aebersold, Ruedi

2015-03-01

Targeted proteomics by selected/multiple reaction monitoring (S/MRM) or, on a larger scale, by SWATH (sequential window acquisition of all theoretical spectra) MS (mass spectrometry) typically relies on spectral reference libraries for peptide identification. Quality and coverage of these libraries are therefore of crucial importance for the performance of the methods. Here we present a detailed protocol that has been successfully used to build high-quality, extensive reference libraries supporting targeted proteomics by SWATH MS. We describe each step of the process, including data acquisition by discovery proteomics, assertion of peptide-spectrum matches (PSMs), generation of consensus spectra and compilation of MS coordinates that uniquely define each targeted peptide. Crucial steps such as false discovery rate (FDR) control, retention time normalization and handling of post-translationally modified peptides are detailed. Finally, we show how to use the library to extract SWATH data with the open-source software Skyline. The protocol takes 2-3 d to complete, depending on the extent of the library and the computational resources available.

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.

Comparison of two DNA extraction protocols from leave samples of Cotinus coggygria, Citrus sinensis and Genus juglans.

PubMed

Fallah, F; Minaei Chenar, H; Amiri, H; Omodipour, S; Shirbande Ghods, F; Kahrizi, D; Sohrabi, M; Ghorbani, T; Kazemi, E

2017-02-28

High quality DNA is essential for molecular research. Secondary metabolites can affect the quantity and quality DNA. In current research two DNA isolation methods including CTAB and Delaporta (protocols 1 & 2 respectively) were applied in three leave samples from Cotinus coggygria, Citrus sinensis and Genus juglans that their leaves are rich of secondary metabolites. We successfully isolated DNA from C. coggygria, C. sinensis and Genus Juglans using the two protocols described above. Good quality DNA was isolated from C. coggygria, C. sinensis and Genus Juglans using protocol 1, while protocol 2 failed to produce usable DNA from these sources. The highest amount of DNA (1.3-1.6) was obtained from them using protocol 1. As we discovered, procedure 1 may work better for plants with secondary metabolites.

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).

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.

Integration and Analysis of Neighbor Discovery and Link Quality Estimation in Wireless Sensor Networks

PubMed Central

Radi, Marjan; Dezfouli, Behnam; Abu Bakar, Kamalrulnizam; Abd Razak, Shukor

2014-01-01

Network connectivity and link quality information are the fundamental requirements of wireless sensor network protocols to perform their desired functionality. Most of the existing discovery protocols have only focused on the neighbor discovery problem, while a few number of them provide an integrated neighbor search and link estimation. As these protocols require a careful parameter adjustment before network deployment, they cannot provide scalable and accurate network initialization in large-scale dense wireless sensor networks with random topology. Furthermore, performance of these protocols has not entirely been evaluated yet. In this paper, we perform a comprehensive simulation study on the efficiency of employing adaptive protocols compared to the existing nonadaptive protocols for initializing sensor networks with random topology. In this regard, we propose adaptive network initialization protocols which integrate the initial neighbor discovery with link quality estimation process to initialize large-scale dense wireless sensor networks without requiring any parameter adjustment before network deployment. To the best of our knowledge, this work is the first attempt to provide a detailed simulation study on the performance of integrated neighbor discovery and link quality estimation protocols for initializing sensor networks. This study can help system designers to determine the most appropriate approach for different applications. PMID:24678277

Low-dose abdominal computed tomography for detection of urinary stone disease - Impact of additional spectral shaping of the X-ray beam on image quality and dose parameters.

PubMed

Dewes, Patricia; Frellesen, Claudia; Scholtz, Jan-Erik; Fischer, Sebastian; Vogl, Thomas J; Bauer, Ralf W; Schulz, Boris

2016-06-01

To evaluate a novel tin filter-based abdominal CT protocol for urolithiasis in terms of image quality and CT dose parameters. 130 consecutive patients with suspected urolithiasis underwent non-enhanced CT with three different protocols: 48 patients (group 1) were examined at tin-filtered 150kV (150kV Sn) on a third-generation dual-source-CT, 33 patients were examined with automated kV-selection (110-140kV) based on the scout view on the same CT-device (group 2), and 49 patients were examined on a second-generation dual-source-CT (group 3) with automated kV-selection (100-140kV). Automated exposure control was active in all groups. Image quality was subjectively evaluated on a 5-point-likert-scale by two radiologists and interobserver agreement as well as signal-to-noise-ratio (SNR) was calculated. Dose-length-product (DLP) and volume CT dose index (CTDIvol) were compared. Image quality was rated in favour for the tin filter protocol with excellent interobserver agreement (ICC=0.86-0.91) and the difference reached statistical significance (p<0.001). SNR was significantly higher in group 1 and 2 compared to second-generation DSCT (p<0.001). On third-generation dual-source CT, there was no significant difference in SNR between the 150kV Sn and the automated kV selection protocol (p=0.5). The DLP of group 1 was 23% and 21% (p<0.002) lower in comparison to group 2 and 3, respectively. So was the CTDIvol of group 1 compared to group 2 (-36%) and 3 (-32%) (p<0.001). Additional shaping of a 150kV source spectrum by a tin filter substantially lowers patient exposure while improving image quality on un-enhanced abdominal computed tomography for urinary stone disease. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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 from the expected phantom result when scanning at low mAs and low kVp in terms of quantitative metrics (Injected Mass Error 15.4%), goodness of fit (R{sup 2}) of 0.91, and ROI sensitivity (increase in minimum input function ROI radius by 146 ± 86%). These tests also confirmed that the ASIR reconstruction process was beneficial in reducing noise without substantially increasing partial volume effects and that vendor specific modes (e.g., axial shuttle) did not significantly affect the phantom results. The phantom and QA protocol were finally able to quickly (<90 min) and successfully validate the DCE-CT imaging protocol utilized at the three separate institutions of a multicenter clinical trial; thereby enhancing the confidence in the patient data collected.Conclusions: A DCE QA protocol was developed that, in combination with a dynamic multimodality flow phantom, allows the intrascanner variability to be separated from other sources of variability such as the impact of injection protocol and ROI selection. This provides a valuable resource that can be utilized at various clinical trial institutions to test conformance with imaging protocols and accuracy requirements as well as ensure that the scanners are performing as expected for dynamic scans.« less

Automatic CT simulation optimization for radiation therapy: A general strategy.

PubMed

Li, Hua; Yu, Lifeng; Anastasio, Mark A; Chen, Hsin-Chen; Tan, Jun; Gay, Hiram; Michalski, Jeff M; Low, Daniel A; Mutic, Sasa

2014-03-01

In radiation therapy, x-ray computed tomography (CT) simulation protocol specifications should be driven by the treatment planning requirements in lieu of duplicating diagnostic CT screening protocols. The purpose of this study was to develop a general strategy that allows for automatically, prospectively, and objectively determining the optimal patient-specific CT simulation protocols based on radiation-therapy goals, namely, maintenance of contouring quality and integrity while minimizing patient CT simulation dose. The authors proposed a general prediction strategy that provides automatic optimal CT simulation protocol selection as a function of patient size and treatment planning task. The optimal protocol is the one that delivers the minimum dose required to provide a CT simulation scan that yields accurate contours. Accurate treatment plans depend on accurate contours in order to conform the dose to actual tumor and normal organ positions. An image quality index, defined to characterize how simulation scan quality affects contour delineation, was developed and used to benchmark the contouring accuracy and treatment plan quality within the predication strategy. A clinical workflow was developed to select the optimal CT simulation protocols incorporating patient size, target delineation, and radiation dose efficiency. An experimental study using an anthropomorphic pelvis phantom with added-bolus layers was used to demonstrate how the proposed prediction strategy could be implemented and how the optimal CT simulation protocols could be selected for prostate cancer patients based on patient size and treatment planning task. Clinical IMRT prostate treatment plans for seven CT scans with varied image quality indices were separately optimized and compared to verify the trace of target and organ dosimetry coverage. Based on the phantom study, the optimal image quality index for accurate manual prostate contouring was 4.4. The optimal tube potentials for patient sizes of 38, 43, 48, 53, and 58 cm were 120, 140, 140, 140, and 140 kVp, respectively, and the corresponding minimum CTDIvol for achieving the optimal image quality index 4.4 were 9.8, 32.2, 100.9, 241.4, and 274.1 mGy, respectively. For patients with lateral sizes of 43-58 cm, 120-kVp scan protocols yielded up to 165% greater radiation dose relative to 140-kVp protocols, and 140-kVp protocols always yielded a greater image quality index compared to the same dose-level 120-kVp protocols. The trace of target and organ dosimetry coverage and the γ passing rates of seven IMRT dose distribution pairs indicated the feasibility of the proposed image quality index for the predication strategy. A general strategy to predict the optimal CT simulation protocols in a flexible and quantitative way was developed that takes into account patient size, treatment planning task, and radiation dose. The experimental study indicated that the optimal CT simulation protocol and the corresponding radiation dose varied significantly for different patient sizes, contouring accuracy, and radiation treatment planning tasks.

Methods for the evaluation of hospital cooperation activities (Systematic review protocol).

PubMed

Rotter, Thomas; Popa, Daniela; Riley, Beatrice; Ellermann, Tim; Ryll, Ulrike; Burazeri, Genc; Daemen, Piet; Peeters, Guy; Brand, Helmut

2012-02-10

Hospital partnerships, mergers and cooperatives are arrangements frequently seen as a means of improving health service delivery. Many of the assumptions used in planning hospital cooperatives are not stated clearly and are often based on limited or poor scientific evidence. This is a protocol for a systematic review, following the Cochrane EPOC methodology. The review aims to document, catalogue and synthesize the existing literature on the reported methods for the evaluation of hospital cooperation activities as well as methods of hospital cooperation. We will search the Database of Abstracts of Reviews of Effectiveness, the Effective Practice and Organisation of Care Register, the Cochrane Central Register of Controlled Trials and bibliographic databases including PubMed (via NLM), Web of Science, NHS EED, Business Source Premier (via EBSCO) and Global Health for publications that report on methods for evaluating hospital cooperatives, strategic partnerships, mergers, alliances, networks and related activities and methods used for such partnerships. The method proposed by the Cochrane EPOC group regarding randomized study designs, controlled clinical trials, controlled before and after studies, and interrupted time series will be followed. In addition, we will also include cohort, case-control studies, and relevant non-comparative publications such as case reports. We will categorize and analyze the review findings according to the study design employed, the study quality (low versus high quality studies) and the method reported in the primary studies. We will present the results of studies in tabular form. Overall, the systematic review aims to identify, assess and synthesize the evidence to underpin hospital cooperation activities as defined in this protocol. As a result, the review will provide an evidence base for partnerships, alliances or other fields of cooperation in a hospital setting. PROSPERO registration number: CRD42011001579.

Improvements in the order, isotropy and electron density of glypican-1 crystals by controlled dehydration

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

Awad, Wael; Cairo University, Cairo; Svensson Birkedal, Gabriel

The anisotropy of crystals of glypican-1 was significantly reduced by controlled dehydration using the HC1 device, allowing the building of previously disordered parts of the structure. The use of controlled dehydration for improvement of protein crystal diffraction quality is increasing in popularity, although there are still relatively few documented examples of success. A study has been carried out to establish whether controlled dehydration could be used to improve the anisotropy of crystals of the core protein of the human proteoglycan glypican-1. Crystals were subjected to controlled dehydration using the HC1 device. The optimal protocol for dehydration was developed by carefulmore » investigation of the following parameters: dehydration rate, final relative humidity and total incubation time T{sub inc}. Of these, the most important was shown to be T{sub inc}. After dehydration using the optimal protocol the crystals showed significantly reduced anisotropy and improved electron density, allowing the building of previously disordered parts of the structure.« less

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 rating scale. This study will contribute to the optimal surgical treatment of patients with deep dermal burn wounds. Dutch Trial Register, NTR6232 . Registered on 23 January 2017.

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 Institute of 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 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 CCR, NCI and NIH policies Collaborates with investigators to resolve any protocol/data issues Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI Institutional Review Board (IRB) and the clinical trial sponsor or the FDA Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events Attends and prepares minutes for the Branch Protocol Review Committees For protocols that are performed with other research centers: contacts coordinators at other centers to obtain review committee approvals at these centers, maintains records of these approvals at the outside centers in the protocol files, and sends protocol amendments and other reports to the participating centers Maintains a schedule of all review committee submission deadline dates and meeting dates Assists clinical investigators in understanding and complying with the entire review process Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document management and tracking system for NCI protocols Converts protocols from Word format to PDF with bookmarks Maintains the PDF version of the most current approved version of each active clinical protocol on a central server    This position has the option to be located in Frederick or Rockville, Maryland.

Quality Assurance of Real-Time Oceanographic Data from the Cabled Array of the Ocean Observatories Initiative

NASA Astrophysics Data System (ADS)

Kawka, O. E.; Nelson, J. S.; Manalang, D.; Kelley, D. S.

2016-02-01

The Cabled Array component of the NSF-funded Ocean Observatories Initiative (OOI) provides access to real-time physical, chemical, geological, and biological data from water column and seafloor platforms/instruments at sites spanning the southern half of the Juan de Fuca Plate. The Quality Assurance (QA) program for OOI data is designed to ensure that data products meet OOI science requirements. This overall data QA plan establishes the guidelines for assuring OOI data quality and summarizes Quality Control (QC) protocols and procedures, based on best practices, which can be utilized to ensure the highest quality data across the OOI program. This presentation will highlight, specifically, the QA/QC approach being utilized for the OOI Cabled Array infrastructure and data and will include a summary of both shipboard and shore-based protocols currently in use. Aspects addressed will be pre-deployment instrument testing and calibration checks, post-deployment and pre-recovery field verification of data, and post-recovery "as-found" testing of instruments. Examples of QA/QC data will be presented and specific cases of cabled data will be discussed in the context of quality assessments and adjustment/correction of OOI datasets overall for inherent sensor drift and/or instrument fouling.

'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 children and an improved BMI and waist circumference. Current Controlled Trials ISRCTN04965410.

[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, nutritional complications, and quality of life.

A protocol for preparing, characterizing and using three RNA-specific, live cell imaging probes: E36, E144 and F22.

PubMed

Li, Qian; Chang, Young-Tae

2006-01-01

This protocol outlines a methodology for the preparation and characterization of three RNA-specific fluorescent probes (E36, E144 and F22) and their use in live cell imaging. It describes a detailed procedure for their chemical synthesis and purification; serial product characterization and quality control tests, including measurements of their fluorescence properties in solution, measurement of RNA specificity and analysis of cellular toxicity; and live cell staining and counterstaining with Hoechst or DAPI. Preparation and application of these RNA imaging probes takes 1 week.

Use of nested PCR to detect Ceratocystis fagacearum in sapwood of diseased northern oak species

USDA-ARS?s Scientific Manuscript database

Early and accurate diagnosis of oak wilt, caused by Ceratocystis fagacearum (Cf), is important when disease control action is planned. When laboratory diagnosis is needed, standard isolation protocols that are used rely on high quality samples and require > 14 days for incubation. Use of a nested P...

The impact of SNP fingerprinting and parentage analysis on the effectiveness of variety recommendations in cacao

USDA-ARS?s Scientific Manuscript database

Evidence for the impact of mislabeling and/or pollen contamination on consistency of field performance has been lacking to reinforce the need for strict adherence to quality control protocols in cacao seed garden and germplasm plot management. The present study used SNP fingerprinting at 64 loci to ...

A COMPREHENSIVE NONPOINT SOURCE FIELD STUDY FOR SEDIMENT, NUTRIENTS, AND PATHOGENS IN THE SOUTH FORK BROAD RIVER WATERSHED IN NORTHEAST GEORGIA

EPA Science Inventory

This technical report provides a description of the field project design, quality control, the sampling protocols and analysis methodology used, and standard operating procedures for the South Fork Broad River Watershed (SFBR) Total Maximum Daily Load (TMDL) project. This watersh...

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE FOR PREPARATION OF STANDARD OPERATING PROCEDURES (SOPS) (UA-G-1.0)

EPA Science Inventory

The purpose of this SOP is to establish a uniform format for the preparation of SOPs. Use of these protocols ensures consistent implementation of project tasks, documents the preparation and implementation of the procedures used, describes quality control measures and the limits...

Raman-based detection of hydroxyethyl starch in kidney allograft biopsies as a potential marker of allograft quality in kidney transplant recipients

NASA Astrophysics Data System (ADS)

Vuiblet, Vincent; Fere, Michael; Bankole, Ezechiel; Wynckel, Alain; Gobinet, Cyril; Birembaut, Philippe; Piot, Olivier; Rieu, Philippe

2016-09-01

In brain-dead donor resuscitation, hydroxyethyl starch (HES) use has been associated with presence of osmotic-nephrosis-like lesions in kidney transplant recipients. Our aim was to determine whether the presence of HES in protocol renal graft biopsies at three months (M3) after transplantation is associated with renal graft quality. According to the HES administered to the donor during the procurement procedure, two groups of patients were defined according graft exposition to HES: HES group, (N = 20) and control group (N = 6). Detection and relative quantification of HES was performed by Raman spectroscopy microimaging on M3 protocol renal graft biopsies. Statistical analyses were used to investigate the association between Raman data and graft characteristics. HES spectral signal was revealed negative in the control group, whereas it was positive in 40% of biopsies from the HES group. In the HES group, a stronger HES signal was associated with a lower risk of graft failure measured by the Kidney Donor Risk Index (KDRI) and was correlated with the allograft kidney function. Thus, HES accumulation in donor kidney, as probed by Raman biophotonic technique, is correlated with the quality of donor kidney and consequently the graft renal function and graft survival.

Aromatherapy for managing menopausal symptoms: A protocol for systematic review and meta-analysis.

PubMed

Choi, Jiae; Lee, Hye Won; Lee, Ju Ah; Lim, Hyun-Ja; Lee, Myeong Soo

2018-02-01

Aromatherapy is often used as a complementary therapy for women's health. This systematic review aims to evaluate the therapeutic effects of aromatherapy as a management for menopausal symptoms. Eleven electronic databases will be searched from inception to February 2018. Randomized controlled trials that evaluated any type of aromatherapy against any type of control in individuals with menopausal symptoms will be eligible. The methodological quality will be assessed using the Cochrane risk of bias tool. Two authors will independently assess each study for eligibility and risk of bias and to extract data. This study will provide a high quality synthesis of current evidence of aromatherapy for menopausal symptoms measured with Menopause Rating Scale, the Kupperman Index, the Greene Climacteric Scale, or other validated questionnaires. The conclusion of our systematic review will provide evidence to judge whether aromatherapy is an effective intervention for patient with menopausal women. Ethical approval will not be required, given that this protocol is for a systematic review. The systematic review will be published in a peer-reviewed journal. The review will also be disseminated electronically and in print. PROSPERO CRD42017079191.

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.

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.

Dynamic quality of service model for improving performance of multimedia real-time transmission in industrial networks.

PubMed

Gopalakrishnan, Ravichandran C; Karunakaran, Manivannan

2014-01-01

Nowadays, quality of service (QoS) is very popular in various research areas like distributed systems, multimedia real-time applications and networking. The requirements of these systems are to satisfy reliability, uptime, security constraints and throughput as well as application specific requirements. The real-time multimedia applications are commonly distributed over the network and meet various time constraints across networks without creating any intervention over control flows. In particular, video compressors make variable bit-rate streams that mismatch the constant-bit-rate channels typically provided by classical real-time protocols, severely reducing the efficiency of network utilization. Thus, it is necessary to enlarge the communication bandwidth to transfer the compressed multimedia streams using Flexible Time Triggered- Enhanced Switched Ethernet (FTT-ESE) protocol. FTT-ESE provides automation to calculate the compression level and change the bandwidth of the stream. This paper focuses on low-latency multimedia transmission over Ethernet with dynamic quality-of-service (QoS) management. This proposed framework deals with a dynamic QoS for multimedia transmission over Ethernet with FTT-ESE protocol. This paper also presents distinct QoS metrics based both on the image quality and network features. Some experiments with recorded and live video streams show the advantages of the proposed framework. To validate the solution we have designed and implemented a simulator based on the Matlab/Simulink, which is a tool to evaluate different network architecture using Simulink blocks.

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 Institute of 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 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 forms. Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies. Collaborates with investigators to resolve any protocol/data issues. Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI IRB, and the clinical trial sponsor or the FDA. Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events. Attends and prepares minutes for the Branch Protocol Review Committees. Contacts coordinators at other centers for protocols that are performed there to obtain review committee approvals at those centers, maintains records of these approvals and sends protocol amendments and other reports to the participating centers. Maintains a schedule of all review committee submission deadline dates and meeting dates. Assists clinical investigators in understanding and complying with the entire review process. Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document and tracking system for NCI protocols. Converts protocols from Word format to .pdf with bookmarks. Maintains the .pdf version of the most current approved version of each active clinical protocol on a central server. This position is located in Rockville, Maryland.

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

PubMed Central

2009-01-01

Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

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.

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.

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

Support and assessment for fall emergency referrals (SAFER 2) research protocol: cluster randomised trial of the clinical and cost effectiveness of new protocols for emergency ambulance paramedics to assess and refer to appropriate community-based care

PubMed Central

Snooks, Helen; Anthony, Rebecca; Chatters, Robin; Cheung, Wai-Yee; Dale, Jeremy; Donohoe, Rachael; Gaze, Sarah; Halter, Mary; Koniotou, Marina; Logan, Phillippa; Lyons, Ronan; Mason, Suzanne; Nicholl, Jon; Phillips, Ceri; Phillips, Judith; Russell, Ian; Siriwardena, A Niroshan; Wani, Mushtaq; Watkins, Alan; Whitfield, Richard; Wilson, Lynsey

2012-01-01

Introduction Emergency calls to ambulance services are frequent for older people who have fallen, but ambulance crews often leave patients at the scene without ongoing care. Evidence shows that when left at home with no further support older people often experience subsequent falls which result in injury and emergency-department attendances. SAFER 2 is an evaluation of a new clinical protocol which allows paramedics to assess and refer older people who have fallen, and do not need hospital care, to community-based falls services. In this protocol paper, we report methods and progress during trial implementation. SAFER 2 is recruiting patients through three ambulance services. A successful trial will provide robust evidence about the value of this new model of care, and enable ambulance services to use resources efficiently. Design Pragmatic cluster randomised trial. Methods and analysis We randomly allocated 25 participating ambulance stations (clusters) in three services to intervention or control group. Intervention paramedics received training and clinical protocols for assessing and referring older people who have fallen to community-based falls services when appropriate, while control paramedics deliver care as usual. Patients are eligible for the trial if they are aged 65 or over; resident in a participating falls service catchment area; and attended by a trial paramedic following an emergency call coded as a fall without priority symptoms. The principal outcome is the rate of further emergency contacts (or death), for any cause and for falls. Secondary outcomes include further falls, health-related quality of life, ‘fear of falling’, patient satisfaction reported by participants through postal questionnaires at 1 and 6 months, and quality and pathways of care at the index incident. We shall compare National Health Service (NHS) and patient/carer costs between intervention and control groups and estimate quality-adjusted life years (QALYs) gained from the intervention and thus incremental cost per QALY. We shall estimate wider system effects on key-performance indicators. We shall interview 60 intervention patients, and conduct focus groups with contributing NHS staff to explore their experiences of the assessment and referral service. We shall analyse quantitative trial data by ‘treatment allocated’; and qualitative data using content analysis. Ethics and dissemination The Research Ethics Committee for Wales gave ethical approval and each participating centre gave NHS Research and Development approval. We shall disseminate study findings through peer-reviewed publications and conference presentations. Trial Registration: ISRCTN 60481756 PMID:23148348

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.

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.

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, presented at national and international meetings and published in peer-reviewed journals. Trial registration number ISRCTN03978701. PMID:26297361

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.

Freezing oocytes or embryos after controlled ovarian hyperstimulation in cancer patients: the state of the art.

PubMed

Bénard, Julie; Duros, Solène; El Hachem, Hady; Sonigo, Charlotte; Sifer, Christophe; Grynberg, Michaël

2016-07-01

Quality of life of young cancer survivors has become a major issue. However, anticancer therapies can have a detrimental impact on fertility. It is now well-established that all patients should receive information about the fertility risks associated with their cancer treatment and the fertility preservation options available. Currently, oocyte or embryo banking after controlled ovarian hyperstimulation represents the most effective method for preserving female fertility. Over the past years innovative protocols of ovarian stimulation have been developed to enable cancer patients to undergo oocyte or embryo cryopreservation irrespective of the phase of the cycle or without exogenous follicle-stimulating hormone-related increase in serum estradiol levels. The present article reviews the different protocols of ovarian hyperstimulation for cancer patients, candidates for fertility preservation.

Does the Introduction of the Ranking Task in Valuation Studies Improve Data Quality and Reduce Inconsistencies? The Case of the EQ-5D-5L.

PubMed

Ramos-Goñi, Juan M; Rand-Hendriksen, Kim; Pinto-Prades, Jose Luis

2016-06-01

Time trade-off (TTO)-based valuation studies for the three-level version of the EuroQol five-dimensional questionnaire (EQ-5D) typically started off with a ranking task (ordering the health states by preference). This was not included in the protocol for the five-level EQ-5D (EQ-5D-5L) valuation study. To test whether reintroducing a ranking task before the composite TTO (C-TTO) could help to reduce inconsistencies in C-TTO responses and improve the data quality. Respondents were randomly assigned to three study arms. The control arm was the present EQ-5D-5L study protocol, without ranking. The second arm (ranking without sorting) preceded the present protocol by asking respondents to rank the target health states using physical cards. The states were then valued in random order using C-TTO. In the third arm (ranking and sorting), the ranked states remained visible through the C-TTO tasks and the order of valuation was determined by the ranking. The study used only 10 EQ-5D-5L health states. We compared the C-TTO-based inconsistent pairs of health states and ties. The final sample size was 196 in the control arm, 205 in the ranking without sorting arm, and 199 in the ranking and sorting arm. The percentages of ties by respondents were 15.1%, 12.5%, and 12.6% for the control arm, the ranking without sorting arm, and the ranking and sorting arm, respectively. The extra cost for adding the ranking task was about 15%. The benefit does not justify the effort involved in the ranking task. For this reason, the addition of the ranking task to the present EQ-5D-5L valuation protocol is not an attractive option. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Physical rehabilitation interventions for adult patients with critical illness across the continuum of recovery: an overview of systematic reviews protocol.

PubMed

Connolly, Bronwen; O'Neill, Brenda; Salisbury, Lisa; McDowell, Kathryn; Blackwood, Bronagh

2015-09-29

Patients admitted to the intensive care unit with critical illness often experience significant physical impairments, which typically persist for many years following resolution of the original illness. Physical rehabilitation interventions that enhance restoration of physical function have been evaluated across the continuum of recovery following critical illness including within the intensive care unit, following discharge to the ward and beyond hospital discharge. Multiple systematic reviews have been published appraising the expanding evidence investigating these physical rehabilitation interventions, although there appears to be variability in review methodology and quality. We aim to conduct an overview of existing systematic reviews of physical rehabilitation interventions for adult intensive care patients across the continuum of recovery. This protocol has been developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines. We will search the Cochrane Systematic Review Database, Database of Abstracts of Reviews of Effectiveness, Cochrane Central Register of Controlled Trials, MEDLINE, Excerpta Medica Database and Cumulative Index to Nursing and Allied Health Literature databases. We will include systematic reviews of randomised controlled trials of adult patients, admitted to the intensive care unit and who have received physical rehabilitation interventions at any time point during their recovery. Data extraction will include systematic review aims and rationale, study types, populations, interventions, comparators, outcomes and quality appraisal method. Primary outcomes of interest will focus on findings reflecting recovery of physical function. Quality of reporting and methodological quality will be appraised using the PRISMA checklist and the Assessment of Multiple Systematic Reviews tool. We anticipate the findings from this novel overview of systematic reviews will contribute to the synthesis and interpretation of existing evidence regarding physical rehabilitation interventions and physical recovery in post-critical illness patients across the continuum of recovery. PROSPERO CRD42015001068.

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...

The use of autologous platelet-rich plasma in the orthopedic setting.

PubMed

Cohn, Claudia S; Lockhart, Evelyn; McCullough, J Jeffrey

2015-07-01

Autologous platelet-rich plasma (aPRP) is widely used with orthopedic patients to help treat injuries to tendons, cartilage, ligaments, and muscle. A comprehensive review of the literature was conducted to evaluate aPRP's efficacy and compare available methods. In addition, the production and administration of aPRP were explored. A literature search was performed. Randomized controlled clinical trials (RCTs) in orthopedic procedures on adult patients were included and assessed for methodologic quality. The main outcomes were pain relief, increase in function, structural integrity, and "healing" based on various validated scales. Twelve RCTs and one controlled cohort were included (four lateral epicondylitis, two chronic Achilles tendinopathy, two anterior cruciate ligament injury, and five rotator cuff injuries). Four trials reported some benefit from aPRP versus controls while eight trials found no benefit from aPRP applications versus control. One study had too many patients withdraw from the control arm for acceptable data interpretation. All protocols used a different aPRP formulation or method of delivery or application. Despite its popularity, there are no standardized criteria that define aPRP. Different techniques yield wide variability in terms of platelet count and concentration. These variations make it difficult to compare clinical trials that use aPRP or draw conclusions concerning its clinical efficacy in orthopedic procedures. Blood bankers have experience in the production of standardized blood components. This expertise may be used to develop and implement protocols for the production and administration of aPRP, as well as quality control measures. © 2015 AABB.

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 completion of the trial, this suggests that barriers are often overcome whilst some are only ever perceived rather than actual barriers. © 2015 Sigma Theta Tau International.

Cost-effective peri-operative pain management: assuring a happy patient after total knee arthroplasty.

PubMed

Kim, K; Elbuluk, A; Yu, S; Iorio, R

2018-01-01

The aim of this study was to determine the optimal regimen for the management of pain following total knee arthroplasty (TKA) by comparing the outcomes and cost-effectiveness of different protocols implemented at a large, urban, academic medical centre. Between September 2013 and September 2015, we used a series of modifications to our standard regimen for the management of pain after TKA. In May 2014, there was a department-wide transition from protocols focused on femoral nerve blocks (FNB) to periarticular injections of liposomal bupivacaine. In February 2015, patient-controlled analgesia (PCA) was removed from the protocol while continuing liposomal bupivacaine injections. Quality measures and hospital costs were compared between the three protocols. The cohort being treated with PCA-less liposomal bupivacaine injections had a significantly higher percentage of patients who were discharged to their home (p = 0.010) and a significantly shorter length of stay (p < 0.001). Patient-reported Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores relating to pain being "well-controlled" and "overall pain management" also favoured this cohort (p = 0.214 and p = 0.463, respectively), in which cost was significantly lower compared with the other two cohorts (p = 0.005). The replacement of FNBs injections and the removal of PCAs, both of which are known to be associated with high rates of adverse outcomes, and the addition of liposomal bupivacaine periarticular injections to a multimodal pain regimen, led to improvements in many quality measures, HCAHPS pain scores, and cost-effectiveness. Cite this article: Bone Joint J 2018;100-B(1 Supple A):55-61. ©2018 The British Editorial Society of Bone & Joint Surgery.

Protocol for the Production of a Vaccine Against Argentinian Hemorrhagic Fever.

PubMed

Ambrosio, Ana María; Mariani, Mauricio Andrés; Maiza, Andrea Soledad; Gamboa, Graciela Susana; Fossa, Sebastián Edgardo; Bottale, Alejando Javier

2018-01-01

Argentinian hemorrhagic Fever (AHF) is a febrile, acute disease caused by Junín virus (JUNV), a member of the Arenaviridae. Different approaches to obtain an effective antigen to prevent AHF using complete live or inactivated virus, as well as molecular constructs, have reached diverse development stages. This chapter refers to JUNV live attenuated vaccine strain Candid #1, currently used in Argentina to prevent AHF. A general standardized protocol used at Instituto Nacional de Enfermedades Virales Humanas (Pergamino, Pcia. Buenos Aires, Argentina) to manufacture the tissue culture derived Candid #1 vaccine is described. Intermediate stages like viral seeds and cell culture bank management, bulk vaccine manufacture, and finished product processing are also separately presented in terms of Production and Quality Control/Quality Assurance requirements, under the Adminitracion Nacional de Medicamentos, Alimentos y Tecnología Medica (ANMAT), the Argentine national regulatory authority.

ICC '86; Proceedings of the International Conference on Communications, Toronto, Canada, June 22-25, 1986, Conference Record. Volumes 1, 2, & 3

NASA Astrophysics Data System (ADS)

Papers are presented on ISDN, mobile radio systems and techniques for digital connectivity, centralized and distributed algorithms in computer networks, communications networks, quality assurance and impact on cost, adaptive filters in communications, the spread spectrum, signal processing, video communication techniques, and digital satellite services. Topics discussed include performance evaluation issues for integrated protocols, packet network operations, the computer network theory and multiple-access, microwave single sideband systems, switching architectures, fiber optic systems, wireless local communications, modulation, coding, and synchronization, remote switching, software quality, transmission, and expert systems in network operations. Consideration is given to wide area networks, image and speech processing, office communications application protocols, multimedia systems, customer-controlled network operations, digital radio systems, channel modeling and signal processing in digital communications, earth station/on-board modems, computer communications system performance evaluation, source encoding, compression, and quantization, and adaptive communications systems.

User Experience, Actual Use, and Effectiveness of an Information Communication Technology-Supported Home Exercise Program for Pre-Frail Older Adults.

PubMed

Dekker-van Weering, Marit; Jansen-Kosterink, Stephanie; Frazer, Sanne; Vollenbroek-Hutten, Miriam

2017-01-01

The main objective of this study was to investigate the use and user experience of an Information Communication Technology-supported home exercise program when offered for independent use to pre-frail older adults. Our secondary aim was to explore whether the program improved quality of life and health status compared to a control group. A cohort multiple randomized controlled trail is being performed. Physically pre-frail older adults (65-75 years) living independently at home were included and randomly assigned to a control group or an intervention group. The intervention group received a home exercise program (strength, balance, and flexibility exercises) for a minimal duration of 12 weeks. The control group received usual care. Primary outcomes were: use of the intervention (frequency and duration), adherence to a 3-day exercise protocol and user experience [System Usability Scale (SUS); rating 1-10]. Secondary outcomes were quality of life measured with the SF12 (Physical Component Scale and Mental Component Scale) and health status (EQ-5D), assessed before the study starts and after 12 weeks of exercising. Thirty-seven independently living older adults participated in the study. Sixteen participants were allocated to the intervention group and 21 to the control group. The average score on the SUS was 84.2 (±13.3), almost reaching an excellent score. Participants rated the intervention with an 8.5. Eighty percent of the participants finished the 12 week exercise protocol. The adherence to the 3-day exercise protocol was 68%. Participants in the intervention group trained on average 2.2 times (±1.3) each week. The mean duration of login for each exercise session was 24 min. The Mental Component Scale of the SF12 was significantly higher in the intervention group compared to the control group. A trend was seen in the change over time in the health status between groups. This study provides evidence that a home-based exercise program is easy to use and has potential in improving quality of life and health status of pre-frail older adults who live at home. However, further refinement of the program is required to improve adherence and maximize the benefits and potential of exercising in the home environment. Unique Identifier: NTR5304. URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5304.

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 as the intervention. The trial primary end-point is the conclusion of the 12-week intervention, and follow-up measures will be collected at the 12-week post-baseline assessment. The findings of this study will provide guidance regarding the feasibility of a full-scale phase III randomised controlled trial, prior to its undertaking. The trial protocol was registered with the Australian Clinical Trials Registry (number: 12614000426684 ) on 17 April 2014.

Cost-effectiveness of an intensive group training protocol compared to physiotherapy guideline care for sub-acute and chronic low back pain: design of a randomised controlled trial with an economic evaluation. [ISRCTN45641649

PubMed Central

van der Roer, Nicole; van Tulder, Maurits W; Barendse, Johanna M; van Mechelen, Willem; Franken, Willemien K; Ooms, Arjan C; de Vet, Henrica CW

2004-01-01

Background Low back pain is a common disorder in western industrialised countries and the type of treatments for low back pain vary considerably. Methods In a randomised controlled trial the cost-effectiveness and cost-utility of an intensive group training protocol versus physiotherapy guideline care for sub-acute and chronic low back pain patients is evaluated. Patients with back pain for longer than 6 weeks who are referred to physiotherapy care by their general practitioner or medical specialist are included in the study. The intensive group training protocol combines exercise therapy with principles of behavioural therapy ("graded activity") and back school. This training protocol is compared to physiotherapy care according to the recently published Low Back Pain Guidelines of the Royal Dutch College for Physiotherapy. Primary outcome measures are general improvement, pain intensity, functional status, work absenteeism and quality of life. The direct and indirect costs will be assessed using cost diaries. Patients will complete questionnaires at baseline and 6, 13, 26 and 52 weeks after randomisation. Discussion No trials are yet available that have evaluated the effect of an intensive group training protocol including behavioural principles and back school in a primary physiotherapy care setting and no data on cost-effectiveness and cost-utility are available. PMID:15560843

Mobile Monitoring and Embedded Control System for Factory Environment

PubMed Central

Lian, Kuang-Yow; Hsiao, Sung-Jung; Sung, Wen-Tsai

2013-01-01

This paper proposes a real-time method to carry out the monitoring of factory zone temperatures, humidity and air quality using smart phones. At the same time, the system detects possible flames, and analyzes and monitors electrical load. The monitoring also includes detecting the vibrations of operating machinery in the factory area. The research proposes using ZigBee and Wi-Fi protocol intelligent monitoring system integration within the entire plant framework. The sensors on the factory site deliver messages and real-time sensing data to an integrated embedded systems via the ZigBee protocol. The integrated embedded system is built by the open-source 32-bit ARM (Advanced RISC Machine) core Arduino Due module, where the network control codes are built in for the ARM chipset integrated controller. The intelligent integrated controller is able to instantly provide numerical analysis results according to the received data from the ZigBee sensors. The Android APP and web-based platform are used to show measurement results. The built-up system will transfer these results to a specified cloud device using the TCP/IP protocol. Finally, the Fast Fourier Transform (FFT) approach is used to analyze the power loads in the factory zones. Moreover, Near Field Communication (NFC) technology is used to carry out the actual electricity load experiments using smart phones. PMID:24351642

Mobile monitoring and embedded control system for factory environment.

PubMed

Lian, Kuang-Yow; Hsiao, Sung-Jung; Sung, Wen-Tsai

2013-12-17

This paper proposes a real-time method to carry out the monitoring of factory zone temperatures, humidity and air quality using smart phones. At the same time, the system detects possible flames, and analyzes and monitors electrical load. The monitoring also includes detecting the vibrations of operating machinery in the factory area. The research proposes using ZigBee and Wi-Fi protocol intelligent monitoring system integration within the entire plant framework. The sensors on the factory site deliver messages and real-time sensing data to an integrated embedded systems via the ZigBee protocol. The integrated embedded system is built by the open-source 32-bit ARM (Advanced RISC Machine) core Arduino Due module, where the network control codes are built in for the ARM chipset integrated controller. The intelligent integrated controller is able to instantly provide numerical analysis results according to the received data from the ZigBee sensors. The Android APP and web-based platform are used to show measurement results. The built-up system will transfer these results to a specified cloud device using the TCP/IP protocol. Finally, the Fast Fourier Transform (FFT) approach is used to analyze the power loads in the factory zones. Moreover, Near Field Communication (NFC) technology is used to carry out the actual electricity load experiments using smart phones.

