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.

NHEXAS PHASE I MARYLAND STUDY--LIST OF AVAILABLE DOCUMENTS: PROTOCOLS AND SOPS

EPA Science Inventory

This document lists available protocols and SOPs for the NHEXAS Phase I Maryland study. It identifies protocols and SOPs for the following study components: (1) Sample collection and field operations, (2) Sample analysis and general laboratory procedures, (3) Data Analysis Proced...

Lack of evidence of a beneficial effect of azathioprine in dogs treated with prednisolone for idiopathic immune-mediated hemolytic anemia: a retrospective cohort study.

PubMed

Piek, Christine J; van Spil, Willem Evert; Junius, Greet; Dekker, Aldo

2011-04-13

Azathioprine is used as an immunosuppressant in canine immune-mediated hemolytic anemia (IMHA), but this potentially toxic and carcinogenic drug has not been proven to be beneficial. The aim of this study was to determine the difference in outcome and survival of dogs with idiopathic IMHA treated with a protocol that included azathioprine and prednisolone versus a protocol that included prednisolone alone. The study included 222 dogs with a hematocrit lower than 0.30 L/L and either a positive Coombs' test or spherocytosis and no evidence of diseases that could trigger IMHA. The clinical and laboratory data at the time of diagnosis and the response to therapy and survival were compared in dogs treated according to the prednisolone and azathioprine protocol (AP protocol; n = 149) and dogs treated according to the prednisolone protocol (P protocol; n = 73). At study entry, the two groups were comparable, except that thrombocyte counts were significantly lower and clinical signs had been present significantly longer in the AP protocol group. No significant difference in survival was found between the two groups: the 1-year survival was 64% (95% CI 54 - 77%) in the P protocol group and 69% (95% CI 59-80%) in the AP protocol group, respectively. Azathioprine would appear not to be beneficial as standard treatment for all cases of IMHA; however, a blinded, randomized clinical trial is needed to establish whether outcome is different with the two treatment protocols.

A Study of Shared-Memory Mutual Exclusion Protocols Using CADP

NASA Astrophysics Data System (ADS)

Mateescu, Radu; Serwe, Wendelin

Mutual exclusion protocols are an essential building block of concurrent systems: indeed, such a protocol is required whenever a shared resource has to be protected against concurrent non-atomic accesses. Hence, many variants of mutual exclusion protocols exist in the shared-memory setting, such as Peterson's or Dekker's well-known protocols. Although the functional correctness of these protocols has been studied extensively, relatively little attention has been paid to their non-functional aspects, such as their performance in the long run. In this paper, we report on experiments with the performance evaluation of mutual exclusion protocols using Interactive Markov Chains. Steady-state analysis provides an additional criterion for comparing protocols, which complements the verification of their functional properties. We also carefully re-examined the functional properties, whose accurate formulation as temporal logic formulas in the action-based setting turns out to be quite involved.

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

PubMed

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

2017-01-01

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

Validity of Assessments of Youth Access to Tobacco: The Familiarity Effect

PubMed Central

Landrine, Hope; Klonoff, Elizabeth A.

2003-01-01

Objectives. We examined the standard compliance protocol and its validity as a measure of youth access to tobacco. Methods. In Study 1, youth smokers reported buying cigarettes in stores where they are regular customers. In Study 2, youths attempted to purchase cigarettes by using the Standard Protocol, in which they appeared at stores once for cigarettes, and by using the Familiarity Protocol, in which they were rendered regular customers by purchasing nontobacco items 4 times and then requested cigarettes during their fifth visit. Results. Sales to youths aged 17 years in the Familiarity Protocol were significantly higher than sales to the same age group in the Standard Protocols (62.5% vs. 6%, respectively). Conclusions. The Standard Protocol does not match how youths obtain cigarettes. Access is low for stranger youths within compliance studies, but access is high for familiar youths outside of compliance studies. PMID:14600057

Protocols and Hospital Mortality in Critically ill Patients: The United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study

PubMed Central

Sevransky, Jonathan E.; Checkley, William; Herrera, Phabiola; Pickering, Brian W.; Barr, Juliana; Brown, Samuel M; Chang, Steven Y; Chong, David; Kaufman, David; Fremont, Richard D; Girard, Timothy D; Hoag, Jeffrey; Johnson, Steven B; Kerlin, Mehta P; Liebler, Janice; O'Brien, James; O'Keefe, Terence; Park, Pauline K; Pastores, Stephen M; Patil, Namrata; Pietropaoli, Anthony P; Putman, Maryann; Rice, Todd W.; Rotello, Leo; Siner, Jonathan; Sajid, Sahul; Murphy, David J; Martin, Greg S

2015-01-01

Objective Clinical protocols may decrease unnecessary variation in care and improve compliance with desirable therapies. We evaluated whether highly protocolized intensive care units have superior patient outcomes compared with less highly protocolized intensive care units. Design Observational study in which participating intensive care units completed a general assessment and enrolled new patients one day each week. Setting and Patients 6179 critically ill patients across 59 intensive care units in the United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study Interventions: None Measurements and Main Results The primary exposure was the number of intensive care unit protocols; the primary outcome was hospital mortality. 5809 participants were followed prospectively and 5454 patients in 57 intensive care units had complete outcome data. The median number of protocols per intensive care unit was 19 (IQR 15 to 21.5). In single variable analyses, there were no differences in intensive care unit and hospital mortality, length of stay, use of mechanical ventilation, vasopressors, or continuous sedation among individuals in intensive care units with a high vs. low number of protocols. The lack of association was confirmed in adjusted multivariable analysis (p=0.70). Protocol compliance with two ventilator management protocols was moderate and did not differ between intensive care units with high vs. low numbers of protocols for lung protective ventilation in ARDS (47% vs. 52%; p=0.28) and for spontaneous breathing trials (55% vs. 51%; p=0.27). Conclusions Clinical protocols are highly prevalent in United States intensive care units. The presence of a greater number of protocols was not associated with protocol compliance or patient mortality. PMID:26110488

Development of a systematic observation protocol of physical exposure of the back: a preliminary study.

PubMed

Tousignant, M; Tougas, G; Rossignol, M; Goulet, L

2002-04-01

At present there is no systematic observation protocol for the assessment of the multi-factorial aspects of physical exposure related to the back used within the constraints of occupational epidemiological research. In this context, a new preliminary systematic observation protocol is proposed to assess exposure to physical loading of the back using nine categories of physical risk factors: the SOPE back protocol. The objective of this study was to investigate whether the new protocol can correctly identify the level of exposure related to measured physical loading of the back. The subjects of this closed cohort study were 451 manual workers at a natural gas distribution company. The assessment of exposure was made with the protocol using groups with different job titles. The workers were followed for a 2 yr period to establish the risk of a new occurrence of complete disability related to the back (NOCD back injury) in each job grouping. Based on the median of the total scores derived from the protocol, two levels of exposure were identified (high and low). Taking into account the limitations of this study, the protocol in development may be a good tool to establish two levels of exposure to physical loading of the back in large epidemiological studies of occupational low back pain. Further research is needed to replicate these results with larger samples and to test the reliability and predictive validity of the protocol.

Clinically Practical Magnetic Resonance Protocol for Improved Specificity in Breast Cancer Diagnosis

DTIC Science & Technology

2007-06-01

Protocol for Improved Specificity in Breast Cancer Diagnosis PRINCIPAL INVESTIGATOR: Luminita Alina Tudorica, Ph.D. CONTRACTING...TITLE AND SUBTITLE 5a. CONTRACT NUMBER Clinically Practical Magnetic Resonance Protocol for Improved Specificity in Breast Cancer Diagnosis 5b... breast cancer study in a clinical setting. This study aims to improve specificity of breast cancer detection by using a combined MRI/MRS protocol. In

Regional gastrointestinal transit and pH studied in 215 healthy volunteers using the wireless motility capsule: influence of age, gender, study country and testing protocol.

PubMed

Wang, Y T; Mohammed, S D; Farmer, A D; Wang, D; Zarate, N; Hobson, A R; Hellström, P M; Semler, J R; Kuo, B; Rao, S S; Hasler, W L; Camilleri, M; Scott, S M

2015-09-01

The wireless motility capsule (WMC) offers the ability to investigate luminal gastrointestinal (GI) physiology in a minimally invasive manner. To investigate the effect of testing protocol, gender, age and study country on regional GI transit times and associated pH values using the WMC. Regional GI transit times and pH values were determined in 215 healthy volunteers from USA and Sweden studied using the WMC over a 6.5-year period. The effects of test protocol, gender, age and study country were examined. For GI transit times, testing protocol was associated with differences in gastric emptying time (GET; shorter with protocol 2 (motility capsule ingested immediately after meal) vs. protocol 1 (motility capsule immediately before): median difference: 52 min, P = 0.0063) and colonic transit time (CTT; longer with protocol 2: median 140 min, P = 0.0189), but had no overall effect on whole gut transit time. Females had longer GET (by median 17 min, P = 0.0307), and also longer CTT by (104 min, P = 0.0285) and whole gut transit time by (263 min, P = 0.0077). Increasing age was associated with shorter small bowel transit time (P = 0.002), and study country also influenced small bowel and CTTs. Whole gut and CTTs showed clustering of data at values separated by 24 h, suggesting that describing these measures as continuous variables is invalid. Testing protocol, gender and study country also significantly influenced pH values. Regional GI transit times and pH values, delineated using the wireless motility capsule (WMC), vary based on testing protocol, gender, age and country. Standardisation of testing is crucial for cross-referencing in clinical practice and future research. © 2015 John Wiley & Sons Ltd.

Security of the arbitrated quantum signature protocols revisited

NASA Astrophysics Data System (ADS)

Kejia, Zhang; Dan, Li; Qi, Su

2014-01-01

Recently, much attention has been paid to the study of arbitrated quantum signature (AQS). Among these studies, the cryptanalysis of some AQS protocols and a series of improved ideas have been proposed. Compared with the previous analysis, we present a security criterion, which can judge whether an AQS protocol is able to prevent the receiver (i.e. one participant in the signature protocol) from forging a legal signature. According to our results, it can be seen that most AQS protocols which are based on the Zeng and Keitel (ZK) model are susceptible to a forgery attack. Furthermore, we present an improved idea of the ZK protocol. Finally, some supplement discussions and several interesting topics are provided.

A kind of universal quantum secret sharing protocol

NASA Astrophysics Data System (ADS)

Chen, Xiu-Bo; Dou, Zhao; Xu, Gang; He, Xiao-Yu; Yang, Yi-Xian

2017-01-01

Universality is an important feature, but less researched in quantum communication protocols. In this paper, a kind of universal quantum secret sharing protocol is investigated. Firstly, we design a quantum secret sharing protocol based on the Borras-Plastino-Batle (BPB) state. Departing from previous research, our protocol has a salient feature in that participants in our protocol only need projective measurement instead of any unitary operations. It makes our protocol more flexible. Secondly, universality of quantum communication protocols is studied for the first time. More specifically, module division of quantum communication protocols and coupling between different modules are discussed. Our aforementioned protocol is analyzed as an example. On one hand, plenty of quantum states (the BPB-class states and the BPB-like-class states, which are proposed in this paper) could be used as carrier to perform our protocol. On the other hand, our protocol also could be regarded as a quantum private comparison protocol with a little revision. These features are rare for quantum communication protocols, and make our protocol more robust. Thirdly, entanglements of the BPB-class states are calculated in the Appendix.

A kind of universal quantum secret sharing protocol.

PubMed

Chen, Xiu-Bo; Dou, Zhao; Xu, Gang; He, Xiao-Yu; Yang, Yi-Xian

2017-01-12

Universality is an important feature, but less researched in quantum communication protocols. In this paper, a kind of universal quantum secret sharing protocol is investigated. Firstly, we design a quantum secret sharing protocol based on the Borras-Plastino-Batle (BPB) state. Departing from previous research, our protocol has a salient feature in that participants in our protocol only need projective measurement instead of any unitary operations. It makes our protocol more flexible. Secondly, universality of quantum communication protocols is studied for the first time. More specifically, module division of quantum communication protocols and coupling between different modules are discussed. Our aforementioned protocol is analyzed as an example. On one hand, plenty of quantum states (the BPB-class states and the BPB-like-class states, which are proposed in this paper) could be used as carrier to perform our protocol. On the other hand, our protocol also could be regarded as a quantum private comparison protocol with a little revision. These features are rare for quantum communication protocols, and make our protocol more robust. Thirdly, entanglements of the BPB-class states are calculated in the Appendix.

A kind of universal quantum secret sharing protocol

PubMed Central

Chen, Xiu-Bo; Dou, Zhao; Xu, Gang; He, Xiao-Yu; Yang, Yi-Xian

2017-01-01

Universality is an important feature, but less researched in quantum communication protocols. In this paper, a kind of universal quantum secret sharing protocol is investigated. Firstly, we design a quantum secret sharing protocol based on the Borras-Plastino-Batle (BPB) state. Departing from previous research, our protocol has a salient feature in that participants in our protocol only need projective measurement instead of any unitary operations. It makes our protocol more flexible. Secondly, universality of quantum communication protocols is studied for the first time. More specifically, module division of quantum communication protocols and coupling between different modules are discussed. Our aforementioned protocol is analyzed as an example. On one hand, plenty of quantum states (the BPB-class states and the BPB-like-class states, which are proposed in this paper) could be used as carrier to perform our protocol. On the other hand, our protocol also could be regarded as a quantum private comparison protocol with a little revision. These features are rare for quantum communication protocols, and make our protocol more robust. Thirdly, entanglements of the BPB-class states are calculated in the Appendix. PMID:28079109

Guidelines and sample protocol for sampling forest gaps.

Treesearch

J.R. Runkle

1992-01-01

A protocol for sampling forest canopy gaps is presented. Methods used in published gap studies are reviewed. The sample protocol will be useful in developing a broader understanding of forest structure and dynamics through comparative studies across different forest ecosystems.

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

Pharmaceutical care for patients with COPD in Belgium and views on protocol implementation.

PubMed

Tommelein, Eline; Tollenaere, Kathleen; Mehuys, Els; Boussery, Koen

2014-08-01

A protocol-based pharmaceutical care program (the PHARMACOP-protocol) focusing on patient counselling during prescription filling has shown to be effective in patients with chronic obstructive pulmonary disease (COPD). However, implementation of this protocol in daily practice has not yet been studied. To describe current implementation level of the items included in the PHARMACOP-protocol in Belgian community pharmacies and to evaluate pharmacists' perspectives on the implementation of this protocol in daily practice. A cross-sectional study was conducted from April to June 2012, in randomly selected community pharmacies in Flanders. Pharmacists were questionned using structured interviews. 125 pharmacies were contacted and 80 managing pharmacists (64 %) participated. In >70 % of pharmacies, 4/7 protocol items for first prescriptions and 3/5 protocol items for follow-up prescriptions were already routinely implemented. For first and follow-up prescriptions, respectively 39 (49 %) and 34 pharmacists (43 %) stated they would need to spend at least 5 min extra to offer optimal patient counselling. Most mentioned barriers preventing protocol implementation included lack of time (80 %), no integration in pharmacy software (61 %) and too much administrative burden (58 %). Approximately 50 % of the PHARMACOP-protocol items are currently routinely provided in Belgian community pharmacies. Nearly all interviewed pharmacists are willing to implement the protocol fully or partially in daily practice.

Development of an HPV Educational Protocol for Adolescents

PubMed Central

Wetzel, Caitlin; Tissot, Abbigail; Kollar, Linda M.; Hillard, Paula A.; Stone, Rachel; Kahn, Jessica A.

2007-01-01

Study Objectives To develop an educational protocol about HPV and Pap tests for adolescents, to evaluate the protocol for understandability and clarity, and to evaluate the protocol for its effectiveness in increasing knowledge about HPV. Design In phase 1, investigators and adolescents developed the protocol. In phase 2, adolescents evaluated the protocol qualitatively, investigators evaluated its effectiveness in increasing HPV knowledge in a sample of adolescents, and the protocol was revised. In phase 3, investigators evaluated the effectiveness of the revised protocol in an additional adolescent sample. Setting Urban, hospital-based teen health center. Participants A total of 252 adolescent girls and boys in the three study phases. Main Outcome Measures Pre- and post-protocol knowledge about HPV, measured using a 10- or 11-item scale. Results Scores on the HPV knowledge scale increased significantly (p<.0001) among adolescents who participated in phases 2 and 3 after they received the protocol. Initial differences in scores based on race, insurance type and condom use were not noted post-protocol. Conclusion The protocol significantly increased knowledge scores about HPV in this population, regardless of sociodemographic characteristics and risk behaviors. Effective, developmentally appropriate educational protocols about HPV and Pap tests are particularly important in clinical settings as cervical cancer screening guidelines evolve, HPV DNA testing is integrated into screening protocols, and HPV vaccines become available. In-depth, one-on-one education about HPV may also prevent adverse psychosocial responses and promote healthy sexual and Pap screening behaviors in adolescents with abnormal HPV or Pap test results. Synopsis The investigators developed an educational protocol about HPV and Pap tests and evaluated its effectiveness in increasing knowledge about HPV among adolescents. PMID:17868894

An electronic specimen collection protocol schema (eSCPS). Document architecture for specimen management and the exchange of specimen collection protocols between biobanking information systems.

PubMed

Eminaga, O; Semjonow, A; Oezguer, E; Herden, J; Akbarov, I; Tok, A; Engelmann, U; Wille, S

2014-01-01

The integrity of collection protocols in biobanking is essential for a high-quality sample preparation process. However, there is not currently a well-defined universal method for integrating collection protocols in the biobanking information system (BIMS). Therefore, an electronic schema of the collection protocol that is based on Extensible Markup Language (XML) is required to maintain the integrity and enable the exchange of collection protocols. The development and implementation of an electronic specimen collection protocol schema (eSCPS) was performed at two institutions (Muenster and Cologne) in three stages. First, we analyzed the infrastructure that was already established at both the biorepository and the hospital information systems of these institutions and determined the requirements for the sufficient preparation of specimens and documentation. Second, we designed an eSCPS according to these requirements. Finally, a prospective study was conducted to implement and evaluate the novel schema in the current BIMS. We designed an eSCPS that provides all of the relevant information about collection protocols. Ten electronic collection protocols were generated using the supplementary Protocol Editor tool, and these protocols were successfully implemented in the existing BIMS. Moreover, an electronic list of collection protocols for the current studies being performed at each institution was included, new collection protocols were added, and the existing protocols were redesigned to be modifiable. The documentation time was significantly reduced after implementing the eSCPS (5 ± 2 min vs. 7 ± 3 min; p = 0.0002). The eSCPS improves the integrity and facilitates the exchange of specimen collection protocols in the existing open-source BIMS.

A comparative study of routing protocols of heterogeneous wireless sensor networks.

PubMed

Han, Guangjie; Jiang, Xu; Qian, Aihua; Rodrigues, Joel J P C; Cheng, Long

2014-01-01

Recently, heterogeneous wireless sensor network (HWSN) routing protocols have drawn more and more attention. Various HWSN routing protocols have been proposed to improve the performance of HWSNs. Among these protocols, hierarchical HWSN routing protocols can improve the performance of the network significantly. In this paper, we will evaluate three hierarchical HWSN protocols proposed recently--EDFCM, MCR, and EEPCA--together with two previous classical routing protocols--LEACH and SEP. We mainly focus on the round of the first node dies (also called the stable period) and the number of packets sent to sink, which is an important aspect to evaluate the monitoring ability of a protocol. We conduct a lot of experiments and simulations on Matlab to analyze the performance of the five routing protocols.

Comparison between stress myocardial perfusion SPECT recorded with cadmium-zinc-telluride and Anger cameras in various study protocols.

PubMed

Verger, Antoine; Djaballah, Wassila; Fourquet, Nicolas; Rouzet, François; Koehl, Grégoire; Imbert, Laetitia; Poussier, Sylvain; Fay, Renaud; Roch, Véronique; Le Guludec, Dominique; Karcher, Gilles; Marie, Pierre-Yves

2013-02-01

The results of stress myocardial perfusion SPECT could be enhanced by new cadmium-zinc-telluride (CZT) cameras, although differences compared to the results with conventional Anger cameras remain poorly known for most study protocols. This study was aimed at comparing the results of CZT and Anger SPECT according to various study protocols while taking into account the influence of obesity. The study population, which was from three different institutions equipped with identical CZT cameras, comprised 276 patients referred for study using protocols involving (201)Tl (n = 120) or (99m)Tc-sestamibi injected at low dose at stress ((99m)Tc-Low; stress/rest 1-day protocol; n = 110) or at high dose at stress ((99m)Tc-High; rest/stress 1-day or 2-day protocol; n = 46). Each Anger SPECT scan was followed by a high-speed CZT SPECT scan (2 to 4 min). Agreement rates between CZT and Anger SPECT were good irrespective of the study protocol (for abnormal SPECT, (201)Tl 92 %, (99m)Tc-Low 86 %, (99m)Tc-High 98 %), although quality scores were much higher for CZT SPECT with all study protocols. Overall correlations were high for the extent of myocardial infarction (r = 0.80) and a little lower for ischaemic areas (r = 0.72), the latter being larger on Anger SPECT (p < 0.001). This larger extent was mainly observed in 50 obese patients who were in the (201)Tl or (99m)Tc-Low group and in whom stress myocardial counts were particularly low with Anger SPECT (228 ± 101 kcounts) and dramatically enhanced with CZT SPECT (+279 ± 251 %). Concordance between the results of CZT and Anger SPECT is good regardless of study protocol and especially when excluding obese patients who have low-count Anger SPECT and for whom myocardial counts are dramatically enhanced on CZT SPECT.

How to write a surgical clinical research protocol: literature review and practical guide.

PubMed

Rosenthal, Rachel; Schäfer, Juliane; Briel, Matthias; Bucher, Heiner C; Oertli, Daniel; Dell-Kuster, Salome

2014-02-01

The study protocol is the core document of every clinical research project. Clinical research in studies involving surgical interventions presents some specific challenges, which need to be accounted for and described in the study protocol. The aim of this review is to provide a practical guide for developing a clinical study protocol for surgical interventions with a focus on methodologic issues. On the basis of an in-depth literature search of methodologic literature and on some cardinal published surgical trials and observational studies, the authors provides a 10-step guide for developing a clinical study protocol in surgery. This practical guide outlines key methodologic issues important when planning an ethically and scientifically sound research project involving surgical interventions, with the ultimate goal of providing high-level evidence relevant for health care decision making in surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

Post-trial period surveillance for randomised controlled cardiovascular studies: submitted protocols, consent forms and the role of the ethics board.

PubMed

Zia, Mohammad I; Heslegrave, Ronald; Newton, Gary E

2011-12-01

The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. An observational study of protocols of randomised trials of chronic therapies for cardiac conditions, approved by the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded. 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period. The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised.

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.

Protecting intellectual property associated with Canadian academic clinical trials - approaches and impact

PubMed Central

2012-01-01

Intellectual property is associated with the creative work needed to design clinical trials. Two approaches have developed to protect the intellectual property associated with multicentre trial protocols prior to site initiation. The ‘open access’ approach involves publishing the protocol, permitting easy access to the complete protocol. The main advantages of the open access approach are that the protocol is freely available to all stakeholders, permitting them to discuss the protocol widely with colleagues, assess the quality and rigour of the protocol, determine the feasibility of conducting the trial at their centre, and after trial completion, to evaluate the reported findings based on a full understanding of the protocol. The main potential disadvantage of this approach is the potential for plagiarism; however if that occurred, it should be easy to identify because of the open access to the original trial protocol, as well as ensure that appropriate sanctions are used to deal with plagiarism. The ‘restricted access’ approach involves the use of non-disclosure agreements, legal documents that must be signed between the trial lead centre and collaborative sites. Potential sites must guarantee they will not disclose any details of the study before they are permitted to access the protocol. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial. The main disadvantages are that ownership of the protocol and intellectual property is assigned to the lead institution; defining who ‘needs to know’ about the study protocol is difficult; and the use of non-disclosure agreements involves review by lawyers and institutional representatives at each site before access is permitted to the protocol, significantly delaying study implementation and adding substantial indirect costs to research institutes. This extra step may discourage sites from joining a trial. It is possible that the restricted access approach may contribute to the failure of well-designed trials without any significant benefit in protecting intellectual property. Funding agencies should formalize rules around open versus restricted access to the study protocol just as they have around open access to results. PMID:23270486

Protecting intellectual property associated with Canadian academic clinical trials--approaches and impact.

PubMed

Ross, Sue; Magee, Laura; Walker, Mark; Wood, Stephen

2012-12-27

Intellectual property is associated with the creative work needed to design clinical trials. Two approaches have developed to protect the intellectual property associated with multicentre trial protocols prior to site initiation. The 'open access' approach involves publishing the protocol, permitting easy access to the complete protocol. The main advantages of the open access approach are that the protocol is freely available to all stakeholders, permitting them to discuss the protocol widely with colleagues, assess the quality and rigour of the protocol, determine the feasibility of conducting the trial at their centre, and after trial completion, to evaluate the reported findings based on a full understanding of the protocol. The main potential disadvantage of this approach is the potential for plagiarism; however if that occurred, it should be easy to identify because of the open access to the original trial protocol, as well as ensure that appropriate sanctions are used to deal with plagiarism. The 'restricted access' approach involves the use of non-disclosure agreements, legal documents that must be signed between the trial lead centre and collaborative sites. Potential sites must guarantee they will not disclose any details of the study before they are permitted to access the protocol. The main advantages of the restricted access approach are for the lead institution and nominated principal investigator, who protect their intellectual property associated with the trial. The main disadvantages are that ownership of the protocol and intellectual property is assigned to the lead institution; defining who 'needs to know' about the study protocol is difficult; and the use of non-disclosure agreements involves review by lawyers and institutional representatives at each site before access is permitted to the protocol, significantly delaying study implementation and adding substantial indirect costs to research institutes. This extra step may discourage sites from joining a trial. It is possible that the restricted access approach may contribute to the failure of well-designed trials without any significant benefit in protecting intellectual property. Funding agencies should formalize rules around open versus restricted access to the study protocol just as they have around open access to results.

Quantum cryptography protocols robust against photon number splitting attacks for weak laser pulse implementations.

PubMed

Scarani, Valerio; Acín, Antonio; Ribordy, Grégoire; Gisin, Nicolas

2004-02-06

We introduce a new class of quantum key distribution protocols, tailored to be robust against photon number splitting (PNS) attacks. We study one of these protocols, which differs from the original protocol by Bennett and Brassard (BB84) only in the classical sifting procedure. This protocol is provably better than BB84 against PNS attacks at zero error.

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.

The impact of the Family Communication Coordinator (FCC) Protocol on the role stress of hospital chaplains.

PubMed

Dodd-McCue, Diane; Tartaglia, Alexander

2005-01-01

The Family Communication Coordinator (FCC) Protocol was implemented to provide early family intervention and to facilitate effective communications during potential organ donation cases. Previous studies found the Protocol associated with improved donor outcome measures and with reduced role stress for ICU nurses caring for potential donors. The present study examines the impact of the Protocol on the perceived role stress of hospital chaplains serving as FCCs. All hospital chaplains serving as FCCs at an academic teaching hospital were surveyed. Their perceptions of job dimensions, role stress, job satisfaction, and commitment were measured; interviews and secondary data supplemented the surveys. The findings demonstrate that the FCC Protocol is associated with improved role stress, specifically role ambiguity and role conflict, among hospital chaplains serving as FCCs. Additionally, the findings suggest that satisfaction with the Protocol may be associated with experience with the Protocol.

Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study Protocol.

PubMed

Hensel, Kendi L; Carnes, Michael S; Stoll, Scott T

2016-11-01

The structural and physiologic changes in a woman's body during pregnancy can predispose pregnant women to low back pain and its associated disability, as well as to complications of pregnancy, labor, and delivery. Anecdotal and empirical evidence has indicated that osteopathic manipulative treatment (OMT) may be efficacious in improving pain and functionality in women who are pregnant. Based on that premise, the Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study was designed as a prospective, randomized, placebo-controlled, and blinded clinical trial to evaluate the efficacy of an OMT protocol for pain during third-trimester pregnancy. The OMT protocol developed for the PROMOTE study was based on physiologic theory and the concept of the interrelationship of structure and function. The 12 well-defined, standardized OMT techniques used in the protocol are commonly taught at osteopathic medical schools in the United States. These techniques can be easily replicated as a 20-minute protocol applied in conjunction with usual prenatal care, thus making it feasible to implement into clinical practice. This article presents an overview of the study design and treatment protocols used in the PROMOTE study.

Sample of Second Grade Classroom Protocols from Special Study A of the Beginning Teacher Evaluation Study for the California Commission for Teacher Preparation and Licensing.

ERIC Educational Resources Information Center

Tikunoff, William J.; And Others

Second grade classroom protocols collected within this volume are examples of the protocols developed by the ethnographers associated with Special Study A: "An Ethnographic Study of the Forty Classrooms of the Beginning Teacher Evaluation Study." Twenty teachers at both the second and fifth grades were observed for one week by an…

Sample of Fifth Grade Classroom Protocols from Special Study A of the Beginning Teacher Evaluation Study for the California Commission for Teacher Preparation and Licensing.

ERIC Educational Resources Information Center

Tikunoff, William J.; And Others

Classroom protocols collected within this volume are examples of the protocols from grade 5 developed by the ethnographers associated with Special Study A: "An Ethnographic Study of the Forty Classrooms of the Beginning Teacher Evaluation Study." Twenty teachers at both the second and fifth grades were observed for one week by an…

CT and MR Protocol Standardization Across a Large Health System: Providing a Consistent Radiologist, Patient, and Referring Provider Experience.

PubMed

Sachs, Peter B; Hunt, Kelly; Mansoubi, Fabien; Borgstede, James

2017-02-01

Building and maintaining a comprehensive yet simple set of standardized protocols for a cross-sectional image can be a daunting task. A single department may have difficulty preventing "protocol creep," which almost inevitably occurs when an organized "playbook" of protocols does not exist and individual radiologists and technologists alter protocols at will and on a case-by-case basis. When multiple departments or groups function in a large health system, the lack of uniformity of protocols can increase exponentially. In 2012, the University of Colorado Hospital formed a large health system (UCHealth) and became a 5-hospital provider network. CT and MR imaging studies are conducted at multiple locations by different radiology groups. To facilitate consistency in ordering, acquisition, and appearance of a given study, regardless of location, we minimized the number of protocols across all scanners and sites of practice with a clinical indication-driven protocol selection and standardization process. Here we review the steps utilized to perform this process improvement task and insure its stability over time. Actions included creation of a standardized protocol template, which allowed for changes in electronic storage and management of protocols, designing a change request form, and formation of a governance structure. We utilized rapid improvement events (1 day for CT, 2 days for MR) and reduced 248 CT protocols into 97 standardized protocols and 168 MR protocols to 66. Additional steps are underway to further standardize output and reporting of imaging interpretation. This will result in an improved, consistent radiologist, patient, and provider experience across the system.

Development of a manualized protocol of massage therapy for clinical trials in osteoarthritis.

PubMed

Ali, Ather; Kahn, Janet; Rosenberger, Lisa; Perlman, Adam I

2012-10-04

Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials. The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists' clinical judgment and maintaining consistency with a prior pilot study. The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated. The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings. Clinicaltrials.gov NCT00970008 (18 August 2009).

Physical Therapy Protocols for Arthroscopic Bankart Repair.

PubMed

DeFroda, Steven F; Mehta, Nabil; Owens, Brett D

Outcomes after arthroscopic Bankart repair can be highly dependent on compliance and participation in physical therapy. Additionally, there are many variations in physician-recommended physical therapy protocols. The rehabilitation protocols of academic orthopaedic surgery departments vary widely despite the presence of consensus protocols. Descriptive epidemiology study. Level 3. Web-based arthroscopic Bankart rehabilitation protocols available online from Accreditation Council for Graduate Medical Education (ACGME)-accredited orthopaedic surgery programs were included for review. Individual protocols were reviewed to evaluate for the presence or absence of recommended therapies, goals for completion of ranges of motion, functional milestones, exercise start times, and recommended time to return to sport. Thirty protocols from 27 (16.4%) total institutions were identified out of 164 eligible for review. Overall, 9 (30%) protocols recommended an initial period of strict immobilization. Variability existed between the recommended time periods for sling immobilization (mean, 4.8 ± 1.8 weeks). The types of exercises and their start dates were also inconsistent. Goals to full passive range of motion (mean, 9.2 ± 2.8 weeks) and full active range of motion (mean, 12.2 ± 2.8 weeks) were consistent with other published protocols; however, wide ranges existed within the reviewed protocols as a whole. Only 10 protocols (33.3%) included a timeline for return to sport, and only 3 (10%) gave an estimate for return to game competition. Variation also existed when compared with the American Society of Shoulder and Elbow Therapists' (ASSET) consensus protocol. Rehabilitation protocols after arthroscopic Bankart repair were found to be highly variable. They also varied with regard to published consensus protocols. This discrepancy may lead to confusion among therapists and patients. This study highlights the importance of attending surgeons being very clear and specific with regard to their physical therapy instructions to patients and therapists.

Comparison of slow and accelerated rehabilitation protocol after arthroscopic rotator cuff repair: pain and functional activity.

PubMed

Düzgün, Irem; Baltacı, Gül; Atay, O Ahmet

2011-01-01

In this study, we sought to compare the effects of the slow and accelerated protocols on pain and functional activity level after arthroscopic rotator cuff repair. The study included 29 patients (3 men, 26 women) who underwent arthroscopic repair of stage 2 and 3 rotator cuff tears. Patients were randomized in two groups: the accelerated protocol group (n=13) and slow protocol group (n=16). Patients in the accelerated protocol group participated in a preoperative rehabilitation program for 4-6 weeks. Patients were evaluated preoperatively and for 24 weeks postoperatively. Pain was assessed by visual analog scale, and functional activity level was assessed by The Disabilities of The Arm Shoulder and Hand (DASH) questionnaire. The active range of motion was initiated at week 3 after surgery for the accelerated rehabilitation protocol and at week 6 for the slow protocol. The rehabilitation program was completed by the 8th week with the accelerated protocol and by the 22nd week with the slow protocol. There was no significant difference between the slow and accelerated protocols with regard to pain at rest (p>0.05). However, the accelerated protocol was associated with less pain during activity at weeks 5 and 16, and with less pain at night during week 5 (p<0.05). The accelerated protocol was superior to the slow protocol in terms of functional activity level, as determined by DASH at weeks 8, 12, and 16 after surgery (p<0.05). The accelerated protocol is recommended to physical therapists during rehabilitation after arthroscopic rotator cuff repair to prevent the negative effects of immobilization and to support rapid reintegration to daily living activities.

Tiered protocol implementation improves treatment of hypoglycaemia in a neurosciences critical care and surgical intensive care unit.

PubMed

Van Berkel, Megan A; MacDermott, Jennifer; Dungan, Kathleen M; Cook, Charles H; Murphy, Claire V

2017-12-01

Although studies demonstrate techniques to limit hypoglycaemia in critically ill patients, there are limited data supporting methods to improve management of existing hypoglycaemia. Assess the impact and sustainability of a computerised, three tiered, nurse driven protocol for hypoglycaemia treatment. Retrospective pre and post protocol study. Neurosciences and surgical intensive care units at a tertiary academic medical centre. Patients with a hypoglycaemic episode were included during a pre-protocol or post-protocol implementation period. An additional six-month cohort was evaluated to assess sustainability. Fifty-four patients were included for evaluation (35 pre- and 19 post-protocol); 122 patients were included in the sustainability cohort. Hypoglycaemia treatment significantly improved in the post-protocol cohort (20% vs. 52.6%, p=0.014); with additional improvement to 79.5% in the sustainability cohort. Time to follow-up blood glucose was decreased after treatment from 122 [Q1-Q3: 46-242] minutes pre-protocol to 25 [Q1-Q3: 9-48] minutes post protocol (p<0.0001). This reduction was maintained in the sustainability cohort [median of 29min (Q1-Q3: 20-51)]. Implementation of a nurse-driven, three-tiered protocol for treatment of hypoglyacemia significantly improved treatment rates, as well as reduced time to recheck blood glucose measurement. These benefits were sustained during a six-month period after protocol implementation. Copyright © 2017 Elsevier Ltd. All rights reserved.

Who needs inpatient detox? Development and implementation of a hospitalist protocol for the evaluation of patients for alcohol detoxification.

PubMed

Stephens, John R; Liles, E Allen; Dancel, Ria; Gilchrist, Michael; Kirsch, Jonathan; DeWalt, Darren A

2014-04-01

Clinicians caring for patients seeking alcohol detoxification face many challenges, including lack of evidence-based guidelines for treatment and high recidivism rates. To develop a standardized protocol for determining which alcohol dependent patients seeking detoxification need inpatient versus outpatient treatment, and to study the protocol's implementation. Review of best evidence by ad hoc task force and subsequent creation of standardized protocol. Prospective observational evaluation of initial protocol implementation. Patients presenting for alcohol detoxification. Development and implementation of a protocol for evaluation and treatment of patients requesting alcohol detoxification. Number of admissions per month with primary alcohol related diagnosis (DRG), 30-day readmission rate, and length of stay, all measured before and after protocol implementation. We identified one randomized clinical trial and three cohort studies to inform the choice of inpatient versus outpatient detoxification, along with one prior protocol in this population, and combined that data with clinical experience to create an institutional protocol. After implementation, the average number of alcohol related admissions was 15.9 per month, compared with 18.9 per month before implementation (p = 0.037). There was no difference in readmission rate or length of stay. Creation and utilization of a protocol led to standardization of care for patients requesting detoxification from alcohol. Initial evaluation of protocol implementation showed a decrease in number of admissions.

A protocol for rheological characterization of hydrogels for tissue engineering strategies.

PubMed

Zuidema, Jonathan M; Rivet, Christopher J; Gilbert, Ryan J; Morrison, Faith A

2014-07-01

Hydrogels are studied extensively for many tissue engineering applications, and their mechanical properties influence both cellular and tissue compatibility. However, it is difficult to compare the mechanical properties of hydrogels between studies due to a lack of continuity between rheological protocols. This study outlines a straightforward protocol to accurately determine hydrogel equilibrium modulus and gelation time using a series of rheological tests. These protocols are applied to several hydrogel systems used within tissue engineering applications: agarose, collagen, fibrin, Matrigel™, and methylcellulose. The protocol is outlined in four steps: (1) Time sweep to determine the gelation time of the hydrogel. (2) Strain sweep to determine the linear-viscoelastic region of the hydrogel with respect to strain. (3) Frequency sweep to determine the linear equilibrium modulus plateau of the hydrogel. (4) Time sweep with values obtained from strain and frequency sweeps to accurately report the equilibrium moduli and gelation time. Finally, the rheological characterization protocol was evaluated using a composite Matrigel™-methylcellulose hydrogel blend whose mechanical properties were previously unknown. The protocol described herein provides a standardized approach for proper analysis of hydrogel rheological properties. © 2013 Wiley Periodicals, Inc.

The Robinson Protocol: a treadmill anaerobic performance test.

PubMed

Robinson, Ellyn M; Graham, Louise B; Headley, Samuel A

2004-08-01

The current investigation was designed to further examine the reliability of the Robinson protocol, which is a run-to-exhaustion treadmill test. Robinson (10) originally examined this protocol with 5 subjects. The significance of the initial exploratory study was the impetus for expanding the study to examine the reliability of the protocol with a larger sample. Fifteen male subjects participated in 3 trial runs on the treadmill. The first trial was a modified McConnell (7) test to determine the aerobic capacity of each subject. The second and third trials were identical Robinson protocols (10). The first trial run mean, in seconds (262.04 +/- 74.50), was not significantly different from the second trial run mean (257.30 +/- 72.65), p = 0.526 (2 tailed). As expected, trial 1 and trial 2 were highly correlated (intraclass) (r = 0.927, p < 0.001). These results provide additional support for the hypothesis that the Robinson protocol with a greater subject pool is a reliable protocol that can be used in research studies interested in examining various physiological interventions or anaerobic training.

Implementation of Symptom Protocols for Nurses Providing Telephone‐Based Cancer Symptom Management: A Comparative Case Study

PubMed Central

Green, Esther; Ballantyne, Barbara; Tarasuk, Joy; Skrutkowski, Myriam; Carley, Meg; Chapman, Kim; Kuziemsky, Craig; Kolari, Erin; Sabo, Brenda; Saucier, Andréanne; Shaw, Tara; Tardif, Lucie; Truant, Tracy; Cummings, Greta G.; Howell, Doris

2016-01-01

ABSTRACT Background The pan‐Canadian Oncology Symptom Triage and Remote Support (COSTaRS) team developed 13 evidence‐informed protocols for symptom management. Aim To build an effective and sustainable approach for implementing the COSTaRS protocols for nurses providing telephone‐based symptom support to cancer patients. Methods A comparative case study was guided by the Knowledge to Action Framework. Three cases were created for three Canadian oncology programs that have nurses providing telephone support. Teams of researchers and knowledge users: (a) assessed barriers and facilitators influencing protocol use, (b) adapted protocols for local use, (c) intervened to address barriers, (d) monitored use, and (e) assessed barriers and facilitators influencing sustained use. Analysis was within and across cases. Results At baseline, >85% nurses rated protocols positively but barriers were identified (64‐80% needed training). Patients and families identified similar barriers and thought protocols would enhance consistency among nurses teaching self‐management. Twenty‐two COSTaRS workshops reached 85% to 97% of targeted nurses (N = 119). Nurses felt more confident with symptom management and using the COSTaRS protocols (p < .01). Protocol adaptations addressed barriers (e.g., health records approval, creating pocket versions, distributing with telephone messages). Chart audits revealed that protocols used were documented for 11% to 47% of patient calls. Sustained use requires organizational alignment and ongoing leadership support. Linking Evidence to Action Protocol uptake was similar to trials that have evaluated tailored interventions to improve professional practice by overcoming identified barriers. Collaborating with knowledge users facilitated interpretation of findings, aided protocol adaptation, and supported implementation. Protocol implementation in nursing requires a tailored approach. A multifaceted intervention approach increased nurses’ use of evidence‐informed protocols during telephone calls with patients about symptoms. Training and other interventions improved nurses’ confidence with using COSTaRS protocols and their uptake was evident in some documented telephone calls. Protocols could be adapted for use by patients and nurses globally. PMID:27243574

Evaluation of Interoperability Protocols in Repositories of Electronic Theses and Dissertations

ERIC Educational Resources Information Center

Hakimjavadi, Hesamedin; Masrek, Mohamad Noorman

2013-01-01

Purpose: The purpose of this study is to evaluate the status of eight interoperability protocols within repositories of electronic theses and dissertations (ETDs) as an introduction to further studies on feasibility of deploying these protocols in upcoming areas of interoperability. Design/methodology/approach: Three surveys of 266 ETD…

The "ComPAS Trial" combined treatment model for acute malnutrition: study protocol for the economic evaluation.

PubMed

Lelijveld, Natasha; Bailey, Jeanette; Mayberry, Amy; Trenouth, Lani; N'Diaye, Dieynaba S; Haghparast-Bidgoli, Hassan; Puett, Chloe

2018-04-24

Acute malnutrition is currently divided into severe (SAM) and moderate (MAM) based on level of wasting. SAM and MAM currently have separate treatment protocols and products, managed by separate international agencies. For SAM, the dose of treatment is allocated by the child's weight. A combined and simplified protocol for SAM and MAM, with a standardised dose of ready-to-use therapeutic food (RUTF), is being trialled for non-inferior recovery rates and may be more cost-effective than the current standard protocols for treating SAM and MAM. This is the protocol for the economic evaluation of the ComPAS trial, a cluster-randomised controlled, non-inferiority trial that compares a novel combined protocol for treating uncomplicated acute malnutrition compared to the current standard protocol in South Sudan and Kenya. We will calculate the total economic costs of both protocols from a societal perspective, using accounting data, interviews and survey questionnaires. The incremental cost of implementing the combined protocol will be estimated, and all costs and outcomes will be presented as a cost-consequence analysis. Incremental cost-effectiveness ratio will be calculated for primary and secondary outcome, if statistically significant. We hypothesise that implementing the combined protocol will be cost-effective due to streamlined logistics at clinic level, reduced length of treatment, especially for MAM, and reduced dosages of RUTF. The findings of this economic evaluation will be important for policymakers, especially given the hypothesised non-inferiority of the main health outcomes. The publication of this protocol aims to improve rigour of conduct and transparency of data collection and analysis. It is also intended to promote inclusion of economic evaluation in other nutrition intervention studies, especially for MAM, and improve comparability with other studies. ISRCTN 30393230 , date: 16/03/2017.

Evaluating anesthetic protocols for functional blood flow imaging in the rat eye

NASA Astrophysics Data System (ADS)

Moult, Eric M.; Choi, WooJhon; Boas, David A.; Baumann, Bernhard; Clermont, Allen C.; Feener, Edward P.; Fujimoto, James G.

2017-01-01

The purpose of this study is to evaluate the suitability of five different anesthetic protocols (isoflurane, isoflurane-xylazine, pentobarbital, ketamine-xylazine, and ketamine-xylazine-vecuronium) for functional blood flow imaging in the rat eye. Total retinal blood flow was measured at a series of time points using an ultrahigh-speed Doppler OCT system. Additionally, each anesthetic protocol was qualitatively evaluated according to the following criteria: (1) time-stability of blood flow, (2) overall rate of blood flow, (3) ocular immobilization, and (4) simplicity. We observed that different anesthetic protocols produced markedly different blood flows. Different anesthetic protocols also varied with respect to the four evaluated criteria. These findings suggest that the choice of anesthetic protocol should be carefully considered when designing and interpreting functional blood flow studies in the rat eye.

Londrina Activities of Daily Living Protocol: Reproducibility, Validity, and Reference Values in Physically Independent Adults Age 50 Years and Older.

PubMed

Paes, Thaís; Belo, Letícia Fernandes; da Silva, Diego Rodrigues; Morita, Andrea Akemi; Donária, Leila; Furlanetto, Karina Couto; Sant'Anna, Thaís; Pitta, Fabio; Hernandes, Nidia Aparecida

2017-03-01

It is important to assess activities of daily living (ADL) in older adults due to impairment of independence and quality of life. However, there is no objective and standardized protocol available to assess this outcome. Thus, the aim of this study was to verify the reproducibility and validity of a new protocol for ADL assessment applied in physically independent adults age ≥50 y, the Londrina ADL protocol, and to establish an equation to predict reference values of the Londrina ADL protocol. Ninety-three physically independent adults age ≥50 y had their performance in ADL evaluated by registering the time spent to conclude the protocol. The protocol was performed twice. The 6-min walk test, which assesses functional exercise capacity, was used as a validation criterion. A multiple linear regression model was applied, including anthropometric and demographic variables that correlated with the protocol, to establish an equation to predict the protocol's reference values. In general, the protocol was reproducible (intraclass correlation coefficient 0.91). The average difference between the first and second protocol was 5.3%. The new protocol was valid to assess ADL performance in the studied subjects, presenting a moderate correlation with the 6-min walk test (r = -0.53). The time spent to perform the protocol correlated significantly with age (r = 0.45) but neither with weight (r = -0.17) nor with height (r = -0.17). A model of stepwise multiple regression including sex and age showed that age was the only determinant factor to the Londrina ADL protocol, explaining 21% ( P < .001) of its variability. The derived reference equation was: Londrina ADL protocol pred (s) = 135.618 + (3.102 × age [y]). The Londrina ADL protocol was reproducible and valid in physically independent adults age ≥50 y. A reference equation for the protocol was established including only age as an independent variable (r 2 = 0.21), allowing a better interpretation of the protocol's results in clinical practice. Copyright © 2017 by Daedalus Enterprises.

Two-party quantum key agreement protocols under collective noise channel

NASA Astrophysics Data System (ADS)

Gao, Hao; Chen, Xiao-Guang; Qian, Song-Rong

2018-06-01

Recently, quantum communication has become a very popular research field. The quantum key agreement (QKA) plays an important role in the field of quantum communication, based on its unconditional security in terms of theory. Among all kinds of QKA protocols, QKA protocols resisting collective noise are widely being studied. In this paper, we propose improved two-party QKA protocols resisting collective noise and present a feasible plan for information reconciliation. Our protocols' qubit efficiency has achieved 26.67%, which is the best among all the two-party QKA protocols against collective noise, thus showing that our protocol can improve the transmission efficiency of quantum key agreement.

Clinical outcomes and mortality before and after implementation of a pediatric sepsis protocol in a limited resource setting: A retrospective cohort study in Bangladesh.

PubMed

Kortz, Teresa Bleakly; Axelrod, David M; Chisti, Mohammod J; Kache, Saraswati

2017-01-01

Pediatric sepsis has a high mortality rate in limited resource settings. Sepsis protocols have been shown to be a cost-effective strategy to improve morbidity and mortality in a variety of populations and settings. At Dhaka Hospital in Bangladesh, mortality from pediatric sepsis in high-risk children previously approached 60%, which prompted the implementation of an evidenced-based protocol in 2010. The clinical effectiveness of this protocol had not been measured. We hypothesized that implementation of a pediatric sepsis protocol improved clinical outcomes, including reducing mortality and length of hospital stay. This was a retrospective cohort study of children 1-59 months old with a diagnosis of sepsis, severe sepsis or septic shock admitted to Dhaka Hospital from 10/25/2009-10/25/2011. The primary outcome was inpatient mortality pre- and post-protocol implementation. Secondary outcomes included fluid overload, heart failure, respiratory insufficiency, length of hospital stay, and protocol compliance, as measured by antibiotic and fluid bolus administration within 60 minutes of hospital presentation. 404 patients were identified by a key-word search of the electronic medical record; 328 patients with a primary diagnosis of sepsis, severe sepsis, or septic shock were included (143 pre- and185 post-protocol) in the analysis. Pre- and post-protocol mortality were similar and not statistically significant (32.17% vs. 34.59%, p = 0.72). The adjusted odds ratio (AOR) for post-protocol mortality was 1.55 (95% CI, 0.88-2.71). The odds for developing fluid overload were significantly higher post-protocol (AOR 3.45, 95% CI, 2.04-5.85), as were the odds of developing heart failure (AOR 4.52, 95% CI, 1.43-14.29) and having a longer median length of stay (AOR 1.81, 95% CI 1.10-2.96). There was no statistically significant difference in respiratory insufficiency (pre- 65.7% vs. post- 70.3%, p = 0.4) or antibiotic administration between the cohorts (pre- 16.08% vs. post- 12.43%, p = 0.42). Implementation of a pediatric sepsis protocol did not improve all-cause mortality or length of stay and may have been associated with increased fluid overload and heart failure during the study period in a large, non-governmental hospital in Bangladesh. Similar rates of early antibiotic administration may indicate poor protocol compliance. Though evidenced-based protocols are a potential cost-effective strategy to improve outcomes, future studies should focus on optimal implementation of context-relevant sepsis protocols in limited resource settings.

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

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

PubMed Central

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

2010-01-01

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

Pilot study to evaluate 3 hygiene protocols on the reduction of bacterial load on the hands of veterinary staff performing routine equine physical examinations.

PubMed

Traub-Dargatz, Josie L; Weese, J Scott; Rousseau, Joyce D; Dunowska, Magdalena; Morley, Paul S; Dargatz, David A

2006-07-01

Reduction factors (RFs) for bacterial counts on examiners' hands were compared when performing a standardized equine physical examination, followed by the use of one of 3 hand-hygiene protocols (washing with soap, ethanol gel application, and chlorohexidine-ethanol application). The mean RFs were 1.29 log10 and 1.44 log10 at 2 study sites for the alcohol-gel (62% ethyl alcohol active ingredient) protocols and 1.47 log10 and 1.94 log10 at 2 study sites for the chlorhexidine-alcohol (61% ethyl alcohol plus 1% chlorhexidine active ingredients) protocols, respectively. The RFs were significantly different (P < 0.0001) between the hand-washing group and the other 2 treatment groups (the alcohol-gel and the chlorhexidine-alcohol lotion). The use of alcohol-based gels or chlorhexidine-alcohol hand hygiene protocols must still be proven effective in equine practice settings, but in this study, these protocols were equivalent or superior to hand washing for reduction in bacterial load on the hands of people after they perform routine physical examinations.

Addressing Participant Validity in a Small Internet Health Survey (The Restore Study): Protocol and Recommendations for Survey Response Validation

PubMed Central

Dewitt, James; Capistrant, Benjamin; Kohli, Nidhi; Mitteldorf, Darryl; Merengwa, Enyinnaya; West, William

2018-01-01

Background While deduplication and cross-validation protocols have been recommended for large Web-based studies, protocols for survey response validation of smaller studies have not been published. Objective This paper reports the challenges of survey validation inherent in a small Web-based health survey research. Methods The subject population was North American, gay and bisexual, prostate cancer survivors, who represent an under-researched, hidden, difficult-to-recruit, minority-within-a-minority population. In 2015-2016, advertising on a large Web-based cancer survivor support network, using email and social media, yielded 478 completed surveys. Results Our manual deduplication and cross-validation protocol identified 289 survey submissions (289/478, 60.4%) as likely spam, most stemming from advertising on social media. The basic components of this deduplication and validation protocol are detailed. An unexpected challenge encountered was invalid survey responses evolving across the study period. This necessitated the static detection protocol be augmented with a dynamic one. Conclusions Five recommendations for validation of Web-based samples, especially with smaller difficult-to-recruit populations, are detailed. PMID:29691203

Pilot study to evaluate 3 hygiene protocols on the reduction of bacterial load on the hands of veterinary staff performing routine equine physical examinations

PubMed Central

Traub-Dargatz, Josie L.; Weese, J. Scott; Rousseau, Joyce D.; Dunowska, Magdalena; Morley, Paul S.; Dargatz, David A.

2006-01-01

Abstract Reduction factors (RFs) for bacterial counts on examiners’ hands were compared when performing a standardized equine physical examination, followed by the use of one of 3 hand-hygiene protocols (washing with soap, ethanol gel application, and chlorohexidine-ethanol application). The mean RFs were 1.29 log10 and 1.44 log10 at 2 study sites for the alcohol-gel (62% ethyl alcohol active ingredient) protocols and 1.47 log10 and 1.94 log10 at 2 study sites for the chlorhexidine-alcohol (61% ethyl alcohol plus 1% chlorhexidine active ingredients) protocols, respectively. The RFs were significantly different (P < 0.0001) between the hand-washing group and the other 2 treatment groups (the alcohol-gel and the chlorhexidine-alcohol lotion). The use of alcohol-based gels or chlorhexidine-alcohol hand hygiene protocols must still be proven effective in equine practice settings, but in this study, these protocols were equivalent or superior to hand washing for reduction in bacterial load on the hands of people after they perform routine physical examinations. PMID:16898109

Intra-protocol repeatability and inter-protocol agreement for the analysis of scapulo-humeral coordination.

PubMed

Parel, I; Cutti, A G; Kraszewski, A; Verni, G; Hillstrom, H; Kontaxis, A

2014-03-01

Multi-center clinical trials incorporating shoulder kinematics are currently uncommon. The absence of repeatability and limits of agreement (LoA) studies between different centers employing different motion analysis protocols has led to a lack dataset compatibility. Therefore, the aim of this work was to determine the repeatability and LoA between two shoulder kinematic protocols. The first one uses a scapula tracker (ST), the International Society of Biomechanics anatomical frames and an optoelectronic measurement system, and the second uses a spine tracker, the INAIL Shoulder and Elbow Outpatient protocol (ISEO) and an inertial and magnetic measurement system. First within-protocol repeatability for each approach was assessed on a group of 23 healthy subjects and compared with the literature. Then, the between-protocol agreement was evaluated. The within-protocol repeatability was similar for the ST ([Formula: see text] = 2.35°, [Formula: see text] = 0.97°, SEM = 2.5°) and ISEO ([Formula: see text] = 2.24°, [Formula: see text] = 0.97°, SEM = 2.3°) protocols and comparable with data from published literature. The between-protocol agreement analysis showed comparable scapula medio-lateral rotation measurements for up to 120° of flexion-extension and up to 100° of scapula plane ab-adduction. Scapula protraction-retraction measurements were in agreement for a smaller range of humeral elevation. The results of this study suggest comparable repeatability for the ST and ISEO protocols and between-protocol agreement for two scapula rotations. Different thresholds for repeatability and LoA may be adapted to suit different clinical hypotheses.

[Acceptance and commitment therapy (ACT) and improving chess performance in promising young chess-players].

PubMed

Ruiz, Francisco J; Luciano, Carmen

2009-08-01

Acceptance and Commitment Therapy (ACT) is shown to be effective in relatively distant fields from the so-called psychological disorders. One of these areas is sport performance improvement. The aim of the current study is to expand the application of brief ACT protocols to improve chess-players' performance. In a previous study, a brief protocol was applied to international-level adult chess-players that was effective. The current study aims to apply an equivalent brief ACT protocol, but in this case, applied in a group format to promising young chess-players. In addition, this brief protocol is compared to a non-intervention control condition. Results show that the ACT brief protocol improved the performance in 5 out of 7 participants, and that none of the chess-players in the control condition reached the established change criterion. The differences between the conditions in chess performance were statistically significant. The results are discussed, emphasizing the replicated impact of a brief ACT protocol on the improvement of chess-players' performance.

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.

Addressing Participant Validity in a Small Internet Health Survey (The Restore Study): Protocol and Recommendations for Survey Response Validation.

PubMed

Dewitt, James; Capistrant, Benjamin; Kohli, Nidhi; Rosser, B R Simon; Mitteldorf, Darryl; Merengwa, Enyinnaya; West, William

2018-04-24

While deduplication and cross-validation protocols have been recommended for large Web-based studies, protocols for survey response validation of smaller studies have not been published. This paper reports the challenges of survey validation inherent in a small Web-based health survey research. The subject population was North American, gay and bisexual, prostate cancer survivors, who represent an under-researched, hidden, difficult-to-recruit, minority-within-a-minority population. In 2015-2016, advertising on a large Web-based cancer survivor support network, using email and social media, yielded 478 completed surveys. Our manual deduplication and cross-validation protocol identified 289 survey submissions (289/478, 60.4%) as likely spam, most stemming from advertising on social media. The basic components of this deduplication and validation protocol are detailed. An unexpected challenge encountered was invalid survey responses evolving across the study period. This necessitated the static detection protocol be augmented with a dynamic one. Five recommendations for validation of Web-based samples, especially with smaller difficult-to-recruit populations, are detailed. ©James Dewitt, Benjamin Capistrant, Nidhi Kohli, B R Simon Rosser, Darryl Mitteldorf, Enyinnaya Merengwa, William West. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.04.2018.

Evaluation of Patient Handoff Methods on an Inpatient Teaching Service

PubMed Central

Craig, Steven R.; Smith, Hayden L.; Downen, A. Matthew; Yost, W. John

2012-01-01

Background The patient handoff process can be a highly variable and unstructured period at risk for communication errors. The morning sign-in process used by resident physicians at teaching hospitals typically involves less rigorous handoff protocols than the resident evening sign-out process. Little research has been conducted on best practices for handoffs during morning sign-in exchanges between resident physicians. Research must evaluate optimal protocols for the resident morning sign-in process. Methods Three morning handoff protocols consisting of written, electronic, and face-to-face methods were implemented over 3 study phases during an academic year. Study participants included all interns covering the internal medicine inpatient teaching service at a tertiary hospital. Study measures entailed intern survey-based interviews analyzed for failures in handoff protocols with or without missed pertinent information. Descriptive and comparative analyses examined study phase differences. Results A scheduled face-to-face handoff process had the fewest protocol deviations and demonstrated best communication of essential patient care information between cross-covering teams compared to written and electronic sign-in protocols. Conclusion Intern patient handoffs were more reliable when the sign-in protocol included scheduled face-to-face meetings. This method provided the best communication of patient care information and allowed for open exchanges of information. PMID:23267259

Comparison of noninferiority margins reported in protocols and publications showed incomplete and inconsistent reporting.

PubMed

Dekkers, Olaf M; Cevallos, Myriam; Bührer, Jonas; Poncet, Antoine; Ackermann Rau, Sabine; Perneger, Thomas V; Egger, Matthias

2015-05-01

To compare noninferiority margins defined in study protocols and trial registry records with margins reported in subsequent publications. Comparison of protocols of noninferiority trials submitted 2001 to 2005 to ethics committees in Switzerland and The Netherlands with corresponding publications and registry records. We searched MEDLINE via PubMed, the Cochrane Controlled Trials Register (Cochrane Library issue 01/2012), and Google Scholar in September 2013 to identify published reports, and the International Clinical Trials Registry Platform of the World Health Organization in March 2013 to identify registry records. Two readers recorded the noninferiority margin and other data using a standardized data-abstraction form. The margin was identical in study protocol and publication in 43 (80%) of 54 pairs of study protocols and articles. In the remaining pairs, reporting was inconsistent (five pairs, 9%), or the noninferiority margin was either not reported in the publication (five pairs, 9%) or not defined in the study protocol (one pair). The confidence interval or the exact P-value required to judge whether the result was compatible with noninferior, inferior, or superior efficacy was reported in 43 (80%) publications. Complete and consistent reporting of both noninferiority margin and confidence interval (or exact P-value) was present in 39 (72%) protocol-publication pairs. Twenty-nine trials (54%) were registered in trial registries, but only one registry record included the noninferiority margin. The reporting of noninferiority margins was incomplete and inconsistent with study protocols in a substantial proportion of published trials, and margins were rarely reported in trial registries. Copyright © 2015 Elsevier Inc. All rights reserved.

Comparative evaluation of total RNA extraction methods in Theobroma cacao using shoot apical meristems.

PubMed

Silva, D V; Branco, S M J; Holanda, I S A; Royaert, S; Motamayor, J C; Marelli, J P; Corrêa, R X

2016-03-04

Theobroma cacao is a species of great economic importance with its beans used for chocolate production. The tree has been a target of various molecular studies. It contains many polyphenols, which complicate the extraction of nucleic acids with the extraction protocols requiring a large amount of plant material. These issues, therefore, necessitate the optimization of the protocols. The aim of the present study was to evaluate different methods for extraction of total RNA from shoot apical meristems of T. cacao 'CCN 51' and to assess the influence of storage conditions for the meristems on the extraction. The study also aimed to identify the most efficient protocol for RNA extraction using a small amount of plant material. Four different protocols were evaluated for RNA extraction using one shoot apical meristem per sample. Among these protocols, one that was more efficient was then tested to extract RNA using four different numbers of shoot apical meristems, subjected to three different storage conditions. The best protocol was tested for cDNA amplification using reverse transcription-polymerase chain reaction; the cDNA quality was determined to be satisfactory for molecular analyses. The study revealed that with the best RNA extraction protocol, one shoot apical meristem was sufficient for extraction of high-quality total RNA. The results obtained might enable advances in genetic analyses and molecular studies using reduced amount of plant material.

Differences in handgrip strength protocols to identify sarcopenia and frailty - a systematic review.

PubMed

Sousa-Santos, A R; Amaral, T F

2017-10-16

Hand grip strength (HGS) is used for the diagnosis of sarcopenia and frailty. Several factors have been shown to influence HGS values during measurement. Therefore, variations in the protocols used to assess HGS, as part of the diagnosis of sarcopenia and frailty, may lead to the identification of different individuals with low HGS, introducing bias. The aim of this systematic review is to gather all the relevant studies that measured HGS to diagnose sarcopenia and frailty and to identify the differences between the protocols used. A systematic review was carried out following the recommendations of The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement. PubMed and Web of Science were systematically searched, until August 16, 2016. The evidence regarding HGS measurement protocols used to diagnose sarcopenia and frailty was summarised and the most recent protocols regarding the procedure were compared. From the described search 4393 articles were identified. Seventy-two studies were included in this systematic review, in which 37 referred to sarcopenia articles, 33 to frailty and two evaluated both conditions. Most studies presented limited information regarding the protocols used. The majority of the studies included did not describe a complete procedure of HGS measurement. The high heterogeneity between the protocols used, in sarcopenia and frailty studies, create an enormous difficulty in drawing comparative conclusions among them.

A comparative study of wireless sensor networks and their routing protocols.

PubMed

Bhattacharyya, Debnath; Kim, Tai-hoon; Pal, Subhajit

2010-01-01

Recent developments in the area of micro-sensor devices have accelerated advances in the sensor networks field leading to many new protocols specifically designed for wireless sensor networks (WSNs). Wireless sensor networks with hundreds to thousands of sensor nodes can gather information from an unattended location and transmit the gathered data to a particular user, depending on the application. These sensor nodes have some constraints due to their limited energy, storage capacity and computing power. Data are routed from one node to other using different routing protocols. There are a number of routing protocols for wireless sensor networks. In this review article, we discuss the architecture of wireless sensor networks. Further, we categorize the routing protocols according to some key factors and summarize their mode of operation. Finally, we provide a comparative study on these various protocols.

Managing symptoms during cancer treatments: evaluating the implementation of evidence-informed remote support protocols

PubMed Central

2012-01-01

Background Management of cancer treatment-related symptoms is an important safety issue given that symptoms can become life-threatening and often occur when patients are at home. With funding from the Canadian Partnership Against Cancer, a pan-Canadian steering committee was established with representation from eight provinces to develop symptom protocols using a rigorous methodology (CAN-IMPLEMENT©). Each protocol is based on a systematic review of the literature to identify relevant clinical practice guidelines. Protocols were validated by cancer nurses from across Canada. The aim of this study is to build an effective and sustainable approach for implementing evidence-informed protocols for nurses to use when providing remote symptom assessment, triage, and guidance in self-management for patients experiencing symptoms while undergoing cancer treatments. Methods A prospective mixed-methods study design will be used. Guided by the Knowledge to Action Framework, the study will involve (a) establishing an advisory knowledge user team in each of three targeted settings; (b) assessing factors influencing nurses’ use of protocols using interviews/focus groups and a standardized survey instrument; (c) adapting protocols for local use, ensuring fidelity of the content; (d) selecting intervention strategies to overcome known barriers and implementing the protocols; (e) conducting think-aloud usability testing; (f) evaluating protocol use and outcomes by conducting an audit of 100 randomly selected charts at each of the three settings; and (g) assessing satisfaction with remote support using symptom protocols and change in nurses’ barriers to use using survey instruments. The primary outcome is sustained use of the protocols, defined as use in 75% of the calls. Descriptive analysis will be conducted for the barriers, use of protocols, and chart audit outcomes. Content analysis will be conducted on interviews/focus groups and usability testing with comparisons across settings. Discussion Given the importance of patient safety, patient-centered care, and delivery of quality services, learning how to effectively implement evidence-informed symptom protocols in oncology healthcare services is essential for ensuring safe, consistent, and effective care for individuals with cancer. This study is likely to have a significant contribution to the delivery of remote oncology services, as well as influence symptom management by patients at home. PMID:23164244

The use of isotope injections in sentinel node biopsy for breast cancer: are the 1- and 2-day protocols equally effective?

PubMed

Dodia, Nazera; El-Sharief, Deena; Kirwan, Cliona C

2015-01-01

Sentinel lymph nodes are mapped using (99m)Technetium, injected on day of surgery (1-day protocol) or day before (2-day protocol). This retrospective cohort study compares efficacy between the two protocols. Histopathology for all unilateral sentinel lymph node biopsies (March 2012-March 2013) in a single centre were reviewed. Number of sentinel lymph nodes, non-sentinel lymph nodes and pathology was compared. 2/270 (0.7 %) in 1-day protocol and 8/192 (4 %) in 2-day protocol had no sentinel lymph nodes removed (p = 0.02). The median (range) number of sentinel lymph nodes removed per patient was 2 (0-7) and 1 (0-11) in the 1- and 2-day protocols respectively (p = 0.08). There was a trend for removing more non-sentinel lymph nodes in 2-day protocol [1-day: 52/270 (19 %); 2-day: 50/192 (26 %), p = 0.07]. Using 2-day, sentinel lymph node identification failure rate is higher, although within acceptable rates. The 1 and 2 day protocols are both effective, therefore choice of protocol should be driven by patient convenience and hospital efficiency. However, this study raises the possibility that 1-day may be preferable when higher sentinel lymph node count is beneficial, for example following neoadjuvant chemotherapy.

Sequence optimization to reduce velocity offsets in cardiovascular magnetic resonance volume flow quantification - A multi-vendor study

PubMed Central

2011-01-01

Purpose Eddy current induced velocity offsets are of concern for accuracy in cardiovascular magnetic resonance (CMR) volume flow quantification. However, currently known theoretical aspects of eddy current behavior have not led to effective guidelines for the optimization of flow quantification sequences. This study is aimed at identifying correlations between protocol parameters and the resulting velocity error in clinical CMR flow measurements in a multi-vendor study. Methods Nine 1.5T scanners of three different types/vendors were studied. Measurements were performed on a large stationary phantom. Starting from a clinical breath-hold flow protocol, several protocol parameters were varied. Acquisitions were made in three clinically relevant orientations. Additionally, a time delay between the bipolar gradient and read-out, asymmetric versus symmetric velocity encoding, and gradient amplitude and slew rate were studied in adapted sequences as exploratory measurements beyond the protocol. Image analysis determined the worst-case offset for a typical great-vessel flow measurement. Results The results showed a great variation in offset behavior among scanners (standard deviation among samples of 0.3, 0.4, and 0.9 cm/s for the three different scanner types), even for small changes in the protocol. Considering the absolute values, none of the tested protocol settings consistently reduced the velocity offsets below the critical level of 0.6 cm/s neither for all three orientations nor for all three scanner types. Using multilevel linear model analysis, oblique aortic and pulmonary slices showed systematic higher offsets than the transverse aortic slices (oblique aortic 0.6 cm/s, and pulmonary 1.8 cm/s higher than transverse aortic). The exploratory measurements beyond the protocol yielded some new leads for further sequence development towards reduction of velocity offsets; however those protocols were not always compatible with the time-constraints of breath-hold imaging and flow-related artefacts. Conclusions This study showed that with current systems there was no generic protocol which resulted into acceptable flow offset values. Protocol optimization would have to be performed on a per scanner and per protocol basis. Proper optimization might make accurate (transverse) aortic flow quantification possible for most scanners. Pulmonary flow quantification would still need further (offline) correction. PMID:21388521

Improvement of "Novel Multiparty Quantum Key Agreement Protocol with GHZ States"

NASA Astrophysics Data System (ADS)

Gu, Jun; Hwang, Tzonelih

2017-10-01

Quantum key agreement (QKA) protocol is a method for negotiating a fair and secure key among mutually untrusted participants. Recently, Xu et al. (Quantum Inf. Process. 13:2587-2594, 2014) proposed a multi-party QKA protocol based on Greenberger-Horne-Zeilinger (GHZ) states. However, this study points out that Xu et al.'s protocol cannot provide the fairness property. That is, the last involved participant in the protocol can manipulate the final shared secret key without being detected by the other participants. Moreover, according to Yu et al.'s research (2015), Xu et al.'s protocol cannot avoid the public discussion attack too. To avoid these weaknesses, an improved QKA protocol is proposed.

MRI of penile fracture: what should be a tailored protocol in emergency?

PubMed

Esposito, Andrea Alessandro; Giannitto, Caterina; Muzzupappa, Claudia; Maccagnoni, Sara; Gadda, Franco; Albo, Giancarlo; Biondetti, Pietro Raimondo

2016-09-01

To conduct a review of literature to summarize the existing MRI protocols for penile trauma, suggesting a tailored protocol to reduce costs and time of examination. A systematic search was performed in Medline, Embase, Cochrane Library, and Cinahl databases from 1995 to 2015 to identify studies evaluating penis trauma with MRI examination. Studies were included if there was the description of MRI protocol with at least sequences and orthogonal planes used. We chose a systematic approach for data extraction and descriptive synthesis. 12 articles were included in our study. Among the list of 12 articles: 2 were case reports, 3 were clinical series, and 7 were reviews. Clinical trials were not found. There is no unanimous consensus among the authors. Summarizing the data, the most used protocol is characterized by T2 sequences in three orthogonal planes plus T1 sequences in one plane (either axial or sagittal) without contrast medium injection. There is a lack of a standard protocol. A tailored protocol to answer the diagnostic question, reducing costs and time of examination, is characterized by T2 sequences in three orthogonal planes plus at least a T1 sequence (either axial or sagittal plane).

Atlas-based analysis of cardiac shape and function: correction of regional shape bias due to imaging protocol for population studies.

