An extended protocol for usability validation of medical devices: Research design and reference model.

Science.gov (United States)

Schmettow, Martin; Schnittker, Raphaela; Schraagen, Jan Maarten

2017-05-01

This paper proposes and demonstrates an extended protocol for usability validation testing of medical devices. A review of currently used methods for the usability evaluation of medical devices revealed two main shortcomings. Firstly, the lack of methods to closely trace the interaction sequences and derive performance measures. Secondly, a prevailing focus on cross-sectional validation studies, ignoring the issues of learnability and training. The U.S. Federal Drug and Food Administration's recent proposal for a validation testing protocol for medical devices is then extended to address these shortcomings: (1) a novel process measure 'normative path deviations' is introduced that is useful for both quantitative and qualitative usability studies and (2) a longitudinal, completely within-subject study design is presented that assesses learnability, training effects and allows analysis of diversity of users. A reference regression model is introduced to analyze data from this and similar studies, drawing upon generalized linear mixed-effects models and a Bayesian estimation approach. The extended protocol is implemented and demonstrated in a study comparing a novel syringe infusion pump prototype to an existing design with a sample of 25 healthcare professionals. Strong performance differences between designs were observed with a variety of usability measures, as well as varying training-on-the-job effects. We discuss our findings with regard to validation testing guidelines, reflect on the extensions and discuss the perspectives they add to the validation process. Copyright © 2017 Elsevier Inc. All rights reserved.

Validation of a Predictive Model for Survival in Metastatic Cancer Patients Attending an Outpatient Palliative Radiotherapy Clinic

International Nuclear Information System (INIS)

Chow, Edward; Abdolell, Mohamed; Panzarella, Tony; Harris, Kristin; Bezjak, Andrea; Warde, Padraig; Tannock, Ian

2009-01-01

Purpose: To validate a predictive model for survival of patients attending a palliative radiotherapy clinic. Methods and Materials: We described previously a model that had good predictive value for survival of patients referred during 1999 (1). The six prognostic factors (primary cancer site, site of metastases, Karnofsky performance score, and the fatigue, appetite and shortness-of-breath items from the Edmonton Symptom Assessment Scale) identified in this training set were extracted from the prospective database for the year 2000. We generated a partial score whereby each prognostic factor was assigned a value proportional to its prognostic weight. The sum of the partial scores for each patient was used to construct a survival prediction score (SPS). Patients were also grouped according to the number of these risk factors (NRF) that they possessed. The probability of survival at 3, 6, and 12 months was generated. The models were evaluated for their ability to predict survival in this validation set with appropriate statistical tests. Results: The median survival and survival probabilities of the training and validation sets were similar when separated into three groups using both SPS and NRF methods. There was no statistical difference in the performance of the SPS and NRF methods in survival prediction. Conclusion: Both the SPS and NRF models for predicting survival in patients referred for palliative radiotherapy have been validated. The NRF model is preferred because it is simpler and avoids the need to remember the weightings among the prognostic factors

Reliability and criterion validity of an observation protocol for working technique assessments in cash register work.

Science.gov (United States)

Palm, Peter; Josephson, Malin; Mathiassen, Svend Erik; Kjellberg, Katarina

2016-06-01

We evaluated the intra- and inter-observer reliability and criterion validity of an observation protocol, developed in an iterative process involving practicing ergonomists, for assessment of working technique during cash register work for the purpose of preventing upper extremity symptoms. Two ergonomists independently assessed 17 15-min videos of cash register work on two occasions each, as a basis for examining reliability. Criterion validity was assessed by comparing these assessments with meticulous video-based analyses by researchers. Intra-observer reliability was acceptable (i.e. proportional agreement >0.7 and kappa >0.4) for 10/10 questions. Inter-observer reliability was acceptable for only 3/10 questions. An acceptable inter-observer reliability combined with an acceptable criterion validity was obtained only for one working technique aspect, 'Quality of movements'. Thus, major elements of the cashiers' working technique could not be assessed with an acceptable accuracy from short periods of observations by one observer, such as often desired by practitioners. Practitioner Summary: We examined an observation protocol for assessing working technique in cash register work. It was feasible in use, but inter-observer reliability and criterion validity were generally not acceptable when working technique aspects were assessed from short periods of work. We recommend the protocol to be used for educational purposes only.

Falls in long-term care institutions for elderly people: protocol validation.