Implementation research to improve quality of maternal and newborn health care, Malawi

PubMed Central

Wilhelm, Danielle; Lohmann, Julia; Kambala, Christabel; Chinkhumba, Jobiba; Muula, Adamson S; De Allegri, Manuela

2017-01-01

Abstract Objective To evaluate the impact of a performance-based financing scheme on maternal and neonatal health service quality in Malawi. Methods We conducted a non-randomized controlled before and after study to evaluate the effects of district- and facility-level performance incentives for health workers and management teams. We assessed changes in the facilities’ essential drug stocks, equipment maintenance and clinical obstetric care processes. Difference-in-difference regression models were used to analyse effects of the scheme on adherence to obstetric care treatment protocols and provision of essential drugs, supplies and equipment. Findings We observed 33 health facilities, 23 intervention facilities and 10 control facilities and 401 pregnant women across four districts. The scheme improved the availability of both functional equipment and essential drug stocks in the intervention facilities. We observed positive effects in respect to drug procurement and clinical care activities at non-intervention facilities, likely in response to improved district management performance. Birth assistants’ adherence to clinical protocols improved across all studied facilities as district health managers supervised and coached clinical staff more actively. Conclusion Despite nation-wide stock-outs and extreme health worker shortages, facilities in the study districts managed to improve maternal and neonatal health service quality by overcoming bottlenecks related to supply procurement, equipment maintenance and clinical performance. To strengthen and reform health management structures, performance-based financing may be a promising approach to sustainable improvements in quality of health care. PMID:28670014

Long-term environmental monitoring for assessment of change: measurement inconsistencies over time and potential solutions.

PubMed

Ellingsen, Kari E; Yoccoz, Nigel G; Tveraa, Torkild; Hewitt, Judi E; Thrush, Simon F

2017-10-30

The importance of long-term environmental monitoring and research for detecting and understanding changes in ecosystems and human impacts on natural systems is widely acknowledged. Over the last decades, a number of critical components for successful long-term monitoring have been identified. One basic component is quality assurance/quality control protocols to ensure consistency and comparability of data. In Norway, the authorities require environmental monitoring of the impacts of the offshore petroleum industry on the Norwegian continental shelf, and in 1996, a large-scale regional environmental monitoring program was established. As a case study, we used a sub-set of data from this monitoring to explore concepts regarding best practices for long-term environmental monitoring. Specifically, we examined data from physical and chemical sediment samples and benthic macroinvertebrate assemblages from 11 stations from six sampling occasions during the period 1996-2011. Despite the established quality assessment and quality control protocols for this monitoring program, we identified several data challenges, such as missing values and outliers, discrepancies in variable and station names, changes in procedures without calibration, and different taxonomic resolution. Furthermore, we show that the use of different laboratories over time makes it difficult to draw conclusions with regard to some of the observed changes. We offer recommendations to facilitate comparison of data over time. We also present a new procedure to handle different taxonomic resolution, so valuable historical data is not discarded. These topics have a broader relevance and application than for our case study.

Towards a five-minute comprehensive cardiac MR examination using highly accelerated parallel imaging with a 32-element coil array: feasibility and initial comparative evaluation.

PubMed

Xu, Jian; Kim, Daniel; Otazo, Ricardo; Srichai, Monvadi B; Lim, Ruth P; Axel, Leon; Mcgorty, Kelly Anne; Niendorf, Thoralf; Sodickson, Daniel K

2013-07-01

To evaluate the feasibility and perform initial comparative evaluations of a 5-minute comprehensive whole-heart magnetic resonance imaging (MRI) protocol with four image acquisition types: perfusion (PERF), function (CINE), coronary artery imaging (CAI), and late gadolinium enhancement (LGE). This study protocol was Health Insurance Portability and Accountability Act (HIPAA)-compliant and Institutional Review Board-approved. A 5-minute comprehensive whole-heart MRI examination protocol (Accelerated) using 6-8-fold-accelerated volumetric parallel imaging was incorporated into and compared with a standard 2D clinical routine protocol (Standard). Following informed consent, 20 patients were imaged with both protocols. Datasets were reviewed for image quality using a 5-point Likert scale (0 = non-diagnostic, 4 = excellent) in blinded fashion by two readers. Good image quality with full whole-heart coverage was achieved using the accelerated protocol, particularly for CAI, although significant degradations in quality, as compared with traditional lengthy examinations, were observed for the other image types. Mean total scan time was significantly lower for the Accelerated as compared to Standard protocols (28.99 ± 4.59 min vs. 1.82 ± 0.05 min, P < 0.05). Overall image quality for the Standard vs. Accelerated protocol was 3.67 ± 0.29 vs. 1.5 ± 0.51 (P < 0.005) for PERF, 3.48 ± 0.64 vs. 2.6 ± 0.68 (P < 0.005) for CINE, 2.35 ± 1.01 vs. 2.48 ± 0.68 (P = 0.75) for CAI, and 3.67 ± 0.42 vs. 2.67 ± 0.84 (P < 0.005) for LGE. Diagnostic image quality for Standard vs. Accelerated protocols was 20/20 (100%) vs. 10/20 (50%) for PERF, 20/20 (100%) vs. 18/20 (90%) for CINE, 18/20 (90%) vs. 18/20 (90%) for CAI, and 20/20 (100%) vs. 18/20 (90%) for LGE. This study demonstrates the technical feasibility and promising image quality of 5-minute comprehensive whole-heart cardiac examinations, with simplified scan prescription and high spatial and temporal resolution enabled by highly parallel imaging technology. The study also highlights technical hurdles that remain to be addressed. Although image quality remained diagnostic for most scan types, the reduced image quality of PERF, CINE, and LGE scans in the Accelerated protocol remain a concern. Copyright © 2012 Wiley Periodicals, Inc.

Primer and platform effects on 16S rRNA tag sequencing

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

Tremblay, Julien; Singh, Kanwar; Fern, Alison

Sequencing of 16S rRNA gene tags is a popular method for profiling and comparing microbial communities. The protocols and methods used, however, vary considerably with regard to amplification primers, sequencing primers, sequencing technologies; as well as quality filtering and clustering. How results are affected by these choices, and whether data produced with different protocols can be meaningfully compared, is often unknown. Here we compare results obtained using three different amplification primer sets (targeting V4, V6–V8, and V7–V8) and two sequencing technologies (454 pyrosequencing and Illumina MiSeq) using DNA from a mock community containing a known number of species as wellmore » as complex environmental samples whose PCR-independent profiles were estimated using shotgun sequencing. We find that paired-end MiSeq reads produce higher quality data and enabled the use of more aggressive quality control parameters over 454, resulting in a higher retention rate of high quality reads for downstream data analysis. While primer choice considerably influences quantitative abundance estimations, sequencing platform has relatively minor effects when matched primers are used. In conclusion, beta diversity metrics are surprisingly robust to both primer and sequencing platform biases.« less

Primer and platform effects on 16S rRNA tag sequencing

DOE PAGES

Tremblay, Julien; Singh, Kanwar; Fern, Alison; ...

2015-08-04

Sequencing of 16S rRNA gene tags is a popular method for profiling and comparing microbial communities. The protocols and methods used, however, vary considerably with regard to amplification primers, sequencing primers, sequencing technologies; as well as quality filtering and clustering. How results are affected by these choices, and whether data produced with different protocols can be meaningfully compared, is often unknown. Here we compare results obtained using three different amplification primer sets (targeting V4, V6–V8, and V7–V8) and two sequencing technologies (454 pyrosequencing and Illumina MiSeq) using DNA from a mock community containing a known number of species as wellmore » as complex environmental samples whose PCR-independent profiles were estimated using shotgun sequencing. We find that paired-end MiSeq reads produce higher quality data and enabled the use of more aggressive quality control parameters over 454, resulting in a higher retention rate of high quality reads for downstream data analysis. While primer choice considerably influences quantitative abundance estimations, sequencing platform has relatively minor effects when matched primers are used. In conclusion, beta diversity metrics are surprisingly robust to both primer and sequencing platform biases.« less

The quest to standardize hemodialysis care.

PubMed

Hegbrant, Jörgen; Gentile, Giorgio; Strippoli, Giovanni F M

2011-01-01

A large global dialysis provider's core activities include providing dialysis care with excellent quality, ensuring a low variability across the clinic network and ensuring strong focus on patient safety. In this article, we summarize the pertinent components of the quality assurance and safety program of the Diaverum Renal Services Group. Concerning medical performance, the key components of a successful quality program are setting treatment targets; implementing evidence-based guidelines and clinical protocols; consistently, regularly, prospectively and accurately collecting data from all clinics in the network; processing collected data to provide feedback to clinics in a timely manner, incorporating information on interclinic and intercountry variations; and revising targets, guidelines and clinical protocols based on sound scientific data. The key activities for ensuring patient safety include a standardized approach to education, i.e. a uniform education program including control of theoretical knowledge and clinical competencies; implementation of clinical policies and procedures in the organization in order to reduce variability and potential defects in clinic practice; and auditing of clinical practice on a regular basis. By applying a standardized and systematic continuous quality improvement approach throughout the entire organization, it has been possible for Diaverum to progressively improve medical performance and ensure patient safety. Copyright © 2011 S. Karger AG, Basel.

U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY--STANDARD OPERATING PROCEDURE FOR PREPARATION OF STANDARD OPERATING PROCEDURES (SOPS) (UA-G-1.0)

EPA Science Inventory

The purpose of this SOP is to establish a uniform format for the preparation of SOPs. Use of these protocols ensures consistent implementation of project tasks, documents the preparation and implementation of the procedures used, describes quality control measures and the limits...

Standard Free Droplet Digital Polymerase Chain Reaction as a New Tool for the Quality Control of High-Capacity Adenoviral Vectors in Small-Scale Preparations

PubMed Central

Boehme, Philip; Stellberger, Thorsten; Solanki, Manish; Zhang, Wenli; Schulz, Eric; Bergmann, Thorsten; Liu, Jing; Doerner, Johannes; Baiker, Armin E.

2015-01-01

Abstract High-capacity adenoviral vectors (HCAdVs) are promising tools for gene therapy as well as for genetic engineering. However, one limitation of the HCAdV vector system is the complex, time-consuming, and labor-intensive production process and the following quality control procedure. Since HCAdVs are deleted for all viral coding sequences, a helper virus (HV) is needed in the production process to provide the sequences for all viral proteins in trans. For the purification procedure of HCAdV, cesium chloride density gradient centrifugation is usually performed followed by buffer exchange using dialysis or comparable methods. However, performing these steps is technically difficult, potentially error-prone, and not scalable. Here, we establish a new protocol for small-scale production of HCAdV based on commercially available adenovirus purification systems and a standard method for the quality control of final HCAdV preparations. For titration of final vector preparations, we established a droplet digital polymerase chain reaction (ddPCR) that uses a standard free-end-point PCR in small droplets of defined volume. By using different probes, this method is capable of detecting and quantifying HCAdV and HV in one reaction independent of reference material, rendering this method attractive for accurately comparing viral titers between different laboratories. In summary, we demonstrate that it is possible to produce HCAdV in a small scale of sufficient quality and quantity to perform experiments in cell culture, and we established a reliable protocol for vector titration based on ddPCR. Our method significantly reduces time and required equipment to perform HCAdV production. In the future the ddPCR technology could be advantageous for titration of other viral vectors commonly used in gene therapy. PMID:25640117

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.

An Efficient and QoS Supported Multichannel MAC Protocol for Vehicular Ad Hoc Networks

PubMed Central

Tan, Guozhen; Yu, Chao

2017-01-01

Vehicular Ad Hoc Networks (VANETs) employ multichannel to provide a variety of safety and non-safety (transport efficiency and infotainment) applications, based on the IEEE 802.11p and IEEE 1609.4 protocols. Different types of applications require different levels Quality-of-Service (QoS) support. Recently, transport efficiency and infotainment applications (e.g., electronic map download and Internet access) have received more and more attention, and this kind of applications is expected to become a big market driver in a near future. In this paper, we propose an Efficient and QoS supported Multichannel Medium Access Control (EQM-MAC) protocol for VANETs in a highway environment. The EQM-MAC protocol utilizes the service channel resources for non-safety message transmissions during the whole synchronization interval, and it dynamically adjusts minimum contention window size for different non-safety services according to the traffic conditions. Theoretical model analysis and extensive simulation results show that the EQM-MAC protocol can support QoS services, while ensuring the high saturation throughput and low transmission delay for non-safety applications. PMID:28991217

Building a Protocol Expressway: The Case of Mayo Clinic Cancer Center

PubMed Central

McJoynt, Terre A.; Hirzallah, Muhanad A.; Satele, Daniel V.; Pitzen, Jason H.; Alberts, Steven R.; Rajkumar, S. Vincent

2009-01-01

Purpose 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. Methods 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. Results 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). Conclusion DMAIC framework combined with Lean methodologies is an effective tool to structure the definition, planning, analysis, and implementation of significant process changes. PMID:19564529

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.

A Power-Optimized Cooperative MAC Protocol for Lifetime Extension in Wireless Sensor Networks.

PubMed

Liu, Kai; Wu, Shan; Huang, Bo; Liu, Feng; Xu, Zhen

2016-10-01

In wireless sensor networks, in order to satisfy the requirement of long working time of energy-limited nodes, we need to design an energy-efficient and lifetime-extended medium access control (MAC) protocol. In this paper, a node cooperation mechanism that one or multiple nodes with higher channel gain and sufficient residual energy help a sender relay its data packets to its recipient is employed to achieve this objective. We first propose a transmission power optimization algorithm to prolong network lifetime by optimizing the transmission powers of the sender and its cooperative nodes to maximize their minimum residual energy after their data packet transmissions. Based on it, we propose a corresponding power-optimized cooperative MAC protocol. A cooperative node contention mechanism is designed to ensure that the sender can effectively select a group of cooperative nodes with the lowest energy consumption and the best channel quality for cooperative transmissions, thus further improving the energy efficiency. Simulation results show that compared to typical MAC protocol with direct transmissions and energy-efficient cooperative MAC protocol, the proposed cooperative MAC protocol can efficiently improve the energy efficiency and extend the network lifetime.

A Power-Optimized Cooperative MAC Protocol for Lifetime Extension in Wireless Sensor Networks

PubMed Central

Liu, Kai; Wu, Shan; Huang, Bo; Liu, Feng; Xu, Zhen

2016-01-01

In wireless sensor networks, in order to satisfy the requirement of long working time of energy-limited nodes, we need to design an energy-efficient and lifetime-extended medium access control (MAC) protocol. In this paper, a node cooperation mechanism that one or multiple nodes with higher channel gain and sufficient residual energy help a sender relay its data packets to its recipient is employed to achieve this objective. We first propose a transmission power optimization algorithm to prolong network lifetime by optimizing the transmission powers of the sender and its cooperative nodes to maximize their minimum residual energy after their data packet transmissions. Based on it, we propose a corresponding power-optimized cooperative MAC protocol. A cooperative node contention mechanism is designed to ensure that the sender can effectively select a group of cooperative nodes with the lowest energy consumption and the best channel quality for cooperative transmissions, thus further improving the energy efficiency. Simulation results show that compared to typical MAC protocol with direct transmissions and energy-efficient cooperative MAC protocol, the proposed cooperative MAC protocol can efficiently improve the energy efficiency and extend the network lifetime. PMID:27706079

A Fair Contention Access Scheme for Low-Priority Traffic in Wireless Body Area Networks

PubMed Central

Sajeel, Muhammad; Bashir, Faisal; Asfand-e-yar, Muhammad; Tauqir, Muhammad

2017-01-01

Recently, wireless body area networks (WBANs) have attracted significant consideration in ubiquitous healthcare. A number of medium access control (MAC) protocols, primarily derived from the superframe structure of the IEEE 802.15.4, have been proposed in literature. These MAC protocols aim to provide quality of service (QoS) by prioritizing different traffic types in WBANs. A contention access period (CAP)with high contention in priority-based MAC protocols can result in higher number of collisions and retransmissions. During CAP, traffic classes with higher priority are dominant over low-priority traffic; this has led to starvation of low-priority traffic, thus adversely affecting WBAN throughput, delay, and energy consumption. Hence, this paper proposes a traffic-adaptive priority-based superframe structure that is able to reduce contention in the CAP period, and provides a fair chance for low-priority traffic. Simulation results in ns-3 demonstrate that the proposed MAC protocol, called traffic- adaptive priority-based MAC (TAP-MAC), achieves low energy consumption, high throughput, and low latency compared to the IEEE 802.15.4 standard, and the most recent priority-based MAC protocol, called priority-based MAC protocol (PA-MAC). PMID:28832495

Digital subtraction angiography during transjugular intrahepatic portosystemic shunt creation or revision: data on radiation exposure and image quality obtained using a standard and a low-dose acquisition protocol in a flat-panel detector-based system.

PubMed

Miraglia, Roberto; Maruzzelli, Luigi; Cortis, Kelvin; Tafaro, Corrado; Gerasia, Roberta; Parisi, Carmelo; Luca, Angelo

2015-08-01

To determine whether the use of a low-dose acquisition protocol (LDP) in digital subtraction angiography during transjugular intrahepatic portosystemic shunt (TIPS) creation/revision results in significant reduction of patient radiation exposure and adequate image quality, as compared to a default reference standard-dose acquisition protocol (SDP). Two angiographic runs were performed during TIPS creation/revision: the first following catheterization of the portal venous system and the second after stent deployment/angioplasty. Constant field of view, object to image-detector distance, and source to image-receptor distance were maintained in each patient during the two angiographic runs. 17 consecutive adult patients who underwent TIPS creation (n = 11) or TIPS revision (n = 6) from December 2013 to March 2014 were considered eligible for this single centre prospective study. In each patient, the LDP and the SDP were used in a random order for the two runs, with each patient serving as his/her own control. The dose-area product (DAP) was calculated for each image and compared. Image quality was graded by two interventional radiologists other than the operator. In all runs acquired with the LDP, image quality was considered adequate for a successful procedural outcome. The DAP per image of the LDP was numerically inferior as compared to the DAP per image of the SDP in all patients. The mean reduction in DAP per image was 75.24% ± 5.7% (p < 0. 001). Radiation exposure during TIPS creation/revision was significantly reduced by selecting a LDP in our flat-panel detector-based system, while maintaining adequate image quality.

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

Automated standardization technique for an inductively-coupled plasma emission spectrometer

USGS Publications Warehouse

Garbarino, John R.; Taylor, Howard E.

1982-01-01

The manifold assembly subsystem described permits real-time computer-controlled standardization and quality control of a commercial inductively-coupled plasma atomic emission spectrometer. The manifold assembly consists of a branch-structured glass manifold, a series of microcomputer-controlled solenoid valves, and a reservoir for each standard. Automated standardization involves selective actuation of each solenoid valve that permits a specific mixed standard solution to be pumped to the nebulizer of the spectrometer. Quality control is based on the evaluation of results obtained for a mixed standard containing 17 analytes, that is measured periodically with unknown samples. An inaccurate standard evaluation triggers restandardization of the instrument according to a predetermined protocol. Interaction of the computer-controlled manifold assembly hardware with the spectrometer system is outlined. Evaluation of the automated standardization system with respect to reliability, simplicity, flexibility, and efficiency is compared to the manual procedure. ?? 1982.

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. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

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 developed system is based on a hardware architecture using FPGAs (Field-Programmable Gate Arrays). This provides means to configure the satellite gateway for different standards and to optimise the transmission parameters for varying user traffic, thus increasing the efficiency significantly. The paper describes the flexible system architecture and focuses particularly on the DAMA access scheme and the chosen quality-of-service implementation. Emphasis has been put on the support of IP Version 6. Different standards (e.g. RCS and possible follow-ups) and the possibility to support them are discussed.

Reporting of methods was better in the Clinical Trials Registry-India than in Indian journal publications.

PubMed

Tharyan, Prathap; George, Aneesh Thomas; Kirubakaran, Richard; Barnabas, Jabez Paul

2013-01-01

We sought to evaluate if editorial policies and the reporting quality of randomized controlled trials (RCTs) had improved since our 2004-05 survey of 151 RCTs in 65 Indian journals, and to compare reporting quality of protocols in the Clinical Trials Registry-India (CTRI). An observational study of endorsement of Consolidated Standards for the Reporting of Trials (CONSORT) and International Committee of Medical Journal Editors (ICMJE) requirements in the instructions to authors in Indian journals, and compliance with selected requirements in all RCTs published during 2007-08 vs. our previous survey and between all RCT protocols in the CTRI on August 31, 2010 and published RCTs from both surveys. Journal policies endorsing the CONSORT statement (22/67, 33%) and ICMJE requirements (35/67, 52%) remained suboptimal, and only 4 of 13 CONSORT items were reported in more than 50% of the 145 RCTs assessed. Reporting of ethical issues had improved significantly, and that of methods addressing internal validity had not improved. Adequate methods were reported significantly more frequently in 768 protocols in the CTRI, than in the 296 published trials. The CTRI template facilitates the reporting of valid methods in registered trial protocols. The suboptimal compliance with CONSORT and ICMJE requirements in RCTs published in Indian journals reduces credibility in the reliability of their results. Copyright © 2013 Elsevier Inc. All rights reserved.

Leo Satellite Communication through a LEO Constellation using TCP/IP Over ATM

NASA Technical Reports Server (NTRS)

Foore, Lawrence R.; Konangi, Vijay K.; Wallett, Thomas M.

1999-01-01

The simulated performance characteristics for communication between a terrestrial client and a Low Earth Orbit (LEO) satellite server are presented. The client and server nodes consist of a Transmission Control Protocol /Internet Protocol (TCP/IP) over ATM configuration. The ATM cells from the client or the server are transmitted to a gateway, packaged with some header information and transferred to a commercial LEO satellite constellation. These cells are then routed through the constellation to a gateway on the globe that allows the client/server communication to take place. Unspecified Bit Rate (UBR) is specified as the quality of service (QoS). Various data rates are considered.

Evaluation of pollutant source strengths and control strategies in an innovative residential high-rise building

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

NONE

1998-12-31

Describes a study undertaken to assess the indoor air quality in the Clos St-Andre, a 78-unit residential complex in downtown Montreal, through the implementation of a monitoring protocol in three of the building`s suites; and to examine the relationships between mechanical ventilation, material emissions, occupant lifestyle, and indoor air pollutant concentrations. The monitoring protocol consisted of tracer gas, air exchange testing, material emission testing, airtightness testing, and the monitoring of air temperature, relative humidity, carbon dioxide, carbon monoxide, formaldehyde, and total volatile organic carbon in the suites. Trends in pollutant concentrations over time in the post-construction period are noted.

Vestibular rehabilitation using video gaming in adults with dizziness: a pilot study.

PubMed

Phillips, J S; Fitzgerald, J; Phillis, D; Underwood, A; Nunney, I; Bath, A

2018-03-01

To determine the effectiveness of vestibular rehabilitation using the Wii Fit balance platform, in adults with dizziness. A single-site prospective clinical trial was conducted in a university hospital in the UK. Forty patients with dizziness, who would normally be candidates for vestibular rehabilitation, were identified and considered as potential participants. Participants were randomised into either the treatment group (the Wii Fit group) or the control group (standard customised vestibular rehabilitation protocol). Participants were assessed over a 16-week period using several balance and quality of life questionnaires. Both exercise regimes resulted in a reduction of dizziness and an improvement in quality of life scores over time, but no statistically significant difference between the two interventions was identified. This pilot study demonstrated that use of the Wii Fit balance platform resulted in a statistically significant improvement in balance function and quality of life. Furthermore, outcomes were comparable to a similar group of individuals following a standard customised vestibular rehabilitation protocol. The study provides useful information to inform the design and execution of a larger clinical trial.

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.

ProDeGe: A computational protocol for fully automated decontamination of genomes

DOE PAGES

Tennessen, Kristin; Andersen, Evan; Clingenpeel, Scott; ...

2015-06-09

Single amplified genomes and genomes assembled from metagenomes have enabled the exploration of uncultured microorganisms at an unprecedented scale. However, both these types of products are plagued by contamination. Since these genomes are now being generated in a high-throughput manner and sequences from them are propagating into public databases to drive novel scientific discoveries, rigorous quality controls and decontamination protocols are urgently needed. Here, we present ProDeGe (Protocol for fully automated Decontamination of Genomes), the first computational protocol for fully automated decontamination of draft genomes. ProDeGe classifies sequences into two classes—clean and contaminant—using a combination of homology and feature-based methodologies.more » On average, 84% of sequence from the non-target organism is removed from the data set (specificity) and 84% of the sequence from the target organism is retained (sensitivity). Lastly, the procedure operates successfully at a rate of ~0.30 CPU core hours per megabase of sequence and can be applied to any type of genome sequence.« less

ProDeGe: A computational protocol for fully automated decontamination of genomes

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

Tennessen, Kristin; Andersen, Evan; Clingenpeel, Scott

Single amplified genomes and genomes assembled from metagenomes have enabled the exploration of uncultured microorganisms at an unprecedented scale. However, both these types of products are plagued by contamination. Since these genomes are now being generated in a high-throughput manner and sequences from them are propagating into public databases to drive novel scientific discoveries, rigorous quality controls and decontamination protocols are urgently needed. Here, we present ProDeGe (Protocol for fully automated Decontamination of Genomes), the first computational protocol for fully automated decontamination of draft genomes. ProDeGe classifies sequences into two classes—clean and contaminant—using a combination of homology and feature-based methodologies.more » On average, 84% of sequence from the non-target organism is removed from the data set (specificity) and 84% of the sequence from the target organism is retained (sensitivity). Lastly, the procedure operates successfully at a rate of ~0.30 CPU core hours per megabase of sequence and can be applied to any type of genome sequence.« less

Experimental Optimal Single Qubit Purification in an NMR Quantum Information Processor

PubMed Central

Hou, Shi-Yao; Sheng, Yu-Bo; Feng, Guan-Ru; Long, Gui-Lu

2014-01-01

High quality single qubits are the building blocks in quantum information processing. But they are vulnerable to environmental noise. To overcome noise, purification techniques, which generate qubits with higher purities from qubits with lower purities, have been proposed. Purifications have attracted much interest and been widely studied. However, the full experimental demonstration of an optimal single qubit purification protocol proposed by Cirac, Ekert and Macchiavello [Phys. Rev. Lett. 82, 4344 (1999), the CEM protocol] more than one and half decades ago, still remains an experimental challenge, as it requires more complicated networks and a higher level of precision controls. In this work, we design an experiment scheme that realizes the CEM protocol with explicit symmetrization of the wave functions. The purification scheme was successfully implemented in a nuclear magnetic resonance quantum information processor. The experiment fully demonstrated the purification protocol, and showed that it is an effective way of protecting qubits against errors and decoherence. PMID:25358758

QALMA: A computational toolkit for the analysis of quality protocols for medical linear accelerators in radiation therapy

NASA Astrophysics Data System (ADS)

Rahman, Md Mushfiqur; Lei, Yu; Kalantzis, Georgios

2018-01-01

Quality Assurance (QA) for medical linear accelerator (linac) is one of the primary concerns in external beam radiation Therapy. Continued advancements in clinical accelerators and computer control technology make the QA procedures more complex and time consuming which often, adequate software accompanied with specific phantoms is required. To ameliorate that matter, we introduce QALMA (Quality Assurance for Linac with MATLAB), a MALAB toolkit which aims to simplify the quantitative analysis of QA for linac which includes Star-Shot analysis, Picket Fence test, Winston-Lutz test, Multileaf Collimator (MLC) log file analysis and verification of light & radiation field coincidence test.

Quality assurance strategies for investigating IAQ problems

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

Collett, C.W.; Ross, J.A.; Sterling, E.M.

Thousands of buildings have now been investigated throughout North America and western Europe. The evaluative strategies and protocols used by various investigators have been described in the scientific and protocols used by various investigators have been described in the scientific and technical literature, including those used by government agencies, private consultants, researchers, and physicians. Review of these strategies shows a consistency and commonly in approach, despite differences in terminology and organization. Most of the published protocols recognize the need to employ a multidisciplinary approach to the evaluation of indoor environmental problems, an approach that views buildings as complex, dynamic systems.more » The multidisciplinary approaches advocated by investigators gather information about the physical building (architectural), the mechanical systems that control indoor environmental conditions (engineering), the type and extent of occupant health and comfort concerns (medical), the objective quality of the air (industrial hygiene) and the occupants subjective perceptions of conditions in their work environment (social science). These components have generally been organized into a series of steps or phases, with each phase extending the information gathered from the preceding phase until a point when the causes of problems may be identified.« less

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 terms of the concatenated protocol parameters. New source-to-destination routes are sought that optimize cross-layer interdependencies to achieve the "best available" performance in the WSN. The protocol design, modified from a known reactive protocol, adapts the achievable performance to the transient network conditions and resource levels. Control of network behavior is realized through the conditional rates of the MVPPs. Optimal cross-layer protocol parameters are determined by stochastic dynamic programming conditions derived from models of transient packetized sensor data flows. Moreover, the defining conditions for WSN configurations, grouping sensor nodes into clusters and establishing data aggregation at processing nodes within those clusters, lead to computationally tractable solutions to the stochastic differential equations that describe network dynamics. Closed-form solution characteristics provide an alternative to the "directed diffusion" methods for resource-efficient WSN protocols published previously by other researchers. Performance verification of the resulting cross-layer designs is found by embedding the optimality conditions for the protocols in actual WSN scenarios replicated in a wireless network simulation environment. Performance tradeoffs among protocol parameters remain for a sequel to the paper.

The Development of Enhanced Recovery After Surgery Across Surgical Specialties.

PubMed

Senturk, James C; Kristo, Gentian; Gold, Jason; Bleday, Ronald; Whang, Edward

2017-09-01

Enhanced recovery after surgery (ERAS ® ) principles have gained traction in variety of surgical disciplines. The promise of a reduced length of stay without compromising patient safety or increasing readmission rates has produced a body of literature examining the implementation of ERAS in the care of general, thoracic, urologic, and gynecologic surgery patients. We performed a review of the literature pertaining to studies of ERAS implementation across colorectal surgery, general surgery, thoracic surgery, urology, and gynecology. The extent of ERAS implementation and reported outcomes across key studies as well as systematic reviews and meta-analyses in each field were summarized. The implementation of ERAS protocols has not been uniform across surgical specialties. Despite this, ERAS has produced improvements in patient outcomes. The most commonly described benefit of ERAS application has been reduced length of stay; complication and readmission rates are most consistently decreased in the colorectal literature. Studies have started to measure more nuanced measures of postoperative patient well-being. Efforts are growing to standardize ERAS protocols across diverse fields and call attention to the need for quality control. Challenges remain in the study and execution of ERAS. Controlling for adherence to ERAS components and implementing uniform ERAS protocols across studies are burgeoning topics that have significant implications for study design. The practice of ERAS and its benefits to patients are expected to evolve. Assessing improvements in postdischarge quality of life, timing of return to work and independent living, and adherence to scheduled delivery of adjuvant treatments will strengthen future ERAS investigations.

Attenuation-based automatic kilovolt (kV)-selection in computed tomography of the chest: effects on radiation exposure and image quality.

PubMed

Eller, Achim; Wuest, Wolfgang; Scharf, Michael; Brand, Michael; Achenbach, Stephan; Uder, Michael; Lell, Michael M

2013-12-01

To evaluate an automated attenuation-based kV-selection in computed tomography of the chest in respect to radiation dose and image quality, compared to a standard 120 kV protocol. 104 patients were examined using a 128-slice scanner. Fifty examinations (58 ± 15 years, study group) were performed using the automated adaption of tube potential (100-140 kV), based on the attenuation profile of the scout scan, 54 examinations (62 ± 14 years, control group) with fixed 120 kV. Estimated CT dose index (CTDI) of the software-proposed setting was compared with a 120 kV protocol. After the scan CTDI volume (CTDIvol) and dose length product (DLP) were recorded. Image quality was assessed by region of interest (ROI) measurements, subjective image quality by two observers with a 4-point scale (3--excellent, 0--not diagnostic). The algorithm selected 100 kV in 78% and 120 kV in 22%. Overall CTDIvol reduction was 26.6% (34% in 100 kV) overall DLP reduction was 22.8% (32.1% in 100 kV) (all p<0.001). Subjective image quality was excellent in both groups. The attenuation based kV-selection algorithm enables relevant dose reduction (~27%) in chest-CT while keeping image quality parameters at high levels. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

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 effective than the TPSAT protocol, this may influence standards of care and best practices for patients with dysphagia involving impaired thin-liquid control as a result of stroke. Clinicaltrials.gov http://NCT01370083.

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 is expected to finish by January 2020.

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 their pets may be different to those previously conjectured, but appetite during chemotherapy remains important.

ZigBee-based wireless intra-oral control system for quadriplegic patients.

PubMed

Peng, Qiyu; Budinger, Thomas F

2007-01-01

A human-to-computer system that includes a wireless intra-oral module, a wireless coordinator and distributed wireless controllers, is presented. The state-of-the-art ZigBee protocol is employed to achieve reliable, low-power and cost-efficient wireless communication between the tongue, computer and controllers. By manipulating five buttons on the wireless intra-oral module using the tongue, the subject can control cursors, computer menus, wheelchair, lights, TV, phone and robotic devices. The system is designed to improve the life quality of patients with stroke and patients with spinal cord injury.

Submillisievert standard-pitch CT pulmonary angiography with ultra-low dose contrast media administration: A comparison to standard CT imaging.

PubMed

Suntharalingam, Saravanabavaan; Mikat, Christian; Stenzel, Elena; Erfanian, Youssef; Wetter, Axel; Schlosser, Thomas; Forsting, Michael; Nassenstein, Kai

2017-01-01

To evaluate the image quality and radiation dose of submillisievert standard-pitch CT pulmonary angiography (CTPA) with ultra-low dose contrast media administration in comparison to standard CTPA. Hundred patients (56 females, 44 males, mean age 69.6±15.4 years; median BMI: 26.6, IQR: 5.9) with suspected pulmonary embolism were examined with two different protocols (n = 50 each, group A: 80 kVp, ref. mAs 115, 25 ml of contrast medium; group B: 100 kVp, ref. mAs 150, 60 ml of contrast medium) using a dual-source CT equipped with automated exposure control. Objective and subjective image qualities, radiation exposure as well as the frequency of pulmonary embolism were evaluated. There was no significant difference in subjective image quality scores between two groups regarding pulmonary arteries (p = 0.776), whereby the interobserver agreement was excellent (group A: k = 0.9; group B k = 1.0). Objective image analysis revealed that signal intensities (SI), signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the pulmonary arteries were equal or significantly higher in group B. There was no significant difference in the frequency of pulmonary embolism (p = 0.65). Using the low dose and low contrast media protocol resulted in a radiation dose reduction by 71.8% (2.4 vs. 0.7 mSv; p<0.001). This 80 kVp standard pitch CTPA protocol with 25 ml contrast agent volume can obtain sufficient image quality to exclude or diagnose pulmonary emboli while reducing radiation dose by approximately 71%.

Effect of home care service on the quality of life in patients with gynecological cancer.

PubMed

Aktas, Demet; Terzioglu, Fusun

2015-01-01

The purpose of the research was to determine the effect of home care service on the quality of life in patients with gynecological cancer. This randomized case control study was carried out in a womans hospital between September 2011 and February 2012. Women undergoing gynecological cancer treatment were separated into intervention and control groups, of 35 patients each. The intervention group was provided with nursing care service through hospital and home visits (1st, 12th weeks) within the framework of a specifically developed nursing care plan. The control group was monitored without any intervention through the hospital routine protocols (1st, 12th weeks). Data were collected using An Interview Form, Home Visit Monitoring Form and Quality of Life Scale/Cancer Survivors. Effects of home care service on the quality of life in gynecological cancer patients were investigated using chi-square tests, McNemar's test, independent t-test and ANOVA. This study found that the intervention group receiving home care service had a moderately high quality of life (average mean: 6.01±0.64), while the control group had comparatively lower quality (average mean: 4.35±0.79) within the 12 week post- discharge period (p<0.05). This study found home care services to be efficient in improving the quality of life in patients with gynecological cancer.

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…

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.

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

RACOON: a multiuser QoS design for mobile wireless body area networks.

PubMed

Cheng, Shihheng; Huang, Chingyao; Tu, Chun Chen

2011-10-01

In this study, Random Contention-based Resource Allocation (RACOON) medium access control (MAC) protocol is proposed to support the quality of service (QoS) for multi-user mobile wireless body area networks (WBANs). Different from existing QoS designs that focus on a single WBAN, a multiuser WBAN QoS should further consider both inter-WBAN interference and inter-WBAN priorities. Similar problems have been studied in both overlapped wireless local area networks (WLANs) and Bluetooth piconets that need QoS supports. However, these solutions are designed for non-medical transmissions that do not consider any priority scheme for medical applications. Most importantly, these studies focus on only static or low mobility networks. Network mobility of WBANs will introduce unnecessary inter-network collisions and energy waste, which are not considered by these solutions. The proposed multiuser-QoS protocol, RACOON, simultaneously satisfies the inter WBAN QoS requirements and overcomes the performance degradation caused by WBAN mobility. Simulation results verify that RACOON provides better latency and energy control, as compared with WBAN QoS protocols without considering the inter-WBAN requirements.

Wheat (Triticum aestivum L.) transformation using mature embryos.

PubMed

Medvecká, Eva; Harwood, Wendy A

2015-01-01

In most protocols for the Agrobacterium-mediated transformation of wheat, the preferred target tissues are immature embryos. However, transformation methods relying on immature embryos require the growth of plants under controlled conditions to provide a continuous supply of good-quality target tissue. The use of mature embryos as a target tissue has the advantage of only requiring good-quality seed as the starting material. Here we describe a transformation method based on the Agrobacterium-mediated transformation of callus cultures derived from mature wheat embryos of the genotype Bobwhite S56.

The use of prostaglandins in controlling estrous cycle of the ewe: a review.

PubMed

Fierro, Sergio; Gil, Jorge; Viñoles, Carolina; Olivera-Muzante, Julio

2013-02-01

This review considers the use of prostaglandin F(2α) and its synthetic analogues (PG) for controlling the estrous cycle of the ewe. Aspects such as phase of the estrus cycle, PG analogues, PG doses, ovarian follicle development pattern, CL formation, progesterone synthesis, ovulation rate, sperm transport, embryo quality, and fertility rates after PG administration are reviewed. Furthermore, protocols for estrus synchronization and their success in timed AI programs are discussed. Based on available information, the ovine CL is refractory to PG treatment for up to 2 days after ovulation. All PG analogues are effective when an appropriate dose is given; in that regard, there is a positive association between the dose administered and the proportion of ewes detected in estrus. Follicular response after PG is dependent on the phase of the estrous cycle at treatment. Altered sperm transport and low pregnancy rates are generally reported. However, reports on alteration of the steroidogenic capacity of preovulatory follicles, ovulation rate, embryo quality, recovery rates, and prolificacy, are controversial. Although various PG-based protocols can be used for estrus synchronization, a second PG injection improves estrus response when the stage of the estrous cycle at the first injection is unknown. The estrus cycle after PG administration has a normal length. Prostaglandin-based protocols for timed AI achieved poor reproductive outcomes, but increasing the interval between PG injections might increase pregnancy rates. Attempts to improve reproductive outcomes have been directed to provide a synchronized LH surge: use of different routes of AI (cervical or intrauterine), different PG doses, and increased intervals between PG injections. Finally we present our point of view regarding future perspectives on the use of PG in programs of controlled sheep reproduction. Copyright © 2013 Elsevier Inc. All rights reserved.