PubMed

Medrano-Gracia, Pau; Cowan, Brett R; Bluemke, David A; Finn, J Paul; Kadish, Alan H; Lee, Daniel C; Lima, Joao A C; Suinesiaputra, Avan; Young, Alistair A

2013-09-13

Cardiovascular imaging studies generate a wealth of data which is typically used only for individual study endpoints. By pooling data from multiple sources, quantitative comparisons can be made of regional wall motion abnormalities between different cohorts, enabling reuse of valuable data. Atlas-based analysis provides precise quantification of shape and motion differences between disease groups and normal subjects. However, subtle shape differences may arise due to differences in imaging protocol between studies. A mathematical model describing regional wall motion and shape was used to establish a coordinate system registered to the cardiac anatomy. The atlas was applied to data contributed to the Cardiac Atlas Project from two independent studies which used different imaging protocols: steady state free precession (SSFP) and gradient recalled echo (GRE) cardiovascular magnetic resonance (CMR). Shape bias due to imaging protocol was corrected using an atlas-based transformation which was generated from a set of 46 volunteers who were imaged with both protocols. Shape bias between GRE and SSFP was regionally variable, and was effectively removed using the atlas-based transformation. Global mass and volume bias was also corrected by this method. Regional shape differences between cohorts were more statistically significant after removing regional artifacts due to imaging protocol bias. Bias arising from imaging protocol can be both global and regional in nature, and is effectively corrected using an atlas-based transformation, enabling direct comparison of regional wall motion abnormalities between cohorts acquired in separate studies.

Three steps to writing adaptive study protocols in the early phase clinical development of new medicines

PubMed Central

2014-01-01

This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully performed in the UK. During adaptive studies evolving data is used to modify the trial design and conduct within the protocol-defined remit. Adaptations within that remit are documented using non-substantial protocol amendments which do not require regulatory or ethical review. This concept is efficient in gathering relevant data in exploratory early phase studies, ethical and time- and cost-effective. PMID:24980283

Comparative Analgesic Efficacy of Pregabalin Administered According to Either a Prevention Protocol or an Intervention Protocol in Rats with Cisplatin-induced Peripheral Neuropathy.

PubMed

Han, F Y; Kuo, A; Nicholson, J R; Corradinni, L; Smith, M T

2018-05-21

Chemotherapy-induced peripheral neuropathy (CIPN) is a type of peripheral neuropathic pain that may be dose-limiting in patients administered potentially curative cancer chemotherapy dosing regimens. In cancer survivors, persistent CIPN adversely affects patient quality of life and so adjuvant drugs (anticonvulsants e.g. pregabalin or antidepressants e.g. amitriptyline) are recommended for the relief of CIPN. However, most studies in rodent models of CIPN involve administration of single bolus doses of adjuvant drugs to assess pain-relieving efficacy. Hence this study was designed to assess the efficacy of pregabalin administered to CIPN-rats according to either a prevention or an intervention protocol. Groups of male Sprague-Dawley rats received four single intraperitoneal bolus doses of cisplatin at 3 mg/kg at once-weekly intervals to induce CIPN. For the prevention protocol, oral pregabalin (or vehicle) was administered to CIPN-rats once-daily for 21 consecutive days from day 0 to day 20 inclusive. For the intervention protocol, oral pregabalin was administered once-daily for 21 consecutive days from day 28 to day 48 inclusive. Mechanical allodynia and mechanical hyperalgesia in the bilateral hindpaws were assessed just prior to each dose of cisplatin and at least once-weekly until study completion (day 27, prevention protocol; or day 48, intervention protocol). Mechanical allodynia and mechanical hyperalgesia were also determined at the time of peak effect at ~2 h post- pregabalin/vehicle administration once-weekly until study completion. For the prevention protocol in CIPN-rats, pregabalin alleviated mechanical hyperalgesia but not mechanical allodynia. For the intervention protocol, pregabalin alleviated both mechanical allodynia and mechanical hyperalgesia in the hindpaws. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

The activity of French research ethics committees and characteristics of biomedical research protocols involving humans: a retrospective cohort study.

PubMed

Decullier, Evelyne; Lhéritier, Véronique; Chapuis, François

2005-10-17

Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis. Retrospective cohort of 976 protocols approved by a representative sample of 25/48 of French Research Ethics Committees in 1994. Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives. Thirty-one percent of protocols were approved with no modifications requested in 16 days (95% CI: 14-17). The number of revisions requested by the committee, and amendments submitted by the investigator was on average respectively 39 (95% CI: 25-53) and 37 (95% CI: 27-46), per committee and per year. When revisions were requested, the main reasons were related to information to the patient (28%) and consent modalities (18%). Drugs were the object of research in 68% of the protocols examined. The majority of the research was national (80%) with a predominance of single-centre studies. Workload per protocol has been estimated at twelve and half hours on average for administrative support and at eleven and half hours for expertise. The estimated workload justifies specific and independent administrative and financial support for Research Ethics Committees.

Transitions of care from Child and Adolescent Mental Health Services to Adult Mental Health Services (TRACK Study): a study of protocols in Greater London.

PubMed

Singh, Swaran P; Paul, Moli; Ford, Tamsin; Kramer, Tami; Weaver, Tim

2008-06-23

Although young people's transition from Child and Adolescent Mental Health Services (CAMHS) to Adult Mental Health Services (AMHS) in England is a significant health issue for service users, commissioners and providers, there is little evidence available to guide service development. The TRACK study aims to identify factors which facilitate or impede effective transition from CAHMS to AMHS. This paper presents findings from a survey of transition protocols in Greater London. A questionnaire survey (Jan-April 2005) of Greater London CAMHS to identify transition protocols and collect data on team size, structure, transition protocols, population served and referral rates to AMHS. Identified transition protocols were subjected to content analysis. Forty two of the 65 teams contacted (65%) responded to the survey. Teams varied in type (generic/targeted/in-patient), catchment area (locality-based, wider or national) and transition boundaries with AMHS. Estimated annual average number of cases considered suitable for transfer to AMHS, per CAMHS team (mean 12.3, range 0-70, SD 14.5, n = 37) was greater than the annual average number of cases actually accepted by AMHS (mean 8.3, range 0-50, SD 9.5, n = 33). In April 2005, there were 13 active and 2 draft protocols in Greater London. Protocols were largely similar in stated aims and policies, but differed in key procedural details, such as joint working between CAHMS and AMHS and whether protocols were shared at Trust or locality level. While the centrality of service users' involvement in the transition process was identified, no protocol specified how users should be prepared for transition. A major omission from protocols was procedures to ensure continuity of care for patients not accepted by AMHS. At least 13 transition protocols were in operation in Greater London in April 2005. Not all protocols meet all requirements set by government policy. Variation in protocol-sharing organisational units and transition process suggest that practice may vary. There is discontinuity of care provision for some patients who 'graduate' from CAMHS services but are not accepted by adult services.

Transitions of Care from Child and Adolescent Mental Health Services to Adult Mental Health Services (TRACK Study): A study of protocols in Greater London

PubMed Central

Singh, Swaran P; Paul, Moli; Ford, Tamsin; Kramer, Tami; Weaver, Tim

2008-01-01

Background Although young people's transition from Child and Adolescent Mental Health Services (CAMHS) to Adult Mental Health Services (AMHS) in England is a significant health issue for service users, commissioners and providers, there is little evidence available to guide service development. The TRACK study aims to identify factors which facilitate or impede effective transition from CAHMS to AMHS. This paper presents findings from a survey of transition protocols in Greater London. Methods A questionnaire survey (Jan-April 2005) of Greater London CAMHS to identify transition protocols and collect data on team size, structure, transition protocols, population served and referral rates to AMHS. Identified transition protocols were subjected to content analysis. Results Forty two of the 65 teams contacted (65%) responded to the survey. Teams varied in type (generic/targeted/in-patient), catchment area (locality-based, wider or national) and transition boundaries with AMHS. Estimated annual average number of cases considered suitable for transfer to AMHS, per CAMHS team (mean 12.3, range 0–70, SD 14.5, n = 37) was greater than the annual average number of cases actually accepted by AMHS (mean 8.3, range 0–50, SD 9.5, n = 33). In April 2005, there were 13 active and 2 draft protocols in Greater London. Protocols were largely similar in stated aims and policies, but differed in key procedural details, such as joint working between CAHMS and AMHS and whether protocols were shared at Trust or locality level. While the centrality of service users' involvement in the transition process was identified, no protocol specified how users should be prepared for transition. A major omission from protocols was procedures to ensure continuity of care for patients not accepted by AMHS. Conclusion At least 13 transition protocols were in operation in Greater London in April 2005. Not all protocols meet all requirements set by government policy. Variation in protocol-sharing organisational units and transition process suggest that practice may vary. There is discontinuity of care provision for some patients who 'graduate' from CAMHS services but are not accepted by adult services. PMID:18573214

Practical State Machine Replication with Confidentiality

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

Duan, Sisi; Zhang, Haibin

2016-01-01

We study how to enable arbitrary randomized algorithms in Byzantine fault-tolerant (BFT) settings. We formalize a randomized BFT protocol and provide a simple and efficient construction that can be built on any existing BFT protocols while adding practically no overhead. We go one step further to revisit a confidential BFT protocol (Yin et al., SOSP '03). We show that their scheme is potentially susceptible to safety and confidentiality attacks. We then present a new protocol that is secure in the stronger model we formalize, by extending the idea of a randomized BFT protocol. Our protocol uses only efficient symmetric cryptography,more » while Yin et al.'s uses costly threshold signatures. We implemented and evaluated our protocols on microbenchmarks and real-world use cases. We show that our randomized BFT protocol is as efficient as conventional BFT protocols, and our confidential BFT protocol is two to three orders of magnitude faster than Yin et al.'s, which is less secure than ours.« less

A comparison of VO2max and metabolic variables between treadmill running and treadmill skating.

PubMed

Koepp, Kriston K; Janot, Jeffrey M

2008-03-01

The purpose of this study was to determine differences in VO2max and metabolic variables between treadmill running and treadmill skating. This study also examined VO2max responses during a continuous skating treadmill protocol and a discontinuous skating treadmill protocol. Sixteen male high school hockey players, who had a mean age of 16 +/- 1 years and were of an above-average fitness level, participated in this study. All subjects completed 4 exercise trials: a 1-hour skating treadmill familiarization trial, a treadmill running trial, and 2 randomized skating treadmill trials. Minute ventilation (VE), oxygen consumption VO2), carbon dioxide production VCO2), respiratory exchange ratio (RER), and heart rate were averaged every 15 seconds up to VO2max for each exercise test. The results showed that there was a significant difference (P < 0.05) for VO2max (mL.kg.min) and maximal VCO2 (L.min) between the running treadmill protocol and discontinuous skating treadmill protocol. There was also a significant difference for maximal RER between the discontinuous and continuous skating treadmill protocol and between the discontinuous skating treadmill protocol and running treadmill protocol. In conclusion, the running treadmill elicited a greater VO2max (mL.kg.min) than the skating treadmill did, but when it comes to specificity of ice skating, the skating treadmill may be ideal. Also, there was no significant difference between the discontinuous and continuous skating treadmill protocols. Therefore, a continuous protocol is possible on the skating treadmill without compromising correct skating position and physiologic responses. However, the continuous skating treadmill protocol should undergo validation before other scientists, coaches, and strength and conditioning professionals can apply it correctly.

Performance comparison of token ring protocols for hard-real-time communication

NASA Technical Reports Server (NTRS)

Kamat, Sanjay; Zhao, Wei

1992-01-01

The ability to guarantee the deadlines of synchronous messages while maintaining a good aggregate throughput is an important consideration in the design of distributed real-time systems. In this paper, we study two token ring protocols, the priority driven protocol and the timed token protocol, for their suitability for hard real-time systems. Both these protocols use a token to control access to the transmission medium. In a priority driven protocol, messages are assigned priorities and the protocol ensures that messages are transmitted in the order of their priorities. Timed token protocols do not provide for priority arbitration but ensure that the maximum access delay for a station is bounded. For both protocols, we first derive the schedulability conditions under which the transmission deadlines of a given set of synchronous messages can be guaranteed. Subsequently, we use these schedulability conditions to quantitatively compare the average case behavior of the protocols. This comparison demonstrates that each of the protocols has its domain of superior performance and neither dominates the other for the entire range of operating conditions.

An in silico method to identify computer-based protocols worthy of clinical study: An insulin infusion protocol use case

PubMed Central

Wong, Anthony F; Pielmeier, Ulrike; Haug, Peter J; Andreassen, Steen

2016-01-01

Objective Develop an efficient non-clinical method for identifying promising computer-based protocols for clinical study. An in silico comparison can provide information that informs the decision to proceed to a clinical trial. The authors compared two existing computer-based insulin infusion protocols: eProtocol-insulin from Utah, USA, and Glucosafe from Denmark. Materials and Methods The authors used eProtocol-insulin to manage intensive care unit (ICU) hyperglycemia with intravenous (IV) insulin from 2004 to 2010. Recommendations accepted by the bedside clinicians directly link the subsequent blood glucose values to eProtocol-insulin recommendations and provide a unique clinical database. The authors retrospectively compared in silico 18 984 eProtocol-insulin continuous IV insulin infusion rate recommendations from 408 ICU patients with those of Glucosafe, the candidate computer-based protocol. The subsequent blood glucose measurement value (low, on target, high) was used to identify if the insulin recommendation was too high, on target, or too low. Results Glucosafe consistently provided more favorable continuous IV insulin infusion rate recommendations than eProtocol-insulin for on target (64% of comparisons), low (80% of comparisons), or high (70% of comparisons) blood glucose. Aggregated eProtocol-insulin and Glucosafe continuous IV insulin infusion rates were clinically similar though statistically significantly different (Wilcoxon signed rank test P = .01). In contrast, when stratified by low, on target, or high subsequent blood glucose measurement, insulin infusion rates from eProtocol-insulin and Glucosafe were statistically significantly different (Wilcoxon signed rank test, P < .001), and clinically different. Discussion This in silico comparison appears to be an efficient nonclinical method for identifying promising computer-based protocols. Conclusion Preclinical in silico comparison analytical framework allows rapid and inexpensive identification of computer-based protocol care strategies that justify expensive and burdensome clinical trials. PMID:26228765

A tonic heat test stimulus yields a larger and more reliable conditioned pain modulation effect compared to a phasic heat test stimulus

PubMed Central

Lie, Marie Udnesseter; Matre, Dagfinn; Hansson, Per; Stubhaug, Audun; Zwart, John-Anker; Nilsen, Kristian Bernhard

2017-01-01

Abstract Introduction: The interest in conditioned pain modulation (CPM) as a clinical tool for measuring endogenously induced analgesia is increasing. There is, however, large variation in the CPM methodology, hindering comparison of results across studies. Research comparing different CPM protocols is needed in order to obtain a standardized test paradigm. Objectives: The aim of the study was to assess whether a protocol with phasic heat stimuli as test-stimulus is preferable to a protocol with tonic heat stimulus as test-stimulus. Methods: In this experimental crossover study, we compared 2 CPM protocols with different test-stimulus; one with tonic test-stimulus (constant heat stimulus of 120-second duration) and one with phasic test-stimuli (3 heat stimulations of 5 seconds duration separated by 10 seconds). Conditioning stimulus was a 7°C water bath in parallel with the test-stimulus. Twenty-four healthy volunteers were assessed on 2 occasions with minimum 1 week apart. Differences in the magnitude and test–retest reliability of the CPM effect in the 2 protocols were investigated with repeated-measures analysis of variance and by relative and absolute reliability indices. Results: The protocol with tonic test-stimulus induced a significantly larger CPM effect compared to the protocol with phasic test-stimuli (P < 0.001). Fair and good relative reliability was found with the phasic and tonic test-stimuli, respectively. Absolute reliability indices showed large intraindividual variability from session to session in both protocols. Conclusion: The present study shows that a CPM protocol with a tonic test-stimulus is preferable to a protocol with phasic test-stimuli. However, we emphasize that one should be cautious to use the CPM effect as biomarker or in clinical decision making on an individual level due to large intraindividual variability. PMID:29392240

Development and evaluation of a study design typology for human research.

PubMed

Carini, Simona; Pollock, Brad H; Lehmann, Harold P; Bakken, Suzanne; Barbour, Edward M; Gabriel, Davera; Hagler, Herbert K; Harper, Caryn R; Mollah, Shamim A; Nahm, Meredith; Nguyen, Hien H; Scheuermann, Richard H; Sim, Ida

2009-11-14

A systematic classification of study designs would be useful for researchers, systematic reviewers, readers, and research administrators, among others. As part of the Human Studies Database Project, we developed the Study Design Typology to standardize the classification of study designs in human research. We then performed a multiple observer masked evaluation of active research protocols in four institutions according to a standardized protocol. Thirty-five protocols were classified by three reviewers each into one of nine high-level study designs for interventional and observational research (e.g., N-of-1, Parallel Group, Case Crossover). Rater classification agreement was moderately high for the 35 protocols (Fleiss' kappa = 0.442) and higher still for the 23 quantitative studies (Fleiss' kappa = 0.463). We conclude that our typology shows initial promise for reliably distinguishing study design types for quantitative human research.

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.

Effectiveness of oxaliplatin desensitization protocols.

PubMed

Cortijo-Cascajares, Susana; Nacle-López, Inmaculada; García-Escobar, Ignacio; Aguilella-Vizcaíno, María José; Herreros-de-Tejada, Alberto; Cortés-Funes Castro, Hernán; Calleja-Hernández, Miguel-Ángel

2013-03-01

Hypersensitivity reaction (HSR) to antineoplastic drugs can force doctors to stop treatment and seek other alternatives. These alternatives may be less effective, not as well tolerated and/or more expensive. Another option is to use desensitization protocols that induce a temporary state of tolerance by gradually administering small quantities of the antineoplastic drug until the therapeutic dosage is reached. The aim of this study is to assess the effectiveness of oxaliplatin desensitization protocols. A retrospective observational study was carried out between January 2006 and May 2011. The inclusion criteria were patients undergoing chemotherapy treatment with oxaliplatin who had developed an HSR to the drug and who were candidates for continuing the treatment using a desensitization protocol. The patients' clinical records were reviewed and variables were gathered relating to the patient, the treatment, the HSR, and the desensitization protocol administered. The data were analysed using version 18.0 of the statistics program SPSS. A total of 53 desensitization protocols were administered to 21 patients. In 89 % of these cases, no new reactions occurred while the drug was being administered. New reactions of mild severity only occurred in 11 % of cases, and none of these reactions were severe enough for treatment to be stopped. All patients were able to complete the desensitization protocol. This study confirms that oxaliplatin desensitization protocols are safe and effective and allow patients to continue with the treatment that initially caused an HSR.

Optimizing the Protocol for Pulmonary Cryoablation: A Comparison of a Dual- and Triple-Freeze Protocol

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

Hinshaw, J. Louis, E-mail: jhinshaw@uwhealth.or; Littrup, Peter J.; Durick, Nathan

2010-12-15

The purpose of this study was to compare a double freeze-thaw protocol to a triple freeze-thaw protocol for pulmonary cryoablation utilizing an in vivo porcine lung model. A total of 18 cryoablations were performed in normal porcine lung utilizing percutaneous technique with 9 each in a double- (10-5-10) and triple-freeze (3-3-7-7-5) protocol. Serial noncontrast CT images were obtained during the ablation. CT imaging findings and pathology were reviewed. No imaging changes were identified during the initial freeze cycle with either protocol. However, during the first thaw cycle, a region of ground glass opacity developed around the probe with both protocols.more » Because the initial freeze was shorter with the triple freeze-thaw protocol, the imaging findings were apparent sooner with this protocol (6 vs. 13 min). Also, despite a shorter total freeze time (15 vs. 20 min), the ablation zone identified with the triple freeze-thaw protocol was not significantly different from the double freeze-thaw protocol (mean diameter: 1.67 {+-} 0.41 cm vs. 1.66 {+-} 0.21 cm, P = 0.77; area: 2.1 {+-} 0.48 cm{sup 2} vs. 1.99 {+-} 0.62 cm{sup 2}, P = 0.7; and circularity: 0.95 {+-} 0.04 vs. 0.96 {+-} 0.03, P = 0.62, respectively). This study suggests that there may be several advantages of a triple freeze-thaw protocol for pulmonary cryoablation, including earlier identification of the imaging findings associated with the ablation, the promise of a shorter procedure time or larger zones of ablation, and theoretically, more effective cytotoxicity related to the additional freeze-thaw cycle.« less

A systematic review of postoperative hand therapy management of basal joint arthritis.

PubMed

Wolfe, Terri; Chu, Jennifer Y; Woods, Tammy; Lubahn, John D

2014-04-01

There are a variety of postoperative immobilization and therapy options for patients with basal joint arthritis. Although prior systematic reviews have compared surgical procedures used to treat basal joint arthritis, none to our knowledge compares therapy protocols for this condition, which are considered an important part of the treatment. (1) We sought to determine whether differences in the length and type of postoperative immobilization affect clinical results after basal joint arthritis surgery. (2) We also compared specific therapy protocols that were prescribed. (3) Finally, we evaluated published protocols to determine when patients were released to full activity to see whether these appeared to affect clinical results. A systematic review of English-language studies in the PubMed and Cochrane databases was performed. Studies were then reviewed to determine what postoperative immobilization and therapy protocols the authors used and when patients were released to full activities. A total of 19 studies were identified using the search criteria. All but one of the studies included a postoperative period of immobilization in either a cast or splint. Immobilization time varied depending on whether Kirschner wires were used for the surgery and whether an implant was placed. Postoperative therapy protocols also varied but followed three general patterns. Some therapy protocols involved teaching patients a home exercise program only, whereas some authors described routine referral to a therapist. The third group consisted of studies in which patients were only referred for therapy if the physicians determined it was necessary during followup. Many studies did not give a specific time for full return to activity and instead described a gradual transition to full activity after immobilization was discontinued. Because of the variability and small numbers, no conclusive recommendations could be made on any of the three study questions. Comparative, multicenter studies comparing different immobilization and therapy protocols after the surgical treatment of basal joint arthritis would be helpful for both surgeons and therapists looking to refine their treatment protocols.

Clinical outcomes and mortality before and after implementation of a pediatric sepsis protocol in a limited resource setting: A retrospective cohort study in Bangladesh

PubMed Central

Axelrod, David M.; Chisti, Mohammod J.; Kache, Saraswati

2017-01-01

Background Pediatric sepsis has a high mortality rate in limited resource settings. Sepsis protocols have been shown to be a cost-effective strategy to improve morbidity and mortality in a variety of populations and settings. At Dhaka Hospital in Bangladesh, mortality from pediatric sepsis in high-risk children previously approached 60%, which prompted the implementation of an evidenced-based protocol in 2010. The clinical effectiveness of this protocol had not been measured. We hypothesized that implementation of a pediatric sepsis protocol improved clinical outcomes, including reducing mortality and length of hospital stay. Materials and methods This was a retrospective cohort study of children 1–59 months old with a diagnosis of sepsis, severe sepsis or septic shock admitted to Dhaka Hospital from 10/25/2009-10/25/2011. The primary outcome was inpatient mortality pre- and post-protocol implementation. Secondary outcomes included fluid overload, heart failure, respiratory insufficiency, length of hospital stay, and protocol compliance, as measured by antibiotic and fluid bolus administration within 60 minutes of hospital presentation. Results 404 patients were identified by a key-word search of the electronic medical record; 328 patients with a primary diagnosis of sepsis, severe sepsis, or septic shock were included (143 pre- and185 post-protocol) in the analysis. Pre- and post-protocol mortality were similar and not statistically significant (32.17% vs. 34.59%, p = 0.72). The adjusted odds ratio (AOR) for post-protocol mortality was 1.55 (95% CI, 0.88–2.71). The odds for developing fluid overload were significantly higher post-protocol (AOR 3.45, 95% CI, 2.04–5.85), as were the odds of developing heart failure (AOR 4.52, 95% CI, 1.43–14.29) and having a longer median length of stay (AOR 1.81, 95% CI 1.10–2.96). There was no statistically significant difference in respiratory insufficiency (pre- 65.7% vs. post- 70.3%, p = 0.4) or antibiotic administration between the cohorts (pre- 16.08% vs. post- 12.43%, p = 0.42). Conclusions Implementation of a pediatric sepsis protocol did not improve all-cause mortality or length of stay and may have been associated with increased fluid overload and heart failure during the study period in a large, non-governmental hospital in Bangladesh. Similar rates of early antibiotic administration may indicate poor protocol compliance. Though evidenced-based protocols are a potential cost-effective strategy to improve outcomes, future studies should focus on optimal implementation of context-relevant sepsis protocols in limited resource settings. PMID:28753618

391 Description of Drug Allergy Study Conducted in a Teaching Hospital between October 2007 and March 2011

PubMed Central

Rodríguez Martínez, Consuelo Fernanda; Rubio, Alicia Sciaraffia

2012-01-01

Background The World Allergy Organization (WAO) in 2003 defined ‘drug allergy’ as an immunologically mediated drug hypersensitivity reaction. The mechanism of drug allergy may be either IgE or non-IgE mediated. The true incidence of drug allergy is not known. There are only few studies/datasets using standardized clinical questionnaires and validated in vivo or in vitro tests to confirm the diagnosis of drug allergy. Here we have analyzed the obtained results of in vivo test in suspected drug allergy patients. Methods Data from the Centre of Allergies of the Clinical Hospital of the Universidad de Chile between the months of October 2007 and March 2011 was obtained. The information of the protocols of drug executed, by defining as Protocol the study of a probable allergy by 2 or more procedures, which can be: Prick Test, intradermal reaction, specific IgE and/or Test Patch. Results For a total of 126 drug protocols, 25% of them were trivírica vaccine, 24% β-lactams, 21% local anaesthetics and 10% to general anesthesia (inductors, muscle relaxants and Latex). Of the total of patients undergoing protocols the most of them were women, there is no clear difference between the number of children and adults. The temporal distribution of protocols was stable between the months of October 2007 and March 2009 (15 protocols/semester), to then become variable, reaching values between 10 and 29 every 6 months. Of total protocols, 30.1% were positive; only one patient presented a mild adverse reaction (local welt). The β-lactams being most often the positive drugs. Protocols involving pethidine 100% was positive, diclofenac 33%, dipyrone, ketoprofen and hydrocortisone each one 25%. The most accomplished protocol was trivírica vaccine, resulting in 100% negative. Of all negative protocols 58% went to provocation, resulting in a 8% positive, including one provocation to the trívirica vaccine. Conclusions Methodologicall study is very important for a possible drug allergy, because history is not enough to certify the diagnosis. To do a provocation test to a negative protocol is crucial.

Health surveillance under adverse ergonomics conditions--validity of a screening method adapted for the occupational health service.

PubMed

Jonker, Dirk; Gustafsson, Ewa; Rolander, Bo; Arvidsson, Inger; Nordander, Catarina

2015-01-01

A new health surveillance protocol for work-related upper-extremity musculoskeletal disorders has been validated by comparing the results with a reference protocol. The studied protocol, Health Surveillance in Adverse Ergonomics Conditions (HECO), is a new version of the reference protocol modified for application in the Occupational Health Service (OHS). The HECO protocol contains both a screening part and a diagnosing part. Sixty-three employees were examined. The screening in HECO did not miss any diagnosis found when using the reference protocol, but in comparison to the reference protocol considerable time savings could be achieved. Fair to good agreement between the protocols was obtained for one or more diagnoses in neck/shoulders (86%, k = 0.62) and elbow/hands (84%, k = 0.49). Therefore, the results obtained using the HECO protocol can be compared with a reference material collected with the reference protocol, and thus provide information of the magnitude of disorders in an examined work group. Practitioner Summary: The HECO protocol is a relatively simple physical examination protocol for identification of musculoskeletal disorders in the neck and upper extremities. The protocol is a reliable and cost-effective tool for the OHS to use for occupational health surveillance in order to detect workplaces at high risk for developing musculoskeletal disorders.

How to Improve the Peer Review Method: Free-Selection vs Assigned-Pair Protocol Evaluated in a Computer Networking Course

ERIC Educational Resources Information Center

Papadopoulos, Pantelis M.; Lagkas, Thomas D.; Demetriadis, Stavros N.

2012-01-01

This study provides field research evidence on the efficiency of a "free-selection" peer review assignment protocol as compared to the typically implemented "assigned-pair" protocol. The study employed 54 sophomore students who were randomly assigned into three groups: Assigned-Pair (AP) (the teacher assigns student works for review to student…

21 CFR 320.30 - Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by...

Code of Federal Regulations, 2012 CFR

2012-04-01

... bioequivalence requirements and review of protocols by the Food and Drug Administration. 320.30 Section 320.30... requirements and review of protocols by the Food and Drug Administration. (a) The Commissioner of Food and... for the study to FDA for review prior to the initiation of the study. (b) FDA may review a proposed...

21 CFR 320.30 - Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by...

Code of Federal Regulations, 2014 CFR

2014-04-01

... bioequivalence requirements and review of protocols by the Food and Drug Administration. 320.30 Section 320.30... requirements and review of protocols by the Food and Drug Administration. (a) The Commissioner of Food and... for the study to FDA for review prior to the initiation of the study. (b) FDA may review a proposed...

21 CFR 320.30 - Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by...

Code of Federal Regulations, 2013 CFR

2013-04-01

... bioequivalence requirements and review of protocols by the Food and Drug Administration. 320.30 Section 320.30... requirements and review of protocols by the Food and Drug Administration. (a) The Commissioner of Food and... for the study to FDA for review prior to the initiation of the study. (b) FDA may review a proposed...

Modified Scoring, Traditional Item Analysis, and Sato's Caution Index Used To Investigate the Reading Recall Protocol.

ERIC Educational Resources Information Center

Deville, Craig W.; Chalhoub-Deville, Micheline

A study demonstrated the utility of item analyses to investigate which items function well or poorly in a second language reading recall protocol instrument. Data were drawn from a larger study of 56 learners of German as a second language at various proficiency levels. Pausal units of scored recall protocols were analyzed using both classical…

Factors that impact on the use of mechanical ventilation weaning protocols in critically ill adults and children: a qualitative evidence-synthesis.

PubMed

Jordan, Joanne; Rose, Louise; Dainty, Katie N; Noyes, Jane; Blackwood, Bronagh

2016-10-04

Prolonged mechanical ventilation is associated with a longer intensive care unit (ICU) length of stay and higher mortality. Consequently, methods to improve ventilator weaning processes have been sought. Two recent Cochrane systematic reviews in ICU adult and paediatric populations concluded that protocols can be effective in reducing the duration of mechanical ventilation, but there was significant heterogeneity in study findings. Growing awareness of the benefits of understanding the contextual factors impacting on effectiveness has encouraged the integration of qualitative evidence syntheses with effectiveness reviews, which has delivered important insights into the reasons underpinning (differential) effectiveness of healthcare interventions. 1. To locate, appraise and synthesize qualitative evidence concerning the barriers and facilitators of the use of protocols for weaning critically-ill adults and children from mechanical ventilation;2. To integrate this synthesis with two Cochrane effectiveness reviews of protocolized weaning to help explain observed heterogeneity by identifying contextual factors that impact on the use of protocols for weaning critically-ill adults and children from mechanical ventilation;3. To use the integrated body of evidence to suggest the circumstances in which weaning protocols are most likely to be used. We used a range of search terms identified with the help of the SPICE (Setting, Perspective, Intervention, Comparison, Evaluation) mnemonic. Where available, we used appropriate methodological filters for specific databases. We searched the following databases: Ovid MEDLINE, Embase, OVID, PsycINFO, CINAHL Plus, EBSCOHost, Web of Science Core Collection, ASSIA, IBSS, Sociological Abstracts, ProQuest and LILACS on the 26th February 2015. In addition, we searched: the grey literature; the websites of professional associations for relevant publications; and the reference lists of all publications reviewed. We also contacted authors of the trials included in the effectiveness reviews as well as of studies (potentially) included in the qualitative synthesis, conducted citation searches of the publications reporting these studies, and contacted content experts.We reran the search on 3rd July 2016 and found three studies, which are awaiting classification. We included qualitative studies that described: the circumstances in which protocols are designed, implemented or used, or both, and the views and experiences of healthcare professionals either involved in the design, implementation or use of weaning protocols or involved in the weaning of critically-ill adults and children from mechanical ventilation not using protocols. We included studies that: reflected on any aspect of the use of protocols, explored contextual factors relevant to the development, implementation or use of weaning protocols, and reported contextual phenomena and outcomes identified as relevant to the effectiveness of protocolized weaning from mechanical ventilation. At each stage, two review authors undertook designated tasks, with the results shared amongst the wider team for discussion and final development. We independently reviewed all retrieved titles, abstracts and full papers for inclusion, and independently extracted selected data from included studies. We used the findings of the included studies to develop a new set of analytic themes focused on the barriers and facilitators to the use of protocols, and further refined them to produce a set of summary statements. We used the Confidence in the Evidence from Reviews of Qualitative Research (CERQual) framework to arrive at a final assessment of the overall confidence of the evidence used in the synthesis. We included all studies but undertook two sensitivity analyses to determine how the removal of certain bodies of evidence impacted on the content and confidence of the synthesis. We deployed a logic model to integrate the findings of the qualitative evidence synthesis with those of the Cochrane effectiveness reviews. We included 11 studies in our synthesis, involving 267 participants (one study did not report the number of participants). Five more studies are awaiting classification and will be dealt with when we update the review.The quality of the evidence was mixed; of the 35 summary statements, we assessed 17 as 'low', 13 as 'moderate' and five as 'high' confidence. Our synthesis produced nine analytical themes, which report potential barriers and facilitators to the use of protocols. The themes are: the need for continual staff training and development; clinical experience as this promotes felt and perceived competence and confidence to wean; the vulnerability of weaning to disparate interprofessional working; an understanding of protocols as militating against a necessary proactivity in clinical practice; perceived nursing scope of practice and professional risk; ICU structure and processes of care; the ability of protocols to act as a prompt for shared care and consistency in weaning practice; maximizing the use of protocols through visibility and ease of implementation; and the ability of protocols to act as a framework for communication with parents. There is a clear need for weaning protocols to take account of the social and cultural environment in which they are to be implemented. Irrespective of its inherent strengths, a protocol will not be used if it does not accommodate these complexities. In terms of protocol development, comprehensive interprofessional input will help to ensure broad-based understanding and a sense of 'ownership'. In terms of implementation, all relevant ICU staff will benefit from general weaning as well as protocol-specific training; not only will this help secure a relevant clinical knowledge base and operational understanding, but will also demonstrate to others that this knowledge and understanding is in place. In order to maximize relevance and acceptability, protocols should be designed with the patient profile and requirements of the target ICU in mind. Predictably, an under-resourced ICU will impact adversely on protocol implementation, as staff will prioritize management of acutely deteriorating and critically-ill patients.

Differential Sarcomere and Electrophysiological Maturation of Human iPSC-Derived Cardiac Myocytes in Monolayer vs. Aggregation-Based Differentiation Protocols

PubMed Central

Jeziorowska, Dorota; Fontaine, Vincent; Jouve, Charlène; Villard, Eric; Dussaud, Sébastien; Akbar, David; Letang, Valérie; Cervello, Pauline; Itier, Jean-Michiel; Pruniaux, Marie-Pierre; Hulot, Jean-Sébastien

2017-01-01

Human induced pluripotent stem cells (iPSCs) represent a powerful human model to study cardiac disease in vitro, notably channelopathies and sarcomeric cardiomyopathies. Different protocols for cardiac differentiation of iPSCs have been proposed either based on embroid body formation (3D) or, more recently, on monolayer culture (2D). We performed a direct comparison of the characteristics of the derived cardiomyocytes (iPSC-CMs) on day 27 ± 2 of differentiation between 3D and 2D differentiation protocols with two different Wnt-inhibitors were compared: IWR1 (inhibitor of Wnt response) or IWP2 (inhibitor of Wnt production). We firstly found that the level of Troponin T (TNNT2) expression measured by FACS was significantly higher for both 2D protocols as compared to the 3D protocol. In the three methods, iPSC-CM show sarcomeric structures. However, iPSC-CM generated in 2D protocols constantly displayed larger sarcomere lengths as compared to the 3D protocol. In addition, mRNA and protein analyses reveal higher cTNi to ssTNi ratios in the 2D protocol using IWP2 as compared to both other protocols, indicating a higher sarcomeric maturation. Differentiation of cardiac myocytes with 2D monolayer-based protocols and the use of IWP2 allows the production of higher yield of cardiac myocytes that have more suitable characteristics to study sarcomeric cardiomyopathies. PMID:28587156

Quantum-key-distribution protocol with pseudorandom bases

NASA Astrophysics Data System (ADS)

Trushechkin, A. S.; Tregubov, P. A.; Kiktenko, E. O.; Kurochkin, Y. V.; Fedorov, A. K.

2018-01-01

Quantum key distribution (QKD) offers a way for establishing information-theoretical secure communications. An important part of QKD technology is a high-quality random number generator for the quantum-state preparation and for post-processing procedures. In this work, we consider a class of prepare-and-measure QKD protocols, utilizing additional pseudorandomness in the preparation of quantum states. We study one of such protocols and analyze its security against the intercept-resend attack. We demonstrate that, for single-photon sources, the considered protocol gives better secret key rates than the BB84 and the asymmetric BB84 protocols. However, the protocol strongly requires single-photon sources.

A Field-Based Testing Protocol for Assessing Gross Motor Skills in Preschool Children: The Children's Activity and Movement in Preschool Study Motor Skills Protocol

ERIC Educational Resources Information Center

Williams, Harriet G.; Pfeiffer, Karin A.; Dowda, Marsha; Jeter, Chevy; Jones, Shaverra; Pate, Russell R.

2009-01-01

The purpose of this study was to develop a valid and reliable tool for use in assessing motor skills in preschool children in field-based settings. The development of the Children's Activity and Movement in Preschool Study Motor Skills Protocol included evidence of its reliability and validity for use in field-based environments as part of large…

Increasing value and reducing waste: addressing inaccessible research.

PubMed

Chan, An-Wen; Song, Fujian; Vickers, Andrew; Jefferson, Tom; Dickersin, Kay; Gøtzsche, Peter C; Krumholz, Harlan M; Ghersi, Davina; van der Worp, H Bart

2014-01-18

The methods and results of health research are documented in study protocols, full study reports (detailing all analyses), journal reports, and participant-level datasets. However, protocols, full study reports, and participant-level datasets are rarely available, and journal reports are available for only half of all studies and are plagued by selective reporting of methods and results. Furthermore, information provided in study protocols and reports varies in quality and is often incomplete. When full information about studies is inaccessible, billions of dollars in investment are wasted, bias is introduced, and research and care of patients are detrimentally affected. To help to improve this situation at a systemic level, three main actions are warranted. First, academic institutions and funders should reward investigators who fully disseminate their research protocols, reports, and participant-level datasets. Second, standards for the content of protocols and full study reports and for data sharing practices should be rigorously developed and adopted for all types of health research. Finally, journals, funders, sponsors, research ethics committees, regulators, and legislators should endorse and enforce policies supporting study registration and wide availability of journal reports, full study reports, and participant-level datasets. Copyright © 2014 Elsevier Ltd. All rights reserved.

Increasing value and reducing waste: addressing inaccessible research

PubMed Central

Chan, An-Wen; Song, Fujian; Vickers, Andrew; Jefferson, Tom; Dickersin, Kay; Gøtzsche, Peter C.; Krumholz, Harlan M.; Ghersi, Davina; van der Worp, H. Bart

2015-01-01

The study protocol, publications, full study report detailing all analyses, and participant-level dataset constitute the main documentation of methods and results for health research. However, journal publications are available for only half of all studies and are plagued by selective reporting of methods and results. The protocol, full study report, and participant-level dataset are rarely available. The quality of information provided in study protocols and reports is variable and often incomplete. Inaccessibility of full information for the vast majority of studies wastes billions of dollars, introduces bias, and has a detrimental impact on patient care and research. To help improve this situation at a systemic level, three main actions are warranted. Firstly, it is important that academic institutions and funders reward investigators who fully disseminate their research protocols, reports, and participant-level datasets. Secondly, standards for the content of protocols, full study reports, and data sharing practices should be rigorously developed and adopted for all types of health research. Finally, journals, funders, sponsors, research ethics committees, regulators, and legislators should implement and enforce policies supporting study registration and availability of journal publications, full study reports, and participant-level datasets. PMID:24411650

A vascular laboratory protocol for improving and managing after-hours suspected acute deep venous thrombosis.

PubMed

Martin, Angela H; Eckert, George; Lemmon, Gary W; Sawchuk, Alan; Dalsing, Michael C

2014-04-01

This study reviews the clinical and workforce impact of a suggested protocol designed for the management of suspected acute deep venous thrombosis (DVT) in patients seen after standard vascular laboratory business hours. The protocol included the use of Wells score, D-dimer and a single dose of therapeutic anticoagulant to defer venous duplex ultrasound (VDU) testing until routine business hours unless contraindicated. Information was collected on medical history, physical exam and the timing of any diagnostic studies and treatment provided. Over 15% of studies done after-hours were deemed unnecessary by our protocol and in every individual the results were negative for an acute DVT. There were no adverse events from a one-time dose of anticoagulant. Limiting emergency VDU coverage to evaluate for acute DVT based on a management protocol can eliminate unnecessary after-hours VDU testing without having a negative impact on patient care.

Histomorphometric assessment of bone necrosis produced by two cryosurgery protocols using liquid nitrogen: an experimental study on rat femurs.

PubMed

Costa, Fábio Wildson Gurgel; Brito, Gerly Anne de Castro; Pessoa, Rosana Maria Andrade; Studart-Soares, Eduardo Costa

2011-01-01

The aim of this study was to evaluate the effects of liquid nitrogen cryosurgery on the femoral diaphysis of rats. The femoral diaphyses of 42 Wistar rats were exposed to three local and sequential applications of liquid nitrogen for 1 or 2 min, intercalated with periods of 5 min of passive thawing. The animals were sacrificed after 1, 2, 4 and 12 weeks and the specimens obtained were processed and analyzed histomorphometrically. The depth and extent of peak bone necrosis were 124.509 µm and 2087.094 µm for the 1-min protocol, respectively, and 436.424 µm and 12046.426 µm for the 2-min protocol. Peak necrosis was observed in the second experimental week with both cryotherapy protocols. The present results indicate that the 2-min protocol produced more marked bone necrosis than the 1-min protocol. Although our results cannot be entirely extrapolated to clinical practice, they contribute to the understanding of the behavior of bone tissue submitted to different cycles of liquid nitrogen freezing and may serve as a basis for new studies.

Effects of a peer support programme for youth social services employees experiencing potentially traumatic events: a protocol for a prospective cohort study

PubMed Central

Guay, Stephane; Tremblay, Nicole; Goncalves, Jane; Bilodeau, Henriette; Geoffrion, Steve

2017-01-01

Introduction The use of peer support programmes to help workers experiencing potentially traumatic events (PTE) has increased in high-risk organisations in the last decades. However, the scientific evidence of its effectiveness is still very limited. This paper aims to describe the protocol of a prospective cohort study that assesses the efficacy of a peer support programme among youth social services employees exposed to a PTE at work on psychological well-being, work functioning and needs of support. Methods and analysis This is a mixed-methods prospective study that will examine workers' evolution four times over a 12-month period in Canada. This study involves: (1) quantitative data obtained through self-administrated questionnaires among 222 workers, and (2) qualitative in-depth interviews with a subsample of 45 workers. This study will compare findings from a cohort who received the support of a peer following a PTE (peer support–experimental protocol) as part of the experimental protocol of the Montreal Youth Social Services-University Institute (MYSS-UI), the second group of workers did not ask for the peer support (no peer support-experimental protocol) but was part of MYSS-UI, and the third group received standard organisational support from the Monteregie Youth Social Services (MYSS) (standard organisational protocol). Ethics and dissemination The protocol and informed consent form complied with the ethics guidelines of the MYSS-UI. The Research Ethics Board of MYSS-UI and MYSS reviewed and accepted the protocol as required. The results of the study will be published in peer-reviewed journals, presented at research and general public conferences, disseminated via a public report for the institute that funded the project and for all workers. Results of this study will influence decision making regarding intervention policies following PTE and peer support interventions may be expanded throughout the youth social services in Canada and worldwide. PMID:28647721

Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight.

PubMed

Engel, Pierre; Almas, Mariana Ferreira; De Bruin, Marieke Louise; Starzyk, Kathryn; Blackburn, Stella; Dreyer, Nancy Ann

2017-04-01

To describe and characterize the first cohort of Post-Authorization Safety Study (PASS) protocols reviewed under the recent European pharmacovigilance legislation. A systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted from July 2012 to July 2015 from Pharmacovigilance Risk Assessment Committee (PRAC) minutes, European Medicines Agency (EMA) and European Network of Pharmacovigilance and Pharmacoepidemiology (ENCePP) webpages. During the study period, 189 different PASS protocols were submitted to the PRAC, half of which were entered in the ENCePP electronic register of post-authorization studies (EU-PAS) by July 2015. Those protocols were assessed during 353 PRAC reviews. The EMA published only 31% of the PRAC feedback, of which the main concerns were study design (37%) and feasibility (30%). Among the 189 PASS, slightly more involved primary data capture (58%). PASS assessing drug utilization mainly leveraged secondary data sources (58%). The majority of the PASS did not include a comparator (65%) and 35% of PASS also evaluated clinical effectiveness endpoints. To the best of our knowledge this is the first comprehensive review of three years of PASS protocols submitted under the new pharmacovigilance legislation. Our results show that both EMA and PASS sponsors could respectively increase the availability of protocol assessments and documents in the EU-PAS. Protocol content review and the high number of PRAC comments related to methodological issues and feasibility concerns should raise awareness among PASS stakeholders to design more thoughtful studies according to pharmacoepidemiological principles and existing guidelines. © 2016 The British Pharmacological Society.

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.

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

PubMed Central

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

2017-01-01

Introduction Publishing protocols of randomized controlled trials (RCT) facilitates a more detailed description of study rational, design, and related ethical and safety issues, which should promote transparency. Little is known about how the practice of publishing protocols developed over time. Therefore, this study describes the worldwide trends in volume and methodological quality of published RCT protocols. Methods A systematic search was performed in PubMed and EMBASE, identifying RCT protocols published over a decade from 1 September 2001. Data were extracted on quality characteristics of RCT protocols. The primary outcome, methodological quality, was assessed by individual methodological characteristics (adequate generation of allocation, concealment of allocation and intention-to-treat analysis). A comparison was made by publication period (First, September 2001- December 2004; Second, January 2005-May 2008; Third, June 2008-September 2011), geographical region and medical specialty. Results The number of published RCT protocols increased from 69 in the first, to 390 in the third period (p<0.0001). Internal medicine and paediatrics were the most common specialty topics. Whereas most published RCT protocols in the first period originated from North America (n = 30, 44%), in the second and third period this was Europe (respectively, n = 65, 47% and n = 190, 48%, p = 0.02). Quality of RCT protocols was higher in Europe and Australasia, compared to North America (OR = 0.63, CI = 0.40–0.99, p = 0.04). Adequate generation of allocation improved with time (44%, 58%, 67%, p = 0.001), as did concealment of allocation (38%, 53%, 55%, p = 0.03). Surgical protocols had the highest quality among the three specialty topics used in this study (OR = 1.94, CI = 1.09–3.45, p = 0.02). Conclusion Publishing RCT protocols has become popular, with a five-fold increase in the past decade. The quality of published RCT protocols also improved, although variation between geographical regions and across medical specialties was seen. This emphasizes the importance of international standards of comprehensive training in RCT methodology. PMID:28296925

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.

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.

Can combined use of low-level lasers and hyaluronic acid injections prolong the longevity of degenerative knee joints?

PubMed Central

Ip, David; Fu, Nga Yue

2015-01-01

Background This study evaluated whether half-yearly hyaluronic acid injection together with low-level laser therapy in addition to standard conventional physical therapy can successfully postpone the need for joint replacement surgery in elderly patients with bilateral symptomatic tricompartmental knee arthritis. Methods In this prospective, double-blind, placebo-controlled study, 70 consecutive unselected elderly patients with bilateral tricompartmental knee arthritis were assigned at random to either one of two conservative treatment protocols to either one of the painful knees. Protocol A consisted of conventional physical therapy plus a sham light source plus saline injection, and protocol B consisted of protocol A with addition of half-yearly hyaluronic acid injection as well as low-level laser treatment instead of using saline and a sham light source. Treatment failure was defined as breakthrough pain necessitating joint replacement. Results Among the 140 painful knees treated with either protocol A or protocol B, only one of the 70 painful knees treated by protocol B required joint replacement, whereas 15 of the 70 painful knees treated by protocol A needed joint replacement surgery (P<0.05). Conclusion We conclude that half-yearly hyaluronic acid injections together with low-level laser therapy should be incorporated into the standard conservative treatment protocol for symptomatic knee arthritis, because it may prolong the longevity of the knee joint without the need for joint replacement. PMID:26346122

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.

Protocol for a Delay-Tolerant Data-Communication Network

NASA Technical Reports Server (NTRS)

Torgerson, Jordan; Hooke, Adrian; Burleigh, Scott; Fall, Kevin

2004-01-01

As its name partly indicates, the Delay-Tolerant Networking (DTN) Bundle Protocol is a protocol for delay-tolerant transmission of data via communication networks. This protocol was conceived as a result of studies of how to adapt Internet protocols so that Internet-like services could be provided across interplanetary distances in support of deep-space exploration. The protocol, and software to implement the protocol, is being developed in collaboration among experts at NASA's Jet Propulsion Laboratory and other institutions. No current Internet protocols can accommodate long transmission delay times or intermittent link connectivity. The DTN Bundle Protocol represents a departure from the standard Internet assumption that a continuous path is available from a host computer to a client computer: It provides for routing of data through networks that may be disjointed and may be characterized by long transmission delays. In addition to networks that include deepspace communication links, examples of such networks include terrestrial ones within which branches are temporarily disconnected. The protocol is based partly on the definition of a message-based overlay above the transport layers of the networks on which it is hosted.

Short Review on Quantum Key Distribution Protocols.

PubMed

Giampouris, Dimitris

2017-01-01

Cryptographic protocols and mechanisms are widely investigated under the notion of quantum computing. Quantum cryptography offers particular advantages over classical ones, whereas in some cases established protocols have to be revisited in order to maintain their functionality. The purpose of this paper is to provide the basic definitions and review the most important theoretical advancements concerning the BB84 and E91 protocols. It also aims to offer a summary on some key developments on the field of quantum key distribution, closely related with the two aforementioned protocols. The main goal of this study is to provide the necessary background information along with a thorough review on the theoretical aspects of QKD, concentrating on specific protocols. The BB84 and E91 protocols have been chosen because most other protocols are similar to these, a fact that makes them important for the general understanding of how the QKD mechanism functions.

Standardized patient walkthroughs in the National Drug Abuse Treatment Clinical Trials Network: common challenges to protocol implementation.

PubMed

Fussell, Holly E; Kunkel, Lynn E; McCarty, Dennis; Lewy, Colleen S

2011-09-01

Training research staff to implement clinical trials occurring in community-based addiction treatment programs presents unique challenges. Standardized patient walkthroughs of study procedures may enhance training and protocol implementation. Examine and discuss cross-site and cross-study challenges of participant screening and data collection procedures identified during standardized patient walkthroughs of multi-site clinical trials. Actors portrayed clients and "walked through" study procedures with protocol research staff. The study completed 57 walkthroughs during implementation of 4 clinical trials. Observers and walkthrough participants identified three areas of concern (consent procedures, screening and assessment processes, and protocol implementation) and made suggestions for resolving the concerns. Standardized patient walkthroughs capture issues with study procedures previously unidentified with didactic training or unscripted rehearsals. Clinical trials within the National Drug Abuse Treatment Clinical Trials Network are conducted in addiction treatment centers that vary on multiple dimensions. Based on walkthrough observations, the national protocol team and local site leadership modify standardized operating procedures and resolve cross-site problems prior to recruiting study participants. The standardized patient walkthrough improves consistency across study sites and reduces potential site variation in study outcomes.

Practical quantum appointment scheduling

NASA Astrophysics Data System (ADS)

Touchette, Dave; Lovitz, Benjamin; Lütkenhaus, Norbert

2018-04-01

We propose a protocol based on coherent states and linear optics operations for solving the appointment-scheduling problem. Our main protocol leaks strictly less information about each party's input than the optimal classical protocol, even when considering experimental errors. Along with the ability to generate constant-amplitude coherent states over two modes, this protocol requires the ability to transfer these modes back-and-forth between the two parties multiple times with very low losses. The implementation requirements are thus still challenging. Along the way, we develop tools to study quantum information cost of interactive protocols in the finite regime.

Redactions in protocols for drug trials: what industry sponsors concealed.

PubMed

Marquardsen, Mikkel; Ogden, Michelle; Gøtzsche, Peter C

2018-04-01

Objective To describe the redactions in contemporary protocols for industry-sponsored randomised drug trials with patient relevant outcomes and to evaluate whether there was a legitimate rationale for the redactions. Design Cohort study. Under the Freedom of Information Act, we requested access to trial protocols approved by a research ethics committee in Denmark from October 2012 to March 2013. We received 17 consecutive protocols, which had been redacted before we got them, and nine protocols without redactions. In five additional cases, the companies refused to let the committees give us access, and in three other cases, documents were missing. Participants Not applicable. Setting Not applicable. Main outcome measure Amount and nature of redactions in 22 predefined key protocol variables. Results The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials: data analysis, handling of missing data, detection and analysis of adverse events, definition of the outcomes, interim analyses and premature termination of the study, sponsor's access to incoming data while the study is running, ownership to the data and investigators' publication rights. The parts of the text that were redacted differed widely, both between companies and within the same company. Conclusions We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.

Intravenous Ketamine Infusions for Neuropathic Pain Management: A Promising Therapy in Need of Optimization.

PubMed

Maher, Dermot P; Chen, Lucy; Mao, Jianren

2017-02-01

Intravenous ketamine infusions have been used extensively to treat often-intractable neuropathic pain conditions. Because there are many widely divergent ketamine infusion protocols described in the literature, the variation in these protocols presents a challenge for direct comparison of one protocol with another and in discerning an optimal protocol. Careful examination of the published literature suggests that ketamine infusions can be useful to treat neuropathic pain and that certain characteristics of ketamine infusions may be associated with better clinical outcomes. Increased duration of relief from neuropathic pain is associated with (1) higher total infused doses of ketamine; (2) prolonged infusion durations, although the rate of infusion does not appear to be a factor; and (3) coadministration of adjunct medications such as midazolam and/or clonidine that mitigate some of the unpleasant psychomimetic side effects. However, there are few studies designed to optimize ketamine infusion protocols by defining what an effective infusion protocol entails with regard to a respective neuropathic pain condition. Therefore, despite common clinical practice, the current state of the literature leaves the use of ketamine infusions without meaningful guidance from high-quality comparative evidence. The objectives of this topical review are to (1) analyze the available clinical evidence related to ketamine infusion protocols and (2) call for clinical studies to identify optimal ketamine infusion protocols tailored for individual neuropathic pain conditions. The Oxford Center for Evidence-Based Medicine classification for levels of evidence was used to stratify the grades of clinical recommendation for each infusion variable studied.

Implementation of an Intensive Care Unit-Specific Alcohol Withdrawal Syndrome Management Protocol Reduces the Need for Mechanical Ventilation.

PubMed

Heavner, Jason J; Akgün, Kathleen M; Heavner, Mojdeh S; Eng, Claire C; Drew, Matthew; Jackson, Peter; Pritchard, David; Honiden, Shyoko

2018-05-25

Alcohol use disorders are prevalent and put patients at risk for developing alcohol withdrawal syndrome (AWS). Treatment of AWS with a symptom-triggered protocol standardizes management and may avoid AWS-related complications. The objective of this study was to evaluate whether implementation of an intensive care unit (ICU)-specific, symptom-triggered protocol for management of AWS was associated with improved clinical outcomes and, in particular, would reduce the risk of patients with AWS requiring mechanical ventilation. Retrospective pre-post-protocol implementation study. Thirty-six-bed, closed medical ICU (MICU) at a large, tertiary care, teaching hospital in an urban setting. A total of 233 adults admitted to the MICU with any diagnosis of alcohol use disorders based on International Classification of Diseases, Ninth Revision codes and who received at least one dose of any benzodiazepine; of these patients, 139 were in the pre-protocol era (August 2009-January 2010 and August 2010-January 2011), and 94 were in the post-protocol era (August 2012-January 2013), after implementation of the Yale Alcohol Withdrawal Protocol (YAWP) in April 2012. The YAWP pairs a modified Minnesota Detoxification Scale with an order set that includes benzodiazepine dosing regimens and suggests adjuvant therapies. AWS was the primary reason for ICU admission (107/233 patients [45.9%]) and did not significantly vary between eras (P=0.2). Of the 233 patients included, 81.1% were male and 67.0% were white, which did not significantly differ by study era. Severity of illness at MICU admission did not significantly differ between patients in the pre-protocol and post-protocol eras (median [interquartile range] Acute Physiology and Chronic Health Evaluation [APACHE] II scores of 12 [9-17] and 12.5 [7-16], respectively, p=0.4). Median lorazepam-equivalent dose per MICU day, duration of benzodiazepine infusion, and use of adjuvant therapy were not significantly different between eras. MICU intubation was less common in the post-protocol era (36/139 patients [25.9%] pre-protocol vs 8/94 patients [8.5%] post-protocol, p=0.0009). ICU-related pneumonia was also decreased in the post-protocol era (30/139 patients [21.6%] pre-protocol vs 10/94 patients [10.6%] post-protocol, p=0.03). After adjusting for demographics, adjuvant therapies, and Acute Physiology and Chronic Health Evaluation II scores, protocol implementation was associated with a decreased odds of MICU intubation (odds ratio 0.13; 95% confidence interval 0.04-0.39). Implementation of YAWP was associated with a decreased risk of MICU intubation in patients at risk for AWS. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

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

ERIC Educational Resources Information Center

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

2015-01-01

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

The Impact of a Management Protocol on the Outcomes of Child Abuse in Hospitalized Children in Hong Kong

ERIC Educational Resources Information Center

Lee, Anselm C. W.; Li, C. H.; So, K. T.

2006-01-01

Objective: To study the outcomes of children hospitalized for suspected child abuse before and after the implementation of a management protocol in a hospital in Hong Kong. Study period: Two 2-year periods before (1994-1995) and after (2002-2003) the implementation of the protocol in 1998. Methods: This is a retrospective hospital chart review in…

Health surveillance under adverse ergonomics conditions – validity of a screening method adapted for the occupational health service

PubMed Central

Jonker, Dirk; Gustafsson, Ewa; Rolander, Bo; Arvidsson, Inger; Nordander, Catarina

2015-01-01

A new health surveillance protocol for work-related upper-extremity musculoskeletal disorders has been validated by comparing the results with a reference protocol. The studied protocol, Health Surveillance in Adverse Ergonomics Conditions (HECO), is a new version of the reference protocol modified for application in the Occupational Health Service (OHS). The HECO protocol contains both a screening part and a diagnosing part. Sixty-three employees were examined. The screening in HECO did not miss any diagnosis found when using the reference protocol, but in comparison to the reference protocol considerable time savings could be achieved. Fair to good agreement between the protocols was obtained for one or more diagnoses in neck/shoulders (86%, k = 0.62) and elbow/hands (84%, k = 0.49). Therefore, the results obtained using the HECO protocol can be compared with a reference material collected with the reference protocol, and thus provide information of the magnitude of disorders in an examined work group. Practitioner Summary: The HECO protocol is a relatively simple physical examination protocol for identification of musculoskeletal disorders in the neck and upper extremities. The protocol is a reliable and cost-effective tool for the OHS to use for occupational health surveillance in order to detect workplaces at high risk for developing musculoskeletal disorders. PMID:25761380

Effect of Acu-TENS on recovery heart rate after treadmill running exercise in subjects with normal health.

PubMed

Cheung, Leo Chin-Ting; Jones, Alice Yee-Men

2007-06-01

This study aims to investigate the effect of transcutaneous electrical nerve stimulation, applied at bilateral acupuncture points PC6 (Acu-TENS), on recovery heart rate (HR) in healthy subjects after treadmill running exercise. A single blinded, randomized controlled trial. Laboratory with healthy male subjects (n=28). Each subject participated in three separate protocols in random order. PROTOCOL A: The subject followed the Bruce protocol and ran on a treadmill until their HR reached 70% of their maximum (220-age). At this 'target' HR, the subject adopted the supine position and Acu-TENS to bilateral PC6 was commenced. PROTOCOL B: Identical to protocol A except that Acu-TENS was applied in the supine position for 45min prior to, but not after exercise. PROTOCOL C: Identical to protocol A except that placebo Acu-TENS was applied. Heart rate was recorded before and at 30s intervals after exercise until it returned to the pre-exercise baseline. The time for HR to return to baseline was compared for each protocol. Acu-TENS applied to bilateral PC6 resulted in a faster return to pre-exercise HR compared to placebo. Time required for HR to return to pre-exercise level in protocols A-C was 5.5+/-3.0; 4.8+/-3.3; 9.4+/-3.7 min, respectively (p<0.001). There was no statistical difference in HR recovery time between protocols A and B. Subjects expressed the lowest rate of perceived exertion score (RPE) at 70% maximum HR with protocol B. This study suggests that Acu-TENS applied to PC6 may facilitate HR recovery after high intensity treadmill exercise.

The effect of four-phasic versus three-phasic contrast media injection protocols on extravasation rate in coronary CT angiography: a randomized controlled trial.

PubMed

Karády, Júlia; Panajotu, Alexisz; Kolossváry, Márton; Szilveszter, Bálint; Jermendy, Ádám L; Bartykowszki, Andrea; Károlyi, Mihály; Celeng, Csilla; Merkely, Béla; Maurovich-Horvat, Pál

2017-11-01

Contrast media (CM) extravasation is a well-known complication of CT angiography (CTA). Our prospective randomized control study aimed to assess whether a four-phasic CM administration protocol reduces the risk of extravasation compared to the routinely used three-phasic protocol in coronary CTA. Patients referred to coronary CTA due to suspected coronary artery disease were included in the study. All patients received 400 mg/ml iomeprol CM injected with dual-syringe automated injector. Patients were randomized into a three-phasic injection-protocol group, with a CM bolus of 85 ml followed by 40 ml of 75%:25% saline/CM mixture and 30 ml saline chaser bolus; and a four-phasic injection-protocol group, with a saline pacer bolus of 10 ml injected at a lower flow rate before the three-phasic protocol. 2,445 consecutive patients were enrolled (mean age 60.6 ± 12.1 years; females 43.6%). Overall rate of extravasation was 0.9% (23/2,445): 1.4% (17/1,229) in the three-phasic group and 0.5% (6/1,216) in the four-phasic group (p = 0.034). Four-phasic CM administration protocol is easy to implement in the clinical routine at no extra cost. The extravasation rate is reduced by 65% with the application of the four-phasic protocol compared to the three-phasic protocol in coronary CTA. • Four-phasic CM injection-protocol reduces extravasation rate by 65% compared to three-phasic. • The saline pacer bolus substantially reduces the risk of CM extravasation. • The implementation of four-phasic injection-protocol is at no cost.

Electroencephalography for children with autistic spectrum disorder: a sedation protocol.

PubMed

Keidan, Ilan; Ben-Menachem, Erez; Tzadok, Michal; Ben-Zeev, Bruria; Berkenstadt, Haim

2015-02-01

To report the effectiveness and efficiency of a predetermined sedation protocol for providing sedation for electroencephalograph (EEG) studies in children with autism. Sleep EEG has been advocated for the majority of children with autism spectrum disorder. In most cases, sedation is required to allow adequate studies. Most sedation drugs have negative effects on the EEG pattern. The sedation protocol we adopted included chloral hydrate, dexmedetomidine, and ketamine and was evaluated prospectively for 2 years. One hundred and eighty-three children with autistic spectrum disorder were sedated with the described drug protocol that was efficient, provided adequate EEG readings, and was not associated with serious adverse events. Our protocol kept costs to a minimum but provided appropriate escalation in care when required. © 2014 John Wiley & Sons Ltd.

Comparison of Bruce treadmill exercise test protocols: is ramped Bruce equal or superior to standard bruce in producing clinically valid studies for patients presenting for evaluation of cardiac ischemia or arrhythmia with body mass index equal to or greater than 30?

PubMed

Bires, Angela Macci; Lawson, Dori; Wasser, Thomas E; Raber-Baer, Donna

2013-12-01

Clinically valid cardiac evaluation via treadmill stress testing requires patients to achieve specific target heart rates and to successfully complete the cardiac examination. A comparison of the standard Bruce protocol and the ramped Bruce protocol was performed using data collected over a 1-y period from a targeted patient population with a body mass index (BMI) equal to or greater than 30 to determine which treadmill protocol provided more successful examination results. The functional capacity, metabolic equivalent units achieved, pressure rate product, and total time on the treadmill as measured for the obese patients were clinically valid and comparable to normal-weight and overweight patients (P < 0.001). Data gathered from each protocol demonstrated that the usage of the ramped Bruce protocol achieved more consistent results in comparison across all BMI groups in achieving 80%-85% of their age-predicted maximum heart rate. This study did not adequately establish that the ramped Bruce protocol was superior to the standard Bruce protocol for the examination of patients with a BMI equal to or greater than 30.

Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols.

PubMed

Reveiz, Ludovic; Haby, Michelle M; Martínez-Vega, Ruth; Pinzón-Flores, Carlos E; Elias, Vanessa; Smith, Emma; Pinart, Mariona; Broutet, Nathalie; Becerra-Posada, Francisco; Aldighieri, Sylvain; Van Kerkhove, Maria D

2017-01-01

Given the severity and impact of the current Zika virus (ZIKV) outbreak in the Americas, numerous countries have rushed to develop research studies to assess ZIKV and its potential health consequences. In an effort to ensure that studies are comprehensive, both internally and externally valid, and with reliable results, the World Health Organization, the Pan American Health Organization, Institut Pasteur, the networks of Fiocruz, the Consortia for the Standardization of Influenza Seroepidemiology (CONSISE) and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) have generated six standardized clinical and epidemiological research protocols and questionnaires to address key public health questions on ZIKV. We conducted a systematic search of ongoing study protocols related to ZIKV research. We analyzed the content of protocols of 32 cohort studies and 13 case control studies for systematic bias that could produce erroneous results. Additionally we aimed to characterize the risks of bias and confounding in observational studies related to ZIKV and to propose ways to minimize them, including the use of six newly standardized research protocols. Observational studies of ZIKV face an array of challenges, including measurement of exposure and outcomes (microcephaly and Guillain-Barré Syndrome). Potential confounders need to be measured where known and controlled for in the analysis. Selection bias due to non-random selection is a significant issue, particularly in the case-control design, and losses to follow-up is equally important for the cohort design. Observational research seeking to answer key questions on the ZIKV should consider these restrictions and take precautions to minimize bias in an effort to provide reliable and valid results. Utilization of the standardized research protocols developed by the WHO, PAHO, Institut Pasteur, and CONSISE will harmonize the key methodological aspects of each study design to minimize bias at different stages of the study. Biases need to be considered by researchers implementing the standardized protocols as well as by users of observational epidemiological studies of ZIKV.

Prospective Evaluation of a Matrix-Assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry System in a Hospital Clinical Microbiology Laboratory for Identification of Bacteria and Yeasts: a Bench-by-Bench Study for Assessing the Impact on Time to Identification and Cost-Effectiveness

PubMed Central

Tan, K. E.; Ellis, B. C.; Lee, R.; Stamper, P. D.; Zhang, S. X.

2012-01-01

Matrix-assisted laser desorption ionization–time of flight mass spectrometry (MALDI-TOF MS) has been found to be an accurate, rapid, and inexpensive method for the identification of bacteria and yeasts. Previous evaluations have compared the accuracy, time to identification, and costs of the MALDI-TOF MS method against standard identification systems or commercial panels. In this prospective study, we compared a protocol incorporating MALDI-TOF MS (MALDI protocol) with the current standard identification protocols (standard protocol) to determine the performance in actual practice using a specimen-based, bench-by-bench approach. The potential impact on time to identification (TTI) and costs had MALDI-TOF MS been the first-line identification method was quantitated. The MALDI protocol includes supplementary tests, notably for Streptococcus pneumoniae and Shigella, and indications for repeat MALDI-TOF MS attempts, often not measured in previous studies. A total of 952 isolates (824 bacterial isolates and 128 yeast isolates) recovered from 2,214 specimens were assessed using the MALDI protocol. Compared with standard protocols, the MALDI protocol provided identifications 1.45 days earlier on average (P < 0.001). In our laboratory, we anticipate that the incorporation of the MALDI protocol can reduce reagent and labor costs of identification by $102,424 or 56.9% within 12 months. The model included the fixed annual costs of the MALDI-TOF MS, such as the cost of protein standards and instrument maintenance, and the annual prevalence of organisms encountered in our laboratory. This comprehensive cost analysis model can be generalized to other moderate- to high-volume laboratories. PMID:22855510

The cumulative effect of multiple critical care protocols on length of stay in a geriatric trauma population.

PubMed

Frederickson, Tiffany A; Renner, Catherine Hackett; Swegle, James R; Sahr, Sheryl M

2013-01-01

The elderly individuals are the most rapidly growing cohort within the US population, and a corresponding increase is being seen in elderly trauma patients. Elderly patients are more likely to have a hospital length of stay (LOS) in excess of 10 days. They account for 60% of total ICU days. Length of stay is frequently used as a proxy measure for improvement in injury outcomes, changes in quality of care, and hospital outcomes. Patient care protocols are typically created from evidence-based guidelines that serve to reduce variation in care from patient to patient. Patient care protocols have been found to positively impact patient care with reduced duration of mechanical ventilation, shorter LOS in the ICU and shorter overall hospitalization time, reduced mortality, and reduced health care costs. The following study was designed to assess the impact of the implementation of 4 patient care protocols within an elderly trauma population. We hypothesized that the implementation of these protocols would have a beneficial impact on patient care that could be measured by a decrease in hospital LOS. An archival, retrospective pretest/posttest study was performed on elderly trauma patients. The new protocols helped guide practical changes in care that resulted in a 32% decrease in LOS for our elderly trauma patients which exceeds the 25% decrease found in other studies. Additionally, the "Other" category for each variable was less frequently used in the post-protocol phase than in the pre-protocol phase, suggesting a spillover effect on the level of detail recorded in the patient chart. With less variation in practices in the post-protocol phase, Injury Severity score, and admission systolic blood pressure emerged as significant predictors of LOS.

Quantitative Comparison of 21 Protocols for Labeling Hippocampal Subfields and Parahippocampal Subregions in In Vivo MRI: Towards a Harmonized Segmentation Protocol

PubMed Central

Yushkevich, Paul A.; Amaral, Robert S. C.; Augustinack, Jean C.; Bender, Andrew R.; Bernstein, Jeffrey D.; Boccardi, Marina; Bocchetta, Martina; Burggren, Alison C.; Carr, Valerie A.; Chakravarty, M. Mallar; Chetelat, Gael; Daugherty, Ana M.; Davachi, Lila; Ding, Song-Lin; Ekstrom, Arne; Geerlings, Mirjam I.; Hassan, Abdul; Huang, Yushan; Iglesias, Eugenio; La Joie, Renaud; Kerchner, Geoffrey A.; LaRocque, Karen F.; Libby, Laura A.; Malykhin, Nikolai; Mueller, Susanne G.; Olsen, Rosanna K.; Palombo, Daniela J.; Parekh, Mansi B; Pluta, John B.; Preston, Alison R.; Pruessner, Jens C.; Ranganath, Charan; Raz, Naftali; Schlichting, Margaret L.; Schoemaker, Dorothee; Singh, Sachi; Stark, Craig E. L.; Suthana, Nanthia; Tompary, Alexa; Turowski, Marta M.; Van Leemput, Koen; Wagner, Anthony D.; Wang, Lei; Winterburn, Julie L.; Wisse, Laura E.M.; Yassa, Michael A.; Zeineh, Michael M.