Science.gov (United States)

Baixinho, Cristina Rosa Soares Lavareda; Dixe, Maria Dos Anjos Coelho Rodrigues; Henriques, Maria Adriana Pereira

2017-01-01

To validate the content of a fall management risk protocol in long-term institutions for elderly people. Methodological, quanti-qualitative study using the Delphi technique. The tool, based on the literature, was sent electronically to obtain consensus among the 14 experts that meet the defined inclusion criteria. The 27 indicators of the protocol are organized in three dimensions: prepare for the institutionalization (IRA=.88); manage the risk of falls throughout the institutionalization (IRA=.9); and lead the communication and formation (IRA=1), with a CVI=.91. Two rounds were performed to get a consensus superior to 80% in every item. The values obtained in the reliability test (>0.8) show that the protocol can be used to meet the intended goal. The next step is the clinic validation of the protocol with residents of long-term care institutions for elderly people. Validar o conteúdo de um protocolo para a gestão do risco de queda em Instituições de Longa Permanência para Idosos. Estudo metodológico, de abordagem quantiqualitativa, utilizando a técnica de Delphi. O instrumento, construído com base na literatura, foi enviado por via electrónica, para obter consenso entre os 14 peritos que respeitam os critérios de inclusão definidos. Os 27 indicadores do protocolo estão organizados em três dimensões: Preparar a Institucionalização (IRA=,88); Gerir o Risco de Queda ao longo da Institucionalização (IRA=,9) e Liderar a comunicação e formação (IRA=1), com um CVI=,91. Foram efetuadas duas rodadas para se obter consenso superior a 80% em todos os itens. Os valores obtidos no teste de fidedignidade (>0,8) atestam que o protocolo pode ser utilizado para atingir o fim que se pretende. A próxima etapa é a validação clínica do protocolo com idosos residentes em Instituições de Longa Permanência para Idosos.

Protocol: validation of the INCODE barometer to measure the innovation compe-tence through the Rasch Measurement Theory

Directory of Open Access Journals (Sweden)

Lidia Sanchez

2017-06-01

Full Text Available This communication presents a protocol in order to show the different phases that must be followed in order to validate the INCODE barometer, which is used to measure the innovation competence, with Rasch Measurement Theory. Five phases are stated: dimensionality analysis, individual reliability and validity analysis of ítems and persons, global reliability and validity analysis, and cathegory analysis.

An extended protocol for usability validation of medical devices : Research design and reference model

NARCIS (Netherlands)

Schmettow, M.; Schnittker, R.; Schraagen, J.M.

2017-01-01

This paper proposes and demonstrates an extended protocol for usability validation testing of medical devices. A review of currently used methods for the usability evaluation of medical devices revealed two main shortcomings. Firstly, the lack of methods to closely trace the interaction sequences

Development and validation of the Emergency Department Assessment of Chest pain Score and 2 h accelerated diagnostic protocol

NARCIS (Netherlands)

Than, Martin; Flaws, Dylan; Sanders, Sharon; Doust, Jenny; Glasziou, Paul; Kline, Jeffery; Aldous, Sally; Troughton, Richard; Reid, Christopher; Parsonage, William A.; Frampton, Christopher; Greenslade, Jaimi H.; Deely, Joanne M.; Hess, Erik; Sadiq, Amr Bin; Singleton, Rose; Shopland, Rosie; Vercoe, Laura; Woolhouse-Williams, Morgana; Ardagh, Michael; Bossuyt, Patrick; Bannister, Laura; Cullen, Louise

2014-01-01

Risk scores and accelerated diagnostic protocols can identify chest pain patients with low risk of major adverse cardiac event who could be discharged early from the ED, saving time and costs. We aimed to derive and validate a chest pain score and accelerated diagnostic protocol (ADP) that could

Developing and Validating a Survival Prediction Model for NSCLC Patients Through Distributed Learning Across 3 Countries.

Science.gov (United States)

Jochems, Arthur; Deist, Timo M; El Naqa, Issam; Kessler, Marc; Mayo, Chuck; Reeves, Jackson; Jolly, Shruti; Matuszak, Martha; Ten Haken, Randall; van Soest, Johan; Oberije, Cary; Faivre-Finn, Corinne; Price, Gareth; de Ruysscher, Dirk; Lambin, Philippe; Dekker, Andre

2017-10-01

Tools for survival prediction for non-small cell lung cancer (NSCLC) patients treated with chemoradiation or radiation therapy are of limited quality. In this work, we developed a predictive model of survival at 2 years. The model is based on a large volume of historical patient data and serves as a proof of concept to demonstrate the distributed learning approach. Clinical data from 698 lung cancer patients, treated with curative intent with chemoradiation or radiation therapy alone, were collected and stored at 2 different cancer institutes (559 patients at Maastro clinic (Netherlands) and 139 at Michigan university [United States]). The model was further validated on 196 patients originating from The Christie (United Kingdon). A Bayesian network model was adapted for distributed learning (the animation can be viewed at https://www.youtube.com/watch?v=ZDJFOxpwqEA). Two-year posttreatment survival was chosen as the endpoint. The Maastro clinic cohort data are publicly available at https://www.cancerdata.org/publication/developing-and-validating-survival-prediction-model-nsclc-patients-through-distributed, and the developed models can be found at www.predictcancer.org. Variables included in the final model were T and N category, age, performance status, and total tumor dose. The model has an area under the curve (AUC) of 0.66 on the external validation set and an AUC of 0.62 on a 5-fold cross validation. A model based on the T and N category performed with an AUC of 0.47 on the validation set, significantly worse than our model (PLearning the model in a centralized or distributed fashion yields a minor difference on the probabilities of the conditional probability tables (0.6%); the discriminative performance of the models on the validation set is similar (P=.26). Distributed learning from federated databases allows learning of predictive models on data originating from multiple institutions while avoiding many of the data-sharing barriers. We believe that

Validity of peptic ulcer disease and upper gastrointestinal bleeding diagnoses in administrative databases: a systematic review protocol.