Very high precision and accuracy analysis of triple isotopic ratios of water. A critical instrumentation comparison study.

NASA Astrophysics Data System (ADS)

Gkinis, Vasileios; Holme, Christian; Morris, Valerie; Thayer, Abigail Grace; Vaughn, Bruce; Kjaer, Helle Astrid; Vallelonga, Paul; Simonsen, Marius; Jensen, Camilla Marie; Svensson, Anders; Maffrezzoli, Niccolo; Vinther, Bo; Dallmayr, Remi

2017-04-01

We present a performance comparison study between two state of the art Cavity Ring Down Spectrometers (Picarro L2310-i, L2140-i). The comparison took place during the Continuous Flow Analysis (CFA) campaign for the measurement of the Renland ice core, over a period of three months. Instant and complete vaporisation of the ice core melt stream, as well as of in-house water reference materials is achieved by accurate control of microflows of liquid into a homemade calibration system by following simple principles of the Hagen-Poiseuille law. Both instruments share the same vaporisation unit in a configuration that minimises sample preparation discrepancies between the two analyses. We describe our SMOW-SLAP calibration and measurement protocols for such a CFA application and present quality control metrics acquired during the full period of the campaign on a daily basis. The results indicate an unprecedented performance for all 3 isotopic ratios (δ2H, δ17O, δ18O ) in terms of precision, accuracy and resolution. We also comment on the precision and accuracy of the second order excess parameters of HD16O and H217O over H218O (Dxs, Δ17O ). To our knowledge these are the first reported CFA measurements at this level of precision and accuracy for all three isotopic ratios. Differences on the performance of the two instruments are carefully assessed during the measurement and reported here. Our quality control protocols extend to the area of low water mixing ratios, a regime in which often atmospheric vapour measurements take place and Cavity Ring Down Analysers show a poorer performance due to the lower signal to noise ratios. We address such issues and propose calibration protocols from which water vapour isotopic analyses can benefit from.

Lean management in health care: definition, concepts, methodology and effects reported (systematic review protocol).

PubMed

Lawal, Adegboyega K; Rotter, Thomas; Kinsman, Leigh; Sari, Nazmi; Harrison, Liz; Jeffery, Cathy; Kutz, Mareike; Khan, Mohammad F; Flynn, Rachel

2014-09-19

Lean is a set of operating philosophies and methods that help create a maximum value for patients by reducing waste and waits. It emphasizes the consideration of the customer's needs, employee involvement and continuous improvement. Research on the application and implementation of lean principles in health care has been limited. This is a protocol for a systematic review, following the Cochrane Effective Practice and Organisation of Care (EPOC) methodology. The review aims to document, catalogue and synthesize the existing literature on the effects of lean implementation in health care settings especially the potential effects on professional practice and health care outcomes. We have developed a Medline keyword search strategy, and this focused strategy will be translated into other databases. All search strategies will be provided in the review. The method proposed by the Cochrane EPOC group regarding randomized study designs, non-randomised controlled trials controlled before and after studies and interrupted time series will be followed. In addition, we will also include cohort, case-control studies, and relevant non-comparative publications such as case reports. We will categorize and analyse the review findings according to the study design employed, the study quality (low- versus high-quality studies) and the reported types of implementation in the primary studies. We will present the results of studies in a tabular form. Overall, the systematic review aims to identify, assess and synthesize the evidence to underpin the implementation of lean activities in health care settings as defined in this protocol. As a result, the review will provide an evidence base for the effectiveness of lean and implementation methodologies reported in health care. PROSPERO CRD42014008853.

Lean management in health care: definition, concepts, methodology and effects reported (systematic review protocol)

PubMed Central

2014-01-01

Background Lean is a set of operating philosophies and methods that help create a maximum value for patients by reducing waste and waits. It emphasizes the consideration of the customer’s needs, employee involvement and continuous improvement. Research on the application and implementation of lean principles in health care has been limited. Methods This is a protocol for a systematic review, following the Cochrane Effective Practice and Organisation of Care (EPOC) methodology. The review aims to document, catalogue and synthesize the existing literature on the effects of lean implementation in health care settings especially the potential effects on professional practice and health care outcomes. We have developed a Medline keyword search strategy, and this focused strategy will be translated into other databases. All search strategies will be provided in the review. The method proposed by the Cochrane EPOC group regarding randomized study designs, non-randomised controlled trials controlled before and after studies and interrupted time series will be followed. In addition, we will also include cohort, case–control studies, and relevant non-comparative publications such as case reports. We will categorize and analyse the review findings according to the study design employed, the study quality (low- versus high-quality studies) and the reported types of implementation in the primary studies. We will present the results of studies in a tabular form. Discussion Overall, the systematic review aims to identify, assess and synthesize the evidence to underpin the implementation of lean activities in health care settings as defined in this protocol. As a result, the review will provide an evidence base for the effectiveness of lean and implementation methodologies reported in health care. Systematic review registration PROSPERO CRD42014008853 PMID:25238974

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.

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

PubMed

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

2015-07-01

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

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.

Evidence-based protocol for structural rehabilitation of the spine and posture: review of clinical biomechanics of posture (CBP®) publications

PubMed Central

Oakley, Paul A.; Harrison, Donald D.; Harrison, Deed E.; Haas, Jason W.

2005-01-01

BACKGROUND Although practice protocols exist for SMT and functional rehabilitation, no practice protocols exist for structural rehabilitation. Traditional chiropractic practice guidelines have been limited to acute and chronic pain treatment, with limited inclusion of functional and exclusion of structural rehabilitation procedures. OBJECTIVE (1) To derive an evidence-based practice protocol for structural rehabilitation from publications on Clinical Biomechanics of Posture (CBP®) methods, and (2) to compare the evidence for Diversified, SMT, and CBP®. METHODS Clinical control trials utilizing CBP® methods and spinal manipulative therapy (SMT) were obtained from searches in Mantis, CINAHL, and Index Medicus. Using data from SMT review articles, evidence for Diversified Technique (as taught in chiropractic colleges), SMT, and CBP® were rated and compared. RESULTS From the evidence from Clinical Control Trials on SMT and CBP®, there is very little evidence support for Diversified (our rating = 18), as taught in chiropractic colleges, for the treatment of pain subjects, while CBP® (our rating = 46) and SMT for neck pain (rating = 58) and low back pain (our rating = 202) have evidence-based support. CONCLUSIONS While CBP® Technique has approximately as much evidence-based support as SMT for neck pain, CBP® has more evidence to support its methods than the Diversified technique taught in chiropractic colleges, but not as much as SMT for low back pain. The evolution of chiropractic specialization has occurred, and doctors providing structural-based chiropractic care require protocol guidelines for patient quality assurance and standardization. A structural rehabilitation protocol was developed based on evidence from CBP® publications. PMID:17549209

Behaviour change interventions for the management of Raynaud's phenomenon: a systematic review protocol.

PubMed

Daniels, Jo; Pauling, John D; Eccelston, Christopher

2017-08-04

Raynaud's phenomenon (RP) describes excessive peripheral vasospasm to cold exposure and/or emotional stress. RP episodes are associated with digital colour changes, pain and reduced quality of life. Pharmacological interventions are of low to moderate efficacy and often result in adverse effects such as facial flushing and headaches. Recommended lifestyle and behavioural interventions have not been evaluated. The objectives of the proposed systematic review are to assess the comparative safety and efficacy of behaviour change interventions for RP and identify what we can learn to inform future interventions. Studies eligible for inclusion include randomised controlled trials testing behaviour change interventions with a control comparator. A comprehensive search strategy will include peer review and grey literature up until 30 April 2017. Search databases will include Medline, Embase, PsychINFO and Cochrane. Initial sifting, eligibility, data extraction, risk of bias and quality assessment will be subject to review by two independent reviewers with a third reviewer resolving discrepancies. Risk of bias assessment will be performed using Cochrane risk of a bias assessment tool with quality of evidence assessed using Grading of Recommendations Assessment, Development and Evaluation(GRADE). A meta-analysis will be performed if there are sufficient data. Two subgroup analyses are planned: primary versus secondary RP outcomes; comparison of theoretically informed interventions with pragmatic interventions. This review does not require ethical approval as it will summarise published studies with non-identifiable data. This protocol complies with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. Findings will be disseminated in peer-reviewed articles and reported according to PRISMA. This review will make a significant contribution to the management of RP where no review of behaviour-change interventions currently exist. The synopsis and protocol for the proposed systematic review is registered in the International Prospective Register of Systematic Reviews (registration number CRD42017049643). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Error characterization and quantum control benchmarking in liquid state NMR using quantum information processing techniques

NASA Astrophysics Data System (ADS)

Laforest, Martin

Quantum information processing has been the subject of countless discoveries since the early 1990's. It is believed to be the way of the future for computation: using quantum systems permits one to perform computation exponentially faster than on a regular classical computer. Unfortunately, quantum systems that not isolated do not behave well. They tend to lose their quantum nature due to the presence of the environment. If key information is known about the noise present in the system, methods such as quantum error correction have been developed in order to reduce the errors introduced by the environment during a given quantum computation. In order to harness the quantum world and implement the theoretical ideas of quantum information processing and quantum error correction, it is imperative to understand and quantify the noise present in the quantum processor and benchmark the quality of the control over the qubits. Usual techniques to estimate the noise or the control are based on quantum process tomography (QPT), which, unfortunately, demands an exponential amount of resources. This thesis presents work towards the characterization of noisy processes in an efficient manner. The protocols are developed from a purely abstract setting with no system-dependent variables. To circumvent the exponential nature of quantum process tomography, three different efficient protocols are proposed and experimentally verified. The first protocol uses the idea of quantum error correction to extract relevant parameters about a given noise model, namely the correlation between the dephasing of two qubits. Following that is a protocol using randomization and symmetrization to extract the probability that a given number of qubits are simultaneously corrupted in a quantum memory, regardless of the specifics of the error and which qubits are affected. Finally, a last protocol, still using randomization ideas, is developed to estimate the average fidelity per computational gates for single and multi qubit systems. Even though liquid state NMR is argued to be unsuitable for scalable quantum information processing, it remains the best test-bed system to experimentally implement, verify and develop protocols aimed at increasing the control over general quantum information processors. For this reason, all the protocols described in this thesis have been implemented in liquid state NMR, which then led to further development of control and analysis techniques.

Potential of Wake-Up Radio-Based MAC Protocols for Implantable Body Sensor Networks (IBSN)—A Survey

PubMed Central

Karuppiah Ramachandran, Vignesh Raja; Ayele, Eyuel D.; Meratnia, Nirvana; Havinga, Paul J. M.

2016-01-01

With the advent of nano-technology, medical sensors and devices are becoming highly miniaturized. Consequently, the number of sensors and medical devices being implanted to accurately monitor and diagnose a disease is increasing. By measuring the symptoms and controlling a medical device as close as possible to the source, these implantable devices are able to save lives. A wireless link between medical sensors and implantable medical devices is essential in the case of closed-loop medical devices, in which symptoms of the diseases are monitored by sensors that are not placed in close proximity of the therapeutic device. Medium Access Control (MAC) is crucial to make it possible for several medical devices to communicate using a shared wireless medium in such a way that minimum delay, maximum throughput, and increased network life-time are guaranteed. To guarantee this Quality of Service (QoS), the MAC protocols control the main sources of limited resource wastage, namely the idle-listening, packet collisions, over-hearing, and packet loss. Traditional MAC protocols designed for body sensor networks are not directly applicable to Implantable Body Sensor Networks (IBSN) because of the dynamic nature of the radio channel within the human body and the strict QoS requirements of IBSN applications. Although numerous MAC protocols are available in the literature, the majority of them are designed for Body Sensor Network (BSN) and Wireless Sensor Network (WSN). To the best of our knowledge, there is so far no research paper that explores the impact of these MAC protocols specifically for IBSN. MAC protocols designed for implantable devices are still in their infancy and one of their most challenging objectives is to be ultra-low-power. One of the technological solutions to achieve this objective so is to integrate the concept of Wake-up radio (WuR) into the MAC design. In this survey, we present a taxonomy of MAC protocols based on their use of WuR technology and identify their bottlenecks to be used in IBSN applications. Furthermore, we present a number of open research challenges and requirements for designing an energy-efficient and reliable wireless communication protocol for IBSN. PMID:27916822

Potential of Wake-Up Radio-Based MAC Protocols for Implantable Body Sensor Networks (IBSN)-A Survey.

PubMed

Karuppiah Ramachandran, Vignesh Raja; Ayele, Eyuel D; Meratnia, Nirvana; Havinga, Paul J M

2016-11-29

With the advent of nano-technology, medical sensors and devices are becoming highly miniaturized. Consequently, the number of sensors and medical devices being implanted to accurately monitor and diagnose a disease is increasing. By measuring the symptoms and controlling a medical device as close as possible to the source, these implantable devices are able to save lives. A wireless link between medical sensors and implantable medical devices is essential in the case of closed-loop medical devices, in which symptoms of the diseases are monitored by sensors that are not placed in close proximity of the therapeutic device. Medium Access Control (MAC) is crucial to make it possible for several medical devices to communicate using a shared wireless medium in such a way that minimum delay, maximum throughput, and increased network life-time are guaranteed. To guarantee this Quality of Service (QoS), the MAC protocols control the main sources of limited resource wastage, namely the idle-listening, packet collisions, over-hearing, and packet loss. Traditional MAC protocols designed for body sensor networks are not directly applicable to Implantable Body Sensor Networks (IBSN) because of the dynamic nature of the radio channel within the human body and the strict QoS requirements of IBSN applications. Although numerous MAC protocols are available in the literature, the majority of them are designed for Body Sensor Network (BSN) and Wireless Sensor Network (WSN). To the best of our knowledge, there is so far no research paper that explores the impact of these MAC protocols specifically for IBSN. MAC protocols designed for implantable devices are still in their infancy and one of their most challenging objectives is to be ultra-low-power. One of the technological solutions to achieve this objective so is to integrate the concept of Wake-up radio (WuR) into the MAC design. In this survey, we present a taxonomy of MAC protocols based on their use of WuR technology and identify their bottlenecks to be used in IBSN applications. Furthermore, we present a number of open research challenges and requirements for designing an energy-efficient and reliable wireless communication protocol for IBSN.

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.

Cross-layer protocol design for QoS optimization in real-time wireless sensor networks

NASA Astrophysics Data System (ADS)

Hortos, William S.

2010-04-01

The metrics of quality of service (QoS) for each sensor type in a wireless sensor network can be associated with metrics for multimedia that describe the quality of fused information, e.g., throughput, delay, jitter, packet error rate, information correlation, etc. These QoS metrics are typically set at the highest, or application, layer of the protocol stack to ensure that performance requirements for each type of sensor data are satisfied. Application-layer metrics, in turn, depend on the support of the lower protocol layers: session, transport, network, data link (MAC), and physical. The dependencies of the QoS metrics on the performance of the higher layers of the Open System Interconnection (OSI) reference model of the WSN protocol, together with that of the lower three layers, are the basis for a comprehensive approach to QoS optimization for multiple sensor types in a general WSN model. The cross-layer design accounts for the distributed power consumption along energy-constrained routes and their constituent nodes. Following the author's previous work, the cross-layer interactions in the WSN protocol are represented by a set of concatenated protocol parameters and enabling resource levels. The "best" cross-layer designs to achieve optimal QoS are established by applying the general theory of martingale representations to the parameterized multivariate point processes (MVPPs) for discrete random events occurring in the WSN. Adaptive control of network behavior through the cross-layer design is realized through the parametric factorization of the stochastic conditional rates of the MVPPs. The cross-layer protocol parameters for optimal QoS are determined in terms of solutions to stochastic dynamic programming conditions derived from models of transient flows for heterogeneous sensor data and aggregate information over a finite time horizon. Markov state processes, embedded within the complex combinatorial history of WSN events, are more computationally tractable and lead to simplifications for any simulated or analytical performance evaluations of the cross-layer designs.

SU-E-I-68: Practical Considerations On Implementation of the Image Gently Pediatric CT Protocols

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

Zhang, J; Adams, C; Lumby, C

Purpose: One limitation associated with the Image Gently pediatric CT protocols is practical implementation of the recommended manual techniques. Inconsistency as a result of different practice is a possibility among technologist. An additional concern is the added risk of data error that would result in over or underexposure. The Automatic Exposure Control (AEC) features automatically reduce radiation for children. However, they do not work efficiently for the patients of very small size and relative large size. This study aims to implement the Image Gently pediatric CT protocols in the practical setting while maintaining the use of AEC features for pediatricmore » patients of varying size. Methods: Anthropomorphological abdomen phantoms were scanned in a CT scanner using the Image Gently pediatric protocols, the AEC technique with a fixed adult baseline, and automatic protocols with various baselines. The baselines were adjusted corresponding to patient age, weight and posterioranterior thickness to match the Image Gently pediatric CT manual techniques. CTDIvol was recorded for each examination. Image noise was measured and recorded for image quality comparison. Clinical images were evaluated by pediatric radiologists. Results: By adjusting vendor default baselines used in the automatic techniques, radiation dose and image quality can match those of the Image Gently manual techniques. In practice, this can be achieved by dividing pediatric patients into three major groups for technologist reference: infant, small child, and large child. Further division can be done but will increase the number of CT protocols. For each group, AEC can efficiently adjust acquisition techniques for children. This implementation significantly overcomes the limitation of the Image Gently manual techniques. Conclusion: Considering the effectiveness in clinical practice, Image Gently Pediatric CT protocols can be implemented in accordance with AEC techniques, with adjusted baselines, to achieve the goal of providing the most appropriate radiation dose for pediatric patients of varying sizes.« less

Establishment of Protocols for Global Metabolomics by LC-MS for Biomarker Discovery.

PubMed

Saigusa, Daisuke; Okamura, Yasunobu; Motoike, Ikuko N; Katoh, Yasutake; Kurosawa, Yasuhiro; Saijyo, Reina; Koshiba, Seizo; Yasuda, Jun; Motohashi, Hozumi; Sugawara, Junichi; Tanabe, Osamu; Kinoshita, Kengo; Yamamoto, Masayuki

2016-01-01

Metabolomics is a promising avenue for biomarker discovery. Although the quality of metabolomic analyses, especially global metabolomics (G-Met) using mass spectrometry (MS), largely depends on the instrumentation, potential bottlenecks still exist at several basic levels in the metabolomics workflow. Therefore, we established a precise protocol initially for the G-Met analyses of human blood plasma to overcome some these difficulties. In our protocol, samples are deproteinized in a 96-well plate using an automated liquid-handling system, and conducted either using a UHPLC-QTOF/MS system equipped with a reverse phase column or a LC-FTMS system equipped with a normal phase column. A normalization protocol of G-Met data was also developed to compensate for intra- and inter-batch differences, and the variations were significantly reduced along with our normalization, especially for the UHPLC-QTOF/MS data with a C18 reverse-phase column for positive ions. Secondly, we examined the changes in metabolomic profiles caused by the storage of EDTA-blood specimens to identify quality markers for the evaluation of the specimens' pre-analytical conditions. Forty quality markers, including lysophospholipids, dipeptides, fatty acids, succinic acid, amino acids, glucose, and uric acid were identified by G-Met for the evaluation of plasma sample quality and established the equation of calculating the quality score. We applied our quality markers to a small-scale study to evaluate the quality of clinical samples. The G-Met protocols and quality markers established here should prove useful for the discovery and development of biomarkers for a wider range of diseases.

Zoom Reconstruction Tool: Evaluation of Image Quality and Influence on the Diagnosis of Root Fracture.

PubMed

Queiroz, Polyane Mazucatto; Santaella, Gustavo Machado; Capelozza, Ana Lúcia Alvares; Rosalen, Pedro Luiz; Freitas, Deborah Queiroz; Haiter-Neto, Francisco

2018-04-01

This study evaluated the image quality and the diagnosis of root fractures when using the Zoom Reconstruction tool (J Morita, Kyoto, Japan). A utility wax phantom with a metal sample inside was used for objective evaluation, and a mandible with 27 single-rooted teeth (with and without obturation and with and without vertical or horizontal fractures) was used for diagnostic evaluation. The images were acquired in 3 protocols: protocol 1, field of view (FOV) of 4 × 4 cm and a voxel size of 0.08 mm; protocol 2, FOV of 10 × 10 cm and a voxel size of 0.2 mm; and protocol 3, Zoom Reconstruction of images from protocol 2 (FOV of 4 × 4 cm and a voxel size of 0.08 mm). The objective evaluation was achieved by measuring the image noise, and the diagnosis of fractures was performed by 3 evaluators. The area under the receiver operating characteristic curve was used to calculate accuracy, and analysis of variance compared the accuracy and image quality of the protocols. Regarding quality, protocol 1 was superior to protocol 2 (P < .0001) and Zoom Reconstruction (P < .0001). Additionally, images of protocol 2 presented less noise than the Zoom Reconstruction image (P < .0001); however, for diagnosis, Zoom Reconstruction was superior in relation to protocol 2 (P = .011) and did not differ from protocol 1 (P = .228) for the diagnosis of a vertical root fracture in filled teeth. The Zoom Reconstruction tool allows better accuracy for vertical root fracture detection in filled teeth, making it possible to obtain a higher-resolution image from a lower-resolution examination without having to expose the patient to more radiation. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

320-row coronary computed tomography angiography (CCTA) with automatic exposure control (AEC): effect of 100 kV versus 120 kV on image quality and dose exposure.

PubMed

Di Cesare, Ernesto; Gennarelli, Antonio; Di Sibio, Alessandra; Felli, Valentina; Perri, Marco; Splendiani, Alessandra; Gravina, Giovanni Luca; Barile, Antonio; Masciocchi, Carlo

2016-08-01

To compare the impact of a 100 kV tube voltage protocol to 120 kV in terms of image quality and radiation dose by a 320 row coronary computed tomography angiography (CCTA) with automatic exposure control (AEC). Using a propensity matched analysis we compared a group of 135 patients scanned using a 100 kV tube voltage protocol with a group of 135 subjects scanned employing a 120 kV tube voltage setting. In all subjects the heart rate (HR) was <65 bpm and all CT scans were acquired using a prospective ECG gating and AEC strategy. Mean effective radiation dose and subjective and objective (Noise or N, signal to noise ratio or SNR, contrast to noise ratio or CNR) image quality, were evaluated. Subjective quality was assessed by two experienced radiologists using a 5-point scale (0: non diagnostic-4: excellent) using the 15-segment American Heart Association (AHA) coronary artery classification. Mean effective dose and noise were non significantly different between the two groups: mean effective dose was 2.89 ± 0.7 mSv in the 100 kV group and 2.80 ± 0.57 mSv in the 120 kV group (p = 0.25) while noise was 28.9 ± 3.3 in the 120 kV group and 29.05 ± 3.6 in the 100 kV group (p = 0.72). Both SNR and CNR were significantly higher in the 100 kV group than in the 120 kV group. This data agrees with the evidence that subjective quality was significantly higher in the 100 kV group in the middle and distal segmental classes. Our study shows that, in using a 320 row CCTA with AEC strategy it is better to employ a 100 kV tube voltage protocol because compared to 120 kV tube voltage setting, it appears to significantly improve both subjective and objective image quality without decreasing the mean effective radiation dose.

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.

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

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.

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

PubMed Central

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

2014-01-01

Background Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols. Methods and Findings We conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specific protocol checklist, alongside the ‘Standard Protocol Items: Recommendations for Interventional Trials’ (SPIRIT) checklist. Disagreements were resolved through discussion with a third investigator. 75 trial protocols were included in the analysis. Protocols included a mean of 32/51 (63%) SPIRIT recommendations (range 16–41, SD 5.62) and 11/33 (33%) PRO-specific items (range 4–18, SD 3.56). Over half (61%) of the PRO items were incomplete. Protocols containing a primary PRO included slightly more PRO checklist items (mean 14/33 (43%)). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively ‘complete’ using SPIRIT were still likely to have omitted a large proportion of PRO checklist items. Conclusions The PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/hypothesis, data collection methods, training and management was often absent. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings suggest there are a number of PRO protocol checklist items that are not fully addressed by the current SPIRIT statement. We therefore advocate the development of consensus-based supplementary guidelines, aimed at improving the completeness and quality of PRO content in clinical trial protocols. PMID:25333349

Progressive cone beam CT dose control in image-guided radiation therapy

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

Yan Hao; Cervino, Laura; Jiang, Steve B.

2013-06-15

Purpose: Cone beam CT (CBCT) in image-guided radiotherapy (IGRT) offers a tremendous advantage for treatment guidance. The associated imaging dose is a clinical concern. One unique feature of CBCT-based IGRT is that the same patient is repeatedly scanned during a treatment course, and the contents of CBCT images at different fractions are similar. The authors propose a progressive dose control (PDC) scheme to utilize this temporal correlation for imaging dose reduction. Methods: A dynamic CBCT scan protocol, as opposed to the static one in the current clinical practice, is proposed to gradually reduce the imaging dose in each treatment fraction.more » The CBCT image from each fraction is processed by a prior-image based nonlocal means (PINLM) module to enhance its quality. The increasing amount of prior information from previous CBCT images prevents degradation of image quality due to the reduced imaging dose. Two proof-of-principle experiments have been conducted using measured phantom data and Monte Carlo simulated patient data with deformation. Results: In the measured phantom case, utilizing a prior image acquired at 0.4 mAs, PINLM is able to improve the image quality of a CBCT acquired at 0.2 mAs by reducing the noise level from 34.95 to 12.45 HU. In the synthetic patient case, acceptable image quality is maintained at four consecutive fractions with gradually decreasing exposure levels of 0.4, 0.1, 0.07, and 0.05 mAs. When compared with the standard low-dose protocol of 0.4 mAs for each fraction, an overall imaging dose reduction of more than 60% is achieved. Conclusions: PINLM-PDC is able to reduce CBCT imaging dose in IGRT utilizing the temporal correlations among the sequence of CBCT images while maintaining the quality.« less

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).

The effect of a nurse-led telephone-based care coordination program on the follow-up and control of cardiovascular risk factors in patients with coronary artery disease.

PubMed

Wong, Ningyan; Chua, Siang Jin Terrance; Gao, Fei; Sim, Sok Tiang Rosalind; Matchar, David; Wong, Sung Lung Aaron; Yeo, Khung Keong; Tan, Wei Chieh Jack; Chin, Chee Tang

2016-12-01

We sought to analyse the impact of a care coordination protocol on transiting patients with coronary artery disease who had undergone percutaneous coronary intervention (PCI) to primary care and its effect on cardiovascular risk factor control. A prospective observational study involving 492 patients who had undergone PCI either electively or after an acute coronary syndrome. A tertiary institution in Singapore. Patients who had undergone a PCI either electively or after an acute coronary syndrome. The SCORE (Standardized Care for Optimal Outcomes, Right-Siting and Rapid Re-evaluation) program was a nurse-led, telephone-based, care coordination protocol. Transition to primary care within 1 year of enrolment, the achievement of low-density lipoprotein (LDL) level of <2.6 mmol/l within 1 year and hospital admissions related to cardiovascular causes within 1 year were studied. Under the SCORE protocol, a significantly higher number of patients transited to primary care and achieved the LDL target within 1 year, as compared with non-SCORE patients. Discharge to primary care and achievement of target LDL continued to be higher among those under the SCORE protocol even after multivariate analysis. Rates of hospital admission due to cardiovascular causes were not significantly different. Care coordination improved the rate of transition of post-PCI patients to primary care and improved LDL control, with no difference in the rate of hospital admissions due to cardiovascular causes. These findings support the implementation of a standardized follow-up protocol in patients who have undergone PCI. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Radiation dose and image quality in pediatric chest CT: effects of iterative reconstruction in normal weight and overweight children.

PubMed

Yoon, Haesung; Kim, Myung-Joon; Yoon, Choon-Sik; Choi, Jiin; Shin, Hyun Joo; Kim, Hyun Gi; Lee, Mi-Jung

2015-03-01

New CT reconstruction techniques may help reduce the burden of ionizing radiation. To quantify radiation dose reduction when performing pediatric chest CT using a low-dose protocol and 50% adaptive statistical iterative reconstruction (ASIR) compared with age/gender-matched chest CT using a conventional dose protocol and reconstructed with filtered back projection (control group) and to determine its effect on image quality in normal weight and overweight children. We retrospectively reviewed 40 pediatric chest CT (M:F = 21:19; range: 0.1-17 years) in both groups. Radiation dose was compared between the two groups using paired Student's t-test. Image quality including noise, sharpness, artifacts and diagnostic acceptability was subjectively assessed by three pediatric radiologists using a four-point scale (superior, average, suboptimal, unacceptable). Eight children in the ASIR group and seven in the control group were overweight. All radiation dose parameters were significantly lower in the ASIR group (P < 0.01) with a greater than 57% dose reduction in overweight children. Image noise was higher in the ASIR group in both normal weight and overweight children. Only one scan in the ASIR group (1/40, 2.5%) was rated as diagnostically suboptimal and there was no unacceptable study. In both normal weight and overweight children, the ASIR technique is associated with a greater than 57% mean dose reduction, without significantly impacting diagnostic image quality in pediatric chest CT examinations. However, CT scans in overweight children may have a greater noise level, even when using the ASIR technique.

Swimming Improves Pain and Functional Capacity of Patients With Fibromyalgia: A Randomized Controlled Trial.

PubMed

Fernandes, Giovana; Jennings, Fabio; Nery Cabral, Michele Vieira; Pirozzi Buosi, Ana Letícia; Natour, Jamil

2016-08-01

To evaluate the effect of swimming on pain, functional capacity, aerobic capacity, and quality of life in patients with fibromyalgia (FM). Randomized controlled trial. Rheumatology outpatient clinics of a university hospital. Women with FM (N=75; age range, 18-60y) randomly assigned to a swimming group (SG) (n=39) or a walking group (WG) (n=36). The SG performed 50 minutes of swimming 3 times a week for 12 weeks, with a heart rate at 11 beats under the anaerobic threshold. The WG performed walking with a heart rate at the anaerobic threshold, with the same duration and frequency as the SG. Participants were evaluated before the exercise protocols (t0), at 6 weeks (t6), and at 12 weeks (t12) after the onset of the protocols. The primary outcome measure was the visual analog scale for pain. The secondary measurements were the Fibromyalgia Impact Questionnaire and the Medical Outcomes Study 36-Item Short-Form Health Survey for quality of life; a spiroergometric test for cardiorespiratory variables; and the timed Up & Go test for functional performance. Patients in both groups experienced improvement in pain after the 12-week program, with no difference between groups (P=.658). The same results were found regarding functional capacity and quality of life. Moreover, no statistical difference between groups was found regarding aerobic capacity over time. Swimming, like walking, is an effective method for reducing pain and improving both functional capacity and quality of life in patients with FM. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

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%.

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.

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.

How to design and write a clinical research protocol in Cosmetic Dermatology*

PubMed Central

Bagatin, Ediléia; Miot, Helio A.

2013-01-01

Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. PMID:23539006

Dose, image quality and spine modeling assessment of biplanar EOS micro-dose radiographs for the follow-up of in-brace adolescent idiopathic scoliosis patients.

PubMed

Morel, Baptiste; Moueddeb, Sonia; Blondiaux, Eleonore; Richard, Stephen; Bachy, Manon; Vialle, Raphael; Ducou Le Pointe, Hubert

2018-05-01

The aim of this study was to compare the radiation dose, image quality and 3D spine parameter measurements of EOS low-dose and micro-dose protocols for in-brace adolescent idiopathic scoliosis (AIS) patients. We prospectively included 25 consecutive patients (20 females, 5 males) followed for AIS and undergoing brace treatment. The mean age was 12 years (SD 2 years, range 8-15 years). For each patient, in-brace biplanar EOS radiographs were acquired in a standing position using both the conventional low-dose and micro-dose protocols. Dose area product (DAP) was systematically recorded. Diagnostic image quality was qualitatively assessed by two radiologists for visibility of anatomical structures. The reliability of 3D spine modeling between two operators was quantitatively evaluated for the most clinically relevant 3D radiological parameters using intraclass correlation coefficient (ICC). The mean DAP for the posteroanterior and lateral acquisitions was 300 ± 134 and 433 ± 181 mGy cm 2 for the low-dose radiographs, and 41 ± 19 and 81 ± 39 mGy cm 2 for micro-dose radiographs. Image quality was lower with the micro-dose protocol. The agreement was "good" to "very good" for all measured clinical parameters when comparing the low-dose and micro-dose protocols (ICC > 0.73). The micro-dose protocol substantially reduced the delivered dose (by a factor of 5-7 compared to the low-dose protocol) in braced children with AIS. Although image quality was reduced, the micro-dose protocol proved to be adapted to radiological follow-up, with adequate image quality and reliable clinical measurements. These slides can be retrieved under Electronic Supplementary Material.

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

Effect of automated tube voltage selection, integrated circuit detector and advanced iterative reconstruction on radiation dose and image quality of 3rd generation dual-source aortic CT angiography: An intra-individual comparison.

PubMed

Mangold, Stefanie; De Cecco, Carlo N; Wichmann, Julian L; Canstein, Christian; Varga-Szemes, Akos; Caruso, Damiano; Fuller, Stephen R; Bamberg, Fabian; Nikolaou, Konstantin; Schoepf, U Joseph

2016-05-01

To compare, on an intra-individual basis, the effect of automated tube voltage selection (ATVS), integrated circuit detector and advanced iterative reconstruction on radiation dose and image quality of aortic CTA studies using 2nd and 3rd generation dual-source CT (DSCT). We retrospectively evaluated 32 patients who had undergone CTA of the entire aorta with both 2nd generation DSCT at 120kV using filtered back projection (FBP) (protocol 1) and 3rd generation DSCT using ATVS, an integrated circuit detector and advanced iterative reconstruction (protocol 2). Contrast-to-noise ratio (CNR) was calculated. Image quality was subjectively evaluated using a five-point scale. Radiation dose parameters were recorded. All studies were considered of diagnostic image quality. CNR was significantly higher with protocol 2 (15.0±5.2 vs 11.0±4.2; p<.0001). Subjective image quality analysis revealed no significant differences for evaluation of attenuation (p=0.08501) but image noise was rated significantly lower with protocol 2 (p=0.0005). Mean tube voltage and effective dose were 94.7±14.1kV and 6.7±3.9mSv with protocol 2; 120±0kV and 11.5±5.2mSv with protocol 1 (p<0.0001, respectively). Aortic CTA performed with 3rd generation DSCT, ATVS, integrated circuit detector, and advanced iterative reconstruction allow a substantial reduction of radiation exposure while improving image quality in comparison to 120kV imaging with FBP. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Residual risk of bacterial contamination of platelets: six years of experience with sterility testing.

PubMed

Ramirez-Arcos, Sandra; DiFranco, Caesar; McIntyre, Terri; Goldman, Mindy

2017-09-01

Canadian Blood Services screens 100% of platelet concentrates (PCs) for bacterial contamination with the BacT/ALERT system. Quality-control sterility testing of 1% (≥10 units) of outdated PCs is performed monthly. Data from routine screening, quality-control testing, and septic reactions obtained from 2010 to 2016 are presented herein. In total, 601,988 buffy coat PC pools and 186,737 apheresis PCs were routinely screened with aerobic cultures over 6 years. Outdate quality-control testing of 8535 buffy coat and 8498 apheresis PCs was performed using aerobic and anaerobic cultures during the same period. Results were classified as "true-positives" when the same bacterium was isolated in initial and confirmatory cultures or "false-negatives" when bacteria were missed in early screening and were captured during quality-control sterility testing or through investigation of sepsis cases. During routine screening, the true-positive rates between buffy coat (0.94 per 10,000) and apheresis (0.96 per 10,000) PCs were similar (p = 0.9473). Seventy-five bacteria isolated during PC screening included Gram-positive and Gram-negative organisms. Six false-negative septic reactions were reported that implicated coagulase-negative staphylococci (n = 3) and Staphylococcus aureus (n = 3) for approximate rates of 1 per 100,000 transfusion reactions and 1 per 500,000 fatalities. During quality-control testing, the false-negative rates between buffy coat (8 per 10,000) and apheresis (9 per 10,000) PCs were similar (p = 0.7897). All 15 quality-control isolates were Gram-positive bacteria. The current bacterial screening protocol is efficacious for identifying Gram-negative bacteria. However, the high proportion of Gram-positive organisms detected on outdate quality-control testing and septic transfusion events demonstrates a residual safety risk that merits further intervention. © 2017 AABB.

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.

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.

An inter- laboratory proficiency testing exercise for rabies diagnosis in Latin America and the Caribbean

PubMed Central

Clavijo, Alfonso; Freire de Carvalho, Mary H.; Orciari, Lillian A.; Velasco-Villa, Andres; Ellison, James A.; Greenberg, Lauren; Yager, Pamela A.; Green, Douglas B.; Vigilato, Marco A.; Cosivi, Ottorino; Del Rio-Vilas, Victor J.

2017-01-01

The direct fluorescent antibody test (DFA), is performed in all rabies reference laboratories across Latin America and the Caribbean (LAC). Despite DFA being a critical capacity in the control of rabies, there is not a standardized protocol in the region. We describe the results of the first inter-laboratory proficiency exercise of national rabies laboratories in LAC countries as part of the regional efforts towards dog-maintained rabies elimination in the American region. Twenty three laboratories affiliated to the Ministries of Health and Ministries of Agriculture participated in this exercise. In addition, the laboratories completed an online questionnaire to assess laboratory practices. Answers to the online questionnaire indicated large variability in the laboratories throughput, equipment used, protocols availability, quality control standards and biosafety requirements. Our results will inform actions to improve and harmonize laboratory rabies capacities across LAC in support for the regional efforts towards elimination of dog-maintained rabies. PMID:28369139

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

The incidence of type 2 diabetes mellitus, a chronic lifestyle disease, and its complications are on the rise. Exercise has been documented as being effective in the management of musculoskeletal pain, depression, and reduction of hyperglycemia in diabetic patients. However, there is no consensus regarding the types of exercise that reduce musculoskeletal pain and depression and improve quality of life as well as respiratory function among individuals with type 2 diabetes. The objective of this study is to determine the effects of rebound and circuit training on musculoskeletal pain, blood glucose level, cholesterol level, quality of life, depression, and respiratory parameters in patients with type 2 diabetes mellitus. A total of 70 participants are expected to be recruited in this single blind randomized controlled trial. Computer-generated random numbers will be used to randomize the participants into 3 groups, namely, the rebound exercise group, the circuit exercise group, and the control group. Measurements will be taken at baseline and at the end of the 8 weeks of the study. Participants' musculoskeletal pain will be assessed using the visual analog scale, quality of life will be assessed using the SF 12 Health Survey Questionnaire, depression using the Beck Depression Inventory, respiratory parameters using the spirometer, and biochemical parameters such as glucose level and cholesterol level using the glucometer. Data will be analyzed using descriptive statistics and inferential statistics of multivariate analysis of variance between the groups and paired t test within the group. Alpha will be set at .05. The results of this study will identify the effectiveness of rebound exercise and circuit training, compared with the control, in the management of type 2 diabetes mellitus and on quality of life, musculoskeletal pain, depression, glycemic control, cholesterol level, as well as improvement in respiratory function. Though different additional strategies 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.