2015-01-01

OBJECTIVE An increasing number of human in vivo magnetic resonance imaging (MRI) studies have focused on examining the structure and function of the subfields of the hippocampal formation (the dentate gyrus, CA fields 1–3, and the subiculum) and subregions of the parahippocampal gyrus (entorhinal, perirhinal, and parahippocampal cortices). The ability to interpret the results of such studies and to relate them to each other would be improved if a common standard existed for labeling hippocampal subfields and parahippocampal subregions. Currently, research groups label different subsets of structures and use different rules, landmarks, and cues to define their anatomical extents. This paper characterizes, both qualitatively and quantitatively, the variability in the existing manual segmentation protocols for labeling hippocampal and parahippocampal substructures in MRI, with the goal of guiding subsequent work on developing a harmonized substructure segmentation protocol. METHOD MRI scans of a single healthy adult human subject were acquired both at 3 Tesla and 7 Tesla. Representatives from 21 research groups applied their respective manual segmentation protocols to the MRI modalities of their choice. The resulting set of 21 segmentations was analyzed in a common anatomical space to quantify similarity and identify areas of agreement. RESULTS The differences between the 21 protocols include the region within which segmentation is performed, the set of anatomical labels used, and the extents of specific anatomical labels. The greatest overall disagreement among the protocols is at the CA1/subiculum boundary, and disagreement across all structures is greatest in the anterior portion of the hippocampal formation relative to the body and tail. CONCLUSIONS The combined examination of the 21 protocols in the same dataset suggests possible strategies towards developing a harmonized subfield segmentation protocol and facilitates comparison between published studies. PMID:25596463

Are emergency medical technician-basics able to use a selective immobilization of the cervical spine protocol?: a preliminary report.

PubMed

Dunn, Thomas M; Dalton, Alice; Dorfman, Todd; Dunn, William W

2004-01-01

To be a first step in determining whether emergency medicine technician (EMT)-Basics are capable of using a protocol that allows for selective immobilization of the cervical spine. Such protocols are coming into use at an advanced life support level and could be beneficial when used by basic life support providers. A convenience sample of participants (n=95) from 11 emergency medical services agencies and one college class participated in the study. All participants evaluated six patients in written scenarios and decided which should be placed into spinal precautions according to a selective spinal immobilization protocol. Systems without an existing selective spinal immobilization protocol received a one-hour continuing education lecture regarding the topic. College students received a similar lecture written so laypersons could understand the protocol. All participants showed proficiency when applying a selective immobilization protocol to patients in paper-based scenarios. Furthermore, EMT-Basics performed at the same level as paramedics when following the protocol. Statistical analysis revealed no significant differences between EMT-Basics and paramedics. A follow-up group of college students (added to have a non-EMS comparison group) also performed as well as paramedics when making decisions to use spinal precautions. Differences between college students and paramedics were also statistically insignificant. The results suggest that EMT-Basics are as accurate as paramedics when making decisions regarding selective immobilization of the cervical spine during paper-based scenarios. That laypersons are also proficient when using the protocol could indicate that it is extremely simple to follow. This study is a first step toward the necessary additional studies evaluating the efficacy of EMT-Basics using selective immobilization as a regular practice.

Prospective evaluation of a matrix-assisted laser desorption ionization-time of flight mass spectrometry system in a hospital clinical microbiology laboratory for identification of bacteria and yeasts: a bench-by-bench study for assessing the impact on time to identification and cost-effectiveness.

PubMed

Tan, K E; Ellis, B C; Lee, R; Stamper, P D; Zhang, S X; Carroll, K C

2012-10-01

Matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) has been found to be an accurate, rapid, and inexpensive method for the identification of bacteria and yeasts. Previous evaluations have compared the accuracy, time to identification, and costs of the MALDI-TOF MS method against standard identification systems or commercial panels. In this prospective study, we compared a protocol incorporating MALDI-TOF MS (MALDI protocol) with the current standard identification protocols (standard protocol) to determine the performance in actual practice using a specimen-based, bench-by-bench approach. The potential impact on time to identification (TTI) and costs had MALDI-TOF MS been the first-line identification method was quantitated. The MALDI protocol includes supplementary tests, notably for Streptococcus pneumoniae and Shigella, and indications for repeat MALDI-TOF MS attempts, often not measured in previous studies. A total of 952 isolates (824 bacterial isolates and 128 yeast isolates) recovered from 2,214 specimens were assessed using the MALDI protocol. Compared with standard protocols, the MALDI protocol provided identifications 1.45 days earlier on average (P < 0.001). In our laboratory, we anticipate that the incorporation of the MALDI protocol can reduce reagent and labor costs of identification by $102,424 or 56.9% within 12 months. The model included the fixed annual costs of the MALDI-TOF MS, such as the cost of protein standards and instrument maintenance, and the annual prevalence of organisms encountered in our laboratory. This comprehensive cost analysis model can be generalized to other moderate- to high-volume laboratories.

Game-theoretic perspective of Ping-Pong protocol

NASA Astrophysics Data System (ADS)

Kaur, Hargeet; Kumar, Atul

2018-01-01

We analyse Ping-Pong protocol from the point of view of a game. The analysis helps us in understanding the different strategies of a sender and an eavesdropper to gain the maximum payoff in the game. The study presented here characterizes strategies that lead to different Nash equilibriums. We further demonstrate the condition for Pareto optimality depending on the parameters used in the game. Moreover, we also analysed LM05 protocol and compared it with PP protocol from the point of view of a generic two-way QKD game with or without entanglement. Our results provide a deeper understanding of general two-way QKD protocols in terms of the security and payoffs of different stakeholders in the protocol.

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.

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

Guidelines for experimental design protocol and validation procedure for the measurement of heat resistance of microorganisms in milk.

PubMed

Condron, Robin; Farrokh, Choreh; Jordan, Kieran; McClure, Peter; Ross, Tom; Cerf, Olivier

2015-01-02

Studies on the heat resistance of dairy pathogens are a vital part of assessing the safety of dairy products. However, harmonized methodology for the study of heat resistance of food pathogens is lacking, even though there is a need for such harmonized experimental design protocols and for harmonized validation procedures for heat treatment studies. Such an approach is of particular importance to allow international agreement on appropriate risk management of emerging potential hazards for human and animal health. This paper is working toward establishment of a harmonized protocol for the study of the heat resistance of pathogens, identifying critical issues for establishment of internationally agreed protocols, including a harmonized framework for reporting and interpretation of heat inactivation studies of potentially pathogenic microorganisms. Copyright © 2014 Elsevier B.V. All rights reserved.

Effects of different duration isometric contractions on tendon elasticity in human quadriceps muscles

PubMed Central

Kubo, Keitaro; Kanehisa, Hiroaki; Fukunaga, Tetsuo

2001-01-01

The present study aimed to investigate the influence of isometric training protocols with long- and short-duration contractions on the elasticity of human tendon structures in vivo. The elasticity was assessed through in vivo determination of the elongation (L) of the tendons and aponeuroses using ultrasonography, while the subjects performed ramp isometric exercise up to maximum voluntary contraction (MVC).Eight young males completed 12 weeks (4 days per week) of a unilateral isometric training programme on knee extensors, which consisted of two different combinations of contraction and relaxation times at 70 % MVC: one leg was trained using a short-duration protocol (3 sets of 50 repetitions of contraction for 1 s and relaxation for 2 s), and the other leg was trained using a long-duration protocol (4 sets of a combination of contraction for 20 s and relaxation for 1 min). The training volume per session, expressed as the integrated torque, was the same for the two protocols.Both protocols resulted in a significant increase in MVC: 31.8 ± 17.2 % for the short-duration protocol and 33.9 ± 14.4 % for the long-duration protocol. Moreover, the training produced significant increases in the muscle volume of the constituents of the quadriceps femoris, with similar relative gains for the two protocols: 7.4 ± 3.9 % for the short-duration protocol and 7.6 ± 4.3 % for the long-duration protocol.The short-duration protocol produced no significant change in L values at any of the force production levels. For the long-duration protocol, however, the L values above 550 N were significantly shorter after training. Analysis revealed that the group × test time interaction effect on tendon stiffness was significant. Stiffness increased significantly for the long-duration protocol, but not for the short-duration protocol.The present study demonstrates a greater increase in stiffness of human tendon structures following isometric training using longer duration contractions compared to shorter contractions. This suggests that the changes in the elasticity of the tendon structures after resistance training may be affected by the duration of muscle contraction. PMID:11600697

Robust Sub-nanomolar Library Preparation for High Throughput Next Generation Sequencing.

PubMed

Wu, Wells W; Phue, Je-Nie; Lee, Chun-Ting; Lin, Changyi; Xu, Lai; Wang, Rong; Zhang, Yaqin; Shen, Rong-Fong

2018-05-04

Current library preparation protocols for Illumina HiSeq and MiSeq DNA sequencers require ≥2 nM initial library for subsequent loading of denatured cDNA onto flow cells. Such amounts are not always attainable from samples having a relatively low DNA or RNA input; or those for which a limited number of PCR amplification cycles is preferred (less PCR bias and/or more even coverage). A well-tested sub-nanomolar library preparation protocol for Illumina sequencers has however not been reported. The aim of this study is to provide a much needed working protocol for sub-nanomolar libraries to achieve outcomes as informative as those obtained with the higher library input (≥ 2 nM) recommended by Illumina's protocols. Extensive studies were conducted to validate a robust sub-nanomolar (initial library of 100 pM) protocol using PhiX DNA (as a control), genomic DNA (Bordetella bronchiseptica and microbial mock community B for 16S rRNA gene sequencing), messenger RNA, microRNA, and other small noncoding RNA samples. The utility of our protocol was further explored for PhiX library concentrations as low as 25 pM, which generated only slightly fewer than 50% of the reads achieved under the standard Illumina protocol starting with > 2 nM. A sub-nanomolar library preparation protocol (100 pM) could generate next generation sequencing (NGS) results as robust as the standard Illumina protocol. Following the sub-nanomolar protocol, libraries with initial concentrations as low as 25 pM could also be sequenced to yield satisfactory and reproducible sequencing results.

Maximizing Interhospital Transfer Resources for Neurosurgical Patients.

PubMed

Schnurman, Zane; Chin, Robert; Fishkin, Edward R; Huang, Paul P

2017-08-01

Delays in patient transfers are associated with worse outcomes for some neurosurgical conditions. One of the primary causes of transfer delay is lack of neurosurgery intensive care unit bed availability. In the present study, we characterize the results of implementing an interhospital transfer protocol to reduce unnecessary transfers and improve bed availability. A transfer protocol was implemented in July 2012 at the Bellevue Hospital Department of Neurosurgery that screened for and prevented transfer of low-risk patients who were unlikely to require specialized inpatient neurosurgical care. The impact of this protocol was assessed with prospectively recorded data on all potential interhospital transfers from May 2011 through June 2016. Of the 1978 calls (regarding 1886 individual patients), 402 occurred before the implementation of the transfer protocol and 1576 occurred after. Before the protocol, 84.1% of transfer requests were accepted, but 15.2% were subsequently denied for bed unavailability. After the protocol, a smaller share of transfer requests were accepted after protocol screening (71.8%, P < 0.001), but only 1.9% (P < 0.001) were subsequently denied because of bed unavailability. The diagnosis demographics changed significantly (P < 0.001), with a larger share of arriving transfers suffering from aneurysms or tumors after the protocol and a smaller share suffering from stenosis/disc disease without neurological symptoms. The transfer protocol implemented in the present study allowed transfer determination based on the need for specialized neurosurgical care rather than chance unavailability of beds. Developing interhospital transfer protocols may be an effective strategy to efficiently allocate limited hospital resources and improve transfer systems. Copyright © 2017 Elsevier Inc. All rights reserved.

Evaluation of a 15-week CHOP protocol for the treatment of canine multicentric lymphoma.

PubMed

Burton, J H; Garrett-Mayer, E; Thamm, D H

2013-12-01

Dose intense CHOP protocols have been shown to improve outcome for people with non-Hodgkin's lymphoma, but evaluation of dose intense CHOP protocols for canine lymphoma is currently limited. The hypothesis of this retrospective study was that a 15-week dose intense CHOP protocol would have shorter treatment duration with similar efficacy to other doxorubicin-based multidrug protocols. Thirty-one client owned dogs with multicentric lymphoma were treated with a 15-week CHOP chemotherapy protocol with an overall response rate of 100% and a median progression-free interval (PFI) of 140 days [95% confidence interval (CI) 91-335 days]. Dogs that had two or more treatment delays had significantly prolonged PFI and overall survival in multivariate analysis. Dose intensity did not correlate with patient outcome. Dogs experiencing multiple treatment delays secondary to adverse events may receive their individual maximally tolerated dose while dogs with no adverse events may be underdosed. Future studies should focus on individual patient dose optimization. © 2012 Blackwell Publishing Ltd.

Study on Cloud Security Based on Trust Spanning Tree Protocol

NASA Astrophysics Data System (ADS)

Lai, Yingxu; Liu, Zenghui; Pan, Qiuyue; Liu, Jing

2015-09-01

Attacks executed on Spanning Tree Protocol (STP) expose the weakness of link layer protocols and put the higher layers in jeopardy. Although the problems have been studied for many years and various solutions have been proposed, many security issues remain. To enhance the security and credibility of layer-2 network, we propose a trust-based spanning tree protocol aiming at achieving a higher credibility of LAN switch with a simple and lightweight authentication mechanism. If correctly implemented in each trusted switch, the authentication of trust-based STP can guarantee the credibility of topology information that is announced to other switch in the LAN. To verify the enforcement of the trusted protocol, we present a new trust evaluation method of the STP using a specification-based state model. We implement a prototype of trust-based STP to investigate its practicality. Experiment shows that the trusted protocol can achieve security goals and effectively avoid STP attacks with a lower computation overhead and good convergence performance.

Does addition of low-level laser therapy (LLLT) in conservative care of knee arthritis successfully postpone the need for joint replacement?

PubMed

Ip, David

2015-12-01

The current study evaluates whether the addition of low-level laser therapy into standard conventional physical therapy in elderly with bilateral symptomatic tri-compartmental knee arthritis can successfully postpone the need for joint replacement surgery. A prospective randomized cohort study of 100 consecutive unselected elderly patients with bilateral symptomatic knee arthritis with each knee randomized to receive either treatment protocol A consisting of conventional physical therapy or protocol B which is the same as protocol A with added low-level laser therapy. The mean follow-up was 6 years. Treatment failure was defined as breakthrough pain which necessitated joint replacement surgery. After a follow-up of 6 years, patients clearly benefited from treatment with protocol B as only one knee needed joint replacement surgery, while nine patients treated with protocol A needed surgery (p < 0.05). We conclude low-level laser therapy should be incorporated into standard conservative treatment protocol for symptomatic knee arthritis.

Analogy motor learning by young children: a study of rope skipping.

PubMed

Tse, Andy C Y; Fong, Shirley S M; Wong, Thomson W L; Masters, Rich

2017-03-01

Research in psychology suggests that provision of an instruction by analogy can enhance acquisition and understanding of knowledge. Limited research has been conducted to test this proposition in motor learning by children. The purpose of the present study was to examine the feasibility of analogy instructions in motor skill acquisition by children. Thirty-two children were randomly assigned to one of the two instruction protocols: analogy and explicit instruction protocols for a two-week rope skipping training. Each participant completed a pretest (Lesson 1), three practice sessions (Lesson 2-4), a posttest and a secondary task test (Lesson 5). Children in the analogy protocol displayed better rope skip performance than those in the explicit instruction protocol (p < .001). Moreover, a cognitive secondary task test indicated that children in the analogy protocol performed more effectively, whereas children in the explicit protocol displayed decrements in performance. Analogy learning may aid children to acquire complex motor skills, and have potential benefits related to reduced cognitive processing requirements.

Calibration and data collection protocols for reliable lattice parameter values in electron pair distribution function studies

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

Abeykoon, A. M. Milinda; Hu, Hefei; Wu, Lijun

2015-01-30

Different protocols for calibrating electron pair distribution function (ePDF) measurements are explored and described for quantitative studies on nanomaterials. It is found that the most accurate approach to determine the camera length is to use a standard calibration sample of Au nanoparticles from the National Institute of Standards and Technology. Different protocols for data collection are also explored, as are possible operational errors, to find the best approaches for accurate data collection for quantitative ePDF studies.

Calibration and data collection protocols for reliable lattice parameter values in electron pair distribution function (ePDF) studies

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

Abeykoon, A. M. Milinda; Hu, Hefei; Wu, Lijun

2015-02-01

We explore and describe different protocols for calibrating electron pair distribution function (ePDF) measurements for quantitative studies on nano-materials. We find the most accurate approach to determine the camera-length is to use a standard calibration sample of Au nanoparticles from National Institute of Standards and Technology. Different protocols for data collection are also explored, as are possible operational errors, to find the best approaches for accurate data collection for quantitative ePDF studies.

Examination of an interventionist-led HIV intervention among criminal justice-involved female prisoners

PubMed Central

Havens, Jennifer R.; Leukefeld, Carl G.; Oser, Carrie B.; Staton-Tindall, Michele; Knudsen, Hannah K.; Mooney, Jennifer; Duvall, Jamieson L.; Clarke, Jennifer G.; Frisman, Linda; Surratt, Hilary L.; Inciardi, James A.

2009-01-01

The purpose of this study was to examine the implementation, adherence and protocol fidelity for the Reducing Risky Relationships for HIV (RRR-HIV) study. The RRR-HIV study is a phase III trial of a randomized intervention to reduce human immunodeficiency virus (HIV) risk behaviors among incarcerated women in four US states: Connecticut, Delaware, Kentucky and Rhode Island. The intervention consists of five interventionist-led prison-based group sessions and a sixth individual community-based session. Data on adherence, implementation, acceptability and fidelity of the intervention were obtained from forms completed after the five prison-based sessions by both the interventionist and participant. Data from the sixth session were collected by the interventionist. Of the 363 women recruited to date, 173 (47.6%) have been randomly allocated to the experimental RRR intervention, of which implementation measures were available for 162 (93.6%). Almost three-quarters of women attended all five sessions, each of which lasted a median of 90 minutes, indicating successful implementation of the protocol across multiple study sites. Interventionists and participants alike reported that all of the topics for each session were discussed, suggesting adherence to the protocol. In addition, protocol interventionists indicated that more than 95% of the women were engaged/involved, interested, and understood the materials presented, indicating high levels of acceptability among the participants and fidelity to the intervention protocols. The majority of participants also answered all of the post-test questions correctly, which is another strong indicator of the fidelity to the intervention. Results suggest that the RRR-HIV study has been successfully implemented across multiple study sites. Adherence to the protocol, as well as protocol fidelity and acceptability, were also strong, which is essential to establish prior to examining outcome data. PMID:20090928

The Acute Effects of Static Stretching Compared to Dynamic Stretching with and without an Active Warm up on Anaerobic Performance

PubMed Central

KENDALL, BRADLEY J.

2017-01-01

The Wingate Anaerobic Test (WAnT) has been used in many studies to determine anaerobic performance. However, there has been poor reporting of warm-up protocols and limited consistency between warm-up methods that have been used. With the WAnT being such a commonly-used test, consistency in warm-up methods is essential in order to compare results across studies. Therefore, this study was designed to compare how static stretching, dynamic stretching, and an active warm-up affect WAnT performance. Ten recreationally active participants (5 males, 5 females) with a mean (SD) age of 23.3 (0.7) volunteered for this study. Subjects were randomized to a specific order of five warm-up protocols, which were performed on individual days followed by a WAnT. Peak power, mean power, power drop, and fatigue index were compared for each trial using a repeated measures ANOVA. For peak power, results revealed that warm-up protocol had a significant effect, F(4,36) = 3.90, p = .01, partial η2 = .302. It was hypothesized that the dynamic stretching would lead to greater peak power than the static stretching protocol. However, results of post hoc analyses failed to detect a significant difference (p =.065). For the other measured variables no significant differences were found. The findings from this study suggest that warm-up protocols may have significantly different impacts on peak power during the WAnT. Additional research should use larger sample sizes and further explore these warm-up protocols. Developing a standardized warm-up protocol for the WAnT may improve consistency between studies. PMID:28479947

The Acute Effects of Static Stretching Compared to Dynamic Stretching with and without an Active Warm up on Anaerobic Performance.

PubMed

Kendall, Bradley J

2017-01-01

The Wingate Anaerobic Test (WAnT) has been used in many studies to determine anaerobic performance. However, there has been poor reporting of warm-up protocols and limited consistency between warm-up methods that have been used. With the WAnT being such a commonly-used test, consistency in warm-up methods is essential in order to compare results across studies. Therefore, this study was designed to compare how static stretching, dynamic stretching, and an active warm-up affect WAnT performance. Ten recreationally active participants (5 males, 5 females) with a mean (SD) age of 23.3 (0.7) volunteered for this study. Subjects were randomized to a specific order of five warm-up protocols, which were performed on individual days followed by a WAnT. Peak power, mean power, power drop, and fatigue index were compared for each trial using a repeated measures ANOVA. For peak power, results revealed that warm-up protocol had a significant effect, F (4,36) = 3.90, p = .01, partial η 2 = .302. It was hypothesized that the dynamic stretching would lead to greater peak power than the static stretching protocol. However, results of post hoc analyses failed to detect a significant difference (p =.065). For the other measured variables no significant differences were found. The findings from this study suggest that warm-up protocols may have significantly different impacts on peak power during the WAnT. Additional research should use larger sample sizes and further explore these warm-up protocols. Developing a standardized warm-up protocol for the WAnT may improve consistency between studies.

Organizational principles of cloud storage to support collaborative biomedical research.

PubMed

Kanbar, Lara J; Shalish, Wissam; Robles-Rubio, Carlos A; Precup, Doina; Brown, Karen; Sant'Anna, Guilherme M; Kearney, Robert E

2015-08-01

This paper describes organizational guidelines and an anonymization protocol for the management of sensitive information in interdisciplinary, multi-institutional studies with multiple collaborators. This protocol is flexible, automated, and suitable for use in cloud-based projects as well as for publication of supplementary information in journal papers. A sample implementation of the anonymization protocol is illustrated for an ongoing study dealing with Automated Prediction of EXtubation readiness (APEX).

Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values.

PubMed

Ozarda, Yesim; Ichihara, Kiyoshi; Barth, Julian H; Klee, George

2013-05-01

The reference intervals (RIs) given in laboratory reports have an important role in aiding clinicians in interpreting test results in reference to values of healthy populations. In this report, we present a proposed protocol and standard operating procedures (SOPs) for common use in conducting multicenter RI studies on a national or international scale. The protocols and consensus on their contents were refined through discussions in recent C-RIDL meetings. The protocol describes in detail (1) the scheme and organization of the study, (2) the target population, inclusion/exclusion criteria, ethnicity, and sample size, (3) health status questionnaire, (4) target analytes, (5) blood collection, (6) sample processing and storage, (7) assays, (8) cross-check testing, (9) ethics, (10) data analyses, and (11) reporting of results. In addition, the protocol proposes the common measurement of a panel of sera when no standard materials exist for harmonization of test results. It also describes the requirements of the central laboratory, including the method of cross-check testing between the central laboratory of each country and local laboratories. This protocol and the SOPs remain largely exploratory and may require a reevaluation from the practical point of view after their implementation in the ongoing worldwide study. The paper is mainly intended to be a basis for discussion in the scientific community.

[The factors that influence the use of clinical protocols according to the opinion of health center coordinators. The Research Group on the Evaluation and Improvement of Clinical Protocols].

PubMed

Saura-Llamas, J; Saturno Hernández, P J; Gaona Ramón, J M; Romero Román, J R; González Barberá, M

1999-11-15

To find the factors that affect the use of clinical protocols in primary care, in the view of primary care team coordinators, and the reasons why they are little followed, and to bring together suggestions for improvement. An opinion study, through a telephone survey. Primary health care. The health centres in Murcia with protocolized activity: 31 at the start of the project. The coordinators and those in charge of nursing, 62 people in all. After a pilot study, a structured telephone survey was carried out, administered by a trained interviewer who posed two open questions: why do you think that the professionals at your centre do not use the existing protocols more often? and: what suggestions would you make to improve the protocols and have them used more? A specialist company did the field-work in June and July 1996. There was a 98% reply rate. To the first question, coordinators thought that low use could be explained by excess demand and lack of time for consultations (33% of all replies), although they also cited other organisational problems in the centre, defects in protocols and lack of training. Those in charge of nursing gave very similar replies, with excess demand (39%) predominating. To the second question, on increasing the use of protocols, coordinators suggested that the protocols needed to be improved (44.8% of replies), and also cited the need for improvements in organisation and on-going training. Very similar answers came from the nursing side, where 43.5% highlighted the need to improve the protocol documents. The coordinators assumed that the clinical protocols were used little and could be improved. In their view the basic reason for their low use is excessive pressure from the patient-load. The key to using them more is improvement in the protocol documents.

Protocol vulnerability detection based on network traffic analysis and binary reverse engineering.

PubMed

Wen, Shameng; Meng, Qingkun; Feng, Chao; Tang, Chaojing

2017-01-01

Network protocol vulnerability detection plays an important role in many domains, including protocol security analysis, application security, and network intrusion detection. In this study, by analyzing the general fuzzing method of network protocols, we propose a novel approach that combines network traffic analysis with the binary reverse engineering method. For network traffic analysis, the block-based protocol description language is introduced to construct test scripts, while the binary reverse engineering method employs the genetic algorithm with a fitness function designed to focus on code coverage. This combination leads to a substantial improvement in fuzz testing for network protocols. We build a prototype system and use it to test several real-world network protocol implementations. The experimental results show that the proposed approach detects vulnerabilities more efficiently and effectively than general fuzzing methods such as SPIKE.

Nonpainful wide-area compression inhibits experimental pain.

PubMed

Honigman, Liat; Bar-Bachar, Ofrit; Yarnitsky, David; Sprecher, Elliot; Granovsky, Yelena

2016-09-01

Compression therapy, a well-recognized treatment for lymphoedema and venous disorders, pressurizes limbs and generates massive non-noxious afferent sensory barrages. The aim of this study was to study whether such afferent activity has an analgesic effect when applied on the lower limbs, hypothesizing that larger compression areas will induce stronger analgesic effects, and whether this effect correlates with conditioned pain modulation (CPM). Thirty young healthy subjects received painful heat and pressure stimuli (47°C for 30 seconds, forearm; 300 kPa for 15 seconds, wrist) before and during 3 compression protocols of either SMALL (up to ankles), MEDIUM (up to knees), or LARGE (up to hips) compression areas. Conditioned pain modulation (heat pain conditioned by noxious cold water) was tested before and after each compression protocol. The LARGE protocol induced more analgesia for heat than the SMALL protocol (P < 0.001). The analgesic effect interacted with gender (P = 0.015). The LARGE protocol was more efficient for females, whereas the MEDIUM protocol was more efficient for males. Pressure pain was reduced by all protocols (P < 0.001) with no differences between protocols and no gender effect. Conditioned pain modulation was more efficient than the compression-induced analgesia. For the LARGE protocol, precompression CPM efficiency positively correlated with compression-induced analgesia. Large body area compression exerts an area-dependent analgesic effect on experimental pain stimuli. The observed correlation with pain inhibition in response to robust non-noxious sensory stimulation may suggest that compression therapy shares similar mechanisms with inhibitory pain modulation assessed through CPM.

The Geneva Protocol of 1925: Past and Present.

ERIC Educational Resources Information Center

Harbison, John L.

1982-01-01

Presents a position paper for use in high school social studies class debates on the Geneva Protocol of 1925. The Protocol was an international agreement to restrict chemical and biological warfare (CBW). The author traces the history of U.S. policies dealing with CBW since 1925. (AM)

Eavesdropping on the improved three-party quantum secret sharing protocol

NASA Astrophysics Data System (ADS)

Gao, Gan

2011-02-01

Lin et al. [Song Lin, Fei Gao, Qiao-yan Wen, Fu-chen Zhu, Opt. Commun. 281 (2008) 4553] pointed out that the multiparty quantum secret sharing protocol [Zhan-jun Zhang, Gan Gao, Xin Wang, Lian-fang Han, Shou-hua Shi, Opt. Commun. 269 (2007) 418] is not secure and proposed an improved three-party quantum secret sharing protocol. In this paper, we study the security of the improved three-party quantum secret sharing protocol and find that it is still not secure. Finally, a further improved three-party quantum secret sharing protocol is proposed.

Bidirectional Teleportation Protocol in Quantum Wireless Multi-hop Network

NASA Astrophysics Data System (ADS)

Cai, Rui; Yu, Xu-Tao; Zhang, Zai-Chen

2018-06-01

We propose a bidirectional quantum teleportation protocol based on a composite GHZ-Bell state. In this protocol, the composite GHZ-Bell state channel is transformed into two-Bell state channel through gate operations and single qubit measurements. The channel transformation will lead to different kinds of quantum channel states, so a method is proposed to help determine the unitary matrices effectively under different quantum channels. Furthermore, we discuss the bidirectional teleportation protocol in the quantum wireless multi-hop network. This paper is aimed to provide a bidirectional teleportation protocol and study the bidirectional multi-hop teleportation in the quantum wireless communication network.

Bidirectional Teleportation Protocol in Quantum Wireless Multi-hop Network

NASA Astrophysics Data System (ADS)

Cai, Rui; Yu, Xu-Tao; Zhang, Zai-Chen

2018-02-01

We propose a bidirectional quantum teleportation protocol based on a composite GHZ-Bell state. In this protocol, the composite GHZ-Bell state channel is transformed into two-Bell state channel through gate operations and single qubit measurements. The channel transformation will lead to different kinds of quantum channel states, so a method is proposed to help determine the unitary matrices effectively under different quantum channels. Furthermore, we discuss the bidirectional teleportation protocol in the quantum wireless multi-hop network. This paper is aimed to provide a bidirectional teleportation protocol and study the bidirectional multi-hop teleportation in the quantum wireless communication network.

Analysis of limiting information characteristics of quantum-cryptography protocols

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

Sych, D V; Grishanin, Boris A; Zadkov, Viktor N

2005-01-31

The problem of increasing the critical error rate of quantum-cryptography protocols by varying a set of letters in a quantum alphabet for space of a fixed dimensionality is studied. Quantum alphabets forming regular polyhedra on the Bloch sphere and the continual alphabet equally including all the quantum states are considered. It is shown that, in the absence of basis reconciliation, a protocol with the tetrahedral alphabet has the highest critical error rate among the protocols considered, while after the basis reconciliation, a protocol with the continual alphabet possesses the highest critical error rate. (quantum optics and quantum computation)

The Rockefeller University Navigation Program: A Structured Multidisciplinary Protocol Development and Educational Program to Advance Translational Research

PubMed Central

Kost, Rhonda G.; Dowd, Kathleen A.; Hurley, Arlene M.; Rainer, Tyler‐Lauren; Coller, Barry S.

2014-01-01

Abstract The development of translational clinical research protocols is complex. To assist investigators, we developed a structured supportive guidance process (Navigation) to expedite protocol development to the standards of good clinical practice (GCP), focusing on research ethics and integrity. Navigation consists of experienced research coordinators leading investigators through a concerted multistep protocol development process from concept initiation to submission of the final protocol. To assess the effectiveness of Navigation, we collect data on the experience of investigators, the intensity of support required for protocol development, IRB review outcomes, and protocol start and completion dates. One hundred forty‐four protocols underwent Navigation and achieved IRB approval since the program began in 2007, including 37 led by trainee investigators, 26 led by MDs, 9 by MD/PhDs, 57 by PhDs, and 12 by investigators with other credentials (e.g., RN, MPH). In every year, more than 50% of Navigated protocols were approved by the IRB within 30 days. For trainees who had more than one protocol navigated, the intensity of Navigation support required decreased over time. Navigation can increase access to translational studies for basic scientists, facilitate GCP training for investigators, and accelerate development and approval of protocols of high ethical and scientific quality. PMID:24405608

Exosome-like vesicles in uterine aspirates: a comparison of ultracentrifugation-based isolation protocols.

PubMed

Campoy, Irene; Lanau, Lucia; Altadill, Tatiana; Sequeiros, Tamara; Cabrera, Silvia; Cubo-Abert, Montserrat; Pérez-Benavente, Assumpción; Garcia, Angel; Borrós, Salvador; Santamaria, Anna; Ponce, Jordi; Matias-Guiu, Xavier; Reventós, Jaume; Gil-Moreno, Antonio; Rigau, Marina; Colas, Eva

2016-06-18

Uterine aspirates are used in the diagnostic process of endometrial disorders, yet further applications could emerge if its complex milieu was simplified. Exosome-like vesicles isolated from uterine aspirates could become an attractive source of biomarkers, but there is a need to standardize isolation protocols. The objective of the study was to determine whether exosome-like vesicles exist in the fluid fraction of uterine aspirates and to compare protocols for their isolation, characterization, and analysis. We collected uterine aspirates from 39 pre-menopausal women suffering from benign gynecological diseases. The fluid fraction of 27 of those aspirates were pooled and split into equal volumes to evaluate three differential centrifugation-based procedures: (1) a standard protocol, (2) a filtration protocol, and (3) a sucrose cushion protocol. Characterization of isolated vesicles was assessed by electron microscopy, nanoparticle tracking analysis and immunoblot. Specifically for RNA material, we evaluate the effect of sonication and RNase A treatment at different steps of the protocol. We finally confirmed the efficiency of the selected methods in non-pooled samples. All protocols were useful to isolate exosome-like vesicles. However, the Standard procedure was the best performing protocol to isolate exosome-like vesicles from uterine aspirates: nanoparticle tracking analysis revealed a higher concentration of vesicles with a mode of 135 ± 5 nm, and immunoblot showed a higher expression of exosome-related markers (CD9, CD63, and CD81) thus verifying an enrichment in this type of vesicles. RNA contained in exosome-like vesicles was successfully extracted with no sonication treatment and exogenous nucleic acids digestion with RNaseA, allowing the analysis of the specific inner cargo by Real-Time qPCR. We confirmed the existence of exosome-like vesicles in the fluid fraction of uterine aspirates. They were successfully isolated by differential centrifugation giving sufficient proteomic and transcriptomic material for further analyses. The Standard protocol was the best performing procedure since the other two tested protocols did not ameliorate neither yield nor purity of exosome-like vesicles. This study contributes to establishing the basis for future comparative studies to foster the field of biomarker research in gynecology.

Evaluating Protocol Lifecycle Time Intervals in HIV/AIDS Clinical Trials

PubMed Central

Schouten, Jeffrey T.; Dixon, Dennis; Varghese, Suresh; Cope, Marie T.; Marci, Joe; Kagan, Jonathan M.

2014-01-01

Background Identifying efficacious interventions for the prevention and treatment of human diseases depends on the efficient development and implementation of controlled clinical trials. Essential to reducing the time and burden of completing the clinical trial lifecycle is determining which aspects take the longest, delay other stages, and may lead to better resource utilization without diminishing scientific quality, safety, or the protection of human subjects. Purpose In this study we modeled time-to-event data to explore relationships between clinical trial protocol development and implementation times, as well as identify potential correlates of prolonged development and implementation. Methods We obtained time interval and participant accrual data from 111 interventional clinical trials initiated between 2006 and 2011 by NIH’s HIV/AIDS Clinical Trials Networks. We determined the time (in days) required to complete defined phases of clinical trial protocol development and implementation. Kaplan-Meier estimates were used to assess the rates at which protocols reached specified terminal events, stratified by study purpose (therapeutic, prevention) and phase group (pilot/phase I, phase II, and phase III/ IV). We also examined several potential correlates to prolonged development and implementation intervals. Results Even though phase grouping did not determine development or implementation times of either therapeutic or prevention studies, overall we observed wide variation in protocol development times. Moreover, we detected a trend toward phase III/IV therapeutic protocols exhibiting longer developmental (median 2 ½ years) and implementation times (>3years). We also found that protocols exceeding the median number of days for completing the development interval had significantly longer implementation. Limitations The use of a relatively small set of protocols may have limited our ability to detect differences across phase groupings. Some timing effects present for a specific study phase may have been masked by combining protocols into phase groupings. Presence of informative censoring, such as withdrawal of some protocols from development if they began showing signs of lost interest among investigators, complicates interpretation of Kaplan-Meier estimates. Because this study constitutes a retrospective examination over an extended period of time, it does not allow for the precise identification of relative factors impacting timing. Conclusions Delays not only increase the time and cost to complete clinical trials, but they also diminish their usefulness by failing to answer research questions in time. We believe that research analyzing the time spent traversing defined intervals across the clinical trial protocol development and implementation continuum can stimulate business process analyses and reengineering efforts that could lead to reductions in the time from clinical trial concept to results, thereby accelerating progress in clinical research. PMID:24980279

Comparison of results of cycles treated with modified mild protocol and short protocol for ovarian stimulation.

PubMed

Coelho, F; Aguiar, L F; Cunha, G S P; Cardinot, N; Lucena, E

2014-01-01

The ovarian stimulation has been applied in order to increase the number of oocytes to compensate for the poor results of in vitro fertilization, allowing the selection of one or more embryos to be transferred. Our aim is to compare the results obtained in IVF/ICSI cycles using the short protocol for controlled ovarian stimulation to the results from the modified mild protocol used in our department. A total of 240 cycles were conducted from January 2010 to December 2011. When comparing both protocols, it could be observed that there was a significant difference in the quantity of gonadotropins doses in the mild protocol and in the short protocol. No significant difference was observed regarding pregnancy rates per cycle, 22% and 26.2%, in short and mild protocols, respectively. The protocols of controlled ovarian stimulation are often associated with high risk of complications such as ovarian hyperstimulation syndrome, excessive emotional stress, high rates of treatment dropouts, and abdominal discomfort. With the data obtained in this study, one can conclude that there are less risks and complications for the patient when using the mild stimulation protocol. It was also observed that in this group there was a slightly higher rate.

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

PubMed Central

2013-01-01

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

The Effect of Therapeutic Exercise on Long-Standing Adductor-Related Groin Pain in Athletes: Modified Hölmich Protocol

PubMed Central

Yousefzadeh, Abbas; Olyaei, Gholam Reza; Naseri, Nasrin; Khazaeipour, Zahra

2018-01-01

Objective The Hölmich protocol in therapeutic exercise is the most appropriate method for the treatment of long-standing adductor-related groin pain (LSAGP). Herein, we evaluated a modified Hölmich protocol to resolve the possible limitations intrinsic to the Hölmich protocol in terms of the rate of return to sport and the recovery period for athletes with LSAGP. Design The study followed a single-blind, before/after study design, where 15 athletes with LSAGP (mean age = 26.13 years; SD = 4.48) performed a 10-week modified Hölmich therapeutic exercise protocol. Results Outcome scores related to pain, hip adductor and abductor muscle strengths, and the ratio of maximum isometric and eccentric hip adduction to abduction strength increased significantly. Likewise, hip abduction and internal rotation ROM improved significantly compared to that at baseline. Furthermore, functional records (t-test, Edgren Side Step Test, and Triple Hop Test) showed significant improvement after treatment. Finally, 13 athletes (86.6% of the participants) successfully returned to sports activity in a mean time of 12.06 weeks (SD = 3.41). Conclusion The findings of this study objectively show that the modified Hölmich protocol may be safer and more effective than the Hölmich protocol in athletes with LSAGP in promoting their return to sports activity. This trial is registered with  IRCT2016080829269N1. PMID:29721339

Level of adherence to an extravasation protocol over 10 years in a tertiary care hospital.

PubMed

Molas-Ferrer, Gloria; Farré-Ayuso, Elisabet; doPazo-Oubiña, Fernando; deAndrés-Lázaro, Ana; Guell-Picazo, Jaume; Borrás-Maixenchs, Núria; Corominas-Bosch, Lourdes; Valverde-Bosch, Montserrat; Creus-Baró, Natalia

2015-04-01

Extravasation of chemotherapy is an undesirable complication related to the administration of antineoplastic therapy. Establishing the real incidence is difficult. Because of the importance of a quick intervention after an extravasation, every hospital should have an extravasation protocol. The purpose of this study was to determine the degree of observance of an extravasation protocol by nursing staff and to determine extravasation incidence. This descriptive, longitudinal, retrospective study was set in a tertiary-level hospital. The researchers reviewed 117 extravasation notification forms received by the pharmacy department during a 10-year period. Nursing actuation, particularly observance of the extravasation protocol, was analyzed. Protocol adherence was 89%. Twelve deviations from the protocol in the application of recommended measures were detected. An antidote was used in 41 patients, and temperature measures were applied in 14 cases. Ninety-nine patients had at least one episode of reported follow-up. No cases of necrosis or skin ulcers were described, except by one patient, who developed a delayed skin ulcer to vinorelbine. Drugs most frequently reported were etoposide, carboplatin, and paclitaxel. Nursing staff should be continuously trained in extravasation protocol because a rapid actuation can prevent skin lesions.

Cardiac Mitochondria l Membrane Stability after Deep Hypothermia using a Xenon Clathrate Cryostasis Protocol – an Electron Microscopy Study

PubMed Central

Sheleg, Sergey; Hixon, Hugh; Cohen, Bruce; Lowry, David; Nedzved, Mikhail

2008-01-01

We investigated a new cryopreservation method using xenon, a clathrate-forming gas, under medium pressure (100psi). The objective of the study was to determine whether this cryostasis protocol could protect cardiac mitochondria at cryogenic temperatures (below 100 degrees Celsius).We analyzed transmission electron microscopy images to obtain information about changes in mitochondrial morphology induced by cryopreservation of the hearts. Our data showed absence of mitochondrial swelling, rupture of inner and outer membranes, and leakage of mitochondrial matrix into the cytoplasm after applying this cryostasis protocol. The electron microscopy results provided the first evidence that a cryostasis protocol using xenon as a clathrate-forming gas under pressure may have protective effects on intracellular membranes. This cryostasis technology may find applications in developing new approaches for long-term cryopreservation protocols. PMID:18787624

Accelerated Storage Stability and Corrosion Characteristics Study Protocol

EPA Pesticide Factsheets

EPA has determined that studies using this protocol will, in certain circumstances, provide the Agency with all the information it needs to make a determination on the storage stability of pesticides.

Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review.

PubMed

van Lent, Marlies; Rongen, Gerard A; Out, Henk J

2014-12-10

Submission of study protocols to research ethics committees (RECs) constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type. The objective of this study was to identify recurring shortcomings in protocols of drug trials based on REC comments and to assess whether these were more common among industry-sponsored or non-industry trials. Retrospective analysis of 226 protocols of drug trials approved in 2010-2011 by three RECs affiliated to academic medical centres in The Netherlands. For each protocol, information on sponsorship, number of participating centres, participating countries, study phase, registration status of the study drug, and type and number of subjects was retrieved. REC comments were extracted from decision letters sent to investigators after review and were classified using a predefined checklist that was based on legislation and guidelines on clinical drug research and previous literature. Most protocols received comments regarding participant information and consent forms (n = 182, 80.5%), methodology and statistical analyses (n = 160, 70.8%), and supporting documentation, including trial agreements and certificates of insurance (n = 154, 68.1%). Of the submitted protocols, 122 (54.0%) were non-industry and 104 (46.0%) were industry-sponsored trials. Non-industry trials more often received comments on subject selection (n = 44, 36.1%) than industry-sponsored trials (n = 18, 17.3%; RR, 1.58; 95% CI, 1.01 to 2.47), and on methodology and statistical analyses (n = 95, 77.9% versus n = 65, 62.5%, respectively; RR, 1.18; 95% CI, 1.01 to 1.37). Non-industry trials less often received comments on supporting documentation (n = 72, 59.0%) than industry-sponsored trials (n = 82, 78.8%; RR, 0.83; 95% CI, 0.72 to 0.95). RECs identified important ethical and methodological shortcomings in protocols of both industry-sponsored and non-industry drug trials. Investigators, especially of non-industry trials, should better prepare their research protocols in order to facilitate the ethical review process.

The impacts of electricity dispatch protocols on the emission reductions due to wind power and carbon tax.

PubMed

Yu, Yang; Rajagopal, Ram

2015-02-17

Two dispatch protocols have been adopted by electricity markets to deal with the uncertainty of wind power but the effects of the selection between the dispatch protocols have not been comprehensively analyzed. We establish a framework to compare the impacts of adopting different dispatch protocols on the efficacy of using wind power and implementing a carbon tax to reduce emissions. We suggest that a market has high potential to achieve greater emission reduction by adopting the stochastic dispatch protocol instead of the static protocol when the wind energy in the market is highly uncertain or the market has enough adjustable generators, such as gas-fired combustion generators. Furthermore, the carbon-tax policy is more cost-efficient for reducing CO2 emission when the market operates according to the stochastic protocol rather than the static protocol. An empirical study, which is calibrated according to the data from the Electric Reliability Council of Texas market, confirms that using wind energy in the Texas market results in a 12% CO2 emission reduction when the market uses the stochastic dispatch protocol instead of the 8% emission reduction associated with the static protocol. In addition, if a 6$/ton carbon tax is implemented in the Texas market operated according to the stochastic protocol, the CO2 emission is similar to the emission level from the same market with a 16$/ton carbon tax operated according to the static protocol. Correspondingly, the 16$/ton carbon tax associated with the static protocol costs 42.6% more than the 6$/ton carbon tax associated with the stochastic protocol.

Bioindicators in the MIDUS National Study: Protocol, Measures, Sample, and Comparative Context

PubMed Central

Love, Gayle Dienberg; Seeman, Teresa E.; Weinstein, Maxine; Ryff, Carol D.

2010-01-01

Objectives MIDUS is a national study of health and aging among individuals aged 25 to 74 at baseline(1995/96). Longitudinal survey assessments (2004/05), were followed by biological assessments on a subsample aged 35–85. To facilitate public use, we describe the protocol, measures, and sample. Methods Respondents traveled to clinics for a two-day data collection protocol that included fasting blood specimens, 12-hour urine specimen, medical history, physical exam, bone densitometry, a laboratory challenge (heart rate variability, blood pressure, respiration, salivary cortisol). Results Response rates for the biological protocol (N = 1,255) were 39.3%, or 43.1% (adjusting for those who could not be located or contacted). Reasons for non-participation were travel, family obligations, and being too busy. Respondents were comparable to the recruitment pool on most demographic characteristics and health assessments. Discussion Strengths of the protocol vis-à-vis other similar studies include opportunities to link biological factors with diverse content from other MIDUS projects. PMID:20876364

SU-F-207-16: CT Protocols Optimization Using Model Observer

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

Tseng, H; Fan, J; Kupinski, M

2015-06-15

Purpose: To quantitatively evaluate the performance of different CT protocols using task-based measures of image quality. This work studies the task of size and the contrast estimation of different iodine concentration rods inserted in head- and body-sized phantoms using different imaging protocols. These protocols are designed to have the same dose level (CTDIvol) but using different X-ray tube voltage settings (kVp). Methods: Different concentrations of iodine objects inserted in a head size phantom and a body size phantom are imaged on a 64-slice commercial CT scanner. Scanning protocols with various tube voltages (80, 100, and 120 kVp) and current settingsmore » are selected, which output the same absorbed dose level (CTDIvol). Because the phantom design (size of the iodine objects, the air gap between the inserted objects and the phantom) is not ideal for a model observer study, the acquired CT images are used to generate simulation images with four different sizes and five different contracts iodine objects. For each type of the objects, 500 images (100 x 100 pixels) are generated for the observer study. The observer selected in this study is the channelized scanning linear observer which could be applied to estimate the size and the contrast. The figure of merit used is the correct estimation ratio. The mean and the variance are estimated by the shuffle method. Results: The results indicate that the protocols with 100 kVp tube voltage setting provides the best performance for iodine insert size and contrast estimation for both head and body phantom cases. Conclusion: This work presents a practical and robust quantitative approach using channelized scanning linear observer to study contrast and size estimation performance from different CT protocols. Different protocols at same CTDIvol setting could Result in different image quality performance. The relationship between the absorbed dose and the diagnostic image quality is not linear.« less

A Systematic Review on Immediate Loading of Implants Used to Support Overdentures Opposed by Conventional Prostheses: Factors That Might Influence Clinical Outcomes.

PubMed

Zygogiannis, Kostas; Wismeijer, Daniel; Aartman, Irene Ha; Osman, Reham B

2016-01-01

Different treatment protocols in terms of number, diameter, and suprastructure design have been proposed for immediately loaded implants that are used to support mandibular overdentures opposed by maxillary conventional dentures. The aim of this study was to investigate the influence of these protocols on survival rates as well as clinical and prosthodontic outcomes. Several electronic databases were searched for all relevant articles published from 1966 to June 2014. Only randomized controlled trials and prospective studies with a minimum follow-up of 12 months were selected. The primary outcomes of interest were the success and survival rates of the implants. Prosthodontic complications were also evaluated. Fourteen studies fulfilled the inclusion criteria. Of the studies identified, nine were randomized controlled trials and five were prospective studies. The mean follow-up period was 3 years or less for the vast majority of the studies. The reported survival and success rates were comparable to that of conventional loading for most of the included studies. No specific immediate loading protocol seemed to perform better in terms of clinical and prosthodontic outcomes. Immediate loading protocols of mandibular overdentures seem to be a viable alternative to conventional loading. It was not possible to recommend a specific treatment protocol related to the number, diameter of the implants, and attachment system used. Long-term, well-designed studies comparing different immediate loading modalities could help to establish a protocol that delivers the most clinically predictable, efficient, and cost-effective outcome for edentulous patients in need of implant overdentures.

Minimization of Hypoglycemia as an Adverse Event During Insulin Infusion: Further Refinement of the Yale Protocol.

PubMed

Marvin, Michael R; Inzucchi, Silvio E; Besterman, Brian J

2016-08-01

The management of hyperglycemia in the intensive care unit has been a controversial topic for more than a decade, with target ranges varying from 80-110 mg/dL to <200 mg/dL. Multiple insulin infusion protocols exist, including several computerized protocols, which have attempted to achieve these targets. Importantly, compliance with these protocols has not been a focus of clinical studies. GlucoCare™, a Food and Drug Administration (FDA)-cleared insulin-dosing calculator, was originally designed based on the Yale Insulin Infusion Protocol to target 100-140 mg/dL and has undergone several modifications to reduce hypoglycemia. The original Yale protocol was modified from 100-140 mg/dL to a range of 120-140 mg/dL (GlucoCare 120-140) and then to 140 mg/dL (GlucoCare 140, not a range but a single blood glucose [BG] level target) in an iterative and evidence-based manner to eliminate hypoglycemia <70 mg/dL. The final modification [GlucoCare 140(B)] includes the addition of bolus insulin "midprotocol" during an insulin infusion to reduce peak insulin rates for insulin-resistant patients. This study examined the results of these protocol modifications and evaluated the role of compliance with the protocol in the incidence of hypoglycemia <70 mg/dL. Protocol modifications resulted in mean BG levels of 133.4, 136.4, 143.8, and 146.4 mg/dL and hypoglycemic BG readings <70 mg/dL of 0.998%, 0.367%, 0.256%, and 0.04% for the 100-140, 120-140, 140, and 140(B) protocols, respectively (P < 0.001). Adherence to the glucose check interval significantly reduced the incidence of hypoglycemia (P < 0.001). Protocol modifications led to a reduction in peak insulin infusion rates (P < 0.001) and the need for dextrose-containing boluses (P < 0.001). This study demonstrates that refinements in protocol design can improve glucose control in critically ill patients and that the use of GlucoCare 140(B) can eliminate all significant hypoglycemia while achieving mean glucose levels between 140 and 150 mg/dL. In addition, attention to the timely performance of glucose levels can also reduce hypoglycemic events.

Comparison of the efficiency of rat papillary muscles during afterloaded isotonic contractions and contractions with sinusoidal length changes.

PubMed

Mellors, L J; Gibbs, C L; Barclay, C J

2001-05-01

The results of previous studies suggest that the maximum mechanical efficiency of rat papillary muscles is lower during a contraction protocol involving sinusoidal length changes than during one involving afterloaded isotonic contractions. The aim of this study was to compare directly the efficiency of isolated rat papillary muscle preparations in isotonic and sinusoidal contraction protocols. Experiments were performed in vitro (27 degrees C) using left ventricular papillary muscles from adult rats. Each preparation performed three contraction protocols: (i) low-frequency afterloaded isotonic contractions (10 twitches at 0.2 Hz), (ii) sinusoidal length change contractions with phasic stimulation (40 twitches at 2 Hz) and (iii) high-frequency afterloaded isotonic contractions (40 twitches at 2 Hz). The first two protocols resembled those used in previous studies and the third combined the characteristics of the first two. The parameters for each protocol were adjusted to those that gave maximum efficiency. For the afterloaded isotonic protocols, the afterload was set to 0.3 of the maximum developed force. The sinusoidal length change protocol incorporated a cycle amplitude of +/-5% resting length and a stimulus phase of -10 degrees. Measurements of force output, muscle length change and muscle temperature change were used to calculate the work and heat produced during and after each protocol. Net mechanical efficiency was defined as the proportion of the energy (enthalpy) liberated by the muscle that appeared as work. The efficiency in the low-frequency, isotonic contraction protocol was 21.1+/-1.4% (mean +/- s.e.m., N=6) and that in the sinusoidal protocol was 13.2+/-0.7%, consistent with previous results. This difference was not due to the higher frequency or greater number of twitches because efficiency in the high-frequency, isotonic protocol was 21.5+/-1.0%. Although these results apparently confirm that efficiency is protocol-dependent, additional experiments designed to measure work output unambiguously indicated that the method used to calculate work output in isotonic contractions overestimated actual work output. When net work output, which excludes work done by parallel elastic elements, rather than total work output was used to determine efficiency in afterloaded isotonic contractions, efficiency was similar to that for sinusoidal contractions. The maximum net mechanical efficiency of rat papillary muscles performing afterloaded isotonic or sinusoidal length change contractions was between 10 and 15%.

Exponentially Decelerated Contrast Media Injection Rate Combined With a Novel Patient-Specific Contrast Formula Reduces Contrast Volume Administration and Radiation Dose During Computed Tomography Pulmonary Angiography.

PubMed

Saade, Charbel; Mayat, Ahmad; El-Merhi, Fadi

2016-01-01

Matching contrast injection timing with vessel dynamics significantly improves vessel opacification and reduces contrast dose in the assessment of pulmonary embolism during computed tomography (CT) pulmonary angiography. The aim of this study was to investigate opacification of the pulmonary vasculature (PV) during CT pulmonary angiography using a patient-specific contrast formula (PSCF) and exponentially decelerated contrast media (EDCM) injection rate. Institutional review board approved this retrospective study. Computed tomography pulmonary angiography was performed on 200 patients with suspected pulmonary embolism using a 64-channel CT scanner. Patient demographics were equally distributed. Patients were randomly assigned to 2 equal protocol groups: protocol A used a PSCF, and protocol B involved the use of a PSCF combined with EDCM. The mean cross-sectional opacification profile of 8 central and 11 peripheral PVs were measured for each patient, and arteriovenous contrast ratio was calculated. Protocols were compared using Mann-Whitney U nonparametric statistics. Jackknife alternative free-response receiver operating characteristic analyses were used to assess diagnostic efficacy. Interobserver variations were investigated using kappa methods. A number of pulmonary arteries demonstrated increases in opacification (P < 0.02) for protocol B compared with A, whereas opacification in all veins was reduced in protocol B (P < 0.03). Subsequently, increased arteriovenous contrast ratio in protocol B compared with A was observed at all anatomic locations (P < 0.0002). An increase in jackknife alternative free-response receiver operating characteristic figure of merit (P < 0.0002) and interobserver variation was observed with protocol B compared with protocol A (κ = 0.3-0.73). Mean contrast volume was reduced in protocol B (29 [4] mL) compared with protocol A (33 [9] mL). Mean effective radiation dose in protocol B (1.2 [0.4] mSv) was reduced by 14% compared with protocol A (1.4 [0.6] mSv). Significant improvements in visualization of the PV can be achieved with a low contrast volume using an EDCM and PSCF. The reduced risk of cancer induction is highlighted.

Implementation of a timed, electronic, assessment-driven potassium-replacement protocol.

PubMed

Zielenski, Christopher; Crabtree, Adam; Le, Tien; Marlatt, Alyse; Ng, Dana; Tran, Alan

2017-06-15

The adherence to and effectiveness and safety of a timed, electronic, assessment-driven potassium-replacement protocol (TARP) were compared with an electronic nurse-driven replacement protocol (NRP) are reported. A retrospective observational study was conducted in a community hospital evaluating protocol adherence, effectiveness, and safety for 2 potassium-replacement protocols. All adults on medical units with an order for potassium replacement per protocol during the 3-month trial periods were reviewed. All patients requiring potassium replacement per protocol were included in the analysis. Adherence to the protocol was assessed by evaluating the dose of potassium administered and performance of reassessments. Effectiveness of the protocol was assessed by evaluating the time to achieve target potassium levels. Safety was assessed by evaluating the route of administration and occurrence of hyperkalemia. A total of 300 patients treated using potassium-replacement protocols required potassium replacement during the study period, with 148 patients in the NRP group requiring 491 instances of potassium replacement. In the TARP group a total of 564 instances requiring potassium replacement corresponded to 152 patients. Of the 491 instances requiring replacement in the NRP group, the correct dose was administered and reassessment performed 117 times (23.8%). Overall adherence ( p < 0.05), correct dose given ( p < 0.05), average time from blood draw to potassium replacement ( p < 0.0001), use of oral replacement ( p < 0.05), and time to achieve target potassium level within 12 hours ( p < 0.05) were significantly improved in the TARP group. The TARP improved the effectiveness and safety of potassium-replacement therapy over the traditional NRP without negatively affecting timeliness of care. Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Neuroimaging paradigms for tonotopic mapping (II): the influence of acquisition protocol.

PubMed

Langers, Dave R M; Sanchez-Panchuelo, Rosa M; Francis, Susan T; Krumbholz, Katrin; Hall, Deborah A

2014-10-15

Numerous studies on the tonotopic organisation of auditory cortex in humans have employed a wide range of neuroimaging protocols to assess cortical frequency tuning. In the present functional magnetic resonance imaging (fMRI) study, we made a systematic comparison between acquisition protocols with variable levels of interference from acoustic scanner noise. Using sweep stimuli to evoke travelling waves of activation, we measured sound-evoked response signals using sparse, clustered, and continuous imaging protocols that were characterised by inter-scan intervals of 8.8, 2.2, or 0.0 s, respectively. With regard to sensitivity to sound-evoked activation, the sparse and clustered protocols performed similarly, and both detected more activation than the continuous method. Qualitatively, tonotopic maps in activated areas proved highly similar, in the sense that the overall pattern of tonotopic gradients was reproducible across all three protocols. However, quantitatively, we observed substantial reductions in response amplitudes to moderately low stimulus frequencies that coincided with regions of strong energy in the scanner noise spectrum for the clustered and continuous protocols compared to the sparse protocol. At the same time, extreme frequencies became over-represented for these two protocols, and high best frequencies became relatively more abundant. Our results indicate that although all three scanning protocols are suitable to determine the layout of tonotopic fields, an exact quantitative assessment of the representation of various sound frequencies is substantially confounded by the presence of scanner noise. In addition, we noticed anomalous signal dynamics in response to our travelling wave paradigm that suggest that the assessment of frequency-dependent tuning is non-trivially influenced by time-dependent (hemo)dynamics when using sweep stimuli. Copyright © 2014. Published by Elsevier Inc.

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.

Improvement of burn pain management through routine pain monitoring and pain management protocol.

PubMed

Yang, Hyeong Tae; Hur, Giyeun; Kwak, In-Suk; Yim, Haejun; Cho, Yong Suk; Kim, Dohern; Hur, Jun; Kim, Jong Hyun; Lee, Boung Chul; Seo, Cheong Hoon; Chun, Wook

2013-06-01

Pain management is an important aspect of burn management. We developed a routine pain monitoring system and pain management protocol for burn patients. The purpose of this study is to evaluate the effectiveness of our new pain management system. From May 2011 to November 2011, the prospective study was performed with 107 burn patients. We performed control group (n=58) data analysis and then developed the pain management protocol and monitoring system. Next, we applied our protocol to patients and performed protocol group (n=49) data analysis, and compared this to control group data. Data analysis was performed using the Numeric Rating Scale (NRS) of background pain and procedural pain, Clinician-Administered PTSD Scale (CAPS), Hamilton Depression Rating Scale (HDRS), State-Trait Anxiety Inventory Scale (STAIS), and Holmes and Rahe Stress Scale (HRSS). The NRS of background pain for the protocol group was significantly decreased compared to the control group (2.8±2.0 versus 3.9±1.9), and the NRS of procedural pain of the protocol group was significantly decreased compared to the control group (4.8±2.8 versus 3.7±2.5). CAPS and HDRS were decreased in the protocol group, but did not have statistical significance. STAIS and HRSS were decreased in the protocol group, but only the STAIS had statistical significance. Our new pain management system was effective in burn pain management. However, adequate pain management can only be accomplished by a continuous and thorough effort. Therefore, pain control protocol and pain monitoring systems need to be under constant revision and improvement using creative ideas and approaches. Copyright © 2012 Elsevier Ltd and ISBI. All rights reserved.

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

PubMed

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

2014-07-16

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

Comparison of carboplatin and doxorubicin-based chemotherapy protocols in 470 dogs after amputation for treatment of appendicular osteosarcoma.

PubMed

Selmic, L E; Burton, J H; Thamm, D H; Withrow, S J; Lana, S E

2014-01-01

Many chemotherapy protocols have been reported for treatment of canine appendicular osteosarcoma (OSA), but outcome comparisons in a single population are lacking. To evaluate the effects of protocol and dose intensity (DI) on treatment outcomes for carboplatin and doxorubicin-based chemotherapy protocols. Four hundred and seventy dogs with appendicular OSA. A retrospective cohort study was performed comprising consecutive dogs treated (1997-2012) with amputation followed by 1 of 5 chemotherapy protocols: carboplatin 300 mg/m(2) IV q21d for 4 or 6 cycles (CARBO6), doxorubicin 30 mg/m(2) IV q14d or q21d for 5 cycles, and alternating carboplatin 300 mg/m(2) IV and doxorubicin 30 mg/m(2) IV q21d for 3 cycles. Adverse events (AE) and DI were evaluated. Kaplan-Meier survival curves and Cox proportional hazards regression were used to compare disease-free interval (DFI) and survival time (ST) among protocols. The overall median DFI and ST were 291 days and 284 days, respectively. A lower proportion of dogs prescribed CARBO6 experienced AEs compared to other protocols (48.4% versus 60.8-75.8%; P = .001). DI was not associated with development of metastases or death. After adjustment for baseline characteristics and prognostic factors, none of the protocols provided a significant reduction in risk of development of metastases or death. Although choice of protocol did not result in significant differences in DFI or ST, the CARBO6 protocol resulted in a lower proportion of dogs experiencing AEs, which could be advantageous in maintaining high quality of life during treatment. DI was not a prognostic indicator in this study. Copyright © 2014 by the American College of Veterinary Internal Medicine.

Effect of Fatigue Protocols on Lower Limb Neuromuscular Function and Implications for Anterior Cruciate Ligament Injury Prevention Training: A Systematic Review.

PubMed

Barber-Westin, Sue D; Noyes, Frank R

2017-12-01

Approximately two-thirds of anterior cruciate ligament (ACL) tears are sustained during noncontact situations when an athlete is cutting, pivoting, decelerating, or landing from a jump. Some investigators have postulated that fatigue may result in deleterious alterations in lower limb biomechanics during these activities that could increase the risk of noncontact ACL injuries. However, prior studies have noted a wide variation in fatigue protocols, athletic tasks studied, and effects of fatigue on lower limb kinetics and kinematics. First, to determine if fatigue uniformly alters lower limb biomechanics during athletic tasks that are associated with noncontact ACL injuries. Second, to determine if changes should be made in ACL injury prevention training programs to alter the deleterious effects of fatigue on lower limb kinetics and kinematics. Systematic review; Level of evidence, 4. A systematic review of the literature using MEDLINE was performed. Key terms were fatigue, neuromuscular, exercise, hop test, and single-legged function tests. Inclusion criteria were original research studies involving healthy participants, use of a fatigue protocol, study of at least 1 lower limb task that involved landing from a hop or jump or cutting, and analysis of at least 1 biomechanical variable. Thirty-seven studies involving 806 athletes (485 female, 321 male; mean age, 22.7 years) met the inclusion criteria. General fatigue protocols were used in 20 investigations, peripheral protocols were used in 17 studies, and 21 different athletic tasks were studied (13 single-legged, 8 double-legged). There was no consistency among investigations regarding the effects of fatigue on hip, knee, or ankle joint angles and moments or surface electromyography muscle activation patterns. The fatigue protocols typically did not produce statistically significant changes in ground-reaction forces. Published fatigue protocols did not uniformly produce alterations in lower limb neuromuscular factors that heighten the risk of noncontact ACL injuries. Therefore, justification does not currently exist for major changes in ACL injury prevention training programs to account for potential fatigue effects. However, the effect of fatigue related to ACL injuries is worthy of further investigation, including the refinement of protocols and methods of analysis.

Effects of a peer support programme for youth social services employees experiencing potentially traumatic events: a protocol for a prospective cohort study.

PubMed

Guay, Stephane; Tremblay, Nicole; Goncalves, Jane; Bilodeau, Henriette; Geoffrion, Steve

2017-06-24

The use of peer support programmes to help workers experiencing potentially traumatic events (PTE) has increased in high-risk organisations in the last decades. However, the scientific evidence of its effectiveness is still very limited. This paper aims to describe the protocol of a prospective cohort study that assesses the efficacy of a peer support programme among youth social services employees exposed to a PTE at work on psychological well-being, work functioning and needs of support. This is a mixed-methods prospective study that will examine workers' evolution four times over a 12-month period in Canada. This study involves: (1) quantitative data obtained through self-administrated questionnaires among 222 workers, and (2) qualitative in-depth interviews with a subsample of 45 workers. This study will compare findings from a cohort who received the support of a peer following a PTE (peer support-experimental protocol) as part of the experimental protocol of the Montreal Youth Social Services-University Institute (MYSS-UI), the second group of workers did not ask for the peer support (no peer support-experimental protocol) but was part of MYSS-UI, and the third group received standard organisational support from the Monteregie Youth Social Services (MYSS) (standard organisational protocol). The protocol and informed consent form complied with the ethics guidelines of the MYSS-UI. The Research Ethics Board of MYSS-UI and MYSS reviewed and accepted the protocol as required. The results of the study will be published in peer-reviewed journals, presented at research and general public conferences, disseminated via a public report for the institute that funded the project and for all workers. Results of this study will influence decision making regarding intervention policies following PTE and peer support interventions may be expanded throughout the youth social services in Canada and worldwide. © 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.

Investigation of the Study Characteristics Affecting Clinical Trial Quality Using the Protocol Deviations Leading to Exclusion of Subjects From the Per Protocol Set Data in Studies for New Drug Application: A Retrospective Analysis.

PubMed

Kohara, Norihito; Kaneko, Masayuki; Narukawa, Mamoru

2018-01-01

The concept of the risk-based approach has been introduced as an effort to secure the quality of clinical trials. In the risk-based approach, identification and evaluation of risk in advance are considered important. For recently completed clinical trials, we investigated the relationship between study characteristics and protocol deviations leading to the exclusion of subjects from Per Protocol Set (PPS) efficacy analysis. New drugs approved in Japan in the fiscal year 2014-2015 were targeted in the research. The reasons for excluding subjects from the PPS efficacy analysis were described in 102 trials out of 492 in the summary of new drug application documents, which was publicly disclosed after the drug's regulatory approval. The author extracted these reasons along with the numbers of the cases and the study characteristics of each clinical trial. Then, the direct comparison, univariate regression analysis, and multivariate regression analysis was carried out based on the exclusion rate. The study characteristics for which exclusion of subjects from the PPS efficacy analysis were frequently observed was multiregional clinical trials in study region; inhalant and external use in administration route; Anti-infective for systemic use; Respiratory system, Dermatologicals, and Nervous system in therapeutic drug under the Anatomical Therapeutic Chemical Classification. In the multivariate regression analysis, the clinical trial variables of inhalant, Respiratory system, or Dermatologicals were selected as study characteristics leading to a higher exclusion rate. The characteristics of the clinical trial that is likely to cause protocol deviations that will affect efficacy analysis were suggested. These studies should be considered for specific attention and priority observation in the trial protocol or its monitoring plan and execution, such as a clear description of inclusion/exclusion criteria in the protocol, development of training materials to site staff, and/or trial subjects as specific risk-alleviating measures.

Majority of systematic reviews published in high-impact journals neglected to register the protocols: a meta-epidemiological study.

PubMed

Tsujimoto, Yasushi; Tsujimoto, Hiraku; Kataoka, Yuki; Kimachi, Miho; Shimizu, Sayaka; Ikenoue, Tatsuyoshi; Fukuma, Shingo; Yamamoto, Yosuke; Fukuhara, Shunichi

2017-04-01

To describe the registration of systematic review (SR) protocols and examine whether or not registration reduced the outcome reporting bias in high-impact journals. We searched MEDLINE via PubMed to identify SRs of randomized controlled trials of interventions. We included SRs published between August 2009 and June 2015 in the 10 general and internal medicinal journals with the highest impact factors in 2013. We examined the proportion of SR protocol registration and investigated the relationship between registration and outcome reporting bias using multivariable logistic regression. Among the 284 included reviews, 60 (21%) protocols were registered. The proportion of registration increased from 5.6% in 2009 to 27% in 2015 (P for trend <0.001). Protocol registration was not associated with outcome reporting bias (adjusted odds ratio [OR] 0.85, 95% confidence interval [CI] 0.39-1.86). The association between Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) adherence and protocol registration was not statistically significant (OR 1.09, 95% CI 0.59-2.01). Six years after the launch of the PRISMA statement, the proportion of protocol registration in high-impact journals has increased some but remains low. The present study found no evidence suggesting that protocol registration reduced outcome reporting bias. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparison of calculation and experiment implicates significant electrostatic contributions to the binding stability of barnase and barstar.

PubMed

Dong, Feng; Vijayakumar, M; Zhou, Huan-Xiang

2003-07-01

The contributions of electrostatic interactions to the binding stability of barnase and barstar were studied by the Poisson-Boltzmann model with three different protocols: a), the dielectric boundary specified as the van der Waals (vdW) surface of the protein along with a protein dielectric constant (epsilon (p)) of 4; b), the dielectric boundary specified as the molecular (i.e., solvent-exclusion (SE)) surface along with epsilon (p) = 4; and c), "SE + epsilon (p) = 20." The "vdW + epsilon (p) = 4" and "SE + epsilon (p) = 20" protocols predicted an overall electrostatic stabilization whereas the "SE + epsilon (p) = 4" protocol predicted an overall electrostatic destabilization. The "vdW + epsilon (p) = 4" protocol was most consistent with experiment. It quantitatively reproduced the observed effects of 17 mutations neutralizing charged residues lining the binding interface and the measured coupling energies of six charge pairs across the interface and reasonably rationalized the experimental ionic strength and pH dependences of the binding constant. In contrast, the "SE + epsilon (p) = 4" protocol predicted significantly larger coupling energies of charge pairs whereas the "SE + epsilon (p) = 20" protocol did not predict any pH dependence. This study calls for further scrutiny of the different Poisson-Boltzmann protocols and demonstrates potential danger in drawing conclusions on electrostatic contributions based on a particular calculation protocol.

Ocean Optics Protocols for Satellite Ocean Color Sensor Validation. Volume 4; Inherent Optical Properties: Instruments, Characterizations, Field Measurements and Data Analysis Protocols; Revised

NASA Technical Reports Server (NTRS)

Mueller, J. L. (Editor); Fargion, Giuletta S. (Editor); McClain, Charles R. (Editor); Pegau, Scott; Zaneveld, J. Ronald V.; Mitchell, B. Gregg; Kahru, Mati; Wieland, John; Stramska, Malgorzat

2003-01-01

This document stipulates protocols for measuring bio-optical and radiometric data for the Sensor Intercomparison and Merger for Biological and Interdisciplinary Oceanic Studies (SIMBIOS) Project activities and algorithm development. The document is organized into 6 separate volumes as Ocean Optics Protocols for Satellite Ocean Color Sensor Validation, Revision 4. Volume I: Introduction, Background and Conventions; Volume II: Instrument Specifications, Characterization and Calibration; Volume III: Radiometric Measurements and Data Analysis Methods; Volume IV: Inherent Optical Properties: Instruments, Characterization, Field Measurements and Data Analysis Protocols; Volume V: Biogeochemical and Bio-Optical Measurements and Data Analysis Methods; Volume VI: Special Topics in Ocean Optics Protocols and Appendices. The earlier version of Ocean Optics Protocols for Satellite Ocean Color Sensor Validation, Revision 3 (Mueller and Fargion 2002, Volumes 1 and 2) is entirely superseded by the six volumes of Revision 4 listed above.

Ocean Optics Protocols for Satellite Ocean Color Sensor Validation, Revision 4, Volume IV: Inherent Optical Properties: Instruments, Characterizations, Field Measurements and Data Analysis Protocols

NASA Technical Reports Server (NTRS)

Mueller, J. L.; Fargion, G. S.; McClain, C. R. (Editor); Pegau, S.; Zanefeld, J. R. V.; Mitchell, B. G.; Kahru, M.; Wieland, J.; Stramska, M.