Science.gov (United States)

Montedori, Alessandro; Abraha, Iosief; Chiatti, Carlos; Cozzolino, Francesco; Orso, Massimiliano; Luchetta, Maria Laura; Rimland, Joseph M; Ambrosio, Giuseppe

2016-09-15

Administrative healthcare databases are useful to investigate the epidemiology, health outcomes, quality indicators and healthcare utilisation concerning peptic ulcers and gastrointestinal bleeding, but the databases need to be validated in order to be a reliable source for research. The aim of this protocol is to perform the first systematic review of studies reporting the validation of International Classification of Diseases, 9th Revision and 10th version (ICD-9 and ICD-10) codes for peptic ulcer and upper gastrointestinal bleeding diagnoses. MEDLINE, EMBASE, Web of Science and the Cochrane Library databases will be searched, using appropriate search strategies. We will include validation studies that used administrative data to identify peptic ulcer disease and upper gastrointestinal bleeding diagnoses or studies that evaluated the validity of peptic ulcer and upper gastrointestinal bleeding codes in administrative data. The following inclusion criteria will be used: (a) the presence of a reference standard case definition for the diseases of interest; (b) the presence of at least one test measure (eg, sensitivity, etc) and (c) the use of an administrative database as a source of data. Pairs of reviewers will independently abstract data using standardised forms and will evaluate quality using the checklist of the Standards for Reporting of Diagnostic Accuracy (STARD) criteria. This systematic review protocol has been produced in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol (PRISMA-P) 2015 statement. Ethics approval is not required given that this is a protocol for a systematic review. We will submit results of this study to a peer-reviewed journal for publication. The results will serve as a guide for researchers validating administrative healthcare databases to determine appropriate case definitions for peptic ulcer disease and upper gastrointestinal bleeding, as well as to perform outcome research using

Split Course Hyperfractionated Accelerated Radio-Chemotherapy (SCHARC) for patients with advanced head and neck cancer: Influence of protocol deviations and hemoglobin on overall survival, a retrospective analysis

International Nuclear Information System (INIS)

Stadler, Peter; Putnik, Kurt; Kreimeyer, Thore; Sprague, Lisa D; Koelbl, Oliver; Schäfer, Christof

2006-01-01

The advantage of hyperfractionated accelerated radiation therapy for advanced head and neck cancer has been reported. Furthermore, randomized trials and meta-analyses have confirmed the survival benefit of additional chemotherapy to radiotherapy. We retrospectively analyzed the efficiency and toxicity of the Regensburg standard therapy protocol 'SCHARC' and the overall survival of our patients. From 1997 to 2004, 64 patients suffering from advanced head and neck cancer (88 % stage IV, 12 % stage III) were assigned to receive the SCHARC protocol. Around half of the patients were diagnosed with oro-hypopharynx carcinoma (52 %), one third with tongue and floor of mouth tumors (29 %) and one fifth (19 %) suffered from H & N cancer at other sites. The schedule consisted of one therapy block with 30 Gy in 20 fractions over a two week period with concomitant chemotherapy (d 1–5: 20 mg/m 2 /d DDP + 750–1000 mg/m 2 /d 5FU (cont. infusion). This therapy block was repeated after a fortnight break up to a cumulative dose of 60 Gy and followed by a boost up to 70 Gy (69–70.5 Gy). All patients assigned to this scheme were included in the survival evaluation. Forty patients (63 %) received both radiation and chemotherapy according to the protocol. The mean follow up was 2.3 years (829 d) and the median follow up was 1.9 years (678 d), respectively. The analysis of survival revealed an estimated 3 year overall survival rate of 57 %. No patient died of complications, 52 patients (80 %) had acute grade 2–3 mucositis, and 33 patients (58 %) suffered from acute grade 3 skin toxicity. Leucopenia was no major problem (mean nadir 3.4 g/nl, no patient < 1.0 g/nl) and the mean hemoglobin value decreased from 13.2 to 10.5 g/dl. Univariate analysis of survival showed a better outcome for patients with a hemoglobin nadir >10.5 g/dl and for patients who completed the protocol. The SCHARC protocol was effective in patients diagnosed with advanced head and neck cancer. It led

Split course hyperfractionated accelerated radio-chemotherapy (SCHARC) for patients with advanced head and neck cancer: influence of protocol deviations and hemoglobin on overall survival, a retrospective analysis.