An Energy-Efficient and High-Quality Video Transmission Architecture in Wireless Video-Based Sensor Networks.

PubMed

Aghdasi, Hadi S; Abbaspour, Maghsoud; Moghadam, Mohsen Ebrahimi; Samei, Yasaman

2008-08-04

Technological progress in the fields of Micro Electro-Mechanical Systems (MEMS) and wireless communications and also the availability of CMOS cameras, microphones and small-scale array sensors, which may ubiquitously capture multimedia content from the field, have fostered the development of low-cost limited resources Wireless Video-based Sensor Networks (WVSN). With regards to the constraints of videobased sensor nodes and wireless sensor networks, a supporting video stream is not easy to implement with the present sensor network protocols. In this paper, a thorough architecture is presented for video transmission over WVSN called Energy-efficient and high-Quality Video transmission Architecture (EQV-Architecture). This architecture influences three layers of communication protocol stack and considers wireless video sensor nodes constraints like limited process and energy resources while video quality is preserved in the receiver side. Application, transport, and network layers are the layers in which the compression protocol, transport protocol, and routing protocol are proposed respectively, also a dropping scheme is presented in network layer. Simulation results over various environments with dissimilar conditions revealed the effectiveness of the architecture in improving the lifetime of the network as well as preserving the video quality.

Magnetic-activated cell sorting before density gradient centrifugation improves recovery of high-quality spermatozoa.

PubMed

Berteli, T S; Da Broi, M G; Martins, W P; Ferriani, R A; Navarro, P A

2017-07-01

Recent studies have evaluated the use of magnetic-activated cell sorting (MACS) to reduce apoptotic spermatozoa and improve sperm quality. However, the efficiency of using MACS alone, before or after sperm processing by density gradient centrifugation (DGC) has not yet been established. The purpose of this study is to determine the optimal protocol of MACS in assisted reproduction techniques (ART). Thus, we compared sperm quality obtained by DGC alone (DGC), DGC followed by MACS (DGC-MACS), MACS followed by DGC (MACS-DGC), and MACS alone (MACS), and found that the combined methods (MACS-DGC and DGC-MACS) led to retrieval of less spermatozoa with fragmented DNA compared to the single protocols. However, MACS-DGC protocol led to a significantly higher percentage of spermatozoa with progressive motility and normal morphology than DGC-MACS protocol. These findings suggest the potential clinical value of using MACS-DGC to improve sperm quality in seminal preparation for ART. © 2017 American Society of Andrology and European Academy of Andrology.

Effect of Dysphagia Screening Strategies on Clinical Outcomes After Stroke: A Systematic Review for the 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke.

PubMed

Smith, Eric E; Kent, David M; Bulsara, Ketan R; Leung, Lester Y; Lichtman, Judith H; Reeves, Mathew J; Towfighi, Amytis; Whiteley, William N; Zahuranec, Darin B

2018-03-01

Dysphagia screening protocols have been recommended to identify patients at risk for aspiration. The American Heart Association convened an evidence review committee to systematically review evidence for the effectiveness of dysphagia screening protocols to reduce the risk of pneumonia, death, or dependency after stroke. The Medline, Embase, and Cochrane databases were searched on November 1, 2016, to identify randomized controlled trials (RCTs) comparing dysphagia screening protocols or quality interventions with increased dysphagia screening rates and reporting outcomes of pneumonia, death, or dependency. Three RCTs were identified. One RCT found that a combined nursing quality improvement intervention targeting fever and glucose management and dysphagia screening reduced death and dependency but without reducing the pneumonia rate. Another RCT failed to find evidence that pneumonia rates were reduced by adding the cough reflex to routine dysphagia screening. A smaller RCT randomly assigned 2 hospital wards to a stroke care pathway including dysphagia screening or regular care and found that patients on the stroke care pathway were less likely to require intubation and mechanical ventilation; however, the study was small and at risk for bias. There were insufficient RCT data to determine the effect of dysphagia screening protocols on reducing the rates of pneumonia, death, or dependency after stroke. Additional trials are needed to compare the validity, feasibility, and clinical effectiveness of different screening methods for dysphagia. © 2018 American Heart Association, Inc.

The application of the Accelerated Stability Assessment Program (ASAP) to quality by design (QbD) for drug product stability.

PubMed

Waterman, Kenneth Craig

2011-09-01

An isoconversion paradigm, where times in different temperature and humidity-controlled stability chambers are set to provide a fixed degradant level, is shown to compensate for the complex, non-single order kinetics of solid drug products. A humidity-corrected Arrhenius equation provides reliable estimates for temperature and relative humidity effects on degradation rates. A statistical protocol is employed to determine best fits for chemical stability data, which in turn allows for accurate estimations of shelf life (with appropriate confidence intervals) at any storage condition including inside packaging (based on the moisture vapor transmission rate of the packaging and moisture sorption isotherms of the internal components). These methodologies provide both faster results and far better predictions of chemical stability limited shelf life (expiry) than previously possible. Precise shelf-life estimations are generally determined using a 2-week, product-specific protocol. Once the model for a product is developed, it can play a critical role in providing the product understanding necessary for a quality by design (QbD) filing for product approval and enable rational control strategies to assure product stability. Moreover, this Accelerated Stability Assessment Program (ASAP) enables the coupling of product attributes (e.g., moisture content, packaging options) to allow for flexibility in how control strategies are implemented to provide a balance of cost, speed, and other factors while maintaining adequate stability.

Is a controlled randomised trial the non-plus-ultra design? A contribution to discussion on comparative, controlled, non-randomised trials.

PubMed

Gaus, Wilhelm; Muche, Rainer

2013-05-01

Clinical studies provide formalised experience for evidence-based medicine (EBM). Many people consider a controlled randomised trial (CRT, identical to a randomised controlled trial RCT) to be the non-plus-ultra design. However, CRTs also have limitations. The problem is not randomisation itself but informed consent for randomisation and masking of therapies according to today's legal and ethical standards. We do not want to de-rate CRTs, but we would like to contribute to the discussion on clinical research methodology. Informed consent to a CRT and masking of therapies plainly select patients. The excellent internal validity of CRTs can be counterbalanced by poor external validity, because internal and external validity act as antagonists. In a CRT, patients may feel like guinea pigs, this can decrease compliance, cause protocol violations, reduce self-healing properties, suppress unspecific therapeutic effects and possibly even modify specific efficacy. A control group (comparative study) is most important for the degree of evidence achieved by a trial. Study control by detailed protocol and good clinical practice (controlled study) is second in importance and randomisation and masking is third (thus the sequence CRT instead of RCT). Controlled non-randomised trials are just as ambitious and detailed as CRTs. We recommend clinicians and biometricians to take high quality controlled non-randomised trials into consideration more often. They combine good internal and external validity, better suit daily medical practice, show better patient compliance and fewer protocol violations, deliver estimators unbiased by alienated patients, and perhaps provide a clearer explanation of the achieved success. Copyright © 2013 Elsevier Inc. All rights reserved.

Protocol for the Assessment of Common Core Teaching: The Impact of Instructional Inclusion on Students with Special Needs

ERIC Educational Resources Information Center

Gallagher, Kathleen L.; Odozi, Anthony

2015-01-01

The quality of instruction in the classroom is the most powerful leverage point for school improvement because it is the only thing over which educators have a significant degree of control. As student assessments change to reflect the higher expectations of Common Core State Standards (CCSS), it is important that the assessment and development of…

Use of attenuated total reflection Fourier transform infrared (ATR FT-IR) spectroscopy in direct, non-destructive, and rapid assessment of developmental cotton fibers grown in planta and in culture

USDA-ARS?s Scientific Manuscript database

Cotton fibers are routinely harvested from cotton plants (in planta), and their end-use qualities depend on their development stages. Cotton fibers are also cultured at controlled laboratory environments, so that cotton researchers can investigate many aspects of experimental protocols in cotton bre...

A framework for developing research protocols for evaluation of microbial hazards and controls during production that pertain to the quality of agricultural water contacting fresh produce that may be consumed raw

USDA-ARS?s Scientific Manuscript database

Agricultural water may contact fresh produce during irrigation and/or when crop protection sprays (e.g., cooling to prevent sunburn, frost protection, and agrochemical mixtures) are applied. This document provides a framework for designing research studies that would add to our understanding of preh...

Rapid analysis of inner and outer bark composition of southern yellow pine bark from industrial sources

Treesearch

Chi-Leung So; Thomas L. Eberhardt

2006-01-01

Differences in bark chemistry between inner and outer bark are well known and may affect the suitability of various bark supplies for a particular application. Accordingly, there is a need for quality control protocols to assess variability and predict product yields. Southern yellow pine bark samples from two industrial sources were separated into inner and outer bark...

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 in peer-reviewed journals. ISRCTN03978701. 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.

Radiation dose reduction in parasinus CT by spectral shaping.

PubMed

May, Matthias S; Brand, Michael; Lell, Michael M; Sedlmair, Martin; Allmendinger, Thomas; Uder, Michael; Wuest, Wolfgang

2017-02-01

Spectral shaping aims to narrow the X-ray spectrum of clinical CT. The aim of this study was to determine the image quality and the extent of radiation dose reduction that can be achieved by tin prefiltration for parasinus CT. All scans were performed with a third generation dual-source CT scanner. A study protocol was designed using 100 kV tube voltage with tin prefiltration (200 mAs) that provides image noise levels comparable to a low-dose reference protocol using 100 kV without spectral shaping (25 mAs). One hundred consecutive patients were prospectively enrolled and randomly assigned to the study or control group. All patients signed written informed consent. The study protocol was approved by the local Institutional Review Board and applies to the HIPAA. Subjective and objective image quality (attenuation values, image noise, and contrast-to-noise ratio (CNR)) were assessed. Radiation exposure was assessed as volumetric CT dose index, and effective dose was estimated. Mann-Whitney U test was performed for radiation exposure and for image noise comparison. All scans were of diagnostic image quality. Image noise in air, in the retrobulbar fat, and in the eye globe was comparable between both groups (all p > 0.05). CNR eye globe/air did not differ significantly between both groups (p = 0.7). Radiation exposure (1.7 vs. 2.1 mGy, p < 0.01) and effective dose (0.055 vs. 0.066 mSv, p < 0.01) were significantly reduced in the study group. Radiation dose can be further reduced by 17% for low-dose parasinus CT by tin prefiltration maintaining diagnostic image quality.

Submillisievert standard-pitch CT pulmonary angiography with ultra-low dose contrast media administration: A comparison to standard CT imaging

PubMed Central

Mikat, Christian; Stenzel, Elena; Erfanian, Youssef; Wetter, Axel; Schlosser, Thomas; Forsting, Michael

2017-01-01

Objectives To evaluate the image quality and radiation dose of submillisievert standard-pitch CT pulmonary angiography (CTPA) with ultra-low dose contrast media administration in comparison to standard CTPA. Materials and methods Hundred patients (56 females, 44 males, mean age 69.6±15.4 years; median BMI: 26.6, IQR: 5.9) with suspected pulmonary embolism were examined with two different protocols (n = 50 each, group A: 80 kVp, ref. mAs 115, 25 ml of contrast medium; group B: 100 kVp, ref. mAs 150, 60 ml of contrast medium) using a dual-source CT equipped with automated exposure control. Objective and subjective image qualities, radiation exposure as well as the frequency of pulmonary embolism were evaluated. Results There was no significant difference in subjective image quality scores between two groups regarding pulmonary arteries (p = 0.776), whereby the interobserver agreement was excellent (group A: k = 0.9; group B k = 1.0). Objective image analysis revealed that signal intensities (SI), signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the pulmonary arteries were equal or significantly higher in group B. There was no significant difference in the frequency of pulmonary embolism (p = 0.65). Using the low dose and low contrast media protocol resulted in a radiation dose reduction by 71.8% (2.4 vs. 0.7 mSv; p<0.001). Conclusions This 80 kVp standard pitch CTPA protocol with 25 ml contrast agent volume can obtain sufficient image quality to exclude or diagnose pulmonary emboli while reducing radiation dose by approximately 71%. PMID:29045463

Mobile phone-based clinical guidance for rural health providers in India.

PubMed

Gautham, Meenakshi; Iyengar, M Sriram; Johnson, Craig W

2015-12-01

There are few tried and tested mobile technology applications to enhance and standardize the quality of health care by frontline rural health providers in low-resource settings. We developed a media-rich, mobile phone-based clinical guidance system for management of fevers, diarrhoeas and respiratory problems by rural health providers. Using a randomized control design, we field tested this application with 16 rural health providers and 128 patients at two rural/tribal sites in Tamil Nadu, Southern India. Protocol compliance for both groups, phone usability, acceptability and patient feedback for the experimental group were evaluated. Linear mixed-model analyses showed statistically significant improvements in protocol compliance in the experimental group. Usability and acceptability among patients and rural health providers were very high. Our results indicate that mobile phone-based, media-rich procedural guidance applications have significant potential for achieving consistently standardized quality of care by diverse frontline rural health providers, with patient acceptance. © The Author(s) 2014.

Interaction of preservation methods and radiation sterilization in human skin processing, with particular insight on the impact of the final water content and collagen disruption. Part I: process validation, water activity and collagen changes in tissues cryopreserved or processed using 50, 85 or 98% glycerol solutions.

PubMed

Herson, M R; Hamilton, K; White, J; Alexander, D; Poniatowski, S; O'Connor, A J; Werkmeister, J A

2018-04-25

Current regulatory requirements demand an in-depth understanding and validation of protocols used in tissue banking. The aim of this work was to characterize the quality of split thickness skin allografts cryopreserved or manufactured using highly concentrated solutions of glycerol (50, 85 or 98%), where tissue water activity (a w ), histology and birefringence changes were chosen as parameters. Consistent a w outcomes validated the proposed processing protocols. While no significant changes in tissue quality were observed under bright-field microscopy or in collagen birefringence, in-process findings can be harnessed to fine-tune and optimize manufacturing outcomes in particular when further radiation sterilization is considered. Furthermore, exposing the tissues to 85% glycerol seems to derive the most efficient outcomes as far as a w and control of microbiological growth.

Automated 3D ultrasound elastography of the breast: a phantom validation study

NASA Astrophysics Data System (ADS)

Hendriks, Gijs A. G. M.; Holländer, Branislav; Menssen, Jan; Milkowski, Andy; Hansen, Hendrik H. G.; de Korte, Chris L.

2016-04-01

In breast cancer screening, the automated breast volume scanner (ABVS) was introduced as an alternative for mammography since the latter technique is less suitable for women with dense breasts. Although clinical studies show promising results, clinicians report two disadvantages: long acquisition times (>90 s) introducing breathing artefacts, and high recall rates due to detection of many small lesions of uncertain malignant potential. Technical improvements for faster image acquisition and better discrimination between benign and malignant lesions are thus required. Therefore, the aim of this study was to investigate if 3D ultrasound elastography using plane-wave imaging is feasible. Strain images of a breast elastography phantom were acquired by an ABVS-mimicking device that allowed axial and elevational movement of the attached transducer. Pre- and post-deformation volumes were acquired with different constant speeds (between 1.25 and 40.0 mm s-1) and by three protocols: Go-Go (pre- and post-volumes with identical start and end positions), Go-Return (similar to Go-Go with opposite scanning directions) and Control (pre- and post-volumes acquired per position, this protocol can be seen as reference). Afterwards, 2D and 3D cross-correlation and strain algorithms were applied to the acquired volumes and the results were compared. The Go-Go protocol was shown to be superior with better strain image quality (CNRe and SNRe) than Go-Return and to be similar as Control. This can be attributed to applying opposite mechanical forces to the phantom during the Go-Return protocol, leading to out-of-plane motion. This motion was partly compensated by using 3D cross-correlation. However, the quality was still inferior to Go-Go. Since these results were obtained in a phantom study with controlled deformations, the effect of possible uncontrolled in vivo tissue motion artefacts has to be addressed in future studies. In conclusion, it seems feasible to implement 3D ultrasound quasi-static elastography on an ABVS-like system and to reduce scan times within one breath-hold (~10 s) by plane-wave acquisitions.

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.

Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol of a controlled clinical trial developed by consensus of an international study group. Part three: individual patient, complication algorithm and quality manage.

PubMed

Stinner, B; Bauhofer, A; Lorenz, W; Rothmund, M; Plaul, U; Torossian, A; Celik, I; Sitter, H; Koller, M; Black, A; Duda, D; Encke, A; Greger, B; van Goor, H; Hanisch, E; Hesterberg, R; Klose, K J; Lacaine, F; Lorijn, R H; Margolis, C; Neugebauer, E; Nyström, P O; Reemst, P H; Schein, M; Solovera, J

2001-05-01

Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). A randomised, placebo controlled, double-blinded, single-centre study is performed at an University Hospital (n = 40 patients for each group). This part presents the course of the individual patient and a complication algorithm for the management of anastomotic leakage and quality management. In part three of the protocol, the three major sections include: The course of the individual patient using a comprehensive graphic display, including the perioperative period, hospital stay and post discharge outcome. A center based clinical practice guideline for the management of the most important postoperative complication--anastomotic leakage--including evidence based support for each step of the algorithm. Data management, ethics and organisational structure. Future studies with immune modifiers will also fail if not better structured (reduction of variance) to achieve uniform patient management in a complex clinical scenario. This new type of a single-centre trial aims to reduce the gap between animal experiments and clinical trials or--if it fails--at least demonstrates new ways for explaining the failures.

Data-quality measures for stakeholder-implemented watershed-monitoring programs

USGS Publications Warehouse

Greve, Adrienne I.

2002-01-01

Community-based watershed groups, many of which collect environmental data, have steadily increased in number over the last decade. The data generated by these programs are often underutilized due to uncertainty in the quality of data produced. The incorporation of data-quality measures into stakeholder monitoring programs lends statistical validity to data. Data-quality measures are divided into three steps: quality assurance, quality control, and quality assessment. The quality-assurance step attempts to control sources of error that cannot be directly quantified. This step is part of the design phase of a monitoring program and includes clearly defined, quantifiable objectives, sampling sites that meet the objectives, standardized protocols for sample collection, and standardized laboratory methods. Quality control (QC) is the collection of samples to assess the magnitude of error in a data set due to sampling, processing, transport, and analysis. In order to design a QC sampling program, a series of issues needs to be considered: (1) potential sources of error, (2) the type of QC samples, (3) inference space, (4) the number of QC samples, and (5) the distribution of the QC samples. Quality assessment is the process of evaluating quality-assurance measures and analyzing the QC data in order to interpret the environmental data. Quality assessment has two parts: one that is conducted on an ongoing basis as the monitoring program is running, and one that is conducted during the analysis of environmental data. The discussion of the data-quality measures is followed by an example of their application to a monitoring program in the Big Thompson River watershed of northern Colorado.

A Pediatric Intensive Care Unit Bedside Computer Clinical Decision Support Protocol for Hyperglycemia Is Feasible, Safe and Offers Advantages

PubMed Central

Lanspa, Michael J.; Wilson, Emily L.; Sward, Katherine A.; Jephson, Al; Larsen, Gitte Y.; Morris, Alan H.

2017-01-01

Abstract Background: Computer clinical decision support (CDS) systems are uncommon in the pediatric intensive care unit (PICU), despite evidence suggesting they improve outcomes in adult ICUs. We reasoned that a bedside CDS protocol for intravenous insulin titration, eProtocol-insulin, would be feasible and safe in critically ill children. Methods: We retrospectively reviewed data from non-diabetic children admitted to the PICU with blood glucose (BG) ≥140 mg/dL who were managed with intravenous insulin by either unaided clinician titration or eProtocol-insulin. Primary outcomes were BG measurements in target range (80–110 mg/dL) and severe hypoglycemia (BG ≤40 mg/dL); secondary outcomes were 60-day mortality and PICU length of stay. We assessed bedside nurse satisfaction with the eProtocol-insulin protocol by using a 5-point Likert scale and measured clinician compliance with eProtocol-insulin recommendations. Results: Over 5 years, 69 children were titrated with eProtocol-insulin versus 104 by unaided clinicians. eProtocol-insulin achieved target range more frequently than clinician titration (41% vs. 32%, P < 0.001). Severe hypoglycemia was uncommon in both groups (4.3% of patients in eProtocol-insulin, 8.7% in clinician titration, P = 0.37). There were no differences in mean time to BG target or median BG between the groups. Mortality was 23% in both groups. Clinician compliance with eProtocol-insulin recommendations was 89%. Nurses believed that eProtocol-insulin was easy to understand and safer than clinician titration. Conclusions: eProtocol-insulin is safe for titration of intravenous insulin in critically ill children. Clinical research protocols and quality improvement initiatives aimed at optimizing BG control should utilize detailed computer protocols that enable replicable clinician decisions. PMID:28248127

Chapter A10. Lakes and reservoirs: Guidelines for study design and sampling

USGS Publications Warehouse

Green, William R.; Robertson, Dale M.; Wilde, Franceska D.

2015-09-29

Within this chapter are references to other chapters of the NFM that provide more detailed guidelines related to specific topics and more detailed protocols for the quality assurance and assessment of the lake and reservoir data. Protocols and procedures to address and document the quality of lake and reservoir investigations are adapted from, or referenced to, the protocols and standard operating procedures contained in related chapters of this National Field Manual.

Ultrafast Brain MRI: Clinical Deployment and Comparison to Conventional Brain MRI at 3T.

PubMed

Prakkamakul, Supada; Witzel, Thomas; Huang, Susie; Boulter, Daniel; Borja, Maria J; Schaefer, Pamela; Rosen, Bruce; Heberlein, Keith; Ratai, Eva; Gonzalez, Gilberto; Rapalino, Otto

2016-09-01

To compare an ultrafast brain magnetic resonance imaging (MRI) protocol to the conventional protocol in motion-prone inpatient clinical settings. This retrospective study was HIPAA compliant and approved by the Institutional Review Board with waived inform consent. Fifty-nine inpatients (30 males, 29 females; mean age 55.1, range 23-93 years)who underwent 3-Tesla brain MRI using ultrafast and conventional protocols, both including five sequences, were included in the study. The total scan time for five ultrafast sequences was 4 minutes 59 seconds. The ideal conventional acquisition time was 10 minutes 32 seconds but the actual acquisition took 15-20 minutes. The average scan times for ultrafast localizers, T1-weighted, T2-weighted, fluid-attenuated inversion recovery (FLAIR), diffusion-weighted, T2*-weighted sequences were 14, 41, 62, 96, 80, 6 seconds, respectively. Two blinded neuroradiologists independently assessed three aspects: (1) image quality, (2) gray-white matter (GM-WM) differentiation, and (3) diagnostic concordance for the detection of six clinically relevant imaging findings. Wilcoxon signed-rank test was used to compare image quality and GM-WM scores. Interobserver reproducibility was calculated. The ultrafast T1-weighted sequence demonstrated significantly better image quality (P = .005) and GM-WM differentiation (P < .001) compared to the conventional sequence. There was high agreement (>85%) between both protocols for the detection of mass-like lesion, hemorrhage, diffusion restriction, WM FLAIR hyperintensities, subarachnoid FLAIR hyperintensities, and hydrocephalus. The ultrafast protocol achieved at least comparable image quality and high diagnostic concordance compared to the conventional protocol. This fast protocol can be a viable option to replace the conventional protocol in motion-prone inpatient clinical settings. Copyright © 2016 by the American Society of Neuroimaging.

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.

Water quality data for selected wells in the Coastal Plain of New Jersey, 1996-98

USGS Publications Warehouse

Hibbs, Kathleen L.; Stackelberg, Paul E.; Kauffman, Leon J.; Ayers, Mark A.

2001-01-01

Water-quality data were collected during 1996-98 for 217 wells in New Jersey and 3 wells in New York as part of the U. S. Geological Survey's National Water Quality Assessment Program. Samples were collected for five ground-water surveys that were designed to assess water quality in major aquifer systems, with an emphasis on recently recharged (shallow) ground water associated with present and recent human activities. This report (1) summarizes the hydrogeologic framework in the areas of data collection; (2) describes the objectives and procedures for designing each ground-water survey; (3) summarizes the procedures and protocols for data collec-tion, analysis, and quality control; and (4) lists the concentrations of inorganic constituents, volatile organic compounds, pesticides, nutrients, and trace elements present in the ground-water samples.

Cryptococcal meningitis management in Tanzania with strict schedule of serial lumber punctures using intravenous tubing sets: an operational research study.

PubMed

Meda, John; Kalluvya, Samuel; Downs, Jennifer A; Chofle, Awilly A; Seni, Jeremiah; Kidenya, Benson; Fitzgerald, Daniel W; Peck, Robert N

2014-06-01

Cryptococcal meningitis (CM) has a mortality rate of ∼70% among HIV-infected adults in low-income countries. Controlling intracranial pressure (ICP) is essential in CM, but it is difficult in low-income countries because manometers and practical ICP management protocols are lacking. As part of a continuous quality improvement project, our Tanzanian hospital initiated a new protocol for ICP management for CM. All adult inpatients with CM are included in a prospective patient registry. At the time of analysis, this registry included data from 2 years before the initiation of this new ICP management protocol and for a 9-month period after. ICP was measured at baseline and at days 3, 7, and 14 by both manometer and intravenous (IV) tubing set. All patients were given IV fluconazole according to Tanzanian treatment guidelines and were followed until 30 days after admission. Among adult inpatients with CM, 32 of 35 patients (91%) had elevated ICP on admission. Cerebrospinal fluid pressure measurements using the improvised IV tubing set demonstrated excellent agreement (r = 0.96) with manometer measurements. Compared with historical controls, the new ICP management protocol was associated with a significant reduction in 30-day mortality (16/35 [46%] vs. 48/64 [75%] in historical controls; hazard ratio = 2.1 [95% CI: 1.1 to 3.8]; P = 0.018]. Increased ICP is almost universal among HIV-infected adults admitted with CM in Tanzania. Intensive ICP management with a strict schedule of serial lumbar punctures reduced in-hospital mortality compared with historical controls. ICP measurement with IV tubing sets may be a good alternative in resource-limited health facilities where manometers are not available.

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

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.

Considerations in establishing a post-mortem brain and tissue bank for the study of myalgic encephalomyelitis/chronic fatigue syndrome: a proposed protocol.

PubMed

Nacul, Luis; O'Donovan, Dominic G; Lacerda, Eliana M; Gveric, Djordje; Goldring, Kirstin; Hall, Alison; Bowman, Erinna; Pheby, Derek

2014-06-18

Our aim, having previously investigated through a qualitative study involving extensive discussions with experts and patients the issues involved in establishing and maintaining a disease specific brain and tissue bank for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), was to develop a protocol for a UK ME/CFS repository of high quality human tissue from well characterised subjects with ME/CFS and controls suitable for a broad range of research applications. This would involve a specific donor program coupled with rapid tissue collection and processing, supplemented by comprehensive prospectively collected clinical, laboratory and self-assessment data from cases and controls. We reviewed the operations of existing tissue banks from published literature and from their internal protocols and standard operating procedures (SOPs). On this basis, we developed the protocol presented here, which was designed to meet high technical and ethical standards and legal requirements and was based on recommendations of the MRC UK Brain Banks Network. The facility would be most efficient and cost-effective if incorporated into an existing tissue bank. Tissue collection would be rapid and follow robust protocols to ensure preservation sufficient for a wide range of research uses. A central tissue bank would have resources both for wide-scale donor recruitment and rapid response to donor death for prompt harvesting and processing of tissue. An ME/CFS brain and tissue bank could be established using this protocol. Success would depend on careful consideration of logistic, technical, legal and ethical issues, continuous consultation with patients and the donor population, and a sustainable model of funding ideally involving research councils, health services, and patient charities. This initiative could revolutionise the understanding of this still poorly-understood disease and enhance development of diagnostic biomarkers and treatments.

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.

Automated image quality assessment for chest CT scans.

PubMed

Reeves, Anthony P; Xie, Yiting; Liu, Shuang

2018-02-01

Medical image quality needs to be maintained at standards sufficient for effective clinical reading. Automated computer analytic methods may be applied to medical images for quality assessment. For chest CT scans in a lung cancer screening context, an automated quality assessment method is presented that characterizes image noise and image intensity calibration. This is achieved by image measurements in three automatically segmented homogeneous regions of the scan: external air, trachea lumen air, and descending aorta blood. Profiles of CT scanner behavior are also computed. The method has been evaluated on both phantom and real low-dose chest CT scans and results show that repeatable noise and calibration measures may be realized by automated computer algorithms. Noise and calibration profiles show relevant differences between different scanners and protocols. Automated image quality assessment may be useful for quality control for lung cancer screening and may enable performance improvements to automated computer analysis methods. © 2017 American Association of Physicists in Medicine.

Quantitative assessment on coronary computed tomography angiography (CCTA) image quality: comparisons between genders and different tube voltage settings.

PubMed

Chian, Teo Chee; Nassir, Norziana Mat; Ibrahim, Mohd Izuan; Yusof, Ahmad Khairuddin Md; Sabarudin, Akmal

2017-02-01

This study was carried out to quantify and compare the quantitative image quality of coronary computed tomography angiography (CCTA) between genders as well as between different tube voltages scan protocols. Fifty-five cases of CCTA were collected retrospectively and all images including reformatted axial images at systolic and diastolic phases as well as images with curved multi planar reformation (cMPR) were obtained. Quantitative image quality including signal intensity, image noise, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of right coronary artery (RCA), left anterior descending artery (LAD), left circumflex artery (LCx) and left main artery (LM) were quantified using Analyze 12.0 software. Six hundred and fifty-seven coronary arteries were evaluated. There were no significant differences in any quantitative image quality parameters between genders. 100 kilovoltage peak (kVp) scanning protocol produced images with significantly higher signal intensity compared to 120 kVp scanning protocol (P<0.001) in all coronary arteries in all types of images. Higher SNR was also observed in 100 kVp scan protocol in all coronary arteries except in LCx where 120 kVp showed better SNR than 100 kVp. There were no significant differences in image quality of CCTA between genders and different tube voltages. Lower tube voltage (100 kVp) scanning protocol is recommended in clinical practice to reduce the radiation dose to patient.

A rapid and efficient SDS-based RNA isolation protocol from different tissues of coffee.

PubMed

Huded, Arun Kumar C; Jingade, Pavankumar; Mishra, Manoj Kumar

2018-03-01

Isolation of high-quality RNA from coffee is challenging because of high level of polysaccharides, polyphenols and other secondary metabolites. In the present study, a rapid and efficient RNA extraction protocol from different tissues of coffee was optimized. Sufficiently high quality and quantity (225.6-454.8 µg/g) of RNA was obtained by using the optimized protocol. The presence of two distinct bands of 28S rRNA and 18S rRNA in agarose gel proved the intactness of the RNA samples. The average spectrophotometric values of the isolated RNA ranged from 1.96 to 2.02 ( A 260/280 ) and 1.95 to 2.14 ( A 260/230 ), indicating the high quality of RNA devoid of polyphenols, polysaccharides and protein contamination. In the optimized protocol, addition of PVPP to the extraction buffer and a brief incubation of samples at 65 °C and subsequent purification with potassium acetate resulted in good-quality RNA isolation. The suitability of RNA for downstream processing was confirmed by PCR amplification with cytochrome c oxidase gene-specific primers. The amplification of a single 392 bp fragment using cDNA and 1.5 kb fragment using genomic DNA samples confirmed the absence of DNA contamination. The present protocol is rapid and yielded good quality and quantity of RNA suitable for functional genomics studies.

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.

Dose reduction in whole-body computed tomography of multiple injuries (DoReMI): protocol for a prospective cohort study

PubMed Central

2014-01-01

Background Single-pass, contrast-enhanced whole body multidetector computed tomography (MDCT) emerged as the diagnostic standard for evaluating patients with major trauma. Modern iterative image algorithms showed high image quality at a much lower radiation dose in the non-trauma setting. This study aims at investigating whether the radiation dose can safely be reduced in trauma patients without compromising the diagnostic accuracy and image quality. Methods/Design Prospective observational study with two consecutive cohorts of patients. Setting: A high-volume, academic, supra-regional trauma centre in Germany. Study population: Consecutive male and female patients who 1. had been exposed to a high-velocity trauma mechanism, 2. present with clinical evidence or high suspicion of multiple trauma (predicted Injury Severity Score [ISS] ≥16) and 3. are scheduled for primary MDCT based on the decision of the trauma leader on call. Imaging protocols: In a before/after design, a consecutive series of 500 patients will undergo single-pass, whole-body 128-row multi-detector computed tomography (MDCT) with a standard, as low as possible radiation dose. This will be followed by a consecutive series of 500 patients undergoing an approved ultra-low dose MDCT protocol using an image processing algorithm. Data: Routine administrative data and electronic patient records, as well as digital images stored in a picture archiving and communications system will serve as the primary data source. The protocol was approved by the institutional review board. Main outcomes: (1) incidence of delayed diagnoses, (2) diagnostic accuracy, as correlated to the reference standard of a synopsis of all subsequent clinical, imaging, surgical and autopsy findings, (3) patients’ safety, (4) radiation exposure (e.g. effective dose), (5) subjective image quality (assessed independently radiologists and trauma surgeons on a 100-mm visual analogue scale), (6) objective image quality (e.g., contrast-to-noise ratio). Analysis: Multivariate regression will be employed to adjust and correct the findings for time and cohort effects. An exploratory interim analysis halfway after introduction of low-dose MDCT will be conducted to assess whether this protocol is clearly inferior or superior to the current standard. Discussion Although non-experimental, this study will generate first large-scale data on the utility of imaging-enhancing algorithms in whole-body MDCT for major blunt trauma. Trial registration Current Controlled Trials ISRCTN74557102. PMID:24589310

Accuracy of Pediatric Trauma Field Triage: A Systematic Review.

PubMed

van der Sluijs, Rogier; van Rein, Eveline A J; Wijnand, Joep G J; Leenen, Luke P H; van Heijl, Mark

2018-05-16

Field triage of pediatric patients with trauma is critical for transporting the right patient to the right hospital. Mortality and lifelong disabilities are potentially attributable to erroneously transporting a patient in need of specialized care to a lower-level trauma center. To quantify the accuracy of field triage and associated diagnostic protocols used to identify children in need of specialized trauma care. MEDLINE, Embase, PsycINFO, and Cochrane Register of Controlled Trials were searched from database inception to November 6, 2017, for studies describing the accuracy of diagnostic tests to identify children in need of specialized trauma care in a prehospital setting. Identified articles with a study population including patients not transported by emergency medical services were excluded. Quality assessment was performed using a modified version of the Quality Assessment of Diagnostic Accuracy Studies-2. After deduplication, 1430 relevant articles were assessed, a full-text review of 38 articles was conducted, and 5 of those articles were included. All studies were observational, published between 1996 and 2017, and conducted in the United States, and data collection was prospective in 1 study. Three different protocols were studied that analyzed a combined total of 1222 children in need of specialized trauma care. One protocol was specifically developed for a pediatric out-of-hospital cohort. The percentage of pediatric patients requiring specialized trauma care in each study varied between 2.6% (110 of 4197) and 54.7% (58 of 106). The sensitivity of the prehospital triage tools ranged from 49.1% to 87.3%, and the specificity ranged from 41.7% to 84.8%. No prehospital triage protocol alone complied with the international standard of 95% or greater sensitivity. Undertriage and overtriage rates, representative of the quality of the full diagnostic strategy to transport a patient to the right hospital, were not reported for inclusive trauma systems or emergency medical services regions. It is crucial to transport the right patient to the right hospital. Yet the quality of the full diagnostic strategy to determine the optimal receiving hospital is unknown. None of the investigated field triage protocols complied with current sensitivity targets. Improved efforts are needed to develop accurate child-specific tools to prevent undertriage and its potential life-threatening consequences.

Device-independent secret-key-rate analysis for quantum repeaters

NASA Astrophysics Data System (ADS)

Holz, Timo; Kampermann, Hermann; Bruß, Dagmar

2018-01-01

The device-independent approach to quantum key distribution (QKD) aims to establish a secret key between two or more parties with untrusted devices, potentially under full control of a quantum adversary. The performance of a QKD protocol can be quantified by the secret key rate, which can be lower bounded via the violation of an appropriate Bell inequality in a setup with untrusted devices. We study secret key rates in the device-independent scenario for different quantum repeater setups and compare them to their device-dependent analogon. The quantum repeater setups under consideration are the original protocol by Briegel et al. [Phys. Rev. Lett. 81, 5932 (1998), 10.1103/PhysRevLett.81.5932] and the hybrid quantum repeater protocol by van Loock et al. [Phys. Rev. Lett. 96, 240501 (2006), 10.1103/PhysRevLett.96.240501]. For a given repeater scheme and a given QKD protocol, the secret key rate depends on a variety of parameters, such as the gate quality or the detector efficiency. We systematically analyze the impact of these parameters and suggest optimized strategies.

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

PubMed

Razaque, Abdul; Elleithy, Khaled M

2014-03-12

This paper introduces the design, implementation, and performance analysis of the scalable and mobility-aware hybrid protocol named boarder node medium access control (BN-MAC) for wireless sensor networks (WSNs), which leverages the characteristics of scheduled and contention-based MAC protocols. Like contention-based MAC protocols, BN-MAC achieves high channel utilization, network adaptability under heavy traffic and mobility, and low latency and overhead. Like schedule-based MAC protocols, BN-MAC reduces idle listening time, emissions, and collision handling at low cost at one-hop neighbor nodes and achieves high channel utilization under heavy network loads. BN-MAC is particularly designed for region-wise WSNs. Each region is controlled by a boarder node (BN), which is of paramount importance. The BN coordinates with the remaining nodes within and beyond the region. Unlike other hybrid MAC protocols, BN-MAC incorporates three promising models that further reduce the energy consumption, idle listening time, overhearing, and congestion to improve the throughput and reduce the latency. One of the models used with BN-MAC is automatic active and sleep (AAS), which reduces the ideal listening time. When nodes finish their monitoring process, AAS lets them automatically go into the sleep state to avoid the idle listening state. Another model used in BN-MAC is the intelligent decision-making (IDM) model, which helps the nodes sense the nature of the environment. Based on the nature of the environment, the nodes decide whether to use the active or passive mode. This decision power of the nodes further reduces energy consumption because the nodes turn off the radio of the transceiver in the passive mode. The third model is the least-distance smart neighboring search (LDSNS), which determines the shortest efficient path to the one-hop neighbor and also provides cross-layering support to handle the mobility of the nodes. The BN-MAC also incorporates a semi-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.

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

PubMed Central

Razaque, Abdul; Elleithy, Khaled M.