2003-01-01

This document stipulates protocols for measuring bio-optical and radiometric data for the Sensor Intercomparision and Merger for Biological and Interdisciplinary Oceanic Studies (SIMBIOS) Project activities and algorithm development. The document is organized into 6 separate volumes as Ocean Optics Protocols for Satellite Ocean Color Sensor Validation, Revision 4. Volume I: Introduction, Background, and Conventions; Volume II: Instrument Specifications, Characterization and Calibration; Volume III: Radiometric Measurements and Data Analysis Methods; Volume IV: Inherent Optical Properties: Instruments, Characterization, Field Measurements and Data Analysis Protocols; Volume V: Biogeochemical and Bio-Optical Measurements and Data Analysis Methods; Volume VI: Special Topics in Ocean Optics Protocols and Appendices. The earlier version of Ocean Optics Protocols for Satellite Ocean Color Sensor Validation, Revision 3 is entirely superseded by the six volumes of Revision 4 listed above.

Ocean Optics Protocols for Satellite Ocean Color Sensor Validation. Volume 6; Special Topics in Ocean Optics Protocols and Appendices; Revised

NASA Technical Reports Server (NTRS)

Mueller, J. L. (Editor); Fargion, Giulietta S. (Editor); McClain, Charles R. (Editor)

2003-01-01

This document stipulates protocols for measuring bio-optical and radiometric data for the Sensor Intercomparison and Merger for Biological and Interdisciplinary Oceanic Studies (SIMBIOS) Project activities and algorithm development. The document is organized into 6 separate volumes as Ocean Optics Protocols for Satellite Ocean Color Sensor Validation, Revision 4. Volume I: Introduction, Background and Conventions; Volume II: Instrument Specifications, Characterization and Calibration; Volume III: Radiometric Measurements and Data Analysis Methods; Volume IV: Inherent Optical Properties: Instruments, Characterization, Field Measurements and Data Analysis Protocols; Volume V: Biogeochemical and Bio-Optical Measurements and Data Analysis Methods; Volume VI: Special Topics in Ocean Optics Protocols and Appendices. The earlier version of Ocean Optics Protocols for Satellite Ocean Color Sensor Validation, Revision 3 (Mueller and Fargion 2002, Volumes 1 and 2) is entirely superseded by the six volumes of Revision 4 listed above.

Optimization of protocol design: a path to efficient, lower cost clinical trial execution

PubMed Central

Malikova, Marina A

2016-01-01

Managing clinical trials requires strategic planning and efficient execution. In order to achieve a timely delivery of important clinical trials’ outcomes, it is useful to establish standardized trial management guidelines and develop robust scoring methodology for evaluation of study protocol complexity. This review will explore the challenges clinical teams face in developing protocols to ensure that the right patients are enrolled and the right data are collected to demonstrate that a drug is safe and efficacious, while managing study costs and study complexity based on proposed comprehensive scoring model. Key factors to consider when developing protocols and techniques to minimize complexity will be discussed. A methodology to identify processes at planning phase, approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials will be addressed. PMID:28031939

NHEXAS PHASE I ARIZONA STUDY--LIST OF STANDARD OPERATING PROCEDURES

EPA Science Inventory

This document lists available protocols and SOPs for the NHEXAS Phase I Arizona study. It identifies protocols and SOPs for the following study components: (1) Sample collection and field operations, (2) Sample analysis, (3) General laboratory procedures, (4) Quality Assurance, (...

Evaluation of an adult insulin infusion protocol at an academic medical center.

PubMed

Petrov, Katerina I; Burns, Tammy L; Drincic, Andjela

2012-05-01

Acknowledging evidence of possible detrimental effects of tightly controlled blood glucose levels, the American Association of Clinical Endocrinologists and the American Diabetes Association published a consensus statement recommending less strict control for most diabetic patients. As a result of these recommendations, our academic center at Creighton University Medical Center revised its adult insulin infusion protocol to target blood glucose levels ranging from 120 to 180 mg/dL for regular (standard) glycemic control and 80 to 120 mg/dL for tight control; previous targets had ranged from 80 to 180 mg/dL and 70 to 110 mg/dL, respectively. The primary objective was to evaluate the time that blood glucose values were within the target range for patients receiving the new protocol, compared with patients receiving the previous protocol. Our study was designed to evaluate the effectiveness and safety of the revised protocol. Using a retrospective chart review, we collected data for 4 months from patients on the old insulin protocol (May to August 2009) and for 4 months from patients on the new protocol (September to December 2009). Secondary endpoints included the number of hypoglycemic episodes (blood glucose below 70 mg/dL) and severe hypoglycemic episodes (blood glucose 40 mg/dL or lower) experienced by patients receiving the new insulin protocol compared with those receiving the former protocol. Patient characteristics were similar at baseline. Blood glucose values stayed within the target range for a significantly shorter time with the new protocol than with the former protocol (44.6% vs. 56.8%, respectively; P < 0.001), probably because of the narrower target range in the revised protocol. No statistically significant differences in hypoglycemia were observed after the protocol was changed. Hypoglycemia occurred in 31% of the former-protocol patients compared with 18% of the revised-protocol patients. Severe hypoglycemia was experienced by 2.1% of patients on the old protocol and by 3.1% of patients on the new protocol. Rates of severe hypoglycemia were low (2.6%) with the original protocol. Patients' blood glucose levels were within the target range for a shorter time with the new protocol. Fewer episodes of hypoglycemia were recorded with the new protocol, but rates of severe hypoglycemia were similar with both protocols.

Instruments for Assessment of Instructional Practices in Standards-Based Teaching

NASA Astrophysics Data System (ADS)

Wainwright, Camille L.

2006-12-01

This paper describes the development of two forms of an instrument used as a classroom observation protocol, designed to document the impact of reform-based professional development with undergraduate mathematics and science faculty and its impact on the resultant preparation of teachers (PreK 12). A rationale for the development and utilization of this instrument (known as the OTOP, or the Oregon Teacher Observation Protocol) is provided. Constructed upon review of the research on teaching and standards documents in mathematics and science, the protocol formed the basis for data collection in a three-year longitudinal study of teaching practice among early career teachers as well as undergraduate college faculty. In addition, this paper suggests further applications of the observation protocol beyond the original research study purpose. One prominent use for the protocol is in supervisor observations of mathematics and science student teachers.

The Effects of Respondents’ Consent to be Recorded on Interview Length and Data Quality in a National Panel Study

PubMed Central

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

2014-01-01

Recording interviews is a key feature of quality control protocols for most survey organizations. We examine the effects on interview length and data quality of a new protocol adopted by a national panel study. The protocol recorded a randomly chosen one-third of all interviews digitally, although all respondents were asked for permission to record their interview, and interviewers were blind to whether or not interviews were recorded. We find that the recording software slowed the interview slightly. Interviewer knowledge that the interview may be recorded improved data quality, but this knowledge also increased the length of the interview. Interviewers with higher education and performance ratings were less reactive to the new recording protocol. Survey managers may face a trade-off between higher data quality and longer interviews when determining recording protocols. PMID:26550000

Entanglement distillation protocols and number theory

NASA Astrophysics Data System (ADS)

Bombin, H.; Martin-Delgado, M. A.

2005-09-01

We show that the analysis of entanglement distillation protocols for qudits of arbitrary dimension D benefits from applying basic concepts from number theory, since the set ZDn associated with Bell diagonal states is a module rather than a vector space. We find that a partition of ZDn into divisor classes characterizes the invariant properties of mixed Bell diagonal states under local permutations. We construct a very general class of recursion protocols by means of unitary operations implementing these local permutations. We study these distillation protocols depending on whether we use twirling operations in the intermediate steps or not, and we study them both analytically and numerically with Monte Carlo methods. In the absence of twirling operations, we construct extensions of the quantum privacy algorithms valid for secure communications with qudits of any dimension D . When D is a prime number, we show that distillation protocols are optimal both qualitatively and quantitatively.

[Protocol of the animal assisted activity program at a university hospital].

PubMed

Silveira, Isa Rodrigues; Santos, Nanci Cristiano; Linhares, Daniela Ribeiro

2011-03-01

Animal-Assisted Activity (AAA) consists in visitation and recreation through contact with animals, aiming at entertainment and improving the interpersonal relationship between patients and staff. Permission for the animals to visit an Institution requires a protocol with rules and safety routines to avoid accidents and zoonoses. The objective of this study is to describe the important points of the protocol to implement the AAA program. The protocol includes: introduction, objectives, inclusion and exclusion criteria for animals, drivers and patients; recommendations to the handlers and the health team, responsibilities of the Nosocomial Infection Control Committee, zoonoses posters, vaccination schedule for dogs and cats, free-informed consent to take part in the program and records with behavioral analysis of the animals. We believe that disclosing the protocol, based on scientific studies, favors the implementation of new programs in institutions considering the lack of national publications.

Protocol to Exploit Waiting Resources for UASNs.

PubMed

Hung, Li-Ling; Luo, Yung-Jeng

2016-03-08

The transmission speed of acoustic waves in water is much slower than that of radio waves in terrestrial wireless sensor networks. Thus, the propagation delay in underwater acoustic sensor networks (UASN) is much greater. Longer propagation delay leads to complicated communication and collision problems. To solve collision problems, some studies have proposed waiting mechanisms; however, long waiting mechanisms result in low bandwidth utilization. To improve throughput, this study proposes a slotted medium access control protocol to enhance bandwidth utilization in UASNs. The proposed mechanism increases communication by exploiting temporal and spatial resources that are typically idle in order to protect communication against interference. By reducing wait time, network performance and energy consumption can be improved. A performance evaluation demonstrates that when the data packets are large or sensor deployment is dense, the energy consumption of proposed protocol is less than that of existing protocols as well as the throughput is higher than that of existing protocols.

Optimization of the scan protocols for CT-based material extraction in small animal PET/CT studies

NASA Astrophysics Data System (ADS)

Yang, Ching-Ching; Yu, Jhih-An; Yang, Bang-Hung; Wu, Tung-Hsin

2013-12-01

We investigated the effects of scan protocols on CT-based material extraction to minimize radiation dose while maintaining sufficient image information in small animal studies. The phantom simulation experiments were performed with the high dose (HD), medium dose (MD) and low dose (LD) protocols at 50, 70 and 80 kVp with varying mA s. The reconstructed CT images were segmented based on Hounsfield unit (HU)-physical density (ρ) calibration curves and the dual-energy CT-based (DECT) method. Compared to the (HU;ρ) method performed on CT images acquired with the 80 kVp HD protocol, a 2-fold improvement in segmentation accuracy and a 7.5-fold reduction in radiation dose were observed when the DECT method was performed on CT images acquired with the 50/80 kVp LD protocol, showing the possibility to reduce radiation dose while achieving high segmentation accuracy.

Secure multiparty computation of a comparison problem.

PubMed

Liu, Xin; Li, Shundong; Liu, Jian; Chen, Xiubo; Xu, Gang

2016-01-01

Private comparison is fundamental to secure multiparty computation. In this study, we propose novel protocols to privately determine [Formula: see text], or [Formula: see text] in one execution. First, a 0-1-vector encoding method is introduced to encode a number into a vector, and the Goldwasser-Micali encryption scheme is used to compare integers privately. Then, we propose a protocol by using a geometric method to compare rational numbers privately, and the protocol is information-theoretical secure. Using the simulation paradigm, we prove the privacy-preserving property of our protocols in the semi-honest model. The complexity analysis shows that our protocols are more efficient than previous solutions.

A multicentre evaluation of two intensive care unit triage protocols for use in an influenza pandemic.

PubMed

Cheung, Winston K; Myburgh, John; Seppelt, Ian M; Parr, Michael J; Blackwell, Nikki; Demonte, Shannon; Gandhi, Kalpesh; Hoyling, Larissa; Nair, Priya; Passer, Melissa; Reynolds, Claire; Saunders, Nicholas M; Saxena, Manoj K; Thanakrishnan, Govindasamy

2012-08-06

To determine the increase in intensive care unit (ICU) bed availability that would result from the use of the New South Wales and Ontario Health Plan for an Influenza Pandemic (OHPIP) triage protocols. Prospective evaluation study conducted in eight Australian, adult, general ICUs, between September 2009 and May 2010. All patients who were admitted to the ICU, excluding those who had elective surgery, were prospectively evaluated using the two triage protocols, simulating a pandemic situation. Both protocols were originally developed to determine which patients should be excluded from accessing ICU resources during an influenza pandemic. Increase in ICU bed availability. At admission, the increases in ICU bed availability using Tiers 1, 2 and 3 of the NSW triage protocol were 3.5%, 14.7% and 22.7%, respectively, and 52.8% using the OHPIP triage protocol (P < 0.001). Re-evaluation of patients at 12 hours after admission using Tiers 1, 2 and 3 of the NSW triage protocol incrementally increased ICU bed availability by 19.2%, 16.1% and 14.1%, respectively (P < 0.001). The maximal cumulative increases in ICU bed availability using Tiers 1, 2 and 3 of the NSW triage protocol were 23.7%, 31.6% and 37.5%, respectively, at 72 hours (P < 0.001), and 65.0% using the OHPIP triage protocol, at 120 hours (P < 0.001). Both triage protocols resulted in increases in ICU bed availability, but the OHPIP protocol provided the greatest increase overall. With the NSW triage protocol, ICU bed availability increased as the protocol was escalated.

Protocols for the Initial Treatment of Moderately Severe Juvenile Dermatomyositis: Results of a Children's Arthritis and Rheumatology Research Alliance Consensus Conference

PubMed Central

Huber, Adam M.; Giannini, Edward H.; Bowyer, Suzanne L.; Kim, Susan; Lang, Bianca; Lindsley, Carol B.; Pachman, Lauren M.; Pilkington, Clarissa; Reed, Ann M.; Rennebohm, Robert M.; Rider, Lisa G.; Wallace, Carol A.; Feldman, Brian M.

2010-01-01

Objective To use juvenile dermatomyositis (JDM) survey data and expert opinion to develop a small number of consensus treatment protocols which reflect current initial treatment of moderately severe JDM. Methods A consensus meeting was held in Toronto, Ontario, Canada on December 1-2, 2007. Nominal group technique was used to achieve consensus on treatment protocols which represented typical management of moderately severe JDM. Consensus was also reached on which patients these protocols would be applicable to (inclusion and exclusion criteria), initial investigations which should be done prior to initiating one of these protocols, data which should be collected to evaluate these protocols, concomitant interventions that would be required or recommended. Results Three protocols were developed which described the first 2 months of treatment. All protocols included corticosteroids and methotrexate. One protocol also included intravenous gammaglobulin. Consensus was achieved for all issues that were addressed by conference participants, although there were some areas of controversy Conclusions This study shows that it is possible to achieve consensus on the initial treatment of JDM, despite considerable variation in clinical practice. Once these protocols are extended beyond 2 months, these protocols will be available for clinical use. By using methods which account for differences between patients (confounding by indication), the comparative effectiveness of the protocols will be evaluated. In the future, the goal will be to identify the optimal treatment of moderately severe JDM. PMID:20191521

Comparison of seven protocols to identify fecal contamination sources using Escherichia coli

USGS Publications Warehouse

Stoeckel, D.M.; Mathes, M.V.; Hyer, K.E.; Hagedorn, C.; Kator, H.; Lukasik, J.; O'Brien, T. L.; Fenger, T.W.; Samadpour, M.; Strickler, K.M.; Wiggins, B.A.

2004-01-01

Microbial source tracking (MST) uses various approaches to classify fecal-indicator microorganisms to source hosts. Reproducibility, accuracy, and robustness of seven phenotypic and genotypic MST protocols were evaluated by use of Escherichia coli from an eight-host library of known-source isolates and a separate, blinded challenge library. In reproducibility tests, measuring each protocol's ability to reclassify blinded replicates, only one (pulsed-field gel electrophoresis; PFGE) correctly classified all test replicates to host species; three protocols classified 48-62% correctly, and the remaining three classified fewer than 25% correctly. In accuracy tests, measuring each protocol's ability to correctly classify new isolates, ribotyping with EcoRI and PvuII approached 100% correct classification but only 6% of isolates were classified; four of the other six protocols (antibiotic resistance analysis, PFGE, and two repetitive-element PCR protocols) achieved better than random accuracy rates when 30-100% of challenge isolates were classified. In robustness tests, measuring each protocol's ability to recognize isolates from nonlibrary hosts, three protocols correctly classified 33-100% of isolates as "unknown origin," whereas four protocols classified all isolates to a source category. A relevance test, summarizing interpretations for a hypothetical water sample containing 30 challenge isolates, indicated that false-positive classifications would hinder interpretations for most protocols. Study results indicate that more representation in known-source libraries and better classification accuracy would be needed before field application. Thorough reliability assessment of classification results is crucial before and during application of MST protocols.

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

PubMed

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

2016-06-27

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

Real-Time QoS Routing Protocols in Wireless Multimedia Sensor Networks: Study and Analysis.

PubMed

Alanazi, Adwan; Elleithy, Khaled

2015-09-02

Many routing protocols have been proposed for wireless sensor networks. These routing protocols are almost always based on energy efficiency. However, recent advances in complementary metal-oxide semiconductor (CMOS) cameras and small microphones have led to the development of Wireless Multimedia Sensor Networks (WMSN) as a class of wireless sensor networks which pose additional challenges. The transmission of imaging and video data needs routing protocols with both energy efficiency and Quality of Service (QoS) characteristics in order to guarantee the efficient use of the sensor nodes and effective access to the collected data. Also, with integration of real time applications in Wireless Senor Networks (WSNs), the use of QoS routing protocols is not only becoming a significant topic, but is also gaining the attention of researchers. In designing an efficient QoS routing protocol, the reliability and guarantee of end-to-end delay are critical events while conserving energy. Thus, considerable research has been focused on designing energy efficient and robust QoS routing protocols. In this paper, we present a state of the art research work based on real-time QoS routing protocols for WMSNs that have already been proposed. This paper categorizes the real-time QoS routing protocols into probabilistic and deterministic protocols. In addition, both categories are classified into soft and hard real time protocols by highlighting the QoS issues including the limitations and features of each protocol. Furthermore, we have compared the performance of mobility-aware query based real-time QoS routing protocols from each category using Network Simulator-2 (NS2). This paper also focuses on the design challenges and future research directions as well as highlights the characteristics of each QoS routing protocol.

Protocol deviations before and after IV tPA in community hospitals

PubMed Central

Adelman, Eric E.; Scott, Phillip A.; Skolarus, Lesli E.; Fox, Allison K.; Frederiksen, Shirley M.; Meurer, William J.

2015-01-01

Background Protocol deviations before and after tPA treatment for ischemic stroke are common. It is unclear if patient or hospital factors predict protocol deviations. We examined predictors of protocol deviations and the effects of protocol violations on symptomatic intracerebral hemorrhage. Methods We used data from the INSTINCT trial, a cluster-randomized, controlled trial evaluating the efficacy of a barrier assessment and educational intervention to increase appropriate tPA use in 24 Michigan community hospitals, to review tPA treatments between 2007 and 2010. Protocol violations were defined as deviations from the standard tPA protocol, both before and after treatment. Multi-level logistic regression models were fitted to determine if patient and hospital variables were associated with pre-treatment or post-treatment protocol deviations. Results During the study, 557 patients (mean age 70; 52% male; median NIHSS 12) were treated with tPA. Protocol deviations occurred in 233 (42%) patients: 16% had pre-treatment deviations, 35% had post-treatment deviations, and 9% had both. The most common protocol deviations included elevated post-treatment blood pressure, antithrombotic agent use within 24 hours of treatment, and elevated pre-treatment blood pressure. Protocol deviations were not associated with symptomatic intracerebral hemorrhage, stroke severity, or hospital factors. Older age was associated with pre-treatment protocol deviations (adjusted OR 0.52; 95% confidence interval 0.30-0.92). Pre-treatment deviations were associated with post-treatment deviations (adjusted OR 3.20; 95% confidence interval 1.91-5.35). Conclusions Protocol deviations were not associated with symptomatic intracerebral hemorrhage. Aside from age, patient and hospital factors were not associated with protocol deviations. PMID:26419527

Comparison of protocols measuring diffusion and partition coefficients in the stratum corneum

PubMed Central

Rothe, H.; Obringer, C.; Manwaring, J.; Avci, C.; Wargniez, W.; Eilstein, J.; Hewitt, N.; Cubberley, R.; Duplan, H.; Lange, D.; Jacques‐Jamin, C.; Klaric, M.; Schepky, A.

2017-01-01

Abstract Partition (K) and diffusion (D) coefficients are important to measure for the modelling of skin penetration of chemicals through the stratum corneum (SC). We compared the feasibility of three protocols for the testing of 50 chemicals in our main studies, using three cosmetics‐relevant model chemicals with a wide range of logP values. Protocol 1: SC concentration‐depth profile using tape‐stripping (measures KSC/v and DSC/HSC 2, where HSC is the SC thickness); Protocol 2A: incubation of isolated SC with chemical (direct measurement of KSC/v only) and Protocol 2B: diffusion through isolated SC mounted on a Franz cell (measures KSC/v and DSC/HSC 2, and is based on Fick's laws). KSC/v values for caffeine and resorcinol using Protocol 1 and 2B were within 30% of each other, values using Protocol 2A were ~two‐fold higher, and all values were within 10‐fold of each other. Only indirect determination of KSC/v by Protocol 2B was different from the direct measurement of KSC/v by Protocol 2A and Protocol 1 for 7‐EC. The variability of KSC/v for all three chemicals using Protocol 2B was higher compared to Protocol 1 and 2A. DSC/HSC 2 values for the three chemicals were of the same order of magnitude using all three protocols. Additionally, using Protocol 1, there was very little difference between parameters measured in pig and human SC. In conclusion, KSC/v, and DSC values were comparable using different methods. Pig skin might be a good surrogate for human skin for the three chemicals tested. Copyright © 2017 The Authors Journal of Applied Toxicology published by John Wiley & Sons Ltd. PMID:28139006

Real-Time QoS Routing Protocols in Wireless Multimedia Sensor Networks: Study and Analysis

PubMed Central

Alanazi, Adwan; Elleithy, Khaled

2015-01-01

Many routing protocols have been proposed for wireless sensor networks. These routing protocols are almost always based on energy efficiency. However, recent advances in complementary metal-oxide semiconductor (CMOS) cameras and small microphones have led to the development of Wireless Multimedia Sensor Networks (WMSN) as a class of wireless sensor networks which pose additional challenges. The transmission of imaging and video data needs routing protocols with both energy efficiency and Quality of Service (QoS) characteristics in order to guarantee the efficient use of the sensor nodes and effective access to the collected data. Also, with integration of real time applications in Wireless Senor Networks (WSNs), the use of QoS routing protocols is not only becoming a significant topic, but is also gaining the attention of researchers. In designing an efficient QoS routing protocol, the reliability and guarantee of end-to-end delay are critical events while conserving energy. Thus, considerable research has been focused on designing energy efficient and robust QoS routing protocols. In this paper, we present a state of the art research work based on real-time QoS routing protocols for WMSNs that have already been proposed. This paper categorizes the real-time QoS routing protocols into probabilistic and deterministic protocols. In addition, both categories are classified into soft and hard real time protocols by highlighting the QoS issues including the limitations and features of each protocol. Furthermore, we have compared the performance of mobility-aware query based real-time QoS routing protocols from each category using Network Simulator-2 (NS2). This paper also focuses on the design challenges and future research directions as well as highlights the characteristics of each QoS routing protocol. PMID:26364639

Protocolized treatment is associated with decreased organ dysfunction in pediatric severe sepsis

PubMed Central

Balamuth, Fran; Weiss, Scott L.; Fitzgerald, Julie C.; Hayes, Katie; Centkowski, Sierra; Chilutti, Marianne; Grundmeier, Robert W.; Lavelle, Jane; Alpern, Elizabeth R.

2016-01-01

Objective To determine whether treatment with a protocolized sepsis guideline in the emergency department (ED) was associated with a lower burden of organ dysfunction (OD) by hospital day 2 compared to non-protocolized usual care in pediatric patients with severe sepsis. Design Retrospective cohort study Setting Tertiary care children’s hospital from January 1, 2012–March 31, 2014. Measurements and Main Results Subjects with international consensus defined severe sepsis and pediatric intensive care unit (PICU) admission within 24 hours of ED arrival were included. The exposure was the use of a protocolized ED sepsis guideline. The primary outcome was complete resolution of OD by hospital day 2. One hundred eighty nine subjects were identified during the study period. Of these, 121 (64%) were treated with the protocolized ED guideline and 68 were not. There were no significant differences between the groups in age, sex, race, number of comorbid conditions, ED triage level, or OD on arrival to the ED. Patients treated with protocolized ED care were more likely to be free of OD on hospital day 2 after controlling for sex, comorbid condition, indwelling central venous catheter, PIM-2 score, and timing of antibiotics and intravenous fluids (adjusted OR 4.2, 95% CI 1.7, 10.4). Conclusions Use of a protocolized ED sepsis guideline was independently associated with resolution of OD by hospital day 2 compared to non-protocolized usual care. These data indicate that morbidity outcomes in children can be improved with the use of protocolized care. PMID:27455114

Nonpainful wide-area compression inhibits experimental pain

PubMed Central

Honigman, Liat; Bar-Bachar, Ofrit; Yarnitsky, David; Sprecher, Elliot; Granovsky, Yelena

2016-01-01

Abstract Compression therapy, a well-recognized treatment for lymphoedema and venous disorders, pressurizes limbs and generates massive non-noxious afferent sensory barrages. The aim of this study was to study whether such afferent activity has an analgesic effect when applied on the lower limbs, hypothesizing that larger compression areas will induce stronger analgesic effects, and whether this effect correlates with conditioned pain modulation (CPM). Thirty young healthy subjects received painful heat and pressure stimuli (47°C for 30 seconds, forearm; 300 kPa for 15 seconds, wrist) before and during 3 compression protocols of either SMALL (up to ankles), MEDIUM (up to knees), or LARGE (up to hips) compression areas. Conditioned pain modulation (heat pain conditioned by noxious cold water) was tested before and after each compression protocol. The LARGE protocol induced more analgesia for heat than the SMALL protocol (P < 0.001). The analgesic effect interacted with gender (P = 0.015). The LARGE protocol was more efficient for females, whereas the MEDIUM protocol was more efficient for males. Pressure pain was reduced by all protocols (P < 0.001) with no differences between protocols and no gender effect. Conditioned pain modulation was more efficient than the compression-induced analgesia. For the LARGE protocol, precompression CPM efficiency positively correlated with compression-induced analgesia. Large body area compression exerts an area-dependent analgesic effect on experimental pain stimuli. The observed correlation with pain inhibition in response to robust non-noxious sensory stimulation may suggest that compression therapy shares similar mechanisms with inhibitory pain modulation assessed through CPM. PMID:27152691

A retrospective review of safety using a nursing driven protocol for autonomic dysreflexia in patients with spinal cord injuries.

PubMed

Solinsky, Ryan; Svircev, Jelena N; James, Jennifer J; Burns, Stephen P; Bunnell, Aaron E

2016-11-01

Autonomic dysreflexia is a potentially life-threatening condition which afflicts a significant proportion of individuals with spinal cord injuries (SCI). To date, the safety and efficacy of several commonly used interventions for this condition have not been studied. A retrospective chart review of the safety of a previously implemented nursing driven inpatient autonomic dysreflexia protocol. Seventy-eight male patients with SCI who experienced autonomic dysreflexia while inpatient at our Veterans Affairs SCI unit over a 3-1/2-year period were included. The safety of a nursing driven protocol utilizing conservative measures, nitroglycerin paste, and oral hydralazine was evaluated. Occurrence of adverse events and relative hypotensive events during all episodes treated with the protocol, and efficacy of attaining target blood pressure for all episodes with protocol adherence and for initial episode experienced by each patient. Four hundred forty-five episodes of autonomic dysreflexia were recorded in the study period, with 92% adherence to the protocol. When the protocol was followed, target blood pressure was achieved for 97.6% of all episodes. Twenty-three total adverse events occurred (5.2% of all episodes). All adverse events were due to hypotension and only 0.9% required interventions beyond clinical monitoring. Of each patient's initial autonomic dysreflexia episode, 97.3% resolved using the protocol without need for further escalation of care. This inpatient nursing driven-protocol for treating autonomic dysreflexia utilizing conservative measures, nitroglycerin paste and oral hydralazine achieved target blood pressure with a high success rate and a low incidence of adverse events.

Individual Optimal Frequency in Whole-Body Vibration: Effect of Protocol, Joint Angle, and Fatiguing Exercise.

PubMed

Carlucci, Flaminia; Felici, Francesco; Piccinini, Alberto; Haxhi, Jonida; Sacchetti, Massimo

2016-12-01

Carlucci, F, Felici, F, Piccinini, A, Haxhi, J, and Sacchetti, M. Individual optimal frequency in whole-body vibration: effect of protocol, joint angle, and fatiguing exercise. J Strength Cond Res 30(12): 3503-3511, 2016-Recent studies have shown the importance of individualizing the vibration intervention to produce greater effects on the neuromuscular system in less time. The purpose of this study was to assess the individual optimal vibration frequency (OVF) corresponding to the highest muscle activation (RMSmax) during vibration at different frequencies, comparing different protocols. Twenty-nine university students underwent 3 continuous (C) and 2 random (R) different vibrating protocols, maintaining a squat position on a vibration platform. The C protocol lasted 50 seconds and involved the succession of ascending frequencies from 20 to 55 Hz, every 5 seconds. The same protocol was performed twice, having the knee angle at 120° (C) and 90° (C90), to assess the effect of joint angle and after a fatiguing squatting exercise (CF) to evaluate the influence of fatigue on OVF assessment. In the random protocols, vibration time was 20 seconds with a 2-minute (R2) and a 4-minute (R4) pauses between tested frequencies. Muscle activation and OVF values did not differ significantly in the C, R2, and R4 protocols. RMSmax was higher in C90 (p < 0.001) and in CF (p = 0.04) compared with the C protocol. Joint angle and fatiguing exercise had no effect on OVF. In conclusion, the shorter C protocol produced similar myoelectrical activity in the R2 and the R4 protocols, and therefore, it could be equally valid in identifying the OVF with considerable time efficiency. Knee joint angle and fatiguing exercise had an effect on surface electromyography response during vibration but did not affect OVF identification significantly.

Impacts of dose and time of boldenone and stanazolol exposure in inflammatory markers, oxidative and nitrosative stress and histopathological changes in the rat testes.

PubMed

Bueno, Andressa; Carvalho, Fabiano B; Gutierres, Jessié M; Lhamas, Cibele L; Brusco, Indiara; Oliveira, Sara M; Amaral, Marta G; Dorneles, Guilherme; Sorraila, Juliana; Duarte, Marta M; de Andrade, Cinthia M

2017-03-01

The present study was conducted to analyze the adverse effects of the anabolic steroids boldenone (BOL) and stanazolol (ST) in the reproductive function of male rats. These molecules were administered using three different protocols. In Protocol I, BOL and ST were administered in a higher dose than what is recommended but for a short period. In Protocol II, a moderate dose of these compounds was applied for an intermediate period, whereas in Protocol III a reduced dose was administered but for an extended period. Notably, Protocol I and III resulted in increased levels of reactive oxygen specimens (ROS [I, p < 0.01] [III, p < 0.001)]) and nitrite plus nitrate (NOx [I, p < 0.01] [II, p < 0.01] [III,p < 0.05]), respectively, whereas non-protein thiols (NPSH) levels were decreased only after Protocol III (p < 0.01). Myeloperoxidase activity was significantly increased after treatment with BOL in protocol II (p < 0.01) and III (p < 0.05) than with ST in protocol III (p < 0.05). Boldenone and ST also caused a significant up-regulation in the levels of serum testosterone when protocols I (p < 0.01) and II (p < 0.05) were performed. There were also visible histopathological alterations in the testes induced by treatment with BOL, namely degenerative changes primarily characterized by a decrease in the germinal epithelium. Together, these results suggest that the administration of BOL or ST exerts a significantly harmful effect in the testes of male rats. Moreover, all the treatment protocols used in this study induced deleterious effects on the testes, as indicated by the different biochemical parameters investigated. However, only the protocols of longer exposure time (II and III) induced morphological changes compatible with infertility. Copyright © 2017 Elsevier Inc. All rights reserved.

Does an oral care protocol reduce VAP in patients with a tracheostomy?

PubMed

Conley, Patricia; McKinsey, David; Graff, Jason; Ramsey, Anthony R

2013-07-01

Several studies have demonstrated that oral care with chlorhexidine gluconate (CHG) 0.12% solution reduces the incidence of ventilator-associated pneumonia (VAP) in mechanically ventilated patients with endotracheal tubes in the ICU. Minimal evidence shows the effectiveness of any oral care protocols in preventing VAP in mechanically ventilated patients with tracheostomies in a step-down or progressive care unit (PCU). To determine the effectiveness of an oral care protocol in reducing the VAP rate in mechanically ventilated patients with tracheostomies in the PCU. A 12-month prospective study was conducted on 75 mechanically ventilated patients who had tracheostomies. The oral care protocol consisted of tooth brushing with toothpaste and applying CHG 0.12% solution every 12 hours. At the conclusion of the study, the VAP rate in the study population was compared with the National Health and Safety Network (NHSN) report for 2009 benchmark of 1.5 per 1,000 ventilator days. After the oral care protocol was implemented in the PCU, the VAP rate was 1.1 per 1,000 ventilator days over 12 months, compared with the NHSN report for 2009 of 1.5 per 1,000 ventilator days. Tooth brushing with toothpaste and applying CHG 0.12% solution may be an effective oral care protocol to reduce the VAP rate in patients in PCUs with tracheostomies who are being mechanically ventilated.

Judges' Agreement and Disagreement Patterns When Encoding Verbal Protocols.

ERIC Educational Resources Information Center

Schael, Jocelyne; Dionne, Jean-Paul

The basis of agreement or disagreement among judges/evaluators when applying a coding scheme to concurrent verbal protocols was studied. The sample included 20 university graduates, from varied backgrounds; 10 subjects had and 10 subjects did not have experience in protocol analysis. The total sample was divided into four balanced groups according…

Fixation and Commitment while Designing and Its Measurement

ERIC Educational Resources Information Center

Gero, John S.

2011-01-01

This paper introduces the notion that fixation and commitment while designing can be measured by studying the protocol of the design session. It is hypothesized that the dynamic entropy of the linkograph of the protocol provides the basis for such a measurement. The hypothesis is empirically tested using a design protocol and the results…

A Comparison of Inquiry and Worked Example Web-Based Instruction Using Physlets

ERIC Educational Resources Information Center

Lee, Kevin M.; Nicoll, Gayle; Brooks, David W.

2004-01-01

This paper compares two protocols for web-based instruction using simulations in an introductory physics class. The Inquiry protocol allowed students to control input parameters while the Worked Example protocol did not. Students in the Worked Example group performed significantly higher on a common assessment. The ramifications of this study are…

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…

Use of Flowchart for Automation of Clinical Protocols in mHealth.

PubMed

Dias, Karine Nóra; Welfer, Daniel; Cordeiro d'Ornellas, Marcos; Pereira Haygert, Carlos Jesus; Dotto, Gustavo Nogara

2017-01-01

For healthcare professionals to use mobile applications we need someone who knows software development, provide them. In healthcare institutions, health professionals use clinical protocols to govern care, and sometimes these documents are computerized through mobile applications to assist them. This work aims to present a proposal of an application of flow as a way of describing clinical protocols for automatic generation of mobile applications to assist health professionals. The purpose of this research is to enable health professionals to develop applications from the description of their own clinical protocols. As a result, we developed a web system that automates clinical protocols for an Android platform, and we validated with two clinical protocols used in a Brazilian hospital. Preliminary results of the developed architecture demonstrate the feasibility of this study.

Evaluation of a single-scan protocol for radiochromic film dosimetry.

PubMed

Shimohigashi, Yoshinobu; Araki, Fujio; Maruyama, Masato; Nakaguchi, Yuji; Kuwahara, Satoshi; Nagasue, Nozomu; Kai, Yudai

2015-03-08

The purpose of this study was to evaluate a single-scan protocol using Gafchromic EBT3 film (EBT3) by comparing it with the commonly used 24-hr measurement protocol for radiochromic film dosimetry. Radiochromic film is generally scanned 24 hr after film exposure (24-hr protocol). The single-scan protocol enables measurement results within a short time using only the verification film, one calibration film, and unirradiated film. The single-scan protocol was scanned 30 min after film irradiation. The EBT3 calibration curves were obtained with the multichannel film dosimetry method. The dose verifications for each protocol were performed with the step pattern, pyramid pattern, and clinical treatment plans for intensity-modulated radiation therapy (IMRT). The absolute dose distributions for each protocol were compared with those calculated by the treatment planning system (TPS) using gamma evaluation at 3% and 3 mm. The dose distribution for the single-scan protocol was within 2% of the 24-hr protocol dose distribution. For the step pattern, the absolute dose discrepancies between the TPS for the single-scan and 24-hr protocols were 2.0 ± 1.8 cGy and 1.4 ± 1.2 cGy at the dose plateau, respectively. The pass rates were 96.0% for the single-scan protocol and 95.9% for the 24-hr protocol. Similarly, the dose discrepancies for the pyramid pattern were 3.6 ± 3.5cGy and 2.9 ± 3.3 cGy, respectively, while the pass rates for the pyramid pattern were 95.3% and 96.4%, respectively. The average pass rates for the four IMRT plans were 96.7% ± 1.8% for the single-scan protocol and 97.3% ± 1.4% for the 24-hr protocol. Thus, the single-scan protocol measurement is useful for dose verification of IMRT, based on its accuracy and efficiency.

Evaluation of a single‐scan protocol for radiochromic film dosimetry

PubMed Central

Araki, Fujio; Maruyama, Masato; Nakaguchi, Yuji; Kuwahara, Satoshi; Nagasue, Nozomu; Kai, Yudai

2015-01-01

The purpose of this study was to evaluate a single‐scan protocol using Gafchromic EBT3 film (EBT3) by comparing it with the commonly used 24‐hr measurement protocol for radiochromic film dosimetry. Radiochromic film is generally scanned 24 hr after film exposure (24‐hr protocol). The single‐scan protocol enables measurement results within a short time using only the verification film, one calibration film, and unirradiated film. The single‐scan protocol was scanned 30 min after film irradiation. The EBT3 calibration curves were obtained with the multichannel film dosimetry method. The dose verifications for each protocol were performed with the step pattern, pyramid pattern, and clinical treatment plans for intensity‐modulated radiation therapy (IMRT). The absolute dose distributions for each protocol were compared with those calculated by the treatment planning system (TPS) using gamma evaluation at 3% and 3 mm. The dose distribution for the single‐scan protocol was within 2% of the 24‐hr protocol dose distribution. For the step pattern, the absolute dose discrepancies between the TPS for the single‐scan and 24‐hr protocols were 2.0±1.8 cGy and 1.4±1.2 cGy at the dose plateau, respectively. The pass rates were 96.0% for the single‐scan protocol and 95.9% for the 24‐hr protocol. Similarly, the dose discrepancies for the pyramid pattern were 3.6±3.5 cGy and 2.9±3.3 cGy, respectively, while the pass rates for the pyramid pattern were 95.3% and 96.4%, respectively. The average pass rates for the four IMRT plans were 96.7%±1.8% for the single‐scan protocol and 97.3%±1.4% for the 24‐hr protocol. Thus, the single‐scan protocol measurement is useful for dose verification of IMRT, based on its accuracy and efficiency. PACS number: 87.55.Qr PMID:26103194

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

PubMed

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

2018-05-31

The ideal meniscal repair postoperative rehabilitation protocol has yet to be determined. Further, patients are attempting to access health care content online at a precipitously increasing rate given the efficiency of modern search engines. The purpose of this investigation was to assess the quality and variability of meniscal repair rehabilitation protocols published online with the hypothesis that there would be a high degree of variability found across available protocols. To this end, Web-based meniscal repair physical therapy protocols from U.S. academic orthopaedic programs as well as the first 10 protocols identified by the Google search engine for the term "meniscal repair physical therapy protocol" were reviewed and assessed via a custom scoring rubric. Twenty protocols were identified from 155 U.S. academic orthopaedic programs for a total of 30 protocols. Twenty-six protocols (86.6%) recommended immediate postoperative bracing. Twelve (40.0%) protocols permitted immediate weight-bearing as tolerated (WBAT) postoperatively, while the remaining protocols permitted WBAT at an average of 4.0 (range, 1-7) weeks. There was considerable variation in range of motion (ROM) goals, with most protocols (73.3%) initiating immediate passive ROM to 90°. The types and timing of strength, proprioception, agility, and pivoting exercises advised were extremely diverse. Only five protocols (16.7%) employed functional testing as a marker for return to athletics. The results of this study indicate that only a minority of academic orthopaedic programs publish meniscal repair physical therapy protocols online and that within the most readily available online protocols there are significant disparities in regards to brace use, ROM, weight-bearing, and strengthening and proprioception exercises. These discrepancies reflect the fact that the best rehabilitation practices after a meniscal repair have yet to be elucidated. This represents a significant area for improved patient care through standardization. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Patient doses from CT examinations in Turkey.

PubMed

Ataç, Gökçe Kaan; Parmaksız, Aydın; İnal, Tolga; Bulur, Emine; Bulgurlu, Figen; Öncü, Tolga; Gündoğdu, Sadi

2015-01-01

We aimed to establish the first diagnostic reference levels (DRLs) for computed tomography (CT) examinations in adult and pediatric patients in Turkey and compare these with international DRLs. CT performance information and examination parameters (for head, chest, high-resolution CT of the chest [HRCT-chest], abdominal, and pelvic protocols) from 1607 hospitals were collected via a survey. Dose length products and effective doses for standard patient sizes were calculated from the reported volume CT dose index (CTDIvol). The median number of protocols reported from the 167 responding hospitals (10% response rate) was 102 across five different age groups. Third quartile CTDIvol values for adult pelvic and all pediatric body protocols were higher than the European Commission standards but were comparable to studies conducted in other countries. The radiation dose indicators for adult patients were similar to those reported in the literature, except for those associated with head protocols. CT protocol optimization is necessary for adult head and pediatric chest, HRCT-chest, abdominal, and pelvic protocols. The findings from this study are recommended for use as national DRLs in Turkey.

An improved ATAC-seq protocol reduces background and enables interrogation of frozen tissues.

PubMed

Corces, M Ryan; Trevino, Alexandro E; Hamilton, Emily G; Greenside, Peyton G; Sinnott-Armstrong, Nicholas A; Vesuna, Sam; Satpathy, Ansuman T; Rubin, Adam J; Montine, Kathleen S; Wu, Beijing; Kathiria, Arwa; Cho, Seung Woo; Mumbach, Maxwell R; Carter, Ava C; Kasowski, Maya; Orloff, Lisa A; Risca, Viviana I; Kundaje, Anshul; Khavari, Paul A; Montine, Thomas J; Greenleaf, William J; Chang, Howard Y

2017-10-01

We present Omni-ATAC, an improved ATAC-seq protocol for chromatin accessibility profiling that works across multiple applications with substantial improvement of signal-to-background ratio and information content. The Omni-ATAC protocol generates chromatin accessibility profiles from archival frozen tissue samples and 50-μm sections, revealing the activities of disease-associated DNA elements in distinct human brain structures. The Omni-ATAC protocol enables the interrogation of personal regulomes in tissue context and translational studies.

Xrootd in dCache - design and experiences

NASA Astrophysics Data System (ADS)

Behrmann, Gerd; Ozerov, Dmitry; Zangerl, Thomas

2011-12-01

dCache is a well established distributed storage solution used in both high energy physics computing and other disciplines. An overview of the implementation of the xrootd data access protocol within dCache is presented. The performance of various access mechanisms is studied and compared and it is concluded that our implementation is as perfomant as other protocols. This makes dCache a compelling alternative to the Scalla software suite implementation of xrootd, with added value from broad protocol support, including the IETF approved NFS 4.1 protocol.

Optimization of coronary attenuation in coronary computed tomography angiography using diluted contrast material.

PubMed

Kawaguchi, Naoto; Kurata, Akira; Kido, Teruhito; Nishiyama, Yoshiko; Kido, Tomoyuki; Miyagawa, Masao; Ogimoto, Akiyoshi; Mochizuki, Teruhito

2014-01-01

The purpose of this study was to evaluate a personalized protocol with diluted contrast material (CM) for coronary computed tomography angiography (CTA). One hundred patients with suspected coronary artery disease underwent retrospective electrocardiogram-gated coronary CTA on a 256-slice multidetector-row CT scanner. In the diluted CM protocol (n=50), the optimal scan timing and CM dilution rate were determined by the timing bolus scan, with 20% CM dilution (5ml/s during 10s) being considered suitable to achieve the target arterial attenuation of 350 Hounsfield units (HU). In the body weight (BW)-adjusted protocol (n=50, 222mg iodine/kg), only the optimal scan timing was determined by the timing bolus scan. The injection rate and volume in the timing bolus scan and real scan were identical between the 2 protocols. We compared the means and variations in coronary attenuation between the 2 protocols. Coronary attenuation (mean±SD) in the diluted CM and BW-adjusted protocols was 346.1±23.9 HU and 298.8±45.2 HU, respectively. The diluted CM protocol provided significantly higher coronary attenuation and lower variance than did the BW-adjusted protocol (P<0.05, in each). The diluted CM protocol facilitates more uniform attenuation on coronary CTA in comparison with the BW-adjusted protocol.  

Comparison of Results of Cycles Treated with Modified Mild Protocol and Short Protocol for Ovarian Stimulation

PubMed Central

Aguiar, L. F.; Cunha, G. S. P.; Cardinot, N.; Lucena, E.

2014-01-01

The ovarian stimulation has been applied in order to increase the number of oocytes to compensate for the poor results of in vitro fertilization, allowing the selection of one or more embryos to be transferred. Our aim is to compare the results obtained in IVF/ICSI cycles using the short protocol for controlled ovarian stimulation to the results from the modified mild protocol used in our department. A total of 240 cycles were conducted from January 2010 to December 2011. When comparing both protocols, it could be observed that there was a significant difference in the quantity of gonadotropins doses in the mild protocol and in the short protocol. No significant difference was observed regarding pregnancy rates per cycle, 22% and 26.2%, in short and mild protocols, respectively. The protocols of controlled ovarian stimulation are often associated with high risk of complications such as ovarian hyperstimulation syndrome, excessive emotional stress, high rates of treatment dropouts, and abdominal discomfort. With the data obtained in this study, one can conclude that there are less risks and complications for the patient when using the mild stimulation protocol. It was also observed that in this group there was a slightly higher rate. PMID:25763398

Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols

PubMed Central

Haby, Michelle M.; Martínez-Vega, Ruth; Pinzón-Flores, Carlos E.; Smith, Emma; Pinart, Mariona; Broutet, Nathalie; Becerra-Posada, Francisco; Aldighieri, Sylvain; Van Kerkhove, Maria D.

2017-01-01

Introduction Given the severity and impact of the current Zika virus (ZIKV) outbreak in the Americas, numerous countries have rushed to develop research studies to assess ZIKV and its potential health consequences. In an effort to ensure that studies are comprehensive, both internally and externally valid, and with reliable results, the World Health Organization, the Pan American Health Organization, Institut Pasteur, the networks of Fiocruz, the Consortia for the Standardization of Influenza Seroepidemiology (CONSISE) and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) have generated six standardized clinical and epidemiological research protocols and questionnaires to address key public health questions on ZIKV. Methods We conducted a systematic search of ongoing study protocols related to ZIKV research. We analyzed the content of protocols of 32 cohort studies and 13 case control studies for systematic bias that could produce erroneous results. Additionally we aimed to characterize the risks of bias and confounding in observational studies related to ZIKV and to propose ways to minimize them, including the use of six newly standardized research protocols. Results Observational studies of ZIKV face an array of challenges, including measurement of exposure and outcomes (microcephaly and Guillain-Barré Syndrome). Potential confounders need to be measured where known and controlled for in the analysis. Selection bias due to non-random selection is a significant issue, particularly in the case-control design, and losses to follow-up is equally important for the cohort design. Conclusion Observational research seeking to answer key questions on the ZIKV should consider these restrictions and take precautions to minimize bias in an effort to provide reliable and valid results. Utilization of the standardized research protocols developed by the WHO, PAHO, Institut Pasteur, and CONSISE will harmonize the key methodological aspects of each study design to minimize bias at different stages of the study. Biases need to be considered by researchers implementing the standardized protocols as well as by users of observational epidemiological studies of ZIKV. PMID:28686621

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.

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.

Biomechanical Comparison of Robotically Applied Pure Moment, Ideal Follower Load, and Novel Trunk Weight Loading Protocols on L4-L5 Cadaveric Segments during Flexion-Extension.

PubMed

Bennett, Charles R; DiAngelo, Denis J; Kelly, Brian P

2015-01-01

Extremely few in-vitro biomechanical studies have incorporated shear loads leaving a gap for investigation, especially when applied in combination with compression and bending under dynamic conditions. The objective of this study was to biomechanically compare sagittal plane application of two standard protocols, pure moment (PM) and follower load (FL), with a novel trunk weight (TW) loading protocol designed to induce shear in combination with compression and dynamic bending in a neutrally potted human cadaveric L4-L5 motion segment unit (MSU) model. A secondary objective and novelty of the current study was the application of all three protocols within the same testing system serving to reduce artifacts due to testing system variability. Six L4-L5 segments were tested in a Cartesian load controlled system in flexion-extension to 8Nm under PM, simulated ideal 400N FL, and vertically oriented 400N TW loading protocols. Comparison metrics used were rotational range of motion (RROM), flexibility, neutral zone (NZ) range of motion, and L4 vertebral body displacements. Significant differences in vertebral body translations were observed with different initial force applications but not with subsequent bending moment application. Significant reductions were observed in combined flexion-extension RROM, in flexibility during extension, and in NZ region flexibility with the TW loading protocol as compared to PM loading. Neutral zone ranges of motion were not different between all protocols. The combined compression and shear forces applied across the spinal joint in the trunk weight protocol may have a small but significantly increased stabilizing effect on segment flexibility and kinematics during sagittal plane flexion and extension.

Biomechanical Comparison of Robotically Applied Pure Moment, Ideal Follower Load, and Novel Trunk Weight Loading Protocols on L4-L5 Cadaveric Segments during Flexion-Extension

PubMed Central

Bennett, Charles R.; DiAngelo, Denis J.

2015-01-01

Background Extremely few in-vitro biomechanical studies have incorporated shear loads leaving a gap for investigation, especially when applied in combination with compression and bending under dynamic conditions. The objective of this study was to biomechanically compare sagittal plane application of two standard protocols, pure moment (PM) and follower load (FL), with a novel trunk weight (TW) loading protocol designed to induce shear in combination with compression and dynamic bending in a neutrally potted human cadaveric L4-L5 motion segment unit (MSU) model. A secondary objective and novelty of the current study was the application of all three protocols within the same testing system serving to reduce artifacts due to testing system variability. Methods Six L4-L5 segments were tested in a Cartesian load controlled system in flexion-extension to 8Nm under PM, simulated ideal 400N FL, and vertically oriented 400N TW loading protocols. Comparison metrics used were rotational range of motion (RROM), flexibility, neutral zone (NZ) range of motion, and L4 vertebral body displacements. Results Significant differences in vertebral body translations were observed with different initial force applications but not with subsequent bending moment application. Significant reductions were observed in combined flexion-extension RROM, in flexibility during extension, and in NZ region flexibility with the TW loading protocol as compared to PM loading. Neutral zone ranges of motion were not different between all protocols. Conclusions The combined compression and shear forces applied across the spinal joint in the trunk weight protocol may have a small but significantly increased stabilizing effect on segment flexibility and kinematics during sagittal plane flexion and extension. PMID:26273551

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.

[Prospective randomised study of long versus short agonist protocol with poor responder patients during in vitro fertilization].

PubMed

Chatillon-Boissier, K; Genod, A; Denis-Belicard, E; Felloni, B; Chene, G; Seffert, P; Chauleur, C

2012-11-01

Different ovarian stimulation protocols are used for in vitro fertilization (IVF) in "poor responder" patients. Our work aims at comparing two ovarian stimulation protocols (long agonist half-dose protocol versus short agonist protocol without pretreatment) in this population of women. This prospective, randomized study was realized at the University Hospital of Saint-Étienne and concerns "poor responder" patients (age between 38 and 42 years and FSH at day 3 more than 9.5 IU/L; and/or antral follicles count less or equal to 6; and/or failure of previous stimulation). The primary endpoint is based on the number of oocytes retrieved at the end of an IVF cycle. Out of the 44 patients randomized, 39 cycles were taken into account (20 in the long protocol, 19 in the short one). At the end of the stimulation (FSH-r 300 to 450 UI/d), the number of follicles recruited appears higher in the long protocol but the difference is not significant (diameter between 14 and 18 mm: 3.0±2.31 vs. 1.88±1.89 and diameter greater than 18 mm: 3.9±2 85 vs. 3.06±2.77). The same tendency is observed for all the following criteria: the number of retrieved oocytes (6.74±2.73 vs. 6.38±4.26), the total number of embryos (3.16±2.03 vs. 2.25±2.11), the pregnancy rate per retrieval (21% vs. 19%) and per cycle (20% vs. 16%), and the number of children born alive. The study did not reveal any difference between the two protocols but the long half-dose seems to be better. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

Validity of Partial Protocols to Assess the Prevalence of Periodontal Outcomes and Associated Sociodemographic and Behavior Factors in Adolescents and Young Adults

PubMed Central

Peres, Marco A.; Peres, Karen G.; Cascaes, Andreia M.; Correa, Marcos B.; Demarco, Flávio F.; Hallal, Pedro C.; Horta, Bernardo L.; Gigante, Denise P.; Menezes, Ana B.

2012-01-01

Background Most studies comparing prevalence of periodontal disease and risk factors by using partial protocols were performed in adult populations, with several studies being conducted in clinical settings. The aim of this study is to assess the accuracy of partial protocols in estimating the prevalence of periodontal outcomes in adolescents and young adults from two population-based birth cohorts from Pelotas, Brazil, and to assess differences in the estimation and strength of the effect measures when partial protocols are adopted compared to full-mouth examination. Methods Gingival bleeding at probing among adolescents (n = 339) and young adults (n = 720) and dental calculus and periodontal probing depth among young adults were assessed using full-mouth examinations and four partial protocols: Ramfjord teeth (RT), community periodontal index (CPI), and two random diagonal quadrants (1 and 3, 2 and 4). Socioeconomic, demographic, and periodontal health-related variables were also collected. Sensitivity, absolute and relative bias, and inflation factors were calculated. Prevalence ratio for each periodontal outcome for the risk factors was estimated. Results Two diagonal quadrants showed better accuracy; RT had the worst, whereas CPI presented an intermediate pattern when compared to full-mouth examination. For bleeding assessment in adolescence, RT and CPI underestimated by 18.4% and 16.2%, respectively, the true outcome prevalence, whereas among young adults, all partial protocols underestimated the prevalence. All partial protocols presented similar magnitude of association measures for all investigated periodontal potential risk factors. Conclusion Two diagonal quadrants protocol may be effective in identifying the risk factors for the most relevant periodontal outcomes in adolescence and in young adulthood. PMID:21859320

Validity of partial protocols to assess the prevalence of periodontal outcomes and associated sociodemographic and behavior factors in adolescents and young adults.

PubMed

Peres, Marco A; Peres, Karen G; Cascaes, Andreia M; Correa, Marcos B; Demarco, Flávio F; Hallal, Pedro C; Horta, Bernardo L; Gigante, Denise P; Menezes, Ana B

2012-03-01

Most studies comparing prevalence of periodontal disease and risk factors by using partial protocols were performed in adult populations, with several studies being conducted in clinical settings. The aim of this study is to assess the accuracy of partial protocols in estimating the prevalence of periodontal outcomes in adolescents and young adults from two population-based birth cohorts from Pelotas, Brazil, and to assess differences in the estimation and strength of the effect measures when partial protocols are adopted compared to full-mouth examination. Gingival bleeding at probing among adolescents (n = 339) and young adults (n = 720) and dental calculus and periodontal probing depth among young adults were assessed using full-mouth examinations and four partial protocols: Ramfjord teeth (RT), community periodontal index (CPI), and two random diagonal quadrants (1 and 3, 2 and 4). Socioeconomic, demographic, and periodontal health-related variables were also collected. Sensitivity, absolute and relative bias, and inflation factors were calculated. Prevalence ratio for each periodontal outcome for the risk factors was estimated. Two diagonal quadrants showed better accuracy; RT had the worst, whereas CPI presented an intermediate pattern when compared to full-mouth examination. For bleeding assessment in adolescence, RT and CPI underestimated by 18.4% and 16.2%, respectively, the true outcome prevalence, whereas among young adults, all partial protocols underestimated the prevalence. All partial protocols presented similar magnitude of association measures for all investigated periodontal potential risk factors. Two diagonal quadrants protocol may be effective in identifying the risk factors for the most relevant periodontal outcomes in adolescence and in young adulthood.

The Association Between Daytime Intensivist Physician Staffing and Mortality in the Context of Other ICU Organizational Practices: A Multicenter Cohort Study.

PubMed

Costa, Deena Kelly; Wallace, David J; Kahn, Jeremy M

2015-11-01

Daytime intensivist physician staffing is associated with improved outcomes in the ICU. However, it is unclear whether this association persists in the era of interprofessional, protocol-directed critical care. We sought to reexamine the association between daytime intensivist physician staffing and ICU mortality and determine if interprofessional rounding and protocols for mechanical ventilation in part mediate this relationship. Retrospective cohort study of ICUs in the Acute Physiology and Chronic Health Evaluation clinical information system from 2009 to 2010. Forty-nine ICUs in 25 U.S. hospitals. Adults (17 yr and older) admitted to a study ICU. None. We defined high-intensity daytime intensivist staffing as either a mandatory consult or closed ICU model; interprofessional rounds as rounds that included a respiratory therapist, pharmacist, physician and nurse; and protocol use as having protocols for liberation from mechanical ventilation and lung protective mechanical ventilation. Using multivariable logistic regression, we estimated the independent effect of daytime intensivist physician staffing on in-hospital mortality controlling for interprofessional rounds and protocols for mechanical ventilation, as well as other patient and hospital characteristics. Twenty-seven ICUs (55%) reported high-intensity daytime physician staffing, 42 ICUs (85%) reported daily interprofessional rounds, and 31 (63%) reported having protocols for mechanical ventilation. There was no association between daytime intensivist physician staffing and in-hospital mortality (adjusted odds ratio, 0.86; 95% CI, 0.65-1.14). After adjusting for interprofessional rounds and protocols for mechanical ventilation, the effect of daytime intensivist physician staffing remained nonsignificant (adjusted odds ratio, 0.90; 95% CI, 0.70-1.17). High-intensity daytime physician staffing in the ICU was not significantly associated with lower mortality in a modern cohort. This association was not affected by interprofessional rounds or protocols for mechanical ventilation.

Usefulness of an injectable anaesthetic protocol for semen collection through urethral catheterisation in domestic cats.

PubMed

Pisu, Maria Carmela; Ponzio, Patrizia; Rovella, Chiara; Baravalle, Michela; Veronesi, Maria Cristina

2017-10-01

Objectives Although less often requested in comparison with dogs, the collection of semen in cats can be necessary for artificial insemination, for semen evaluation in tom cats used for breeding and for semen storage. Urethral catheterisation after pharmacological induction with medetomidine has proved to be useful for the collection of semen in domestic cats. However, most of the previously used protocols require the administration of high doses of medetomidine that can increase the risk of side effects, especially on the cardiovascular system. In routine clinical practice, one safe and useful injectable anaesthetic protocol for short-term clinical investigations or surgery in cats involves premedication with low intramuscular doses of dexmedetomidine with methadone, followed by intravenous propofol bolus injection. We aimed to assess the usefulness of this injectable anaesthetic protocol for semen collection, via urethral catheterisation, in domestic cats. Methods The study was performed on 38 purebred, adult cats, during the breeding season, and semen was collected via urethral catheterisation using an injectable anaesthesia protocol with methadone (0.2 mg/kg) and dexmedetomidine (5 µg/kg) premedication, followed by induction with propofol. Results The anaesthetic protocol used in the present study allowed the collection of large-volume semen samples, characterised by good parameters and without side effects. Conclusions and relevance The results from the present study suggest that the injectable anaesthetic protocol using methadone and dexmedetomidine premedication, followed by induction with propofol, could be suitable and safe for the collection of a good-quality semen sample, via urethral catheterisation, in domestic cats. It can therefore be used as an alternative to previous medetomidine-based sedation protocols.

Assessment of Healthcare Worker Protocol Deviations and Self-Contamination During Personal Protective Equipment Donning and Doffing.

PubMed

Kwon, Jennie H; Burnham, Carey-Ann D; Reske, Kimberly A; Liang, Stephen Y; Hink, Tiffany; Wallace, Meghan A; Shupe, Angela; Seiler, Sondra; Cass, Candice; Fraser, Victoria J; Dubberke, Erik R

2017-09-01

OBJECTIVE To evaluate healthcare worker (HCW) risk of self-contamination when donning and doffing personal protective equipment (PPE) using fluorescence and MS2 bacteriophage. DESIGN Prospective pilot study. SETTING Tertiary-care hospital. PARTICIPANTS A total of 36 HCWs were included in this study: 18 donned/doffed contact precaution (CP) PPE and 18 donned/doffed Ebola virus disease (EVD) PPE. INTERVENTIONS HCWs donned PPE according to standard protocols. Fluorescent liquid and MS2 bacteriophage were applied to HCWs. HCWs then doffed their PPE. After doffing, HCWs were scanned for fluorescence and swabbed for MS2. MS2 detection was performed using reverse transcriptase PCR. The donning and doffing processes were videotaped, and protocol deviations were recorded. RESULTS Overall, 27% of EVD PPE HCWs and 50% of CP PPE HCWs made ≥1 protocol deviation while donning, and 100% of EVD PPE HCWs and 67% of CP PPE HCWs made ≥1 protocol deviation while doffing (P=.02). The median number of doffing protocol deviations among EVD PPE HCWs was 4, versus 1 among CP PPE HCWs. Also, 15 EVD PPE protocol deviations were committed by doffing assistants and/or trained observers. Fluorescence was detected on 8 EVD PPE HCWs (44%) and 5 CP PPE HCWs (28%), most commonly on hands. MS2 was recovered from 2 EVD PPE HCWs (11%) and 3 CP PPE HCWs (17%). CONCLUSIONS Protocol deviations were common during both EVD and CP PPE doffing, and some deviations during EVD PPE doffing were committed by the HCW doffing assistant and/or the trained observer. Self-contamination was common. PPE donning/doffing are complex and deserve additional study. Infect Control Hosp Epidemiol 2017;38:1077-1083.

40 CFR 792.130 - Conduct of a study.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 32 2011-07-01 2011-07-01 false Conduct of a study. 792.130 Section... ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Protocol for and Conduct of A Study § 792.130 Conduct of a study. (a) The study shall be conducted in accordance with the protocol. (b) The test systems...

Effects of a Short Drilling Implant Protocol on Osteotomy Site Temperature and Drill Torque.

PubMed

Mihali, Sorin G; Canjau, Silvana; Cernescu, Anghel; Bortun, Cristina M; Wang, Hom-Lay; Bratu, Emanuel

2018-02-01

To establish a protocol for reducing the drilling sequence during implant site preparation based on temperature and insertion torque. The traditional conventional drilling sequence (used several drills with 0.6-mm increment each time) was compared with the proposed short drilling protocol (only used 2 drills: initial and final drill). One hundred drilling osteotomies were performed in bovine and porcine bones. Sets of 2 osteotomy sites were created in 5 bone densities using 2 types of drilling protocols. Thermographic pictures were captured throughout all drilling procedures and analyzed using ThermaCAM Researcher Professional 2.10. Torque values were determined during drilling by measuring electrical input and drill speed. There were statistically significant differences in bone temperature between the conventional and short drilling protocols during implant site preparation (analysis of variance P = 0.0008). However, there were no significant differences between the 2 types of drilling protocols for both implant diameters. Implant site preparation time was significantly reduced when using the short drilling protocol compared with the conventional drilling protocol (P < 0.001). Within the limitations of the study, the short drilling protocol proposed herein may represent a safe approach for implant site preparation.

Detailed analysis of routing protocols with different network limitations

NASA Astrophysics Data System (ADS)

Masood, Mohsin; Abuhelala, Mohamed; Glesk, Ivan

2016-12-01

In network communication field, routing protocols have got a significant role which are not only used in networks to handle the user data but also to monitor the different network environments. Dynamic routing protocols such as OSPF, EIGRP and RIP are used for forwarding user data to its destination by instantly detecting the dynamic changes across the network. The dynamic changes in the network can be in the form of topological changes, congestions, links failure etc. Therefore, it becomes a challenge to develop and implement dynamic routing protocols that fulfills the network requirements. Hence, each routing protocol has its own characteristics such as convergence activity, routing metric, routing table etc. and will perform differently in various network environments. This paper presents a comprehensive study of static and dynamic routing, along with dynamic routing protocols. Experiments that are conducted under various network limitations are presented using the OPNET tool. The performance of each of dynamic routing protocols are monitored and explained in the form of simulated results using network parameters. The results are analyzed, in order to provide a clear understanding of each protocol performance for the selection of the proper protocol for a given network environment.

Deterministic generation of remote entanglement with active quantum feedback

DOE PAGES

Martin, Leigh; Motzoi, Felix; Li, Hanhan; ...

2015-12-10

We develop and study protocols for deterministic remote entanglement generation using quantum feedback, without relying on an entangling Hamiltonian. In order to formulate the most effective experimentally feasible protocol, we introduce the notion of average-sense locally optimal feedback protocols, which do not require real-time quantum state estimation, a difficult component of real-time quantum feedback control. We use this notion of optimality to construct two protocols that can deterministically create maximal entanglement: a semiclassical feedback protocol for low-efficiency measurements and a quantum feedback protocol for high-efficiency measurements. The latter reduces to direct feedback in the continuous-time limit, whose dynamics can bemore » modeled by a Wiseman-Milburn feedback master equation, which yields an analytic solution in the limit of unit measurement efficiency. Our formalism can smoothly interpolate between continuous-time and discrete-time descriptions of feedback dynamics and we exploit this feature to derive a superior hybrid protocol for arbitrary nonunit measurement efficiency that switches between quantum and semiclassical protocols. Lastly, we show using simulations incorporating experimental imperfections that deterministic entanglement of remote superconducting qubits may be achieved with current technology using the continuous-time feedback protocol alone.« less

Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory.

PubMed

Hróbjartsson, Asbjørn; Pildal, Julie; Chan, An-Wen; Haahr, Mette T; Altman, Douglas G; Gøtzsche, Peter C

2009-09-01

To compare the reporting on blinding in protocols and articles describing randomized controlled trials. We studied 73 protocols of trials approved by the scientific/ethical committees for Copenhagen and Frederiksberg, 1994 and 1995, and their corresponding publications. Three out of 73 trials (4%) reported blinding in the protocol that contradicted that in the publication (e.g., "open" vs. "double blind"). The proportion of "double-blind" trials with a clear description of the blinding of participants increased from 11 out of 58 (19%) when based on publications alone to 39 (67%) when adding the information in the protocol. The similar proportions for the blinding of health care providers were 2 (3%) and 22 (38%); and for the blinding of data collectors, they were 8 (14%) and 14 (24%). In 52 of 58 publications (90%), it was unclear whether all patients, health care providers, and data collectors had been blinded. In 4 of the 52 trials (7%), the protocols clarified that all three key trial persons had been blinded. The reporting on blinding in both trial protocols and publications is often inadequate. We suggest developing international guidelines for the reporting of trial protocols and public access to protocols.

Actions of the fall prevention protocol: mapping with the classification of nursing interventions.

PubMed

Alves, Vanessa Cristina; Freitas, Weslen Carlos Junior de; Ramos, Jeferson Silva; Chagas, Samantha Rodrigues Garbis; Azevedo, Cissa; Mata, Luciana Regina Ferreira da

2017-12-21

to analyze the correspondence between the actions contained in the fall prevention protocol of the Ministry of Health and the Nursing Interventions Classification (NIC) by a cross-mapping. this is a descriptive study carried out in four stages: protocol survey, identification of NIC interventions related to nursing diagnosis, the risk of falls, cross-mapping, and validation of the mapping from the Delphi technique. there were 51 actions identified in the protocol and 42 interventions in the NIC. Two rounds of mapping evaluation were carried out by the experts. There were 47 protocol actions corresponding to 25 NIC interventions. The NIC interventions that presented the highest correspondence with protocol actions were: fall prevention, environmental-safety control, and risk identification. Regarding the classification of similarity and comprehensiveness of the 47 actions of the protocol mapped, 44.7% were considered more detailed and specific than the NIC, 29.8% less specific than the NIC and 25.5% were classified as similar in significance to the NIC. most of the actions contained in the protocol are more specific and detailed, however, the NIC contemplates a greater diversity of interventions and may base a review of the protocol to increase actions related to falls prevention..

Development of Next Generation Energy Audit Protocols for the Rapid and Advanced Analysis of Building Energy Use

NASA Astrophysics Data System (ADS)

Hartley, Christopher Ahlvin

Current building energy auditing techniques are outdated and lack targeted, actionable information. These analyses only use one year's worth of monthly electricity and gas bills to define energy conservation and efficiency measures. These limited data sets cannot provide robust, directed energy reduction recommendations. The need is apparent for an overhaul of existing energy audit protocols to utilize all data that is available from the building's utility provider, installed energy management system (EMS), and sub-metering devices. This thesis analyzed the current state-of-the-art in energy audits, generated a next generation energy audit protocol, and conducted both audits types on four case study buildings to find out what additional information can be obtained from additional data sources and increased data gathering resolutions. Energy data from each case study building were collected using a variety of means including utility meters, whole building energy meters, EMS systems, and sub-metering devices. In addition to conducting an energy analysis for each case study building using the current and next generation energy audit protocols, two building energy models were created using the programs eQuest and EnergyPlus. The current and next generation energy audit protocol results were compared to one another upon completion. The results show that using the current audit protocols, only variations in season are apparent. Results from the developed next generation energy audit protocols show that in addition to seasonal variations, building heating, ventilation and air conditioning (HVAC) schedules, occupancy schedules, baseline and peak energy demand levels, and malfunctioning equipment can be found. This new protocol may also be used to quickly generate accurate building models because of the increased resolution that yields scheduling information. The developed next generation energy auditing protocol is scalable and can work for many building types across the United States, and perhaps the world.

Combination Protocol of Low-Frequency rTMS and Intensive Occupational Therapy for Post-stroke Upper Limb Hemiparesis: a 6-year Experience of More Than 1700 Japanese Patients.

PubMed

Kakuda, Wataru; Abo, Masahiro; Sasanuma, Jinichi; Shimizu, Masato; Okamoto, Takatsugu; Kimura, Chikou; Kakita, Kiyohito; Hara, Hiroyoshi

2016-06-01

Several years ago, we proposed a combination protocol of repetitive transcranial magnetic stimulation (rTMS) and intensive occupational therapy (OT) for upper limb hemiparesis after stroke. Subsequently, the number of patients treated with the protocol has increased in Japan. We aimed to present the latest data on our proposed combination protocol for post-stroke upper limb hemiparesis as a result of a multi-institutional study. After confirming that a patient met the inclusion criteria for the protocol, they were scheduled to receive the 15-day inpatient protocol. In the protocol, two sessions of 20-min rTMS and 120-min occupational therapy were provided daily, except for Sundays and the days of admission/discharge. Motor function of the affected upper limb was evaluated by the Fugl-Meyer assessment (FMA) and Wolf motor function test (WMFT) at admission/discharge and at 4 weeks after discharge if possible. A total of 1725 post-stroke patients were studied (mean age at admission 61.4 ± 13.0 years). The scheduled 15-day protocol was completed by all patients. At discharge, the increase in FMA score, shortening in performance time of WMFT, and increase in functional ability scale (FAS) score of WMFT were significant (FMA score 46.8 ± 12.2 to 50.9 ± 11.4 points, p < 0.001; performance time of WMFT 2.57 ± 1.32 to 2.21 ± 1.33, p < 0.001; FAS score of WMFT 47.4 ± 14. to 51.4 ± 14.3 points, p < 0.001). Our proposed combination protocol can be a potentially safe and useful therapeutic intervention for upper limb hemiparesis after stroke, although its efficacy should be confirmed in a randomized controlled study.