Science.gov (United States)

Stadler, Peter; Putnik, Kurt; Kreimeyer, Thore; Sprague, Lisa D; Koelbl, Oliver; Schäfer, Christof

2006-12-07

The advantage of hyperfractionated accelerated radiation therapy for advanced head and neck cancer has been reported. Furthermore, randomized trials and meta-analyses have confirmed the survival benefit of additional chemotherapy to radiotherapy. We retrospectively analyzed the efficiency and toxicity of the Regensburg standard therapy protocol "SCHARC" and the overall survival of our patients. From 1997 to 2004, 64 patients suffering from advanced head and neck cancer (88 % stage IV, 12 % stage III) were assigned to receive the SCHARC protocol. Around half of the patients were diagnosed with oro-hypopharynx carcinoma (52 %), one third with tongue and floor of mouth tumors (29 %) and one fifth (19 %) suffered from H & N cancer at other sites. The schedule consisted of one therapy block with 30 Gy in 20 fractions over a two week period with concomitant chemotherapy (d 1-5: 20 mg/m2/d DDP + 750-1000 mg/m2/d 5FU (cont. infusion). This therapy block was repeated after a fortnight break up to a cumulative dose of 60 Gy and followed by a boost up to 70 Gy (69-70.5 Gy). All patients assigned to this scheme were included in the survival evaluation. Forty patients (63 %) received both radiation and chemotherapy according to the protocol. The mean follow up was 2.3 years (829 d) and the median follow up was 1.9 years (678 d), respectively. The analysis of survival revealed an estimated 3 year overall survival rate of 57 %. No patient died of complications, 52 patients (80 %) had acute grade 2-3 mucositis, and 33 patients (58 %) suffered from acute grade 3 skin toxicity. Leucopenia was no major problem (mean nadir 3.4 g/nl, no patient hemoglobin value decreased from 13.2 to 10.5 g/dl. Univariate analysis of survival showed a better outcome for patients with a hemoglobin nadir >10.5 g/dl and for patients who completed the protocol. The SCHARC protocol was effective in patients diagnosed with advanced head and neck cancer. It led to long-term disease control and survival in

The validity of EORTC GBM prognostic calculator on survival of GBM patients in the West of Scotland.

Science.gov (United States)

Teo, Mario; Clark, Brian; MacKinnon, Mairi; Stewart, Willie; Paul, James; St George, Jerome

2014-06-01

It is now accepted that the addition of temozolomide to radiotherapy in the treatment of patients with newly diagnosed glioblastoma multiforme (GBM) significantly improves survival. In 2008, a subanalysis of the original study data was performed, and an online "GBM Calculator" was made available on the European Organisation for Research and Treatment of Cancer (EORTC) website allowing users to estimate patients' survival outcomes. We tested this calculator against actual local survival data to validate its use in our patients. Prospectively collected clinical data were analysed on 105 consecutive patients receiving concurrent chemoradiotherapy following surgical treatment of GBM between December 2004 and February 2009. Using the EORTC online calculator, survival outcomes were generated for these patients and compared with their actual survival. The median overall survival for the entire cohort was 15.3 months (range 2.8-50.5 months), with 1-year and 2-year overall survival of 65.7% and 19%, respectively. This is in comparison to the median overall predictive survival of 21.3 months, with 1-year and 2-year survival of 95% and 39.5%, respectively. Case by case analysis also showed that the survival was overestimated in nearly 80% of patients. Subgroup analyses showed similar overestimation of patients' survival, except calculator Model 3 which utilised MGMT status. Use of the EORTC GBM prognostic calculator would have overestimated the survival of the majority of our patients with GBM. Uncertainty exists as to the cause of overestimation in the cohort although local socioeconomic factors might play a role. The different calculator models yielded different outcomes and the "best" predictor of survival for the cohort under study utilised the tumour MGMT status. We would strongly encourage similar local studies of validity testing prior to employing the online prognostic calculator for other population groups.

Split Course Hyperfractionated Accelerated Radio-Chemotherapy (SCHARC for patients with advanced head and neck cancer: Influence of protocol deviations and hemoglobin on overall survival, a retrospective analysis

Directory of Open Access Journals (Sweden)

Sprague Lisa D

2006-12-01

Full Text Available Abstract Background The advantage of hyperfractionated accelerated radiation therapy for advanced head and neck cancer has been reported. Furthermore, randomized trials and meta-analyses have confirmed the survival benefit of additional chemotherapy to radiotherapy. We retrospectively analyzed the efficiency and toxicity of the Regensburg standard therapy protocol "SCHARC" and the overall survival of our patients. Methods From 1997 to 2004, 64 patients suffering from advanced head and neck cancer (88 % stage IV, 12 % stage III were assigned to receive the SCHARC protocol. Around half of the patients were diagnosed with oro-hypopharynx carcinoma (52 %, one third with tongue and floor of mouth tumors (29 % and one fifth (19 % suffered from H & N cancer at other sites. The schedule consisted of one therapy block with 30 Gy in 20 fractions over a two week period with concomitant chemotherapy (d 1–5: 20 mg/m2/d DDP + 750–1000 mg/m2/d 5FU (cont. infusion. This therapy block was repeated after a fortnight break up to a cumulative dose of 60 Gy and followed by a boost up to 70 Gy (69–70.5 Gy. All patients assigned to this scheme were included in the survival evaluation. Results Forty patients (63 % received both radiation and chemotherapy according to the protocol. The mean follow up was 2.3 years (829 d and the median follow up was 1.9 years (678 d, respectively. The analysis of survival revealed an estimated 3 year overall survival rate of 57 %. No patient died of complications, 52 patients (80 % had acute grade 2–3 mucositis, and 33 patients (58 % suffered from acute grade 3 skin toxicity. Leucopenia was no major problem (mean nadir 3.4 g/nl, no patient 10.5 g/dl and for patients who completed the protocol. Conclusion The SCHARC protocol was effective in patients diagnosed with advanced head and neck cancer. It led to long-term disease control and survival in about 50 % of the patients with significant but acceptable toxicity. Most patients