2014-01-01

This paper introduces the design, implementation, and performance analysis of the scalable and mobility-aware hybrid protocol named boarder node medium access control (BN-MAC) for wireless sensor networks (WSNs), which leverages the characteristics of scheduled and contention-based MAC protocols. Like contention-based MAC protocols, BN-MAC achieves high channel utilization, network adaptability under heavy traffic and mobility, and low latency and overhead. Like schedule-based MAC protocols, BN-MAC reduces idle listening time, emissions, and collision handling at low cost at one-hop neighbor nodes and achieves high channel utilization under heavy network loads. BN-MAC is particularly designed for region-wise WSNs. Each region is controlled by a boarder node (BN), which is of paramount importance. The BN coordinates with the remaining nodes within and beyond the region. Unlike other hybrid MAC protocols, BN-MAC incorporates three promising models that further reduce the energy consumption, idle listening time, overhearing, and congestion to improve the throughput and reduce the latency. One of the models used with BN-MAC is automatic active and sleep (AAS), which reduces the ideal listening time. When nodes finish their monitoring process, AAS lets them automatically go into the sleep state to avoid the idle listening state. Another model used in BN-MAC is the intelligent decision-making (IDM) model, which helps the nodes sense the nature of the environment. Based on the nature of the environment, the nodes decide whether to use the active or passive mode. This decision power of the nodes further reduces energy consumption because the nodes turn off the radio of the transceiver in the passive mode. The third model is the least-distance smart neighboring search (LDSNS), which determines the shortest efficient path to the one-hop neighbor and also provides cross-layering support to handle the mobility of the nodes. The BN-MAC also incorporates a semi-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

Adaptive Peer Sampling with Newscast

NASA Astrophysics Data System (ADS)

Tölgyesi, Norbert; Jelasity, Márk

The peer sampling service is a middleware service that provides random samples from a large decentralized network to support gossip-based applications such as multicast, data aggregation and overlay topology management. Lightweight gossip-based implementations of the peer sampling service have been shown to provide good quality random sampling while also being extremely robust to many failure scenarios, including node churn and catastrophic failure. We identify two problems with these approaches. The first problem is related to message drop failures: if a node experiences a higher-than-average message drop rate then the probability of sampling this node in the network will decrease. The second problem is that the application layer at different nodes might request random samples at very different rates which can result in very poor random sampling especially at nodes with high request rates. We propose solutions for both problems. We focus on Newscast, a robust implementation of the peer sampling service. Our solution is based on simple extensions of the protocol and an adaptive self-control mechanism for its parameters, namely—without involving failure detectors—nodes passively monitor local protocol events using them as feedback for a local control loop for self-tuning the protocol parameters. The proposed solution is evaluated by simulation experiments.

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.

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.

A modified Mediterranean dietary intervention for adults with major depression: Dietary protocol and feasibility data from the SMILES trial.

PubMed

Opie, Rachelle S; O'Neil, Adrienne; Jacka, Felice N; Pizzinga, Josephine; Itsiopoulos, Catherine

2017-04-19

The SMILES trial was the first randomized controlled trial (RCT) explicitly designed to evaluate a dietary intervention, conducted by qualified dietitians, for reducing depressive symptomatology in adults with clinical depression. Here we detail the development of the prescribed diet (modified Mediterranean diet (ModiMedDiet)) for individuals with major depressive disorders (MDDs) that was designed specifically for the SMILES trial. We also present data demonstrating the extent to which this intervention achieved improvements in diet quality. The ModiMedDiet was designed using a combination of existing dietary guidelines and scientific evidence from the emerging field of nutritional psychiatric epidemiology. Sixty-seven community dwelling individuals (Melbourne, Australia) aged 18 years or over, with current poor quality diets, and MDDs were enrolled into the SMILES trial. A retention rate of 93.9 and 73.5% was observed for the dietary intervention and social support control group, respectively. The dietary intervention (ModiMedDiet) consisted of seven individual nutrition counselling sessions delivered by a qualified dietitian. The control condition comprised a social support protocol matched to the same visit schedule and length. This manuscript details the first prescriptive individualized dietary intervention delivered by dietitians for adults with major depression. Significant improvements in dietary quality were observed among individuals randomized to the ModiMedDiet group. These dietary improvements were also found to be associated with changes in depressive symptoms. The ModiMedDiet, a novel and individually tailored intervention designed specifically for adults with major depression, can be effectively implemented in clinical practice to manage this highly prevalent and debilitating condition. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000251820. Registered 29 February 2012.

UK quantitative WB-DWI technical workgroup: consensus meeting recommendations on optimisation, quality control, processing and analysis of quantitative whole-body diffusion-weighted imaging for cancer.

PubMed

Barnes, Anna; Alonzi, Roberto; Blackledge, Matthew; Charles-Edwards, Geoff; Collins, David J; Cook, Gary; Coutts, Glynn; Goh, Vicky; Graves, Martin; Kelly, Charles; Koh, Dow-Mu; McCallum, Hazel; Miquel, Marc E; O'Connor, James; Padhani, Anwar; Pearson, Rachel; Priest, Andrew; Rockall, Andrea; Stirling, James; Taylor, Stuart; Tunariu, Nina; van der Meulen, Jan; Walls, Darren; Winfield, Jessica; Punwani, Shonit

2018-01-01

Application of whole body diffusion-weighted MRI (WB-DWI) for oncology are rapidly increasing within both research and routine clinical domains. However, WB-DWI as a quantitative imaging biomarker (QIB) has significantly slower adoption. To date, challenges relating to accuracy and reproducibility, essential criteria for a good QIB, have limited widespread clinical translation. In recognition, a UK workgroup was established in 2016 to provide technical consensus guidelines (to maximise accuracy and reproducibility of WB-MRI QIBs) and accelerate the clinical translation of quantitative WB-DWI applications for oncology. A panel of experts convened from cancer centres around the UK with subspecialty expertise in quantitative imaging and/or the use of WB-MRI with DWI. A formal consensus method was used to obtain consensus agreement regarding best practice. Questions were asked about the appropriateness or otherwise on scanner hardware and software, sequence optimisation, acquisition protocols, reporting, and ongoing quality control programs to monitor precision and accuracy and agreement on quality control. The consensus panel was able to reach consensus on 73% (255/351) items and based on consensus areas made recommendations to maximise accuracy and reproducibly of quantitative WB-DWI studies performed at 1.5T. The panel were unable to reach consensus on the majority of items related to quantitative WB-DWI performed at 3T. This UK Quantitative WB-DWI Technical Workgroup consensus provides guidance on maximising accuracy and reproducibly of quantitative WB-DWI for oncology. The consensus guidance can be used by researchers and clinicians to harmonise WB-DWI protocols which will accelerate clinical translation of WB-DWI-derived QIBs.

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 drilling protocol and to minimize surgical trauma.

Evaluation of a continuous-rotation, high-speed scanning protocol for micro-computed tomography.

PubMed

Kerl, Hans Ulrich; Isaza, Cristina T; Boll, Hanne; Schambach, Sebastian J; Nolte, Ingo S; Groden, Christoph; Brockmann, Marc A

2011-01-01

Micro-computed tomography is used frequently in preclinical in vivo research. Limiting factors are radiation dose and long scan times. The purpose of the study was to compare a standard step-and-shoot to a continuous-rotation, high-speed scanning protocol. Micro-computed tomography of a lead grid phantom and a rat femur was performed using a step-and-shoot and a continuous-rotation protocol. Detail discriminability and image quality were assessed by 3 radiologists. The signal-to-noise ratio and the modulation transfer function were calculated, and volumetric analyses of the femur were performed. The radiation dose of the scan protocols was measured using thermoluminescence dosimeters. The 40-second continuous-rotation protocol allowed a detail discriminability comparable to the step-and-shoot protocol at significantly lower radiation doses. No marked differences in volumetric or qualitative analyses were observed. Continuous-rotation micro-computed tomography significantly reduces scanning time and radiation dose without relevantly reducing image quality compared with a normal step-and-shoot protocol.

XPS Protocol for the Characterization of Pristine and Functionalized Single Wall Carbon Nanotubes

NASA Technical Reports Server (NTRS)

Sosa, E. D.; Allada, R.; Huffman, C. B.; Arepalli, S.

2009-01-01

Recent interest in developing new applications for carbon nanotubes (CNT) has fueled the need to use accurate macroscopic and nanoscopic techniques to characterize and understand their chemistry. X-ray photoelectron spectroscopy (XPS) has proved to be a useful analytical tool for nanoscale surface characterization of materials including carbon nanotubes. Recent nanotechnology research at NASA Johnson Space Center (NASA-JSC) helped to establish a characterization protocol for quality assessment for single wall carbon nanotubes (SWCNTs). Here, a review of some of the major factors of the XPS technique that can influence the quality of analytical data, suggestions for methods to maximize the quality of data obtained by XPS, and the development of a protocol for XPS characterization as a complementary technique for analyzing the purity and surface characteristics of SWCNTs is presented. The XPS protocol is then applied to a number of experiments including impurity analysis and the study of chemical modifications for SWCNTs.

Real-time distributed scheduling algorithm for supporting QoS over WDM networks

NASA Astrophysics Data System (ADS)

Kam, Anthony C.; Siu, Kai-Yeung

1998-10-01

Most existing or proposed WDM networks employ circuit switching, typically with one session having exclusive use of one entire wavelength. Consequently they are not suitable for data applications involving bursty traffic patterns. The MIT AON Consortium has developed an all-optical LAN/MAN testbed which provides time-slotted WDM service and employs fast-tunable transceivers in each optical terminal. In this paper, we explore extensions of this service to achieve fine-grained statistical multiplexing with different virtual circuits time-sharing the wavelengths in a fair manner. In particular, we develop a real-time distributed protocol for best-effort traffic over this time-slotted WDM service with near-optical fairness and throughput characteristics. As an additional design feature, our protocol supports the allocation of guaranteed bandwidths to selected connections. This feature acts as a first step towards supporting integrated services and quality-of-service guarantees over WDM networks. To achieve high throughput, our approach is based on scheduling transmissions, as opposed to collision- based schemes. Our distributed protocol involves one MAN scheduler and several LAN schedulers (one per LAN) in a master-slave arrangement. Because of propagation delays and limits on control channel capacities, all schedulers are designed to work with partial, delayed traffic information. Our distributed protocol is of the `greedy' type to ensure fast execution in real-time in response to dynamic traffic changes. It employs a hybrid form of rate and credit control for resource allocation. We have performed extensive simulations, which show that our protocol allocates resources (transmitters, receivers, wavelengths) fairly with high throughput, and supports bandwidth guarantees.

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.

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.

Comparison of greenhouse gas offset quantification protocols for nitrogen management in dryland wheat cropping systems in the Pacific Northwest

USDA-ARS?s Scientific Manuscript database

In the carbon market, greenhouse gas (GHG) offset protocols need to ensure that emission reductions are of high quality, quantifiable and real. However, lack of consistency across protocols for quantifying emission reductions compromise the credibility of offsets generated. Thus, protocol quantifica...

Bayesian deconvolution and quantification of metabolites in complex 1D NMR spectra using BATMAN.

PubMed

Hao, Jie; Liebeke, Manuel; Astle, William; De Iorio, Maria; Bundy, Jacob G; Ebbels, Timothy M D

2014-01-01

Data processing for 1D NMR spectra is a key bottleneck for metabolomic and other complex-mixture studies, particularly where quantitative data on individual metabolites are required. We present a protocol for automated metabolite deconvolution and quantification from complex NMR spectra by using the Bayesian automated metabolite analyzer for NMR (BATMAN) R package. BATMAN models resonances on the basis of a user-controllable set of templates, each of which specifies the chemical shifts, J-couplings and relative peak intensities for a single metabolite. Peaks are allowed to shift position slightly between spectra, and peak widths are allowed to vary by user-specified amounts. NMR signals not captured by the templates are modeled non-parametrically by using wavelets. The protocol covers setting up user template libraries, optimizing algorithmic input parameters, improving prior information on peak positions, quality control and evaluation of outputs. The outputs include relative concentration estimates for named metabolites together with associated Bayesian uncertainty estimates, as well as the fit of the remainder of the spectrum using wavelets. Graphical diagnostics allow the user to examine the quality of the fit for multiple spectra simultaneously. This approach offers a workflow to analyze large numbers of spectra and is expected to be useful in a wide range of metabolomics studies.

A simple method to evaluate the number of bradyrhizobia on soybean seeds and its implication on inoculant quality control

PubMed Central

2011-01-01

Soybean seeds are non-sterile and their bacterial population interferes with the enumeration of beneficial bacteria, making it difficult to assess survival under different conditions. Within this context, the principal aims of this work were: (1) to improve a selective media for the enumeration of B. japonicum recovered from inoculated soybean seeds; (2) to establish the most representative mathematical function for B. japonicum mortality on soybean seeds after inoculation; (3) to evaluate if environmental or physiological conditions modify B. japonicum mortality on soybean seeds; and (4) to create a new protocol for quality control of soybean inoculants. We successfully evaluated the combination of pentachloronitrobenzene and vancomycin added to the yeast-mannitol medium to inhibit most fungi and Gram-positive soybean microbiota, thus producing reliable counts of B. japonicum from inoculated soybean seeds. Percentages of recovery and survival factors were obtained and used to construct a two-phase exponential decay non-linear regression function. High temperature and desiccation decreased these parameters, while the optimization of temperature and the use of osmoprotective compounds with inoculants increased them. The use of this protocol minimized heterogeneity between experiments and may be considered more reliable than the simple expression of direct colony count of bacteria recovered from seeds. PMID:21906377

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.

Radionuclide bone scan SPECT-CT: lowering the dose of CT significantly reduces radiation dose without impacting CT image quality

PubMed Central

Gupta, Sandeep Kumar; Trethewey, Scott; Brooker, Bree; Rutherford, Natalie; Diffey, Jenny; Viswanathan, Suresh; Attia, John

2017-01-01

The CT component of SPECT-CT is required for attenuation correction and anatomical localization of the uptake on SPECT but there is no guideline about the optimal CT acquisition parameters. In our department, a standard CT acquisition protocol was changed in 2013 to give lower radiation dose to the patient. In this study, we retrospectively compared the effects on patient dose as well as the CT image quality with current versus older CT protocols. Ninety nine consecutive patients [n=51 Standard dose ‘old’ protocol (SDP); n=48 lower dose ‘new’ protocol (LDP)] with lumbar spine SPECT-CT for bone scan were examined. The main differences between the two protocols were that SDP used 130 kVp tube voltage and reference current-time product of 70 mAs whereas the LDP used 110 kVp and 40 mAs respectively. Various quantitative parameters from the CT images were obtained and the images were also rated blindly by two experienced nuclear medicine physicians for bony definition and noise. The mean calculated dose length product of the LDP group (121.5±39.6 mGy.cm) was significantly lower compared to the SDP group patients (266.9±96.9 mGy.cm; P<0.0001). This translated into a significant reduction in the mean effective dose to 1.8 mSv from 4.0 mSv. The physicians reported better CT image quality for the bony structures in LDP group although for soft tissue structures, the SDP group had better image quality. The optimized new CT acquisition protocol significantly reduced the radiation dose to the patient and in-fact improved CT image quality for the assessment of bony structures. PMID:28533938

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.

Computed tomographic venography for varicose veins of the lower extremities: prospective comparison of 80-kVp and conventional 120-kVp protocols.

PubMed

Cho, Eun-Suk; Kim, Joo Hee; Kim, Sungjun; Yu, Jeong-Sik; Chung, Jae-Joon; Yoon, Choon-Sik; Lee, Hyeon-Kyeong; Lee, Kyung Hee

2012-01-01

To prospectively investigate the feasibility of an 80-kilovolt (peak) (kVp) protocol in computed tomographic venography for varicose veins of the lower extremities by comparison with conventional 120-kVp protocol. Attenuation values and signal-to-noise ratio of iodine contrast medium (CM) were determined in a water phantom for 2 tube voltages (80 kVp and 120 kVp). Among 100 patients, 50 patients were scanned with 120 kVp and 150 effective milliampere second (mAs(eff)), and the other 50 patients were scanned with 80 kVp and 390 mAs(eff) after the administration of 1.7-mL/kg CM (370 mg of iodine per milliliter). The 2 groups were compared for venous attenuation, contrast-to-noise ratio, and subjective degree of venous enhancement, image noise, and overall diagnostic image quality. In the phantom, the attenuation value and signal-to-noise ratio value for iodine CM at 80 kVp were 63.8% and 33.0% higher, respectively, than those obtained at 120 kVp. The mean attenuation of the measured veins of the lower extremities was 148.3 Hounsfield units (HU) for the 80-kVp protocol and 94.8 HU for the 120-kVp protocol. Contrast-to-noise ratio was also significantly higher with the 80-kVp protocol. The overall diagnostic image quality of the 3-dimensional volume-rendered images was good with both protocols. The subjective score for venous enhancement was higher at the 80-kVp protocol. The mean volume computed tomography dose index of the 80-kVp (5.6 mGy) protocol was 23.3% lower than that of the 120-kVp (7.3 mGy) protocol. The use of the 80-kVp protocol improved overall venous attenuation, especially in perforating vein, and provided similarly high diagnostic image quality with a lower radiation dose when compared to the conventional 120-kVp protocol.

Packetized Video On MAGNET

NASA Astrophysics Data System (ADS)

Lazar, Aurel A.; White, John S.

1987-07-01

Theoretical analysis of integrated local area network model of MAGNET, an integrated network testbed developed at Columbia University, shows that the bandwidth freed up during video and voice calls during periods of little movement in the images and periods of silence in the speech signals could be utilized efficiently for graphics and data transmission. Based on these investigations, an architecture supporting adaptive protocols that are dynamicaly controlled by the requirements of a fluctuating load and changing user environment has been advanced. To further analyze the behavior of the network, a real-time packetized video system has been implemented. This system is embedded in the real-time multimedia workstation EDDY, which integrates video, voice, and data traffic flows. Protocols supporting variable-bandwidth, fixed-quality packetized video transport are described in detail.

Packetized video on MAGNET

NASA Astrophysics Data System (ADS)

Lazar, Aurel A.; White, John S.

1986-11-01

Theoretical analysis of an ILAN model of MAGNET, an integrated network testbed developed at Columbia University, shows that the bandwidth freed up by video and voice calls during periods of little movement in the images and silence periods in the speech signals could be utilized efficiently for graphics and data transmission. Based on these investigations, an architecture supporting adaptive protocols that are dynamically controlled by the requirements of a fluctuating load and changing user environment has been advanced. To further analyze the behavior of the network, a real-time packetized video system has been implemented. This system is embedded in the real time multimedia workstation EDDY that integrates video, voice and data traffic flows. Protocols supporting variable bandwidth, constant quality packetized video transport are descibed in detail.

Performance Improvement in Geographic Routing for Vehicular Ad Hoc Networks

PubMed Central

Kaiwartya, Omprakash; Kumar, Sushil; Lobiyal, D. K.; Abdullah, Abdul Hanan; Hassan, Ahmed Nazar

2014-01-01

Geographic routing is one of the most investigated themes by researchers for reliable and efficient dissemination of information in Vehicular Ad Hoc Networks (VANETs). Recently, different Geographic Distance Routing (GEDIR) protocols have been suggested in the literature. These protocols focus on reducing the forwarding region towards destination to select the Next Hop Vehicles (NHV). Most of these protocols suffer from the problem of elevated one-hop link disconnection, high end-to-end delay and low throughput even at normal vehicle speed in high vehicle density environment. This paper proposes a Geographic Distance Routing protocol based on Segment vehicle, Link quality and Degree of connectivity (SLD-GEDIR). The protocol selects a reliable NHV using the criteria segment vehicles, one-hop link quality and degree of connectivity. The proposed protocol has been simulated in NS-2 and its performance has been compared with the state-of-the-art protocols: P-GEDIR, J-GEDIR and V-GEDIR. The empirical results clearly reveal that SLD-GEDIR has lower link disconnection and end-to-end delay, and higher throughput as compared to the state-of-the-art protocols. It should be noted that the performance of the proposed protocol is preserved irrespective of vehicle density and speed. PMID:25429415

Performance improvement in geographic routing for Vehicular Ad Hoc Networks.

PubMed

Kaiwartya, Omprakash; Kumar, Sushil; Lobiyal, D K; Abdullah, Abdul Hanan; Hassan, Ahmed Nazar

2014-11-25

Geographic routing is one of the most investigated themes by researchers for reliable and efficient dissemination of information in Vehicular Ad Hoc Networks (VANETs). Recently, different Geographic Distance Routing (GEDIR) protocols have been suggested in the literature. These protocols focus on reducing the forwarding region towards destination to select the Next Hop Vehicles (NHV). Most of these protocols suffer from the problem of elevated one-hop link disconnection, high end-to-end delay and low throughput even at normal vehicle speed in high vehicle density environment. This paper proposes a Geographic Distance Routing protocol based on Segment vehicle, Link quality and Degree of connectivity (SLD-GEDIR). The protocol selects a reliable NHV using the criteria segment vehicles, one-hop link quality and degree of connectivity. The proposed protocol has been simulated in NS-2 and its performance has been compared with the state-of-the-art protocols: P-GEDIR, J-GEDIR and V-GEDIR. The empirical results clearly reveal that SLD-GEDIR has lower link disconnection and end-to-end delay, and higher throughput as compared to the state-of-the-art protocols. It should be noted that the performance of the proposed protocol is preserved irrespective of vehicle density and speed.

A Combinatorial Auction among Versatile Experts and Amateurs

NASA Astrophysics Data System (ADS)

Ito, Takayuki; Yokoo, Makoto; Matsubara, Shigeo

Auctions have become an integral part of electronic commerce and a promising field for applying multi-agent technologies. Correctly judging the quality of auctioned goods is often difficult for amateurs, in particular, in Internet auctions. However, experts can correctly judge the quality of goods. In this situation, it is difficult to make experts tell the truth and attain an efficient allocation, since experts have a clear advantage over amateurs and they would not reveal their valuable information without some reward. In our previous work, we have succeeded in developing such auction protocols under the following two cases: (1) the case of a single-unit auction among experts and amateurs, and (2) the case of a combinatorial auction among single-skilled experts and amateurs. In this paper, we focus on versatile experts. Versatile experts have an interest in, and expert knowledge on the qualities of several goods. In the case of versatile experts, there would be several problems, e.g., free riding problems, if we simply extended the previous VCG-style auction protocol. Thus, in this paper, we employ PORF (price-oriented, rationing-free) protocol for designing our new protocol to realize a strategy-proof auction protocol for experts. In the protocol, the dominant strategy for experts is truth-telling. Also, for amateurs, truth-telling is the best response when two or more experts select the dominant strategy. Furthermore, the protocol is false-name-proof.

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) according to the examined body region (head, lung, body, bone) combined with a split bolus CA injection protocol allows for a high-quality CT examination and a relevant reduction of radiation exposure in the examination of polytraumatized patients Key Points   · Dedicated adaption of the CT trauma protocol allows for an optimized examination.. · Different levels of iterative reconstruction, tube voltage and the CA injection protocol are crucial.. · A reduction of radiation exposure of more than 40 % with good image quality is possible.. Citation Format · Kahn J, Kaul D, Böning G et al. Quality and Dose Optimized CT Trauma Protocol - Recommendation from a University Level-I Trauma Center. Fortschr Röntgenstr 2017; 189: 844 - 854. © Georg Thieme Verlag KG Stuttgart · New York.

The Development and Piloting of a Mobile Data Collection Protocol to Assess Compliance With a National Tobacco Advertising, Promotion, and Product Display Ban at Retail Venues in the Russian Federation

PubMed Central

Grant, Ashley S; Spires, Mark H; Cohen, Joanna E

2016-01-01

Background Tobacco control policies that lead to a significant reduction in tobacco industry marketing can improve public health by reducing consumption of tobacco and preventing initiation of tobacco use. Laws that ban or restrict advertising and promotion in point-of-sale (POS) environments, in the moment when consumers decide whether or not to purchase a tobacco product, must be correctly implemented to achieve the desired public health benefits. POS policy compliance assessments can support implementation; however, there are challenges to conducting evaluations that are rigorous, cost-effective, and timely. Data collection must be discreet, accurate, and systematic, and ideally collected both before and after policies take effect. The use of mobile phones and other mobile technology provide opportunities to efficiently collect data and support effective tobacco control policies. The Russian Federation (Russia) passed a comprehensive national tobacco control law that included a ban on most forms of tobacco advertising and promotion, effective November 15, 2013. The legislation further prohibited the display of tobacco products at retail trade sites and eliminated kiosks as a legal trade site, effective June 1, 2014. Objective The objective of the study was to develop and test a mobile data collection protocol including: (1) retailer sampling, (2) adaptation of survey instruments for mobile phones, and (3) data management protocols. Methods Two waves of observations were conducted; wave 1 took place during April-May 2014, after the advertising and promotion bans were effective, and again in August-September 2014, after the product display ban and elimination of tobacco sales in kiosks came into effect. Sampling took place in 5 Russian cities: Moscow, St. Petersburg, Novosibirsk, Yekaterinburg, and Kazan. Lack of access to a comprehensive list of licensed tobacco retailers necessitated a sampling approach that included the development of a walking protocol to identify tobacco retailers to observe. Observation instruments were optimized for use on mobile devices and included the collection of images/photos and the geographic location of retailers. Data were uploaded in real-time to a remote (“cloud-based”) server accessible via Internet and verified with the use of a data management protocol that included submission of daily field notes from the research team for review by project managers. Results The walking protocol was a practical means of identifying 780 relevant retail venues in Russia, in the absence of reliable sampling resources. Mobile phones were convenient tools for completing observation checklists discretely and accurately. Daily field notes and meticulous oversight of collected data were critical to ensuring data quality. Conclusions Mobile technology can support timely and accurate data collection and also help monitor data quality through the use of real-time uploads. These protocols can be adapted to assess compliance with other types of public health policies. PMID:27580800

The Development and Piloting of a Mobile Data Collection Protocol to Assess Compliance With a National Tobacco Advertising, Promotion, and Product Display Ban at Retail Venues in the Russian Federation.

PubMed

Grant, Ashley S; Kennedy, Ryan D; Spires, Mark H; Cohen, Joanna E

2016-08-31

Tobacco control policies that lead to a significant reduction in tobacco industry marketing can improve public health by reducing consumption of tobacco and preventing initiation of tobacco use. Laws that ban or restrict advertising and promotion in point-of-sale (POS) environments, in the moment when consumers decide whether or not to purchase a tobacco product, must be correctly implemented to achieve the desired public health benefits. POS policy compliance assessments can support implementation; however, there are challenges to conducting evaluations that are rigorous, cost-effective, and timely. Data collection must be discreet, accurate, and systematic, and ideally collected both before and after policies take effect. The use of mobile phones and other mobile technology provide opportunities to efficiently collect data and support effective tobacco control policies. The Russian Federation (Russia) passed a comprehensive national tobacco control law that included a ban on most forms of tobacco advertising and promotion, effective November 15, 2013. The legislation further prohibited the display of tobacco products at retail trade sites and eliminated kiosks as a legal trade site, effective June 1, 2014. The objective of the study was to develop and test a mobile data collection protocol including: (1) retailer sampling, (2) adaptation of survey instruments for mobile phones, and (3) data management protocols. Two waves of observations were conducted; wave 1 took place during April-May 2014, after the advertising and promotion bans were effective, and again in August-September 2014, after the product display ban and elimination of tobacco sales in kiosks came into effect. Sampling took place in 5 Russian cities: Moscow, St. Petersburg, Novosibirsk, Yekaterinburg, and Kazan. Lack of access to a comprehensive list of licensed tobacco retailers necessitated a sampling approach that included the development of a walking protocol to identify tobacco retailers to observe. Observation instruments were optimized for use on mobile devices and included the collection of images/photos and the geographic location of retailers. Data were uploaded in real-time to a remote ("cloud-based") server accessible via Internet and verified with the use of a data management protocol that included submission of daily field notes from the research team for review by project managers. The walking protocol was a practical means of identifying 780 relevant retail venues in Russia, in the absence of reliable sampling resources. Mobile phones were convenient tools for completing observation checklists discretely and accurately. Daily field notes and meticulous oversight of collected data were critical to ensuring data quality. Mobile technology can support timely and accurate data collection and also help monitor data quality through the use of real-time uploads. These protocols can be adapted to assess compliance with other types of public health policies.

The effect of two pre-cryopreservation single layer colloidal centrifugation protocols in combination with different freezing extenders on the fragmentation dynamics of thawed equine sperm DNA

PubMed Central

2012-01-01

Background Variability among stallions in terms of semen cryopreservation quality renders it difficult to arrive at a standardized cryopreservation method. Different extenders and processing techniques (such us colloidal centrifugation) are used in order to optimize post-thaw sperm quality. Sperm chromatin integrity analysis is an effective tool for assessing such quality. The aim of the present study was to compare the effect of two single layer colloidal centrifugation protocols (prior to cryopreservation) in combination with three commercial freezing extenders on the post-thaw chromatin integrity of equine sperm samples at different post-thaw incubation (37°C) times (i.e., their DNA fragmentation dynamics). Results Post-thaw DNA fragmentation levels in semen samples subjected to either of the colloidal centrifugation protocols were significantly lower (p<0.05) immediately after thawing and after 4 h of incubation at 37°C compared to samples that underwent standard (control) centrifugation. The use of InraFreeze® extender was associated with significantly less DNA fragmentation than the use of Botu-Crio® extender at 6 h of incubation, and than the use of either Botu-Crio® or Gent® extender at 24 h of incubation (p<0.05). Conclusions These results suggest that single layer colloidal centrifugation performed with extended or raw semen prior to cryopreservation reduces DNA fragmentation during the first four hours after thawing. Further studies are needed to determine the influence of freezing extenders on equine sperm DNA fragmentation dynamics. PMID:23217215

Quantitative assessment on coronary computed tomography angiography (CCTA) image quality: comparisons between genders and different tube voltage settings

PubMed Central

Chian, Teo Chee; Nassir, Norziana Mat; Ibrahim, Mohd Izuan; Yusof, Ahmad Khairuddin Md

2017-01-01

Background This study was carried out to quantify and compare the quantitative image quality of coronary computed tomography angiography (CCTA) between genders as well as between different tube voltages scan protocols. Methods Fifty-five cases of CCTA were collected retrospectively and all images including reformatted axial images at systolic and diastolic phases as well as images with curved multi planar reformation (cMPR) were obtained. Quantitative image quality including signal intensity, image noise, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of right coronary artery (RCA), left anterior descending artery (LAD), left circumflex artery (LCx) and left main artery (LM) were quantified using Analyze 12.0 software. Results Six hundred and fifty-seven coronary arteries were evaluated. There were no significant differences in any quantitative image quality parameters between genders. 100 kilovoltage peak (kVp) scanning protocol produced images with significantly higher signal intensity compared to 120 kVp scanning protocol (P<0.001) in all coronary arteries in all types of images. Higher SNR was also observed in 100 kVp scan protocol in all coronary arteries except in LCx where 120 kVp showed better SNR than 100 kVp. Conclusions There were no significant differences in image quality of CCTA between genders and different tube voltages. Lower tube voltage (100 kVp) scanning protocol is recommended in clinical practice to reduce the radiation dose to patient. PMID:28275559

Evaluation of Introduction of a Delayed Cord Clamping Protocol for Premature Neonates in a High-Volume Maternity Center.

PubMed

Liu, Lilly Y; Feinglass, Joe M; Khan, Janine Y; Gerber, Susan E; Grobman, William A; Yee, Lynn M

2017-05-01

To evaluate adherence to a delayed cord clamping protocol for preterm births in the first 2 years after its introduction, perform a quality improvement assessment, and determine neonatal outcomes associated with protocol implementation and adherence. This is a retrospective cohort study of women delivering singleton neonates at 23-32 weeks of gestation in the 2 years before (preprotocol) and 2 years after (postprotocol) introduction of a 30-second delayed cord clamping protocol at a large-volume academic center. This policy was communicated to obstetric and pediatric health care providers and nurses and reinforced with intermittent educational reviews. Barriers to receiving delayed cord clamping were assessed using χ tests and multivariable logistic regression. Neonatal outcomes then were compared between all neonates in the preprotocol period and all neonates in the postprotocol period and between all neonates in the preprotocol period and neonates receiving delayed cord clamping in the postprotocol period using multivariable linear and logistic regression analyses. Of the 427 eligible neonates, 187 were born postprotocol. Of these, 53.5% (n=100) neonates received delayed cord clamping according to the protocol. The rate of delayed cord clamping preprotocol was 0%. Protocol uptake and frequency of delayed cord clamping increased over the 2 years after its introduction. In the postprotocol period, cesarean delivery was the only factor independently associated with failing to receive delayed cord clamping (adjusted odds ratio [OR] 0.49, 95% confidence interval [CI] 0.25-0.96). In comparison with the preprotocol period, those who received delayed cord clamping in the postprotocol period had significantly higher birth hematocrit (β=2.46, P=.007) and fewer blood transfusions in the first week of life (adjusted OR 0.49, 95% CI 0.25-0.96). After introduction of an institutional delayed cord clamping protocol followed by continued health care provider education and quality feedback, the frequency of delayed cord clamping progressively increased. Compared with historical controls, performing delayed cord clamping in eligible preterm neonates was associated with improved neonatal hematologic indices, demonstrating the effectiveness of delayed cord clamping in a large-volume maternity unit.

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...

Optimization of dose and image quality in adult and pediatric computed tomography scans

NASA Astrophysics Data System (ADS)

Chang, Kwo-Ping; Hsu, Tzu-Kun; Lin, Wei-Ting; Hsu, Wen-Lin

2017-11-01

Exploration to maximize CT image and reduce radiation dose was conducted while controlling for multiple factors. The kVp, mAs, and iteration reconstruction (IR), affect the CT image quality and radiation dose absorbed. The optimal protocols (kVp, mAs, IR) are derived by figure of merit (FOM) based on CT image quality (CNR) and CT dose index (CTDIvol). CT image quality metrics such as CT number accuracy, SNR, low contrast materials' CNR and line pair resolution were also analyzed as auxiliary assessments. CT protocols were carried out with an ACR accreditation phantom and a five-year-old pediatric head phantom. The threshold values of the adult CT scan parameters, 100 kVp and 150 mAs, were determined from the CT number test and line pairs in ACR phantom module 1and module 4 respectively. The findings of this study suggest that the optimal scanning parameters for adults be set at 100 kVp and 150-250 mAs. However, for improved low- contrast resolution, 120 kVp and 150-250 mAs are optimal. Optimal settings for pediatric head CT scan were 80 kVp/50 mAs, for maxillary sinus and brain stem, while 80 kVp /300 mAs for temporal bone. SNR is not reliable as the independent image parameter nor the metric for determining optimal CT scan parameters. The iteration reconstruction (IR) approach is strongly recommended for both adult and pediatric CT scanning as it markedly improves image quality without affecting radiation dose.

A network architecture for International Business Satellite communications

NASA Astrophysics Data System (ADS)

Takahata, Fumio; Nohara, Mitsuo; Takeuchi, Yoshio

Demand Assignment (DA) control is expected to be introduced in the International Business Satellte communications (IBS) network in order to cope with a growing international business traffic. The paper discusses the DA/IBS network from the viewpoints of network configuration, satellite channel configuration and DA control. The network configuration proposed here consists of one Central Station with network management function and several Network Coordination Stations with user management function. A satellite channel configuration is also presented along with a tradeoff study on transmission bit rate, high power amplifier output power requirement, and service quality. The DA control flow and protocol based on CCITT Signalling System No. 7 are also proposed.

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

Randomized Trial of Hypnosis as a Pain and Symptom Management Strategy in Adults with Sickle Cell Disease

PubMed Central

Wallen, Gwenyth R; Middleton, Kimberly R; Ames, Nancy; Brooks, Alyssa T; Handel, Daniel

2014-01-01

Sickle cell disease (SCD) is the most common genetic disease in African-Americans, characterized by recurrent painful vaso-occlusive crises. Medical therapies for controlling or preventing crises are limited because of efficacy and/or toxicity. This is a randomized, controlled, single-crossover protocol of hypnosis for managing pain in SCD patients. Participants receive hypnosis from a trained hypnosis therapist followed by six weeks of self-hypnosis using digital media. Those in the control arm receive SCD education followed by a six-week waiting period before crossing over to the hypnosis arm of the study. Outcome measures include assessments of pain (frequency, intensity and quality), anxiety, coping strategies, sleep, depression, and health care utilization. To date, there are no published randomized, controlled trials evaluating the efficacy of hypnosis on SCD pain modulation in adults. Self-hypnosis for pain management may be helpful in modulating chronic pain, improving sleep quality, and decreasing use of narcotics in patients with SCD. TRIAL REGISTRATION ClinicalTrials.gov: NCT00393250 PMID:25520557

Interventions for the prevention of cardiovascular diseases: a protocol for a systematic review of economic evaluations in low-income and middle-income countries.

PubMed

Aminde, Leopold Ndemnge; Veerman, Lennert

2016-12-21

Low-income and middle-income countries (LMICs) are experiencing a growing disease burden due to cardiovascular and other chronic non-communicable diseases. Interventions for the control of these diseases are paramount; however, these countries are faced with competing health and financial needs. There is an urgent need for quality evidence on cost-effective strategies to address these chronic diseases. We aim to synthesise the current literature on economic evaluations of interventions for primary and secondary cardiovascular disease prevention in LMICs. A systematic review of studies (published and unpublished) in LMICs up to 30 October 2016 will be conducted. The following databases will be searched: PubMed/MEDLINE, EMBASE, SCOPUS, CINAHL, Web of Science, EconLit, NHS Economic Evaluations Database (NHS EED). Data sources specific to African literature, such as the WHO AFROLIB, Africa Index Medicus and African Journals online (AJOL) as well as grey literature, will also be searched. 2 reviewers shall independently screen potential articles for inclusion and disagreements shall be resolved by consensus. Quality appraisal of studies shall be done using Drummond's checklist for economic evaluation of studies. A descriptive synthesis of the evidence obtained is planned. The primary outcomes will be costs per life years gained or unit of clinical outcome, cost per quality-adjusted life years or disability-adjusted life years. This systematic review protocol has been prepared according to the Preferred Reporting Items for Systematic reviews and Meta-analyses for Protocols (PRISMA-P) 2015 statement. Ethics approval is not required considering that this is a protocol for a systematic review of published studies. Results from this review will be disseminated via conference presentations and peer-reviewed journal publications. CRD42016043510. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Human DNA extraction from whole saliva that was fresh or stored for 3, 6 or 12 months using five different protocols

PubMed Central

GARBIERI, Thais Francini; BROZOSKI, Daniel Thomas; DIONÍSIO, Thiago José; SANTOS, Carlos Ferreira; NEVES, Lucimara Teixeira das

2017-01-01

Abstract Saliva when compared to blood collection has the following advantages: it requires no specialized personnel for collection, allows for remote collection by the patient, is painless, well accepted by participants, has decreased risks of disease transmission, does not clot, can be frozen before DNA extraction and possibly has a longer storage time. Objective and Material and Methods This study aimed to compare the quantity and quality of human DNA extracted from saliva that was fresh or frozen for three, six and twelve months using five different DNA extraction protocols: protocol 1 – Oragene™ commercial kit, protocol 2 – QIAamp DNA mini kit, protocol 3 – DNA extraction using ammonium acetate, protocol 4 – Instagene™ Matrix and protocol 5 – Instagene™ Matrix diluted 1:1 using proteinase K and 1% SDS. Briefly, DNA was analyzed using spectrophotometry, electrophoresis and PCR. Results Results indicated that time spent in storage typically decreased the DNA quantity with the exception of protocol 1. The purity of DNA was generally not affected by storage times for the commercial based protocols, while the purity of the DNA samples extracted by the noncommercial protocols typically decreased when the saliva was stored longer. Only protocol 1 consistently extracted unfragmented DNA samples. In general, DNA samples extracted through protocols 1, 2, 3 and 4, regardless of storage time, were amplified by human specific primers whereas protocol 5 produced almost no samples that were able to be amplified by human specific primers. Depending on the protocol used, it was possible to extract DNA in high quantities and of good quality using whole saliva, and furthermore, for the purposes of DNA extraction, saliva can be reliably stored for relatively long time periods. Conclusions In summary, a complicated picture emerges when taking into account the extracted DNA’s quantity, purity and quality; depending on a given researchers needs, one protocol’s particular strengths and costs might be the deciding factor for its employment. PMID:28403355

Standardizing Quality Assessment of Fused Remotely Sensed Images

NASA Astrophysics Data System (ADS)

Pohl, C.; Moellmann, J.; Fries, K.