Protocolized fluid therapy in brain-dead donors: The multi-center randomized MOnIToR trial

PubMed Central

Al-Khafaji, Ali; Elder, Michele; Lebovitz, Daniel J; Murugan, Raghavan; Souter, Michael; Stuart, Susan; Wahed, Abdus S.; Keebler, Ben; Dils, Dorrie; Mitchell, Stephanie; Shutterly, Kurt; Wilkerson, Dawn; Pearse, Rupert; Kellum, John A

2015-01-01

BACKGROUND Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multi-center randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases organs transplanted. METHODS We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A “protocol-guided fluid therapy” algorithm targeting cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor and our primary analysis was intention-to-treat. Secondary analyses included: 1) modified intention-to-treat where only subjects able to receive the intervention were included, and 2) twelve-month survival in transplant recipients. The study was stopped early. RESULTS We enrolled 556 donors; 279 protocolized care, 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76% of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor, (95%CI: 3.14-3.63) with protocolized care, compared to usual care 3.29 (95%CI: 3.04-3.54) (mean difference, 0.1, 95%CI: -0.25 to 0.45; p=0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95%CI: 3.23-3.8) but was not statistically significant (mean difference, 0.23, 95%CI: -0.15-0.61; p=0.23). Among the 1430 recipients of organs from study subjects, with data available, 56 deaths (7.8%) occurred in the protocolized care arm and 56 (7.9%) in the usual care arm in the first year (Hazard Ratio: 0.97, p=0.86). CONCLUSIONS In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor. PMID:25583616

A New Cellular Architecture for Information Retrieval from Sensor Networks through Embedded Service and Security Protocols

PubMed Central

Shahzad, Aamir; Landry, René; Lee, Malrey; Xiong, Naixue; Lee, Jongho; Lee, Changhoon

2016-01-01

Substantial changes have occurred in the Information Technology (IT) sectors and with these changes, the demand for remote access to field sensor information has increased. This allows visualization, monitoring, and control through various electronic devices, such as laptops, tablets, i-Pads, PCs, and cellular phones. The smart phone is considered as a more reliable, faster and efficient device to access and monitor industrial systems and their corresponding information interfaces anywhere and anytime. This study describes the deployment of a protocol whereby industrial system information can be securely accessed by cellular phones via a Supervisory Control And Data Acquisition (SCADA) server. To achieve the study goals, proprietary protocol interconnectivity with non-proprietary protocols and the usage of interconnectivity services are considered in detail. They support the visualization of the SCADA system information, and the related operations through smart phones. The intelligent sensors are configured and designated to process real information via cellular phones by employing information exchange services between the proprietary protocol and non-proprietary protocols. SCADA cellular access raises the issue of security flaws. For these challenges, a cryptography-based security method is considered and deployed, and it could be considered as a part of a proprietary protocol. Subsequently, transmission flows from the smart phones through a cellular network. PMID:27314351

Robot training of upper limb in multiple sclerosis: comparing protocols with or without manipulative task components.

PubMed

Carpinella, Ilaria; Cattaneo, Davide; Bertoni, Rita; Ferrarin, Maurizio

2012-05-01

In this pilot study, we compared two protocols for robot-based rehabilitation of upper limb in multiple sclerosis (MS): a protocol involving reaching tasks (RT) requiring arm transport only and a protocol requiring both objects' reaching and manipulation (RMT). Twenty-two MS subjects were assigned to RT or RMT group. Both protocols consisted of eight sessions. During RT training, subjects moved the handle of a planar robotic manipulandum toward circular targets displayed on a screen. RMT protocol required patients to reach and manipulate real objects, by moving the robotic arm equipped with a handle which left the hand free for distal tasks. In both trainings, the robot generated resistive and perturbing forces. Subjects were evaluated with clinical and instrumental tests. The results confirmed that MS patients maintained the ability to adapt to the robot-generated forces and that the rate of motor learning increased across sessions. Robot-therapy significantly reduced arm tremor and improved arm kinematics and functional ability. Compared to RT, RMT protocol induced a significantly larger improvement in movements involving grasp (improvement in Grasp ARAT sub-score: RMT 77.4%, RT 29.5%, p=0.035) but not precision grip. Future studies are needed to evaluate if longer trainings and the use of robotic handles would significantly improve also fine manipulation.

A New Cellular Architecture for Information Retrieval from Sensor Networks through Embedded Service and Security Protocols.

PubMed

Shahzad, Aamir; Landry, René; Lee, Malrey; Xiong, Naixue; Lee, Jongho; Lee, Changhoon

2016-06-14

Substantial changes have occurred in the Information Technology (IT) sectors and with these changes, the demand for remote access to field sensor information has increased. This allows visualization, monitoring, and control through various electronic devices, such as laptops, tablets, i-Pads, PCs, and cellular phones. The smart phone is considered as a more reliable, faster and efficient device to access and monitor industrial systems and their corresponding information interfaces anywhere and anytime. This study describes the deployment of a protocol whereby industrial system information can be securely accessed by cellular phones via a Supervisory Control And Data Acquisition (SCADA) server. To achieve the study goals, proprietary protocol interconnectivity with non-proprietary protocols and the usage of interconnectivity services are considered in detail. They support the visualization of the SCADA system information, and the related operations through smart phones. The intelligent sensors are configured and designated to process real information via cellular phones by employing information exchange services between the proprietary protocol and non-proprietary protocols. SCADA cellular access raises the issue of security flaws. For these challenges, a cryptography-based security method is considered and deployed, and it could be considered as a part of a proprietary protocol. Subsequently, transmission flows from the smart phones through a cellular network.

Is it really good to talk? Testing the impact of providing concurrent verbal protocols on driving performance.

PubMed

Salmon, Paul Matthew; Goode, Natassia; Spiertz, Antje; Thomas, Miles; Grant, Eryn; Clacy, Amanda

2017-06-01

Questions have been raised regarding the impact that providing concurrent verbal protocols has on task performance in various settings; however, there has been little empirical testing of this in road transport. The aim of this study was to examine the impact of providing concurrent verbal protocols on driving performance. Participants drove an instrumented vehicle around a set route, twice whilst providing a concurrent verbal protocol, and twice without. A comparison revealed no differences in behaviour related to speed, braking and steering wheel angle when driving mid-block, but a significant difference in aspects of braking and acceleration at roundabouts. When not providing a verbal protocol, participants were found to brake harder on approach to a roundabout and accelerate more heavily coming out of roundabouts. It is concluded that providing verbal protocols may have a positive effect on braking and accelerating. Practical implications related to driver training and future research are discussed. Practitioner Summary: Verbal protocol analysis is used by ergonomists to understand aspects of cognition and decision-making during complex tasks such as driving and control room operation. This study examines the impact that it has on driving performance, providing evidence to support its continued use in ergonomics applications.

A harmonized segmentation protocol for hippocampal and parahippocampal subregions: why do we need one and what are the key goals?

PubMed Central

Olsen, Rosanna K.; Berron, David; Carr, Valerie A.; Stark, Craig E.L.; Amaral, Robert S.C.; Amunts, Katrin; Augustinack, Jean C.; Bender, Andrew R.; Bernstein, Jeffrey D.; Boccardi, Marina; Bocchetta, Martina; Burggren, Alison; Chakravarty, M. Mallar; Chupin, Marie; Ekstrom, Arne; de Flores, Robin; Insausti, Ricardo; Kanel, Prabesh; Kedo, Olga; Kennedy, Kristen M.; Kerchner, Geoffrey A.; LaRocque, Karen F.; Liu, Xiuwen; Maass, Anne; Malykhin, Nicolai; Mueller, Susanne G.; Ofen, Noa; Palombo, Daniela J.; Parekh, Mansi B.; Pluta, John B.; Pruessner, Jens C.; Raz, Naftali; Rodrigue, Karen M.; Schoemaker, Dorothee; Shafer, Andrea T.; Steve, Trevor A.; Suthana, Nanthia; Wang, Lei; Winterburn, Julie L.; Yassa, Michael A.; Yushkevich, Paul A.; la Joie, Renaud

2016-01-01

The advent of high-resolution magnetic resonance imaging (MRI) has enabled in vivo research in a variety of populations and diseases on the structure and function of hippocampal subfields and subdivisions of the parahippocampal gyrus. Due to the many extant and highly discrepant segmentation protocols, comparing results across studies is difficult. To overcome this barrier, the Hippocampal Subfields Group was formed as an international collaboration with the aim of developing a harmonized protocol for manual segmentation of hippocampal and parahippocampal subregions on high-resolution MRI. In this commentary we discuss the goals for this protocol and the associated key challenges involved in its development. These include differences among existing anatomical reference materials, striking the right balance between reliability of measurements and anatomical validity, and the development of a versatile protocol that can be adopted for the study of populations varying in age and health. The commentary outlines these key challenges, as well as the proposed solution of each, with concrete examples from our working plan. Finally, with two examples, we illustrate how the harmonized protocol, once completed, is expected to impact the field by producing measurements that are quantitatively comparable across labs and by facilitating the synthesis of findings across different studies. PMID:27862600

A comparison of maximal bioenergetic enzyme activities obtained with commonly used homogenization techniques.

PubMed

Grace, M; Fletcher, L; Powers, S K; Hughes, M; Coombes, J

1996-12-01

Homogenization of tissue for analysis of bioenergetic enzyme activities is a common practice in studies examining metabolic properties of skeletal muscle adaptation to disease, aging, inactivity or exercise. While numerous homogenization techniques are in use today, limited information exists concerning the efficacy of specific homogenization protocols. Therefore, the purpose of this study was to compare the efficacy of four commonly used approaches to homogenizing skeletal muscle for analysis of bioenergetic enzyme activity. The maximal enzyme activity (Vmax) of citrate synthase (CS) and lactate dehydrogenase (LDH) were measured from homogenous muscle samples (N = 48 per homogenization technique) and used as indicators to determine which protocol had the highest efficacy. The homogenization techniques were: (1) glass-on-glass pestle; (2) a combination of a mechanical blender and a teflon pestle (Potter-Elvehjem); (3) a combination of the mechanical blender and a biological detergent; and (4) the combined use of a mechanical blender and a sonicator. The glass-on-glass pestle homogenization protocol produced significantly higher (P < 0.05) enzyme activities compared to all other protocols for both enzymes. Of the four protocols examined, the data demonstrate that the glass-on-glass pestle homogenization protocol is the technique of choice for studying bioenergetic enzyme activity in skeletal muscle.

Use of the HR index to predict maximal oxygen uptake during different exercise protocols.

PubMed

Haller, Jeannie M; Fehling, Patricia C; Barr, David A; Storer, Thomas W; Cooper, Christopher B; Smith, Denise L

2013-10-01

This study examined the ability of the HRindex model to accurately predict maximal oxygen uptake ([Formula: see text]O2max) across a variety of incremental exercise protocols. Ten men completed five incremental protocols to volitional exhaustion. Protocols included three treadmill (Bruce, UCLA running, Wellness Fitness Initiative [WFI]), one cycle, and one field (shuttle) test. The HRindex prediction equation (METs = 6 × HRindex - 5, where HRindex = HRmax/HRrest) was used to generate estimates of energy expenditure, which were converted to body mass-specific estimates of [Formula: see text]O2max. Estimated [Formula: see text]O2max was compared with measured [Formula: see text]O2max. Across all protocols, the HRindex model significantly underestimated [Formula: see text]O2max by 5.1 mL·kg(-1)·min(-1) (95% CI: -7.4, -2.7) and the standard error of the estimate (SEE) was 6.7 mL·kg(-1)·min(-1). Accuracy of the model was protocol-dependent, with [Formula: see text]O2max significantly underestimated for the Bruce and WFI protocols but not the UCLA, Cycle, or Shuttle protocols. Although no significant differences in [Formula: see text]O2max estimates were identified for these three protocols, predictive accuracy among them was not high, with root mean squared errors and SEEs ranging from 7.6 to 10.3 mL·kg(-1)·min(-1) and from 4.5 to 8.0 mL·kg(-1)·min(-1), respectively. Correlations between measured and predicted [Formula: see text]O2max were between 0.27 and 0.53. Individual prediction errors indicated that prediction accuracy varied considerably within protocols and among participants. In conclusion, across various protocols the HRindex model significantly underestimated [Formula: see text]O2max in a group of aerobically fit young men. Estimates generated using the model did not differ from measured [Formula: see text]O2max for three of the five protocols studied; nevertheless, some individual prediction errors were large. The lack of precision among estimates may limit the utility of the HRindex model; however, further investigation to establish the model's predictive accuracy is warranted.

An Enhanced LoRaWAN Security Protocol for Privacy Preservation in IoT with a Case Study on a Smart Factory-Enabled Parking System.

PubMed

You, Ilsun; Kwon, Soonhyun; Choudhary, Gaurav; Sharma, Vishal; Seo, Jung Taek

2018-06-08

The Internet of Things (IoT) utilizes algorithms to facilitate intelligent applications across cities in the form of smart-urban projects. As the majority of devices in IoT are battery operated, their applications should be facilitated with a low-power communication setup. Such facility is possible through the Low-Power Wide-Area Network (LPWAN), but at a constrained bit rate. For long-range communication over LPWAN, several approaches and protocols are adopted. One such protocol is the Long-Range Wide Area Network (LoRaWAN), which is a media access layer protocol for long-range communication between the devices and the application servers via LPWAN gateways. However, LoRaWAN comes with fewer security features as a much-secured protocol consumes more battery because of the exorbitant computational overheads. The standard protocol fails to support end-to-end security and perfect forward secrecy while being vulnerable to the replay attack that makes LoRaWAN limited in supporting applications where security (especially end-to-end security) is important. Motivated by this, an enhanced LoRaWAN security protocol is proposed, which not only provides the basic functions of connectivity between the application server and the end device, but additionally averts these listed security issues. The proposed protocol is developed with two options, the Default Option (DO) and the Security-Enhanced Option (SEO). The protocol is validated through Burrows⁻Abadi⁻Needham (BAN) logic and the Automated Validation of Internet Security Protocols and Applications (AVISPA) tool. The proposed protocol is also analyzed for overheads through system-based and low-power device-based evaluations. Further, a case study on a smart factory-enabled parking system is considered for its practical application. The results, in terms of network latency with reliability fitting and signaling overheads, show paramount improvements and better performance for the proposed protocol compared with the two handshake options, Pre-Shared Key (PSK) and Elliptic Curve Cryptography (ECC), of Datagram Transport Layer Security (DTLS).

NASA Exercise Physiology and Countermeasures Project Overview

NASA Technical Reports Server (NTRS)

Loerch, Linda; Ploutz-Snyder, Lori

2009-01-01

Efficient exercise countermeasures are necessary to offset or minimize spaceflight-induced deconditioning and to maximize crew performance of mission tasks. These countermeasure protocols should use the fewest crew and vehicle resources. NASA s Exercise Physiology and Countermeasures (ExPC) Project works to identify, collect, interpret, and summarize evidence that results in effective exercise countermeasure protocols which protect crew health and performance during International Space Station (ISS) and future exploration-class missions. The ExPC and NASA s Human Research Program are sponsoring multiple studies to evaluate and improve the efficacy of spaceflight exercise countermeasures. First, the Project will measure maximal aerobic capacity (VO2max) during cycle ergometry before, during, and after ISS missions. Second, the Project is sponsoring an evaluation of a new prototype harness that offers improved comfort and increased loading during treadmill operations. Third, the Functional Tasks Test protocol will map performance of anticipated lunar mission tasks with physiologic systems before and after short and long-duration spaceflight, to target system contributions and the tailoring of exercise protocols to maximize performance. In addition to these studies that are actively enrolling crewmember participants, the ExPC is planning new studies that include an evaluation of a higher-intensity/lower-volume exercise countermeasure protocol aboard the ISS using the Advanced Resistive Exercise Device and second-generation treadmill, studies that evaluate bone loading during spaceflight exercise, and ground-based studies that focus on fitness for duty standards required to complete lunar mission tasks and for which exercise protocols need to protect. Summaries of these current and future studies and strategies will be provided to international colleagues for knowledge sharing and possible collaboration.

40 CFR 160.130 - Conduct of a study.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Conduct of a study. 160.130 Section... LABORATORY PRACTICE STANDARDS Protocol for and Conduct of a Study § 160.130 Conduct of a study. (a) The study... conformity with the protocol. (c) Specimens shall be identified by test system, study, nature, and date of...

40 CFR 160.130 - Conduct of a study.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Conduct of a study. 160.130 Section... LABORATORY PRACTICE STANDARDS Protocol for and Conduct of a Study § 160.130 Conduct of a study. (a) The study... conformity with the protocol. (c) Specimens shall be identified by test system, study, nature, and date of...

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.

A pilot investigation to optimise methods for a future satiety preload study.

PubMed

Hobden, Mark R; Guérin-Deremaux, Laetitia; Commane, Daniel M; Rowland, Ian; Gibson, Glenn R; Kennedy, Orla B

2017-01-01

Preload studies are used to investigate the satiating effects of foods and food ingredients. However, the design of preload studies is complex, with many methodological considerations influencing appetite responses. The aim of this pilot investigation was to determine acceptability, and optimise methods, for a future satiety preload study. Specifically, we investigated the effects of altering (i) energy intake at a standardised breakfast (gender-specific or non-gender specific), and (ii) the duration between mid-morning preload and ad libitum lunch meal, on morning appetite scores and energy intake at lunch. Participants attended a single study visit. Female participants consumed a 214-kcal breakfast ( n  = 10) or 266-kcal breakfast ( n  = 10), equivalent to 10% of recommended daily energy intakes for females and males, respectively. Male participants ( n  = 20) consumed a 266-kcal breakfast. All participants received a 250-ml orange juice preload 2 h after breakfast. The impact of different study timings was evaluated in male participants, with 10 males following one protocol (protocol 1) and 10 males following another (protocol 2). The duration between preload and ad libitum lunch meal was 2 h (protocol 1) or 2.5 h (protocol 2), with the ad libitum lunch meal provided at 12.00 or 13.00, respectively. All female participants followed protocol 2. Visual analogue scale (VAS) questionnaires were used to assess appetite responses and food/drink palatability. Correlation between male and female appetite scores was higher with the provision of a gender-specific breakfast, compared to non-gender-specific breakfast (Pearson correlation of 0.747 and 0.479, respectively). No differences in subjective appetite or ad libitum energy intake were found between protocols 1 and 2. VAS mean ratings of liking, enjoyment, and palatability were all > 66 out of 100 mm for breakfast, preload, and lunch meals. The findings of this pilot study confirm the acceptability of this methodology for future satiety preload studies. Appetite scores increased from preload to ad libitum lunch meal; however, no specific differences were found between protocols. The results highlight the importance of considering energy intake prior to preload provision, with a gender-specific breakfast improving the correlation between male and female appetite score responses to a morning preload.

U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY--LIST OF STANDARD OPERATING PROCEDURES

EPA Science Inventory

This document lists available protocols and SOPs for the U.S.-Mexico Border Program study. It identifies protocols and SOPs for the following study components: (1) Sample collection and field operations, (2) Sample analysis, (3) General laboratory procedures, (4) Quality Assuranc...

Comparison of Calculation and Experiment Implicates Significant Electrostatic Contributions to the Binding Stability of Barnase and Barstar

PubMed Central

Dong, Feng; Vijayakumar, M.; Zhou, Huan-Xiang

2003-01-01

The contributions of electrostatic interactions to the binding stability of barnase and barstar were studied by the Poisson-Boltzmann model with three different protocols: a), the dielectric boundary specified as the van der Waals (vdW) surface of the protein along with a protein dielectric constant (ɛp) of 4; b), the dielectric boundary specified as the molecular (i.e., solvent-exclusion (SE)) surface along with ɛp = 4; and c), “SE + ɛp = 20.” The “vdW + ɛp = 4” and “SE + ɛp = 20” protocols predicted an overall electrostatic stabilization whereas the “SE + ɛp = 4” protocol predicted an overall electrostatic destabilization. The “vdW + ɛp = 4” protocol was most consistent with experiment. It quantitatively reproduced the observed effects of 17 mutations neutralizing charged residues lining the binding interface and the measured coupling energies of six charge pairs across the interface and reasonably rationalized the experimental ionic strength and pH dependences of the binding constant. In contrast, the “SE + ɛp = 4” protocol predicted significantly larger coupling energies of charge pairs whereas the “SE + ɛp = 20” protocol did not predict any pH dependence. This study calls for further scrutiny of the different Poisson-Boltzmann protocols and demonstrates potential danger in drawing conclusions on electrostatic contributions based on a particular calculation protocol. PMID:12829463

An investigation into the bacterial contamination of goniolenses in use in clinical practice.

PubMed

Grundon, Rachael; Scurrell, Emma; Mould, John; Hayton-Lee, Emma; Heinrich, Christine

2017-12-18

Objectives To report the incidence and evaluate the clinical significance of goniolens bacterial contamination in clinical use in dogs with three different usage protocols and one with an added cleaning protocol. Animals Studied and Methods Three groups of twenty dogs undergoing gonioscopy at a private practice in the UK had the goniolenses swabbed for bacteriology culture and identification prior to placement on the cornea. Three protocols of lens use, with 2 different types of goniolens, were studied. One protocol was then repeated with 21 dogs with a lens cleaning protocol prior to storage. Results Low levels of bacterial contamination were found in all 3 initial groups (10-15%). No correlation was found between usage protocol used and rate of contamination and no correlation was found between length of storage between use and contamination. All bacteria cultured were considered naturally occurring commensals for the canine eye and environment. The group with a cleaning protocol had a 4.7% contamination rate. This was not statistically different from the non-cleaning groups. Conclusions The rate of bacterial contamination of goniolenses in clinical practice is low and the bacterial contaminants consist of commensal bacteria, unlikely to be of detriment to the eye. Minimal contamination of the goniolenses was found and this did not appear to be of clinical significance. The introduction of a simple cleaning protocol did not produce a statistically significant reduction in bacterial contamination. © 2017 American College of Veterinary Ophthalmologists.

Influence of lead apron shielding on absorbed doses from panoramic radiography

PubMed Central

Rottke, D; Grossekettler, L; Sawada, K; Poxleitner, P; Schulze, D

2013-01-01

Objectives: This study investigated the absorbed doses in a full anthropomorphic body phantom from two different panoramic radiography devices, performing protocols with and without applying a lead apron. Methods: A RANDO® full body phantom (Alderson Research Laboratories Inc., Stamford, CT) was equipped with 110 thermoluminescent dosemeters at 55 different sites and set up in two different panoramic radiography devices [SCANORA® three-dimensional (3D) (SOREDEX, Tuusula, Finland) and ProMax® 3D (Planmeca, Helsinki, Finland)] and exposed. Two different protocols were performed in the two devices. The first protocol was performed without any lead shielding, whereas the phantom was equipped with a standard adult lead apron for the second protocol. Results: A two-tailed paired samples t-test for the SCANORA 3D revealed that there is no difference between the protocol using lead apron shielding (m = 87.99, s = 102.98) and the protocol without shielding (m = 87.34, s = 107.49), t(54) = −0.313, p > 0.05. The same test for the ProMax 3D showed that there is also no difference between the protocol using shielding (m = 106.48, s = 117.38) and the protocol without shielding (m = 107.75, s = 114,36), t(54) = 0.938, p > 0.05. Conclusions: In conclusion, the results of this study showed no statistically significant differences between a panoramic radiography with or without the use of lead apron shielding. PMID:24174012

Influence of lead apron shielding on absorbed doses from panoramic radiography.

PubMed

Rottke, D; Grossekettler, L; Sawada, K; Poxleitner, P; Schulze, D

2013-01-01

This study investigated the absorbed doses in a full anthropomorphic body phantom from two different panoramic radiography devices, performing protocols with and without applying a lead apron. A RANDO(®) full body phantom (Alderson Research Laboratories Inc., Stamford, CT) was equipped with 110 thermoluminescent dosemeters at 55 different sites and set up in two different panoramic radiography devices [SCANORA(®) three-dimensional (3D) (SOREDEX, Tuusula, Finland) and ProMax(®) 3D (Planmeca, Helsinki, Finland)] and exposed. Two different protocols were performed in the two devices. The first protocol was performed without any lead shielding, whereas the phantom was equipped with a standard adult lead apron for the second protocol. A two-tailed paired samples t-test for the SCANORA 3D revealed that there is no difference between the protocol using lead apron shielding (m = 87.99, s = 102.98) and the protocol without shielding (m = 87.34, s = 107.49), t(54) = -0.313, p > 0.05. The same test for the ProMax 3D showed that there is also no difference between the protocol using shielding (m = 106.48, s = 117.38) and the protocol without shielding (m = 107.75, s = 114,36), t(54) = 0.938, p > 0.05. In conclusion, the results of this study showed no statistically significant differences between a panoramic radiography with or without the use of lead apron shielding.

Influence of lead apron shielding on absorbed doses from panoramic radiography.

PubMed

Rottke, D; Grossekettler, L; Sawada, K; Poxleitner, P; Schulze, D

2013-01-01

This study investigated the absorbed doses in a full anthropomorphic body phantom from two different panoramic radiography devices, performing protocols with and without applying a lead apron. A RANDO® full body phantom (Alderson Research Laboratories Inc., Stamford, CT) was equipped with 110 thermoluminescent dosemeters at 55 different sites and set up in two different panoramic radiography devices [SCANORA® three-dimensional (3D) (SOREDEX, Tuusula, Finland) and ProMax® 3D (Planmeca, Helsinki, Finland)] and exposed. Two different protocols were performed in the two devices. The first protocol was performed without any lead shielding, whereas the phantom was equipped with a standard adult lead apron for the second protocol. A two-tailed paired samples t-test for the SCANORA 3D revealed that there is no difference between the protocol using lead apron shielding (m = 87.99, s = 102.98) and the protocol without shielding (m = 87.34, s = 107.49), t(54) = −0.313, p > 0.05. The same test for the ProMax 3D showed that there is also no difference between the protocol using shielding (m = 106.48, s = 117.38) and the protocol without shielding (m = 107.75, s = 114,36), t(54) = 0.938, p > 0.05. In conclusion, the results of this study showed no statistically significant differences between a panoramic radiography with or without the use of lead apron shielding.

Delta Alert: Expanding Gerotrauma Criteria to Improve Patient Outcomes: A 2-Year Study.

PubMed

Wiles, Lynn L; Day, Mark D

Because of their decreased physical reserve and increased risk of complications, the geriatric trauma patient (GTP) population warrants heightened awareness by clinical staff. The purpose of this study is to determine whether the institution of a third-tier trauma protocol results in a change in GTP outcomes, complications, and mortality rates. Researchers conducted a retrospective review of 2 years of data from the trauma registry, hospital quality improvement audits, and patient charts to examine what, if any, patient outcomes were impacted by the institution of the expanded GTP protocol. Sample homogeneity was determined. Emergency department (ED) length of stay and time to the operating room decreased in the protocol cohort. The rate of complications decreased from 16.4% preprotocol to 1.6% postprotocol. Discharge to home rates in the GTP population improved from 31% preprotocol to nearly 77% postimplementation of the protocol. The expanded GTP protocol front loads evaluation and resuscitation to be consistent with ED trauma protocols already in place. By fast-tracking radiology and laboratory testing, patients injuries are identified and the appropriate consultations are initiated. Appropriate inpatient nursing unit placement is identified or treatment and discharge from the ED are expedited. The expanded GTP protocol provided early and comprehensive evaluation and interventions for GTPs who fall outside of traditional trauma alert criteria. Patients spend less time in the ED and the hospital. Patients had decreased length of stay in the ED, less complications, and return to home rates showed significant improvement after the protocol was implemented.

[PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study].

PubMed

Nydahl, P; Diers, A; Günther, U; Haastert, B; Hesse, S; Kerschensteiner, C; Klarmann, S; Köpke, S

2017-10-12

Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.

An Efficient and Reproducible Protocol for Distraction Osteogenesis in a Rat Model Leading to a Functional Regenerated Femur.

PubMed

Pithioux, Martine; Roseren, Flavy; Jalain, Christian; Launay, Franck; Charpiot, Philippe; Chabrand, Patrick; Roffino, Sandrine; Lamy, Edouard

2017-10-23

This protocol describes the use of a newly developed external fixator for distraction osteogenesis in a rat femoral model. Distraction osteogenesis (DO) is a surgical technique leading to bone regeneration after an osteotomy. The osteotomized extremities are moved away from each other by gradual distraction to reach the desired elongation. This procedure is widely used in humans for lower and upper limb lengthening, treatment after a bone nonunion, or the regeneration of a bone defect following surgery for bone tumor excision, as well as in maxillofacial reconstruction. Only a few studies clearly demonstrate the efficiency of their protocol in obtaining a functional regenerated bone, i.e., bone that will support physiological weight-bearing without fracture after removal of the external fixator. Moreover, protocols for DO vary and reproducibility is limited by lack of information, making comparison between studies difficult. The aim of this study was to develop a reproducible protocol comprising an appropriate external fixator design for rat limb lengthening, with a detailed surgical technique that permits physiological weight-bearing by the animal after removal of the external fixator.

[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.

Development and implementation of clinical trial protocol templates at the National Institute of Allergy and Infectious Diseases.

PubMed

Bridge, Heather; Smolskis, Mary; Bianchine, Peter; Dixon, Dennis O; Kelly, Grace; Herpin, Betsey; Tavel, Jorge

2009-08-01

A clinical research protocol document must reflect both sound scientific rationale as well as local, national and, when applicable, international regulatory and human subject protections requirements. These requirements originate from a variety of sources, undergo frequent revision and are subject to interpretation. Tools to assist clinical investigators in the production of clinical protocols could facilitate navigating these requirements and ultimately increase the efficiency of clinical research. The National Institute of Allergy and Infectious Diseases (NIAID) developed templates for investigators to serve as the foundation for protocol development. These protocol templates are designed as tools to support investigators in developing clinical protocols. NIAID established a series of working groups to determine how to improve its capacity to conduct clinical research more efficiently and effectively. The Protocol Template Working Group was convened to determine what protocol templates currently existed within NIAID and whether standard NIAID protocol templates should be produced. After review and assessment of existing protocol documents and requirements, the group reached consensus about required and optional content, determined the format and identified methods for distribution as well as education of investigators in the use of these templates. The templates were approved by the NIAID Executive Committee in 2006 and posted as part of the NIAID Clinical Research Toolkit [1] website for broad access. These documents require scheduled revisions to stay current with regulatory and policy changes. The structure of any clinical protocol template, whether comprehensive or specific to a particular study phase, setting or design, affects how it is used by investigators. Each structure presents its own set of advantages and disadvantages. While useful, protocol templates are not stand-alone tools for creating an optimal protocol document, but must be complemented by institutional resources and support. Education and guidance of investigators in the appropriate use of templates is necessary to ensure a complete yet concise protocol document. Due to changing regulatory requirements, clinical protocol templates cannot become static, but require frequent revisions.

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...

EVALUATION OF THE PROTOCOL FOR THE NATURAL ATTENUATION OF CHLORINATED SOLVENTS: CASE STUDY AT THE TWIN CITIES ARMY AMMUNITION PLANT

EPA Science Inventory

At the request of staff in the EPA Regions, EPA?s Office of Research and Development carried out an independent evaluation of the Technical Protocol for Evaluating Natural Attenuation of Chlorinated Solvents in Ground Water (EPA/600/R-98/128). The Protocol was developed around c...

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

Analysis of the contribution of experimental bias, experimental noise, and inter-subject biological variability on the assessment of developmental trajectories in diffusion MRI studies of the brain.

PubMed

Sadeghi, Neda; Nayak, Amritha; Walker, Lindsay; Okan Irfanoglu, M; Albert, Paul S; Pierpaoli, Carlo

2015-04-01

Metrics derived from the diffusion tensor, such as fractional anisotropy (FA) and mean diffusivity (MD) have been used in many studies of postnatal brain development. A common finding of previous studies is that these tensor-derived measures vary widely even in healthy populations. This variability can be due to inherent inter-individual biological differences as well as experimental noise. Moreover, when comparing different studies, additional variability can be introduced by different acquisition protocols. In this study we examined scans of 61 individuals (aged 4-22 years) from the NIH MRI study of normal brain development. Two scans were collected with different protocols (low and high resolution). Our goal was to separate the contributions of biological variability and experimental noise to the overall measured variance, as well as to assess potential systematic effects related to the use of different protocols. We analyzed FA and MD in seventeen regions of interest. We found that biological variability for both FA and MD varies widely across brain regions; biological variability is highest for FA in the lateral part of the splenium and body of the corpus callosum along with the cingulum and the superior longitudinal fasciculus, and for MD in the optic radiations and the lateral part of the splenium. These regions with high inter-individual biological variability are the most likely candidates for assessing genetic and environmental effects in the developing brain. With respect to protocol-related effects, the lower resolution acquisition resulted in higher MD and lower FA values for the majority of regions compared with the higher resolution protocol. However, the majority of the regions did not show any age-protocol interaction, indicating similar trajectories were obtained irrespective of the protocol used. Published by Elsevier Inc.

A comparison of sennosides-based bowel protocols with and without docusate in hospitalized patients with cancer.

PubMed

Hawley, Philippa Helen; Byeon, Jai Jun

2008-05-01

Constipation is a common and distressing condition in patients with cancer, especially those taking opioid analgesics. Many institutions prevent and treat constipation with titrated laxatives, which is known as a bowel protocol. An effective and well-tolerated bowel protocol is a very important component of cancer care, and there is little evidence on which to base selection of the most appropriate agents. This study compares a protocol of the stimulant laxative sennosides alone with a protocol of sennosides plus the stool softener docusate, in hospitalized patients at an oncology center. The docusate-containing protocol had an initial docusate-only step for patients not taking opioids, and four to six 100-mg capsules of docusate sodium in addition to the sennosides for the rest of the protocol. Thirty patients received the sennosides-only (S) protocol and 30 the sennosides plus docusate (DS) protocol. The efficacy and adverse effects of the protocols were monitored for 5-12 days. The two protocols were used sequentially, creating two cohorts, one on each protocol. Eighty percent of patients were taking oral opioids and 72% were admitted for symptom control/supportive care. Over a total of 488 days of observation it was found that the S protocol produced more bowel movements than the DS protocol, and in the symptom control/supportive care patients this difference was statistically significant (p < 0.05). In the S group admitted for symptom control/supportive care 62.5% had a bowel movement more than 50% of days, as compared with 32% in those receiving the DS protocol. Fifty-seven percent of the DS group required additional interventions (lactulose, suppositories or enemas) compared to 40% in the S group. Cramps were reported equally by 3 (10%) patients in each group. Eight patients (27%) experienced diarrhea in the S group compared to 4 (13%) in the DS group. The addition of the initial docusate-only step and adding docusate 400-600 mg/d to the sennosides did not reduce bowel cramps, and was less effective in inducing laxation than the sennosides-only protocol. Further research into the appropriate use of docusate and into the details of bowel protocol design are required.

Variability of United States Online Rehabilitation Protocols for Proximal Hamstring Tendon Repair.

PubMed

Lightsey, Harry M; Kantrowitz, David E; Swindell, Hasani W; Trofa, David P; Ahmad, Christopher S; Lynch, T Sean

2018-02-01

The optimal postoperative rehabilitation protocol following repair of complete proximal hamstring tendon ruptures is the subject of ongoing investigation, with a need for more standardized regimens and evidence-based modalities. To assess the variability across proximal hamstring tendon repair rehabilitation protocols published online by United States (US) orthopaedic teaching programs. Cross-sectional study. Online proximal hamstring physical therapy protocols from US academic orthopaedic programs were reviewed. A web-based search using the search term complete proximal hamstring repair rehabilitation protocol provided an additional 14 protocols. A comprehensive scoring rubric was developed after review of all protocols and was used to assess each protocol for both the presence of various rehabilitation components and the point at which those components were introduced. Of 50 rehabilitation protocols identified, 35 satisfied inclusion criteria and were analyzed. Twenty-five protocols (71%) recommended immediate postoperative bracing: 12 (34%) prescribed knee bracing, 8 (23%) prescribed hip bracing, and 5 (14%) did not specify the type of brace recommended. Fourteen protocols (40%) advised immediate nonweightbearing with crutches, while 16 protocols (46%) permitted immediate toe-touch weightbearing. Advancement to full weightbearing was allowed at a mean of 7.1 weeks (range, 4-12 weeks). Most protocols (80%) recommended gentle knee and hip passive range of motion and active range of motion, starting at a mean 1.4 weeks (range, 0-3 weeks) and 4.0 weeks (range, 0-6 weeks), respectively. However, only 6 protocols (17%) provided specific time points to initiate full hip and knee range of motion: a mean 8.0 weeks (range, 4-12 weeks) and 7.8 weeks (range, 0-12 weeks), respectively. Considerable variability was noted in the inclusion and timing of strengthening, stretching, proprioception, and cardiovascular exercises. Fifteen protocols (43%) required completion of specific return-to-sport criteria before resuming training. Marked variability is found in both the composition and timing of rehabilitation components across the various complete proximal hamstring repair rehabilitation protocols published online. This finding mirrors the variability of proposed rehabilitation protocols in the professional literature and represents an opportunity to improve patient care.

Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.

PubMed

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

2016-06-01

Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol.

Tooth Tissue Engineering: The Importance of Blood Products as a Supplement in Tissue Culture Medium for Human Pulp Dental Stem Cells.

PubMed

Pisciolaro, Ricardo Luiz; Duailibi, Monica Talarico; Novo, Neil Ferreira; Juliano, Yara; Pallos, Debora; Yelick, Pamela Crotty; Vacanti, Joseph Phillip; Ferreira, Lydia Masako; Duailibi, Silvio Eduardo

2015-11-01

One of the goals in using cells for tissue engineering (TE) and cell therapy consists of optimizing the medium for cell culture. The present study compares three different blood product supplements for improved cell proliferation and protection against DNA damage in cultured human dental pulp stem cells for tooth TE applications. Human cells from dental pulp were first characterized as adult stem cells (ectomesenchymal mixed origin) by flow cytometry. Next, four different cell culture conditions were tested: I, supplement-free; II, supplemented with fetal bovine serum; III, allogeneic human serum; and IV, autologous human serum. Cultured cells were then characterized for cell proliferation, mineralized nodule formation, and colony-forming units (CFU) capability. After 28 days in culture, the comet assay was performed to assess possible damage in cellular DNA. Our results revealed that Protocol IV achieved higher cell proliferation than Protocol I (p = 0.0112). Protocols II and III resulted in higher cell proliferation than Protocol I, but no statistical differences were found relative to Protocol IV. The comet assay revealed less cell damage in cells cultured using Protocol IV as compared to Protocols II and III. The damage percentage observed on Protocol II was significantly higher than all other protocols. CFUs capability was highest using Protocol IV (p = 0.0018) and III, respectively, and the highest degree of mineralization was observed using Protocol IV as compared to Protocols II and III. Protocol IV resulted in significantly improved cell proliferation, and no cell damage was observed. These results demonstrate that human blood product supplements can be used as feasible supplements for culturing adult human dental stem cells.

Standardization of a Videofluoroscopic Swallow Study Protocol to Investigate Dysphagia in Dogs.

PubMed

Harris, R A; Grobman, M E; Allen, M J; Schachtel, J; Rawson, N E; Bennett, B; Ledyayev, J; Hopewell, B; Coates, J R; Reinero, C R; Lever, T E

2017-03-01

Videofluoroscopic swallow study (VFSS) is the gold standard for diagnosis of dysphagia in veterinary medicine but lacks standardized protocols that emulate physiologic feeding practices. Age impacts swallow function in humans but has not been evaluated by VFSS in dogs. To develop a protocol with custom kennels designed to allow free-feeding of 3 optimized formulations of contrast media and diets that address limitations of current VFSS protocols. We hypothesized that dogs evaluated by a free-feeding VFSS protocol would show differences in objective swallow metrics based on age. Healthy juvenile, adult, and geriatric dogs (n = 24). Prospective, experimental study. Custom kennels were developed to maintain natural feeding behaviors during VFSS. Three food consistencies (thin liquid, pureed food, and dry kibble) were formulated with either iohexol or barium to maximize palatability and voluntary prehension. Dogs were evaluated by 16 swallow metrics and compared across age groups. Development of a standardized VFSS protocol resulted in successful collection of swallow data in healthy dogs. No significant differences in swallow metrics were observed among age groups. Substantial variability was observed in healthy dogs when evaluated under these physiologic conditions. Features typically attributed to pathologic states, such as gastric reflux, were seen in healthy dogs. Development of a VFSS protocol that reflects natural feeding practices may allow emulation of physiology resulting in clinical signs of dysphagia. Age did not result in significant changes in swallow metrics, but additional studies are needed, particularly in light of substantial normal variation. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

The role of MRI in axillary lymph node imaging in breast cancer patients: a systematic review.

PubMed

Kuijs, V J L; Moossdorff, M; Schipper, R J; Beets-Tan, R G H; Heuts, E M; Keymeulen, K B M I; Smidt, M L; Lobbes, M B I

2015-04-01

To assess whether MRI can exclude axillary lymph node metastasis, potentially replacing sentinel lymph node biopsy (SLNB), and consequently eliminating the risk of SLNB-associated morbidity. PubMed, Cochrane, Medline and Embase databases were searched for relevant publications up to July 2014. Studies were selected based on predefined inclusion and exclusion criteria and independently assessed by two reviewers using a standardised extraction form. Sixteen eligible studies were selected from 1,372 publications identified by the search. A dedicated axillary protocol [sensitivity 84.7 %, negative predictive value (NPV) 95.0 %] was superior to a standard protocol covering both the breast and axilla simultaneously (sensitivity 82.0 %, NPV 82.6 %). Dynamic, contrast-enhanced MRI had a lower median sensitivity (60.0 %) and NPV (80.0 %) compared to non-enhanced T1w/T2w sequences (88.4, 94.7 %), diffusion-weighted imaging (84.2, 90.6 %) and ultrasmall superparamagnetic iron oxide (USPIO)- enhanced T2*w sequences (83.0, 95.9 %). The most promising results seem to be achievable when using non-enhanced T1w/T2w and USPIO-enhanced T2*w sequences in combination with a dedicated axillary protocol (sensitivity 84.7 % and NPV 95.0 %). The diagnostic performance of some MRI protocols for excluding axillary lymph node metastases approaches the NPV needed to replace SLNB. However, current observations are based on studies with heterogeneous study designs and limited populations. • Some axillary MRI protocols approach the NPV of an SLNB procedure. • Dedicated axillary MRI is more accurate than protocols also covering the breast. • T1w/T2w protocols combined with USPIO-enhanced sequences are the most promising sequences.

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

PubMed Central

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

2016-01-01

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

Cryptography in the Bounded-Quantum-Storage Model

NASA Astrophysics Data System (ADS)

Schaffner, Christian

2007-09-01

This thesis initiates the study of cryptographic protocols in the bounded-quantum-storage model. On the practical side, simple protocols for Rabin Oblivious Transfer, 1-2 Oblivious Transfer and Bit Commitment are presented. No quantum memory is required for honest players, whereas the protocols can only be broken by an adversary controlling a large amount of quantum memory. The protocols are efficient, non-interactive and can be implemented with today's technology. On the theoretical side, new entropic uncertainty relations involving min-entropy are established and used to prove the security of protocols according to new strong security definitions. For instance, in the realistic setting of Quantum Key Distribution (QKD) against quantum-memory-bounded eavesdroppers, the uncertainty relation allows to prove the security of QKD protocols while tolerating considerably higher error rates compared to the standard model with unbounded adversaries.

Taking the Politics Out of Satellite and Space-Based Communications Protocols

NASA Technical Reports Server (NTRS)

Ivancic, William D.

2006-01-01

After many years of studies, experimentation, and deployment, large amounts of misinformation and misconceptions remain regarding applicability of various communications protocols for use in satellite and space-based networks. This paper attempts to remove much of the politics, misconceptions, and misinformation that have plagued spacebased communications protocol development and deployment. This paper provides a common vocabulary for communications; a general discussion of the requirements for various communication environments; an evaluation of tradeoffs between circuit and packet-switching technologies, and the pros and cons of various link, network, transport, application, and security protocols. Included is the applicability of protocol enhancing proxies to NASA, Department of Defense (DOD), and commercial space communication systems.

Medical management of ectopic pregnancy with single-dose and 2-dose methotrexate protocols: human chorionic gonadotropin trends and patient outcomes.

PubMed

Mergenthal, Michelle C; Senapati, Suneeta; Zee, Jarcy; Allen-Taylor, Lynne; Whittaker, Paul G; Takacs, Peter; Sammel, Mary D; Barnhart, Kurt T

2016-11-01

Ectopic pregnancy, although rare, is an important cause of female morbidity and mortality and early, effective treatment is critical. Systemic methotrexate has become widely accepted as a safe and effective alternative to surgery in the stable patient. As the number and timing of methotrexate doses differ in the 3 main medical treatment regimens, one might expect trends in serum human chorionic gonadotropin and time to resolution to vary depending on protocol. Furthermore, human chorionic gonadotropin trends and time to resolution may predict ultimate treatment success. This study hypothesized that the 2-dose methotrexate protocol would be associated with a faster initial decline in serum human chorionic gonadotropin levels and a shorter time to resolution compared to the single-dose protocol. A prospective multicenter cohort study included clinical data from women who received medical management for ectopic pregnancy. Rates of human chorionic gonadotropin change and successful pregnancy resolution were assessed. Propensity score modeling addressed confounding by indication, the potential for differential assignment of patients with better prognosis to the single-dose methotrexate protocol. In all, 162 ectopic pregnancies were in the final analysis; 114 (70%) were treated with the single-dose methotrexate and 48 (30%) with the 2-dose protocol. Site, race, ethnicity, and reported pain level were associated with differential protocol allocation (P < .001, P = .011, P < .001, and P = .035, respectively). Women had similar initial human chorionic gonadotropin levels in either protocol but the mean rate of decline of human chorionic gonadotropin from day 0 (day of administration of first dose of methotrexate) to day 7 was significantly more rapid in women who received the single-dose protocol compared to those treated with the 2-dose protocol (mean change -31.3% vs -10.4%, P = .037, adjusted for propensity score and site). The 2 protocols had no significant differences in success rate or time to resolution. In a racially and geographically diverse group of women, the single- and double-dose methotrexate protocols had comparable outcomes. The more rapid human chorionic gonadotropin initial decline in the single-dose group suggested these patients were probably at lower risk for ectopic rupture than those getting the 2-dose protocol. A prospective randomized controlled design is needed to remove confounding by indication. Copyright © 2016 Elsevier Inc. All rights reserved.

Might digital drains speed up the time to thoracic drain removal?

PubMed

Afoke, Jonathan; Tan, Carol; Hunt, Ian; Zakkar, Mustafa

2014-07-01

A best evidence topic in thoracic surgery was written according to a structured protocol. The question addressed was: might digital drains speed up the time to thoracic drain removal in terms of time till chest drain removal, hospital stay and overall cost? A total of 296 papers were identified as a result of the search as described below. Of these, five papers provided the best evidence to answer the clinical question. The author, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of the papers are tabulated. A literature search revealed that several single-centre prospective randomized studies have shown significantly earlier removal of chest drains with digital drains ranging between 0.8 and 2.1 days sooner. However, there was heterogeneity in studies in the management protocol of chest drains in terms of the use of suction, number of drains and assessment for drain removal. Some protocols such as routinely keeping drains irrespective of the presence of air leak or drain output may have skewed results. Differences in exclusion criteria and protocols for discharging home with portable devices may have biased results. Due to heterogeneity in the management protocol of chest drains, there is conflicting evidence regarding hospital stay. The limited data on cost suggest that there may be significantly lower postoperative costs in the digital drain group. All the studies were single-centre series generally including patients with good preoperative lung function tests. Further larger studies with more robust chest drain management protocols are required especially to assess length of hospital stay, cost and whether the results are applicable to a larger patient population. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Diagnostic performance of a streamlined 18F-choline PET-CT protocol for the detection of prostate carcinoma recurrence in combination with appropriate-use criteria.

PubMed

Frood, R; Baren, J; McDermott, G; Bottomley, D; Patel, C; Scarsbrook, A

2018-04-30

To evaluate the efficacy of single time-point half-body (skull base to thighs) fluorine-18 choline positron emission tomography-computed tomography (PET-CT) compared to a triple-phase acquisition protocol in the detection of prostate carcinoma recurrence. Consecutive choline PET-CT studies performed at a single tertiary referral centre in patients with biochemical recurrence of prostate carcinoma between September 2012 and March 2017 were reviewed retrospectively. The indication for the study, imaging protocol used, imaging findings, whether management was influenced by the PET-CT, and subsequent patient outcome were recorded. Ninety-one examinations were performed during the study period; 42 were carried out using a triple-phase protocol (dynamic pelvic imaging for 20 minutes after tracer injection, half-body acquisition at 60 minutes and delayed pelvic scan at 90 minutes) between 2012 and August 2015. Subsequently following interim review of diagnostic performance, a streamlined protocol and appropriate-use criteria were introduced. Forty-nine examinations were carried out using the single-phase protocol between 2015 and 2017. Twenty-nine (69%) of the triple-phase studies were positive for recurrence compared to 38 (78%) of the single-phase studies. Only one patient who had a single-phase study would have benefited from a dynamic acquisition, they have required no further treatment or imaging and are currently under prostate-specific antigen (PSA) surveillance. Choline PET-CT remains a useful tool for the detection of prostate recurrence when used in combination with appropriate-use criteria. Removal of dynamic and delayed acquisition phases reduces study time without adversely affecting accuracy. Benefits include shorter imaging time which improves patient comfort, reduced cost, and improved scanner efficiency. Copyright © 2018 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

40 CFR 792.130 - Conduct of a study.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Conduct of a study. 792.130 Section 792... (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Protocol for and Conduct of A Study § 792.130 Conduct of a study. (a) The study shall be conducted in accordance with the protocol. (b) The test systems shall be...

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.

Cryptanalysis and improvement of a biometrics-based authentication and key agreement scheme for multi-server environments.

PubMed

Yang, Li; Zheng, Zhiming

2018-01-01

According to advancements in the wireless technologies, study of biometrics-based multi-server authenticated key agreement schemes has acquired a lot of momentum. Recently, Wang et al. presented a three-factor authentication protocol with key agreement and claimed that their scheme was resistant to several prominent attacks. Unfortunately, this paper indicates that their protocol is still vulnerable to the user impersonation attack, privileged insider attack and server spoofing attack. Furthermore, their protocol cannot provide the perfect forward secrecy. As a remedy of these aforementioned problems, we propose a biometrics-based authentication and key agreement scheme for multi-server environments. Compared with various related schemes, our protocol achieves the stronger security and provides more functionality properties. Besides, the proposed protocol shows the satisfactory performances in respect of storage requirement, communication overhead and computational cost. Thus, our protocol is suitable for expert systems and other multi-server architectures. Consequently, the proposed protocol is more appropriate in the distributed networks.

Performing private database queries in a real-world environment using a quantum protocol.

PubMed

Chan, Philip; Lucio-Martinez, Itzel; Mo, Xiaofan; Simon, Christoph; Tittel, Wolfgang

2014-06-10

In the well-studied cryptographic primitive 1-out-of-N oblivious transfer, a user retrieves a single element from a database of size N without the database learning which element was retrieved. While it has previously been shown that a secure implementation of 1-out-of-N oblivious transfer is impossible against arbitrarily powerful adversaries, recent research has revealed an interesting class of private query protocols based on quantum mechanics in a cheat sensitive model. Specifically, a practical protocol does not need to guarantee that the database provider cannot learn what element was retrieved if doing so carries the risk of detection. The latter is sufficient motivation to keep a database provider honest. However, none of the previously proposed protocols could cope with noisy channels. Here we present a fault-tolerant private query protocol, in which the novel error correction procedure is integral to the security of the protocol. Furthermore, we present a proof-of-concept demonstration of the protocol over a deployed fibre.

Performing private database queries in a real-world environment using a quantum protocol

PubMed Central

Chan, Philip; Lucio-Martinez, Itzel; Mo, Xiaofan; Simon, Christoph; Tittel, Wolfgang

2014-01-01

In the well-studied cryptographic primitive 1-out-of-N oblivious transfer, a user retrieves a single element from a database of size N without the database learning which element was retrieved. While it has previously been shown that a secure implementation of 1-out-of-N oblivious transfer is impossible against arbitrarily powerful adversaries, recent research has revealed an interesting class of private query protocols based on quantum mechanics in a cheat sensitive model. Specifically, a practical protocol does not need to guarantee that the database provider cannot learn what element was retrieved if doing so carries the risk of detection. The latter is sufficient motivation to keep a database provider honest. However, none of the previously proposed protocols could cope with noisy channels. Here we present a fault-tolerant private query protocol, in which the novel error correction procedure is integral to the security of the protocol. Furthermore, we present a proof-of-concept demonstration of the protocol over a deployed fibre. PMID:24913129

Cryptanalysis and improvement of a biometrics-based authentication and key agreement scheme for multi-server environments

PubMed Central

Zheng, Zhiming

2018-01-01

According to advancements in the wireless technologies, study of biometrics-based multi-server authenticated key agreement schemes has acquired a lot of momentum. Recently, Wang et al. presented a three-factor authentication protocol with key agreement and claimed that their scheme was resistant to several prominent attacks. Unfortunately, this paper indicates that their protocol is still vulnerable to the user impersonation attack, privileged insider attack and server spoofing attack. Furthermore, their protocol cannot provide the perfect forward secrecy. As a remedy of these aforementioned problems, we propose a biometrics-based authentication and key agreement scheme for multi-server environments. Compared with various related schemes, our protocol achieves the stronger security and provides more functionality properties. Besides, the proposed protocol shows the satisfactory performances in respect of storage requirement, communication overhead and computational cost. Thus, our protocol is suitable for expert systems and other multi-server architectures. Consequently, the proposed protocol is more appropriate in the distributed networks. PMID:29534085

Protocol dependence of mechanical properties in granular systems.

PubMed

Inagaki, S; Otsuki, M; Sasa, S

2011-11-01

We study the protocol dependence of the mechanical properties of granular media by means of computer simulations. We control a protocol of realizing disk packings in a systematic manner. In 2D, by keeping material properties of the constituents identical, we carry out compaction with various strain rates. The disk packings exhibit the strain rate dependence of the critical packing fraction above which the pressure becomes non-zero. The observed behavior contrasts with the well-studied jamming transitions for frictionless disk packings. We also observe that the elastic moduli of the disk packings depend on the strain rate logarithmically. Our results suggest that there exists a time-dependent state variable to describe macroscopic material properties of disk packings, which depend on its protocol.

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

PubMed Central

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

2018-01-01

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

Participation in Pediatric Oncology Research Protocols: Racial/ethnic, Language and Age-based Disparities

PubMed Central

Aristizabal, Paula; Singer, Jenelle; Cooper, Renee; Wells, Kristen J.; Nodora, Jesse; Milburn, Mehrzad; Gahagan, Sheila; Schiff, Deborah E.; Martinez, Maria Elena

2015-01-01

Background Survival rates in pediatric oncology have improved dramatically, in part due to high patient participation in clinical trials. Although racial/ethnic inequalities in clinical trial participation have been reported in adults, pediatric data and studies comparing participation rates by socio-demographic characteristics are scarce. The goal of this study was to assess differences in research protocol participation for childhood cancer by age, sex, race/ethnicity, parental language, cancer type and insurance status. Procedure Data on enrollment in any protocol, biospecimen, or therapeutic protocols were collected and analyzed for newly diagnosed pediatric patients with cancer from 2008–2012 at Rady Children’s Hospital. Results Among the 353 patients included in the analysis, 304 (86.1%) were enrolled in any protocol. Enrollment in biospecimen and therapeutic protocols was 84.2% (261/310) and 81.1% (206/254), respectively. Logistic regression analyses revealed significant enrollment underrepresentation in any protocol for Hispanics compared to Non-Hispanic whites (81% vs. 91%; Odds Ratio [OR], 0.43; 95% Confidence Interval [CI], 0.21–0.90; p=0.021) and among children of Spanish-speaking vs. English-speaking parents (78% vs. 89%; OR, 0.45; 95%CI, 0.23–0.87; p=0.016). Compared to patients aged 0–4 years, significant underrepresentation was also found among patients 15–21 years old (92% vs.72%; OR, 0.21; 95% CI, 0.09–0.48; p<0.001). Similar trends were observed when analyzing enrollment in biospecimen and therapeutic protocols separately. Conclusions There was significant underrepresentation in protocol participation for Hispanics, children of Spanish-speaking parents, and patients ages 15–21. Research is urgently needed to understand barriers to research participation among these groups underrepresented in pediatric oncology clinical trials. PMID:25755225

Development and validation of a remote home safety protocol.

PubMed

Romero, Sergio; Lee, Mi Jung; Simic, Ivana; Levy, Charles; Sanford, Jon

2018-02-01

Environmental assessments and subsequent modifications conducted by healthcare professionals can enhance home safety and promote independent living. However, travel time, expense and the availability of qualified professionals can limit the broad application of this intervention. Remote technology has the potential to increase access to home safety evaluations. This study describes the development and validation of a remote home safety protocol that can be used by a caregiver of an elderly person to video-record their home environment for later viewing and evaluation by a trained professional. The protocol was developed based on literature reviews and evaluations from clinical and content experts. Cognitive interviews were conducted with a group of six caregivers to validate the protocol. The final protocol included step-by-step directions to record indoor and outdoor areas of the home. The validation process resulted in modifications related to safety, clarity of the protocol, readability, visual appearance, technical descriptions and usability. Our final protocol includes detailed instructions that a caregiver should be able to follow to record a home environment for subsequent evaluation by a home safety professional. Implications for Rehabilitation The results of this study have several implications for rehabilitation practice The remote home safety evaluation protocol can potentially improve access to rehabilitation services for clients in remote areas and prevent unnecessary delays for needed care. Using our protocol, a patient's caregiver can partner with therapists to quickly and efficiently evaluate a patient's home before they are released from the hospital. Caregiver narration, which reflects a caregiver's own perspective, is critical to evaluating home safety. In-home safety evaluations, currently not available to all who need them due to access barriers, can enhance a patient's independence and provide a safer home environment.

Comparison of Ovulation Induction Protocols After Endometrioma Resection

PubMed Central

Yasa, Cenk; Dural, Ozlem; Mutlu, Mehmet Firat; Celik, Cem; Ugurlucan, Funda Gungor; Buyru, Faruk

2014-01-01

Background and Objectives: The aim of this study was to compare the in vitro fertilization (IVF) outcomes of long gonadotropin-releasing hormone agonist (GnRH-a) and GnRH-antagonist (GnRH-ant) protocols in endometriosis patients who have undergone laparoscopic endometrioma resection surgery. To our knowledge, there is no study in the current literature that compares the effectiveness of long GnRH-a and GnRH-ant protocols in management of IVF cycles in endometriosis patients who underwent laparoscopic endometrioma resection surgery. Methods: Eighty-six patients with stage III to IV endometriosis who had undergone laparoscopic resection surgery for endometrioma were divided into 2 groups: those who had ovarian stimulation with a long GnRH-a protocol (n = 44), and those who had ovarian stimulation with a GnRH-ant protocol (n = 42). Results: The number of follicles on human chorionic gonadotropin injection day, duration of hyperstimulation, number of retrieved metaphase II oocytes, and total number of grade 1 embryos were statically significantly higher in the long GnRH-a protocol. There were no significant differences in positive β-human chorionic gonadotropin pregnancy rates (25% vs 21.4%; P = .269) and ongoing pregnancy rates per patient (20.5% vs 19.1%; P = .302) between the 2 protocols. Conclusions: Long GnRH-a and GnRH-ant protocols both present similar IVF outcomes in patients with endometriosis who have undergone laparoscopic endometrioma resection surgery. A long GnRH-a protocol may lead to a higher number of embryos that can be cryopreserved, providing the possibility of additional embryo transfers without having to go through the process of ovarian stimulation again. PMID:25392665

Healthy individuals' perspectives on clinical research protocols and influences on enrollment decisions.

PubMed

Roberts, Laura Weiss; Kim, Jane Paik

2017-01-01

Understanding the perspectives of healthy individuals is important ethically and for the advancement of science. We assessed perceptions of risk associated with research procedures, comparing views of healthy individuals with and without experience in clinical research, and the respondents' reported willingness to volunteer. Semistructured interviews and written surveys were conducted. Study participants were healthy individuals, half of whom were currently enrolled in clinical research and half of whom had no prior experience in clinical research. Participants were queried regarding seven "minimal risk" or "greater than minimal risk" protocol vignettes with procedures of three types: routine diagnostic tests, more burdensome (i.e., more effort or potential harm) diagnostic tests, and pharmacologic interventions. Views of influences on enrollment decisions were also assessed. Most healthy individuals indicated that protocols with more burdensome or pharmacologic interventions were very risky (59%, 58%), as opposed to routine diagnostic test procedures (32%). Respondents' willingness to enroll in protocols varied by type of protocol (p value < .001) and was inversely correlated with risk assessments (regression coefficients from GEE = -0.4; -0.5; -0.7). The odds of healthy individuals with research experience expressing strong willingness to enroll in the depicted protocols were twice the odds of healthy individuals without research experience expressing the same level of willingness (OR = 2.0 95% CI: [1.1, 3.9]). Respondents did not assign risk categories as institutional review boards (IRBs) would, as indicated by low agreement (26%) between respondent and expert opinion on minimal risk protocols. Perceptions of procedure risk appear to influence healthy individuals' willingness to enroll in protocols. Participants with experience in clinical research were far more likely to express willingness to enroll, a finding with important scientific and ethical implications. The lack of alignment between healthy individuals' views of protocol risk and IRB categorization warrants further study.

Components That Affect the Personal Motivation to Implement Campus Safety Protocols

ERIC Educational Resources Information Center

Burt, Ernest, III

2013-01-01

This study examined components that have an effect on crisis response team members' personal motivation to perform campus safety protocols. The research method for this study was a quantitative design. The variables measured were compensation, experience, training, and communication. The motivation sources for this study included instrumental…

Diagnostic and Therapeutic Knowledge and Practices in the Management of Congenital Syphilis by Pediatricians in Public Maternity Hospitals in Brazil.

PubMed

Dos Santos, Raquel Rodrigues; Niquini, Roberta Pereira; Bastos, Francisco Inácio; Domingues, Rosa Maria Soares Madeira

2017-01-01

The study aimed to assess conformity with Brazil's standard protocol for diagnostic and therapeutic practices in the management of congenital syphilis by pediatricians in public maternity hospitals. A cross-sectional study was conducted in 2015 with 41 pediatricians working in all the public maternity hospitals in Teresina, the capital of Piauí State, Northeast Brazil, through self-completed questionnaires. The study assessed the conformity of knowledge and practices according to the Brazilian Ministry of Health protocols. The study has made evident low access to training courses (54%) and insufficient knowledge of the case definition of congenital syphilis (42%) and rapid tests for syphilis (39%). Flaws were observed in the diagnostic workup and treatment of newborns. Requesting VDRL (88%) and correct treatment of neurosyphilis (88%) were the practices that showed the highest conformity with standard protocols. Low conformity with protocols leads to missed opportunities for identifying and adequately treating congenital syphilis. Based on the barriers identified in the study, better access to diagnostic and treatment protocols, improved recording on prenatal cards and hospital patient charts, availability of tests and medicines, and educational work with pregnant women should be urgently implemented, aiming to reverse the currently inadequate management of congenital syphilis and to curb its spread.

A novel protocol for antibiotic prophylaxis based on preoperative kidney function in patients undergoing open heart surgery under cardiopulmonary bypass.

PubMed

Odaka, Mizuho; Minakata, Kenji; Toyokuni, Hideaki; Yamazaki, Kazuhiro; Yonezawa, Atsushi; Sakata, Ryuzo; Matsubara, Kazuo

2015-08-01

This study aimed to develop and assess the effectiveness of a protocol for antibiotic prophylaxis based on preoperative kidney function in patients undergoing open heart surgery. We established a protocol for antibiotic prophylaxis based on preoperative kidney function in patients undergoing open heart surgery. This novel protocol was assessed by comparing patients undergoing open heart surgery before (control group; n = 30) and after its implementation (protocol group; n = 31) at Kyoto University Hospital between July 2012 and January 2013. Surgical site infections (SSIs) were observed in 4 control group patients (13.3 %), whereas no SSIs were observed in the protocol group patients (P < 0.05). The total duration of antibiotic use decreased significantly from 80.7 ± 17.6 h (mean ± SD) in the control group to 55.5 ± 14.9 h in the protocol group (P < 0.05). Similarly, introduction of the protocol significantly decreased the total antibiotic dose used in the perioperative period (P < 0.05). Furthermore, antibiotic regimens were changed under suspicion of infection in 5 of 30 control group patients, whereas none of the protocol group patients required this additional change in the antibiotic regimen (P < 0.05). Our novel antibiotic prophylaxis protocol based on preoperative kidney function effectively prevents SSIs in patients undergoing open heart surgery.

Peer Review and Publication of Research Protocols and Proposals: A Role for Open Access Journals

PubMed Central

2004-01-01

Peer-review and publication of research protocols offer several advantages to all parties involved. Among these are the following opportunities for authors: external expert opinion on the methods, demonstration to funding agencies of prior expert review of the protocol, proof of priority of ideas and methods, and solicitation of potential collaborators. We think that review and publication of protocols is an important role for Open Access journals. Because of their electronic form, openness for readers, and author-pays business model, they are better suited than traditional journals to ensure the sustainability and quality of protocol reviews and publications. In this editorial, we describe the workflow for investigators in eHealth research, from protocol submission to a funding agency, to protocol review and (optionally) publication at JMIR, to registration of trials at the International eHealth Study Registry (IESR), and to publication of the report. One innovation at JMIR is that protocol peer reviewers will be paid a honorarium, which will be drawn partly from a new submission fee for protocol reviews. Separating the article processing fee into a submission and a publishing fee will allow authors to opt for “peer-review only” (without subsequent publication) at reduced costs, if they wish to await a funding decision or for other reasons decide not to make the protocol public. PMID:15471763

Model Checking a Byzantine-Fault-Tolerant Self-Stabilizing Protocol for Distributed Clock Synchronization Systems

NASA Technical Reports Server (NTRS)

Malekpour, Mahyar R.

2007-01-01

This report presents the mechanical verification of a simplified model of a rapid Byzantine-fault-tolerant self-stabilizing protocol for distributed clock synchronization systems. This protocol does not rely on any assumptions about the initial state of the system. This protocol tolerates bursts of transient failures, and deterministically converges within a time bound that is a linear function of the self-stabilization period. A simplified model of the protocol is verified using the Symbolic Model Verifier (SMV) [SMV]. The system under study consists of 4 nodes, where at most one of the nodes is assumed to be Byzantine faulty. The model checking effort is focused on verifying correctness of the simplified model of the protocol in the presence of a permanent Byzantine fault as well as confirmation of claims of determinism and linear convergence with respect to the self-stabilization period. Although model checking results of the simplified model of the protocol confirm the theoretical predictions, these results do not necessarily confirm that the protocol solves the general case of this problem. Modeling challenges of the protocol and the system are addressed. A number of abstractions are utilized in order to reduce the state space. Also, additional innovative state space reduction techniques are introduced that can be used in future verification efforts applied to this and other protocols.

Peer-review and publication of research protocols and proposals: a role for open access journals.

PubMed

Eysenbach, Gunther

2004-09-30

Peer-review and publication of research protocols offer several advantages to all parties involved. Among these are the following opportunities for authors: external expert opinion on the methods, demonstration to funding agencies of prior expert review of the protocol, proof of priority of ideas and methods, and solicitation of potential collaborators. We think that review and publication of protocols is an important role for Open Access journals. Because of their electronic form, openness for readers, and author-pays business model, they are better suited than traditional journals to ensure the sustainability and quality of protocol reviews and publications. In this editorial, we describe the workflow for investigators in eHealth research, from protocol submission to a funding agency, to protocol review and (optionally) publication at JMIR, to registration of trials at the International eHealth Study Registry (IESR), and to publication of the report. One innovation at JMIR is that protocol peer reviewers will be paid a honorarium, which will be drawn partly from a new submission fee for protocol reviews. Separating the article processing fee into a submission and a publishing fee will allow authors to opt for "peer-review only" (without subsequent publication) at reduced costs, if they wish to await a funding decision or for other reasons decide not to make the protocol public.

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.

Biofeedback treatment of constipation: a critical review.

PubMed

Heymen, Steve; Jones, Kenneth R; Scarlett, Yolanda; Whitehead, William E

2003-09-01

This review was designed to 1) critically examine the research design used in investigations of biofeedback for pelvic floor dyssynergia, 2) compare the various biofeedback treatment protocols for pelvic floor dyssynergia-type constipation used in this research, 3) identify factors that influence treatment outcome, and 4) identify goals for future biofeedback research for pelvic floor dyssynergia. A comprehensive review of both the pediatric and adult research from 1970 to 2002 on "biofeedback for constipation" was conducted using a Medline search in all languages. Only prospective studies including five or more subjects that described the treatment protocol were included. In addition, a meta-analysis of these studies was performed to compare the outcome of different biofeedback protocols for treating constipation. Thirty-eight studies were reviewed, and sample size, treatment protocol, outcome rates, number of sessions, and etiology are shown in a table. Ten studies using a parallel treatment design were reviewed in detail, including seven that randomized subjects to treatment groups. A meta-analysis (weighted by subjects) was performed to compare the results of two treatment protocols prevalent in the literature. The mean success rate of studies using pressure biofeedback (78 percent) was superior (P = 0.018) to the mean success rate for studies using electromyography biofeedback (70 percent). However, the mean success rates comparing studies using intra-anal electromyography sensors to studies using perianal electromyography sensors were 69 and 72 percent, respectively, indicating no advantages for one type of electromyography protocol over the other (P = 0.428). In addition to the varied protocols and instrumentation used, there also are inconsistencies in the literature regarding the severity and etiology of symptoms, patient selection criteria, and the definition of a successful outcome. Finally, no anatomic, physiologic, or demographic variables were identified that would assist in predicting successful outcome. Having significant psychological symptoms was identified as a factor that may influence treatment outcome, but this requires further study. Although most studies report positive results using biofeedback to treat constipation, quality research is lacking. Specific recommendations are made for future investigations to 1) improve experimental design, 2) clearly define outcome measures, 3) identify the etiology and severity of symptoms, 4) determine which treatment protocol and which component of treatment is most effective for different types of subjects, 5) systematically explore the role of psychopathology in this population, 6) use an adequate sample size that allows for meaningful analysis, and 7) include long-term follow-up data.

Implementation of a 5-Minute Magnetic Resonance Imaging Screening Protocol for Prostate Cancer in Men With Elevated Prostate-Specific Antigen Before Biopsy.

PubMed

Weiss, Jakob; Martirosian, Petros; Notohamiprodjo, Mike; Kaufmann, Sascha; Othman, Ahmed E; Grosse, Ulrich; Nikolaou, Konstantin; Gatidis, Sergios

2018-03-01

The aims of this study were to establish a 5-minute magnetic resonance (MR) screening protocol for prostate cancer in men before biopsy and to evaluate effects on Prostate Imaging Reporting and Data System (PI-RADS) V2 scoring in comparison to a conventional, fully diagnostic multiparametric MR imaging (mpMRI) approach. Fifty-two patients with elevated prostate-specific antigen levels and without prior biopsy were prospectively included in this institutional review board-approved study. In all patients, an mpMRI protocol according to the PI-RADS recommendations was acquired on a 3 T MRI system. In addition, an accelerated diffusion-weighted imaging sequence was acquired using simultaneous multislice technique (DW-EPISMS). Two readers independently evaluated the images for the presence/absence of prostate cancer according to the PI-RADS criteria and for additional findings. In a first reading session, only the screening protocol consisting of axial T2-weighted and DW-EPISMS images was made available. In a subsequent reading session, the mpMRI protocol was assessed blinded to the results of the first reading, serving as reference standard. Both readers successfully established a final diagnosis according to the PI-RADS criteria in the screening and mpMRI protocol. Mean lesion size was 1.2 cm in the screening and 1.4 cm in the mpMRI protocol (P = 0.4) with 35% (18/52) of PI-RADS IV/V lesions. Diagnostic performance of the screening protocol was excellent with a sensitivity and specificity of 100% for both readers with no significant differences in comparison to the mpMRI standard (P = 1.0). In 3 patients, suspicious lymph nodes were reported as additional finding, which were equally detectable in the screening and mpMRI protocol. A 5-minute MR screening protocol for prostate cancer in men with elevated prostate-specific antigen levels before biopsy is applicable for clinical routine with similar diagnostic performance as the full diagnostic mpMRI approach.