Body surface posture evaluation: construction, validation and protocol of the SPGAP system (Posture evaluation rotating platform system).

Science.gov (United States)

Schwertner, Debora Soccal; Oliveira, Raul; Mazo, Giovana Zarpellon; Gioda, Fabiane Rosa; Kelber, Christian Roberto; Swarowsky, Alessandra

2016-05-04

Several posture evaluation devices have been used to detect deviations of the vertebral column. However it has been observed that the instruments present measurement errors related to the equipment, environment or measurement protocol. This study aimed to build, validate, analyze the reliability and describe a measurement protocol for the use of the Posture Evaluation Rotating Platform System (SPGAP, Brazilian abbreviation). The posture evaluation system comprises a Posture Evaluation Rotating Platform, video camera, calibration support and measurement software. Two pilot studies were carried out with 102 elderly individuals (average age 69 years old, SD = ±7.3) to establish a protocol for SPGAP, controlling the measurement errors related to the environment, equipment and the person under evaluation. Content validation was completed with input from judges with expertise in posture measurement. The variation coefficient method was used to validate the measurement by the instrument of an object with known dimensions. Finally, reliability was established using repeated measurements of the known object. Expert content judges gave the system excellent ratings for content validity (mean 9.4 out of 10; SD 1.13). The measurement of an object with known dimensions indicated excellent validity (all measurement errors reality. To verify the images of objects with known dimensions the values for the width and height were, respectively, CV 0.88 (width) and 2.33 (height), SD 0.22 (width) and 0.35 (height), minimum and maximum values 24.83-25.2 (width) and 14.56 - 15.75 (height). In the analysis of different images (similar) of an individual, greater discrepancies were observed in the values found. The cervical index, for example, presented minimum and maximum values of 15.38 and 37.5, a coefficient of variation of 0.29 and a standard deviation of 6.78. The SPGAP was shown to be a valid and reliable instrument for the quantitative analysis of body posture with applicability and

Validation of a ramp running protocol for determination of the true VO2max in mice

Directory of Open Access Journals (Sweden)

Mohamed Ayachi

2016-08-01

Full Text Available In the field of comparative physiology, it remains to be established whether the concept of VO2max is valid in the mouse and, if so, how this value can be accurately determined. In humans, VO2max is generally considered to correspond to the plateau observed when VO2 no longer rises with an increase in workload. In contrast, the concept of VO2peak tends to be used in murine studies. The objectives of the present study were to determine whether (i a continuous ramp protocol yielded a higher VO2peak than a stepwise, incremental protocol, and (ii the VO2peak measured in the ramp protocol corresponded to VO2max. The three protocols (based on intensity-controlled treadmill running until exhaustion with eight female FVB/N mice were performed in random order: (a an incremental protocol that begins at 10 m.min-1 speed and increases by 3 m.min-1 every 3 min. (b a ramp protocol with slow acceleration (3 m.min-2, and (c a ramp protocol with fast acceleration (12 m.min-2. Each protocol was performed with two slopes (0° and 25°. Hence, each mouse performed six exercise tests. We found that the value of VO2peak was protocol-dependent (p 8 mmol.l-1 and a respiratory exchange ratio >1. The total duration of the 3 m.min-2 0° ramp protocol was shorter than that of the incremental protocol. Taken as a whole, our results suggest that VO2max in the mouse is best determined by applying a ramp exercise protocol with slow acceleration and no treadmill slope.