2017-09-01

The multitude of available operational remote sensing satellites led to the development of many image fusion techniques to provide high spatial, spectral and temporal resolution images. The comparison of different techniques is necessary to obtain an optimized image for the different applications of remote sensing. There are two approaches in assessing image quality: 1. Quantitatively by visual interpretation and 2. Quantitatively using image quality indices. However an objective comparison is difficult due to the fact that a visual assessment is always subject and a quantitative assessment is done by different criteria. Depending on the criteria and indices the result varies. Therefore it is necessary to standardize both processes (qualitative and quantitative assessment) in order to allow an objective image fusion quality evaluation. Various studies have been conducted at the University of Osnabrueck (UOS) to establish a standardized process to objectively compare fused image quality. First established image fusion quality assessment protocols, i.e. Quality with No Reference (QNR) and Khan's protocol, were compared on varies fusion experiments. Second the process of visual quality assessment was structured and standardized with the aim to provide an evaluation protocol. This manuscript reports on the results of the comparison and provides recommendations for future research.

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.

The Role of Liposomal Bupivacaine in Value-Based Care.

PubMed

Iorio, Richard

Multimodal pain control strategies are crucial in reducing opioid use and delivering effective pain management to facilitate improved surgical outcomes. The utility of liposomal bupivacaine in enabling effective pain control in multimodal strategies has been demonstrated in several studies, but others have found the value of liposomal bupivacaine in such approaches to be insignificant. At New York University Langone Medical Center, liposomal bupivacaine injection and femoral nerve block were compared in their delivery of efficacious and cost-effective multimodal analgesia among patients undergoing total joint arthroplasty (TJA). Retrospective analysis revealed that including liposomal bupivacaine in a multimodal pain control protocol for TJA resulted in improved quality and efficiency metrics, decreased narcotic use, and faster mobilization, all relative to femoral nerve block, and without a significant increase in admission costs. In addition, liposomal bupivacaine use was associated with elimination of the need for patient-controlled analgesia in TJA. Thus, at Langone Medical Center, the introduction of liposomal bupivacaine to TJA has been instrumental in achieving adequate pain control, delivering high-level quality of care, and controlling costs.

Measurement properties of maximal cardiopulmonary exercise tests protocols in persons after stroke: A systematic review.

PubMed

Wittink, Harriet; Verschuren, Olaf; Terwee, Caroline; de Groot, Janke; Kwakkel, Gert; van de Port, Ingrid

2017-11-21

To systematically review and critically appraise the literature on measurement properties of cardiopulmonary exercise test protocols for measuring aerobic capacity, VO2max, in persons after stroke. PubMed, Embase and Cinahl were searched from inception up to 15 June 2016. A total of 9 studies were identified reporting on 9 different cardiopulmonary exercise test protocols. VO2max measured with cardiopulmonary exercise test and open spirometry was the construct of interest. The target population was adult persons after stroke. We included all studies that evaluated reliability, measurement error, criterion validity, content validity, hypothesis testing and/or responsiveness of cardiopulmonary exercise test protocols. Two researchers independently screened the literature, assessed methodological quality using the COnsensus-based Standards for the selection of health Measurement INstruments checklist and extracted data on measurement properties of cardiopulmonary exercise test protocols. Most studies reported on only one measurement property. Best-evidence synthesis was derived taking into account the methodological quality of the studies, the results and the consistency of the results. No judgement could be made on which protocol is "best" for measuring VO2max in persons after stroke due to lack of high-quality studies on the measurement properties of the cardiopulmonary exercise test.

Assessing the structure of non-routine decision processes in Airline Operations Control.

PubMed

Richters, Floor; Schraagen, Jan Maarten; Heerkens, Hans

2016-03-01

Unfamiliar severe disruptions challenge Airline Operations Control professionals most, as their expertise is stretched to its limits. This study has elicited the structure of Airline Operations Control professionals' decision process during unfamiliar disruptions by mapping three macrocognitive activities on the decision ladder: sensemaking, option evaluation and action planning. The relationship between this structure and decision quality was measured. A simulated task was staged, based on which think-aloud protocols were obtained. Results show that the general decision process structure resembles the structure of experts working under routine conditions, in terms of the general structure of the macrocognitive activities, and the rule-based approach used to identify options and actions. Surprisingly, high quality of decision outcomes was found to relate to the use of rule-based strategies. This implies that successful professionals are capable of dealing with unfamiliar problems by reframing them into familiar ones, rather than to engage in knowledge-based processing. Practitioner Summary: We examined the macrocognitive structure of Airline Operations Control professionals' decision process during a simulated unfamiliar disruption in relation to decision quality. Results suggest that successful professionals are capable of dealing with unfamiliar problems by reframing them into familiar ones, rather than to engage in knowledge-based processing.

Influence of study design on digital pathology image quality evaluation: the need to define a clinical task

PubMed Central

Platiša, Ljiljana; Brantegem, Leen Van; Kumcu, Asli; Ducatelle, Richard; Philips, Wilfried

2017-01-01

Abstract. Despite the current rapid advance in technologies for whole slide imaging, there is still no scientific consensus on the recommended methodology for image quality assessment of digital pathology slides. For medical images in general, it has been recommended to assess image quality in terms of doctors’ success rates in performing a specific clinical task while using the images (clinical image quality, cIQ). However, digital pathology is a new modality, and already identifying the appropriate task is difficult. In an alternative common approach, humans are asked to do a simpler task such as rating overall image quality (perceived image quality, pIQ), but that involves the risk of nonclinically relevant findings due to an unknown relationship between the pIQ and cIQ. In this study, we explored three different experimental protocols: (1) conducting a clinical task (detecting inclusion bodies), (2) rating image similarity and preference, and (3) rating the overall image quality. Additionally, within protocol 1, overall quality ratings were also collected (task-aware pIQ). The experiments were done by diagnostic veterinary pathologists in the context of evaluating the quality of hematoxylin and eosin-stained digital pathology slides of animal tissue samples under several common image alterations: additive noise, blurring, change in gamma, change in color saturation, and JPG compression. While the size of our experiments was small and prevents drawing strong conclusions, the results suggest the need to define a clinical task. Importantly, the pIQ data collected under protocols 2 and 3 did not always rank the image alterations the same as their cIQ from protocol 1, warning against using conventional pIQ to predict cIQ. At the same time, there was a correlation between the cIQ and task-aware pIQ ratings from protocol 1, suggesting that the clinical experiment context (set by specifying the clinical task) may affect human visual attention and bring focus to their criteria of image quality. Further research is needed to assess whether and for which purposes (e.g., preclinical testing) task-aware pIQ ratings could substitute cIQ for a given clinical task. PMID:28653011

Influence of study design on digital pathology image quality evaluation: the need to define a clinical task.

PubMed

Platiša, Ljiljana; Brantegem, Leen Van; Kumcu, Asli; Ducatelle, Richard; Philips, Wilfried

2017-04-01

Despite the current rapid advance in technologies for whole slide imaging, there is still no scientific consensus on the recommended methodology for image quality assessment of digital pathology slides. For medical images in general, it has been recommended to assess image quality in terms of doctors' success rates in performing a specific clinical task while using the images (clinical image quality, cIQ). However, digital pathology is a new modality, and already identifying the appropriate task is difficult. In an alternative common approach, humans are asked to do a simpler task such as rating overall image quality (perceived image quality, pIQ), but that involves the risk of nonclinically relevant findings due to an unknown relationship between the pIQ and cIQ. In this study, we explored three different experimental protocols: (1) conducting a clinical task (detecting inclusion bodies), (2) rating image similarity and preference, and (3) rating the overall image quality. Additionally, within protocol 1, overall quality ratings were also collected (task-aware pIQ). The experiments were done by diagnostic veterinary pathologists in the context of evaluating the quality of hematoxylin and eosin-stained digital pathology slides of animal tissue samples under several common image alterations: additive noise, blurring, change in gamma, change in color saturation, and JPG compression. While the size of our experiments was small and prevents drawing strong conclusions, the results suggest the need to define a clinical task. Importantly, the pIQ data collected under protocols 2 and 3 did not always rank the image alterations the same as their cIQ from protocol 1, warning against using conventional pIQ to predict cIQ. At the same time, there was a correlation between the cIQ and task-aware pIQ ratings from protocol 1, suggesting that the clinical experiment context (set by specifying the clinical task) may affect human visual attention and bring focus to their criteria of image quality. Further research is needed to assess whether and for which purposes (e.g., preclinical testing) task-aware pIQ ratings could substitute cIQ for a given clinical task.

Impact of a risk management plan on Legionella contamination of dental unit water.

PubMed

Leoni, Erica; Dallolio, Laura; Stagni, Francesca; Sanna, Tiziana; D'Alessandro, Giovanni; Piana, Gabriela

2015-02-23

The study aimed to assess the prevalence of Legionella spp. in dental unit waterlines of a dental clinic and to verify whether the microbiological parameters used as indicators of water quality were correlated with Legionella contamination. A risk management plan was subsequently implemented in the dental health care setting, in order to verify whether the adopted disinfection protocols were effective in preventing Legionella colonization. The water delivered from syringes and turbines of 63 dental units operating in a dental clinic, was monitored for counts of the heterotrophic bacteria P. aeruginosa and Legionella spp. (22 °C and 37 °C). At baseline, output water from dental units continuously treated with disinfection products was more compliant with the recommended standards than untreated and periodically treated water. However, continuous disinfection was still not able to prevent contamination by Legionella and P. aeruginosa. Legionella was isolated from 36.4%, 24.3% and 53.3% of samples from untreated, periodically and continuously treated waterlines, respectively. The standard microbiological parameters used as indicators of water quality proved to be unreliable as predictors of the presence of Legionella, whose source was identified as the tap water used to supply the dental units. The adoption of control measures, including the use of deionized water in supplying the dental unit waterlines and the application of a combined protocol of continuous and periodic disinfection, with different active products for the different devices, resulted in good control of Legionella contamination. The efficacy of the measures adopted was mainly linked to the strict adherence to the planned protocols, which placed particular stress on staff training and ongoing environmental monitoring.

Refining dosing by oral gavage in the dog: A protocol to harmonise welfare

PubMed Central

Hall, Laura E.; Robinson, Sally; Buchanan-Smith, Hannah M.

2015-01-01

Introduction The dog is a frequently-used, non-rodent species in the safety assessment of new chemical entities. We have a scientific and ethical obligation to ensure that the best quality of data is achieved from their use. Oral gavage is a technique frequently used to deliver a compound directly into the stomach. As with other animals, in the dog, gavage is aversive and the frequency of its use is a cause for welfare concern but little research has been published on the technique nor how to Refine it. A Welfare Assessment Framework (Hall, 2014) was previously developed for use with the laboratory-housed dog and a contrasting pattern of behaviour, cardiovascular and affective measures were found in dogs with positive and negative welfare. Methods Using the framework, this study compared the effects of sham dosing (used to attempt to habituate dogs to dosing) and a Refined training protocol against a control, no-training group to determine the benefit to welfare and scientific output of each technique. Results Our findings show that sham dosing is ineffective as a habituation technique and ‘primes’ rather than desensitises dogs to dosing. Dogs in the control group showed few changes in parameters across the duration of the study, with some undesirable changes during dosing, while dogs in the Refined treatment group showed improvements in many parameters. Discussion It is recommended that if there is no time allocated for pre-study training a no-sham dosing protocol is used. However, brief training periods show a considerable benefit for welfare and quality of data to be obtained from the dogs' use. PMID:25575806

Does chlorhexidine prevent dry socket?

PubMed

Richards, Derek

2012-01-01

The BBO (Bibliografia Brasileira de Odontologia), Biomed Central, Cochrane Library, Directory of Open Access Journals, LILACS, Open-J-Gate, OpenSIGLE, PubMed, Sabinet and Science-Direct databases were searched. Articles were selected for review from the search results on the basis of their compliance with the broad inclusion criteria: relevant to the review question; and prospective two-arm (or more) clinical study. The primary outcome measure was the incidence of AO reported at the patient level. Two reviewers (VY and SM) independently extracted data and assessed the quality of the accepted articles. Individual dichotomous datasets for the control and test group were extracted from each article. Where possible, missing data were calculated from information given in the text or tables. In addition, authors were contacted in order to obtain missing information. Datasets were assessed for their clinical and methodological heterogeneity following Cochrane guidelines. Meta-analysis was conducted with homogeneous datasets. Publication bias was assessed by use of a funnel plot and Egger's regression. Ten randomised trials were included; almost all involved the removal of third molars. Only two of six identified application protocols (single application of chlorhexidine 0.2% gel or multiple application of 0.12% rinse versus placebo) were found to significantly decrease the incidence of AO. Within the limitations of this review, only two of six identified application protocols were found to significantly decrease the incidence of AO. The evidence for both protocols is weak and may be challenged on the grounds of high risk of selection, detection/performance and attrition bias. This systematic review could not identify sufficient evidence supporting the use of chlorhexidine for the prevention of AO. Chlorhexidine seems not to cause any significantly higher adverse reactions than placebo. Future high-quality randomised control trials are needed to provide conclusive evidence on this topic.

Effects of periodontal treatment on exacerbation frequency and lung function in patients with chronic periodontitis: study protocol of a 1-year randomized controlled trial.

PubMed

Romero, Sergio dos Santos; Pinto, Erika Horácio; Longo, Priscila Larcher; Dal Corso, Simone; Lanza, Fernanda Cordoba; Stelmach, Rafael; Rached, Samia Zahi; Lino-Dos-Santos-Franco, Adriana; Mayer, Marcia Pinto Alves; Bussadori, Sandra Kalil; Fernandes, Kristianne Porta Santos; Mesquita-Ferrari, Raquel Agnelli; Horliana, Anna Carolina Ratto Tempestini

2017-01-23

Chronic obstructive pulmonary disease (COPD) has been associated with periodontal disease (PD), and periodontal treatment (PT) has been connected to reduction of lung disease exacerbations. Bronchiectasis has many clinical similarities with COPD but, although it is also a chronic lung disease, to date it has not been studied with relation to PD. The aim of this study is to evaluate whether PT associated with photodynamic therapy (PDT) reduces the number of exacerbations, improves pulmonary function, periodontal clinical parameters and quality of life after 1 year of periodontal treatment follow-up. Bronchiectasis patients will undergo medical anamnesis and periodontal examination. Participants with periodontitis will be divided into two groups and PT will be performed as G1 control group (n = 32) - OHO (oral hygiene orientation) + supragingival treatment + simulation of using photodynamic therapy (PDT); G2 experimental (n = 32) - scaling and root planing + PDT + OHO. Lung function will be assessed both at baseline and after 1 year by spirometry, exacerbation history will be analyzed through clinical records monitoring. Three instruments for quality of life assessment will also be applied - Saint George's Respiratory Questionnaire and Impact Profile Analysis Oral health (OHIP-14). It is expected that periodontal treatment can improve the analyzed parameters after 1 year. Although only one study evaluates exacerbation in COPD after 1 year of PT, bronchiectasis has not been studied in the dentistry field to date. NCT02514226. Version #1. This study protocol receives grant from FAPESP (São Paulo Research Foundation) #2015/20535-1. First received: July 22, 2015, 1 st version. This protocol has been approved by the Research Ethics Committee of Nove de Julho University.

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.

LESS: Link Estimation with Sparse Sampling in Intertidal WSNs

PubMed Central

Ji, Xiaoyu; Chen, Yi-chao; Li, Xiaopeng; Xu, Wenyuan

2018-01-01

Deploying wireless sensor networks (WSN) in the intertidal area is an effective approach for environmental monitoring. To sustain reliable data delivery in such a dynamic environment, a link quality estimation mechanism is crucial. However, our observations in two real WSN systems deployed in the intertidal areas reveal that link update in routing protocols often suffers from energy and bandwidth waste due to the frequent link quality measurement and updates. In this paper, we carefully investigate the network dynamics using real-world sensor network data and find it feasible to achieve accurate estimation of link quality using sparse sampling. We design and implement a compressive-sensing-based link quality estimation protocol, LESS, which incorporates both spatial and temporal characteristics of the system to aid the link update in routing protocols. We evaluate LESS in both real WSN systems and a large-scale simulation, and the results show that LESS can reduce energy and bandwidth consumption by up to 50% while still achieving more than 90% link quality estimation accuracy. PMID:29494557

Evaluating the effect of increased pitch, iterative reconstruction and dual source CT on dose reduction and image quality.

PubMed

Gariani, Joanna; Martin, Steve P; Botsikas, Diomidis; Becker, Christoph D; Montet, Xavier

2018-06-14

To compare radiation dose and image quality of thoracoabdominal scans obtained with a high-pitch protocol (pitch 3.2) and iterative reconstruction (Sinogram Affirmed Iterative Reconstruction) in comparison to standard pitch reconstructed with filtered back projection (FBP) using dual source CT. 114 CT scans (Somatom Definition Flash, Siemens Healthineers, Erlangen, Germany), 39 thoracic scans, 54 thoracoabdominal scans and 21 abdominal scans were performed. Analysis of three protocols was undertaken; pitch of 1 reconstructed with FBP, pitch of 3.2 reconstructed with SAFIRE, pitch of 3.2 with stellar detectors reconstructed with SAFIRE. Objective and subjective image analysis were performed. Dose differences of the protocols used were compared. Dose was reduced when comparing scans with a pitch of 1 reconstructed with FBP to high-pitch scans with a pitch of 3.2 reconstructed with SAFIRE with a reduction of volume CT dose index of 75% for thoracic scans, 64% for thoracoabdominal scans and 67% for abdominal scans. There was a further reduction after the implementation of stellar detectors reflected in a reduction of 36% of the dose-length product for thoracic scans. This was not at the detriment of image quality, contrast-to-noise ratio, signal-to-noise ratio and the qualitative image analysis revealed a superior image quality in the high-pitch protocols. The combination of a high pitch protocol with iterative reconstruction allows significant dose reduction in routine chest and abdominal scans whilst maintaining or improving diagnostic image quality, with a further reduction in thoracic scans with stellar detectors. Advances in knowledge: High pitch imaging with iterative reconstruction is a tool that can be used to reduce dose without sacrificing image quality.

[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.

Methods for Monitoring Fish Communities of Buffalo National River and Ozark National Scenic Riverways in the Ozark Plateaus of Arkansas and Missouri: Version 1.0

USGS Publications Warehouse

Petersen, James C.; Justus, B.G.; Dodd, H.R.; Bowles, D.E.; Morrison, L.W.; Williams, M.H.; Rowell, G.A.

2008-01-01

Buffalo National River located in north-central Arkansas, and Ozark National Scenic Riverways, located in southeastern Missouri, are the two largest units of the National Park Service in the Ozark Plateaus physiographic province. The purpose of this report is to provide a protocol that will be used by the National Park Service to sample fish communities and collect related water-quality, habitat, and stream discharge data of Buffalo National River and Ozark National Scenic Riverways to meet inventory and long-term monitoring objectives. The protocol includes (1) a protocol narrative, (2) several standard operating procedures, and (3) supplemental information helpful for implementation of the protocol. The protocol narrative provides background information about the protocol such as the rationale of why a particular resource or resource issue was selected for monitoring, information concerning the resource or resource issue of interest, a description of how monitoring results will inform management decisions, and a discussion of the linkages between this and other monitoring projects. The standard operating procedures cover preparation, training, reach selection, water-quality sampling, fish community sampling, physical habitat collection, measuring stream discharge, equipment maintenance and storage, data management and analysis, reporting, and protocol revision procedures. Much of the information in the standard operating procedures was gathered from existing protocols of the U.S. Geological Survey National Water Quality Assessment program or other sources. Supplemental information that would be helpful for implementing the protocol is included. This information includes information on fish species known or suspected to occur in the parks, sample sites, sample design, fish species traits, index of biotic integrity metrics, sampling equipment, and field forms.

Effects of communication media choice on the quality and efficacy of emergency calls assisted by a mobile nursing protocol tool.

PubMed

Castro, Luis A; Favela, Jesus; Garcia-Peña, Carmen

2014-11-01

The transition from paper to electronic-based records in the healthcare industry has posed several challenges to conventional medical practices. The introduction of technology in day-to-day medical and nursing practices deserves careful consideration. In this work, we report the results of a controlled experiment to compare nurses' consultation in emergency calls in six different conditions. We studied the effect that the type of communication media (face-to-face, telephone, videoconference) and type of nursing protocol media (paper-based, electronic-based) can have on consultation time, mistakes made, pauses during consultation, eye contact, and efficacy of the consultation. We found that the type of communication media has an effect on consultation time; on average, fewer mistakes were made during telephone-based consultations; for eye contact, there were significantly fewer eye contacts during face-to-face than during videoconference consultations; finally, the type of communication media or protocol media did not have any effect in the efficacy of the consultation.

Large Volume, Behaviorally-relevant Illumination for Optogenetics in Non-human Primates.

PubMed

Acker, Leah C; Pino, Erica N; Boyden, Edward S; Desimone, Robert

2017-10-03

This protocol describes a large-volume illuminator, which was developed for optogenetic manipulations in the non-human primate brain. The illuminator is a modified plastic optical fiber with etched tip, such that the light emitting surface area is > 100x that of a conventional fiber. In addition to describing the construction of the large-volume illuminator, this protocol details the quality-control calibration used to ensure even light distribution. Further, this protocol describes techniques for inserting and removing the large volume illuminator. Both superficial and deep structures may be illuminated. This large volume illuminator does not need to be physically coupled to an electrode, and because the illuminator is made of plastic, not glass, it will simply bend in circumstances when traditional optical fibers would shatter. Because this illuminator delivers light over behaviorally-relevant tissue volumes (≈ 10 mm 3 ) with no greater penetration damage than a conventional optical fiber, it facilitates behavioral studies using optogenetics in non-human primates.

Tailoring protocols for chest CT applications: when and how?

PubMed Central

Iezzi, Roberto; Larici, Anna Rita; Franchi, Paola; Marano, Riccardo; Magarelli, Nicola; Posa, Alessandro; Merlino, Biagio; Manfredi, Riccardo; Colosimo, Cesare

2017-01-01

In the medical era of early detection of diseases and tailored therapies, an accurate characterization and staging of the disease is pivotal for treatment planning. The widespread use of computed tomography (CT)—often with the use of contrast material (CM)—probably represents the most important advance in diagnostic radiology. The result is a marked increase in radiation exposure of the population for medical purposes, with its intrinsic carcinogenic potential, and CM affecting kidney function. The radiologists should aim to minimize patient’s risk by reducing radiation exposure and CM amount, while maintaining the highest image quality. To achieve this goal, it is necessary to perform “patient-centric imaging”. The purpose of this review is to provide radiologists with “tips and tricks” to control radiation dose at CT, summarizing technical artifices in order to reduce image noise and increase image contrast. Also chest CT tailored protocols are supplied, with particular attention to three most common thoracic CT protocols: aortic/cardiac CT angiography (CTA), pulmonary CTA, and routine chest CT. PMID:29097345

Computational Biology Methods for Characterization of Pluripotent Cells.

PubMed

Araúzo-Bravo, Marcos J

2016-01-01

Pluripotent cells are a powerful tool for regenerative medicine and drug discovery. Several techniques have been developed to induce pluripotency, or to extract pluripotent cells from different tissues and biological fluids. However, the characterization of pluripotency requires tedious, expensive, time-consuming, and not always reliable wet-lab experiments; thus, an easy, standard quality-control protocol of pluripotency assessment remains to be established. Here to help comes the use of high-throughput techniques, and in particular, the employment of gene expression microarrays, which has become a complementary technique for cellular characterization. Research has shown that the transcriptomics comparison with an Embryonic Stem Cell (ESC) of reference is a good approach to assess the pluripotency. Under the premise that the best protocol is a computer software source code, here I propose and explain line by line a software protocol coded in R-Bioconductor for pluripotency assessment based on the comparison of transcriptomics data of pluripotent cells with an ESC of reference. I provide advice for experimental design, warning about possible pitfalls, and guides for results interpretation.

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 East Midlands-Derby Research Ethics Committee (16/EM/0178); peer-reviewed publications. Trial registration Clinicaltrials.gov: NCT02391337; ISRCTN: 95259705. Pre-results. PMID:28729311

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. Clinicaltrials.gov: NCT02391337; ISRCTN: 95259705. Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A design of wireless sensor networks for a power quality monitoring system.

PubMed

Lim, Yujin; Kim, Hak-Man; Kang, Sanggil

2010-01-01

Power grids deal with the business of generation, transmission, and distribution of electric power. Recently, interest in power quality in electrical distribution systems has increased rapidly. In Korea, the communication network to deliver voltage, current, and temperature measurements gathered from pole transformers to remote monitoring centers employs cellular mobile technology. Due to high cost of the cellular mobile technology, power quality monitoring measurements are limited and data gathering intervals are large. This causes difficulties in providing the power quality monitoring service. To alleviate the problems, in this paper we present a communication infrastructure to provide low cost, reliable data delivery. The communication infrastructure consists of wired connections between substations and monitoring centers, and wireless connections between pole transformers and substations. For the wireless connection, we employ a wireless sensor network and design its corresponding data forwarding protocol to improve the quality of data delivery. For the design, we adopt a tree-based data forwarding protocol in order to customize the distribution pattern of the power quality information. We verify the performance of the proposed data forwarding protocol quantitatively using the NS-2 network simulator.

Improving plan quality for prostate volumetric-modulated arc therapy.

PubMed

Wright, Katrina; Ferrari-Anderson, Janet; Barry, Tamara; Bernard, Anne; Brown, Elizabeth; Lehman, Margot; Pryor, David

2017-01-01

We critically evaluated the quality and consistency of volumetric-modulated arc therapy (VMAT) prostate planning at a single institution to quantify objective measures for plan quality and establish clear guidelines for plan evaluation and quality assurance. A retrospective analysis was conducted on 34 plans generated on the Pinnacle 3 version 9.4 and 9.8 treatment planning system to deliver 78 Gy in 39 fractions to the prostate only using VMAT. Data were collected on contoured structure volumes, overlaps and expansions, planning target volume (PTV) and organs at risk volumes and relationship, dose volume histogram, plan conformity, plan homogeneity, low-dose wash, and beam parameters. Standard descriptive statistics were used to describe the data. Despite a standardized planning protocol, we found variability was present in all steps of the planning process. Deviations from protocol contours by radiation oncologists and radiation therapists occurred in 12% and 50% of cases, respectively, and the number of optimization parameters ranged from 12 to 27 (median 17). This contributed to conflicts within the optimization process reflected by the mean composite objective value of 0.07 (range 0.01 to 0.44). Methods used to control low-intermediate dose wash were inconsistent. At the PTV rectum interface, the dose-gradient distance from the 74.1 Gy to 40 Gy isodose ranged from 0.6 cm to 2.0 cm (median 1.0 cm). Increasing collimator angle was associated with a decrease in monitor units and a single full 6 MV arc was sufficient for the majority of plans. A significant relationship was found between clinical target volume-rectum distance and rectal tolerances achieved. A linear relationship was determined between the PTV volume and volume of 40 Gy isodose. Objective values and composite objective values were useful in determining plan quality. Anatomic geometry and overlap of structures has a measurable impact on the plan quality achieved for prostate patients being treated with VMAT. By evaluating multiple planning variables, we have been able to determine important factors influencing plan quality and develop predictive models for quality metrics that have been incorporated into our new protocol and will be tested and refined in future studies. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

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.

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.S. Government work and is in the public domain in the USA.

DARPA Internet Program. Internet and Transmission Control Specifications,

DTIC Science & Technology

1981-09-01

Internet Program Protocol Specification", RFC 791, USC/ Information Sciences Institute, September 1981. [34] Postel, J., ed., "Transmission Control Protocol...DARPA Internet Program Protocol Specification", RFC 793, USC/ Information Sciences Institute, September 1981. [35] Postel, J., "Echo Process", RFC 347...Newman, March 1981. [53] Postel, J., " Internet Control Message Protocol - DARPA Internet Program Protocol Specification", RFC 792, USC/ Information

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.

Assessing the effectiveness of the NICHD investigative interview protocol when interviewing French-speaking alleged victims of child sexual abuse in Quebec.

PubMed

Cyr, Mireille; Lamb, Michael E

2009-05-01

The study was designed to assess the effectiveness of the flexibly structured NICHD Investigative Interview Protocol for child sexual abuse (CSA) investigative interviews by police officers and mental health workers in Quebec. The NICHD Protocol was designed to operationalize "best practice" guidelines and to help forensic interviewers use open-ended prompts to facilitate free recall by alleged victims. A total of 83 interviews with 3- to 13-year-old alleged victims were matched with 83 interviews conducted by the same interviewers before they were trained to use the Protocol. Interviews were matched with respect to the children's ages, children-perpetrator relationships, and the types and frequency of abuse. Coders categorized each of the prompts used to elicit information about the abuse and tabulated the numbers of new forensically relevant details provided in each response. Interviewers used three times as many open-ended prompts in Protocol interviews than in non-Protocol interviews, whereas use of all other types of questions was halved, and the total number of questions asked decreased by 25%. Protocol-guided interviews yielded more details than comparison interviews. The mean number of details per prompt increased from 3 to 5 details when the Protocol was used. Even with young children, interviewers using the Protocol employed more invitations to elicit forensically relevant details. French-speaking investigators using the NICHD Protocol used open-ended prompts rather than focused questions when interviewing alleged victims. In addition, these interviewers needed fewer questions to get relevant information when using the Protocol. A French version of the NICHD Protocol is now available to police officers and social workers who investigate the alleged sexual abuse of young children in French-speaking countries. This French version allowed trained interviewers to increase the use of invitations and reduce the use of more focused and risky questions. When the number of questions was controlled, more central details and more details in total were obtained in Protocol interviews, because the average prompt elicited more detailed answers in Protocol interviews. However, learning to use the NICHD Protocol required extended training and continued feedback sessions to maintain the high quality of interviewing.

System approach to distributed sensor management

NASA Astrophysics Data System (ADS)

Mayott, Gregory; Miller, Gordon; Harrell, John; Hepp, Jared; Self, Mid

2010-04-01

Since 2003, the US Army's RDECOM CERDEC Night Vision Electronic Sensor Directorate (NVESD) has been developing a distributed Sensor Management System (SMS) that utilizes a framework which demonstrates application layer, net-centric sensor management. The core principles of the design support distributed and dynamic discovery of sensing devices and processes through a multi-layered implementation. This results in a sensor management layer that acts as a System with defined interfaces for which the characteristics, parameters, and behaviors can be described. Within the framework, the definition of a protocol is required to establish the rules for how distributed sensors should operate. The protocol defines the behaviors, capabilities, and message structures needed to operate within the functional design boundaries. The protocol definition addresses the requirements for a device (sensors or processes) to dynamically join or leave a sensor network, dynamically describe device control and data capabilities, and allow dynamic addressing of publish and subscribe functionality. The message structure is a multi-tiered definition that identifies standard, extended, and payload representations that are specifically designed to accommodate the need for standard representations of common functions, while supporting the need for feature-based functions that are typically vendor specific. The dynamic qualities of the protocol enable a User GUI application the flexibility of mapping widget-level controls to each device based on reported capabilities in real-time. The SMS approach is designed to accommodate scalability and flexibility within a defined architecture. The distributed sensor management framework and its application to a tactical sensor network will be described in this paper.

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

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

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

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

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.

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.

Effects of standard training in the use of closed-circuit televisions in visually impaired adults: design of a training protocol and a randomized controlled trial.

PubMed

Burggraaff, Marloes C; van Nispen, Ruth M A; Melis-Dankers, Bart J M; van Rens, Ger H M B

2010-03-10

Reading problems are frequently reported by visually impaired persons. A closed-circuit television (CCTV) can be helpful to maintain reading ability, however, it is difficult to learn how to use this device. In the Netherlands, an evidence-based rehabilitation program in the use of CCTVs was lacking. Therefore, a standard training protocol needed to be developed and tested in a randomized controlled trial (RCT) to provide an evidence-based training program in the use of this device. To develop a standard training program, information was collected by studying literature, observing training in the use of CCTVs, discussing the content of the training program with professionals and organizing focus and discussion groups. The effectiveness of the program was evaluated in an RCT, to obtain an evidence-based training program. Dutch patients (n = 122) were randomized into a treatment group: normal instructions from the supplier combined with training in the use of CCTVs, or into a control group: instructions from the supplier only. The effect of the training program was evaluated in terms of: change in reading ability (reading speed and reading comprehension), patients' skills to operate the CCTV, perceived (vision-related) quality of life and tasks performed in daily living. The development of the CCTV training protocol and the design of the RCT in the present study may serve as an example to obtain an evidence-based training program. The training program was adjusted to the needs and learning abilities of individual patients, however, for scientific reasons it might have been preferable to standardize the protocol further, in order to gain more comparable results. http://www.trialregister.nl, identifier: NTR1031.

Effects of standard training in the use of closed-circuit televisions in visually impaired adults: design of a training protocol and a randomized controlled trial

PubMed Central

2010-01-01

Background Reading problems are frequently reported by visually impaired persons. A closed-circuit television (CCTV) can be helpful to maintain reading ability, however, it is difficult to learn how to use this device. In the Netherlands, an evidence-based rehabilitation program in the use of CCTVs was lacking. Therefore, a standard training protocol needed to be developed and tested in a randomized controlled trial (RCT) to provide an evidence-based training program in the use of this device. Methods/Design To develop a standard training program, information was collected by studying literature, observing training in the use of CCTVs, discussing the content of the training program with professionals and organizing focus and discussion groups. The effectiveness of the program was evaluated in an RCT, to obtain an evidence-based training program. Dutch patients (n = 122) were randomized into a treatment group: normal instructions from the supplier combined with training in the use of CCTVs, or into a control group: instructions from the supplier only. The effect of the training program was evaluated in terms of: change in reading ability (reading speed and reading comprehension), patients' skills to operate the CCTV, perceived (vision-related) quality of life and tasks performed in daily living. Discussion The development of the CCTV training protocol and the design of the RCT in the present study may serve as an example to obtain an evidence-based training program. The training program was adjusted to the needs and learning abilities of individual patients, however, for scientific reasons it might have been preferable to standardize the protocol further, in order to gain more comparable results. Trial registration http://www.trialregister.nl, identifier: NTR1031 PMID:20219120

Randomized controlled trial of relaxation music to reduce heart rate in patients undergoing cardiac CT.

PubMed

Ng, Ming Yen; Karimzad, Yasser; Menezes, Ravi J; Wintersperger, Bernd J; Li, Qin; Forero, Julian; Paul, Narinder S; Nguyen, Elsie T

2016-10-01

To evaluate the heart rate lowering effect of relaxation music in patients undergoing coronary CT angiography (CCTA), pulmonary vein CT (PVCT) and coronary calcium score CT (CCS). Patients were randomised to a control group (i.e. standard of care protocol) or to a relaxation music group (ie. standard of care protocol with music). The groups were compared for heart rate, radiation dose, image quality and dose of IV metoprolol. Both groups completed State-Trait Anxiety Inventory anxiety questionnaires to assess patient experience. One hundred and ninety-seven patients were recruited (61.9 % males); mean age 56y (19-86 y); 127 CCTA, 17 PVCT, 53 CCS. No significant difference in heart rate, radiation dose, image quality, metoprolol dose and anxiety scores. 86 % of patients enjoyed the music. 90 % of patients in the music group expressed a strong preference to have music for future examinations. The patient cohort demonstrated low anxiety levels prior to CT. Relaxation music in CCTA, PVCT and CCS does not reduce heart rate or IV metoprolol use. Patients showed low levels of anxiety indicating that anxiolytics may not have a significant role in lowering heart rate. Music can be used in cardiac CT to improve patient experience. • Relaxation music does not reduce heart rate in cardiac CT • Relaxation music does not reduce beta-blocker use in cardiac CT • Relaxation music has no effect on cardiac CT image quality • Low levels of anxiety are present in patients prior to cardiac CT • Patients enjoyed the relaxation music and this results in improved patient experience.

Visual grading characteristics and ordinal regression analysis during optimisation of CT head examinations.

PubMed

Zarb, Francis; McEntee, Mark F; Rainford, Louise

2015-06-01

To evaluate visual grading characteristics (VGC) and ordinal regression analysis during head CT optimisation as a potential alternative to visual grading assessment (VGA), traditionally employed to score anatomical visualisation. Patient images (n = 66) were obtained using current and optimised imaging protocols from two CT suites: a 16-slice scanner at the national Maltese centre for trauma and a 64-slice scanner in a private centre. Local resident radiologists (n = 6) performed VGA followed by VGC and ordinal regression analysis. VGC alone indicated that optimised protocols had similar image quality as current protocols. Ordinal logistic regression analysis provided an in-depth evaluation, criterion by criterion allowing the selective implementation of the protocols. The local radiology review panel supported the implementation of optimised protocols for brain CT examinations (including trauma) in one centre, achieving radiation dose reductions ranging from 24 % to 36 %. In the second centre a 29 % reduction in radiation dose was achieved for follow-up cases. The combined use of VGC and ordinal logistic regression analysis led to clinical decisions being taken on the implementation of the optimised protocols. This improved method of image quality analysis provided the evidence to support imaging protocol optimisation, resulting in significant radiation dose savings. • There is need for scientifically based image quality evaluation during CT optimisation. • VGC and ordinal regression analysis in combination led to better informed clinical decisions. • VGC and ordinal regression analysis led to dose reductions without compromising diagnostic efficacy.