Clinical outcomes and cost effectiveness of accelerated diagnostic protocol in a chest pain center compared with routine care of patients with chest pain.

PubMed

Asher, Elad; Reuveni, Haim; Shlomo, Nir; Gerber, Yariv; Beigel, Roy; Narodetski, Michael; Eldar, Michael; Or, Jacob; Hod, Hanoch; Shamiss, Arie; Matetzky, Shlomi

2015-01-01

The aim of this study was to compare in patients presenting with acute chest pain the clinical outcomes and cost-effectiveness of an accelerated diagnostic protocol utilizing contemporary technology in a chest pain unit versus routine care in an internal medicine department. Hospital and 90-day course were prospectively studied in 585 consecutive low-moderate risk acute chest pain patients, of whom 304 were investigated in a designated chest pain center using a pre-specified accelerated diagnostic protocol, while 281 underwent routine care in an internal medicine ward. Hospitalization was longer in the routine care compared with the accelerated diagnostic protocol group (p<0.001). During hospitalization, 298 accelerated diagnostic protocol patients (98%) vs. 57 (20%) routine care patients underwent non-invasive testing, (p<0.001). Throughout the 90-day follow-up, diagnostic imaging testing was performed in 125 (44%) and 26 (9%) patients in the routine care and accelerated diagnostic protocol patients, respectively (p<0.001). Ultimately, most patients in both groups had non-invasive imaging testing. Accelerated diagnostic protocol patients compared with those receiving routine care was associated with a lower incidence of readmissions for chest pain [8 (3%) vs. 24 (9%), p<0.01], and acute coronary syndromes [1 (0.3%) vs. 9 (3.2%), p<0.01], during the follow-up period. The accelerated diagnostic protocol remained a predictor of lower acute coronary syndromes and readmissions after propensity score analysis [OR = 0.28 (CI 95% 0.14-0.59)]. Cost per patient was similar in both groups [($2510 vs. $2703 for the accelerated diagnostic protocol and routine care group, respectively, (p = 0.9)]. An accelerated diagnostic protocol is clinically superior and as cost effective as routine in acute chest pain patients, and may save time and resources.

Clinical Outcomes and Cost Effectiveness of Accelerated Diagnostic Protocol in a Chest Pain Center Compared with Routine Care of Patients with Chest Pain

PubMed Central

Asher, Elad; Reuveni, Haim; Shlomo, Nir; Gerber, Yariv; Beigel, Roy; Narodetski, Michael; Eldar, Michael; Or, Jacob; Hod, Hanoch; Shamiss, Arie; Matetzky, Shlomi

2015-01-01

Aims The aim of this study was to compare in patients presenting with acute chest pain the clinical outcomes and cost-effectiveness of an accelerated diagnostic protocol utilizing contemporary technology in a chest pain unit versus routine care in an internal medicine department. Methods and Results Hospital and 90-day course were prospectively studied in 585 consecutive low-moderate risk acute chest pain patients, of whom 304 were investigated in a designated chest pain center using a pre-specified accelerated diagnostic protocol, while 281 underwent routine care in an internal medicine ward. Hospitalization was longer in the routine care compared with the accelerated diagnostic protocol group (p<0.001). During hospitalization, 298 accelerated diagnostic protocol patients (98%) vs. 57 (20%) routine care patients underwent non-invasive testing, (p<0.001). Throughout the 90-day follow-up, diagnostic imaging testing was performed in 125 (44%) and 26 (9%) patients in the routine care and accelerated diagnostic protocol patients, respectively (p<0.001). Ultimately, most patients in both groups had non-invasive imaging testing. Accelerated diagnostic protocol patients compared with those receiving routine care was associated with a lower incidence of readmissions for chest pain [8 (3%) vs. 24 (9%), p<0.01], and acute coronary syndromes [1 (0.3%) vs. 9 (3.2%), p<0.01], during the follow-up period. The accelerated diagnostic protocol remained a predictor of lower acute coronary syndromes and readmissions after propensity score analysis [OR = 0.28 (CI 95% 0.14–0.59)]. Cost per patient was similar in both groups [($2510 vs. $2703 for the accelerated diagnostic protocol and routine care group, respectively, (p = 0.9)]. Conclusion An accelerated diagnostic protocol is clinically superior and as cost effective as routine in acute chest pain patients, and may save time and resources. PMID:25622029

The Effects of Alternative Resuscitation Strategies on Acute Kidney Injury in Patients with Septic Shock.

PubMed

Kellum, John A; Chawla, Lakhmir S; Keener, Christopher; Singbartl, Kai; Palevsky, Paul M; Pike, Francis L; Yealy, Donald M; Huang, David T; Angus, Derek C

2016-02-01

Septic shock is a common cause of acute kidney injury (AKI), and fluid resuscitation is a major part of therapy. To determine if structured resuscitation designed to alter fluid, blood, and vasopressor use affects the development or severity of AKI or outcomes. Ancillary study to the ProCESS (Protocolized Care for Early Septic Shock) trial of alternative resuscitation strategies (two protocols vs. usual care) for septic shock. We studied 1,243 patients and classified AKI using serum creatinine and urine output. We determined recovery status at hospital discharge, examined rates of renal replacement therapy and fluid overload, and measured biomarkers of kidney damage. Among patients without evidence of AKI at enrollment, 37.6% of protocolized care and 38.1% of usual care patients developed kidney injury (P = 0.90). AKI duration (P = 0.59) and rates of renal replacement therapy did not differ between study arms (6.9% for protocolized care and 4.3% for usual care; P = 0.08). Fluid overload occurred in 8.3% of protocolized care and 6.3% of usual care patients (P = 0.26). Among patients with severe AKI, complete and partial recovery was 50.7 and 13.2% for protocolized patients and 49.1 and 13.4% for usual care patients (P = 0.93). Sixty-day hospital mortality was 6.2% for patients without AKI, 16.8% for those with stage 1, and 27.7% for stages 2 to 3. In patients with septic shock, AKI is common and associated with adverse outcomes, but it is not influenced by protocolized resuscitation compared with usual care.

Feasibility of dietary assessment methods, other tools and procedures for a pan-European food consumption survey among infants, toddlers and children.

PubMed

Ocké, Marga; Brants, Henny; Dofkova, Marcela; Freisling, Heinz; van Rossum, Caroline; Ruprich, Jiri; Slimani, Nadia; Temme, Elisabeth; Trolle, Ellen; Vandevijvere, Stefanie; Huybrechts, Inge; de Boer, Evelien

2015-08-01

To test the feasibility of tools and procedures for a pan-European food consumption survey among children 0-10 years and to recommend one of two tested dietary assessment methods. Two pilot studies including 378 children were conducted in Belgium and the Czech Republic in the Pilot studies for Assessment of Nutrient intake and food Consumption among Kids in Europe. One protocol included a 3-day food diary which was checked with a parent, and data were entered afterwards using EPIC-Soft. The alternative protocol consisted of two non-consecutive 1-day food diaries followed by EPIC-Soft completion interviews. Both protocols included general and food propensity questionnaires and anthropometric measurements. The protocols were compared using evaluation questionnaires among the participating parents and study personnel. The parents found the questionnaires and instructions for filling in the food diaries understandable. Food description and food quantification was evaluated as problematic by 29 and 15% of the participants for the 3-day diaries versus 15 and 12% for the 1-day diaries. The protocol with 1-day food diaries was evaluated as less burdensome by the parents and logistically more challenging by the interviewers. Both dietary assessment methods with related tools and administration protocols were evaluated as feasible. The administration protocol with two 1-day food diaries with completion interviews offers more advantages for the future pan-European survey in children 0-10 years. The positive evaluation of feasibility of tools and materials is an important step towards harmonised food consumption data at European level among the younger age groups.

Comparison of two cooling protocols for llama semen: with and without collagenase and seminal plasma in the medium.

PubMed

Carretero, M I; Giuliano, S M; Arraztoa, C C; Santa Cruz, R C; Fumuso, F G; Neild, D M

2017-08-01

Seminal plasma (SP) of South American Camelids could interfere with the interaction of spermatozoa with the extenders; therefore it becomes necessary to improve semen management using enzymatic treatment. Our objective was to compare two cooling protocols for llama semen. Twelve ejaculates were incubated in 0.1% collagenase and then were divided into two aliquots. One was extended in lactose and egg yolk (LEY) (Protocol A: collagenase and SP present). The other aliquot was centrifuged, and the pellet was resuspended in LEY (Protocol B: collagenase and SP absent). Both samples were maintained at 5°C during 24 hr. Routine and DNA evaluations were carried out in raw and cooled semen. Both cooling protocols maintained sperm viability, membrane function and DNA fragmentation, with Protocol A showing a significantly lowered total and progressive motility (p < .05) and Protocol B showing a significant increase in chromatin decondensation (p < .05). Protocol A avoids centrifugation, reducing processing times and making application in the field simpler. However, as neither protocol showed a significant superiority over the other, studies should be carried out in vivo to evaluate the effect on pregnancy rates of the presence of collagenase and SP in semen samples prior to either cooling or freeze-thawing. © 2016 Blackwell Verlag GmbH.

Comparison of Cryopreservation Protocols (Single and Two-steps) and Thawing (Fast and Slow) for Canine Sperm.

PubMed

Brito, Maíra M; Lúcio, Cristina F; Angrimani, Daniel S R; Losano, João Diego A; Dalmazzo, Andressa; Nichi, Marcílio; Vannucchi, Camila I

2017-01-02

In addition to the existence of several cryopreservation protocols, no systematic research has been carried out in order to confirm the suitable protocol for canine sperm. This study aims to assess the effect of adding 5% glycerol during cryopreservation at 37°C (one-step) and 5°C (two-steps), in addition of testing two thawing protocols (37°C for 30 seconds, and 70°C for 8 seconds). We used 12 sperm samples divided into four experimental groups: Single-Step - Slow Thawing Group; Two-Step - Slow Thawing Group; Single-Step - Fast Thawing Group; and Two-Step - Fast Thawing Group. Frozen-thawed samples were submitted to automated analysis of sperm motility, evaluation of plasmatic membrane integrity, acrosomal integrity, mitochondrial activity, sperm morphology, sperm susceptibility to oxidative stress, and sperm binding assay to perivitellinic membrane of chicken egg yolk. Considering the comparison between freezing protocols, no statistical differences were verified for any of the response variables. When comparison between thawing protocols was performed, slow thawing protocol presented higher sperm count bound to perivitelline membrane of chicken egg yolk, compared to fast thawing protocol. Regardless of the freezing process, the slow thawing protocol can be recommended for the large scale cryopreservation of canine semen, since it shows a consistent better functional result.

Validation of the Pangao PG-800A11 wrist device assessed according to the European Society of Hypertension and the British Hypertension Society protocols.

PubMed

Xie, Peigen; Wang, Yanling; Xu, Xiaoying; Huang, Fei; Pan, Jingru

2015-04-01

The objective of this study was to determine the accuracy of the Pangao PG-800A11 wrist blood pressure monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010 and the protocol of the British Hypertension Society (BHS). The device evaluations were performed in 85 participants, 33 of whom were included according to the ESH-IP revision 2010 and 52 of whom were included on the basis of the requirements of the BHS protocol. The validation procedure and data analysis followed the protocols precisely. The device achieved an A/A grading for the BHS protocol and passed all phases of the ESH-IP revision 2010 protocol. The mean difference ±SD for the ESH and BHS protocols, respectively, was -0.6±4.5 and -0.8±6.2 mmHg for systolic pressure and 1.2±4.6 and -0.5±5.1 mmHg for diastolic pressure. The device maintained its A/A grading throughout the low, medium, and high-pressure ranges. The Pangao PG-800A11 wrist blood pressure monitor passed all requirements of the ESH-IP revision 2010 and achieved A/A grade of the BHS protocol in an adult population.

Verification of a Byzantine-Fault-Tolerant Self-stabilizing Protocol for Clock Synchronization

NASA Technical Reports Server (NTRS)

Malekpour, Mahyar R.

2008-01-01

This paper presents the mechanical verification of a simplified model of a rapid Byzantine-fault-tolerant self-stabilizing protocol for distributed clock synchronization systems. This protocol does not rely on any assumptions about the initial state of the system except for the presence of sufficient good nodes, thus making the weakest possible assumptions and producing the strongest results. This protocol tolerates bursts of transient failures, and deterministically converges within a time bound that is a linear function of the self-stabilization period. A simplified model of the protocol is verified using the Symbolic Model Verifier (SMV). The system under study consists of 4 nodes, where at most one of the nodes is assumed to be Byzantine faulty. The model checking effort is focused on verifying correctness of the simplified model of the protocol in the presence of a permanent Byzantine fault as well as confirmation of claims of determinism and linear convergence with respect to the self-stabilization period. Although model checking results of the simplified model of the protocol confirm the theoretical predictions, these results do not necessarily confirm that the protocol solves the general case of this problem. Modeling challenges of the protocol and the system are addressed. A number of abstractions are utilized in order to reduce the state space.

The Effect of Visual Supports on Performance of the TGMD-2 for Children with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Breslin, Casey M.; Rudisill, Mary E.

2011-01-01

The purpose of this study was to examine the effects of visual supports on the performance of the Test of Gross Motor Development (TGMD-2) for children with autism spectrum disorder (ASD). Participants (N = 22) performed the TGMD-2 under three different protocols (traditional protocol, picture task card protocol, and picture activity schedule…

Development of Protocol Materials in Teacher Education: A Case Study in Relating Theory and Practice.

ERIC Educational Resources Information Center

University of South Florida, Tampa.

A protocol materials program was developed to (1) train personnel who produce, use, and make budgetary decisions about protocol materials and (2) produce and disseminate effective materials and knowledge acquired as a result of the program. Two groups were selected to meet the goals of the program--one group consisting of project directors who…

Design and Evaluation of a Protocol to Assess Electronic Travel Aids for Persons Who Are Visually Impaired

ERIC Educational Resources Information Center

Havik, Else M.; Steyvers, Frank J. J. M.; van der Velde, Hanneke; Pinkster, J. Christiaan; Kooijman, Aart C.

2010-01-01

This study evaluated a protocol that was developed to assess how beneficial electronic travel aids are for persons who are visually impaired. Twenty persons with visual impairments used an electronic travel device (Trekker) for six weeks to conform to the protocol, which proved useful in identifying successful users of the device. (Contains 2…

Internet and Intranet Use with a PC: Effects of Adapter Cards, Windows Versions and TCP/IP Software on Networking Performance.

ERIC Educational Resources Information Center

Nieuwenhuysen, Paul

1997-01-01

Explores data transfer speeds obtained with various combinations of hardware and software components through a study of access to the Internet from a notebook computer connected to a local area network based on Ethernet and TCP/IP (transmission control protocol/Internet protocol) network protocols. Upgrading is recommended for higher transfer…

Comparison of protocols measuring diffusion and partition coefficients in the stratum corneum.

PubMed

Rothe, H; Obringer, C; Manwaring, J; Avci, C; Wargniez, W; Eilstein, J; Hewitt, N; Cubberley, R; Duplan, H; Lange, D; Jacques-Jamin, C; Klaric, M; Schepky, A; Grégoire, S

2017-07-01

Partition (K) and diffusion (D) coefficients are important to measure for the modelling of skin penetration of chemicals through the stratum corneum (SC). We compared the feasibility of three protocols for the testing of 50 chemicals in our main studies, using three cosmetics-relevant model chemicals with a wide range of logP values. Protocol 1: SC concentration-depth profile using tape-stripping (measures K SC/v and D SC /H SC 2 , where H SC is the SC thickness); Protocol 2A: incubation of isolated SC with chemical (direct measurement of K SC/v only) and Protocol 2B: diffusion through isolated SC mounted on a Franz cell (measures K SC/v and D SC /H SC 2 , and is based on Fick's laws). K SC/v values for caffeine and resorcinol using Protocol 1 and 2B were within 30% of each other, values using Protocol 2A were ~two-fold higher, and all values were within 10-fold of each other. Only indirect determination of K SC/v by Protocol 2B was different from the direct measurement of K SC/v by Protocol 2A and Protocol 1 for 7-EC. The variability of K SC/v for all three chemicals using Protocol 2B was higher compared to Protocol 1 and 2A. D SC /H SC 2 values for the three chemicals were of the same order of magnitude using all three protocols. Additionally, using Protocol 1, there was very little difference between parameters measured in pig and human SC. In conclusion, K SC/v, and D SC values were comparable using different methods. Pig skin might be a good surrogate for human skin for the three chemicals tested. Copyright © 2017 The Authors Journal of Applied Toxicology published by John Wiley & Sons Ltd. Copyright © 2017 The Authors Journal of Applied Toxicology published by John Wiley & Sons Ltd.

The acute effects of manipulating volume and load of back squats on countermovement vertical jump performance.

PubMed

Moir, Gavin L; Mergy, David; Witmer, Ca; Davis, Shala E

2011-06-01

The acute effects of manipulating the volume and load of back squats on subsequent countermovement vertical jump performance were investigated in the present study. Eleven National Collegiate Athletic Association division II female volleyball players performed 10 countermovement vertical jumps (CMJs) on a force platform 2 minutes after the last squat repetition of a high-load (HL) or high-volume (HV) squat protocol. Two minutes of rest was provided between each CMJ. The HL protocol culminated in the subjects having to perform 3 repetitions with a load equivalent to 90% 1 repetition maximum (1RM) back squat, whereas 12 repetitions with a load equivalent to 37% 1RM were performed in the HV protocol. During an initial familiarization session, knee angles were recorded during a series of CMJs, and these angles were used to control the depth of descent during all subsequent back squats. Jump height (JH) and vertical stiffness (VStiff) were calculated during each of the 10 CMJ, and the change in these variables after the 2 squat protocols was assessed using an analysis of variance model with repeated measures on 2 factors (Protocol [2-levels]; Time [2-levels]). There was no significant difference in JH after the HL and HV protocols (p > 0.05). A significant Protocol × Time interaction for VStiff resulted from the increase after the HL protocol being greater than that after the HV protocol (p = 0.03). The knee angles before the HL and HV protocols were significantly greater than those measured during the initial familiarization session (p = 0.001). Although neither squat protocol provided any benefit in improving JH, the heavy squat protocol produced greater increases in VStiff during the CMJ. Because of the increased VStiff caused by the HL protocol, volleyball coaches may consider using such protocols with their players to improve performance in jumps performed from a run such as the spike and on-court agility.

Disinfection of human cardiac valve allografts in tissue banking: systematic review report.

PubMed

Germain, M; Strong, D M; Dowling, G; Mohr, J; Duong, A; Garibaldi, A; Simunovic, N; Ayeni, O R

2016-12-01

Cardiovascular allografts are usually disinfected using antibiotics, but protocols vary significantly between tissue banks. It is likely that different disinfection protocols will not have the same level of efficacy; they may also have varying effects on the structural integrity of the tissue, which could lead to significant differences in terms of clinical outcome in recipients. Ideally, a disinfection protocol should achieve the greatest bioburden reduction with the lowest possible impact on tissue integrity. We conducted a systematic review of methods applied to disinfect cardiovascular tissues. The use of multiple broad spectrum antibiotics in conjunction with an antifungal agent resulted in the greatest reduction in bioburden. Antibiotic incubation periods were limited to less than 24 h, and most protocols incubated tissues at 4 °C, however one study demonstrated a greater reduction of microbial load at 37 °C. None of the reviewed studies looked at the impact of these disinfection protocols on the risk of infection or any other clinical outcome in recipients.

Isolating Spermathecae and Determining Mating Status of Drosophila suzukii: A Protocol for Tissue Dissection and Its Applications

PubMed Central

Avanesyan, Alina; Jaffe, Benjamin D.; Guédot, Christelle

2017-01-01

The spotted wing drosophila, Drosophila suzukii (Diptera: Drosophilidae), is an emerging invasive pest, which attacks a wide variety of fruits and berries. Although previous studies have focused on different aspects of D. suzukii reproductive biology, there are no protocols available for determining the mating status of D. suzukii females and drosophilids in general. In this study, a step-by-step protocol for tissue dissection, isolating spermathecae, and determining the mating status of females was developed specifically for D. suzukii. This protocol is an effective and relatively quick method for determining female mating status. It has important applications from exploring reproductive output of D. suzukii females to understanding the biology of D. suzukii winter morph, which presumably plays the main role in the overwintering of this invasive species. We demonstrated applicability of this protocol for both field collected flies and flies reared in the lab, including fly specimens stored on a long-term basis. PMID:28287438

The Simulation of Read-time Scalable Coherent Interface

NASA Technical Reports Server (NTRS)

Li, Qiang; Grant, Terry; Grover, Radhika S.

1997-01-01

Scalable Coherent Interface (SCI, IEEE/ANSI Std 1596-1992) (SCI1, SCI2) is a high performance interconnect for shared memory multiprocessor systems. In this project we investigate an SCI Real Time Protocols (RTSCI1) using Directed Flow Control Symbols. We studied the issues of efficient generation of control symbols, and created a simulation model of the protocol on a ring-based SCI system. This report presents the results of the study. The project has been implemented using SES/Workbench. The details that follow encompass aspects of both SCI and Flow Control Protocols, as well as the effect of realistic client/server processing delay. The report is organized as follows. Section 2 provides a description of the simulation model. Section 3 describes the protocol implementation details. The next three sections of the report elaborate on the workload, results and conclusions. Appended to the report is a description of the tool, SES/Workbench, used in our simulation, and internal details of our implementation of the protocol.

Leveraging the trusted clinician: documenting disease management program enrollment.

PubMed

Frazee, Sharon Glave; Kirkpatrick, Patricia; Fabius, Raymond; Chimera, Joseph

2007-02-01

The objective of this study was to test the hypothesis that an integrated disease management (IDM) protocol (patent-pending), which combines telephonic-delivered disease management (TDM) with a worksite-based primary care center and pharmacy delivery, would yield higher contact and enrollment rates than traditional remote disease management alone. IDM is characterized by the combination of standard TDM with a worksite-based primary care and pharmacy delivery protocol led by trusted clinicians. This prospective cohort study tracks contact and enrollment rates for persons assigned to either IDM or traditional TDM protocols, and compares them on contact and enrollment efficiency. The IDM protocol showed a significant improvement in contact and enrollment rates over traditional TDM. Integrating a worksite-based primary care and pharmacy delivery system led by trusted clinicians with traditional TDM increases contact and enrollment rates, resulting in higher patient engagement. The IDM protocol should be adopted by employers seeking higher returns on their investment in disease management programming.

Effect of two complex training protocols of back squats in blood indicators of muscular damage in military athletes

PubMed Central

Ojeda, Álvaro Huerta; Ríos, Luis Chirosa; Barrilao, Rafael Guisado; Ríos, Ignacio Chirosa; Serrano, Pablo Cáceres

2016-01-01

[Purpose] The aim of this study was to determine the variations in the blood muscular damage indicators post application of two complex training programs for back squats. [Subjects and Methods] Seven military athletes were the subjects of this study. The study had a quasi-experimental cross-over intra-subject design. Two complex training protocols were applied, and the variables to be measured were cortisol, metabolic creatine kinase, and total creatine kinase. For the statistical analysis, Student’s t-test was used. [Results] Twenty-four hours post effort, a significant decrease in cortisol level was shown for both protocols; however, the metabolic creatine kinase and total creatine kinase levels showed a significant increase. [Conclusion] Both protocols lowered the indicator of main muscular damage in the blood supply (cortisol). This proved that the work weight did not generate significant muscular damage in the 24-hour post-exercise period. PMID:27313356

The Emergency Public Relations Protocol: How to Work Effectively on Controversial Projects in an Academic Health Setting

PubMed Central

Rosser, B. R. Simon; Kilian, Gunna; West, William G.

2012-01-01

Certain research topics - including studies of sexual behavior, substance use, and HIV risk -- are more likely to be scrutinized by the media and groups opposed to this area of research. When studying topics that others might deem controversial, it is critical that researchers anticipate potential negative media events prior to their occurrence. By developing an Emergency Public Relations Protocol at the genesis of a study, researchers can identify and plan for events that might result in higher scrutiny. For each identified risk, a good protocol details procedures to enact before, during and after a media event. This manuscript offers recommendations for developing a protocol based on both Situational Crisis Communication Theory and our experience as an HIV prevention research group who recently experienced such an event. The need to have procedures in place to monitor and address social media is highlighted. PMID:23565067

The Emergency Public Relations Protocol: How to Work Effectively on Controversial Projects in an Academic Health Setting.

PubMed

Rosser, B R Simon; Kilian, Gunna; West, William G

2013-03-01

Certain research topics - including studies of sexual behavior, substance use, and HIV risk -- are more likely to be scrutinized by the media and groups opposed to this area of research. When studying topics that others might deem controversial, it is critical that researchers anticipate potential negative media events prior to their occurrence. By developing an Emergency Public Relations Protocol at the genesis of a study, researchers can identify and plan for events that might result in higher scrutiny. For each identified risk, a good protocol details procedures to enact before, during and after a media event. This manuscript offers recommendations for developing a protocol based on both Situational Crisis Communication Theory and our experience as an HIV prevention research group who recently experienced such an event. The need to have procedures in place to monitor and address social media is highlighted.

Using generalizability theory to develop clinical assessment protocols.

PubMed

Preuss, Richard A

2013-04-01

Clinical assessment protocols must produce data that are reliable, with a clinically attainable minimal detectable change (MDC). In a reliability study, generalizability theory has 2 advantages over classical test theory. These advantages provide information that allows assessment protocols to be adjusted to match individual patient profiles. First, generalizability theory allows the user to simultaneously consider multiple sources of measurement error variance (facets). Second, it allows the user to generalize the findings of the main study across the different study facets and to recalculate the reliability and MDC based on different combinations of facet conditions. In doing so, clinical assessment protocols can be chosen based on minimizing the number of measures that must be taken to achieve a realistic MDC, using repeated measures to minimize the MDC, or simply based on the combination that best allows the clinician to monitor an individual patient's progress over a specified period of time.

Effect of two complex training protocols of back squats in blood indicators of muscular damage in military athletes.

PubMed

Ojeda, Álvaro Huerta; Ríos, Luis Chirosa; Barrilao, Rafael Guisado; Ríos, Ignacio Chirosa; Serrano, Pablo Cáceres

2016-05-01

[Purpose] The aim of this study was to determine the variations in the blood muscular damage indicators post application of two complex training programs for back squats. [Subjects and Methods] Seven military athletes were the subjects of this study. The study had a quasi-experimental cross-over intra-subject design. Two complex training protocols were applied, and the variables to be measured were cortisol, metabolic creatine kinase, and total creatine kinase. For the statistical analysis, Student's t-test was used. [Results] Twenty-four hours post effort, a significant decrease in cortisol level was shown for both protocols; however, the metabolic creatine kinase and total creatine kinase levels showed a significant increase. [Conclusion] Both protocols lowered the indicator of main muscular damage in the blood supply (cortisol). This proved that the work weight did not generate significant muscular damage in the 24-hour post-exercise period.

Hymenoptera Venom Immunotherapy: Tolerance and Efficacy of an Ultrarush Protocol versus a Rush and a Slow Conventional Protocol

PubMed Central

Patella, Vincenzo; Florio, Giovanni; Giuliano, Ada; Oricchio, Carmine; Spadaro, Giuseppe; Marone, Gianni; Genovese, Arturo

2012-01-01

Background and Objective. Various venom immunotherapy (VIT) protocols are available for Hymenoptera allergy. Although adverse reactions (ADRs) to VIT are widely reported, controlled trials are still needed. We conducted a randomized prospective study to evaluate ADRs and the efficacy of three VIT regimens. Methods. 76 patients with Hymenoptera allergy, aged 16–76 years, were randomized to receive an ultrarush protocol (group A: 27 patients), a rush protocol (group B: 25), or a slow protocol (group C: 24). Aqueous venom extract was used in incremental phase and an adsorbed depot in maintenance phase. ADRs and accidental Hymenoptera stings during VIT were used to evaluate efficacy. Results. During incremental treatment, ADRs occurred in 1.99%, 3.7%, and 3.9% of patients in groups A, B, and C, and in 0.99%, 1.46%, and 2.7%, respectively, during maintenance. ADRs were significantly fewer in group A (incremental + maintenance phase) than in group C (1.29% versus 3.2%; P = 0.013). Reactions to accidental Hymenoptera stings did not differ among groups (1.1%, 1.2%, and 1.1%). Conclusion. Ultrarush was as effective as the rush and slow protocols and was associated with a low incidence of reactions to stings. This study indicates that ultrarush VIT is a valid therapeutic option for Hymenoptera allergy. PMID:22693521

Pathologic Outcomes in Men with Low-risk Prostate Cancer Who Are Potential Candidates for Contemporary, Active Surveillance Protocols.

PubMed

Kang, Ho Won; Lee, Joo Yong; Kwon, Jong Kyou; Jeh, Seong Uk; Jung, Hae Do; Cho, Kang Su; Ham, Won Sik; Choi, Young Deuk

2015-07-01

The purpose of this study was to determine whether contemporary active surveillance (AS) protocols could sufficiently discriminate significant from indolent tumors in men with low-risk prostate cancer. We retrospectively analyzed 312 patients with low-risk prostate cancer treated with radical prostatectomy. After exclusion of patients with fewer than 10 cores taken at biopsy and those who received neo-adjuvant treatment, 205 subjects satisfied the final inclusion criteria. Five widely accepted AS protocols were employed in this study. A total of 82.0% of the patients met the inclusion criteria of at least one protocol, and 18% did not meet any criteria of published AS protocols. A significant proportion of patients had non-organ-confined disease (8.6% to 10.6%) or a Gleason score of 7 or greater (18.6% to 23.9%) between the different AS criteria. Among patients who did not meet any AS criteria, 32.4% of patients had a pathologically insignificant cancer. Our results indicated a significant adverse pathology in patients who met the contemporary AS protocols. On the other hand, some patients in whom expectant management would be appropriate did not meet any criteria of published AS protocols. None of the clinical or histological criteria reported to date is able to sufficiently discriminate aggressive tumors from indolent ones.

Validation of the content of the prevention protocol for early sepsis caused by Streptococcus agalactiaein newborns

PubMed Central

da Silva, Fabiana Alves; Vidal, Cláudia Fernanda de Lacerda; de Araújo, Ednaldo Cavalcante

2015-01-01

Abstract Objective: to validate the content of the prevention protocol for early sepsis caused by Streptococcus agalactiaein newborns. Method: a transversal, descriptive and methodological study, with a quantitative approach. The sample was composed of 15 judges, 8 obstetricians and 7 pediatricians. The validation occurred through the assessment of the content of the protocol by the judges that received the instrument for data collection - checklist - which contained 7 items that represent the requisites to be met by the protocol. The validation of the content was achieved by applying the Content Validity Index. Result: in the judging process, all the items that represented requirements considered by the protocol obtained concordance within the established level (Content Validity Index > 0.75). Of 7 items, 6 have obtained full concordance (Content Validity Index 1.0) and the feasibility item obtained a Content Validity Index of 0.93. The global assessment of the instruments obtained a Content Validity Index of 0.99. Conclusion: the validation of content that was done was an efficient tool for the adjustment of the protocol, according to the judgment of experienced professionals, which demonstrates the importance of conducting a previous validation of the instruments. It is expected that this study will serve as an incentive for the adoption of universal tracking by other institutions through validated protocols. PMID:26444165

Improving post-stroke dysphagia outcomes through a standardized and multidisciplinary protocol: an exploratory cohort study.

PubMed

Gandolfi, Marialuisa; Smania, Nicola; Bisoffi, Giulia; Squaquara, Teresa; Zuccher, Paola; Mazzucco, Sara

2014-12-01

Stroke is a major cause of dysphagia. Few studies to date have reported on standardized multidisciplinary protocolized approaches to the management of post-stroke dysphagia. The aim of this retrospective cohort study was to evaluate the impact of a standardized multidisciplinary protocol on clinical outcomes in patients with post-stroke dysphagia. We performed retrospective chart reviews of patients with post-stroke dysphagia admitted to the neurological ward of Verona University Hospital from 2004 to 2008. Outcomes after usual treatment for dysphagia (T- group) were compared versus outcomes after treatment under a standardized diagnostic and rehabilitative multidisciplinary protocol (T+ group). Outcome measures were death, pneumonia on X-ray, need for respiratory support, and proportion of patients on tube feeding at discharge. Of the 378 patients admitted with stroke, 84 had dysphagia and were enrolled in the study. A significantly lower risk of in-hospital death (odds ratio [OR] 0.20 [0.53-0.78]), pneumonia (OR 0.33 [0.10-1.03]), need for respiratory support (OR 0.48 [0.14-1.66]), and tube feeding at discharge (OR 0.30 [0.09-0.91]) was recorded for the T+ group (N = 39) as compared to the T- group (N = 45). The adjusted OR showed no difference between the two groups for in-hospital death and tube feeding at discharge. Use of a standardized multidisciplinary protocolized approach to the management of post-stroke dysphagia may significantly reduce rates of aspiration pneumonia, in-hospital mortality, and tube feeding in dysphagic stroke survivors. Consistent with the study's exploratory purposes, our findings suggest that the multidisciplinary protocol applied in this study offers an effective model of management of post-stroke dysphagia.

Ex post facto assessment of diffusion tensor imaging metrics from different MRI protocols: preparing for multicentre studies in ALS.

PubMed

Rosskopf, Johannes; Müller, Hans-Peter; Dreyhaupt, Jens; Gorges, Martin; Ludolph, Albert C; Kassubek, Jan

2015-03-01

Diffusion tensor imaging (DTI) for assessing ALS-associated white matter alterations has still not reached the level of a neuroimaging biomarker. Since large-scale multicentre DTI studies in ALS may be hampered by differences in scanning protocols, an approach for pooling of DTI data acquired with different protocols was investigated. Three hundred and nine datasets from 170 ALS patients and 139 controls were collected ex post facto from a monocentric database reflecting different scanning protocols. A 3D correction algorithm was introduced for a combined analysis of DTI metrics despite different acquisition protocols, with the focus on the CST as the tract correlate of ALS neuropathological stage 1. A homogenous set of data was obtained by application of 3D correction matrices. Results showed that a fractional anisotropy (FA) threshold of 0.41 could be defined to discriminate ALS patients from controls (sensitivity/specificity, 74%/72%). For the remaining test sample, sensitivity/specificity values of 68%/74% were obtained. In conclusion, the objective was to merge data recorded with different DTI protocols with 3D correction matrices for analyses at group level. These post processing tools might facilitate analysis of large study samples in a multicentre setting for DTI analysis at group level to aid in establishing DTI as a non-invasive biomarker for ALS.

A harmonized segmentation protocol for hippocampal and parahippocampal subregions: Why do we need one and what are the key goals?

PubMed

Wisse, Laura E M; Daugherty, Ana M; Olsen, Rosanna K; Berron, David; Carr, Valerie A; Stark, Craig E L; Amaral, Robert S C; Amunts, Katrin; Augustinack, Jean C; Bender, Andrew R; Bernstein, Jeffrey D; Boccardi, Marina; Bocchetta, Martina; Burggren, Alison; Chakravarty, M Mallar; Chupin, Marie; Ekstrom, Arne; de Flores, Robin; Insausti, Ricardo; Kanel, Prabesh; Kedo, Olga; Kennedy, Kristen M; Kerchner, Geoffrey A; LaRocque, Karen F; Liu, Xiuwen; Maass, Anne; Malykhin, Nicolai; Mueller, Susanne G; Ofen, Noa; Palombo, Daniela J; Parekh, Mansi B; Pluta, John B; Pruessner, Jens C; Raz, Naftali; Rodrigue, Karen M; Schoemaker, Dorothee; Shafer, Andrea T; Steve, Trevor A; Suthana, Nanthia; Wang, Lei; Winterburn, Julie L; Yassa, Michael A; Yushkevich, Paul A; la Joie, Renaud

2017-01-01

The advent of high-resolution magnetic resonance imaging (MRI) has enabled in vivo research in a variety of populations and diseases on the structure and function of hippocampal subfields and subdivisions of the parahippocampal gyrus. Because of the many extant and highly discrepant segmentation protocols, comparing results across studies is difficult. To overcome this barrier, the Hippocampal Subfields Group was formed as an international collaboration with the aim of developing a harmonized protocol for manual segmentation of hippocampal and parahippocampal subregions on high-resolution MRI. In this commentary we discuss the goals for this protocol and the associated key challenges involved in its development. These include differences among existing anatomical reference materials, striking the right balance between reliability of measurements and anatomical validity, and the development of a versatile protocol that can be adopted for the study of populations varying in age and health. The commentary outlines these key challenges, as well as the proposed solution of each, with concrete examples from our working plan. Finally, with two examples, we illustrate how the harmonized protocol, once completed, is expected to impact the field by producing measurements that are quantitatively comparable across labs and by facilitating the synthesis of findings across different studies. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Assessment of the ability of wheelchair subjects with spinal cord injury to perform a specific protocol of shoulder training: a pilot study.

PubMed

Merolla, Giovanni; Dellabiancia, Fabio; Filippi, Maria Vittoria; De Santis, Elisa; Alpi, Daniele; Magrini, Paola; Porcellini, Giuseppe

2014-04-01

a regular program of exercises in subjects with spinal cord injury (SCI) can contribute to reduce the risk of upper extremities injuries. in this prospective laboratory study we tested the hypothesis that a training machine developed for able-body users is suitable for a shoulder training protocol in 11 paraplegic subjects with SCI. Overall subjects were assessed with the SCIM III, CS, DASH and standard shoulder examination. We set a protocol of shoulder exercises performed with a training machine. Overall subjects were able to perform the protocol but 2 did not complete the exercises n° 6 and 7. The position of the wheelchair during each exercise was recorded. Wheelchair position/loading level were significantly correlated with the protocol n° 2, 3 and 5 as well as BMI/loading level for the exercises n° 5 and 9 and age/loading level for the exercise n° 7. Clinical scores were neither correlated with loading nor with anthropometric data. FROM THE ANALYSIS OF DATA COLLECTED IN THIS STUDY ARISED THAT: 1) the training machine needs some adjustments for paraplegic subjects, 2) the training protocol was appropriate except for the exercises needing a torso-rotation and 3) the template for wheelchair position may be a valid guide for an optimal paraplegic shoulder training.

Fluid resuscitation for major burn patients with the TMMU protocol.

PubMed

Luo, Gaoxing; Peng, Yizhi; Yuan, Zhiqiang; Cheng, Wenguang; Wu, Jun; Tang, Jin; Huang, Yuesheng; Fitzgerald, Mark

2009-12-01

Fluid resuscitation is one of the critical treatments for the major burn patient in the early phases after injury. We evaluated the practice of fluid resuscitation for severely burned patients with the Third Military Medical University (TMMU) protocol, which is most widely used in many regions of China. Patients with major burns (>30% total body surface area (TBSA)) presenting to Southwest Hospital, Third Military Medical University, between January 2005 and October 2007, were included in this study. Fluid resuscitation was initiated by the TMMU protocol. A total of 71 patients were (46 adults and 25 children) included in this study. All patients survived the first 48 h after injury smoothly and none developed abdominal compartment syndrome or other recognised complications associated with fluid resuscitation. The average quantity of fluid infused was 3.3-61.33% more than that calculated based on the TMMU protocol in both adult and paediatric groups. The average urine output during the first 24h after injury was about 1.2 ml per kg body weight per hour in the two groups, but reached 1.2 ml and 1.7 ml during the second 24h in adult and pediatric groups, respectively. This study indicates that the TMMU protocol for fluid resuscitation is a feasible option for burn patients. Individualised resuscitation - guided by the physiological response to fluid administration - is still important as in other protocols.

Additional considerations are required when preparing a protocol for a systematic review with multiple interventions.

PubMed

Chaimani, Anna; Caldwell, Deborah M; Li, Tianjing; Higgins, Julian P T; Salanti, Georgia

2017-03-01

The number of systematic reviews that aim to compare multiple interventions using network meta-analysis is increasing. In this study, we highlight aspects of a standard systematic review protocol that may need modification when multiple interventions are to be compared. We take the protocol format suggested by Cochrane for a standard systematic review as our reference and compare the considerations for a pairwise review with those required for a valid comparison of multiple interventions. We suggest new sections for protocols of systematic reviews including network meta-analyses with a focus on how to evaluate their assumptions. We provide example text from published protocols to exemplify the considerations. Standard systematic review protocols for pairwise meta-analyses need extensions to accommodate the increased complexity of network meta-analysis. Our suggested modifications are widely applicable to both Cochrane and non-Cochrane systematic reviews involving network meta-analyses. Copyright © 2017 Elsevier Inc. All rights reserved.

The Lorazepam and Diazepam Protocol for Catatonia Due to General Medical Condition and Substance in Liaison Psychiatry.

PubMed

Lin, Chin-Chuen; Hung, Yi-Yung; Tsai, Meng-Chang; Huang, Tiao-Lai

2017-01-01

The lorazepam-diazepam protocol had been proved to rapidly and effectively relieve catatonia in patients with schizophrenia or mood disorder. This study aims to investigate the efficacy of lorazepam-diazepam protocol in catatonia due to general medical conditions (GMC) and substance. Patients with catatonia that required psychiatric intervention in various settings of a medical center were included. The lorazepam-diazepam protocol had been used to treat the catatonia due to GMC or substance according to DSM-IV criteria. The treatment response had been assessed by two psychiatrists. Eighteen (85.7%) of 21 catatonic patients due to GMC or substance became free of catatonia after the lorazepam-diazepam protocol. Five (23.8%) of the 21 patients had passed away with various causes of death and wide range of time periods after catatonia. Our results showed that the lorazepam-diazepam protocol could rapidly and effectively relieve catatonia due to GMC and substance.

Position paper: Rationale for the treatment of Wilms tumour in the UMBRELLA SIOP-RTSG 2016 protocol.

PubMed

van den Heuvel-Eibrink, Marry M; Hol, Janna A; Pritchard-Jones, Kathy; van Tinteren, Harm; Furtwängler, Rhoikos; Verschuur, Arnauld C; Vujanic, Gordan M; Leuschner, Ivo; Brok, Jesper; Rübe, Christian; Smets, Anne M; Janssens, Geert O; Godzinski, Jan; Ramírez-Villar, Gema L; de Camargo, Beatriz; Segers, Heidi; Collini, Paola; Gessler, Manfred; Bergeron, Christophe; Spreafico, Filippo; Graf, Norbert

2017-12-01

The Renal Tumour Study Group of the International Society of Paediatric Oncology (SIOP-RTSG) has developed a new protocol for the diagnosis and treatment of childhood renal tumours, the UMBRELLA SIOP-RTSG 2016 (the UMBRELLA protocol), to continue international collaboration in the treatment of childhood renal tumours. This protocol will support integrated biomarker and imaging research, focussing on assessing the independent prognostic value of genomic changes within the tumour and the volume of the blastemal component that survives preoperative chemotherapy. Treatment guidelines for Wilms tumours in the UMBRELLA protocol include recommendations for localized, metastatic, and bilateral disease, for all age groups, and for relapsed disease. These recommendations have been established by a multidisciplinary panel of leading experts on renal tumours within the SIOP-RTSG. The UMBRELLA protocol should promote international collaboration and research and serve as the SIOP-RTSG best available treatment standard.

Numerical approach for unstructured quantum key distribution

PubMed Central

Coles, Patrick J.; Metodiev, Eric M.; Lütkenhaus, Norbert

2016-01-01

Quantum key distribution (QKD) allows for communication with security guaranteed by quantum theory. The main theoretical problem in QKD is to calculate the secret key rate for a given protocol. Analytical formulas are known for protocols with symmetries, since symmetry simplifies the analysis. However, experimental imperfections break symmetries, hence the effect of imperfections on key rates is difficult to estimate. Furthermore, it is an interesting question whether (intentionally) asymmetric protocols could outperform symmetric ones. Here we develop a robust numerical approach for calculating the key rate for arbitrary discrete-variable QKD protocols. Ultimately this will allow researchers to study ‘unstructured' protocols, that is, those that lack symmetry. Our approach relies on transforming the key rate calculation to the dual optimization problem, which markedly reduces the number of parameters and hence the calculation time. We illustrate our method by investigating some unstructured protocols for which the key rate was previously unknown. PMID:27198739

Protocol Support for a New Satellite-Based Airspace Communication Network

NASA Technical Reports Server (NTRS)

Shang, Yadong; Hadjitheodosiou, Michael; Baras, John

2004-01-01

We recommend suitable transport protocols for an aeronautical network supporting Internet and data services via satellite. We study the characteristics of an aeronautical satellite hybrid network and focus on the problems that cause dramatically degraded performance of the Transport Protocol. We discuss various extensions to standard TCP that alleviate some of these performance problems. Through simulation, we identify those TCP implementations that can be expected to perform well. Based on the observation that it is difficult for an end-to-end solution to solve these problems effectively, we propose a new TCP-splitting protocol, termed Aeronautical Transport Control Protocol (AeroTCP). The main idea of this protocol is to use a fixed window for flow control and one duplicated acknowledgement (ACK) for fast recovery. Our simulation results show that AeroTCP can maintain higher utilization for the satellite link than end-to-end TCP, especially in high BER environment.

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

Comparison of inter-trial recovery times for the determination of critical power and W' in cycling.

PubMed

Karsten, Bettina; Hopker, James; Jobson, Simon A; Baker, Jonathan; Petrigna, Luca; Klose, Andreas; Beedie, Christopher

2017-07-01

Critical Power (CP) and W' are often determined using multi-day testing protocols. To investigate this cumbersome testing method, the purpose of this study was to compare the differences between the conventional use of a 24-h inter-trial recovery time with those of 3 h and 30 min for the determination of CP and W'. 9 moderately trained cyclists performed an incremental test to exhaustion to establish the power output associated with the maximum oxygen uptake (p[Formula: see text] max ), and 3 protocols requiring time-to-exhaustion trials at a constant work-rate performed at 80%, 100% and 105% of p[Formula: see text] max. Design: Protocol A utilised 24-h inter-trial recovery (CP 24 /W' 24 ), protocol B utilised 3-h inter-trial recovery (CP 3 /W' 3 ), and protocol C used 30-min inter-trial recovery period (CP 0.5 /W' 0.5 ). CP and W' were calculated using the inverse time (1/t) versus power (P) relation (P = W'(1/t) + CP). 95% Limits of Agreement between protocol A and B were -9 to 15 W; -7.4 to 7.8 kJ (CP/W') and between protocol A and protocol C they were -27 to 22 W; -7.2 to 15.1 kJ (CP/W'). Compared to criterion protocol A, the average prediction error of protocol B was 2.5% (CP) and 25.6% (W'), whilst for protocol C it was 3.7% (CP) and 32.9% (W'). 3-h and 30-min inter-trial recovery time protocols provide valid methods of determining CP but not W' in cycling.

Influence of basis images and skull position on evaluation of cortical bone thickness in cone beam computed tomography.

PubMed

Nascimento, Monikelly do Carmo Chagas; Boscolo, Solange Maria de Almeida; Haiter-Neto, Francisco; Santos, Emanuela Carla Dos; Lambrichts, Ivo; Pauwels, Ruben; Jacobs, Reinhilde

2017-06-01

The aim of this study was to assess the influence of the number of basis images and the orientation of the skull on the evaluation of cortical alveolar bone in cone beam computed tomography (CBCT). Eleven skulls with a total of 59 anterior teeth were selected. CBCT images were acquired by using 4 protocols, by varying the rotation of the tube-detector arm and the orientation of the skull (protocol 1: 360°/0°; protocol 2: 180°/0°; protocol 3: 180°/90°; protocol 4: 180°/180°). Observers evaluated cortical bone as absent, thin, or thick. Direct observation of the skulls was used as the gold standard. Intra- and interobserver agreement, as well as agreement of scoring between the 3 bone thickness classifications, were calculated by using the κ statistic. The Wilcoxon signed-rank test was used to compare the 4 protocols. For lingual cortical bone, protocol 1 showed no statistical difference from the gold standard. Higher reliability was found in protocol 3 for absent (κ = 0.80) and thin (κ = 0.47) cortices, whereas for thick cortical bone, protocol 2 was more consistent (κ = 0.60). In buccal cortical bone, protocol 1 obtained the highest agreement for absent cortices (κ = 0.61), whereas protocol 4 was better for thin cortical plates (κ = 0.38) and protocol 2 for thick cortical plates (κ = 0.40). No consistent effect of the number of basis images or head orientation for visual detection of alveolar bone was detected, except for lingual cortical bone, for which full rotation scanning showed improved visualization. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparison between publicly accessible publications, registries, and protocols of phase III trials indicated persistence of selective outcome reporting.

PubMed

Zhang, Sheng; Liang, Fei; Li, Wenfeng

2017-11-01

The decision to make protocols of phase III randomized controlled trials (RCTs) publicly accessible by leading journals was a landmark event in clinical trial reporting. Here, we compared primary outcomes defined in protocols with those in publications describing the trials and in trial registration. We identified phase III RCTs published between January 1, 2012, and June 30, 2015, in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, and The BMJ with available protocols. Consistency in primary outcomes between protocols and registries (articles) was evaluated. We identified 299 phase III RCTs with available protocols in this analysis. Out of them, 25 trials (8.4%) had some discrepancy for primary outcomes between publications and protocols. Types of discrepancies included protocol-defined primary outcome reported as nonprimary outcome in publication (11 trials, 3.7%), protocol-defined primary outcome omitted in publication (10 trials, 3.3%), new primary outcome introduced in publication (8 trials, 2.7%), protocol-defined nonprimary outcome reported as primary outcome in publication (4 trials, 1.3%), and different timing of assessment of primary outcome (4 trials, 1.3%). Out of trials with discrepancies in primary outcome, 15 trials (60.0%) had discrepancies that favored statistically significant results. Registration could be seen as a valid surrogate of protocol in 237 of 299 trials (79.3%) with regard to primary outcome. Despite unrestricted public access to protocols, selective outcome reporting persists in a small fraction of phase III RCTs. Only studies from four leading journals were included, which may cause selection bias and limit the generalizability of this finding. Copyright © 2017 Elsevier Inc. All rights reserved.

Evaluation of a new chest tube removal protocol using digital air leak monitoring after lobectomy: a prospective randomised trial.

PubMed

Brunelli, Alessandro; Salati, Michele; Refai, Majed; Di Nunzio, Luca; Xiumé, Francesco; Sabbatini, Armando

2010-01-01

The objective of this randomised trial was to assess the effectiveness of a new fast-track chest tube removal protocol taking advantage of digital monitoring of air leak compared to a traditional protocol using visual and subjective assessment of air leak (bubbles). One hundred and sixty-six patients submitted to pulmonary lobectomy for lung cancer were randomised in two groups with different chest tube removal protocols: (1) in the new protocol, chest tube was removed based on digitally recorded measurements of air leak flow; (2) in the traditional protocol, the chest tube removal was based on an instantaneous assessment of air leak during daily rounds. The two groups were compared in terms of chest tube duration, hospital stay and costs. The two groups were well matched for several preoperative and operative variables. Compared to the traditional protocol, the new digital recording protocol showed mean reductions in chest tube duration (p=0.0007), hospital stay (p=0.007) of 0.9 day, and a mean cost saving of euro 476 per patient (p=0.008). In the new chest tube removal protocol, 51% of patients had their chest tube removed by the second postoperative day versus only 12% of those in the traditional protocol. The application of a chest tube removal protocol using a digital drainage unit featuring a continuous recording of air leak was safe and cost effective. Although future studies are warranted to confirm these results in other settings, the use of this new protocol is now routinely applied in our practice. Copyright 2009 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Efficiency Improvement in a Busy Radiology Practice: Determination of Musculoskeletal Magnetic Resonance Imaging Protocol Using Deep-Learning Convolutional Neural Networks.

PubMed

Lee, Young Han

2018-04-04

The purposes of this study are to evaluate the feasibility of protocol determination with a convolutional neural networks (CNN) classifier based on short-text classification and to evaluate the agreements by comparing protocols determined by CNN with those determined by musculoskeletal radiologists. Following institutional review board approval, the database of a hospital information system (HIS) was queried for lists of MRI examinations, referring department, patient age, and patient gender. These were exported to a local workstation for analyses: 5258 and 1018 consecutive musculoskeletal MRI examinations were used for the training and test datasets, respectively. The subjects for pre-processing were routine or tumor protocols and the contents were word combinations of the referring department, region, contrast media (or not), gender, and age. The CNN Embedded vector classifier was used with Word2Vec Google news vectors. The test set was tested with each classification model and results were output as routine or tumor protocols. The CNN determinations were evaluated using the receiver operating characteristic (ROC) curves. The accuracies were evaluated by a radiologist-confirmed protocol as the reference protocols. The optimal cut-off values for protocol determination between routine protocols and tumor protocols was 0.5067 with a sensitivity of 92.10%, a specificity of 95.76%, and an area under curve (AUC) of 0.977. The overall accuracy was 94.2% for the ConvNet model. All MRI protocols were correct in the pelvic bone, upper arm, wrist, and lower leg MRIs. Deep-learning-based convolutional neural networks were clinically utilized to determine musculoskeletal MRI protocols. CNN-based text learning and applications could be extended to other radiologic tasks besides image interpretations, improving the work performance of the radiologist.

Comparison of eye lens dose on neuroimaging protocols between 16- and 64-section multidetector CT: achieving the lowest possible dose.

PubMed

Tan, J S P; Tan, K-L; Lee, J C L; Wan, C-M; Leong, J-L; Chan, L-L

2009-02-01

To our knowledge, there has been no study that compares the radiation dose delivered to the eye lens by 16- and 64-section multidetector CT (MDCT) for standard clinical neuroimaging protocols. Our aim was to assess radiation-dose differences between 16- and 64-section MDCT from the same manufacturer, by using near-identical neuroimaging protocols. Three cadaveric heads were scanned on 16- and 64-section MDCT by using standard neuroimaging CT protocols. Eye lens dose was measured by using thermoluminescent dosimeters (TLD), and each scanning was repeated to reduce random error. The dose-length product, volume CT dose index (CTDI(vol)), and TLD readings for each imaging protocol were averaged and compared between scanners and protocols, by using the paired Student t test. Statistical significance was defined at P < .05. The radiation dose delivered and eye lens doses were lower by 28.1%-45.7% (P < .000) on the 64-section MDCT for near-identical imaging protocols. On the 16-section MDCT, lens dose reduction was greatest (81.1%) on a tilted axial mode, compared with a nontilted helical mode for CT brain scans. Among the protocols studied, CT of the temporal bone delivered the greatest radiation dose to the eye lens. Eye lens radiation doses delivered by the 64-section MDCT are significantly lower, partly due to improvements in automatic tube current modulation technology. However, where applicable, protection of the eyes from the radiation beam by either repositioning the head or tilting the gantry remains the best way to reduce eye lens dose.

Frequency of whole breast irradiation (WBRT) after intraoperative radiotherapy (IORT) is strongly influenced by institutional protocol qualification criteria.

PubMed

Falco, Michał; Masojć, Bartłomiej; Milchert-Leszczyńska, Marta; Kram, Andrzej

2018-01-01

Accelerated partial breast irradiation (APBI) is a promising method of adjuvant radiotherapy for select patients. Intraoperative radiotherapy (IORT) is a form of APBI, and appropriate patient selection is important. The aim of our study was to analyse the influence of our protocol on the frequency of WBRT after IORT and our protocol's correlation with the reported use of WBRT according to TARGIT guidelines. We also aimed to verify how changes in our protocol influenced the frequency of WBRT. Between April 20, 2010 and May 10, 2017, we identified 207 patients irradiated with IORT for APBI. Ninety-one patients (44%) met the criteria for APBI only, while 116 (56%) should have been offered additional WBRT. Retrospective analysis showed that WBRT was applied statistically significantly less frequently compared with strict protocol indications: 99 patients (47.8%) received APBI only and 108 (51.2%) underwent adjuvant WBRT ( p  < 0.0001). Applying the TARGIT trial guidelines, 69 patients (33.4%) should have been offered WBRT ( p  < 0.0001), which is twice the number of patients treated with WBRT in our study. Changing the protocol to less restrictive criteria would have statistically significantly decreased the number of patients (95, 46%) offered WBRT ( p  < 0.0001). Following international guidelines, 46% of patients should receive WBRT after IORT, which is 1.5-2 times more than for the TARGIT criteria. In our analysis, a high percentage of patients (19%) did not receive WBRT after IORT despite the protocol recommendations. The chosen protocol strongly influences the frequency of adjuvant WBRT.

The effects of superset configuration on kinetic, kinematic, and perceived exertion in the barbell bench press.

PubMed

Weakley, Jonathon Js; Till, Kevin; Read, Dale B; Phibbs, Padraic J; Roe, Gregory; Darrall-Jones, Joshua; Jones, Ben L

2017-08-04

Training that is efficient and effective is of great importance to an athlete. One method of improving efficiency is by incorporating supersets into resistance training routines. However, the structuring of supersets is still unexplored. Therefore, the purpose of this study was to assess the effects of agonist-antagonist (A-A), alternate peripheral (A-P), and similar biomechanical (SB) superset configurations on rate of perceived exertion (RPE), kinetic and kinematic changes during the bench press. 10 subjects performed resistance training protocols in a randomized-crossover design, with magnitude-based inferences assessing changes/differences within and between protocols. Changes in RPE were very likely and almost certainly greater in the A-P and SB protocols when compared with the A-A, while all superset protocols had very likely to almost certain reductions in mean velocity and power from baseline. Reductions in mean velocity and power were almost certainly greater in the SB protocol, with differences between the A-A and A-P protocols being unclear. Decreases in peak force were likely and almost certain in the A-A and SB protocols respectively, with changes in A-P being unclear. Differences between these protocols showed likely greater decreases in SB peak forces when compared to A-A, with all other superset comparisons being unclear. This study demonstrates the importance of exercise selection when incorporating supersets into a training routine. It is suggested that the practitioner uses A-A supersets when aiming to improve training efficiency and minimize reductions in kinetic and kinematic output of the agonist musculature while completing the barbell bench press.

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.

Optimization of a sample processing protocol for recovery of Bacillus anthracis spores from soil

USGS Publications Warehouse

Silvestri, Erin E.; Feldhake, David; Griffin, Dale; Lisle, John T.; Nichols, Tonya L.; Shah, Sanjiv; Pemberton, A; Schaefer III, Frank W

2016-01-01

Following a release of Bacillus anthracis spores into the environment, there is a potential for lasting environmental contamination in soils. There is a need for detection protocols for B. anthracis in environmental matrices. However, identification of B. anthracis within a soil is a difficult task. Processing soil samples helps to remove debris, chemical components, and biological impurities that can interfere with microbiological detection. This study aimed to optimize a previously used indirect processing protocol, which included a series of washing and centrifugation steps. Optimization of the protocol included: identifying an ideal extraction diluent, variation in the number of wash steps, variation in the initial centrifugation speed, sonication and shaking mechanisms. The optimized protocol was demonstrated at two laboratories in order to evaluate the recovery of spores from loamy and sandy soils. The new protocol demonstrated an improved limit of detection for loamy and sandy soils over the non-optimized protocol with an approximate matrix limit of detection at 14 spores/g of soil. There were no significant differences overall between the two laboratories for either soil type, suggesting that the processing protocol will be robust enough to use at multiple laboratories while achieving comparable recoveries.

Protocols for treating patients with end-stage renal disease: a survey of undergraduate dental programs.

PubMed

Sturgill, Jeremiah; Howell, Scott; Perry, Maureen Munnelly; Kothari, Hemali

2016-11-01

Approximately 14% of Americans are living with chronic kidney disease (CKD). The prevalence of end-stage renal disease (ESRD), the result of progressing CKD continues to rise by 21,000 per year. There are no updated, evidence-based antibiotic prophylaxis guidelines for patients with renal disease undergoing dental treatment. The most recent was a scientific statement from the American Heart Association (AHA) in 2003. Presented in three parts, the goal of the first part of this study is to determine the current protocol being used to treat renal patients at U.S. dental schools. A 21 multiple-choice question survey was e-mailed to 58 clinic deans of accredited dental schools in the United States regarding renal treatment protocol details including antibiotic prophylaxis. Fifty-two percent of programs report having no established renal patient treatment protocol. For programs with a protocol, when using prophylactic antibiotics, 54% followed AHA protocol, whereas 62% used a modified protocol. There is a lack of consistent, established protocols among undergraduate dental programs. It is suggested that evidence-based guidelines for the safe treatment of patients be developed. © 2016 Special Care Dentistry Association and Wiley Periodicals, Inc.

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.

LAN (Local Area Network) Interoperability Study of Protocols Needed for Distributed Command and Control

DTIC Science & Technology

1985-03-01

model referred to by the study group . IMCKIiN cuINICATION 31215FOR SDATA TWSU•l Sa *BSTtEO POOTO• AA14FTICT’WI PEM1 ITS ...operating systems, compared the DOD and ISO networking protocol architecture models , the protocols for LAN’s developed by the IEEE and ANSI, reviewed and...be initiated, so as to provide the Air Force a roadmap to guide its * "technology develop •ents. 4,’ �/LAN 3-4 .°. SECTION 4.0

The Interface of Clinical Decision-Making With Study Protocols for Knowledge Translation From a Walking Recovery Trial.

PubMed

Hershberg, Julie A; Rose, Dorian K; Tilson, Julie K; Brutsch, Bettina; Correa, Anita; Gallichio, Joann; McLeod, Molly; Moore, Craig; Wu, Sam; Duncan, Pamela W; Behrman, Andrea L

2017-01-01

Despite efforts to translate knowledge into clinical practice, barriers often arise in adapting the strict protocols of a randomized, controlled trial (RCT) to the individual patient. The Locomotor Experience Applied Post-Stroke (LEAPS) RCT demonstrated equal effectiveness of 2 intervention protocols for walking recovery poststroke; both protocols were more effective than usual care physical therapy. The purpose of this article was to provide knowledge-translation tools to facilitate implementation of the LEAPS RCT protocols into clinical practice. Participants from 2 of the trial's intervention arms: (1) early Locomotor Training Program (LTP) and (2) Home Exercise Program (HEP) were chosen for case presentation. The two cases illustrate how the protocols are used in synergy with individual patient presentations and clinical expertise. Decision algorithms and guidelines for progression represent the interface between implementation of an RCT standardized intervention protocol and clinical decision-making. In each case, the participant presents with a distinct clinical challenge that the therapist addresses by integrating the participant's unique presentation with the therapist's expertise while maintaining fidelity to the LEAPS protocol. Both participants progressed through an increasingly challenging intervention despite their own unique presentation. Decision algorithms and exercise progression for the LTP and HEP protocols facilitate translation of the RCT protocol to the real world of clinical practice. The two case examples to facilitate translation of the LEAPS RCT into clinical practice by enhancing understanding of the protocols, their progression, and their application to individual participants.Video Abstract available for more insights from the authors (see Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A147).

40 CFR 161.70 - Acceptable protocols.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Development (OECD) Protocols. Tests conducted in accordance with the requirements and recommendations of the... data generated by the study will satisfy the requirements of this part. (c) Procedures for requesting...

Finite-data-size study on practical universal blind quantum computation

NASA Astrophysics Data System (ADS)

Zhao, Qiang; Li, Qiong

2018-07-01

The universal blind quantum computation with weak coherent pulses protocol is a practical scheme to allow a client to delegate a computation to a remote server while the computation hidden. However, in the practical protocol, a finite data size will influence the preparation efficiency in the remote blind qubit state preparation (RBSP). In this paper, a modified RBSP protocol with two decoy states is studied in the finite data size. The issue of its statistical fluctuations is analyzed thoroughly. The theoretical analysis and simulation results show that two-decoy-state case with statistical fluctuation is closer to the asymptotic case than the one-decoy-state case with statistical fluctuation. Particularly, the two-decoy-state protocol can achieve a longer communication distance than the one-decoy-state case in this statistical fluctuation situation.

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

PubMed

Cheikh Ismail, L; Knight, H E; Bhutta, Z; 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 selection of anthropometric personnel, equipment, and measurement and calibration protocols used to construct the new standards. Implementing these protocols at each study site ensures that the anthropometric data are of the highest quality to construct the international standards. © 2013 Royal College of Obstetricians and Gynaecologists.

Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol

PubMed Central

Agot, Kawango

2017-01-01

Background Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. Objective The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. Methods The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. Results The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (PrEP), conditional cash transfer (CCT), and contraceptives for females; and (4) referrals for HIV care among those identified as HIV-positive. The combination package platform selected is mobile health teams in an integrated services delivery model. A cross-sectional analysis will be conducted to determine the uptake of the interventions. To determine long-term impact, the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts (HIV-positive, PrEP, CCT, and HIV-negative) followed by using mobile phone text messages (short message service, SMS) and in-person surveys to prospectively assess prevention method uptake, adherence, and risk compensation behaviors. Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake. Conclusions The literature review, focus groups, and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical, behavioral, and structural interventions can have an impact on HIV risk reduction. Implementing this protocol will show the feasibility of delivering these services at scale. The MP3 Youth study is one of the few combination HIV prevention intervention protocols incorporating youth- and gender-specific interventions in one delivery setting. Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA settings. Trial Registration ClinicalTrials.gov NCT01571128; http://clinicaltrials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 (Archived by WebCite at http://www.webcitation.org/6nmioPd54) PMID:28274904

Periradicular Infiltration of the Cervical Spine: How New CT Scanner Techniques and Protocol Modifications Contribute to the Achievement of Low-Dose Interventions.

PubMed

Elsholtz, Fabian Henry Jürgen; Kamp, Julia Evi-Katrin; Vahldiek, Janis Lucas; Hamm, Bernd; Niehues, Stefan Markus

2018-06-18

 CT-guided periradicular infiltration of the cervical spine is an effective symptomatic treatment in patients with radiculopathy-associated pain syndromes. This study evaluates the robustness and safety of a low-dose protocol on a CT scanner with iterative reconstruction software.  A total of 183 patients who underwent periradicular infiltration therapy of the cervical spine were included in this study. 82 interventions were performed on a new CT scanner with a new intervention protocol using an iterative reconstruction algorithm. Spot scanning was implemented for planning and a basic low-dose setup of 80 kVp and 5 mAs was established during intermittent fluoroscopy. The comparison group included 101 prior interventions on a scanner without iterative reconstruction. The dose-length product (DLP), number of acquisitions, pain reduction on a numeric analog scale, and protocol changes to achieve a safe intervention were recorded.  The median DLP for the whole intervention was 24.3 mGy*cm in the comparison group and 1.8 mGy*cm in the study group. The median pain reduction was -3 in the study group and -2 in the comparison group. A 5 mAs increase in the tube current-time product was required in 5 patients of the study group.  Implementation of a new scanner and intervention protocol resulted in a 92.6 % dose reduction without a compromise in safety and pain relief. The dose needed here is more than 75 % lower than doses used for similar interventions in published studies. An increase of the tube current-time product was needed in only 6 % of interventions.   · The presented ultra-low-dose protocol allows for a significant dose reduction without compromising outcome.. · The protocol includes spot scanning for planning purposes and a basic setup of 80 kVp and 5 mAs.. · The iterative reconstruction algorithm is activated during fluoroscopy.. · Elsholtz FH, Kamp JE, Vahldiek JL et al. Periradicular Infiltration of the Cervical Spine: How New CT Scanner Techniques and Protocol Modifications Contribute to the Achievement of Low-Dose Interventions. Fortschr Röntgenstr 2018; DOI: 10.1055/a-0632-3930. © Georg Thieme Verlag KG Stuttgart · New York.

Economical impact associated with a biological therapy prioritization protocol in patients with rheumatoid arthritis in the Hospital of Sagunto.

PubMed

Borrás-Blasco, Joaquín; Casterá, M Dolores-Elvira; Cortes, Xavier; Rosique-Robles, J Dolores; Abad, F Javier

2014-11-01

Until 2010 the cost of biological treatments in Rheumatoid Arthritis (RA) was increasing annually by 15% in our hospital. In 1st January 2011, a Hospital Commission of Biological Therapies involving rheumatology and pharmacy services was created to improve the management of biological drugs and a biological therapy prioritization protocol in RA patients was also established to improve the efficient usage of biological drugs in RA. To evaluate the economic impact associated with a biological therapy prioritization protocol for RA patients in the Hospital of Sagunto. Observational, ambispective study comparing the associated cost of RA patients treated with biological drugs in the pre-protocol (2009 - 2010) versus post-protocol periods (2011 - 2012). RA patients treated with Abatacept (ABA), Adalimumab (ADA), Etanercept (ETN) or Infliximab (IFX) for at least 6 months during the study period (2009 - 2012) were included. In 2012, Tocilizumab (TCZ) was also included in the prioritization protocol. Prioritization protocol was established based on both clinical and economical aspects and supervised case by case by our Commission. Cost savings and economic impact were calculated using Spanish official prices. In the pre-protocol period (2009 - 2010), total expenses were increasing by €110,000, up to €1,761,000 in 2010 (€11,362 pat/year). After protocol implementation, total expenses decreased by 53,676€ on the 2010 - 2011 period, and 149,200€ on the 2011 - 2012 period. On the 2010 - 2011 period the cost of biological therapy per patient-year decreased 355€ (11,007€ pat/year) and additional 653€ (up to 10,354€ pat/year) by 2012, with a cumulative effect of the protocol implementation of 1,008€ per patient-year. In the pre-protocol period (2009), the annual cost/patient was 10.812€ with ETN, 10.942€ with IFX, 12.961€ with ADA and 12.739€ with ABA. By 1st January 2013, the annual cost per patient was 9,469€ with ETN, 10,579€ with IFX, 11,117€ with ADA, 13,540€ with ABA and 14,932€ with TCZ. The creation of our Commission of Biological Therapies is key to rational management of RA patients and optimization of resources, allowing us to save 200,000€ after 2-year efficiency protocol implementation.

Studying a population undergoing nutrition transition: a practical case study of dietary assessment in urban South African adolescents

PubMed Central

Zingoni, Chiedza; Norris, Shane A.; Griffiths, Paula L.; Cameron, Noël

2010-01-01

The South African Medical Research Council food frequency questionnaire (FFQ) and protocol was used to determine food intake in 83 adolescents from the Birth To Twenty study. The FFQ was piloted on a small group (n=8). Specific problems which resulted in overestimation of energy intake were identified. The protocol was modified and administered to the remainder of the adolescents and their caregivers. Reasonable energy intakes were obtained, and time spent completing the FFQ was reduced. The modified protocol was more successful in determining habitual food intake although it would benefit from validation against other dietary intake techniques. PMID:20852725

An Examination of the Design, Development, and Implementation of an Internet Protocol Version 6 Network: The ADTRAN Inc. Case Study

ERIC Educational Resources Information Center

Perigo, Levi

2013-01-01

In this dissertation, the author examined the capabilities of Internet Protocol version 6 (IPv6) in regard to replacing Internet Protocol version 4 (IPv4) as the internetworking technology for Medium-sized Businesses (MBs) in the Information Systems (IS) field. Transition to IPv6 is inevitable, and, thus, organizations are adopting this protocol…

A protocol using coho salmon to monitor Tongass National Forest Land and Resource Management Plan standards and guidelines for fish habitat.

Treesearch

M.D. Bryant; Trent McDonald; R. Aho; B.E. Wright; Michelle Bourassa Stahl

2008-01-01

We describe a protocol to monitor the effectiveness of the Tongass Land Management Plan (TLMP) management standards for maintaining fish habitat. The protocol uses juvenile coho salmon (Oncorhynchus kisutch) in small tributary streams in forested watersheds. We used a 3-year pilot study to develop detailed methods to estimate juvenile salmonid...

A Comparison of ectoparasite infestation by chigger mite larvae (Acarina: Trombiculidae) on resident and migratory birds in Chiapas, Mexico illustrating a rapid visual assessment protocol

Treesearch

Thomas V. Dietsch

2005-01-01

This study presents a protocol developed to rapidly assess ectoparasite prevalence and intensity. Using this protocol during a mist-netting project in two different coffee agroecosystems in Chiapas, Mexico, data were collected on ectoparasitic chigger mite larvae (Acarina: Trombiculidae) found on resident and migratory birds. Surprisingly high infestation rates were...

Improving Leishmania Species Identification in Different Types of Samples from Cutaneous Lesions

PubMed Central

Cruz-Barrera, Mónica L.; Ovalle-Bracho, Clemencia; Ortegon-Vergara, Viviana; Pérez-Franco, Jairo E.

2015-01-01

The discrimination of Leishmania species from patient samples has epidemiological and clinical relevance. In this study, different gene target PCR-restriction fragment length polymorphism (RFLP) protocols were evaluated for their robustness as Leishmania species discriminators in 61 patients with cutaneous leishmaniasis. We modified the hsp70-PCR-RFLP protocol and found it to be the most reliable protocol for species identification. PMID:25609727

The usefulness and reliability of fitness testing protocols for ice hockey players: a literature review.