Review and evaluation of performance measures for survival prediction models in external validation settings

Directory of Open Access Journals (Sweden)

M. Shafiqur Rahman

2017-04-01

Full Text Available Abstract Background When developing a prediction model for survival data it is essential to validate its performance in external validation settings using appropriate performance measures. Although a number of such measures have been proposed, there is only limited guidance regarding their use in the context of model validation. This paper reviewed and evaluated a wide range of performance measures to provide some guidelines for their use in practice. Methods An extensive simulation study based on two clinical datasets was conducted to investigate the performance of the measures in external validation settings. Measures were selected from categories that assess the overall performance, discrimination and calibration of a survival prediction model. Some of these have been modified to allow their use with validation data, and a case study is provided to describe how these measures can be estimated in practice. The measures were evaluated with respect to their robustness to censoring and ease of interpretation. All measures are implemented, or are straightforward to implement, in statistical software. Results Most of the performance measures were reasonably robust to moderate levels of censoring. One exception was Harrell’s concordance measure which tended to increase as censoring increased. Conclusions We recommend that Uno’s concordance measure is used to quantify concordance when there are moderate levels of censoring. Alternatively, Gönen and Heller’s measure could be considered, especially if censoring is very high, but we suggest that the prediction model is re-calibrated first. We also recommend that Royston’s D is routinely reported to assess discrimination since it has an appealing interpretation. The calibration slope is useful for both internal and external validation settings and recommended to report routinely. Our recommendation would be to use any of the predictive accuracy measures and provide the corresponding predictive

Validation of internal dosimetry protocols based on stochastic method

International Nuclear Information System (INIS)

Mendes, Bruno M.; Fonseca, Telma C.F.; Almeida, Iassudara G.; Trindade, Bruno M.; Campos, Tarcisio P.R.

2015-01-01

Computational phantoms adapted to Monte Carlo codes have been applied successfully in radiation dosimetry fields. NRI research group has been developing Internal Dosimetry Protocols - IDPs, addressing distinct methodologies, software and computational human-simulators, to perform internal dosimetry, especially for new radiopharmaceuticals. Validation of the IDPs is critical to ensure the reliability of the simulations results. Inter comparisons of data from literature with those produced by our IDPs is a suitable method for validation. The aim of this study was to validate the IDPs following such inter comparison procedure. The Golem phantom has been reconfigured to run on MCNP5. The specific absorbed fractions (SAF) for photon at 30, 100 and 1000 keV energies were simulated based on the IDPs and compared with reference values (RV) published by Zankl and Petoussi-Henss, 1998. The SAF average differences from RV and those obtained in IDP simulations was 2.3 %. The SAF largest differences were found in situations involving low energy photons at 30 keV. The Adrenals and thyroid, i.e. the lowest mass organs, had the highest SAF discrepancies towards RV as 7.2 % and 3.8 %, respectively. The statistic differences of SAF applying our IDPs from reference values were considered acceptable at the 30, 100 and 1000 keV spectra. We believe that the main reason for the discrepancies in IDPs run, found in lower masses organs, was due to our source definition methodology. Improvements of source spatial distribution in the voxels may provide outputs more consistent with reference values for lower masses organs. (author)

Validation of internal dosimetry protocols based on stochastic method

Energy Technology Data Exchange (ETDEWEB)

Mendes, Bruno M.; Fonseca, Telma C.F., E-mail: bmm@cdtn.br [Centro de Desenvolvimento da Tecnologia Nuclear (CDTN/CNEN-MG), Belo Horizonte, MG (Brazil); Almeida, Iassudara G.; Trindade, Bruno M.; Campos, Tarcisio P.R., E-mail: tprcampos@yahoo.com.br [Universidade Federal de Minas Gerais (DEN/UFMG), Belo Horizonte, MG (Brazil). Departamento de Engenharia Nuclear

2015-07-01

Computational phantoms adapted to Monte Carlo codes have been applied successfully in radiation dosimetry fields. NRI research group has been developing Internal Dosimetry Protocols - IDPs, addressing distinct methodologies, software and computational human-simulators, to perform internal dosimetry, especially for new radiopharmaceuticals. Validation of the IDPs is critical to ensure the reliability of the simulations results. Inter comparisons of data from literature with those produced by our IDPs is a suitable method for validation. The aim of this study was to validate the IDPs following such inter comparison procedure. The Golem phantom has been reconfigured to run on MCNP5. The specific absorbed fractions (SAF) for photon at 30, 100 and 1000 keV energies were simulated based on the IDPs and compared with reference values (RV) published by Zankl and Petoussi-Henss, 1998. The SAF average differences from RV and those obtained in IDP simulations was 2.3 %. The SAF largest differences were found in situations involving low energy photons at 30 keV. The Adrenals and thyroid, i.e. the lowest mass organs, had the highest SAF discrepancies towards RV as 7.2 % and 3.8 %, respectively. The statistic differences of SAF applying our IDPs from reference values were considered acceptable at the 30, 100 and 1000 keV spectra. We believe that the main reason for the discrepancies in IDPs run, found in lower masses organs, was due to our source definition methodology. Improvements of source spatial distribution in the voxels may provide outputs more consistent with reference values for lower masses organs. (author)

Validation of four automatic devices for self-measurement of blood pressure according to the international protocol of the European Society of Hypertension

Directory of Open Access Journals (Sweden)