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

GMP-based CD133+ cells isolation maintains progenitor angiogenic properties and enhances standardization in cardiovascular cell therapy

PubMed Central

Gaipa, Giuseppe; Tilenni, Manuela; Straino, Stefania; Burba, Ilaria; Zaccagnini, Germana; Belotti, Daniela; Biagi, Ettore; Valentini, Marco; Perseghin, Paolo; Parma, Matteo; Campli, Cristiana Di; Biondi, Andrea; Capogrossi, Maurizio C; Pompilio, Giulio; Pesce, Maurizio

2010-01-01

Abstract The aim of the present study was to develop and validate a good manufacturing practice (GMP) compliant procedure for the preparation of bone marrow (BM) derived CD133+ cells for cardiovascular repair. Starting from available laboratory protocols to purify CD133+ cells from human cord blood, we implemented these procedures in a GMP facility and applied quality control conditions defining purity, microbiological safety and vitality of CD133+ cells. Validation of CD133+ cells isolation and release process were performed according to a two-step experimental program comprising release quality checking (step 1) as well as ‘proofs of principle’ of their phenotypic integrity and biological function (step 2). This testing program was accomplished using in vitro culture assays and in vivo testing in an immunosuppressed mouse model of hindlimb ischemia. These criteria and procedures were successfully applied to GMP production of CD133+ cells from the BM for an ongoing clinical trial of autologous stem cells administration into patients with ischemic cardiomyopathy. Our results show that GMP implementation of currently available protocols for CD133+ cells selection is feasible and reproducible, and enables the production of cells having a full biological potential according to the most recent quality requirements by European Regulatory Agencies. PMID:19627397

Measurement Challenges for Carbon Nanotube Material

NASA Technical Reports Server (NTRS)

Sosa, Edward; Arepalli, Sivaram; Nikolaev, Pasha; Gorelik, Olga; Yowell, Leonard

2006-01-01

The advances in large scale applications of carbon nanotubes demand a reliable supply of raw and processed materials. It is imperative to have a consistent quality control of these nanomaterials to distinguish material inconsistency from the modifications induced by processing of nanotubes for any application. NASA Johnson Space Center realized this need five years back and started a program to standardize the characterization methods. The JSC team conducted two workshops (2003 and 2005) in collaboration with NIST focusing on purity and dispersion measurement issues of carbon nanotubes [1]. In 2004, the NASA-JSC protocol was developed by combining analytical techniques of SEM, TEM, UV-VIS-NIR absorption, Raman, and TGA [2]. This protocol is routinely used by several researchers across the world as a first step in characterizing raw and purified carbon nanotubes. A suggested practice guide consisting of detailed chapters on TGA, Raman, electron microscopy and NIR absorption is in the final stages and is undergoing revisions with input from the nanotube community [3]. The possible addition of other techniques such as XPS, and ICP to the existing protocol will be presented. Recent activities at ANSI and ISO towards implementing these protocols as nanotube characterization standards will be discussed.

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 alone for persistent hip pain. This study has the potential to guide clinical practice toward innovative modes of psychosocial health care provision. PMID:26023213

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 modes of psychosocial health care provision. © 2015 American Physical Therapy Association.

The Cost-Effectiveness of an Intensive Treatment Protocol for Severe Dyslexia in Children

ERIC Educational Resources Information Center

Hakkaart-van Roijen, Leona; Goettsch, Wim G.; Ekkebus, Michel; Gerretsen, Patty; Stolk, Elly A.

2011-01-01

Studies of interventions for dyslexia have focused entirely on outcomes related to literacy. In this study, we considered a broader picture assessing improved quality of life compared with costs. A model served as a tool to compare costs and effects of treatment according to a new protocol and care as usual. Quality of life was measured and valued…

Development of the supply chain oriented quality assurance system for aerospace manufacturing SMEs and its implementation perspectives

NASA Astrophysics Data System (ADS)

Hussein, Abdullahi; Cheng, Kai

2016-10-01

Aerospace manufacturing SMEs are continuously facing the challenge on managing their supply chain and complying with the aerospace manufacturing quality standard requirement due to their lack of resources and the nature of business. In this paper, the ERP system based approach is presented to quality control and assurance work in light of seamless integration of in-process production data and information internally and therefore managing suppliers more effectively and efficiently. The Aerospace Manufacturing Quality Assurance Standard (BS/EN9100) is one of the most recognised and essential protocols for developing the industry-operated-and-driven quality assurance systems. The research investigates using the ERP based system as an enabler to implement BS/EN9100 quality management system at manufacturing SMEs and the associated implementation and application perspectives. An application case study on a manufacturing SME is presented by using the SAP based implementation, which helps further evaluate and validate the approach and application system development.

Whole-body computed tomography in trauma patients: optimization of the patient scanning position significantly shortens examination time while maintaining diagnostic image quality.

PubMed

Hickethier, Tilman; Mammadov, Kamal; Baeßler, Bettina; Lichtenstein, Thorsten; Hinkelbein, Jochen; Smith, Lucy; Plum, Patrick Sven; Chon, Seung-Hun; Maintz, David; Chang, De-Hua

2018-01-01

The study was conducted to compare examination time and artifact vulnerability of whole-body computed tomographies (wbCTs) for trauma patients using conventional or optimized patient positioning. Examination time was measured in 100 patients scanned with conventional protocol (Group A: arms positioned alongside the body for head and neck imaging and over the head for trunk imaging) and 100 patients scanned with optimized protocol (Group B: arms flexed on a chest pillow without repositioning). Additionally, influence of two different scanning protocols on image quality in the most relevant body regions was assessed by two blinded readers. Total wbCT duration was about 35% or 3:46 min shorter in B than in A. Artifacts in aorta (27 vs 6%), liver (40 vs 8%) and spleen (27 vs 5%) occurred significantly more often in B than in A. No incident of non-diagnostic image quality was reported, and no significant differences for lungs and spine were found. An optimized wbCT positioning protocol for trauma patients allows a significant reduction of examination time while still maintaining diagnostic image quality.

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.

Effects of modifying the World Health Organization standard operating procedures for malaria microscopy to improve surveillance in resource poor settings.

PubMed

Fernando, Sumadhya D; Ihalamulla, Ratnasiri L; Wickremasinghe, Renu; de Silva, Nipun L; Thilakarathne, Janani H; Wijeyaratne, Pandu; Premaratne, Risintha G

2014-03-15

Individuals with fever are screened for malaria in specially-established malaria diagnostic laboratories set up in rural hospitals in the Northern and Eastern Provinces of Sri Lanka. Large numbers of blood smears negative for malaria parasites are being screened daily. Good quality smears are essential to maintain a high diagnostic competency among the technical staff. The modifications made to the World Health Organization (WHO) standard operating procedures to improve the quality of smears have been studied. A blinded, controlled, interventional study was conducted in 22 intervention and 21 control malaria diagnostic laboratories. Changes were made to the WHO standard operating procedure protocols to prepare, stain and examine blood smears for malaria parasite detection which were implemented in intervention laboratories. These included wipe-cleaning slides, preparing both thick and thin smears on the same slide, reversing the order of collecting blood for thick and thin smears, dry fixing thick smear for 20-25 minutes under table lamp, polishing the edge of spreader slide with sand paper and fixing the thin smear with methanol if not stained within four hours. Parameters with respect to quality of the smear as per WHO criteria were studied using randomly selected slides, and time taken for the report to be issued was recorded in both groups before and after the intervention. There were no significant differences observed in the parameters studied at baseline between the two groups or pre and post intervention in the control group. In the intervention group streak formation in thin smears was reduced from 29.4% to 5.0%. The average fixing time of thick smears was reduced from 2.4 hours to 20 minutes. Inappropriate thickness of thick smears reduced from 18.3% to 1.5%. Overall quality of thick smears and thin smears increased from 76.1% to 98.0% and 81.7% to 87.0%, respectively. The quality of slides bearing both thick and thin smears increased from 60.0% to 87.0%. New protocols with amendments to the WHO standard technical procedures ensure that good quality blood smears are prepared rapidly to diagnose malaria and the time required to issue the reports was reduced.

Interoceptive Accuracy in Youth with Tic Disorders: Exploring Links with Premonitory Urge, Anxiety and Quality of Life.

PubMed

Pile, Victoria; Lau, Jennifer Y F; Topor, Marta; Hedderly, Tammy; Robinson, Sally

2018-05-18

Aberrant interoceptive accuracy could contribute to the co-occurrence of anxiety and premonitory urge in chronic tic disorders (CTD). If it can be manipulated through intervention, it would offer a transdiagnostic treatment target for tics and anxiety. Interoceptive accuracy was first assessed consistent with previous protocols and then re-assessed following an instruction attempting to experimentally enhance awareness. The CTD group demonstrated lower interoceptive accuracy than controls but, importantly, this group difference was no longer significant following instruction. In the CTD group, better interoceptive accuracy was associated with higher anxiety and lower quality of life, but not with premonitory urge. Aberrant interoceptive accuracy may represent an underlying trait in CTD that can be manipulated, and relates to anxiety and quality of life.

[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)

Exacerbations in patients with chronic obstructive pulmonary disease receiving physical therapy: a cohort-nested randomised controlled trial

PubMed Central

2014-01-01

Background Physical exercise training aims at reducing disease-specific impairments and improving quality of life in patients with chronic obstructive pulmonary disease (COPD). COPD exacerbations in particular negatively impact COPD progression. Physical therapy intervention seems indicated to influence exacerbations and their consequences. However, information on the effect of physical therapy on exacerbation occurrence is scarce. This study aims to investigate the potential of a protocol-directed physical therapy programme as a means to prevent or postpone exacerbations, to shorten the duration or to decrease the severity of exacerbations in patients with COPD who have recently experienced an exacerbation. Besides, this study focuses on the effect of protocol-directed physical therapy on health status and quality of life and on cost-effectiveness and cost-utility in patients with COPD who have recently experienced an exacerbation. Methods/Design A prospective cohort of 300 COPD patients in all GOLD stages will be constructed. Patients will receive usual multidisciplinary COPD care including guideline-directed physical therapy. Patients in this cohort who have GOLD stage 2 to 4 (post-bronchodilator FEV1/FVC < 0.7 and FEV1 < 80% of predicted), who receive reimbursement by health insurance companies for physical therapy (post-bronchodilator Tiffeneau-index < 0.6) and who experience a COPD exacerbation will be asked within 56 days to participate in a cohort-nested prospective randomised controlled trial (RCT). In this RCT, the intervention group will receive a strict physical therapy programme for patients with COPD. This protocol-directed physical therapy (pdPT) will be compared to a control group that will receive sham-treatment, meaning no or very low-intensity exercise training (ST). An economic evaluation will be embedded in the RCT. Anthropometric measurements, comorbidities, smoking, functional exercise capacity, peripheral muscle strength, physical activity level, health related quality of life, patients’ perceived benefit, physical therapy compliance, motivation level, level of effective mucus clearance, exacerbation symptoms and health care contacts due to COPD will be recorded. Follow-up measurements are scheduled at 3 and 6 weeks, 3, 6, 12 and 24 months after inclusion. Discussion Ways to minimise potential problems regarding the execution of this study will be discussed. Trial registration The Netherlands National Trial Register NTR1972. PMID:24767519

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. Pulmonary Resection and Intensive Rehabilitation study (PuReAIR) will contribute significantly in investigating the effects of perioperative rehabilitation on exercise capacity, symptoms, lung function and long-term outcomes in surgically treated lung cancer patients. This study protocol will facilitate interpretation of future results and wide application of evidence-based practice. ClinicalTrials.gov Registry n. NCT02405273 [31.03.2015].

Air pollution effects on food quality. 2nd annual progress report

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

Pell, E.J.

1979-02-01

Progress is reported in studies to determine the effect of acute, toxic exposures of ozone to alfalfa, potato, and soybean plants. The objective has been to correlate the foliar response with alterations in quality of the edible portion of the plant viz. the leaf, tuber and seed of alfalfa, potato and soybean, respectively. In 1977 we (1) modified our fumigation facilities, (2) developed protocol for studies with alfalfa and potato, and (3) conducted studies on flavonoid status of alfalfa and a series of parameters of potato tubers. In 1978 we (1) conducted more indepth studies with alfalfa, (2) repeated themore » potato study, (3) began to develop protocol for measuring additional parameters of alfalfa and potato quality, and (4) developed protocol for cultivating and exposing soybean plants.« less

A multicentre randomised controlled trial of levetiracetam versus phenytoin for convulsive status epilepticus in children (protocol): Convulsive Status Epilepticus Paediatric Trial (ConSEPT) - a PREDICT study.

PubMed

Dalziel, Stuart R; Furyk, Jeremy; Bonisch, Megan; Oakley, Ed; Borland, Meredith; Neutze, Jocelyn; Donath, Susan; Sharpe, Cynthia; Harvey, Simon; Davidson, Andrew; Craig, Simon; Phillips, Natalie; George, Shane; Rao, Arjun; Cheng, Nicholas; Zhang, Michael; Sinn, Kam; Kochar, Amit; Brabyn, Christine; Babl, Franz E

2017-06-22

Convulsive status epilepticus (CSE) is the most common life-threatening childhood neurological emergency. Despite this, there is a lack of high quality evidence supporting medication use after first line benzodiazepines, with current treatment protocols based solely on non-experimental evidence and expert opinion. The current standard of care, phenytoin, is only 60% effective, and associated with considerable adverse effects. A newer anti-convulsant, levetiracetam, can be given faster, is potentially more efficacious, with a more tolerable side effect profile. The primary aim of the study presented in this protocol is to determine whether intravenous (IV) levetiracetam or IV phenytoin is the better second line treatment for the emergency management of CSE in children. 200 children aged between 3 months and 16 years presenting to 13 emergency departments in Australia and New Zealand with CSE, that has failed to stop with first line benzodiazepines, will be enrolled into this multicentre open randomised controlled trial. Participants will be randomised to 40 mg/kg IV levetiracetam infusion over 5 min or 20 mg/kg IV phenytoin infusion over 20 min. The primary outcome for the study is clinical cessation of seizure activity five minutes following the completion of the infusion of the study medication. Blinded confirmation of the primary outcome will occur with the primary outcome assessment being video recorded and assessed by a primary outcome assessment team blinded to treatment allocation. Secondary outcomes include: Clinical cessation of seizure activity at two hours; Time to clinical seizure cessation; Need for rapid sequence induction; Intensive care unit (ICU) admission; Serious adverse events; Length of Hospital/ICU stay; Health care costs; Seizure status/death at one-month post discharge. This paper presents the background, rationale, and design for a randomised controlled trial comparing levetiracetam to phenytoin in children presenting with CSE in whom benzodiazepines have failed. This study will provide the first high quality evidence for management of paediatric CSE post first-line benzodiazepines. Prospectively registered with the Australian and New Zealand Clinical Trial Registry (ANZCTR): ACTRN12615000129583 (11/2/2015). UTN U1111-1144-5272. ConSEPT protocol version 4 (12/12/2014).

SU-F-R-11: Designing Quality and Safety Informatics Through Implementation of a CT Radiation Dose Monitoring Program

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

Wilson, JM; Samei, E; Departments of Physics, Electrical and Computer Engineering, and Biomedical Engineering, and Medical Physics Graduate Program, Duke University, Durham, NC

2016-06-15

Purpose: Recent legislative and accreditation requirements have driven rapid development and implementation of CT radiation dose monitoring solutions. Institutions must determine how to improve quality, safety, and consistency of their clinical performance. The purpose of this work was to design a strategy and meaningful characterization of results from an in-house, clinically-deployed dose monitoring solution. Methods: A dose monitoring platform was designed by our imaging physics group that focused on extracting protocol parameters, dose metrics, and patient demographics and size. Compared to most commercial solutions, which focus on individual exam alerts and global thresholds, the program sought to characterize overall consistencymore » and targeted thresholds based on eight analytic interrogations. Those were based on explicit questions related to protocol application, national benchmarks, protocol and size-specific dose targets, operational consistency, outliers, temporal trends, intra-system variability, and consistent use of electronic protocols. Using historical data since the start of 2013, 95% and 99% intervals were used to establish yellow and amber parameterized dose alert thresholds, respectively, as a function of protocol, scanner, and size. Results: Quarterly reports have been generated for three hospitals for 3 quarters of 2015 totaling 27880, 28502, 30631 exams, respectively. Four adult and two pediatric protocols were higher than external institutional benchmarks. Four protocol dose levels were being inconsistently applied as a function of patient size. For the three hospitals, the minimum and maximum amber outlier percentages were [1.53%,2.28%], [0.76%,1.8%], [0.94%,1.17%], respectively. Compared with the electronic protocols, 10 protocols were found to be used with some inconsistency. Conclusion: Dose monitoring can satisfy requirements with global alert thresholds and patient dose records, but the real value is in optimizing patient-specific protocols, balancing image quality trade-offs that dose-reduction strategies promise, and improving the performance and consistency of a clinical operation. Data plots that capture patient demographics and scanner performance demonstrate that value.« less

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 model is also a must to adapt with the diabetic cohort. Copyright © 2018 Elsevier B.V. All rights reserved.

Effect of pay for performance to improve quality of maternal and child care in low- and middle-income countries: a systematic review.

PubMed

Das, Ashis; Gopalan, Saji S; Chandramohan, Daniel

2016-04-14

Pay for Performance (P4P) mechanisms to health facilities and providers are currently being tested in several low- and middle-income countries (LMIC) to improve maternal and child health (MCH). This paper reviews the existing evidence on the effect of P4P program on quality of MCH care in LMICs. A systematic review of literature was conducted according to a registered protocol. MEDLINE, Web of Science, and Embase were searched using the key words maternal care, quality of care, ante natal care, emergency obstetric and neonatal care (EmONC) and child care. Of 4535 records retrieved, only eight papers met the inclusion criteria. Primary outcome of interest was quality of MCH disaggregated into structural quality, process quality and outcomes. Risk of bias across studies was assessed through a customized quality checklist. There were four controlled before after intervention studies, three cluster randomized controlled trials and one case control with post-intervention comparison of P4P programs for MCH care in Burundi, Democratic Republic of Congo, Egypt, the Philippines, and Rwanda. There is some evidence of positive effect of P4P only on process quality of MCH. The effect of P4P on delivery, EmONC, post natal care and under-five child care were not evaluated in these studies. There is weak evidence for P4P's positive effect on maternal and neonatal health outcomes and out-of-pocket expenses. P4P program had a few negative effects on structural quality. P4P is effective to improve process quality of ante natal care. However, further research is needed to understand P4P's impact on MCH and their causal pathways in LMICs. PROSPERO registration number CRD42014013077 .

Cross-layer protocols optimized for real-time multimedia services in energy-constrained mobile ad hoc networks

NASA Astrophysics Data System (ADS)

Hortos, William S.

2003-07-01

Mobile ad hoc networking (MANET) supports self-organizing, mobile infrastructures and enables an autonomous network of mobile nodes that can operate without a wired backbone. Ad hoc networks are characterized by multihop, wireless connectivity via packet radios and by the need for efficient dynamic protocols. All routers are mobile and can establish connectivity with other nodes only when they are within transmission range. Importantly, ad hoc wireless nodes are resource-constrained, having limited processing, memory, and battery capacity. Delivery of high quality-ofservice (QoS), real-time multimedia services from Internet-based applications over a MANET is a challenge not yet achieved by proposed Internet Engineering Task Force (IETF) ad hoc network protocols in terms of standard performance metrics such as end-to-end throughput, packet error rate, and delay. In the distributed operations of route discovery and maintenance, strong interaction occurs across MANET protocol layers, in particular, the physical, media access control (MAC), network, and application layers. The QoS requirements are specified for the service classes by the application layer. The cross-layer design must also satisfy the battery-limited energy constraints, by minimizing the distributed power consumption at the nodes and of selected routes. Interactions across the layers are modeled in terms of the set of concatenated design parameters including associated energy costs. Functional dependencies of the QoS metrics are described in terms of the concatenated control parameters. New cross-layer designs are sought that optimize layer interdependencies to achieve the "best" QoS available in an energy-constrained, time-varying network. The protocol design, based on a reactive MANET protocol, adapts the provisioned QoS to dynamic network conditions and residual energy capacities. The cross-layer optimization is based on stochastic dynamic programming conditions derived from time-dependent models of MANET packet flows. Regulation of network behavior is modeled by the optimal control of the conditional rates of multivariate point processes (MVPPs); these rates depend on the concatenated control parameters through a change of probability measure. The MVPP models capture behavior of many service applications, e.g., voice, video and the self-similar behavior of Internet data sessions. Performance verification of the cross-layer protocols, derived from the dynamic programming conditions, can be achieved by embedding the conditions in a reactive routing protocol for MANETs, in a simulation environment, such as the wireless extension of ns-2. A canonical MANET scenario consists of a distributed collection of battery-powered laptops or hand-held terminals, capable of hosting multimedia applications. Simulation details and performance tradeoffs, not presented, remain for a sequel to the paper.

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.

Variability among electronic cigarettes in the pressure drop, airflow rate, and aerosol production.

PubMed

Williams, Monique; Talbot, Prue

2011-12-01

This study investigated the performance of electronic cigarettes (e-cigarettes), compared different models within a brand, compared identical copies of the same model within a brand, and examined performance using different protocols. Airflow rate required to generate aerosol, pressure drop across e-cigarettes, and aerosol density were examined using three different protocols. First 10 puff protocol: The airflow rate required to produce aerosol and aerosol density varied among brands, while pressure drop varied among brands and between the same model within a brand. Total air hole area correlated with pressure drop for some brands. Smoke-out protocol: E-cigarettes within a brand generally performed similarly when puffed to exhaustion; however, there was considerable variation between brands in pressure drop, airflow rate required to produce aerosol, and the total number of puffs produced. With this protocol, aerosol density varied significantly between puffs and gradually declined. CONSECUTIVE TRIAL PROTOCOL: Two copies of one model were subjected to 11 puffs in three consecutive trials with breaks between trials. One copy performed similarly in each trial, while the second copy of the same model produced little aerosol during the third trial. The different performance properties of the two units were attributed to the atomizers. There was significant variability between and within brands in the airflow rate required to produce aerosol, pressure drop, length of time cartridges lasted, and production of aerosol. Variation in performance properties within brands suggests a need for better quality control during e-cigarette manufacture.

Does prolonged pituitary down-regulation with gonadotropin-releasing hormone agonist improve the live-birth rate in in vitro fertilization treatment?

PubMed

Ren, Jianzhi; Sha, Aiguo; Han, Dongmei; Li, Ping; Geng, Jie; Ma, Chaihui

2014-07-01

To evaluate the effects of a prolonged duration of gonadotropin-releasing hormone agonist (GnRH-a) in pituitary down-regulation for controlled ovarian hyperstimulation (COH) on the live-birth rate in nonendometriotic women undergoing in vitro fertilization and embryo transfer (IVF-ET). Retrospective cohort study. University-affiliated hospital. Normogonadotropic women undergoing IVF. Three hundred seventy-eight patients receiving a prolonged pituitary down-regulation with GnRH-a before ovarian stimulation and 422 patients receiving a GnRH-a long protocol. Live-birth rate per fresh ET. In comparison with the long protocol, the prolonged down-regulation protocol required a higher total dose of gonadotropins. A lower serum luteinizing hormone (LH) level on the starting day of gonadotropin and the day of human chorionic gonadotropin (hCG) and a fewer number of oocytes and embryos were observed in the prolonged down-regulation protocol. However, the duration of stimulation and number of high-quality embryos were comparable between the two groups. A statistically significantly higher implantation rate (50.27% vs. 39.69%), clinical pregnancy rate (64.02% vs. 56.87%) and live-birth rate per fresh transfer cycle (55.56% vs. 45.73%) were observed in the prolonged protocol. Prolonged down-regulation in a GnRH-a protocol might increase the live-birth rates in normogonadotropic women. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

The Controlled Cortical Impact Model of Experimental Brain Trauma: Overview, Research Applications, and Protocol

PubMed Central

Osier, Nicole; Dixon, C. Edward

2017-01-01

Controlled cortical impact (CCI) is a commonly used and highly regarded model of brain trauma that uses a pneumatically or electromagnetically controlled piston to induce reproducible and well-controlled injury. The CCI model was originally used in ferrets and it has since been scaled for use in many other species. This chapter will describe the historical development of the CCI model, compare and contrast the pneumatic and electromagnetic models, and summarize key short- and long-term consequences of TBI that have been gleaned using this model. In accordance with the recent efforts to promote high-quality evidence through the reporting of common data elements (CDEs), relevant study details—that should be reported in CCI studies—will be noted. PMID:27604719

The Controlled Cortical Impact Model of Experimental Brain Trauma: Overview, Research Applications, and Protocol.

PubMed

Osier, Nicole; Dixon, C Edward

2016-01-01

Controlled cortical impact (CCI) is a commonly used and highly regarded model of brain trauma that uses a pneumatically or electromagnetically controlled piston to induce reproducible and well-controlled injury. The CCI model was originally used in ferrets and it has since been scaled for use in many other species. This chapter will describe the historical development of the CCI model, compare and contrast the pneumatic and electromagnetic models, and summarize key short- and long-term consequences of TBI that have been gleaned using this model. In accordance with the recent efforts to promote high-quality evidence through the reporting of common data elements (CDEs), relevant study details-that should be reported in CCI studies-will be noted.

Considerations in establishing a post-mortem brain and tissue bank for the study of myalgic encephalomyelitis/chronic fatigue syndrome: a proposed protocol

PubMed Central

2014-01-01

Background Our aim, having previously investigated through a qualitative study involving extensive discussions with experts and patients the issues involved in establishing and maintaining a disease specific brain and tissue bank for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), was to develop a protocol for a UK ME/CFS repository of high quality human tissue from well characterised subjects with ME/CFS and controls suitable for a broad range of research applications. This would involve a specific donor program coupled with rapid tissue collection and processing, supplemented by comprehensive prospectively collected clinical, laboratory and self-assessment data from cases and controls. Findings We reviewed the operations of existing tissue banks from published literature and from their internal protocols and standard operating procedures (SOPs). On this basis, we developed the protocol presented here, which was designed to meet high technical and ethical standards and legal requirements and was based on recommendations of the MRC UK Brain Banks Network. The facility would be most efficient and cost-effective if incorporated into an existing tissue bank. Tissue collection would be rapid and follow robust protocols to ensure preservation sufficient for a wide range of research uses. A central tissue bank would have resources both for wide-scale donor recruitment and rapid response to donor death for prompt harvesting and processing of tissue. Conclusion An ME/CFS brain and tissue bank could be established using this protocol. Success would depend on careful consideration of logistic, technical, legal and ethical issues, continuous consultation with patients and the donor population, and a sustainable model of funding ideally involving research councils, health services, and patient charities. This initiative could revolutionise the understanding of this still poorly-understood disease and enhance development of diagnostic biomarkers and treatments. PMID:24938650

Delayed luminescence: an experimental protocol for Chinese herbal medicines.

PubMed

Sun, Mengmeng; van Wijk, Roeland; van Wijk, Eduard; Wang, Mei; van Wietmarschen, Herman; Hankemeier, Thomas; van der Greef, Jan

2016-09-01

In Chinese medicine, raw herbal materials are used in processed and unprocessed forms aiming to meet the different requirements of clinical practice. To assure the chemical quality and therapeutic properties of the herbs, fast and integrated systematic assays are required. So far, such assays have not been established. Delayed luminescence (DL) refers to a decaying long-term ultraweak photon emission after exposure to light. Its decay kinetics under certain conditions may be a sensitive indicator reflecting the internal structural and chemical/physiological state of a biological system. DL measurements have been used in many applications for quality control. However, relatively little research has been reported on dried plant material such as Chinese herbs. The objective of the present study is to establish a protocol for direct and rapid DL measurements of dried Chinese herbal materials, including the determination of the dependence on: (a) the optimal excitation time utilizing a white light source; (b) the optimal size of the grinded herbal particle; and (c) the humidity conditions before and during measurement. Results indicate that stable and reproducible curves of DL photon emission depend mainly on the water content of herbal materials. To investigate the application of the established DL measurement protocol, non-processed and processed Aconitum (Aconitum carmichaelii Debx.), wild and cultivated rhubarb (Rheum palmatum L.) and ginseng (Panax ginseng C.A.Mey) of different ages were measured using DL. The results suggest that DL technology is a potential tool for assessment of dried Chinese herb qualities. The results warrant a further exploration of this technique in relation to therapeutic properties of the herbs. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Comparative study of 2 oral care protocols in intensive care units.

PubMed

Ory, Jérôme; Raybaud, Evelyne; Chabanne, Russell; Cosserant, Bernard; Faure, Jean Sébastien; Guérin, Renaud; Calvet, Laure; Pereira, Bruno; Mourgues, Charline; Guelon, Dominique; Traore, Ousmane

2017-03-01

The quality of oral care is important in limiting the emergence of ventilator-associated pneumonia (VAP) in intubated patients. Our main objective was to measure the quality improvement in oral care following the implementation of a new oral care protocol. We also monitored VAP rates. This was a cohort study of patients in 5 adult ICUs covering different specialties. During period 1, caregivers used a foam stick for oral care and during period 2 a stick and tooth brushing with aspiration. Oral chlorhexidine was used during both periods. The caregivers rated improvement in oral health on the basis of 4 criteria (tongue, mucous membranes, gingivae, and teeth). Caregiver satisfaction was also assessed. The incidence of VAP was monitored. A total of 2,030 intubated patients admitted to intensive care units benefited from oral care. The patient populations during the 2 periods were similar with regard to demographic data and VAP potential risk factors. Oral health was significantly better from the third day of oral care in period 2 onward (period 1, 6.4 ± 2.1; period 2, 5.6 ± 1.8; P = .043). Caregivers found the period 2 protocol easier to implement and more effective. VAP rates decreased significantly between the 2 periods (period 1, 12.8%; period 2, 8.5%; P = .002). Our study showed that the implementation of a simple strategy improved the quality of oral care of patients in intensive care units, and decreased VAP rates. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

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 quality during CT protocol optimization, especially when investigating the effects of new technologies.« less

Energy Efficient Link Aware Routing with Power Control in Wireless Ad Hoc Networks.

PubMed

Katiravan, Jeevaa; Sylvia, D; Rao, D Srinivasa

2015-01-01

In wireless ad hoc networks, the traditional routing protocols make the route selection based on minimum distance between the nodes and the minimum number of hop counts. Most of the routing decisions do not consider the condition of the network such as link quality and residual energy of the nodes. Also, when a link failure occurs, a route discovery mechanism is initiated which incurs high routing overhead. If the broadcast nature and the spatial diversity of the wireless communication are utilized efficiently it becomes possible to achieve improvement in the performance of the wireless networks. In contrast to the traditional routing scheme which makes use of a predetermined route for packet transmission, such an opportunistic routing scheme defines a predefined forwarding candidate list formed by using single network metrics. In this paper, a protocol is proposed which uses multiple metrics such as residual energy and link quality for route selection and also includes a monitoring mechanism which initiates a route discovery for a poor link, thereby reducing the overhead involved and improving the throughput of the network while maintaining network connectivity. Power control is also implemented not only to save energy but also to improve the network performance. Using simulations, we show the performance improvement attained in the network in terms of packet delivery ratio, routing overhead, and residual energy of the network.

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.

The efficacy of the addition of the Pilates method over a minimal intervention in the treatment of chronic nonspecific low back pain: a study protocol of a randomized controlled trial☆

PubMed Central

Miyamoto, Gisela C.; Costa, Leonardo O.P.; Galvanin, Thalissa; Cabral, Cristina M.N.

2011-01-01

Objective There is little high-quality evidence on the efficacy of the Pilates-based exercises for the treatment of chronic nonspecific low back pain. Therefore, the objective of this paper is to present a study protocol to investigate the efficacy of adding Pilates-based exercises to a minimum intervention in patients with chronic non-specific low back pain. Methods This randomized controlled trial will recruit 86 patients of both sexes, aged between 18 and 60 years, with chronic non-specific low back pain. The participants will be randomly allocated into 2 treatment groups: the Booklet Group, which will receive a booklet with postural orientations, and the Pilates Group, which will receive the same booklet in addition to a Pilates-based exercises program. The general and specific functional capacities of the patient, kinesiophobia, pain intensity, and the global perceived effect will be evaluated by a blinded assessor before randomization and at 6 weeks and 6 months after randomization. In addition, the expectations of the participants and their confidence in the treatment will be evaluated before the randomization and after the first treatment session, respectively. Conclusions It is hoped that the results of this study will provide high-quality evidence on the usefulness of Pilates-based exercises in the treatment of chronic non-specific low back pain. PMID:22654682

The Plasma-Lyte 148 v Saline (PLUS) study protocol: a multicentre, randomised controlled trial of the effect of intensive care fluid therapy on mortality.

PubMed

Hammond, Naomi E; Bellomo, Rinaldo; Gallagher, Martin; Gattas, David; Glass, Parisa; Mackle, Diane; Micallef, Sharon; Myburgh, John; Saxena, Manoj; Taylor, Colman; Young, Paul; Finfer, Simon

2017-09-01

0.9% sodium chloride (saline) is the most commonly administered resuscitation fluid on a global basis but emerging evidence suggests that its high chloride content may have important adverse effects. To describe the study protocol for the Plasma- Lyte 148 v Saline study, which will test the hypothesis that in critically ill adult patients the use of Plasma-Lyte 148 (a buffered crystalloid solution) for fluid therapy results in different 90-day all-cause mortality when compared with saline. We will conduct this multicentre, blinded, randomised controlled trial in approximately 50 intensive care units in Australia and New Zealand. We will randomly assign 8800 patients to either Plasma-Lyte 148 or saline for all resuscitation fluid, maintenance fluid and compatible drug dilution therapy while in the ICU for up to 90 days after randomisation. The primary outcome is 90-day all-cause mortality; secondary outcomes include mean and peak creatinine concentration, incidence of renal replacement therapy, incidence and duration of vasoactive drug treatment, duration of mechanical ventilation, ICU and hospital length of stay, and quality of life and health services use at 6 months. The PLUS study will provide high-quality data on the comparative safety and efficacy of Plasma-Lyte 148 compared with saline for resuscitation and compatible crystalloid fluid therapy in critically ill adult patients.

Energy Efficient Link Aware Routing with Power Control in Wireless Ad Hoc Networks

PubMed Central

Katiravan, Jeevaa; Sylvia, D.; Rao, D. Srinivasa

2015-01-01

In wireless ad hoc networks, the traditional routing protocols make the route selection based on minimum distance between the nodes and the minimum number of hop counts. Most of the routing decisions do not consider the condition of the network such as link quality and residual energy of the nodes. Also, when a link failure occurs, a route discovery mechanism is initiated which incurs high routing overhead. If the broadcast nature and the spatial diversity of the wireless communication are utilized efficiently it becomes possible to achieve improvement in the performance of the wireless networks. In contrast to the traditional routing scheme which makes use of a predetermined route for packet transmission, such an opportunistic routing scheme defines a predefined forwarding candidate list formed by using single network metrics. In this paper, a protocol is proposed which uses multiple metrics such as residual energy and link quality for route selection and also includes a monitoring mechanism which initiates a route discovery for a poor link, thereby reducing the overhead involved and improving the throughput of the network while maintaining network connectivity. Power control is also implemented not only to save energy but also to improve the network performance. Using simulations, we show the performance improvement attained in the network in terms of packet delivery ratio, routing overhead, and residual energy of the network. PMID:26167529

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.

[Adaptation of the (18)FDG module for the preparation of a sodium fluoride [(18)F] injection solution in agreement with the United States (USP 32) and European Pharmacopeia (PhEur 6)].

PubMed

Martínez, T; Cordero, B; Medín, S; Sánchez Salmón, A

2011-01-01

To establish an automated procedure for the preparation of sodium fluoride (18)F injection using the resources available in our laboratory for the preparation of (18)FDG and to analyze the repercussion of the conditioning column of the fluoride ion entrapment on the characteristics of the final product. The sequence of an (18)FDG synthesis module prepared so that it traps the fluoride ion from the cyclotron in ion-exchange resin diluted with 0.9% sodium chloride. The final solution was dosified and sterilized in a final vial in an automatized dispensing module. Three different column conditioning protocols within the process were tested. Quality controls were run according to USP 32 and EurPh 6, adding control of ethanol levels of residual solvent and quality controls of the solution at 8 h post-preparation. Activation of the resin cartridges with ethanol and water was the chosen procedure, with fluoride ion trapping > 95% and pH around 7. Ethanol levels were < 5.000 ppm. Quality controls at 8 h indicated that the solution was in compliance with the USP 32 and EurPh 6 specifications. This is an easy, low-cost, reliable automated method for sodium fluoride preparation in PET facilities with existing equipment for (18)FDG synthesis and quality control. Copyright © 2010 Elsevier España, S.L. y SEMNIM. All rights reserved.

A Structured Forensic Interview Protocol Improves the Quality and Informativeness of Investigative Interviews with Children: A Review of Research Using the NICHD Investigative Interview Protocol

ERIC Educational Resources Information Center

Lamb, Michael; Orbach, Yael; Hershkowitz, Irit; Esplin, Phillip W.; Horowitz, Dvora

2007-01-01

Objective: To show how the results of research on children's memory, communicative skills, social knowledge, and social tendencies can be translated into guidelines that improve the quality of forensic interviews of children. Method: We review studies designed to evaluate children's capacities as witnesses, explain the development of the…

Race to the Top--Early Learning Challenge (RTT-ELC): Descriptive Study of Tiered Quality Rating and Improvement Systems (TQRIS). Master Data Collection Protocol

ERIC Educational Resources Information Center

Mathematica Policy Research, Inc., 2015

2015-01-01

This master data collection protocol describes the data that Mathematica collected for the Race to the Top-Early Learning Challenge Study of Tiered Quality Rating and Improvement Systems. This study was conducted for the Department of Education's Institute of Education Sciences. The data were collected from reviews of applications, documents, and…

Optimal molecular profiling of tissue and tissue components: defining the best processing and microdissection methods for biomedical applications.

PubMed

Bova, G Steven; Eltoum, Isam A; Kiernan, John A; Siegal, Gene P; Frost, Andra R; Best, Carolyn J M; Gillespie, John W; Emmert-Buck, Michael R

2005-01-01

Isolation of well-preserved pure cell populations is a prerequisite for sound studies of the molecular basis of pancreatic malignancy and other biological phenomena. This chapter reviews current methods for obtaining anatomically specific signals from molecules isolated from tissues, a basic requirement for productive linking of phenotype and genotype. The quality of samples isolated from tissue and used for molecular analysis is often glossed-over or omitted from publications, making interpretation and replication of data difficult or impossible. Fortunately, recently developed techniques allow life scientists to better document and control the quality of samples used for a given assay, creating a foundation for improvement in this area. Tissue processing for molecular studies usually involves some or all of the following steps: tissue collection, gross dissection/identification, fixation, processing/embedding, storage/archiving, sectioning, staining, microdissection/annotation, and pure analyte labeling/identification. High-quality tissue microdissection does not necessarily mean high-quality samples to analyze. The quality of biomaterials obtained for analysis is highly dependent on steps upstream and downstream from tissue microdissection. We provide protocols for each of these steps, and encourage you to improve upon these. It is worth the effort of every laboratory to optimize and document its technique at each stage of the process, and we provide a starting point for those willing to spend the time to optimize. In our view, poor documentation of tissue and cell type of origin and the use of nonoptimized protocols is a source of inefficiency in current life science research. Even incremental improvement in this area will increase productivity significantly.