PubMed

Nightingale, Steven C; Miller, Stuart; Turner, Anthony

2013-06-01

Ice hockey, like most sports, uses fitness testing to assess athletes. This study reviews the current commonly used fitness testing protocols for ice hockey players, discussing their predictive values and reliability. It also discusses a range of less commonly used measures and limitations in current testing protocols. The article concludes with a proposed testing program suitable for ice hockey players.

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

ERIC Educational Resources Information Center

Paez-Blarrina, Marisa; Luciano, Carmen; Gutierrez-Martinez, Olga; Valdivia, Sonsoles; Rodriguez-Valverde, Miguel; Ortega, Jose

2008-01-01

This study compares the effect of an acceptance-based protocol (ACT) and a cognitive control-based (CONT) protocol on three measures of pain coping: tolerance, self-report, and believability. Specific methodological controls were employed to further isolate the role of the value of participating in a pain task, compared to previous investigations…

Paperless protocoling of CT and MRI requests at an outpatient imaging center.

PubMed

Bassignani, Matthew J; Dierolf, David A; Roberts, David L; Lee, Steven

2010-04-01

We created our imaging center (IC) to move outpatient imaging from our busy inpatient imaging suite off-site to a location that is more inviting to ambulatory patients. Nevertheless, patients scanned at our IC still represent the depth and breadth of illness complexity seen with our tertiary care population. Thus, we protocol exams on an individualized basis to ensure that the referring clinician's question is fully answered by the exam performed. Previously, paper based protocoling was a laborious process for all those involved where the IC business office would fax the requests to various reading rooms for protocoling by the subspecialist radiologists who are 3 miles away at the main hospital. Once protocoled, reading room coordinators would fax back the protocoled request to the IC technical area in preparation for the next day's scheduled exams. At any breakdown in this process (e.g., lost paperwork), patient exams were delayed and clinicians and patients became upset. To improve this process, we developed a paper free process whereby protocoling is accomplished through scanning of exam requests into our PACS. Using the common worklist functionality found in most PACS, we created "protocoling worklists" that contain these scanned documents. Radiologists protocol these studies in the PACS worklist (with the added benefit of having all imaging and report data available), and subsequently, the technologists can see and act on the protocols they find in PACS. This process has significantly decreased interruptions in our busy reading rooms and decreased rework of IC staff.

Comparison of Physiological and Perceptual Responses Between Continuous and Intermittent Cycling

PubMed Central

Brasil, Roxana M.; Barreto, Ana C.; Nogueira, Leandro; Santos, Edil; Novaes, Jefferson S.; Reis, Victor M.

2011-01-01

The present study tested the hypothesis that the exercise protocol (continuous vs. intermittent) would affect the physiological response and the perception of effort during aquatic cycling. Each protocol was divided on four stages. Heart rate, arterial blood pressure, blood lactate concentration, central and peripheral rate of perceived exertion were collected in both protocols in aquatic cycling in 10 women (values are mean ± SD): age=32.8 ± 4.8 years; height=1.62 ± 0.05 cm; body mass=61.60 ± 5.19 kg; estimated body fat=27.13 ± 4.92%. Protocols were compared through two way ANOVA with Scheffé’s post-hoc test and the test of Mann- Whitney for rate of perceived exertion with α=0.05. No systematic and consistent differences in heart rate, arterial blood pressure, double product and blood lactate concentration were found between protocols. On the other hand, central rate of perceived exertion was significantly higher at stage four during continuous protocol compared with intermittent protocol (p=0.01), while the peripheral rate of perceived exertion presented higher values at stages three (p=0.02) and four (p=0.00) in the continuous protocol when compared to the results found in intermittent protocol. These findings suggest that although the aquatic cycling induces similar physiologic demands in both protocols, the rate of perceived exertion may vary according to the continuous vs. intermittent nature of the exercise. PMID:23487483

Automatic Determination of the Need for Intravenous Contrast in Musculoskeletal MRI Examinations Using IBM Watson's Natural Language Processing Algorithm.

PubMed

Trivedi, Hari; Mesterhazy, Joseph; Laguna, Benjamin; Vu, Thienkhai; Sohn, Jae Ho

2018-04-01

Magnetic resonance imaging (MRI) protocoling can be time- and resource-intensive, and protocols can often be suboptimal dependent upon the expertise or preferences of the protocoling radiologist. Providing a best-practice recommendation for an MRI protocol has the potential to improve efficiency and decrease the likelihood of a suboptimal or erroneous study. The goal of this study was to develop and validate a machine learning-based natural language classifier that can automatically assign the use of intravenous contrast for musculoskeletal MRI protocols based upon the free-text clinical indication of the study, thereby improving efficiency of the protocoling radiologist and potentially decreasing errors. We utilized a deep learning-based natural language classification system from IBM Watson, a question-answering supercomputer that gained fame after challenging the best human players on Jeopardy! in 2011. We compared this solution to a series of traditional machine learning-based natural language processing techniques that utilize a term-document frequency matrix. Each classifier was trained with 1240 MRI protocols plus their respective clinical indications and validated with a test set of 280. Ground truth of contrast assignment was obtained from the clinical record. For evaluation of inter-reader agreement, a blinded second reader radiologist analyzed all cases and determined contrast assignment based on only the free-text clinical indication. In the test set, Watson demonstrated overall accuracy of 83.2% when compared to the original protocol. This was similar to the overall accuracy of 80.2% achieved by an ensemble of eight traditional machine learning algorithms based on a term-document matrix. When compared to the second reader's contrast assignment, Watson achieved 88.6% agreement. When evaluating only the subset of cases where the original protocol and second reader were concordant (n = 251), agreement climbed further to 90.0%. The classifier was relatively robust to spelling and grammatical errors, which were frequent. Implementation of this automated MR contrast determination system as a clinical decision support tool may save considerable time and effort of the radiologist while potentially decreasing error rates, and require no change in order entry or workflow.

Research ethics review at University Eduardo Mondlane (UEM)/Maputo Central Hospital, Mozambique (2013-2016): a descriptive analysis of the start-up of a new research ethics committee (REC).

PubMed

Sacarlal, Jahit; Muchanga, Vasco; Mabutana, Carlos; Mabui, Matilde; Mariamo, Arlete; Cuamba, Assa Júlio; Fumo, Leida Artur; Silveira, Jacinta; Heitman, Elizabeth; Moon, Troy D

2018-05-23

Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique (CNBS) encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine (FM) of University Eduardo Mondlane (UEM) and the Maputo Central Hospital (MCH) established a joint Institutional Committee on Bioethics for Health (CIBS FM & MCH). This study examines the experience of the first 4 years of the CIBS FM & MCH. This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee's respective reviews and actions. A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master's degree research (42%). Descriptive cross-sectional studies were the most frequently reviewed research (61%). The majority were prospective (71%) and used quantitative methodologies (51%). The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS's average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS. Our results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training and ethical capacity building for CIBS across the country continue to be needed, as Mozambique develops greater capacity for research and makes progress toward improving the health of all its citizens.

Protocolized fluid therapy in brain-dead donors: the multicenter randomized MOnIToR trial.

PubMed

Al-Khafaji, Ali; Elder, Michele; Lebovitz, Daniel J; Murugan, Raghavan; Souter, Michael; Stuart, Susan; Wahed, Abdus S; Keebler, Ben; Dils, Dorrie; Mitchell, Stephanie; Shutterly, Kurt; Wilkerson, Dawn; Pearse, Rupert; Kellum, John A

2015-03-01

Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multicenter randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases the number of organs transplanted. We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A "protocol-guided fluid therapy" algorithm targeting the cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor, and our primary analysis was intention to treat. Secondary analyses included: (1) modified intention to treat where only subjects able to receive the intervention were included and (2) 12-month survival in transplant recipients. The study was stopped early. We enrolled 556 donors: 279 protocolized care and 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76 % of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor (95 % CI 3.14-3.63) with protocolized care compared to 3.29 usual care (95 % CI 3.04-3.54; mean difference, 0.1, 95 % CI -0.25 to 0.45; p = 0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95 % CI 3.23-3.8), but not statistically significantly (mean difference, 0.23, 95 % CI -0.15 to 0.61; p = 0.23). Among the 1,430 recipients of organs from study subjects with data available, 56 deaths (7.8 %) occurred in the protocolized care arm and 56 (7.9 %) in the usual care arm in the first year (hazard ratio: 0.97, p = 0.86). In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor.

Comparison of Diffusion MRI Acquisition Protocols for the In Vivo Characterization of the Mouse Spinal Cord: Variability Analysis and Application to an Amyotrophic Lateral Sclerosis Model

PubMed Central

Marcuzzo, Stefania; Bonanno, Silvia; Padelli, Francesco; Moreno-Manzano, Victoria; García-Verdugo, José Manuel; Bernasconi, Pia; Mantegazza, Renato; Bruzzone, Maria Grazia; Zucca, Ileana

2016-01-01

Diffusion-weighted Magnetic Resonance Imaging (dMRI) has relevant applications in the microstructural characterization of the spinal cord, especially in neurodegenerative diseases. Animal models have a pivotal role in the study of such diseases; however, in vivo spinal dMRI of small animals entails additional challenges that require a systematical investigation of acquisition parameters. The purpose of this study is to compare three acquisition protocols and identify the scanning parameters allowing a robust estimation of the main diffusion quantities and a good sensitivity to neurodegeneration in the mouse spinal cord. For all the protocols, the signal-to-noise and contrast-to noise ratios and the mean value and variability of Diffusion Tensor metrics were evaluated in healthy controls. For the estimation of fractional anisotropy less variability was provided by protocols with more diffusion directions, for the estimation of mean, axial and radial diffusivity by protocols with fewer diffusion directions and higher diffusion weighting. Intermediate features (12 directions, b = 1200 s/mm2) provided the overall minimum inter- and intra-subject variability in most cases. In order to test the diagnostic sensitivity of the protocols, 7 G93A-SOD1 mice (model of amyotrophic lateral sclerosis) at 10 and 17 weeks of age were scanned and the derived diffusion parameters compared with those estimated in age-matched healthy animals. The protocols with an intermediate or high number of diffusion directions provided the best differentiation between the two groups at week 17, whereas only few local significant differences were highlighted at week 10. According to our results, a dMRI protocol with an intermediate number of diffusion gradient directions and a relatively high diffusion weighting is optimal for spinal cord imaging. Further work is needed to confirm these results and for a finer tuning of acquisition parameters. Nevertheless, our findings could be important for the optimization of acquisition protocols for preclinical and clinical dMRI studies on the spinal cord. PMID:27560686

80-kVp CT Using Iterative Reconstruction in Image Space Algorithm for the Detection of Hypervascular Hepatocellular Carcinoma: Phantom and Initial Clinical Experience

PubMed Central

Hur, Saebeom; Kim, Soo Jin; Park, Ji Hoon; Han, Joon Koo; Choi, Byung Ihn

2012-01-01

Objective To investigate whether the low-tube-voltage (80-kVp), intermediate-tube-current (340-mAs) MDCT using the Iterative Reconstruction in Image Space (IRIS) algorithm improves lesion-to-liver contrast at reduced radiation dosage while maintaining acceptable image noise in the detection of hepatocellular carcinomas (HCC) in thin (mean body mass index, 24 ± 0.4 kg/m2) adults. Subjects and Methods A phantom simulating the liver with HCC was scanned at 50-400 mAs for 80, 100, 120 and 140-kVp. In addition, fifty patients with HCC who underwent multiphasic liver CT using dual-energy (80-kVp and 140-kVp) arterial scans were enrolled. Virtual 120-kVP scans (protocol A) and 80-kVp scans (protocol B) of the late arterial phase were reconstructed with filtered back-projection (FBP), while corresponding 80-kVp scans were reconstructed with IRIS (protocol C). Contrast-to-noise ratio (CNR) of HCCs and abdominal organs were assessed quantitatively, whereas lesion conspicuity, image noise, and overall image quality were assessed qualitatively. Results IRIS effectively reduced image noise, and yielded 29% higher CNR than the FBP at equivalent tube voltage and current in the phantom study. In the quantitative patient study, protocol C helped improve CNR by 51% and 172% than protocols A and B (p < 0.001), respectively, at equivalent radiation dosage. In the qualitative study, protocol C acquired the highest score for lesion conspicuity albeit with an inferior score to protocol A for overall image quality (p < 0.001). Mean effective dose was 2.63-mSv with protocol A and 1.12-mSv with protocols B and C. Conclusion CT using the low-tube-voltage, intermediate-tube-current and IRIS help improve lesion-to-liver CNR of HCC in thin adults during the arterial phase at a lower radiation dose when compared with the standard technique using 120-kVp and FBP. PMID:22438682

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.

Security of two-state and four-state practical quantum bit-commitment protocols

NASA Astrophysics Data System (ADS)

Loura, Ricardo; Arsenović, Dušan; Paunković, Nikola; Popović, Duška B.; Prvanović, Slobodan

2016-12-01

We study cheating strategies against a practical four-state quantum bit-commitment protocol [A. Danan and L. Vaidman, Quant. Info. Proc. 11, 769 (2012)], 10.1007/s11128-011-0284-4 and its two-state variant [R. Loura et al., Phys. Rev. A 89, 052336 (2014)], 10.1103/PhysRevA.89.052336 when the underlying quantum channels are noisy and the cheating party is constrained to using single-qubit measurements only. We show that simply inferring the transmitted photons' states by using the Breidbart basis, optimal for ambiguous (minimum-error) state discrimination, does not directly produce an optimal cheating strategy for this bit-commitment protocol. We introduce a strategy, based on certain postmeasurement processes and show it to have better chances at cheating than the direct approach. We also study to what extent sending forged geographical coordinates helps a dishonest party in breaking the binding security requirement. Finally, we investigate the impact of imperfect single-photon sources in the protocols. Our study shows that, in terms of the resources used, the four-state protocol is advantageous over the two-state version. The analysis performed can be straightforwardly generalized to any finite-qubit measurement, with the same qualitative results.

A genotyping protocol for multiple tissue types from the polyploid tree species Sequoia sempervirens (Cupressaceae)1

PubMed Central

Narayan, Lakshmi; Dodd, Richard S.; O’Hara, Kevin L.

2015-01-01

Premise of the study: Identifying clonal lineages in asexually reproducing plants using microsatellite markers is complicated by the possibility of nonidentical genotypes from the same clonal lineage due to somatic mutations, null alleles, and scoring errors. We developed and tested a clonal identification protocol that is robust to these issues for the asexually reproducing hexaploid tree species coast redwood (Sequoia sempervirens). Methods: Microsatellite data from four previously published and two newly developed primers were scored using a modified protocol, and clones were identified using Bruvo genetic distances. The effectiveness of this clonal identification protocol was assessed using simulations and by genotyping a test set of paired samples of different tissue types from the same trees. Results: Data from simulations showed that our protocol allowed us to accurately identify clonal lineages. Multiple test samples from the same trees were identified correctly, although certain tissue type pairs had larger genetic distances on average. Discussion: The methods described in this paper will allow for the accurate identification of coast redwood clones, facilitating future studies of the reproductive ecology of this species. The techniques used in this paper can be applied to studies of other clonal organisms as well. PMID:25798341

The effect of relational training on intelligence quotient: a case study.

PubMed

Vizcaíno-Torres, Rosa M; Ruiz, Francisco J; Luciano, Carmen; López-López, Juan C; Barbero-Rubio, Adrián; Gil, Enriquel

2015-01-01

Relational training protocols based on Relational Frame Theory (RFT) are showing promising results in increasing intelligence quotient. This case study aimed at analyzing the effect of a training protocol in fluency and flexibility in relational responding on intelligence quotient with a 4-year-old child. The child’s cognitive and psychomotor development was evaluated before and after the implementation of the training protocol using the McCarthy’s Aptitudes and Psychomotricity Scale (MSCA). The training protocol consisted of a multiple-exemplar-training (MET) in relational framing in accordance with COORDINATION (Phases 1 and 2), OPPOSITION (Phase 3 and 4), and COMPARISON (Phases 5 and 6). The MET protocol was implemented in approximately 12 hours throughout five and one half months. The training was effective in establishing relational responding in OPPOSITION and COMPARISON frames as well as in promoting fluency and flexibility in all the three types of trained relations. After this training, the child showed an increase above 1.5 SD in the General Cognitive Index of the MSCA (from 106 to 131). This case study adds further empirical evidence of the potential of RFT training to improve cognitive abilities and intelligence.

Performance evaluation of reactive and proactive routing protocol in IEEE 802.11 ad hoc network

NASA Astrophysics Data System (ADS)

Hamma, Salima; Cizeron, Eddy; Issaka, Hafiz; Guédon, Jean-Pierre

2006-10-01

Wireless technology based on the IEEE 802.11 standard is widely deployed. This technology is used to support multiple types of communication services (data, voice, image) with different QoS requirements. MANET (Mobile Adhoc NETwork) does not require a fixed infrastructure. Mobile nodes communicate through multihop paths. The wireless communication medium has variable and unpredictable characteristics. Furthermore, node mobility creates a continuously changing communication topology in which paths break and new one form dynamically. The routing table of each router in an adhoc network must be kept up-to-date. MANET uses Distance Vector or Link State algorithms which insure that the route to every host is always known. However, this approach must take into account the adhoc networks specific characteristics: dynamic topologies, limited bandwidth, energy constraints, limited physical security, ... Two main routing protocols categories are studied in this paper: proactive protocols (e.g. Optimised Link State Routing - OLSR) and reactive protocols (e.g. Ad hoc On Demand Distance Vector - AODV, Dynamic Source Routing - DSR). The proactive protocols are based on periodic exchanges that update the routing tables to all possible destinations, even if no traffic goes through. The reactive protocols are based on on-demand route discoveries that update routing tables only for the destination that has traffic going through. The present paper focuses on study and performance evaluation of these categories using NS2 simulations. We have considered qualitative and quantitative criteria. The first one concerns distributed operation, loop-freedom, security, sleep period operation. The second are used to assess performance of different routing protocols presented in this paper. We can list end-to-end data delay, jitter, packet delivery ratio, routing load, activity distribution. Comparative study will be presented with number of networking context consideration and the results show the appropriate routing protocol for two kinds of communication services (data and voice).

The impact of protocol on nurses' role stress: a longitudinal perspective.

PubMed

Dodd-McCue, Diane; Tartaglia, Alexander; Veazey, Kenneth W; Streetman, Pamela S

2005-04-01

The study examined the impact of a protocol directed at increasing organ donation on the role stress and work attitudes of critical care nurses involved in potential organ donation cases. The research examined whether the protocol could positively affect nurses' perceptions of role stress, and if so, could the work environment improvements be sustained over time. The Family Communication Coordinator (FCC) protocol promotes effective communication during potential organ donation cases using a multidisciplinary team approach. Previous research found it associated with improved donation outcomes and with improved perceptions of role stress by critical care nurses. However, the previous study lacked methodological rigor necessary to determine causality and sustainability over time. The study used a quasi-experimental prospective longitudinal design. The sample included critical care nurses who had experience with potential organ donation cases with the protocol. Survey data were collected at 4 points over 2 years. Surveys used previously validated and reliable measures of role stress (role ambiguity, role conflict, role overload) and work attitudes (commitment, satisfaction). Interviews supplemented these data. The nurses' perceptions of role stress associated with potential organ donation cases dramatically dropped after the protocol was implemented. All measures of role stress, particularly role ambiguity and role conflict, showed statistically significant and sustained improvement. Nurses' professional, unit, and hospital commitment and satisfaction reflect an increasingly positive workplace. The results demonstrate that the FCC protocol positively influenced the workplace through its impact on role stress over the first 2 years following its implementation. The findings suggest that similar protocols may be appropriate in improving the critical care environment by reducing the stress and uncertainty of professionals involved in other end-of-life situations. However, the most striking implication relates to the reality of the workplace: meeting the goals of improved patient care outcomes and those of improving the healthcare work environment are not mutually exclusive and may be mutually essential.

THE DEVELOPMENT AND INTER-LABORATORY VERIFICATION OF LC-MS LIBRARIES FOR ORGANIC CHEMICALS OF ENVIRONMENTAL CONCERN

EPA Science Inventory

The development, verification, and comparison study between LC-MS libraries for two manufacturers’ instruments and a verified protocol are discussed. The LC-MS library protocol was verified through an inter-laboratory study that involved Federal, State, and private laboratories. ...

Comment on "Dynamic quantum secret sharing"

NASA Astrophysics Data System (ADS)

Liao, Ci-Hong; Yang, Chun-Wei; Hwang, Tzonelish

2013-10-01

Hsu et al. (Quantum Inf Process 12:331-344,2013) proposed a dynamic quantum secret sharing (DQSS) protocol using the entanglement swapping of Bell states for an agent to easily join (or leave) the system. In 2013, Wang and Li (Quantum Inf Process 12(5):1991-1997, 2013) proposed a collusion attack on Hsu et al.'s DQSS protocol. Nevertheless, this study points out a new security issue on Hsu et al.'s DQSS protocol regarding to the honesty of a revoked agent. Without considering this issue, the DQSS protocol could be failed to provide secret sharing function.

COGNITIVE-HD study: protocol of an observational study of neurocognitive functioning and association with clinical outcomes in adults with end-stage kidney disease treated with haemodialysis.

PubMed

Palmer, Suetonia C; Ruospo, Marinella; Barulli, Maria Rosaria; Iurillo, Annalisa; Saglimbene, Valeria; Natale, Patrizia; Gargano, Letizia; Murgo, Angelo M; Loy, Clement; van Zwieten, Anita; Wong, Germaine; Tortelli, Rosanna; Craig, Jonathan C; Johnson, David W; Tonelli, Marcello; Hegbrant, Jörgen; Wollheim, Charlotta; Logroscino, Giancarlo; Strippoli, G F M

2015-12-09

The prevalence of cognitive impairment may be increased in adults with end-stage kidney disease compared with the general population. However, the specific patterns of cognitive impairment and association of cognitive dysfunction with activities of daily living and clinical outcomes (including withdrawal from treatment) among haemodialysis patients remain incompletely understood. The COGNITIVE impairment in adults with end-stage kidney disease treated with HemoDialysis (COGNITIVE-HD) study aims to characterise the age-adjusted and education-adjusted patterns of cognitive impairment (using comprehensive testing for executive function, perceptual-motor function, language, learning and memory, and complex attention) in patients on haemodialysis and association with clinical outcomes. A prospective, longitudinal, cohort study of 750 adults with end-stage kidney disease treated with long-term haemodialysis has been recruited within haemodialysis centres in Italy (July 2013 to April 2014). Testing for neurocognitive function was carried out by a trained psychologist at baseline to assess cognitive functioning. The primary study factor is cognitive impairment and secondary study factors will be specific domains of cognitive function. The primary outcome will be total mortality. Secondary outcomes will be cause-specific mortality, major cardiovascular events, fatal and non-fatal myocardial infarction and stroke, institutionalisation, and withdrawal from treatment at 12 months. This protocol was approved before study conduct by the following responsible ethics committees: Catania (approval reference 186/BE; 26/09/2013), Agrigento (protocol numbers 61-62; 28/6/2013), USL Roma C (CE 39217; 24/6/2013), USL Roma F (protocol number 0041708; 23/7/2013), USL Latina (protocol number 20090/A001/2011; 12/7/2013), Trapani (protocol number 3413; 16/7/2013) and Brindisi (protocol number 40259; 6/6/2013). All participants have provided written and informed consent and can withdraw from the study at any time. The findings of the study will be disseminated through peer-reviewed journals and national and international conference presentations and to the participants through communication within the dialysis network in which this study is conducted. 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/

Protocol standards and implementation within the digital engineering laboratory computer network (DELNET) using the universal network interface device (UNID). Part 2

NASA Astrophysics Data System (ADS)

Phister, P. W., Jr.

1983-12-01

Development of the Air Force Institute of Technology's Digital Engineering Laboratory Network (DELNET) was continued with the development of an initial draft of a protocol standard for all seven layers as specified by the International Standards Organization's (ISO) Reference Model for Open Systems Interconnections. This effort centered on the restructuring of the Network Layer to perform Datagram routing and to conform to the developed protocol standards and actual software module development of the upper four protocol layers residing within the DELNET Monitor (Zilog MCZ 1/25 Computer System). Within the guidelines of the ISO Reference Model the Transport Layer was developed utilizing the Internet Header Format (IHF) combined with the Transport Control Protocol (TCP) to create a 128-byte Datagram. Also a limited Application Layer was created to pass the Gettysburg Address through the DELNET. This study formulated a first draft for the DELNET Protocol Standard and designed, implemented, and tested the Network, Transport, and Application Layers to conform to these protocol standards.

Examining a New Method to Studying Velopharyngeal Structures in a Child With 22q11.2 Deletion Syndrome.

PubMed

Kollara, Lakshmi; Schenck, Graham; Jaskolka, Michael; Perry, Jamie L

2017-04-14

To date, no studies have imaged the velopharynx in children with 22q11.2 deletion syndrome (22q11.2 DS) without the use of sedation. Dysmorphology in velopharyngeal structures has been shown to have significant negative implications on speech among these individuals. This single case study was designed to assess the feasibility of a child-friendly magnetic resonance imaging (MRI) scanning protocol in this clinically challenging population and to determine the utility of this MRI protocol for future work in this area. One 6-year-old White girl diagnosed with 22q11.2 DS was imaged using a child-friendly, nonsedated MRI protocol. Quantitative and qualitative measures of the velopharyngeal area and associated structures were evaluated, and comparisons were made to age-matched control subjects with normal velopharyngeal anatomy. MRI data were successfully obtained using the child-friendly scanning protocol in the subject in the present study. Quantitative and qualitative differences of the levator muscle and associated velopharyngeal structures were noted. Using these MRI and structural analyses methods, insights related to muscle morphology can be obtained and considered as part of the research and clinical examination of children with 22q11.2 DS. The imaging protocol described in this study presents an effective means to counteract difficulties in imaging young children.

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

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

Nielsen, Yousef W., E-mail: yujwni01@heh.regionh.d; Eiberg, Jonas P., E-mail: Eiberg@dadlnet.d; Logager, Vibeke B., E-mail: viloe@heh.regionh.d

The purpose of this study was to determine the diagnostic performance of 3T whole-body magnetic resonance angiography (WB-MRA) using a hybrid protocol in comparison with a standard protocol in patients with peripheral arterial disease (PAD). In 26 consecutive patients with PAD two different protocols were used for WB-MRA: a standard sequential protocol (n = 13) and a hybrid protocol (n = 13). WB-MRA was performed using a gradient echo sequence, body coil for signal reception, and gadoterate meglumine as contrast agent (0.3 mmol/kg body weight). Two blinded observers evaluated all WB-MRA examinations with regard to presence of stenoses, as wellmore » as diagnostic quality and degree of venous contamination in each of the four stations used in WB-MRA. Digital subtraction angiography served as the method of reference. Sensitivity for detecting significant arterial disease (luminal narrowing {>=} 50%) using standard-protocol WB-MRA for the two observers was 0.63 (95%CI: 0.51-0.73) and 0.66 (0.58-0.78). Specificities were 0.94 (0.91-0.97) and 0.96 (0.92-0.98), respectively. In the hybrid protocol WB-MRA sensitivities were 0.75 (0.64-0.84) and 0.70 (0.58-0.8), respectively. Specificities were 0.93 (0.88-0.96) and 0.95 (0.91-0.97). Interobserver agreement was good using both the standard and the hybrid protocol, with {kappa} = 0.62 (0.44-0.67) and {kappa} = 0.70 (0.59-0.79), respectively. WB-MRA quality scores were significantly higher in the lower leg using the hybrid protocol compared to standard protocol (p = 0.003 and p = 0.03, observers 1 and 2). Distal venous contamination scores were significantly lower with the hybrid protocol (p = 0.02 and p = 0.01, observers 1 and 2). In conclusion, hybrid-protocol WB-MRA shows a better diagnostic performance than standard protocol WB-MRA at 3 T in patients with PAD.« less

Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

PubMed Central

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

2016-01-01

Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner’s right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol. PMID:27352244

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.

Oncosurgical Management of Liver Limited Stage IV Colorectal Cancer: Preliminary Data and Protocol for a Randomized Controlled Trial.

PubMed

Sutton, Paul; Vimalachandran, Dale; Poston, Graeme; Fenwick, Stephen; Malik, Hassan

2018-05-09

Colorectal cancer is the fourth commonest cancer and second commonest cause of cancer-related death in the United Kingdom. Almost 15% of patients have metastases on presentation. An increasing number of surgical strategies and better neoadjuvant treatment options are responsible for more patients undergoing resection of liver metastases, with prolonged survival in a select group of patients who present with synchronous disease. It is clear that the optimal strategy for the management of these patients remains unclear, and there is certainly a complete absence of Level 1 evidence in the literature. The objective of this study is to undertake preliminary work and devise an outline trial protocol to inform the future development of clinical studies to investigate the management of patients with liver limited stage IV colorectal cancer. We have undertaken some preliminary work and begun the process of designing a randomized controlled trial and present a draft trial protocol here. This study is at the protocol development stage only, and as such no results are available. There is no funding in place for this study, and no anticipated start date. We have presented preliminary work and an outline trial protocol which we anticipate will inform the future development of clinical studies to investigate the management of patients with liver limited stage IV colorectal cancer. We do not believe that the trial we have designed will answer the most significant clinical questions, nor that it is feasible to be delivered within the United Kingdom's National Health Service at this current time. ©Paul Sutton, Dale Vimalachandran, Graeme Poston, Stephen Fenwick, Hassan Malik. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.05.2018.

Stimulation of the ovaries in women with breast cancer undergoing fertility preservation: Alternative versus standard stimulation protocols; the study protocol of the STIM-trial.

PubMed

Dahhan, T; Balkenende, E M E; Beerendonk, C C M; Fleischer, K; Stoop, D; Bos, A M E; Lambalk, C B; Schats, R; van Golde, R J T; Schipper, I; Louwé, L A; Cantineau, A E P; Smeenk, J M J; de Bruin, J P; Reddy, N; Kopeika, Y; van der Veen, F; van Wely, M; Linn, S C; Goddijn, M

2017-10-01

Chemotherapy for breast cancer may have a negative impact on reproductive function due to gonadotoxicity. Fertility preservation via banking of oocytes or embryos after ovarian stimulation with FSH can increase the likelihood of a future live birth. It has been hypothesized that elevated serum estrogen levels during ovarian stimulation may induce breast tumour growth. This has led to the use of alternative stimulation protocols with addition of tamoxifen or letrozole. The effectiveness of these stimulation protocols in terms of oocyte yield is unknown. Randomized open-label trial comparing ovarian stimulation plus tamoxifen and ovarian stimulation plus letrozole with standard ovarian stimulation in the course of fertility preservation. The study population consists of women with breast cancer who opt for banking of oocytes or embryos, aged 18-43years at randomisation. Primary outcome is the number of oocytes retrieved at follicle aspiration. Secondary outcomes are number of mature oocytes retrieved, number of oocytes or embryos banked and peak E2 levels during ovarian stimulation. Concerning the lack of evidence on which stimulation protocol should be used in women with breast cancer and the growing demand for fertility preservation, there is an urgent need to undertake this study. By performing this study, we will be able to closely monitor the effects of various stimulation protocols in women with breast cancer and pave the way for long term follow up on the safety of this procedure in terms of breast cancer prognosis. NTR4108. Copyright © 2017 Elsevier Inc. All rights reserved.

The effects of physical therapy with neuromuscular electrical stimulation in patients with septic shock: Study protocol for a randomized cross-over design.

PubMed

Lago, Alessandra Fabiane; de Oliveira, Anamaria Siriani; de Souza, Hugo Celso Dutra; da Silva, João Santana; Basile-Filho, Anibal; Gastaldi, Ada Clarice

2018-02-01

Septic shock is a potentially fatal organ dysfunction caused by an imbalance of the host response to infection. The changes in microcirculation during sepsis can be explained by the alterations in the endothelial barrier function. Endothelial progenitor cells (EPCs) are a potential recovery index of endothelial function and it an increase in response to neuromuscular electrical stimulation (NMES) was demonstrated. Therefore, the objective of this study is to investigate the effects of NMES in patients with septic shock. It is a study protocol for a randomized cross-over design in an intensive care unit of a tertiary University hospital. Thirty-one patients aged 18 to 65 years. The study will be divided in 2 phases: the phase one will be held in the first 72 hours of septic shock and the phase two after 3 days of first assessment. Patients will be randomly selected to the intervention protocol (decubitus position with the limbs raised and NMES) and control protocol (decubitus position with the limbs raised without NMES). After this procedure, the patients will be allocated in group 1 (intervention and control protocol) or group 2 (control and intervention protocol) with a wash-out period of 4 to 6 hours between them. The main outcome is mobilization of EPCs. The secondary outcome is metabolic and hemodynamic data. A linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.

Using salivary cortisol to measure the effects of a Wilbarger protocol-based procedure on sympathetic arousal: a pilot study.

PubMed

Kimball, Judith G; Lynch, Keara M; Stewart, Kelli C; Williams, Nicole E; Thomas, Meghan A; Atwood, Kam D

2007-01-01

This study investigated changes in salivary cortisol, the stress hormone, after administration of a procedure based on the Wilbarger protocol to children diagnosed with sensory defensiveness (SD), a type of sensory modulation dysfunction. Using a single-subject design across participants, we studied 4 boys with SD ages 3 to 5 years. Each participant completed four sessions consisting of the collection of a saliva sample, administration of a procedure based on the Wilbarger protocol, 15 min of quiet neutral activities to allow time for any changes in cortisol level to manifest in the saliva, and the second collection of saliva. Saliva samples were analyzed using enzyme-linked immunosorbent assay (ELISA). Salivary cortisol levels in all participants changed after each of four applications of a procedure based on the Wilbarger protocol. The cortisol levels of 2 children whose levels were relatively higher on pretest decreased at each posttest. The levels of 1 child whose cortisol was higher on pretest three times decreased those three times and increased the one time the pretest cortisol was lower. The levels of 1 child who had the lowest cortisol levels of any of the children increased each time. Therefore, in all participants, cortisol moved in the direction of modulation. In these 4 boys, a procedure based on the Wilbarger protocol modulated cortisol levels toward a middle range. This pilot study indicates that there is an association between sympathetic nervous system response and the Wilbarger protocol-based procedure, as indicated by salivary cortisol levels.

Optimization of stent implantation using a high pressure inflation protocol.

PubMed

Vallurupalli, Srikanth; Bahia, Amit; Ruiz-Rodriguez, Ernesto; Ahmed, Zubair; Hakeem, Abdul; Uretsky, Barry F

2016-01-01

High-pressure inflation is the universal standard for stent deployment but a specific protocol for its use is lacking. We developed a standardized "pressure optimization protocol" (POP) using time to inflation pressure stability as an endpoint for determining the required duration of stent inflation. The primary study purpose was to determine the stent inflation time (IT) in a large patient cohort using the standardized inflation protocol, to correlate various patient and lesion characteristics with IT, and ascertain in an in vitro study the time for pressure accommodation within an inflation system. Six hundred fifteen stent implants in 435 patients were studied. Multivariate analysis was performed to determine predictors of longer ITs. In an in vitro study, various stents and balloons were inflated in air to determine the pressure accommodation time of the inflation system. The mean stent IT was 104 ± 41 sec (range 30-380 sec). Stent length was the only predictor of prolonged stent inflation. The "accommodation time" in vitro of the stent inflation system itself was 33 ± 24 sec. The protocol was safe requiring premature inflation termination in <3% of stent implants. No serious adverse events occurred. Achieving stable inflation pressure requires on average over 100 sec and may require several minutes in individual cases. Stent length increases IT. These results suggest that the widespread practice of rapid inflation/deflation may not be sufficient to fully expand the stent and that the use of a pressure stability protocol will allow for safe, predictable, and more complete stent deployment. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

An investigation into the nutritional status of patients receiving an Enhanced Recovery After Surgery (ERAS) protocol versus standard care following Oesophagectomy.

PubMed

Benton, Katie; Thomson, Iain; Isenring, Elisabeth; Mark Smithers, B; Agarwal, Ekta

2018-06-01

Enhanced Recovery After Surgery (ERAS) protocols have been effectively expanded to various surgical specialities including oesophagectomy. Despite nutrition being a key component, actual nutrition outcomes and specific guidelines are lacking. This cohort comparison study aims to compare nutritional status and adherence during implementation of a standardised post-operative nutritional support protocol, as part of ERAS, compared to those who received usual care. Two groups of patients undergoing resection of oesophageal cancer were studied. Group 1 (n = 17) underwent oesophagectomy between Oct 2014 and Nov 2016 during implementation of an ERAS protocol. Patients in group 2 (n = 16) underwent oesophagectomy between Jan 2011 and Dec 2012 prior to the implementation of ERAS. Demographic, nutritional status, dietary intake and adherence data were collected. Ordinal data was analysed using independent t tests, and categorical data using chi-square tests. There was no significant difference in nutrition status, dietary intake or length of stay following implementation of an ERAS protocol. Malnutrition remained prevalent in both groups at day 42 post surgery (n = 10, 83% usual care; and n = 9, 60% ERAS). A significant difference was demonstrated in adherence with earlier initiation of oral free fluids (p <0.008), transition to soft diet (p <0.004) and continuation of jejunostomy feeds on discharge (p <0.000) for the ERAS group. A standardised post-operative nutrition protocol, within an ERAS framework, results in earlier transition to oral intake; however, malnutrition remains prevalent post surgery. Further large-scale studies are warranted to examine individualised decision-making regarding nutrition support within an ERAS protocol.

In-shoe plantar pressure measurements for the evaluation and adaptation of foot orthoses in patients with rheumatoid arthritis: A proof of concept study.

PubMed

Tenten-Diepenmaat, Marloes; Dekker, Joost; Steenbergen, Menno; Huybrechts, Elleke; Roorda, Leo D; van Schaardenburg, Dirkjan; Bus, Sicco A; van der Leeden, Marike

2016-03-01

Improving foot orthoses (FOs) in patients with rheumatoid arthritis (RA) by using in-shoe plantar pressure measurements seems promising. The objectives of this study were to evaluate (1) the outcome on plantar pressure distribution of FOs that were adapted using in-shoe plantar pressure measurements according to a protocol and (2) the protocol feasibility. Forty-five RA patients with foot problems were included in this observational proof-of concept study. FOs were custom-made by a podiatrist according to usual care. Regions of Interest (ROIs) for plantar pressure reduction were selected. According to a protocol, usual care FOs were evaluated using in-shoe plantar pressure measurements and, if necessary, adapted. Plantar pressure-time integrals at the ROIs were compared between the following conditions: (1) no-FO versus usual care FO and (2) usual care FO versus adapted FO. Semi-structured interviews were held with patients and podiatrists to evaluate the feasibility of the protocol. Adapted FOs were developed in 70% of the patients. In these patients, usual care FOs showed a mean 9% reduction in pressure-time integral at forefoot ROIs compared to no-FOs (p=0.01). FO adaptation led to an additional mean 3% reduction in pressure-time integral (p=0.05). The protocol was considered feasible by patients. Podiatrists considered the protocol more useful to achieve individual rather than general treatment goals. A final protocol was proposed. Using in-shoe plantar pressure measurements for adapting foot orthoses for patients with RA leads to a small additional plantar pressure reduction in the forefoot. Further research on the clinical relevance of this outcome is required. Copyright © 2016. Published by Elsevier B.V.

Low Dose MDCT with Tube Current Modulation: Role in Detection of Urolithiasis and Patient Effective Dose Reduction

PubMed Central

Kakkar, Chandan; Sripathi, Smiti; Parakh, Anushri; Shrivastav, Rajendra

2016-01-01

Introduction Urolithiasis is one of the major, recurring problem in young individuals and CT being the commonest diagnostic modality used. In order to reduce the radiation dose to the patient who are young and as stone formation is a recurring process; one of the simplest way would be, low dose CT along with tube current modulation. Aim Aim of this study was to compare the sensitivity and specificity of low dose (70mAs) with standard dose (250mAs) protocol in detecting urolithiasis and to define the tube current and mean effective patient dose by these protocols. Materials and Methods A prospective study was conducted in 200 patients over a period of 2 years with acute flank pain presentation. CT was performed in 100 cases with standard dose and another 100 with low dose protocol using tube current modulation. Sensitivity and specificity for calculus detection, percentage reduction of dose and tube current with low dose protocol was calculated. Results Urolithiasis was detected in 138 patients, 67 were examined by high dose and 71 were by low dose protocol. Sensitivity and Specificity of low dose protocol was 97.1% and 96.4% with similar results found in high BMI patients. Tube current modulation resulted in reduction of effective tube current by 12.17%. The mean effective patient dose for standard dose was 10.33 mSv whereas 2.92 mSv for low dose with 51.13–53.8% reduction in low dose protocol. Conclusion The study has reinforced that low-dose CT with tube current modulation is appropriate for diagnosis of urolithiasis with significant reduction in tube current and patient effective dose. PMID:27437322

Low Dose MDCT with Tube Current Modulation: Role in Detection of Urolithiasis and Patient Effective Dose Reduction.

PubMed

Koteshwar, Prakashini; Kakkar, Chandan; Sripathi, Smiti; Parakh, Anushri; Shrivastav, Rajendra

2016-05-01

Urolithiasis is one of the major, recurring problem in young individuals and CT being the commonest diagnostic modality used. In order to reduce the radiation dose to the patient who are young and as stone formation is a recurring process; one of the simplest way would be, low dose CT along with tube current modulation. Aim of this study was to compare the sensitivity and specificity of low dose (70mAs) with standard dose (250mAs) protocol in detecting urolithiasis and to define the tube current and mean effective patient dose by these protocols. A prospective study was conducted in 200 patients over a period of 2 years with acute flank pain presentation. CT was performed in 100 cases with standard dose and another 100 with low dose protocol using tube current modulation. Sensitivity and specificity for calculus detection, percentage reduction of dose and tube current with low dose protocol was calculated. Urolithiasis was detected in 138 patients, 67 were examined by high dose and 71 were by low dose protocol. Sensitivity and Specificity of low dose protocol was 97.1% and 96.4% with similar results found in high BMI patients. Tube current modulation resulted in reduction of effective tube current by 12.17%. The mean effective patient dose for standard dose was 10.33 mSv whereas 2.92 mSv for low dose with 51.13-53.8% reduction in low dose protocol. The study has reinforced that low-dose CT with tube current modulation is appropriate for diagnosis of urolithiasis with significant reduction in tube current and patient effective dose.

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%.

In-Space Networking on NASA's SCAN Testbed

NASA Technical Reports Server (NTRS)

Brooks, David E.; Eddy, Wesley M.; Clark, Gilbert J.; Johnson, Sandra K.

2016-01-01

The NASA Space Communications and Navigation (SCaN) Testbed, an external payload onboard the International Space Station, is equipped with three software defined radios and a flight computer for supporting in-space communication research. New technologies being studied using the SCaN Testbed include advanced networking, coding, and modulation protocols designed to support the transition of NASAs mission systems from primarily point to point data links and preplanned routes towards adaptive, autonomous internetworked operations needed to meet future mission objectives. Networking protocols implemented on the SCaN Testbed include the Advanced Orbiting Systems (AOS) link-layer protocol, Consultative Committee for Space Data Systems (CCSDS) Encapsulation Packets, Internet Protocol (IP), Space Link Extension (SLE), CCSDS File Delivery Protocol (CFDP), and Delay-Tolerant Networking (DTN) protocols including the Bundle Protocol (BP) and Licklider Transmission Protocol (LTP). The SCaN Testbed end-to-end system provides three S-band data links and one Ka-band data link to exchange space and ground data through NASAs Tracking Data Relay Satellite System or a direct-to-ground link to ground stations. The multiple data links and nodes provide several upgradable elements on both the space and ground systems. This paper will provide a general description of the testbeds system design and capabilities, discuss in detail the design and lessons learned in the implementation of the network protocols, and describe future plans for continuing research to meet the communication needs for evolving global space systems.

Clinically applied procedures for human ovarian tissue cryopreservation result in different levels of efficacy and efficiency.

PubMed

Bastings, Lobke; Westphal, Johan R; Beerendonk, Catharina C M; Bekkers, Ruud L M; Zusterzeel, Petra L M; Hendriks, Jan C M; Braat, Didi D M; Peek, Ronald

2016-12-01

Different protocols are being used worldwide for the cryopreservation of human ovarian tissue for fertility preservation purposes. The efficiency and efficacy of the majority of these protocols has not been extensively evaluated, possibly resulting in sub-optimally cryopreserved ovarian tissue. To address the impact of this issue, we assessed the effects of two clinically successful human ovarian tissue slow-freezing cryopreservation procedures on the quality of the cryopreserved tissue. To differentiate between cryopreservation ( C ) versus thawing ( T ) related effects, four combinations of these two (A and B) very different cryopreservation/thawing protocols (A C A T , A C B T , B C A T , B C B T ) were studied. Before and after cryopreservation and thawing, the percentage of living and morphologically normal follicles, as well as the overall tissue viability, was assessed. Our experiments revealed that the choice of the cryopreservation protocol noticeably affected the overall tissue viability and percentage of living follicles, with a higher viability after protocol B C when compared to A C . No statistically significant differences in tissue viability were observed between the two thawing protocols, but thawing protocol B T required considerably more human effort and materials than thawing protocol A T . Tissue morphology was best retained using the B C A T combination. Our results indicate that extensive and systematical evaluation of clinically used protocols is warranted.

Incidence of C4d stain in protocol biopsies from renal allografts: results from a multicenter trial.

PubMed

Mengel, Michael; Bogers, Johannes; Bosmans, Jean-Louis; Serón, Daniel; Moreso, Francesc; Carrera, Marta; Gwinner, Wilfried; Schwarz, Anke; De Broe, Marc; Kreipe, Hans; Haller, Hermann

2005-05-01

C4d staining of renal allografts is regarded as an in situ marker of active humoral rejection. Few data are available about the incidence of C4d deposition in protocol biopsies compared to indication biopsies. To evaluate whether center-specific factors influence the incidence of C4d detection, we performed a multicenter study. From three European centers, 551 protocol and 377 indication biopsies were reclassified according to the updated Banff criteria and stained for C4d. C4d results were recorded as diffuse or focal positive and statistically correlated to clinical parameters, morphology and graft survival. In the protocol biopsies, a diffuse C4d stain was found in 2.0%, and a focal stain in 2.4%. In indication biopsies, 12.2% were diffusely and 8.5% focally C4d positive (protocol:indication p < 0.0001). The incidence of C4d deposition varied significantly between centers, attributable to variable numbers of presensitized patients with more C4d positive indication and protocol biopsies. Diffuse and focal C4d stain correlated with morphology of humoral rejection in protocol as well as in indication biopsies. Protocol biopsies show a significantly lower incidence of C4d deposition than indication biopsies. Subclinical C4d detection in protocol biopsies had no significant impact on allograft survival in our series.

Comparison of GnRH agonist, GnRH antagonist, and GnRH antagonist mild protocol of controlled ovarian hyperstimulation in good prognosis patients.

PubMed

Stimpfel, Martin; Vrtacnik-Bokal, Eda; Pozlep, Barbara; Virant-Klun, Irma

2015-01-01

The reports on how to stimulate the ovaries for oocyte retrieval in good prognosis patients are contradictory and often favor one type of controlled ovarian hyperstimulation (COH). For this reason, we retrospectively analyzed data from IVF/ICSI cycles carried out at our IVF Unit in good prognosis patients (aged <38 years, first and second attempts of IVF/ICSI, more than 3 oocytes retrieved) to elucidate which type of COH is optimal at our condition. The included patients were undergoing COH using GnRH agonist, GnRH antagonist or GnRH antagonist mild protocol in combination with gonadotrophins. We found significant differences in the average number of retrieved oocytes, immature oocytes, fertilized oocytes, embryos, transferred embryos, embryos frozen per cycle, and cycles with embryo freezing between studied COH protocols. Although there were no differences in live birth rate (LBR), miscarriages, and ectopic pregnancies between compared protocols, pregnancy rate was significantly higher in GnRH antagonist mild protocol in comparison with both GnRH antagonist and GnRH agonist protocols and cumulative LBR per cycle was significantly higher in GnRH antagonist mild protocol in comparison to GnRH agonist protocol. Our data show that GnRH antagonist mild protocol of COH could be the best method of choice in good prognosis patients.

Comparison of the ultrashort gonadotropin-releasing hormone agonist-antagonist protocol with microdose flare -up protocol in poor responders: a preliminary study.

PubMed

Berker, Bülent; Duvan, Candan İltemir; Kaya, Cemil; Aytaç, Ruşen; Satıroğlu, Hakan

2010-01-01

To determine the potential effect of the ultrashort gonadotropin-releasing hormone (GnRH) agonist/GnRH antagonist protocol versus the microdose GnRH agonist protocol in poor responders undergoing intracytoplasmic sperm injection (ICSI). The patients in the Agonist-Antagonist Group (n=41) were administered the ultrashort GnRH-agonist/ antagonist protocol, while the patients in the Microdose Group (n=41) were stimulated according to the microdose flare-up protocol. The mean number of mature oocytes retrieved was the primary outcome measure. Fertilization rate, implantation rate per embryo and clinical pregnancy rates were secondary outcome measures. There was no differenc between the mean number of mature oocytes retrieved in the two groups. There were also no statistical differences between the two groups in terms of peak serum E2 level, canceled cycles, endometrial thickness on hCG day, number of 2 pronucleus and number of embryos transferred. However, the total gonadotropin consumption and duration of stimulation were significantly higher with the Agonist-Antagonist Group compared with the Microdose Group. The implantation and clinical pregnancy rates were similar between the two groups. Despite the high dose of gonadotropin consumption and longer duration of stimulation with the ultrashort GnRH agonist/ antagonist protocol, it seems that the Agonist-Antagonist Protocol is not inferior to the microdose protocol in poor responders undergoing ICSI.

Study on Quality of IUD Services Provided by Trained Professionals at Teaching Institutes.

PubMed

Prasad, Noopur; Jain, M L; Meena, B S

2018-06-01

Access the completeness in IUD services provided by trained professionals and find out the weak links. Study was conducted on 100 IUD trained professionals of tertiary care hospital and nursing teaching institute. All were given questionnaire that was duly filled by them. Data obtained were analysed. Protocols of case selection, pre-insertion counselling, insertion process and follow-up were assessed. All the four criteria were assessed on score of ten. Study group could not get ten points under any of the set criteria. Average of 53% case selection, 31.4% pre-insertion counselling, 42.5% insertion protocols and 46.1% follow-up counselling criteria were observed by study group. Highest compliance of protocols was seen among postgraduate students. Although IUD training is given to all medical professionals and IUD facility is available up to subcentres but the study shows that completeness in services is still lacking. Ensuring ideal place for IUD insertion, proper case selection, use of specific instruments for insertion and observance of insertion protocols are very vital for the success of IUD.

Evaluation of a Low-risk Mild Traumatic Brain Injury and Intracranial Hemorrhage Emergency Department Observation Protocol.

PubMed

Yun, Brian J; Borczuk, Pierre; Wang, Lulu; Dorner, Stephen; White, Benjamin A; Raja, Ali S

2017-11-20

Among emergency physicians, there is wide variation in admitting practices for patients who suffered a mild traumatic brain injury (TBI) with an intracranial hemorrhage (ICH). The purpose of this study was to evaluate the effects of implementing a protocol in the emergency department (ED) observation unit for patients with mild TBI and ICH. This retrospective cohort study was approved by the institutional review board. Study subjects were patients ≥ 18 years of age with an International Classification of Diseases code corresponding to a traumatic ICH and admitted to an ED observation unit (EDOU) of an urban, academic Level I trauma center between February 1, 2015, and January 31, 2017. Patient data and discharge disposition were abstracted from the electronic health record, and imaging data, from the final neuroradiologist report. To measure kappa, two abstractors independently collected data for presence of neuro deficit from a 10% random sample of the medical charts. Using a multivariable logistic regression model with a propensity score of the probability of placement in the EDOU before and after protocol implementation as a covariate, we sought to determine the pre-post effects of implementing a protocol on the composite outcome of admission to the floor, intensive care unit, or operating room from the EDOU and the proportion of patients with worsening findings on repeat computed tomography (CT) head scan in the EDOU. A total of 379 patients were identified during the study period; 83 were excluded as they were found to have no ICH on chart review. Inter-rater reliability kappa statistic was 0.63 for 30 charts. Among the 296 patients who remained eligible and comprised the study population, 143 were in the preprotocol period and 153 after protocol implementation. The EDOU protocol was associated with an independently statistically significant decreased odds ratio (OR) for admission or worsening ICH on repeat CT scan (OR = 0.45, 95% confidence interval [CI] = 0.25-0.82, p = 0.009) in the observation unit. After a stay in the EDOU, 26% (37/143) of patients required an inpatient admission before implementation of the protocol and 13% (20/153) of patients required an inpatient admission after protocol implementation. There was no statistically significant difference in log transformed EDOU length of stay (LOS) between the groups after adjusting for propensity score (p = 0.34). While there was no difference in EDOU LOS, implementing a low-risk mild TBI and ICH protocol in the EDOU may decrease the rate of inpatient admissions from the EDOU. A protocol-driven observation unit may help physicians by standardizing eligibility criteria and by providing guidance on management. As the propensity score method limits our ability to create a straightforward predictive model, a future larger study should validate the results. © 2017 by the Society for Academic Emergency Medicine.

Stalking Antibiotic-Resistant Bacteria in Common Vegetables

ERIC Educational Resources Information Center

Brock, David; Boeke, Caroline; Josowitz, Rebecca; Loya, Katherine

2004-01-01

The study developed a simple experimental protocol for studying antibiotic resistant bacteria that will allow students to determine the proportion of such bacteria found on common fruit and vegetable crops. This protocol can open up the world of environmental science and show how human behavior can dramatically alter ecosystems.

Broken symmetry in a two-qubit quantum control landscape

NASA Astrophysics Data System (ADS)

Bukov, Marin; Day, Alexandre G. R.; Weinberg, Phillip; Polkovnikov, Anatoli; Mehta, Pankaj; Sels, Dries

2018-05-01

We analyze the physics of optimal protocols to prepare a target state with high fidelity in a symmetrically coupled two-qubit system. By varying the protocol duration, we find a discontinuous phase transition, which is characterized by a spontaneous breaking of a Z2 symmetry in the functional form of the optimal protocol, and occurs below the quantum speed limit. We study in detail this phase and demonstrate that even though high-fidelity protocols come degenerate with respect to their fidelity, they lead to final states of different entanglement entropy shared between the qubits. Consequently, while globally both optimal protocols are equally far away from the target state, one is locally closer than the other. An approximate variational mean-field theory which captures the physics of the different phases is developed.

Classification of pregnancies of unknown location according to four different hCG-based protocols.

PubMed

Fistouris, J; Bergh, C; Strandell, A

2016-10-01

How do four protocols based on serial human chorionic gonadotropin (hCG) measurements perform when classifying pregnancies of unknown location (PULs) as low or high risk of being an ectopic pregnancy (EP)? The use of cut-offs in hCG level changes published by NICE, and a logistic regression model, M4, correctly classify more PULs as high risk, compared with two other protocols. A logistic regression model, M4, based on the mean of two consecutive hCG values and the hCG ratio (hCG 48 h/hCG 0 h) that classify PULs into low- and high-risk groups for triage purposes, identifies more EPs than a protocol using the cut-offs between a 13% decline and a 66% rise in hCG levels over 48 h. A retrospective comparative study of four different hCG-based protocols classifying PULs as low or high risk of being an EP was performed at a gynaecological emergency unit over 3 years. We identified 915 women with a PUL. Initial transvaginal ultrasonography (TVS) findings categorised 187 of the PULs as probable intrauterine pregnancies (IUPs) and 16 as probable EPs. The rate of change in hCG levels over 48 h was calculated for each patient and subjected to three different hCG threshold intervals and a logistic regression model for outcome prediction. Each PUL was subsequently dichotomised to either low-risk (i.e. failed PUL/IUP) or high-risk (i.e. EP) classification, which allowed us to compare the diagnostic performance. In 'Protocol A', a PUL was classified as low risk if >13% hCG level decline or >66% hCG level rise was achieved; otherwise, the PUL was classified as high risk of being an EP. 'Protocol B' classified a PUL as low or high risk using cut-offs of 35-50% declining hCG levels and of 53% rising hCG levels. Similarly, 'Protocol C' used hCG level cut-offs published by NICE, 50% for declining hCG levels and 63% for rising hCG levels. Finally, if a logistic regression model 'Protocol M4' calculated a ≥5% risk of the PUL being an EP, it was classified as high risk, and otherwise the PUL was classified as low risk. When the time interval between two hCG measurements failed to meet an exact 48 h, extrapolation and interpolation of hCG values was made, using log linear transformation. Protocols A, B, C and M4 classified 73, 66, 55 and 56% of PULs as low risk. The sensitivity for protocols A, B, C and M4 was 68% (95% confidence interval (CI) 61-75%), 81% (74-86%), 87% (82-92%) and 88% (83-93%), respectively. The specificity was 82% (80-85%), 77% (74-80%), 66% (62-69%) and 67% (63-70%) for protocols A, B, C and M4, respectively. All comparisons of sensitivity and specificity between the protocols were statistically significant except for protocol C versus protocol M4. In protocol C, 87% (66-97%) of misclassified EPs had rising hCG levels, compared with 19% (6-41%) for protocol M4 (P < 0.01). In a secondary analysis excluding probable IUPs and probable EPs, the results for 712 PULs were analysed. The sensitivity subsequently remained stable for all protocols. Protocol M4 reached a 78% (74-81%) specificity, which was significantly higher than 70% (66-74%) for protocol C (P = 0.01) and protocol M4 classified 63% of PULs as low risk compared with 58% for protocol C. The retrospective design of the study is a limitation. The results are derived from a population where laparoscopy played an important role in PUL management and diagnosis of EPs, although it did reflect real clinical practice. Although we tried to adhere to definitions of PUL and final outcomes as in previous studies and a recent consensus statement, potential differences in this regard must be acknowledged. Where the time interval between two serial hCG measurements deviated from 48 h we estimated 48 h hCG values. A logistic regression model, M4, classifies more PULs correctly as low risk in a selected PUL population without probable IUPs and EPs and identifies as many EPs, in comparison with the cut-offs available in the NICE guideline. This advantage for model M4 may result in a reduction of unnecessary follow-up visits, when fewer low-risk PULs are misclassified as high risk. These findings, however, ought to be clarified in a randomised controlled trial. The study was supported by LUA/ALF grant No. 70940. There are no competing interests. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A randomized trial of protocol-based care for early septic shock.

PubMed

Yealy, Donald M; Kellum, John A; Huang, David T; Barnato, Amber E; Weissfeld, Lisa A; Pike, Francis; Terndrup, Thomas; Wang, Henry E; Hou, Peter C; LoVecchio, Frank; Filbin, Michael R; Shapiro, Nathan I; Angus, Derek C

2014-05-01

In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock, mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT), in which intravenous fluids, vasopressors, inotropes, and blood transfusions were adjusted to reach central hemodynamic targets, than among those receiving usual care. We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary. In 31 emergency departments in the United States, we randomly assigned patients with septic shock to one of three groups for 6 hours of resuscitation: protocol-based EGDT; protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions; or usual care. The primary end point was 60-day in-hospital mortality. We tested sequentially whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy. Secondary outcomes included longer-term mortality and the need for organ support. We enrolled 1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based standard therapy, and 456 to usual care. Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids, vasopressors, inotropes, and blood transfusions. By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 81 in the protocol-based standard-therapy group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care, 1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83; relative risk with protocol-based EGDT vs. protocol-based standard therapy, 1.15; 95% CI, 0.88 to 1.51; P=0.31). There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support. In a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes. (Funded by the National Institute of General Medical Sciences; ProCESS ClinicalTrials.gov number, NCT00510835.).

Development and Implementation of Clinical Trial Protocol Templates at the National Institute of Allergy and Infectious Diseases

PubMed Central

Bridge, Heather; Smolskis, Mary; Bianchine, Peter; Dixon, Dennis O.; Kelly, Grace; Herpin, Betsey; Tavel, Jorge

2009-01-01

Background: A clinical research protocol document must reflect both sound scientific rationale as well as local, national and, when applicable, international regulatory and human subject protections requirements. These requirements originate from a variety of sources, undergo frequent revision and are subject to interpretation. Tools to assist clinical investigators in the production of clinical protocols could facilitate navigating these requirements and ultimately increase the efficiency of clinical research. Purpose: The National Institute of Allergy and Infectious Diseases (NIAID) developed templates for investigators to serve as the foundation for protocol development. These protocol templates are designed as tools to support investigators in developing clinical protocols. Methods: NIAID established a series of working groups to determine how to improve its capacity to conduct clinical research more efficiently and effectively. The Protocol Template Working Group was convened to determine what protocol templates currently existed within NIAID and whether standard NIAID protocol templates should be produced. After review and assessment of existing protocol documents and requirements, the group reached consensus about required and optional content, determined the format and identified methods for distribution as well as education of investigators in the use of these templates. Results: The templates were approved by the NIAID Executive Committee in 2006 and posted as part of the NIAID Clinical Research Toolkit[1]website for broad access. These documents require scheduled revisions to stay current with regulatory and policy changes. Limitations: The structure of any clinical protocol template, whether comprehensive or specific to a particular study phase, setting or design, affects how it is used by investigators. Each structure presents its own set of advantages and disadvantages. While useful, protocol templates are not stand-alone tools for creating an optimal protocol document but must be complemented by institutional resources and support. Education and guidance of investigators in the appropriate use of templates is necessary to ensure a complete yet concise protocol document. Due to changing regulatory requirements, clinical protocol templates cannot become static but require frequent revisions. Conclusions: Standard protocol templates that meet applicable regulations can be important tools to assist investigators in the effective conduct of clinical research, but they require dedicated resources and ongoing input from key stakeholders. PMID:19625326

Comparison of a CHOP-LAsp-based protocol with and without maintenance for canine multicentric lymphoma.

PubMed

Lautscham, E M; Kessler, M; Ernst, T; Willimzig, L; Neiger, R

2017-03-25

The recommendation to treat canine lymphoma with a discontinuous protocol is based on small case numbers and mostly historic controls. This study compares duration of first remission (DFR) and overall survival time (ST) with a discontinuous protocol to the same protocol with maintenance phase. 408 dogs were treated with a CHOP-LAsp (C=cyclophosphamide; H=hydroxydaunorubicin; O=Oncovin; P=prednisolone; LAsp=l-asparaginase)-based 28-week induction protocol. In 75 dogs (cohort 1), this was followed by a maintenance phase consisting of vincristine, chlorambucil and actinomycin-D with a total treatment duration of two years. In the subsequent 333 dogs, therapy was discontinued after induction (cohort 2). Median DFR and ST in cohort 1 were 216 and 375 days and 184 and 304 days in cohort 2. 6-Month, 1-year and 2-year survival rates in cohort 1 were 73 per cent, 50 per cent, 24 per cent and 67 per cent, 39 per cent, 21 per cent in cohort 2. There was no significant difference between the two protocols (P=0.291 for ST, P=0.071 for DFR). On multivariate analysis, corticosteroid pretreatment (P=0.005), thrombocytopenia at diagnosis (P=0.019), stage (P=0.009), substage b at relapse (P<0.001), age (P=0.002) and incomplete or unstable remission necessitating intensification of therapy (P=0.004) were negatively correlated with ST in both groups. This study supports the use of a discontinuous protocol for canine multicentric lymphoma. British Veterinary Association.

Subconscious Visual Cues during Movement Execution Allow Correct Online Choice Reactions

PubMed Central

Leukel, Christian; Lundbye-Jensen, Jesper; Christensen, Mark Schram; Gollhofer, Albert; Nielsen, Jens Bo; Taube, Wolfgang

2012-01-01

Part of the sensory information is processed by our central nervous system without conscious perception. Subconscious processing has been shown to be capable of triggering motor reactions. In the present study, we asked the question whether visual information, which is not consciously perceived, could influence decision-making in a choice reaction task. Ten healthy subjects (28±5 years) executed two different experimental protocols. In the Motor reaction protocol, a visual target cue was shown on a computer screen. Depending on the displayed cue, subjects had to either complete a reaching movement (go-condition) or had to abort the movement (stop-condition). The cue was presented with different display durations (20–160 ms). In the second Verbalization protocol, subjects verbalized what they experienced on the screen. Again, the cue was presented with different display durations. This second protocol tested for conscious perception of the visual cue. The results of this study show that subjects achieved significantly more correct responses in the Motor reaction protocol than in the Verbalization protocol. This difference was only observed at the very short display durations of the visual cue. Since correct responses in the Verbalization protocol required conscious perception of the visual information, our findings imply that the subjects performed correct motor responses to visual cues, which they were not conscious about. It is therefore concluded that humans may reach decisions based on subconscious visual information in a choice reaction task. PMID:23049749

The utilization of unified protocols in behavioral cognitive therapy in transdiagnostic group subjects: A clinical trial.

PubMed

de Ornelas Maia, Ana Claudia Corrêa; Nardi, Antonio Egidio; Cardoso, Adriana

2015-02-01

The practicing of protocols based on behavioral cognitive therapy (CBT) have been frequently used in the last decades and adapted to better manage the necessities of patients and providers. The goal is to build a treatment that is evidence-based - for that reason the unified protocol for multiple emotional disorders (transdiagnostics) have been utilized to simplify treatment - without losing scientific traits. The main goal of this study is to evaluate the unified protocol in groups of patients with depression and anxiety disorders. In a pool of 48 subjects, divided in two groups, one was submitted to 12 intervention sessions of the unified protocol while the other was solely given medication. MINI, BAI and BDI were the instruments used at the beginning and at the end of treatment. The results were highly significant (p<0.001) in as much as with the improvement of anxiety and depressive disorders as it was in the group which was treated with the unified protocol compared with the group which was only given medication Limitations of this study were the number of sample participants and the non-randomization of subjects in both groups. Group therapy has not been largely implemented though it is deemed very useful for treatments when the unified protocol is used in transdiagnostic patients. Not only does it allow for emotional stabilizing and socialization but it also enables subjects with an altruistic feeling amongst themselves. Copyright © 2014 Elsevier B.V. All rights reserved.

Merging video coaching and an anthropologic approach to understand health care provider behavior toward hand hygiene protocols.

PubMed

Boudjema, Sophia; Tarantini, Clément; Peretti-Watel, Patrick; Brouqui, Philippe

2017-05-01

We used videorecordings of routine care to analyze health care providers' deviance from protocols and organized follow-up interviews that were conducted by an anthropologist and a nurse. After consent, health care workers were recorded during routine care by an automatic video remote control. Each participant was invited to watch her or his recorded behaviors on 2 different videos showing routine practices and her or his deviance from protocols, and to comment on them. After this step an in-depth interview based on preestablished guidelines was organized and explanations regarding the observed deviance was discussed. This design was intended to reveal the HCWs' subjectivity; that is, how they perceive hand hygiene issues in their daily routine, what concrete difficulties they face, and how they try to resolve them. We selected 43 of 250 videorecordings created during the study, which allowed us to study 15 out of 20 health care professionals. Twenty out of 43 videos showed 1 or more breaches in the hand hygiene protocol. The breaches were frequently linked to glove abuse. Deviance from protocols was explained by the health care workers as the result of an adaptive behavior; that is, facing work constraints that were disconnected from infection control protocols. Professional practices and protocols should be revisited to create simple messages that are adapted to the mandatory needs in a real life clinic environment. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Breakthrough reactions of iodinated and gadolinium contrast media after oral steroid premedication protocol.

PubMed

Jingu, Akiko; Fukuda, Junya; Taketomi-Takahashi, Ayako; Tsushima, Yoshito

2014-10-06

Adverse reactions to iodinated and gadolinium contrast media are an important clinical issue. Although some guidelines have proposed oral steroid premedication protocols to prevent adverse reactions, some patients may have reactions to contrast media in spite of premedication (breakthrough reaction; BTR).The purpose of this study was to assess the frequency, type and severity of BTR when following an oral steroid premedication protocol. All iodinated and gadolinium contrast-enhanced radiologic examinations between August 2011 and February 2013 for which the premedication protocol was applied in our institution were assessed for BTRs. The protocol was applied to a total of 252 examinations (153 patients, ages 15-87 years; 63 males, 90 females). Of these, 152 were for prior acute adverse reactions to contrast media, 85 were for a history of bronchial asthma, and 15 were for other reasons. There were 198 contrast enhanced CTs and 54 contrast enhanced MRIs. There were nine BTR (4.5%) for iodinated contrast media, and only one BTR (1.9%) for gadolinium contrast media: eight were mild and one was moderate. No patient who had a mild index reaction (IR) had a severe BTR. Incidence of BTRs when following the premedication protocol was low. This study by no means proves the efficacy of premedication, but provides some support for following a premedication protocol to improve safety of contrast-enhanced examinations when prior adverse reactions are mild, or when there is a history of asthma.

Breakthrough reactions of iodinated and gadolinium contrast media after oral steroid premedication protocol

PubMed Central

2014-01-01

Background Adverse reactions to iodinated and gadolinium contrast media are an important clinical issue. Although some guidelines have proposed oral steroid premedication protocols to prevent adverse reactions, some patients may have reactions to contrast media in spite of premedication (breakthrough reaction; BTR). The purpose of this study was to assess the frequency, type and severity of BTR when following an oral steroid premedication protocol. Methods All iodinated and gadolinium contrast-enhanced radiologic examinations between August 2011 and February 2013 for which the premedication protocol was applied in our institution were assessed for BTRs. Results The protocol was applied to a total of 252 examinations (153 patients, ages 15–87 years; 63 males, 90 females). Of these, 152 were for prior acute adverse reactions to contrast media, 85 were for a history of bronchial asthma, and 15 were for other reasons. There were 198 contrast enhanced CTs and 54 contrast enhanced MRIs. There were nine BTR (4.5%) for iodinated contrast media, and only one BTR (1.9%) for gadolinium contrast media: eight were mild and one was moderate. No patient who had a mild index reaction (IR) had a severe BTR. Conclusion Incidence of BTRs when following the premedication protocol was low. This study by no means proves the efficacy of premedication, but provides some support for following a premedication protocol to improve safety of contrast-enhanced examinations when prior adverse reactions are mild, or when there is a history of asthma. PMID:25287952

Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol.

PubMed

Buttolph, Jasmine; Inwani, Irene; Agot, Kawango; Cleland, Charles M; Cherutich, Peter; Kiarie, James N; Osoti, Alfred; Celum, Connie L; Baeten, Jared M; Nduati, Ruth; Kinuthia, John; Hallett, Timothy B; Alsallaq, Ramzi; Kurth, Ann E

2017-03-08

Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (PrEP), conditional cash transfer (CCT), and contraceptives for females; and (4) referrals for HIV care among those identified as HIV-positive. The combination package platform selected is mobile health teams in an integrated services delivery model. A cross-sectional analysis will be conducted to determine the uptake of the interventions. To determine long-term impact, the protocol outlines enrolling selected participants in mutually exclusive longitudinal cohorts (HIV-positive, PrEP, CCT, and HIV-negative) followed by using mobile phone text messages (short message service, SMS) and in-person surveys to prospectively assess prevention method uptake, adherence, and risk compensation behaviors. Cross-sectional and sub-cohort analyses will be conducted to determine intervention packages uptake. The literature review, focus groups, and modeling indicate that offering age- and gender- specific combination HIV prevention interventions that include biomedical, behavioral, and structural interventions can have an impact on HIV risk reduction. Implementing this protocol will show the feasibility of delivering these services at scale. The MP3 Youth study is one of the few combination HIV prevention intervention protocols incorporating youth- and gender-specific interventions in one delivery setting. Lessons learned from the design of the protocol can be incorporated into the national guidance for combination HIV prevention for youth in Kenya and other high-burden SSA settings. ClinicalTrials.gov NCT01571128; http://clinicaltrials.gov/ct2/show/NCT01571128?term=MP3+youth&rank=1 (Archived by WebCite at http://www.webcitation.org/6nmioPd54). ©Jasmine Buttolph, Irene Inwani, Kawango Agot, Charles M Cleland, Peter Cherutich, James N Kiarie, Alfred Osoti, Connie L Celum, Jared M Baeten, Ruth Nduati, John Kinuthia, Timothy B Hallett, Ramzi Alsallaq, Ann E Kurth. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.03.2017.