Asmar R

2011-11-01

Full Text Available Jirar Topouchian1, Davide Agnoletti1, Jacques Blacher1, Ahmed Youssef1, Isabel Ibanez2,3, Jose Khabouth2, Salwa Khawaja2, Layale Beaino2, Roland Asmar1–31Centre de Diagnostic, Hôpital Hôtel-Dieu, Paris, France; 2Hôpital Libanais and Faculté Libanaise de Médecine, Beirut, Lebanon; 3Foundation-Medical Research Institutes, Geneva, SwitzerlandBackground: Four oscillometric devices for self-measurement of blood pressure (SBPM were evaluated according to the European Society of Hypertension (ESH international protocol and its 2010 revision in four separate studies. The Omron® M2, Omron M3, and Omron M6 measure blood pressure (BP at the brachial level, while the Omron R2 measures BP at the wrist level.Methods: The international protocol requires a total number of 33 subjects in which the validation is performed. The Omron M2 and Omron R2 were validated in 2009 according to the ESH international protocol, while the Omron M3 and Omron M6 were validated in 2010–2011 according to the 2010 ESH international protocol revision. The protocol procedures were followed precisely.Results: All four tested devices passed the validation process. The mean differences between the device and mercury readings were 2.7 ± 5.0 and –1.4 ± 3.2 mmHg for systolic and diastolic BP, respectively, using the Omron M2 device, and 1.7 ± 3.2 and –0.9 ± 2.6 mmHg using the Omron M3, 1.6 ± 2.9 and -0.9 ± 2.5 mmHg using the Omron M6, and –1.1 ± 4.8 and –0.9 ± 4.3 mmHg using the Omron R2.Conclusion: Readings from the Omron M2, Omron M3, Omron M6, and Omron R2, differing by less than 5, 10, and 15 mmHg, fulfill the ESH international protocol and its 2010 revision requirements. Therefore, each of these four devices can be used by patients for SBPM.Keywords: Omron R2, M2, M3, M6, blood pressure measurement, validation, international protocol, European Society of Hypertension

A Validated Prediction Model for Overall Survival From Stage III Non-Small Cell Lung Cancer: Toward Survival Prediction for Individual Patients

Energy Technology Data Exchange (ETDEWEB)

Oberije, Cary, E-mail: cary.oberije@maastro.nl [Radiation Oncology, Research Institute GROW of Oncology, Maastricht University Medical Center, Maastricht (Netherlands); De Ruysscher, Dirk [Radiation Oncology, Research Institute GROW of Oncology, Maastricht University Medical Center, Maastricht (Netherlands); Universitaire Ziekenhuizen Leuven, KU Leuven (Belgium); Houben, Ruud [Radiation Oncology, Research Institute GROW of Oncology, Maastricht University Medical Center, Maastricht (Netherlands); Heuvel, Michel van de; Uyterlinde, Wilma [Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam (Netherlands); Deasy, Joseph O. [Memorial Sloan Kettering Cancer Center, New York (United States); Belderbos, Jose [Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam (Netherlands); Dingemans, Anne-Marie C. [Department of Pulmonology, University Hospital Maastricht, Research Institute GROW of Oncology, Maastricht (Netherlands); Rimner, Andreas; Din, Shaun [Memorial Sloan Kettering Cancer Center, New York (United States); Lambin, Philippe [Radiation Oncology, Research Institute GROW of Oncology, Maastricht University Medical Center, Maastricht (Netherlands)

2015-07-15

Purpose: Although patients with stage III non-small cell lung cancer (NSCLC) are homogeneous according to the TNM staging system, they form a heterogeneous group, which is reflected in the survival outcome. The increasing amount of information for an individual patient and the growing number of treatment options facilitate personalized treatment, but they also complicate treatment decision making. Decision support systems (DSS), which provide individualized prognostic information, can overcome this but are currently lacking. A DSS for stage III NSCLC requires the development and integration of multiple models. The current study takes the first step in this process by developing and validating a model that can provide physicians with a survival probability for an individual NSCLC patient. Methods and Materials: Data from 548 patients with stage III NSCLC were available to enable the development of a prediction model, using stratified Cox regression. Variables were selected by using a bootstrap procedure. Performance of the model was expressed as the c statistic, assessed internally and on 2 external data sets (n=174 and n=130). Results: The final multivariate model, stratified for treatment, consisted of age, gender, World Health Organization performance status, overall treatment time, equivalent radiation dose, number of positive lymph node stations, and gross tumor volume. The bootstrapped c statistic was 0.62. The model could identify risk groups in external data sets. Nomograms were constructed to predict an individual patient's survival probability ( (www.predictcancer.org)). The data set can be downloaded at (https://www.cancerdata.org/10.1016/j.ijrobp.2015.02.048). Conclusions: The prediction model for overall survival of patients with stage III NSCLC highlights the importance of combining patient, clinical, and treatment variables. Nomograms were developed and validated. This tool could be used as a first building block for a decision support system.