Clinical implementation of RNA signatures for pharmacogenomic decision-making

PubMed Central

Tang, Weihua; Hu, Zhiyuan; Muallem, Hind; Gulley, Margaret L

2011-01-01

RNA profiling is increasingly used to predict drug response, dose, or toxicity based on analysis of drug pharmacokinetic or pharmacodynamic pathways. Before implementing multiplexed RNA arrays in clinical practice, validation studies are carried out to demonstrate sufficient evidence of analytic and clinical performance, and to establish an assay protocol with quality assurance measures. Pathologists assure quality by selecting input tissue and by interpreting results in the context of the input tissue as well as the technologies that were used and the clinical setting in which the test was ordered. A strength of RNA profiling is the array-based measurement of tens to thousands of RNAs at once, including redundant tests for critical analytes or pathways to promote confidence in test results. Instrument and reagent manufacturers are crucial for supplying reliable components of the test system. Strategies for quality assurance include careful attention to RNA preservation and quality checks at pertinent steps in the assay protocol, beginning with specimen collection and proceeding through the various phases of transport, processing, storage, analysis, interpretation, and reporting. Specimen quality is checked by probing housekeeping transcripts, while spiked and exogenous controls serve as a check on analytic performance of the test system. Software is required to manipulate abundant array data and present it for interpretation by a laboratory physician who reports results in a manner facilitating therapeutic decision-making. Maintenance of the assay requires periodic documentation of personnel competency and laboratory proficiency. These strategies are shepherding genomic arrays into clinical settings to provide added value to patients and to the larger health care system. PMID:23226056

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.

Geochemical and mineralogical data for soils of the conterminous United States

USGS Publications Warehouse

Smith, David B.; Cannon, William F.; Woodruff, Laurel G.; Solano, Federico; Kilburn, James E.; Fey, David L.

2013-01-01

In 2007, the U.S. Geological Survey initiated a low-density (1 site per 1,600 square kilometers, 4,857 sites) geochemical and mineralogical survey of soils of the conterminous United States as part of the North American Soil Geochemical Landscapes Project. Sampling and analytical protocols were developed at a workshop in 2003, and pilot studies were conducted from 2004 to 2007 to test and refine these recommended protocols. The final sampling protocol for the national-scale survey included, at each site, a sample from a depth of 0 to 5 centimeters, a composite of the soil A horizon, and a deeper sample from the soil C horizon or, if the top of the C horizon was at a depth greater than 1 meter, from a depth of approximately 80–100 centimeters. The <2-millimeter fraction of each sample was analyzed for a suite of 45 major and trace elements by methods that yield the total or near-total elemental content. The major mineralogical components in the samples from the soil A and C horizons were determined by a quantitative X-ray diffraction method using Rietveld refinement. Sampling in the conterminous United States was completed in 2010, with chemical and mineralogical analyses completed in May 2013. The resulting dataset provides an estimate of the abundance and spatial distribution of chemical elements and minerals in soils of the conterminous United States and represents a baseline for soil geochemistry and mineralogy against which future changes may be recognized and quantified. This report (1) describes the sampling, sample preparation, and analytical methods used; (2) gives details of the quality control protocols used to monitor the quality of chemical and mineralogical analyses over approximately six years; and (3) makes available the soil geochemical and mineralogical data in downloadable tables.

Living with diabetes: a group-based self-management support programme for T2DM patients in the early phases of illness and their partners, study protocol of a randomised controlled trial.

PubMed

van Puffelen, Anne L; Rijken, Mieke; Heijmans, Monique J W M; Nijpels, Giel; Rutten, Guy E H M; Schellevis, François G

2014-04-01

The present article presents the protocol for a randomised controlled trial to test the effectiveness of a group-based self-management support programme for recently diagnosed type 2 diabetes mellitus (T2DM) patients (one to three years post-diagnosis) and their partners. The course aims to support T2DM patients and their partners in successfully integrating diabetes care into their daily lives and hereby enhance self-management and diabetes-specific health-related quality of life. The content of the course is based on the Common-Sense Model of Self-Regulation (CSM). Furthermore, principles from the Social Cognitive Theory (SCT) and social support theories are integrated. We aim to recruit 160 recently diagnosed T2DM patients and their partners from general practices in six different regions in the Netherlands. Patients need to be diagnosed with T2DM for one to three years and have to experience some degree of diabetes-related difficulties, as measured with a three-item screener. Participating patients and their partners are randomly allocated to the intervention or control condition. Participants in the intervention condition receive three monthly group sessions and a booster session three months later. Participants in the control condition receive a single information meeting. Data will be collected at baseline (T0), directly after the programme (T1) and six months post-programme (T2), including: self-management, diabetes-specific health-related quality of life, illness perceptions, attitudes, social support and empowerment. A three-level multilevel model will be used to compare change-scores between the conditions (intervention/control) on each outcome. Our study will be the first to determine whether a group-based support programme based on the CSM is effective in enhancing self-management and diabetes-specific health-related quality of life in recently diagnosed T2DM patients. The important role of patients' partners in effective diabetes care is also acknowledged in the study. Netherlands National Trial Register (NTR) NTR3302.

Radiation dose to patients and image quality evaluation from coronary 256-slice computed tomographic angiography

NASA Astrophysics Data System (ADS)

Chen, Liang-Kuang; Wu, Tung-Hsin; Yang, Ching-Ching; Tsai, Chia-Jung; Lee, Jason J. S.

2010-07-01

The aim of this study is to assess radiation dose and the corresponding image quality from suggested CT protocols which depends on different mean heart rate and high heart rate variability by using 256-slice CT. Fifty consecutive patients referred for a cardiac CT examination were included in this study. All coronary computed tomographic angiography (CCTA) examinations were performed on a 256-slice CT scanner with one of five different protocols: retrospective ECG-gating (RGH) with full dose exposure in all R-R intervals (protocol A), RGH of 30-80% pulsing window with tube current modulation (B), RGH of 78±5% pulsing window with tube current modulation (C), prospective ECG-triggering (PGT) of 78% R-R interval with 5% padding window (D) and PGT of 78% R-R interval without padding window (E). Radiation dose parameters and image quality scoring were determined and compared. In this study, no significant differences were found in comparison on image quality of the five different protocols. Protocol A obtained the highest radiation dose comparing with those of protocols B, C, D and E by a factor of 1.6, 2.4, 2.5 and 4.3, respectively ( p<0.001), which were ranged between 2.7 and 11.8 mSv. The PGT could significantly reduce radiation dose delivered to patients, as compared to the RGH. However, the use of PGT has limitations and is only good in assessing cases with lower mean heart rate and stable heart rate variability. With higher mean heart rate and high heart rate variability circumstances, the RGH within 30-80% of R-R interval pulsing window is suggested as a feasible technique for assessing diagnostic performance.

Patient-Centred Innovations for Persons with Multimorbidity: funded evaluation protocol.

PubMed

Stewart, Moira; Fortin, Martin

2017-05-09

The high prevalence of multimorbidity necessitates rethinking of the health care system. The overarching goal of the Patient-Centred Innovations for Persons with Multimorbidity program is to build on existing structures and find and evaluate patient-centred innovations relevant to multimorbidity. We describe the protocol for a proposed multijurisdictional (Quebec and Ontario) concurrent triangulation mixed-methods study. In both provinces, a qualitative descriptive study will be used to explore innovations in patient-centred multimorbidity care. Two randomized controlled trials, 1 in either province, will evaluate the innovations in a wait-list-controlled design using patient-reported outcomes. An additional control group, matched on age, sex, enrolment/index date (± 3 mo) and propensity score, will be created with the use of health administrative data. Patients will be 18-80 years of age and will have 3 or more chronic conditions. The innovations will have elements of relevance to multimorbidity care, patient-centred partnerships and integration of care. The primary outcome measures will be 2 patient-reported outcomes: patient education and self-efficacy. Secondary outcomes will include patient-reported health status, quality of life, psychological distress and health behaviours, and costs of care. This protocol describes a mixed-method study in 2 jurisdictions. The studies will answer the questions of what innovations work and how they work for patients, health care professionals and policy-makers. Trial registration: ClinicalTrials.gov, no NCT02789800 (Quebec Trial), NCT02742597 (Ontario Trial). Copyright 2017, Joule Inc. or its licensors.

Protocol for a systematic review of psychological interventions for cancer-related fatigue in post-treatment cancer survivors.

PubMed

Corbett, Teresa; Devane, Declan; Walsh, Jane C; Groarke, AnnMarie; McGuire, Brian E

2015-12-04

Fatigue is a common symptom in cancer patients that can persist beyond the curative treatment phase. Some evidence has been reported for interventions for fatigue during active treatment. However, to date, there is no systematic review on psychological interventions for fatigue after the completion of curative treatment for cancer. This is a protocol for a systematic review that aims to evaluate the effectiveness of psychological interventions for cancer-related fatigue in post-treatment cancer survivors. This systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) database. We will search the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library), PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, and relevant sources of grey literature. Randomised controlled trials (RCTs) which have evaluated psychological interventions in adult cancer patients after the completion of treatment, with fatigue as an outcome measure, will be included. Two review authors will independently extract data from the selected studies and assess the methodological quality using the Cochrane Collaboration Risk of Bias Tool. Most existing evidence on cancer-related fatigue is from those in active cancer treatment. This systematic review and meta-analysis will build upon previous evaluations of psychological interventions in people during and after cancer treatment. With the growing need for stage-specific research in cancer, this review seeks to highlight a gap in current practice and to strengthen the evidence base of randomised controlled trials in the area. PROSPERO CRD42014015219.

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.

System for verifiable CT radiation dose optimization based on image quality. part II. process control system.

PubMed

Larson, David B; Malarik, Remo J; Hall, Seth M; Podberesky, Daniel J

2013-10-01

To evaluate the effect of an automated computed tomography (CT) radiation dose optimization and process control system on the consistency of estimated image noise and size-specific dose estimates (SSDEs) of radiation in CT examinations of the chest, abdomen, and pelvis. This quality improvement project was determined not to constitute human subject research. An automated system was developed to analyze each examination immediately after completion, and to report individual axial-image-level and study-level summary data for patient size, image noise, and SSDE. The system acquired data for 4 months beginning October 1, 2011. Protocol changes were made by using parameters recommended by the prediction application, and 3 months of additional data were acquired. Preimplementation and postimplementation mean image noise and SSDE were compared by using unpaired t tests and F tests. Common-cause variation was differentiated from special-cause variation by using a statistical process control individual chart. A total of 817 CT examinations, 490 acquired before and 327 acquired after the initial protocol changes, were included in the study. Mean patient age and water-equivalent diameter were 12.0 years and 23.0 cm, respectively. The difference between actual and target noise increased from -1.4 to 0.3 HU (P < .01) and the standard deviation decreased from 3.9 to 1.6 HU (P < .01). Mean SSDE decreased from 11.9 to 7.5 mGy, a 37% reduction (P < .01). The process control chart identified several special causes of variation. Implementation of an automated CT radiation dose optimization system led to verifiable simultaneous decrease in image noise variation and SSDE. The automated nature of the system provides the opportunity for consistent CT radiation dose optimization on a broad scale. © RSNA, 2013.

Effect of cooling rate on sperm quality of cryopreserved Andalusian donkey spermatozoa.

PubMed

Demyda-Peyrás, S; Bottrel, M; Acha, D; Ortiz, I; Hidalgo, M; Carrasco, J J; Gómez-Arrones, V; Gósalvez, J; Dorado, J

2018-06-01

The aim of this study was to evaluate the effect of different cooling rates on post-thaw quality of cryopreserved donkey spermatozoa. Eighteen ejaculates from six adult Andalusian donkeys (three ejaculates per donkey) were collected using an artificial vagina. Pooled semen samples (two ejaculates per pool) were divided into three aliquots, and frozen in Gent freezing extender using three different cryopreservation protocols (P): P1 (conventional slow freezing, as control): semen pre-cooled in an Equitainer for 2 h and frozen in liquid nitrogen (LN 2 ) vapour; P2 (controlled pre-freeze cooling rate): semen pre-cooled at a controlled rate for 73 min and frozen in LN 2 vapour; and P3 (rapid freezing) semen frozen immediately in LN 2 vapour. After thawing at 37 °C for 30 s, semen samples were assessed for motility, morphology, acrosome and plasma membrane integrity; spermatozoa were also tested for DNA integrity. Significant (P < 0.01) differences were found between the cryopreservation protocols for all sperm parameters evaluated, except for DNA integrity. Semen samples frozen using P2 showed significantly (P < 0.01) higher values for sperm motility, morphology, sperm membrane integrity, and acrosome integrity. On the contrary, P3 reduced sperm motility (P < 0.01) and increased the percentage of spermatozoa with damaged plasma membrane (P < 0.001). In our study, we demonstrated that the sperm of Andalusian donkey is particularly sensitive to the cooling rate used before freezing. Furthermore, Andalusian donkey semen can be successfully cryopreserved using controlled cooling rates combined with freezing in LN 2 vapour. Copyright © 2018 Elsevier B.V. All rights reserved.

Comparison of Image Quality and Radiation Dose of Coronary Computed Tomography Angiography Between Conventional Helical Scanning and a Strategy Incorporating Sequential Scanning

PubMed Central

Einstein, Andrew J.; Wolff, Steven D.; Manheimer, Eric D.; Thompson, James; Terry, Sylvia; Uretsky, Seth; Pilip, Adalbert; Peters, M. Robert

2009-01-01

Radiation dose from coronary computed tomography angiography may be reduced using a sequential scanning protocol rather than a conventional helical scanning protocol. Here we compare radiation dose and image quality from coronary computed tomography angiography in a single center between an initial period during which helical scanning with electrocardiographically-controlled tube current modulation was used for all patients (n=138) and after adoption of a strategy incorporating sequential scanning whenever appropriate (n=261). Using the sequential-if-appropriate strategy, sequential scanning was employed in 86.2% of patients. Compared to the helical-only strategy, this strategy was associated with a 65.1% dose reduction (mean dose-length product of 305.2 vs. 875.1 and mean effective dose of 14.9 mSv vs. 5.2 mSv, respectively), with no significant change in overall image quality, step artifacts, motion artifacts, or perceived image noise. For the 225 patients undergoing sequential scanning, the dose-length product was 201.9 ± 90.0 mGy·cm, while for patients undergoing helical scanning under either strategy, the dose-length product was 890.9 ± 293.3 mGy·cm (p<0.0001), corresponding to mean effective doses of 3.4 mSv and 15.1 mSv, respectively, a 77.5% reduction. Image quality was significantly greater for the sequential studies, reflecting the poorer image quality in patients undergoing helical scanning in the sequential-if-appropriate strategy. In conclusion, a sequential-if-appropriate diagnostic strategy reduces dose markedly compared to a helical-only strategy, with no significant difference in image quality. PMID:19892048

Temperature management during semen processing: Impact on boar sperm quality under laboratory and field conditions.

PubMed

Schulze, M; Henning, H; Rüdiger, K; Wallner, U; Waberski, D

2013-12-01

Freshly collected boar spermatozoa are sensitive to a fast reduction in temperature because of lipid phase transition and phase separation processes. Temperature management during semen processing may determine the quality of stored samples. The aim of this study was to evaluate the influence of isothermic and hypothermic semen processing protocols on boar sperm quality under laboratory and field conditions. In the laboratory study, ejaculates (n = 12) were first diluted (1:1) with Beltsville Thawing Solution (BTS) at 32 °C, then processed either with isothermic (32 °C) or hypothermic (21 °C) BTS, stored at 17 °C, and assessed on days 1, 3, and 6. Temperature curves showed that 150 minutes after the first dilution, semen doses of both groups reached the same temperature. Two-step hypothermic processing resulted in lower sperm motility on days 1 and 6 (P < 0.05). Concomitantly, hypothermally processed samples contained less membrane intact sperm on days 3 and 6 (P < 0.05). Using AndroStar Plus extender instead of BTS reduced the negative effect of hypothermic processing. In the field study, 15 semen samples from each of 23 European artificial insemination studs were evaluated as part of an external quality control program. Semen quality based on motility, membrane integrity, mitochondrial activity, and a thermoresistance test was higher for stations using one-step isothermic dilutions (n = 7) compared with artificial insemination centers using two-step hypothermic protocols (n = 16). Both studies show that chilling injury associated with hypothermic dilution results in lower quality of stored boar semen compared with isothermic dilution and that the type of semen extender affects the outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

Whole-body ultra-low dose CT using spectral shaping for detection of osteolytic lesion in multiple myeloma.

PubMed

Suntharalingam, Saravanabavaan; Mikat, Christian; Wetter, Axel; Guberina, Nika; Salem, Ahmed; Heil, Philipp; Forsting, Michael; Nassenstein, Kai

2018-06-01

The aim of this study was to investigate the radiation dose and image quality of a whole-body low-dose CT (WBLDCT) using spectral shaping at 100 kV (Sn 100 kV) for the assessment of osteolytic lesions in patients with multiple myeloma. Thirty consecutive patients were retrospectively selected, who underwent a WBLDCT on a third-generation dual-source CT (DSCT) (Sn 100 kV, ref. mAs: 130). They were matched with patients, who were examined on a second-generation DSCT with a standard low-dose protocol (100 kV, ref. mAs: 111). Objective and subjective image quality, radiation exposure as well as the frequency of osteolytic lesions were evaluated. All scans were of diagnostic image quality. Subjective overall image quality was significantly higher in the study group (p = 0.0003). Objective image analysis revealed that signal intensities, signal-to-noise ratio and contrast-to-noise ratio of the bony structures were equal or significantly higher in the control group. There was no significant difference in the frequency of osteolytic lesions (p = 0.259). The median effective dose of the study protocol was significantly lower (1.45 mSv vs. 5.65 mSv; p < 0.0001). WBLDCT with Sn 100 kV can obtain sufficient image quality for the depiction of osteolytic lesions while reducing the radiation dose by approximately 74%. • Spectral shaping using tin filtration is beneficial for whole-body low-dose CT • Sn 100 kV yields sufficient image quality for depiction of osteolytic lesions • Whole-body low-dose CT can be performed with a median dose of 1.5 mSv.

WE-A-BRC-00: The Quality Gap

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

NONE

Quality and safety in healthcare are inextricably linked. There are compelling data that link poor quality radiation therapy to inferior patient survival. Radiation Oncology clinical trial protocol deviations often involve incorrect target volume delineation or dosing, akin to radiotherapy incidents which also often involve partial geometric miss or improper radiation dosing. When patients with radiation protocol variations are compared to those without significant protocol variations, clinical outcome is negatively impacted. Traditionally, quality assurance in radiation oncology has been driven largely by new technological advances, and safety improvement has been driven by reactive responses to past system failures and prescriptive mandatesmore » recommended by professional organizations and promulgated by regulators. Prescriptive approaches to quality and safety alone often do not address the huge variety of process and technique used in radiation oncology. Risk-based assessments of radiotherapy processes provide a mechanism to enhance quality and safety, both for new and for established techniques. It is imperative that we explore such a paradigm shift at this time, when expectations from patients as well as providers are rising while available resources are falling. There is much we can learn from our past experiences to be applied towards the new risk-based assessments. Learning Objectives: Understand the impact of clinical and technical quality on outcomes Understand the importance of quality care in radiation oncology Learn to assess the impact of quality on clinical outcomes D. Followill, NIH Grant CA180803.« less

Evaluation of commercial DNA and RNA extraction methods for high-throughput sequencing of FFPE samples.

PubMed

Kresse, Stine H; Namløs, Heidi M; Lorenz, Susanne; Berner, Jeanne-Marie; Myklebost, Ola; Bjerkehagen, Bodil; Meza-Zepeda, Leonardo A

2018-01-01

Nucleic acid material of adequate quality is crucial for successful high-throughput sequencing (HTS) analysis. DNA and RNA isolated from archival FFPE material are frequently degraded and not readily amplifiable due to chemical damage introduced during fixation. To identify optimal nucleic acid extraction kits, DNA and RNA quantity, quality and performance in HTS applications were evaluated. DNA and RNA were isolated from five sarcoma archival FFPE blocks, using eight extraction protocols from seven kits from three different commercial vendors. For DNA extraction, the truXTRAC FFPE DNA kit from Covaris gave higher yields and better amplifiable DNA, but all protocols gave comparable HTS library yields using Agilent SureSelect XT and performed well in downstream variant calling. For RNA extraction, all protocols gave comparable yields and amplifiable RNA. However, for fusion gene detection using the Archer FusionPlex Sarcoma Assay, the truXTRAC FFPE RNA kit from Covaris and Agencourt FormaPure kit from Beckman Coulter showed the highest percentage of unique read-pairs, providing higher complexity of HTS data and more frequent detection of recurrent fusion genes. truXTRAC simultaneous DNA and RNA extraction gave similar outputs as individual protocols. These findings show that although successful HTS libraries could be generated in most cases, the different protocols gave variable quantity and quality for FFPE nucleic acid extraction. Selecting the optimal procedure is highly valuable and may generate results in borderline quality specimens.

General introduction for the “National Field Manual for the Collection of Water-Quality Data”

USGS Publications Warehouse

,

2018-02-28

BackgroundAs part of its mission, the U.S. Geological Survey (USGS) collects data to assess the quality of our Nation’s water resources. A high degree of reliability and standardization of these data are paramount to fulfilling this mission. Documentation of nationally accepted methods used by USGS personnel serves to maintain consistency and technical quality in data-collection activities. “The National Field Manual for the Collection of Water-Quality Data” (NFM) provides documented guidelines and protocols for USGS field personnel who collect water-quality data. The NFM provides detailed, comprehensive, and citable procedures for monitoring the quality of surface water and groundwater. Topics in the NFM include (1) methods and protocols for sampling water resources, (2) methods for processing samples for analysis of water quality, (3) methods for measuring field parameters, and (4) specialized procedures, such as sampling water for low levels of mercury and organic wastewater chemicals, measuring biological indicators, and sampling bottom sediment for chemistry. Personnel who collect water-quality data for national USGS programs and projects, including projects supported by USGS cooperative programs, are mandated to use protocols provided in the NFM per USGS Office of Water Quality Technical Memorandum 2002.13. Formal training, for example, as provided in the USGS class, “Field Water-Quality Methods for Groundwater and Surface Water,” and field apprenticeships supplement the guidance provided in the NFM and ensure that the data collected are high quality, accurate, and scientifically defensible.

Standardized Transportation of Human Islets: An Islet Cell Resource Center Study of More Than 2,000 Shipments

PubMed Central

Kaddis, John S.; Hanson, Matthew S.; Cravens, James; Qian, Dajun; Olack, Barbara; Antler, Martha; Papas, Klearchos K.; Iglesias, Itzia; Barbaro, Barbara; Fernandez, Luis; Powers, Alvin C.; Niland, Joyce C.

2013-01-01

Preservation of cell quality during shipment of human pancreatic islets for use in laboratory research is a crucial, but neglected, topic. Mammalian cells, including islets, have been shown to be adversely affected by temperature changes in vitro and in vivo, yet protocols that control for thermal fluctuations during cell transport are lacking. To evaluate an optimal method of shipping human islets, an initial assessment of transportation conditions was conducted using standardized materials and operating procedures in 48 shipments sent to a central location by 8 pancreas-processing laboratories using a single commercial airline transporter. Optimization of preliminary conditions was conducted, and human islet quality was then evaluated in 2,338 shipments pre- and post-implementation of a finalized transportation container and standard operating procedures. The initial assessment revealed that the outside temperature ranged from a mean of −4.6±10.3°C to 20.9±4.8°C. Within-container temperature drops to or below 15°C occurred in 16 shipments (36%), while the temperature was found to be stabilized between 15–29°C in 29 shipments (64%). Implementation of an optimized transportation container and operating procedure reduced the number of within-container temperature drops (≤15°C) to 13% (n=37 of 289 winter shipments), improved the number desirably maintained between 15–29°C to 86% (n=250), but also increased the number reaching or exceeding 29°C to 1% (n=2; overall p<0.0001). Additionally, post-receipt quality ratings of excellent to good improved pre- vs. post- implementation of the standardized protocol, adjusting for pre-shipment purity/viability levels (p<0.0001). Our results show that extreme temperature fluctuations during transport of human islets, occurring when using a commercial airline transporter for long distance shipping, can be controlled using standardized containers, materials, and operating procedures. This cost-effective and pragmatic standardized protocol for the transportation of human islets can potentially be adapted for use with other mammalian cell systems, and is available online at: http://iidp.coh.org/sops.aspx. PMID:22889479

Are child-centric aspects in newborn and child health systematic review and meta-analysis protocols and reports adequately reported?-two systematic reviews.

PubMed

Farid-Kapadia, Mufiza; Joachim, Kariym C; Balasingham, Chrinna; Clyburne-Sherin, April; Offringa, Martin

2017-03-06

Evidence suggests that newborn and child health systematic reviews and meta-analyses exhibit poor quality in reporting. The "Preferred Reporting Items in Systematic Review and Meta-Analysis" (PRISMA) and PRISMA-Protocols (PRISMA-P) checklists have been developed to improve the reporting of systematic review results and protocols, respectively. We aimed to evaluate the clarity and transparency in reporting of child-centric items in child health systematic reviews (SRs) and SR protocols and to identify areas where reporting could be strengthened. Two preliminary lists of potential child-centric reporting items were used to examine current reporting. The Cochrane, DARE, MEDLINE, and EMBASE libraries were searched from 2010 to 2014 for systematic reviews that included children. Each report and protocol that met the inclusion criteria had their quality of reporting assessed by their reporting of child-centric items. Quality of reporting was assessed per whether one third, one to two thirds, or more than two thirds of papers complied with potential child-centric potential modifications/extensions to PRISMA and were analyzed by the following: (i) paper type (i.e., report vs. protocol), (ii) publication type (i.e., Cochrane vs. non-Cochrane), and (iii) population type (i.e., child-only vs. mixed populations vs. family/maternal). Of the 414 eligible articles, 248 reports and 76 protocols were included. In 21 of 24 potential SR reporting items and 13 of 14 potential SR protocol reporting items, less than two thirds of papers met the child-centric reporting item requirements. Mixed population studies displayed significantly poorer reporting in comparison to child-only and family/maternal intervention studies for 11 potential SR reporting items (p < 0.05) and five potential SR protocol items (p < 0.05). When comparing non-Cochrane to Cochrane reports and protocols, five items in both lists were found to perform significantly poorer in non-Cochrane reports (p < 0.05). Significant differences in reporting quality were found in three of 14 items shared between the potential SR reporting items and potential SR protocol reporting items (p < 0.05). Newborn and child health systematic reviews and meta-analyses exhibit incomplete reporting, thereby hindering prudent decision-making by healthcare providers and policy makers. These results provide a rationale for the implementation of child-centric extensions and modifications to current PRISMA and PRISMA-P, such as to improve reporting in this population.

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.

Cislan-2 extension final document by University of Twente (Netherlands)

NASA Astrophysics Data System (ADS)

Niemegeers, Ignas; Baumann, Frank; Beuwer, Wim; Jordense, Marcel; Pras, Aiko; Schutte, Leon; Tracey, Ian

1992-01-01

Results of worked performed under the so called Cislan extension contract are presented. The adaptation of the Cislan 2 prototype design to an environment of interconnected Local Area Networks (LAN's) instead of a single 802.5 token ring LAN is considered. In order to extend the network architecture, the Interconnection Function (IF) protocol layer was subdivided into two protocol layers: a new IF layer, and below the Medium Enhancement (ME) protocol layer. Some small enhancements to the distributed bandwidth allocation protocol were developed, which in fact are also applicable to the 'normal' Cislan 2 system. The new services and protocols are described together with some scenarios and requirements for the new internetting Cislan 2 system. How to overcome the degradation of the quality of speech due to packet loss on the LAN subsystem was studied. Experiments were planned in order to measure this speech quality degradation. Simulations were performed of two Cislan subsystems, the bandwidth allocation protocol and the clock synchronization mechanism. Results on both simulations, performed on SUN workstations using QNAP as a simulation tool, are given. Results of the simulations of the clock synchronization mechanism, and results of the simulation of the distributed bandwidth allocation protocol are given.

A Flexible Multidose GnRH Antagonist versus a Microdose Flare-Up GnRH Agonist Combined with a Flexible Multidose GnRH Antagonist Protocol in Poor Responders to IVF.

PubMed

Çelik, Gayem İnayet Turgay; Sütçü, Havva Kömür; Akpak, Yaşam Kemal; Akar, Münire Erman

2015-01-01

To compare the effectiveness of a flexible multidose gonadotropin-releasing hormone (GnRH) antagonist against the effectiveness of a microdose flare-up GnRH agonist combined with a flexible multidose GnRH antagonist protocol in poor responders to in vitro fertilization (IVF). A retrospective study in Akdeniz University, Faculty of Medicine, Department of Obstetrics and Gynecology, IVF Center, for 131 poor responders in the intracytoplasmic sperm injection-embryo transfer (ICSI-ET) program between January 2006 and November 2012. The groups were compared to the patients' characteristics, controlled ovarian stimulation (COH) results, and laboratory results. Combination protocol was applied to 46 patients (group 1), and a single protocol was applied to 85 patients (group 2). In group 1, the duration of the treatment was longer and the dose of FSH was higher. The cycle cancellation rate was significantly higher in group 2 (26.1% versus 38.8%). A significant difference was not observed with respect to the number and quality of oocytes and embryos or to the number of embryos transferred. There were no statistically significant differences in the hCG positivity (9.5% versus 9.4%) or the clinical pregnancy rates (7.1% versus 10.6%). The combination protocol does not provide additional efficacy.

A Flexible Multidose GnRH Antagonist versus a Microdose Flare-Up GnRH Agonist Combined with a Flexible Multidose GnRH Antagonist Protocol in Poor Responders to IVF

PubMed Central

Turgay Çelik, Gayem İnayet; Sütçü, Havva Kömür; Akpak, Yaşam Kemal; Akar, Münire Erman

2015-01-01

Objective. To compare the effectiveness of a flexible multidose gonadotropin-releasing hormone (GnRH) antagonist against the effectiveness of a microdose flare-up GnRH agonist combined with a flexible multidose GnRH antagonist protocol in poor responders to in vitro fertilization (IVF). Study Design. A retrospective study in Akdeniz University, Faculty of Medicine, Department of Obstetrics and Gynecology, IVF Center, for 131 poor responders in the intracytoplasmic sperm injection-embryo transfer (ICSI-ET) program between January 2006 and November 2012. The groups were compared to the patients' characteristics, controlled ovarian stimulation (COH) results, and laboratory results. Results. Combination protocol was applied to 46 patients (group 1), and a single protocol was applied to 85 patients (group 2). In group 1, the duration of the treatment was longer and the dose of FSH was higher. The cycle cancellation rate was significantly higher in group 2 (26.1% versus 38.8%). A significant difference was not observed with respect to the number and quality of oocytes and embryos or to the number of embryos transferred. There were no statistically significant differences in the hCG positivity (9.5% versus 9.4%) or the clinical pregnancy rates (7.1% versus 10.6%). Conclusion. The combination protocol does not provide additional efficacy. PMID:26161425

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.

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

Despite compelling evidence linking physical activity and quality of life among adults with spinal cord injury (SCI), exercise participation rates are extremely low in this population. Unfortunately, a lack of behavioral exercise interventions, in particular theory-based randomized controlled trials (RCT), exists within the SCI literature. A pilot RCT is needed to first examine the feasibility to conduct such interventions and determine the appropriate effect size to inform future full-scale interventions. The overall goal of this pilot RCT is to test an 8-week innovative, video-based telerehabilitation intervention based on self-determination theory and aimed at enhancing the basic psychological needs, motivation, exercise participation, and quality of life‒related outcomes of adults with paraplegia. The objectives are to (1) determine if individuals in the intervention group have greater increases in their basic psychological needs and autonomous motivation and a decrease in controlled motivation compared to the control group, (2) determine whether the intervention group reports greater increases in exercise participation and quality of life‒related variables (eg, life satisfaction, participation in daily/social activities, depressive symptoms) compared to the control group, and (3) examine if adults with paraplegia who received the intervention report improved scores on psychosocial predictors of exercise (eg, action planning) and well-being (eg, positive affect) compared to the control group. We also aimed to examine the implementation characteristics of the intervention (eg, satisfaction with the technology, counselor's ability to foster the psychological needs). Adults with paraplegia (N=24) living in the community will be recruited. All participants will be invited to complete assessments of their psychological needs, motivation, exercise, and quality of life‒related variables at three time points (baseline, 6, and 10 weeks). Following the baseline 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.

Development of Research-Based Protocol Aligned to Predict High Levels of Teaching Quality

ERIC Educational Resources Information Center

Schumacher, Gary; Grigsby, Bettye; Vesey, Winona

2011-01-01

This study proposes a research-based teacher selection protocol. The protocol is intended to offer school district hiring authorities a tool to identify teacher candidates with the behaviors expected to predict effective teaching. It is hypothesized that a particular series of research-based interview questions focusing on teaching behaviors in…

Extraction of High Quality DNA from Seized Moroccan Cannabis Resin (Hashish)

PubMed Central

El Alaoui, Moulay Abdelaziz; Melloul, Marouane; Alaoui Amine, Sanaâ; Stambouli, Hamid; El Bouri, Aziz; Soulaymani, Abdelmajid; El Fahime, Elmostafa

2013-01-01

The extraction and purification of nucleic acids is the first step in most molecular biology analysis techniques. The objective of this work is to obtain highly purified nucleic acids derived from Cannabis sativa resin seizure in order to conduct a DNA typing method for the individualization of cannabis resin samples. To obtain highly purified nucleic acids from cannabis resin (Hashish) free from contaminants that cause inhibition of PCR reaction, we have tested two protocols: the CTAB protocol of Wagner and a CTAB protocol described by Somma (2004) adapted for difficult matrix. We obtained high quality genomic DNA from 8 cannabis resin seizures using the adapted protocol. DNA extracted by the Wagner CTAB protocol failed to give polymerase chain reaction (PCR) amplification of tetrahydrocannabinolic acid (THCA) synthase coding gene. However, the extracted DNA by the second protocol permits amplification of THCA synthase coding gene using different sets of primers as assessed by PCR. We describe here for the first time the possibility of DNA extraction from (Hashish) resin derived from Cannabis sativa. This allows the use of DNA molecular tests under special forensic circumstances. PMID:24124454

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

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 trial designed to evaluate resistance exercises in older patients with sarcopenic obesity. If our hypothesis proves correct, both intervention programmes will be effective, with the land-based exercises conferring better results in muscle performance. Trial registration Registro Brasileiro de Ensaios Clínicos: RBR-9p5q67 PMID:24041219

Effects of a pulmonary rehabilitation program on physical capacity, peripheral muscle function and inflammatory markers in asthmatic children and adolescents: study protocol for a randomized controlled trial.

PubMed

Reimberg, Mariana Mazzuca; Castro, Rejane Agnelo Silva; Selman, Jessyca Pachi Rodrigues; Meneses, Aline Santos; Politti, Fabiano; Mallozi, Márcia Carvalho; Wandalsen, Gustavo Falbo; Solé, Dirceu; De Angelis, Kátia; Dal Corso, Simone; Lanza, Fernanda Cordoba

2015-08-13

Individuals with chronic lung disease are more susceptible to present reduction in exercise tolerance and muscles strength not only due to pulmonary limitations but also due systemic repercussions of the pulmonary disease. The aim of this study is to assess the physical capacity, peripheral muscle function, physical activity in daily life, and the inflammatory markers in children and adolescents with asthma after pulmonary rehabilitation program. This is a study protocol of randomized controlled trial in asthmatic patients between 6 to 18 years old. The assessments will be conducted in three different days and will be performed at the beginning and at the end of the protocol. First visit: quality of life questionnaire, asthma control questionnaire, pre- and post-bronchodilator spirometry (400 μcg salbutamol), inflammatory assessment (blood collection), and cardiopulmonary exercise test on a cycle ergometer to determine aerobic capacity. Second visit: assessment of strength and endurance of the quadriceps femoris and biceps brachii muscles with concomitant electromyography to assess peripheral muscle strength. Third visit: incremental shuttle walk test (ISWT) and accelerometer to evaluate functional capacity and physical activity in daily life during 7 days. Then, the volunteers will be randomized to receive pulmonary rehabilitation program (intervention group) or chest physiotherapy + stretching exercises (control group). Both groups will have a supervised session, twice a week, each session will have 60 minutes duration, with minimum interval of 24 hours, for a period of 8 weeks. Intervention group: aerobic training (35 minutes) intensity between 60 to 80 % of the maximum workload of cardiopulmonary exercise testing or of ISWT; strength muscle training will be applied to the quadriceps femoris, biceps brachii and deltoid muscles (intensity: 40 to 70 % of maximal repetition, 3 x 8 repetition); finally the oral high-frequency oscillation device (Flutter®) will be used for 5 minutes. The control group: oral high-frequency oscillation device (Flutter®) for 10 minutes followed by the stretching of upper and lower limbs for 40 minutes. It is expected to observe the improvement in aerobic capacity, physical activity in daily life, muscle strength and quality of life of patients in the intervention group, and reduction in inflammatory markers. NCT02383069. Data of registration: 03/03/2015.

Supporting Heart Failure Patient Transitions From Acute to Community Care With Home Telemonitoring Technology: A Protocol for a Provincial Randomized Controlled Trial (TEC4Home).

PubMed

2016-12-18

Seniors with chronic diseases such as heart failure have complex care needs. They are vulnerable to their condition deteriorating and, without timely intervention, may require multiple emergency department visits and/or repeated hospitalizations. Upon discharge, the transition from the emergency department to home can be a vulnerable time for recovering patients with disruptions in the continuity of care. Remote monitoring of heart failure patients using home telemonitoring, coupled with clear communication protocols between health care professionals, can be effective in increasing the safety and quality of care for seniors with heart failure discharged from the emergency department. The aim of the Telehealth for Emergency-Community Continuity of Care Connectivity via Home Telemonitoring (TEC4Home) study is to generate evidence through a programmatic evaluation and a clinical trial to determine how home telemonitoring may improve care and increase patient safety during the transition of care and determine how it is best implemented to support patients with heart failure within this context. This 4-year project consists of 3 studies to comprehensively evaluate the outcomes and effectiveness of TEC4Home. Study 1 is a feasibility study with 90 patients recruited from 2 emergency department sites to test implementation and evaluation procedures. Findings from the feasibility study will be used to refine protocols for the larger trial. Study 2 is a cluster randomized controlled trial that will include 30 emergency department sites and 900 patients across British Columbia. The primary outcome of the randomized controlled trial will be emergency department revisits and hospital readmission rates. Secondary outcomes include health care resource utilization/costs, communication between members of the care team, and patient quality of life. Study 3 will run concurrently to study 2 and test the effectiveness of predictive analytic software to detect patient deterioration sooner. It is hypothesized that TEC4Home will be a cost-effective strategy to decrease 90-day emergency department revisits and hospital admission rates and improve comfort and quality of life for seniors with heart failure. The results from this project will also help establish an innovation pathway for rapid and rigorous introduction of innovation into the health system. While there is some evidence about the effectiveness of home telemonitoring for some patients and conditions, the TEC4Home project will be one of the first protocols that implements and evaluates the technology for patients with heart failure as they transition from the emergency department to home care. The results from this research are expected to inform the full scale and spread of the home monitoring approach throughout British Columbia and Canada and to other chronic diseases. ClinicalTrials.gov NCT02821065; https://clinicaltrials.gov/ct2/show/NCT02821065 (Archived by WebCite at http://www.webcitation.org/6ml2iwKax). ©TEC4Home Healthcare Innovation Community. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.12.2016.