Optimization of 64-MDCT urography: effect of dual-phase imaging with furosemide on collecting system opacification and radiation dose.

PubMed

Portnoy, Orith; Guranda, Larisa; Apter, Sara; Eiss, David; Amitai, Marianne Michal; Konen, Eli

2011-11-01

The purpose of this study was to compare opacification of the urinary collecting system and radiation dose associated with three-phase 64-MDCT urographic protocols and those associated with a split-bolus dual-phase protocol including furosemide. Images from 150 CT urographic examinations performed with three scanning protocols were retrospectively evaluated. Group A consisted of 50 sequentially registered patients who underwent a three-phase protocol with saline infusion. Group B consisted of 50 sequentially registered patients who underwent a reduced-radiation three-phase protocol with saline. Group C consisted of 50 sequentially registered patients who underwent a dual-phase split-bolus protocol that included a low-dose furosemide injection. Opacification of the urinary collecting system was evaluated with segmental binary scoring. Contrast artifacts were evaluated, and radiation doses were recorded. Results were compared by analysis of variance. A significant reduction in mean effective radiation dose was found between groups A and B (p < 0.001) and between groups B and C (p < 0.001), resulting in 65% reduction between groups A and C (p < 0.001). This reduction did not significantly affect opacification score in any of the 12 urinary segments (p = 0.079). In addition, dense contrast artifacts overlying the renal parenchyma observed with the three-phase protocols (groups A and B) were avoided with the dual-phase protocol (group C) (p < 0.001). A dual-phase protocol with furosemide injection is the preferable technique for CT urography. In comparison with commonly used three-phase protocols, the dual-phase protocol significantly reduces radiation exposure dose without reduction in image quality.

Analysis of agreement between cardiac risk stratification protocols applied to participants of a center for cardiac rehabilitation

PubMed Central

Santos, Ana A. S.; Silva, Anne K. F.; Vanderlei, Franciele M.; Christofaro, Diego G. D.; Gonçalves, Aline F. L.; Vanderlei, Luiz C. M.

2016-01-01

ABSTRACT Background Cardiac risk stratification is related to the risk of the occurrence of events induced by exercise. Despite the existence of several protocols to calculate risk stratification, studies indicating that there is similarity between these protocols are still unknown. Objective To evaluate the agreement between the existing protocols on cardiac risk rating in cardiac patients. Method The records of 50 patients from a cardiac rehabilitation program were analyzed, from which the following information was extracted: age, sex, weight, height, clinical diagnosis, medical history, risk factors, associated diseases, and the results from the most recent laboratory and complementary tests performed. This information was used for risk stratification of the patients in the protocols of the American College of Sports Medicine, the Brazilian Society of Cardiology, the American Heart Association, the protocol designed by Frederic J. Pashkow, the American Association of Cardiovascular and Pulmonary Rehabilitation, the Société Française de Cardiologie, and the Sociedad Española de Cardiología. Descriptive statistics were used to characterize the sample and the analysis of agreement between the protocols was calculated using the Kappa coefficient. Differences were considered with a significance level of 5%. Results Of the 21 analyses of agreement, 12 were considered significant between the protocols used for risk classification, with nine classified as moderate and three as low. No agreements were classified as excellent. Different proportions were observed in each risk category, with significant differences between the protocols for all risk categories. Conclusion The agreements between the protocols were considered low and moderate and the risk proportions differed between protocols. PMID:27556385

Effect of cold air inhalation and isometric exercise on coronary blood flow and myocardial function in humans

PubMed Central

Muller, Matthew D.; Gao, Zhaohui; Drew, Rachel C.; Herr, Michael D.; Leuenberger, Urs A.

2011-01-01

The effects of cold air inhalation and isometric exercise on coronary blood flow are currently unknown, despite the fact that both cold air and acute exertion trigger angina in clinical populations. In this study, we used transthoracic Doppler echocardiography to measure coronary blood flow velocity (CBV; left anterior descending coronary artery) and myocardial function during cold air inhalation and handgrip exercise. Ten young healthy subjects underwent the following protocols: 5 min of inhaling cold air (cold air protocol), 5 min of inhaling thermoneutral air (sham protocol), 2 min of isometric handgrip at 30% of maximal voluntary contraction (grip protocol), and 5 min of isometric handgrip at 30% maximal voluntary contraction while breathing cold air (cold + grip protocol). Heart rate, blood pressure, inspired air temperature, CBV, myocardial function (tissue Doppler imaging), O2 saturation, and pulmonary function were measured. The rate-pressure product (RPP) was used as an index of myocardial O2 demand, whereas CBV was used as an index of myocardial O2 supply. Compared with the sham protocol, the cold air protocol caused a significantly higher RPP, but there was a significant reduction in CBV. The cold + grip protocol caused a significantly greater increase in RPP compared with the grip protocol (P = 0.045), but the increase in CBV was significantly less (P = 0.039). However, myocardial function was not impaired during the cold + grip protocol relative to the grip protocol alone. Collectively, these data indicate that there is a supply-demand mismatch in the coronary vascular bed when cold ambient air is breathed during acute exertion but myocardial function is preserved, suggesting an adequate redistribution of blood flow. PMID:21940852

Improvements in Clinical Trials Information Will Improve the Reproductive Health and Fertility of Cancer Patients.

PubMed

Dauti, Angela; Gerstl, Brigitte; Chong, Serena; Chisholm, Orin; Anazodo, Antoinette

2017-06-01

There are a number of barriers that result in cancer patients not being referred for oncofertility care, which include knowledge about reproductive risks of antineoplastic agents. Without this information, clinicians do not always make recommendations for oncofertility care. The objective of this study was to describe the level of reproductive information and recommendations that clinicians have available in clinical trial protocols regarding oncofertility management and follow-up, and the information that patients may receive in clinical trials patient information sheets or consent forms. A literature review of the 71 antineoplastic drugs included in the 68 clinical trial protocols showed that 68% of the antineoplastic drugs had gonadotoxic animal data, 32% had gonadotoxic human data, 83% had teratogenic animal data, and 32% had teratogenic human data. When the clinical trial protocols were reviewed, only 22% of the protocols reported the teratogenic risks and 32% of the protocols reported the gonadotoxic risk. Only 56% of phase 3 protocols had gonadotoxic information and 13% of phase 3 protocols had teratogenic information. Nine percent of the protocols provided fertility preservation recommendations and 4% provided reproductive information in the follow-up and survivorship period. Twenty-six percent had a section in the clinical trials protocol, which identified oncofertility information easily. When gonadotoxic and teratogenic effects of treatment were known, they were not consistently included in the clinical trial protocols and the lack of data for new drugs was not reported. Very few protocols gave recommendations for oncofertility management and follow-up following the completion of cancer treatment. The research team proposes a number of recommendations that should be required for clinicians and pharmaceutical companies developing new trials.

A study of battered women presenting in an emergency department.

PubMed Central

McLeer, S V; Anwar, R

1989-01-01

Medical records of female trauma patients were retrospectively reviewed prior to introducing a protocol for enhancing identification of battered women; 5.6 per cent of 359 female trauma patients were identified as having injuries caused by battering; 30 per cent of 412 patients following use of the protocol were so identified. Standardized protocols for identifying battered women among female trauma patients should be instituted in emergency departments. PMID:2909183

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.

Dynamic aftereffects in supplementary motor network following inhibitory transcranial magnetic stimulation protocols.

PubMed

Ji, Gong-Jun; Yu, Fengqiong; Liao, Wei; Wang, Kai

2017-04-01

The supplementary motor area (SMA) is a key node of the motor network. Inhibitory repetitive transcranial magnetic stimulation (rTMS) of the SMA can potentially improve movement disorders. However, the aftereffects of inhibitory rTMS on brain function remain largely unknown. Using a single-blind, crossover within-subject design, we investigated the role of aftereffects with two inhibitory rTMS protocols [1800 pulses of either 1-Hz repetitive stimulation or continuous theta burst stimulation (cTBS)] on the left SMA. A total of 19 healthy volunteers participated in the rTMS sessions on 2 separate days. Firstly, short-term aftereffects were estimated at three levels (functional connectivity, local activity, and network properties) by comparing the resting-state functional magnetic resonance imaging datasets (9min) acquired before and after each rTMS session. Local activity and network properties were not significantly altered by either protocol. Functional connectivity within the SMA network was increased (in the left paracentral gyrus) by 1-Hz stimulation and decreased (in the left inferior frontal gyrus and SMA/middle cingulate cortex) by cTBS. The subsequent three-way analysis of variance (site×time×protocol) did not show a significant interaction effect or "protocol" main effect, suggesting that the two protocols share an underlying mechanism. Secondly, sliding-window analysis was used to evaluate the dynamic features of aftereffects in the ~29min after the end of stimulation. Aftereffects were maintained for a maximum of 9.8 and 6.6min after the 1-Hz and cTBS protocols, respectively. In summary, this study revealed topographical and temporal aftereffects in the SMA network following inhibitory rTMS protocols, providing valuable information for their application in future neuroscience and clinical studies. Copyright © 2017 Elsevier Inc. All rights reserved.

Early cessation of triptorelin in in vitro fertilization: a double-blind, randomized study.

PubMed

Simons, Arnold H M; Roelofs, Henny J M; Schmoutziguer, Alex P E; Roozenburg, Brigitte J; van't Hof-van den Brink, Eefje P; Schoonderwoerd, Simon A

2005-04-01

To compare the efficacy of two early cessation protocols of triptorelin treatment in controlled ovarian hyperstimulation with the conventional long protocol in in vitro fertilization/intracytoplasmic sperm injection. A double-blind, randomized, multicenter study. Three Dutch hospitals. One hundred seventy-eight women randomized to one of three treatment groups at the start of stimulation. Midluteally started triptorelin administration was continued until the first day of hMG treatment (group S), or up to and including the fourth day of hMG treatment (group M) or the day of hCG injection (group L). Occurrence of a premature LH surge. One premature LH surge was observed in group M but not in groups S and L. Both early cessation protocols (S and M) are at least as effective as the long protocol (L) with regard to the number of oocytes (11.1 and 10.3 vs. 9.3), number of embryos (7.3 and 6.5 vs. 5.5), and ongoing pregnancy rate (28% and 24% vs. 21%). Early cessation of triptorelin on day 1 of hMG treatment in a midluteally started IVF protocol is as effective as the traditional long protocol in preventing a premature LH surge and results in similar fertility effects.

Comparison of 2 intravenous insulin protocols: Glycemia variability in critically ill patients.

PubMed

Gómez-Garrido, Marta; Rodilla-Fiz, Ana M; Girón-Lacasa, María; Rodríguez-Rubio, Laura; Martínez-Blázquez, Anselmo; Martínez-López, Fernando; Pardo-Ibáñez, María Dolores; Núñez-Marín, Juan M

2017-05-01

Glycemic variability is an independent predictor of mortality in critically ill patients. The objective of this study was to compare two intravenous insulin protocols in critically ill patients regarding the glycemic variability. This was a retrospective observational study performed by reviewing clinical records of patients from a Critical Care Unit for 4 consecutive months. First, a simpler Scale-Based Intravenous Insulin Protocol (SBIIP) was reviewed and later it was compared for the same months of the following year with a Sliding Scale-Based Intravenous Insulin Protocol (SSBIIP). All adult patients admitted to the unit during the referred months were included. Patients in whom the protocol was not adequately followed were excluded. A total of 557 patients were reviewed, of whom they had needed intravenous insulin 73 in the first group and 52 in the second group. Four and two patients were excluded in each group respectively. Glycemic variability for both day 1 (DS1) and total stay (DST) was lower in SSBIIP patients compared to SBIIP patients: SD1 34.88 vs 18.16 and SDT 36.45 vs 23.65 (P<.001). A glycemic management protocol in critically ill patients based on sliding scales decreases glycemic variability. Copyright © 2017 SEEN. Publicado por Elsevier España, S.L.U. All rights reserved.

Testing warning messages on smokers’ cigarette packages: A standardized protocol

PubMed Central

Brewer, Noel T.; Hall, Marissa G.; Lee, Joseph G. L.; Peebles, Kathryn; Noar, Seth M.; Ribisl, Kurt M.

2015-01-01

Purpose Lab experiments on cigarette warnings typically use a brief one-time exposure that is not paired with the cigarette packs smokers use every day, leaving open the question of how repeated warning exposure over several weeks may affect smokers. This proof of principle study sought to develop a new protocol for testing cigarette warnings that better reflects real-world exposure by presenting them on cigarette smokers’ own packs. Methods We tested a cigarette pack labeling protocol with 76 US smokers ages 18 and older. We applied graphic warnings to the front and back of smokers’ cigarette packs. Results Most smokers reported that at least 75% of the packs of cigarettes they smoked during the study had our warnings. Nearly all said they would participate in the study again. Using cigarette packs with the study warnings increased quit intentions (p<.05). Conclusion Our findings suggest a feasible pack labeling protocol with six steps: (1) schedule appointments at brief intervals; (2) determine typical cigarette consumption; (3) ask smokers to bring a supply of cigarette packs to study appointments; (4) apply labels to smokers’ cigarette packs; (5) provide participation incentives at the end of appointments; and (6) refer smokers to cessation services at end of the study. When used in randomized controlled trials in settings with real-world message exposure over time, this protocol may help identify the true impact of warnings and thus better inform tobacco product labeling policy. PMID:25564282

Tracheal decannulation protocol in patients affected by traumatic brain injury.

PubMed

Zanata, Isabel de Lima; Santos, Rosane Sampaio; Hirata, Gisela Carmona

2014-04-01

Introduction The frequency of tracheostomy in patients with traumatic brain injury (TBI) contrasts with the lack of objective criteria for its management. The study arose from the need for a protocol in the decision to remove the tracheal tube. Objective To evaluate the applicability of a protocol for tracheal decannulation. Methods A prospective study with 20 patients, ranging between 21 and 85 years of age (average 33.55), 4 of whom were women (20%) and 16 were men (80%). All patients had been diagnosed by a neurologist as having TBI, and the anatomical region of the lesion was known. Patients were evaluated following criteria for tracheal decannulation through a clinical evaluation protocol developed by the authors. Results Decannulation was performed in 12 (60%) patients. Fourteen (70%) had a score greater than 8 on the Glasgow Coma Scale and only 2 (14%) of these were not able to undergo decannulation. Twelve (60%) patients maintained the breathing pattern with occlusion of the tube and were successfully decannulated. Of the 20 patients evaluated, 11 (55%) showed no signs suggestive of tracheal aspiration, and of these, 9 (82%) began training on occlusion of the cannula. The protocol was relevant to establish the beginning of the decannulation process. The clinical assessment should focus on the patient's condition to achieve early tracheal decannulation. Conclusion This study allowed, with the protocol, to establish six criteria for tracheal decannulation: level of consciousness, respiration, tracheal secretion, phonation, swallowing, and coughing.

Tracheal Decannulation Protocol in Patients Affected by Traumatic Brain Injury

PubMed Central

Zanata, Isabel de Lima; Santos, Rosane Sampaio; Hirata, Gisela Carmona

2014-01-01

Introduction The frequency of tracheostomy in patients with traumatic brain injury (TBI) contrasts with the lack of objective criteria for its management. The study arose from the need for a protocol in the decision to remove the tracheal tube. Objective To evaluate the applicability of a protocol for tracheal decannulation. Methods A prospective study with 20 patients, ranging between 21 and 85 years of age (average 33.55), 4 of whom were women (20%) and 16 were men (80%). All patients had been diagnosed by a neurologist as having TBI, and the anatomical region of the lesion was known. Patients were evaluated following criteria for tracheal decannulation through a clinical evaluation protocol developed by the authors. Results Decannulation was performed in 12 (60%) patients. Fourteen (70%) had a score greater than 8 on the Glasgow Coma Scale and only 2 (14%) of these were not able to undergo decannulation. Twelve (60%) patients maintained the breathing pattern with occlusion of the tube and were successfully decannulated. Of the 20 patients evaluated, 11 (55%) showed no signs suggestive of tracheal aspiration, and of these, 9 (82%) began training on occlusion of the cannula. The protocol was relevant to establish the beginning of the decannulation process. The clinical assessment should focus on the patient's condition to achieve early tracheal decannulation. Conclusion This study allowed, with the protocol, to establish six criteria for tracheal decannulation: level of consciousness, respiration, tracheal secretion, phonation, swallowing, and coughing. PMID:25992074

Lung donor treatment protocol in brain dead-donors: A multicenter study.

PubMed

Miñambres, Eduardo; Pérez-Villares, Jose Miguel; Chico-Fernández, Mario; Zabalegui, Arturo; Dueñas-Jurado, Jose María; Misis, Maite; Mosteiro, Fernando; Rodriguez-Caravaca, Gil; Coll, Elisabeth

2015-06-01

The shortage of lung donors for transplantation is the main limitation among patients awaiting this type of surgery. We previously demonstrated that an intensive lung donor-treatment protocol succeeded in increasing the lung procurement rate. We aimed to validate our protocol for centers with or without lung transplant programs. A quasi-experimental study was performed to compare lung donor rate before (historical group, 2010 to 2012) and after (prospective group, 2013) the application of a lung management protocol for donors after brain death (DBDs) in six Spanish hospitals. Lung donor selection criteria remained unchanged in both periods. Outcome measures for lung recipients were early survival and primary graft dysfunction (PGD) rates. A total of 618 DBDs were included: 453 in the control period and 165 in the protocol period. Donor baseline characteristics were similar in both periods. Lung donation rate in the prospective group was 27.3%, more than twice that of the historical group (13%; p < 0.001). The number of lungs retrieved, grafts transplanted, and transplants performed more than doubled over the study period. No differences in early recipients' survival between groups were observed (87.6% vs. 84.5%; p = 0.733) nor in the rate of PGD. Implementing our intensive lung donor-treatment protocol increases lung procurement rates. This allows more lung transplants to be performed without detriment to either early survival or PGD rate. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Efficacy of a Creon delayed-release pancreatic enzyme protocol for clearing occluded enteral feeding tubes.

PubMed

Stumpf, Janice L; Kurian, Rebecca M; Vuong, Jennifer; Dang, Kimberlyn; Kraft, Michael D

2014-04-01

Alkalinized Viokase pancreatic enzyme tablets restored patency to 71.9% of occluded Dobhoff tubes in a prospective study. After removal of Viokase tablets from the US market, the hospital protocol for unclogging enteral feeding tubes was adapted to use Creon pancreatic enzyme delayed-release capsules, despite the lack of published data. To evaluate the effectiveness of a Creon-based protocol to clear occluded enteral feeding tubes. This retrospective study included all adult and pediatric patients seen in the emergency department or in an inpatient setting who received Creon 12 000 units lipase delayed-release capsule dissolved in a solution of sodium bicarbonate 650 mg and sterile water for clearing occluded enteral feeding tubes between May 1 and November 30, 2010. The Creon protocol was deemed effective if tube clearance was documented in the medical record or if enteral feedings were resumed with no note regarding tube replacement. Alkalinized Creon delayed-release capsules were administered to 83 patients with a total of 118 clogged tubes. Three poorly documented cases and 5 tubes with mechanical clogs were excluded from data analysis. Patency was restored to 53 of 110 (48.2%) occluded tubes. More than 1 treatment course was attempted in 5 cases, with success in 3. An alkalinized Creon pancreatic enzyme protocol was effective in clearing approximately half of the occluded enteral feeding tubes in this retrospective study, an efficacy rate much less than that previously reported in the literature with a Viokase-based protocol.

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.

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

Comparison of COAP and UW-19 protocols for dogs with multicentric lymphoma.

PubMed

Hosoya, Kenji; Kisseberth, William C; Lord, Linda K; Alvarez, Francisco J; Lara-Garcia, Ana; Kosarek, Carrie E; London, Cheryl A; Couto, C Guillermo

2007-01-01

Various chemotherapy protocols for treating lymphoma in dogs have been published; however, comparison of protocols from different studies is difficult, especially when evaluating survival time and toxicoses. The choice of COAP (C, cyclophosphamide; O, vincristine; A, cytosine arabinoside; P, prednisone) and a modified University of Wisconsin 19-week (UW-19) induction protocol has no influence on overall survival times in dogs with lymphoma. One hundred and one dogs with multicentric lymphoma. Retrospective study (2001-2006). Dogs induced with either an 8-week COP-based protocol (C, cyclophosphamide; O, vincristine; and P, prednisone) with maintenance therapy (COAP group) or a 19-week CHOP (C, cyclophosphamide; H, doxorubicin; O, vincristine; and P, prednisone) based protocol (UW-19 group) were compared in terms of the duration of first remission, survival time, toxicoses, and cost. There were 71 dogs in the COAP group and 30 dogs in the UW-19 group. Various protocols were used after the first relapse. The median duration of the first remission for the COAP and UW-19 groups were 94 days (range, 6-356 days) and 174 days (28-438 days), respectively (P < .01). The median survival times for dogs in the COAP and UW-19 groups were 309 days (6-620 days) and 275 days (70-1102+ days), respectively (P = .09). Dogs in the COAP group had a hazard ratio of 1.9 (95% CI 1.1-3.4) for death relative to the UW-19 group (P = .03), after controlling for the confounders (World Health Organization clinical stage, age, sex, use of doxorubicin during reinduction). The severity of neutropenia and gastrointestinal toxicoses were significantly higher in the UW-19 group than in the COAP group (P = .01 and P < .01, respectively). Use of a long-term doxorubicin-containing sequential combination chemotherapy protocol is associated with a decreased risk of relapse and death relative to a non-doxorubicin-containing protocol.

Maternal-Fetal Monitoring of Opioid-Exposed Pregnancies: Analysis of a Pilot Community-Based Protocol and Review of the Literature.

PubMed

Ryan, Gareth; Dooley, Joe; Windrim, Rory; Bollinger, Megan; Gerber Finn, Lianne; Kelly, Len

2017-06-01

To describe/analyse a novel, community-based prenatal monitoring protocol for opioid-exposed pregnancies developed by our centre in 2014 to optimize prenatal care for this population. A literature review of published monitoring protocols for this population is also presented. Retrospective comparison of pre-protocol (n = 215) and post-protocol (n = 251) cohorts. Medline and Embase were searched between 2000-2016 using MeSH terms: [fetal monitoring OR prenatal care] AND [opioid-related disorders OR substance-related disorders] in Medline and [fetal monitoring OR prenatal care] AND [opiate addiction OR substance abuse] in Embase, producing 518 results. Thirteen studies included protocols for monitoring opioid-exposed pregnancies. No comprehensive monitoring protocols with high-quality supporting evidence were found. We evaluated 466 opioid-exposed pregnancies, 215 before and 251 after introduction of the protocol. Since implementation, there was a significant increase in the number of opioid-exposed patients who have underwent urine drug screening (72.6% to 89.2%, P < 0.0001); a significant reduction in the number of urine drug screenings positive for illicit opioids (50.2% to 29.1%, P < 0.0001); and a significant increase in the number of patients who discontinued illicit opioid use by the time of delivery (24.7% to 39.4%, P < 0.01). There was no difference in the CS rate (27.4% vs. 26.3%, P > 0.05). There were no observed differences in the rate of preterm birth, birth weight <2500 g, or Apgar score <7 (P > 0.05). Care of women with increased opioid use during pregnancy is an important but under-studied health issue. A novel protocol for focused antenatal care provision for women with opioid-exposed pregnancies improves standard of care and maternal/fetal outcomes. Copyright © 2017. Published by Elsevier Inc.

Differences in disinfection protocols for root canal treatments between general dentists and endodontists: A Web-based survey.

PubMed

de Gregorio, Cesar; Arias, Ana; Navarrete, Natalia; Cisneros, Rafael; Cohenca, Nestor

2015-07-01

The purpose of this study was to determine whether differences exist in disinfection protocols between endodontists and general dentists. The authors sent an invitation to participate in a Web-based survey to 950 dentists affiliated with the Spanish Board of Dentistry. Participants responded to 9 questions about irrigation protocols and other factors related to disinfection during root canal therapy. A total of 238 (25.05%) study participants successfully completed and returned the surveys. Among these participants, 50% were general dentists and 50% were endodontists. The authors found no statistically significant differences in respondents' first choice of an irrigant solution (that is, sodium hypochlorite), but they noted statistically significant differences in the protocols used by general dentists and by endodontists in relation to the concentration of sodium hypochlorite (P = .0003), the use and type of irrigant used to remove the smear layer (P = 5.39 × 10(-10)), the use of adjuncts to irrigation (P = 5.98 × 10(-8)), the enlargement of the apical preparation when shaping a necrotic tooth (P = .001), and the maintenance of apical patency throughout the debridement and shaping procedure (P = .04). General dentists and endodontists embrace different disinfection protocols. The results of the survey demonstrated that endodontists keep up to date with protocols published in the literature, whereas general dentists use protocols learned during their dental training. Both groups of clinicians should be aware of the importance of disinfection techniques and their relationship to treatment outcomes. Controlling microorganisms during a root canal treatment, especially in cases with necrotic pulp, is essential to improve treatment outcomes. Clinicians should update their protocols and also consider referring patients to a specialist when their protocols are based on traditional techniques, especially in those cases with necrotic pulp. Copyright © 2015 American Dental Association. Published by Elsevier Inc. All rights reserved.

The use of high-fidelity human patient simulation as an evaluative tool in the development of clinical research protocols and procedures.

PubMed

Wright, Melanie C; Taekman, Jeffrey M; Barber, Linda; Hobbs, Gene; Newman, Mark F; Stafford-Smith, Mark

2005-12-01

Errors in clinical research can be costly, in terms of patient safety, data integrity, and data collection. Data inaccuracy in early subjects of a clinical study may be associated with problems in the design of the protocol, procedures, and data collection tools. High-fidelity patient simulation centers provide an ideal environment to apply human-centered design to clinical trial development. A draft of a complex clinical protocol was designed, evaluated and modified using a high-fidelity human patient simulator in the Duke University Human Simulation and Patient Safety Center. The process included walk-throughs, detailed modifications of the protocol and development of procedural aids. Training of monitors and coordinators provided an opportunity for observation of performance that was used to identify further improvements to the protocol. Evaluative steps were used to design the research protocol and procedures. Iterative modifications were made to the protocol and data collection tools. The success in use of human simulation in the preparation of a complex clinical drug trial suggests the benefits of human patient simulation extend beyond training and medical equipment evaluation. Human patient simulation can provide a context for informal expert evaluation of clinical protocol design and for formal "rehearsal" to evaluate the efficacy of procedures and support tools.

A semi-nested real-time PCR method to detect low chimerism percentage in small quantity of hematopoietic stem cell transplant DNA samples.

PubMed

Aloisio, Michelangelo; Bortot, Barbara; Gandin, Ilaria; Severini, Giovanni Maria; Athanasakis, Emmanouil

2017-02-01

Chimerism status evaluation of post-allogeneic hematopoietic stem cell transplantation samples is essential to predict post-transplant relapse. The most commonly used technique capable of detecting small increments of chimerism is quantitative real-time PCR. Although this method is already used in several laboratories, previously described protocols often lack sensitivity and the amount of the DNA required for each chimerism analysis is too high. In the present study, we compared a novel semi-nested allele-specific real-time PCR (sNAS-qPCR) protocol with our in-house standard allele-specific real-time PCR (gAS-qPCR) protocol. We selected two genetic markers and analyzed technical parameters (slope, y-intercept, R2, and standard deviation) useful to determine the performances of the two protocols. The sNAS-qPCR protocol showed better sensitivity and precision. Moreover, the sNAS-qPCR protocol requires, as input, only 10 ng of DNA, which is at least 10-fold less than the gAS-qPCR protocols described in the literature. Finally, the proposed sNAS-qPCR protocol could prove very useful for performing chimerism analysis with a small amount of DNA, as in the case of blood cell subsets.

Simultaneous validation of the Grandway MD2301 digital automatic blood pressure monitor by the British Hypertension Society and the Association for the Advancement of Medical Instrumentation/the International Organization for Standardization protocols.

PubMed

Huang, Jinhua; Wang, Yun; Liu, Zhaoying; Wang, Yuling

2017-02-01

The aim of this study was to determine the accuracy of the Grandway MD2301 digital automatic blood pressure monitor by the British Hypertension Society (BHS) and the Association for the Advancement of Medical Instrumentation (AAMI)/the International Organization for Standardization (ISO) protocols. A total of 85 participants were included for evaluation based on the requirements of the BHS and the AAMI/ISO protocols. The validation procedure and data analysis followed the protocols precisely. The device achieved A/A grading for the BHS protocol and maintained A/A grading throughout the low, medium and high blood pressure ranges. The device also fulfilled the requirement of the AAMI/ISO protocol with device-observer differences of -0.9±5.6 and 0.8±5.2 mmHg for systolic and diastolic blood pressure, respectively, for criterion 1, and -0.9±4.7 and 0.8±4.2 mmHg, respectively, for criterion 2. The Grandway MD2301 digital automatic blood pressure monitor achieved A/A grade of the BHS protocol and passed the requirements of the AAMI/ISO protocol in adults.

Evaluation of a protocol for the non-operative management of perforated peptic ulcer.

PubMed

Marshall, C; Ramaswamy, P; Bergin, F G; Rosenberg, I L; Leaper, D J

1999-01-01

The non-operative management of perforated peptic ulcer has previously been shown to be both safe and effective although it remains controversial. A protocol for non-operative management was set up in this hospital in 1989. Adherence to the guidelines in the protocol has been audited over a 6-year period with a review of outcome. The case-notes of patients with a diagnosis of perforated peptic ulcer were reviewed. Twelve guidelines from the protocol were selected for evaluation of compliance to the protocol. Forty-nine patients underwent non-operative treatment initially. Eight patients failed to respond and underwent operation. Complications included abscess formation (seven patients), renal failure (one), gastric ileus (one), chest infection (two), and cardiac failure and stroke (one). Four deaths occurred in this group. Adherence to certain protocol guidelines was poor, notably those concerning prevention of thromboembolism, use of antibiotics, use of contrast examination to confirm the diagnosis and referral for follow-up endoscopy. Two gastric cancers were detected on subsequent endoscopy. This experience demonstrates that non-operative treatment can be used successfully in a general hospital. Adherence to protocol guidelines was found to be variable and the protocol has therefore been simplified. This study highlights the need for an accurate diagnosis and the importance of follow-up endoscopy.

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

Neurofeedback Treatment and Posttraumatic Stress Disorder: Effectiveness of Neurofeedback on Posttraumatic Stress Disorder and the Optimal Choice of Protocol.

PubMed

Reiter, Karen; Andersen, Søren Bo; Carlsson, Jessica

2016-02-01

Neurofeedback is an alternative, noninvasive approach used in the treatment of a wide range of neuropsychiatric disorders, including posttraumatic stress disorder (PTSD). Many different neurofeedback protocols and methods exist. Likewise, PTSD is a heterogeneous disorder. To review the evidence on effectiveness and preferred protocol when using neurofeedback treatment on PTSD, a systematic search of PubMed, PsychInfo, Embase, and Cochrane databases was undertaken. Five studies were included in this review. Neurofeedback had a statistically significant effect in three studies. Neurobiological changes were reported in three studies. Interpretation of results is, however, limited by differences between the studies and several issues regarding design. The optimistic results presented here qualify neurofeedback as probably efficacious for PTSD treatment.

Time to publication for publicly funded clinical trials in Australia: an observational study.

PubMed

Strand, Linn Beate; Clarke, Philip; Graves, Nicholas; Barnett, Adrian G

2017-03-22

To examine the length of time between receiving funding and publishing the protocol and main paper for randomised controlled trials. An observational study using survival analysis. Publicly funded health and medical research in Australia. Randomised controlled trials funded by the National Health and Medical Research Council of Australia between 2008 and 2010. Time from funding to the protocol paper and main results paper. Multiple variable survival models examining whether study characteristics predicted publication times. We found 77 studies with a total funding of $A59 million. The median time to publication of the protocol paper was 6.4 years after funding (95% CI 4.1 to 8.1). The proportion with a published protocol paper 8 years after funding was 0.61 (95% CI 0.48 to 0.74). The median time to publication of the main results paper was 7.1 years after funding (95% CI 6.3 to 7.6). The proportion with a published main results paper 8 years after funding was 0.72 (95% CI 0.56 to 0.87). The HRs for how study characteristics might influence timing were generally close to one with narrow CIs, the notable exception was that a longer study length lengthened the time to the main paper (HR=0.62 per extra study year, 95% CI 0.43 to 0.89). Despite the widespread registration of clinical trials, there remain serious concerns of trial results not being published or being published with a long delay. We have found that these same concerns apply to protocol papers, which should be publishable soon after funding. Funding agencies could set a target of publishing the protocol paper within 18 months of funding. 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/.

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

Direct costs of osteoporosis and hip fracture: an analysis for the Mexican Social Insurance Health Care System.

PubMed

Carlos, Fernando; Clark, Patricia; Maciel, Humberto; Tamayo, Juan A

2009-01-01

To compare costs of diagnosis and annual treatment of osteoporosis and hip fracture between the Instituto Nacional de Rehabilitación (INR) and the protocol used by the Seguro Popular de Salud (SPSS). Direct costs gathered in a prospective study with real cases at the INR are presented, and then this data is re-analyzed with the methodology and protocol for the SPSS to estimate the costs of those cases if treated with the SPSS protocol. Important differences were found in the cost of hip fracture: the SPSS estimates ($37,363.73 MXN) almost double the INR cost ($20,286.86 MXN ). This discrepancy was caused by the different types of surgeries the INR and SPSS protocols call for (the SPSS assumes that all hip fractures will necessitate a hip replacement) and the cost of subsequent hospitalization. A prospective study at the SPSS is needed to validate these results. Important differences were found between treatment of the same osteoporosis related problems at the INR and SPSS. We recommend revising the SPSS protocol to include less costly surgical treatments.

Application of two segmentation protocols during the processing of virtual images in rapid prototyping: ex vivo study with human dry mandibles.

PubMed

Ferraz, Eduardo Gomes; Andrade, Lucio Costa Safira; dos Santos, Aline Rode; Torregrossa, Vinicius Rabelo; Rubira-Bullen, Izabel Regina Fischer; Sarmento, Viviane Almeida

2013-12-01

The aim of this study was to evaluate the accuracy of virtual three-dimensional (3D) reconstructions of human dry mandibles, produced from two segmentation protocols ("outline only" and "all-boundary lines"). Twenty virtual three-dimensional (3D) images were built from computed tomography exam (CT) of 10 dry mandibles, in which linear measurements between anatomical landmarks were obtained and compared to an error probability of 5 %. The results showed no statistically significant difference among the dry mandibles and the virtual 3D reconstructions produced from segmentation protocols tested (p = 0,24). During the designing of a virtual 3D reconstruction, both "outline only" and "all-boundary lines" segmentation protocols can be used. Virtual processing of CT images is the most complex stage during the manufacture of the biomodel. Establishing a better protocol during this phase allows the construction of a biomodel with characteristics that are closer to the original anatomical structures. This is essential to ensure a correct preoperative planning and a suitable treatment.

Radiation safety protocol using real-time dose reporting reduces patient exposure in pediatric electrophysiology procedures.

PubMed

Patel, Akash R; Ganley, Jamie; Zhu, Xiaowei; Rome, Jonathan J; Shah, Maully; Glatz, Andrew C

2014-10-01

Radiation exposure during pediatric catheterization is significant. We sought to describe radiation exposure and the effectiveness of radiation safety protocols in reducing exposure during catheter ablations with electrophysiology studies in children and patients with congenital heart disease. We additionally sought to identify at-risk patients. We retrospectively reviewed all interventional electrophysiology procedures performed from April 2009 to September 2011 (6 months preceding intervention, 12 months following implementation of initial radiation safety protocol, and 8 months following implementation of modified protocol). The protocols consisted of low pulse rate fluoroscopy settings, operator notification of skin entrance dose every 1,000 mGy, adjusting cameras by >5 at every 1,000 mGy, and appropriate collimation. The cohort consisted of 291 patients (70 pre-intervention, 137 after initial protocol implementation, 84 after modified protocol implementation) at a median age of 14.9 years with congenital heart disease present in 11 %. Diagnoses included atrioventricular nodal reentrant tachycardia (25 %), atrioventricular reentrant tachycardia (61 %), atrial tachycardias (12 %), and ventricular tachycardia (2 %). There were no differences between groups based on patient, arrhythmia, and procedural characteristics. Following implementation of the protocols, there were significant reductions in all measures of radiation exposure: fluoroscopy time (17.8 %), dose area product (80.2 %), skin entry dose (81.0 %), and effective dose (76.9 %), p = 0.0001. Independent predictors of increased radiation exposure included larger patient weight, longer fluoroscopy time, and lack of radiation safety protocol. Implementation of a radiation safety protocol for pediatric and congenital catheter ablations can drastically reduce radiation exposure to patients without affecting procedural success.

A randomized noninferiority trial of condensed protocols for genetic risk disclosure of Alzheimer's disease.

PubMed

Green, Robert C; Christensen, Kurt D; Cupples, L Adrienne; Relkin, Norman R; Whitehouse, Peter J; Royal, Charmaine D M; Obisesan, Thomas O; Cook-Deegan, Robert; Linnenbringer, Erin; Butson, Melissa Barber; Fasaye, Grace-Ann; Levinson, Elana; Roberts, J Scott

2015-10-01

Conventional multisession genetic counseling is currently recommended when disclosing apolipoprotein E (APOE) genotype for the risk of Alzheimer's disease (AD) in cognitively normal individuals. The objective of this study was to evaluate the safety of brief disclosure protocols for disclosing APOE genotype for the risk of AD. A randomized, multicenter noninferiority trial was conducted at four sites. Participants were asymptomatic adults having a first-degree relative with AD. A standard disclosure protocol by genetic counselors (SP-GC) was compared with condensed protocols, with disclosures by genetic counselors (CP-GC) and by physicians (CP-MD). Preplanned co-primary outcomes were anxiety and depression scales 12 months after disclosure. Three hundred and forty-three adults (mean age 58.3, range 33-86 years, 71% female, 23% African American) were randomly assigned to the SP-GC protocol (n = 115), CP-GC protocol (n = 116), or CP-MD protocol (n = 112). Mean postdisclosure scores on all outcomes were well below cut-offs for clinical concern across protocols. Comparing CP-GC with SP-GC, the 97.5% upper confidence limits at 12 months after disclosure on co-primary outcomes of anxiety and depression ranged from a difference of 1.2 to 2.0 in means (all P < .001 on noninferiority tests), establishing noninferiority for condensed protocols. Results were similar between European Americans and African Americans. These data support the safety of condensed protocols for APOE disclosure for those free of severe anxiety or depression who are actively seeking such information. Copyright © 2015 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

International Laboratory Comparison of Influenza Microneutralization Assays for A(H1N1)pdm09, A(H3N2), and A(H5N1) Influenza Viruses by CONSISE

PubMed Central

Engelhardt, Othmar G.; Wood, John; Heath, Alan; Katz, Jacqueline M.; Peiris, Malik; Hoschler, Katja; Hungnes, Olav; Zhang, Wenqing; Van Kerkhove, Maria D.

2015-01-01

The microneutralization assay is commonly used to detect antibodies to influenza virus, and multiple protocols are used worldwide. These protocols differ in the incubation time of the assay as well as in the order of specific steps, and even within protocols there are often further adjustments in individual laboratories. The impact these protocol variations have on influenza serology data is unclear. Thus, a laboratory comparison of the 2-day enzyme-linked immunosorbent assay (ELISA) and 3-day hemagglutination (HA) microneutralization (MN) protocols, using A(H1N1)pdm09, A(H3N2), and A(H5N1) viruses, was performed by the CONSISE Laboratory Working Group. Individual laboratories performed both assay protocols, on multiple occasions, using different serum panels. Thirteen laboratories from around the world participated. Within each laboratory, serum sample titers for the different assay protocols were compared between assays to determine the sensitivity of each assay and were compared between replicates to assess the reproducibility of each protocol for each laboratory. There was good correlation of the results obtained using the two assay protocols in most laboratories, indicating that these assays may be interchangeable for detecting antibodies to the influenza A viruses included in this study. Importantly, participating laboratories have aligned their methodologies to the CONSISE consensus 2-day ELISA and 3-day HA MN assay protocols to enable better correlation of these assays in the future. PMID:26108286

Evaluation of Protocol Uniformity Concerning Laparoscopic Cholecystectomy in The Netherlands

PubMed Central

Goossens, Richard H. M.; van Eijk, Daan J.; Lange, Johan F.

2008-01-01

Background Iatrogenic bile duct injury remains a current complication of laparoscopic cholecystectomy. One uniform and standardized protocol, based on the “critical view of safety” concept of Strasberg, should reduce the incidence of this complication. Furthermore, owing to the rapid development of minimally invasive surgery, technicians are becoming more frequently involved. To improve communication between the operating team and technicians, standardized actions should also be defined. The aim of this study was to compare existing protocols for laparoscopic cholecystectomy from various Dutch hospitals. Methods Fifteen Dutch hospitals were contacted for evaluation of their protocols for laparoscopic cholecystectomy. All evaluated protocols were divided into six steps and were compared accordingly. Results In total, 13 hospitals responded—5 academic hospitals, 5 teaching hospitals, 3 community hospitals—of which 10 protocols were usable for comparison. Concerning the trocar positions, only minor differences were found. The concept of “critical view of safety” was represented in just one protocol. Furthermore, the order of clipping and cutting the cystic artery and duct differed. Descriptions of instruments and apparatus were also inconsistent. Conclusions Present protocols differ too much to define a universal procedure among surgeons in The Netherlands. The authors propose one (inter)national standardized protocol, including standardized actions. This uniform standardized protocol has to be officially released and recommended by national scientific associations (e.g., the Dutch Society of Surgery) or international societies (e.g., European Association for Endoscopic Surgery and Society of American Gastrointestinal and Endoscopic Surgeons). The aim is to improve patient safety and professional communication, which are necessary for new developments. PMID:18224485

Evaluation of the use of automatic exposure control and automatic tube potential selection in low-dose cerebrospinal fluid shunt head CT.

PubMed

Wallace, Adam N; Vyhmeister, Ross; Bagade, Swapnil; Chatterjee, Arindam; Hicks, Brandon; Ramirez-Giraldo, Juan Carlos; McKinstry, Robert C

2015-06-01

Cerebrospinal fluid shunts are primarily used for the treatment of hydrocephalus. Shunt complications may necessitate multiple non-contrast head CT scans resulting in potentially high levels of radiation dose starting at an early age. A new head CT protocol using automatic exposure control and automated tube potential selection has been implemented at our institution to reduce radiation exposure. The purpose of this study was to evaluate the reduction in radiation dose achieved by this protocol compared with a protocol with fixed parameters. A retrospective sample of 60 non-contrast head CT scans assessing for cerebrospinal fluid shunt malfunction was identified, 30 of which were performed with each protocol. The radiation doses of the two protocols were compared using the volume CT dose index and dose length product. The diagnostic acceptability and quality of each scan were evaluated by three independent readers. The new protocol lowered the average volume CT dose index from 15.2 to 9.2 mGy representing a 39 % reduction (P < 0.01; 95 % CI 35-44 %) and lowered the dose length product from 259.5 to 151.2 mGy/cm representing a 42 % reduction (P < 0.01; 95 % CI 34-50 %). The new protocol produced diagnostically acceptable scans with comparable image quality to the fixed parameter protocol. A pediatric shunt non-contrast head CT protocol using automatic exposure control and automated tube potential selection reduced patient radiation dose compared with a fixed parameter protocol while producing diagnostic images of comparable quality.

Guidelines for randomized clinical trial protocol content: a systematic review

PubMed Central

2012-01-01

Background All randomized clinical trials (RCTs) require a protocol; however, numerous studies have highlighted protocol deficiencies. Reporting guidelines may improve the content of research reports and, if developed using robust methods, may increase the utility of reports to stakeholders. The objective of this study was to systematically identify and review RCT protocol guidelines, to assess their characteristics and methods of development, and to compare recommendations. Methods We conducted a systematic review of indexed literature (MEDLINE, EMBASE and the Cochrane Methodology Register from inception to September 2010; reference lists; related article features; forward citation searching) and a targeted search of supplementary sources, including a survey of major trial funding agencies in six countries. Records were eligible if they described a content guideline in English or French relevant to RCT protocols. Guidelines were excluded if they specified content for protocols for trials of specific procedures or conditions or were intended to assess trial quality. We extracted guideline characteristics and methods. Content was mapped for a subset of guidelines that described development methods or had institutional endorsement. Results Forty guidelines published in journals, books and institutional reports were included in the review; seven were specific to RCT protocols. Only eight (20%) described development methods which included informal consensus methods, pilot testing and formal validation; no guideline described all of these methods. No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development. The guidelines included a median of 23 concepts per guideline (interquartile range (IQR) = 14 to 34; range = 7 to 109). Among the subset of guidelines (n = 23) for which content was mapped, approximately 380 concepts were explicitly addressed (median concepts per guideline IQR = 31 (24,80); range = 16 to 150); most concepts were addressed in a minority of guidelines. Conclusions Existing guidelines for RCT protocol content varied substantially in their recommendations. Few reports described the methods of guideline development, limiting comparisons of guideline validity. Given the importance of protocols to diverse stakeholders, we believe a systematically developed, evidence-informed guideline for clinical trial protocols is needed. PMID:23006870

Clomiphene Stair-Step Protocol for Women With Polycystic Ovary Syndrome.

PubMed

Jones, Tiffanny; Ho, Jacqueline R; Gualtieri, Marc; Bruno-Gaston, Janet; Chung, Karine; Paulson, Richard J; Bendikson, Kristin A

2018-01-01

To compare time to ovulation, ovulation rates, and side effect profile of traditional and the stair-step protocol for ovulation induction using clomiphene citrate in women with polycystic ovary syndrome (PCOS). We performed a retrospective study of women seeking care for infertility with a diagnosis of PCOS at a university-based infertility clinic from July 2012 to July 2014. We included patients who were resistant to the initial starting dose of 50 mg clomiphene. The primary outcome was time to ovulation. Secondary outcomes included ovulation rates, clinical pregnancy rates, and mild and moderate-to-severe side effects based on dose. For the traditional protocol, higher doses of clomiphene were used each subsequent month if no ovulation occurred. For the stair-step protocol, higher doses of clomiphene were given 7 days after the last dose if no dominant follicles were seen on ultrasonography. Our study had 80% power to detect a 20% difference in ovulation. One hundred nine patients were included in the analysis with 66 (60.6%) in the traditional and 43 (39.4%) in the stair-step protocol. Age and body mass index were similar between groups. The time to ovulation was decreased in the stair-step protocol group compared with the traditional protocol group (23.1±0.9 days vs 47.5±6.3 days). Ovulation rates were increased in the stair-step group compared with the traditional group at 150 mg (16 [37%] vs 8 [12%], P=.004) and at 200 mg (9 [21%] vs 3 [5%], P=.01). Pregnancy rates were similar between groups once ovulation was achieved (12 [18.1%] vs 7 [16.3%], P=.08). The stair-step protocol had an increased incidence of mild side effects (vasomotor flushes, headaches, gastrointestinal disturbance, mastalgia, changes in mood; 18 [41%] vs 8 [12%]), but there was no difference in the incidence of severe side effects (headaches, visual disturbances). For women with PCOS, the stair-step clomiphene protocol is associated with decreased time to ovulation and increased ovulation rates at higher doses when compared with the traditional protocol.

Guidelines for randomized clinical trial protocol content: a systematic review.

PubMed

Tetzlaff, Jennifer M; Chan, An-Wen; Kitchen, Jessica; Sampson, Margaret; Tricco, Andrea C; Moher, David

2012-09-24

All randomized clinical trials (RCTs) require a protocol; however, numerous studies have highlighted protocol deficiencies. Reporting guidelines may improve the content of research reports and, if developed using robust methods, may increase the utility of reports to stakeholders. The objective of this study was to systematically identify and review RCT protocol guidelines, to assess their characteristics and methods of development, and to compare recommendations. We conducted a systematic review of indexed literature (MEDLINE, EMBASE and the Cochrane Methodology Register from inception to September 2010; reference lists; related article features; forward citation searching) and a targeted search of supplementary sources, including a survey of major trial funding agencies in six countries. Records were eligible if they described a content guideline in English or French relevant to RCT protocols. Guidelines were excluded if they specified content for protocols for trials of specific procedures or conditions or were intended to assess trial quality. We extracted guideline characteristics and methods. Content was mapped for a subset of guidelines that described development methods or had institutional endorsement. Forty guidelines published in journals, books and institutional reports were included in the review; seven were specific to RCT protocols. Only eight (20%) described development methods which included informal consensus methods, pilot testing and formal validation; no guideline described all of these methods. No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development. The guidelines included a median of 23 concepts per guideline (interquartile range (IQR) = 14 to 34; range = 7 to 109). Among the subset of guidelines (n = 23) for which content was mapped, approximately 380 concepts were explicitly addressed (median concepts per guideline IQR = 31 (24,80); range = 16 to 150); most concepts were addressed in a minority of guidelines. Existing guidelines for RCT protocol content varied substantially in their recommendations. Few reports described the methods of guideline development, limiting comparisons of guideline validity. Given the importance of protocols to diverse stakeholders, we believe a systematically developed, evidence-informed guideline for clinical trial protocols is needed.

Modified classification and single-stage microsurgical repair of posttraumatic infected massive bone defects in lower extremities.

PubMed

Yang, Yun-fa; Xu, Zhong-he; Zhang, Guang-ming; Wang, Jian-wei; Hu, Si-wang; Hou, Zhi-qi; Xu, Da-chuan

2013-11-01

Posttraumatic infected massive bone defects in lower extremities are difficult to repair because they frequently exhibit massive bone and/or soft tissue defects, serious bone infection, and excessive scar proliferation. This study aimed to determine whether these defects could be classified and repaired at a single stage. A total of 51 cases of posttraumatic infected massive bone defect in lower extremity were included in this study. They were classified into four types on the basis of the conditions of the bone defects, soft tissue defects, and injured limb length, including Type A (without soft tissue defects), Type B (with soft tissue defects of 10 × 20 cm or less), Type C (with soft tissue defects of 10 × 20 cm or more), and Type D (with the limb shortening of 3 cm or more). Four types of single-stage microsurgical repair protocols were planned accordingly and implemented respectively. These protocols included the following: Protocol A, where vascularized fibular graft was implemented for Type A; Protocol B, where vascularized fibular osteoseptocutaneous graft was implemented for Type B; Protocol C, where vascularized fibular graft and anterior lateral thigh flap were used for Type C; and Protocol D, where limb lengthening and Protocols A, B, or C were used for Type D. There were 12, 33, 4, and 2 cases of Types A, B, C, and D, respectively, according to this classification. During the surgery, three cases of planned Protocol B had to be shifted into Protocol C; however, all microsurgical repairs were completed. With reference to Johner-Wruhs evaluation method, the total percentage of excellent and good results was 82.35% after 6 to 41 months of follow-up. It was concluded that posttraumatic massive bone defects could be accurately classified into four types on the basis of the conditions of bone defects, soft tissue coverage, and injured limb length, and successfully repaired with the single-stage repair protocols after thorough debridement. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

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

Empirical Examinations of Modifications and Adaptations to Evidence-Based Psychotherapies: Methodologies, Impact, and Future Directions.

PubMed

Stirman, Shannon Wiltsey; Gamarra, Jennifer; Bartlett, Brooke; Calloway, Amber; Gutner, Cassidy

2017-12-01

This review describes methods used to examine the modifications and adaptations to evidence-based psychological treatments (EBPTs), assesses what is known about the impact of modifications and adaptations to EBPTs, and makes recommendations for future research and clinical care. One hundred eight primary studies and three meta-analyses were identified. All studies examined planned adaptations, and many simultaneously investigated multiple types of adaptations. With the exception of studies on adding or removing specific EBPT elements, few studies compared adapted EBPTs to the original protocols. There was little evidence that adaptations in the studies were detrimental, but there was also limited consistent evidence that adapted protocols outperformed the original protocols, with the exception of adding components to EBPTs. Implications for EBPT delivery and future research are discussed.

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

On the Search for Retrotransposons: Alternative Protocols to Obtain Sequences to Learn Profile Hidden Markov Models.

PubMed

Fischer, Carlos N; Campos, Victor De A; Barella, Victor H

2018-05-01

Profile hidden Markov models (pHMMs) have been used to search for transposable elements (TEs) in genomes. For the learning of pHMMs aimed to search for TEs of the retrotransposon class, the conventional protocol is to use the whole internal nucleotide portions of these elements as representative sequences. To further explore the potential of pHMMs in such a search, we propose five alternative ways to obtain the sets of representative sequences of TEs other than the conventional protocol. In this study, we are interested in Bel-PAO, Copia, Gypsy, and DIRS superfamilies from the retrotransposon class. We compared the pHMMs of all six protocols. The test results show that, for each TE superfamily, the pHMMs of at least two of the proposed protocols performed better than the conventional one and that the number of correct predictions provided by the latter can be improved by considering together the results of one or more of the alternative protocols.

Efficacy of Chinese auriculotherapy for stress in nursing staff: a randomized clinical trial

PubMed Central

Kurebayashi, Leonice Fumiko Sato; da Silva, Maria Júlia Paes

2014-01-01

Objective this randomized single blind clinical study aimed to evaluate the efficacy of auriculotherapy with and without a protocol for reducing stress levels among nursing staff. Method a total of 175 nursing professionals with medium and high scores according to Vasconcelos' Stress Symptoms List were divided into 3 groups: Control (58), Group with protocol (58), Group with no protocol (59). They were assessed at the baseline, after 12 sessions, and at the follow-up (30 days). Results in the analysis of variance, statistically significant differences between the Control and Intervention groups were found in the two evaluations (p<0.05) with greater size of effect indices (Cohen) for the No protocol group. The Yang Liver 1 and 2, Kidney, Brain Stem and Shen Men were the points most used. Conclusion individualized auriculotherapy, with no protocol, could expand the scope of the technique for stress reduction compared with auriculotherapy with a protocol. NCT: 01420835 PMID:25029046

Design and Development of Layered Security: Future Enhancements and Directions in Transmission

PubMed Central

Shahzad, Aamir; Lee, Malrey; Kim, Suntae; Kim, Kangmin; Choi, Jae-Young; Cho, Younghwa; Lee, Keun-Kwang

2016-01-01

Today, security is a prominent issue when any type of communication is being undertaken. Like traditional networks, supervisory control and data acquisition (SCADA) systems suffer from a number of vulnerabilities. Numerous end-to-end security mechanisms have been proposed for the resolution of SCADA-system security issues, but due to insecure real-time protocol use and the reliance upon open protocols during Internet-based communication, these SCADA systems can still be compromised by security challenges. This study reviews the security challenges and issues that are commonly raised during SCADA/protocol transmissions and proposes a secure distributed-network protocol version 3 (DNP3) design, and the implementation of the security solution using a cryptography mechanism. Due to the insecurities found within SCADA protocols, the new development consists of a DNP3 protocol that has been designed as a part of the SCADA system, and the cryptographically derived security is deployed within the application layer as a part of the DNP3 stack. PMID:26751443

Comparative Study on Various Authentication Protocols in Wireless Sensor Networks.

PubMed

Rajeswari, S Raja; Seenivasagam, V

2016-01-01

Wireless sensor networks (WSNs) consist of lightweight devices with low cost, low power, and short-ranged wireless communication. The sensors can communicate with each other to form a network. In WSNs, broadcast transmission is widely used along with the maximum usage of wireless networks and their applications. Hence, it has become crucial to authenticate broadcast messages. Key management is also an active research topic in WSNs. Several key management schemes have been introduced, and their benefits are not recognized in a specific WSN application. Security services are vital for ensuring the integrity, authenticity, and confidentiality of the critical information. Therefore, the authentication mechanisms are required to support these security services and to be resilient to distinct attacks. Various authentication protocols such as key management protocols, lightweight authentication protocols, and broadcast authentication protocols are compared and analyzed for all secure transmission applications. The major goal of this survey is to compare and find out the appropriate protocol for further research. Moreover, the comparisons between various authentication techniques are also illustrated.

Switching From Age-Based Stimulus Dosing to Dose Titration Protocols in Electroconvulsive Therapy: Empirical Evidence for Better Patient Outcomes With Lower Peak and Cumulative Energy Doses.

PubMed

O'Neill-Kerr, Alex; Yassin, Anhar; Rogers, Stephen; Cornish, Janie

2017-09-01

The aim of this study was to test the proposition that adoption of a dose titration protocol may be associated with better patient outcomes, at lower treatment dose, and with comparable cumulative dose to that in patients treated using an age-based stimulus dosing protocol. This was an analysis of data assembled from archived records and based on cohorts of patients treated respectively on an age-based stimulus dosing protocol and on a dose titration protocol in the National Health Service in England. We demonstrated a significantly better response in the patient cohort treated with dose titration than with age-based stimulus dosing. Peak doses were less and the total cumulative dose was less in the dose titration group than in the age-based stimulus dosing group. Our findings are consistent with superior outcomes in patients treated using a dose titration protocol when compared with age-based stimulus dosing in a similar cohort of patients.

The Lorazepam and Diazepam Protocol for Catatonia Due to General Medical Condition and Substance in Liaison Psychiatry

PubMed Central

Lin, Chin-Chuen; Hung, Yi-Yung; Tsai, Meng-Chang; Huang, Tiao-Lai

2017-01-01

Objective The lorazepam-diazepam protocol had been proved to rapidly and effectively relieve catatonia in patients with schizophrenia or mood disorder. This study aims to investigate the efficacy of lorazepam-diazepam protocol in catatonia due to general medical conditions (GMC) and substance. Method Patients with catatonia that required psychiatric intervention in various settings of a medical center were included. The lorazepam-diazepam protocol had been used to treat the catatonia due to GMC or substance according to DSM-IV criteria. The treatment response had been assessed by two psychiatrists. Results Eighteen (85.7%) of 21 catatonic patients due to GMC or substance became free of catatonia after the lorazepam-diazepam protocol. Five (23.8%) of the 21 patients had passed away with various causes of death and wide range of time periods after catatonia. Conclusion Our results showed that the lorazepam-diazepam protocol could rapidly and effectively relieve catatonia due to GMC and substance. PMID:28114315

Comparative Study on Various Authentication Protocols in Wireless Sensor Networks

PubMed Central

Rajeswari, S. Raja; Seenivasagam, V.

2016-01-01

Wireless sensor networks (WSNs) consist of lightweight devices with low cost, low power, and short-ranged wireless communication. The sensors can communicate with each other to form a network. In WSNs, broadcast transmission is widely used along with the maximum usage of wireless networks and their applications. Hence, it has become crucial to authenticate broadcast messages. Key management is also an active research topic in WSNs. Several key management schemes have been introduced, and their benefits are not recognized in a specific WSN application. Security services are vital for ensuring the integrity, authenticity, and confidentiality of the critical information. Therefore, the authentication mechanisms are required to support these security services and to be resilient to distinct attacks. Various authentication protocols such as key management protocols, lightweight authentication protocols, and broadcast authentication protocols are compared and analyzed for all secure transmission applications. The major goal of this survey is to compare and find out the appropriate protocol for further research. Moreover, the comparisons between various authentication techniques are also illustrated. PMID:26881272

Design and Development of Layered Security: Future Enhancements and Directions in Transmission.

PubMed

Shahzad, Aamir; Lee, Malrey; Kim, Suntae; Kim, Kangmin; Choi, Jae-Young; Cho, Younghwa; Lee, Keun-Kwang

2016-01-06

Today, security is a prominent issue when any type of communication is being undertaken. Like traditional networks, supervisory control and data acquisition (SCADA) systems suffer from a number of vulnerabilities. Numerous end-to-end security mechanisms have been proposed for the resolution of SCADA-system security issues, but due to insecure real-time protocol use and the reliance upon open protocols during Internet-based communication, these SCADA systems can still be compromised by security challenges. This study reviews the security challenges and issues that are commonly raised during SCADA/protocol transmissions and proposes a secure distributed-network protocol version 3 (DNP3) design, and the implementation of the security solution using a cryptography mechanism. Due to the insecurities found within SCADA protocols, the new development consists of a DNP3 protocol that has been designed as a part of the SCADA system, and the cryptographically derived security is deployed within the application layer as a part of the DNP3 stack.

Establishment and optimization of NMR-based cell metabonomics study protocols for neonatal Sprague-Dawley rat cardiomyocytes.

PubMed

Zhang, Ming; Sun, Bo; Zhang, Qi; Gao, Rong; Liu, Qiao; Dong, Fangting; Fang, Haiqin; Peng, Shuangqing; Li, Famei; Yan, Xianzhong

2017-01-15

A quenching, harvesting, and extraction protocol was optimized for cardiomyocytes NMR metabonomics analysis in this study. Trypsin treatment and direct scraping cells in acetonitrile were compared for sample harvesting. The results showed trypsin treatment cause normalized concentration increasing of phosphocholine and metabolites leakage, since the trypsin-induced membrane broken and long term harvesting procedures. Then the intracellular metabolite extraction efficiency of methanol and acetonitrile were compared. As a result, washing twice with phosphate buffer, direct scraping cells and extracting with acetonitrile were chosen to prepare cardiomyocytes extracts samples for metabonomics studies. This optimized protocol is rapid, effective, and exhibits greater metabolite retention. Copyright © 2016 Elsevier Inc. All rights reserved.

EVA Human Health and Performance Benchmarking Study Overview and Development of a Microgravity Protocol

NASA Technical Reports Server (NTRS)

Norcross, Jason; Jarvis, Sarah; Bekdash, Omar; Cupples, Scott; Abercromby, Andrew

2017-01-01

The primary objective of this study is to develop a protocol to reliably characterize human health and performance metrics for individuals working inside various EVA suits under realistic spaceflight conditions. Expected results and methodologies developed during this study will provide the baseline benchmarking data and protocols with which future EVA suits and suit configurations (e.g., varied pressure, mass, center of gravity [CG]) and different test subject populations (e.g., deconditioned crewmembers) may be reliably assessed and compared. Results may also be used, in conjunction with subsequent testing, to inform fitness-for-duty standards, as well as design requirements and operations concepts for future EVA suits and other exploration systems.

Music therapy protocol development to enhance swallowing training for stroke patients with dysphagia.

PubMed

Kim, Soo Ji

2010-01-01

Considering the devastating condition of dysphagia, it is necessary to provide intensive therapeutic regimen based on interdisciplinary approach. In this aspect, music-enhanced swallowing protocol was developed through a pilot study. Then, the modified protocol from a pilot study was examined with 8 stroke patients in a local hospital. The protocol was designed to improve oral motor control, laryngeal elevation, breathing, and swallowing functions. The dependent variables measured included reflex, respiration, and laryngeal functions using the Frenchay Dysarthria assessment. Results from the initial to the midevaluation showed that pitch in the laryngeal category were statistically significant after 6th sessions. After the 12th session, when the final evaluation was compared with the initial assessment, additional categories revealed statistically significant changes. It is recommended that this study should be replicated with a control group and a larger sample using either FEES or video fluoroscopy for scientific data to further substantiate music therapy outcomes in stroke rehabilitation.

Flow-mediated Dilation: Can New Approaches Provide Greater Mechanistic Insight into Vascular Dysfunction in Preeclampsia and Other Diseases?

PubMed Central

Weissgerber, Tracey L.

2015-01-01

Endothelial dysfunction is a key feature of preeclampsia, and may contribute to increased cardiovascular disease risk years after pregnancy. Flow-mediated dilation (FMD) is a non-invasive endothelial function test that predicts cardiovascular event risk. New protocols allow researchers to measure three components of the FMD response: FMD, low flow-mediated constriction and the shear stimulus. This review encourages researchers to think beyond “low FMD” by examining how these three components may provide additional insights into the mechanisms and location of vascular dysfunction. The review then examines what FMD studies reveal about vascular dysfunction in preeclampsia, while highlighting opportunities to gain greater mechanistic insight from new protocols. Studies using traditional protocols show that FMD is low in mid-pregnancy prior to preeclampsia, at diagnosis, and for three years post-partum. However, FMD returns to normal by ten years post-partum. Studies using new protocols are needed to gain more mechanistic insight. PMID:25182159

Flow-mediated dilation: can new approaches provide greater mechanistic insight into vascular dysfunction in preeclampsia and other diseases?

PubMed

Weissgerber, Tracey L

2014-11-01

Endothelial dysfunction is a key feature of preeclampsia and may contribute to increased cardiovascular disease risk years after pregnancy. Flow-mediated dilation (FMD) is a non-invasive endothelial function test that predicts cardiovascular event risk. New protocols allow researchers to measure three components of the FMD response: FMD, low flow-mediated constriction, and shear stimulus. This review encourages researchers to think beyond "low FMD" by examining how these three components may provide additional insights into the mechanisms and location of vascular dysfunction. The review then examines what FMD studies reveal about vascular dysfunction in preeclampsia while highlighting opportunities to gain greater mechanistic insight from new protocols. Studies using traditional protocols show that FMD is low in mid-pregnancy prior to preeclampsia, at diagnosis, and for 3 years post-partum. However, FMD returns to normal by 10 years post-partum. Studies using new protocols are needed to gain more mechanistic insight.

Elementary Teachers' Ideas about, Planning for and Implementation of Learner-Directed and Teacher-Directed Inquiry: A Mixed Methods Study

ERIC Educational Resources Information Center

Biggers, Mandy Sue

2013-01-01

Using a framework for variations of classroom inquiry (National Research Council [NRC], 2000, p. 29), this study explored 40 inservice elementary teachers' planning, modification, and enactment of kit-based science curriculum materials. As part of the study, a new observation protocol was modified from an existing protocol (Practices of…

TU-G-BRD-04: A Round Robin Dosimetry Intercomparison of Gamma Stereotactic Radiosurgery Calibration Protocols

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

Drzymala, R; Alvarez, P; Bednarz, G

2015-06-15

Purpose: The purpose of this multi-institutional study was to compare two new gamma stereotactic radiosurgery (GSRS) dosimetry protocols to existing calibration methods. The ultimate goal was to guide AAPM Task Group 178 in recommending a standard GSRS dosimetry protocol. Methods: Nine centers (ten GSRS units) participated in the study. Each institution made eight sets of dose rate measurements: six with two different ionization chambers in three different 160mm-diameter spherical phantoms (ABS plastic, Solid Water and liquid water), and two using the same ionization chambers with a custom in-air positioning jig. Absolute dose rates were calculated using a newly proposed formalismmore » by the IAEA working group for small and non-standard radiation fields and with a new air-kerma based protocol. The new IAEA protocol requires an in-water ionization chamber calibration and uses previously reported Monte-Carlo generated factors to account for the material composition of the phantom, the type of ionization chamber, and the unique GSRS beam configuration. Results obtained with the new dose calibration protocols were compared to dose rates determined by the AAPM TG-21 and TG-51 protocols, with TG-21 considered as the standard. Results: Averaged over all institutions, ionization chambers and phantoms, the mean dose rate determined with the new IAEA protocol relative to that determined with TG-21 in the ABS phantom was 1.000 with a standard deviation of 0.008. For TG-51, the average ratio was 0.991 with a standard deviation of 0.013, and for the new in-air formalism it was 1.008 with a standard deviation of 0.012. Conclusion: Average results with both of the new protocols agreed with TG-21 to within one standard deviation. TG-51, which does not take into account the unique GSRS beam configuration or phantom material, was not expected to perform as well as the new protocols. The new IAEA protocol showed remarkably good agreement with TG-21. Conflict of Interests: Paula Petti, Josef Novotny, Gennady Neyman and Steve Goetsch are consultants for Elekta Instrument A/B; Elekta Instrument AB, PTW Freiburg GmbH, Standard Imaging, Inc., and The Phantom Laboratory, Inc. loaned equipment for use in these experiments; The University of Wisconsin Accredited Dosimetry Calibration Laboratory provided calibration services.« less

A standardised protocol for the validation of banking methodologies for arterial allografts.

PubMed

Lomas, R J; Dodd, P D F; Rooney, P; Pegg, D E; Hogg, P A; Eagle, M E; Bennett, K E; Clarkson, A; Kearney, J N

2013-09-01

The objective of this study was to design and test a protocol for the validation of banking methodologies for arterial allografts. A series of in vitro biomechanical and biological assessments were derived, and applied to paired fresh and banked femoral arteries. The ultimate tensile stress and strain, suture pullout stress and strain, expansion/rupture under hydrostatic pressure, histological structure and biocompatibility properties of disinfected and cryopreserved femoral arteries were compared to those of fresh controls. No significant differences were detected in any of the test criteria. This validation protocol provides an effective means of testing and validating banking protocols for arterial allografts.

Breaking Megrelishvili protocol using matrix diagonalization

NASA Astrophysics Data System (ADS)

Arzaki, Muhammad; Triantoro Murdiansyah, Danang; Adi Prabowo, Satrio

2018-03-01

In this article we conduct a theoretical security analysis of Megrelishvili protocol—a linear algebra-based key agreement between two participants. We study the computational complexity of Megrelishvili vector-matrix problem (MVMP) as a mathematical problem that strongly relates to the security of Megrelishvili protocol. In particular, we investigate the asymptotic upper bounds for the running time and memory requirement of the MVMP that involves diagonalizable public matrix. Specifically, we devise a diagonalization method for solving the MVMP that is asymptotically faster than all of the previously existing algorithms. We also found an important counterintuitive result: the utilization of primitive matrix in Megrelishvili protocol makes the protocol more vulnerable to attacks.

Permissive weight bearing in trauma patients with fracture of the lower extremities: prospective multicenter comparative cohort study.

PubMed

Kalmet, Pishtiwan H S; Meys, Guido; V Horn, Yvette Y; Evers, Silvia M A A; Seelen, Henk A M; Hustinx, Paul; Janzing, Heinrich; Vd Veen, Alexander; Jaspars, Coen; Sintenie, Jan Bernard; Blokhuis, Taco J; Poeze, Martijn; Brink, Peter R G

2018-02-02

The standard aftercare treatment in surgically treated trauma patients with fractures around or in a joint, known as (peri)- or intra-articular fractures of the lower extremities, is either non-weight bearing or partial weight bearing. We have developed an early permissive weight bearing post-surgery rehabilitation protocol in surgically treated patients with fractures of the lower extremities. In this proposal we want to compare our early permissive weight bearing protocol to the existing current non-weight bearing guidelines in a prospective comparative cohort study. The study is a prospective multicenter comparative cohort study in which two rehabilitation aftercare treatments will be contrasted, i.e. permissive weight bearing and non-weight bearing according to the AO-guideline. The study population consists of patients with a surgically treated fracture of the pelvis/acetabulum or a surgically treated (peri)- or intra-articular fracture of the lower extremities. The inclusion period is 12 months. The duration of follow up is 6 months, with measurements taken at baseline, 2,6,12 and 26 weeks post-surgery. ADL with Lower Extremity Functional Scale. Outcome variables for compliance, as measured with an insole pressure measurement system, encompass peak load and step duration. This study will investigate the (cost-) effectiveness of a permissive weight bearing aftercare protocol. The results will provide evidence whether a permissive weight bearing protocol is more effective than the current non-weight bearing protocol. The study is registered in the Dutch Trial Register ( NTR6077 ). Date of registration: 01-09-2016.

A protocol of early aggressive acceleration of tube feeding increases ileus without perceptible benefit in severely burned patients.

PubMed

Kesey, Jennifer; Dissanaike, Sharmila

2013-01-01

Optimal nutrition is essential to the recovery of burned patients. The authors evaluated the efficacy of an aggressive nutrition delivery protocol. The following protocol was implemented: initiation of tube feeds within 4 hours, acceleration to goal rate within 8 hours, and tolerance of gastric residual volumes of 400 ml. Patients on the protocol formed the study group whereas patients admitted immediately before implementation served as controls for a study period of 7 days after admission. Outcome variables included ileus, prokinetic medication use, intensive care unit and overall length of stay, ventilator days and mortality. Variables were compared using bivariate analysis. The 42 study subjects and 34 controls were similar at baseline. Time to initiation was similar (6.8 vs 9.4 hours; P = .226), however, goal rate was achieved much sooner in the study group (11.2 vs 20.9 hours; P < .001). Number of hours spent at goal was different on days 1 and 2 (6.62 vs 2.74, P = .003 and 17.24 vs 13.18, P = .032) with no difference thereafter. Residual volumes in the study group were higher from day 2 onward, and remained increased throughout the study period (401 vs 234 ml average; P = .449). Clinical ileus was much more common in the study group (8 cases vs 1, P = .037). There was no difference in length of stay or mortality. The protocol was successfully implemented and resulted in early achievement of goal tube feed rates. However, this resulted in tube feed intolerance as manifested by more cases of clinical ileus.