Development, appraisal, validation and implementation of a consensus protocol for the assessment of cerebral amyloid angiopathy in post-mortem brain tissue

Science.gov (United States)

Love, Seth; Chalmers, Katy; Ince, Paul; Esiri, Margaret; Attems, Johannes; Jellinger, Kurt; Yamada, Masahito; McCarron, Mark; Minett, Thais; Matthews, Fiona; Greenberg, Steven; Mann, David; Kehoe, Patrick Gavin

2014-01-01

In a collaboration involving 11 groups with research interests in cerebral amyloid angiopathy (CAA), we used a two-stage process to develop and in turn validate a new consensus protocol and scoring scheme for the assessment of CAA and associated vasculopathic abnormalities in post-mortem brain tissue. Stage one used an iterative Delphi-style survey to develop the consensus protocol. The resultant scoring scheme was tested on a series of digital images and paraffin sections that were circulated blind to a number of scorers. The scoring scheme and choice of staining methods were refined by open-forum discussion. The agreed protocol scored parenchymal and meningeal CAA on a 0-3 scale, capillary CAA as present/absent and vasculopathy on 0-2 scale, in the 4 cortical lobes that were scored separately. A further assessment involving three centres was then undertaken. Neuropathologists in three centres (Bristol, Oxford and Sheffield) independently scored sections from 75 cases (25 from each centre) and high inter-rater reliability was demonstrated. Stage two used the results of the three-centre assessment to validate the protocol by investigating previously described associations between APOE genotype (previously determined), and both CAA and vasculopathy. Association of capillary CAA with or without arteriolar CAA with APOE ε4 was confirmed. However APOE ε2 was also found to be a strong risk factor for the development of CAA, not only in AD but also in elderly non-demented controls. Further validation of this protocol and scoring scheme is encouraged, to aid its wider adoption to facilitate collaborative and replication studies of CAA. PMID:24754000

IMPROVED COMPUTATIONAL NEUTRONICS METHODS AND VALIDATION PROTOCOLS FOR THE ADVANCED TEST REACTOR

Energy Technology Data Exchange (ETDEWEB)

David W. Nigg; Joseph W. Nielsen; Benjamin M. Chase; Ronnie K. Murray; Kevin A. Steuhm

2012-04-01

The Idaho National Laboratory (INL) is in the process of modernizing the various reactor physics modeling and simulation tools used to support operation and safety assurance of the Advanced Test Reactor (ATR). Key accomplishments so far have encompassed both computational as well as experimental work. A new suite of stochastic and deterministic transport theory based reactor physics codes and their supporting nuclear data libraries (HELIOS, KENO6/SCALE, NEWT/SCALE, ATTILA, and an extended implementation of MCNP5) has been installed at the INL. Corresponding models of the ATR and ATRC are now operational with all five codes, demonstrating the basic feasibility of the new code packages for their intended purpose. Of particular importance, a set of as-run core depletion HELIOS calculations for all ATR cycles since August 2009 was successfully completed during 2011. This demonstration supported a decision late in the year to proceed with the phased incorporation of the HELIOS methodology into the ATR fuel cycle management process beginning in 2012. On the experimental side of the project, new hardware was fabricated, measurement protocols were finalized, and the first four of six planned physics code validation experiments based on neutron activation spectrometry were conducted at the ATRC facility. Data analysis for the first three experiments, focused on characterization of the neutron spectrum in one of the ATR flux traps, has been completed. The six experiments will ultimately form the basis for a flexible, easily-repeatable ATR physics code validation protocol that is consistent with applicable ASTM standards.

Validation of a Five Plate Test, the STAR protocol, for the screening of antibiotic residues in muscle from different animal species according to European Decision 2002/657/EC.

Science.gov (United States)

Gaudin, V; Hedou, C; Rault, A; Verdon, E

2010-07-01

The STAR protocol is a Five Plate Test (FPT) developed several years ago at the Community Reference Laboratory (CRL) for the screening of antimicrobial residues in milk and muscle. This paper presents the validation of this method according to European Decision 2002/657/EC and to an internal guideline for validation. A validation protocol based on 'simulated tissues' and on a list of 16 representative antimicrobials to be validated was implemented in our laboratory during several months for the STAR protocol. The performance characteristics of the method were determined (specificity, detection capabilities CCbeta, applicability, ruggedness). In conclusion, the STAR protocol is applicable to the broad-spectrum detection of antibiotic residues in muscles of different animal species (pig, cattle, sheep, poultry). The method has good specificity (false-positive rate = 4%). The detection capabilities were determined for 16 antibiotics from different families in relation to their respective maximum residue limit (MRL): beta-lactams (penicillins and cephalosporins 8 MRL) and florfenicol (MRL). The two objectives of this study were met: firstly, to validate the STAR protocol according to European Decision 2002/657/EC, then to demonstrate that the validation guideline developed to implement this decision is applicable to microbiological plate tests even for muscle. The use of simulated tissue appeared a good compromise between spiked discs with antibiotic solutions and incurred tissues. In addition, the choice of a list of representative antibiotics allowed the reduction of the scope of the validation, which was already costly in time and effort.

Growth, survival and bone alterations in Piaractus mesopotamicus larvae under different rearing protocols

Directory of Open Access Journals (Sweden)

David Roque Hernández

2015-09-01

Full Text Available The pacu (Piaractus mesopotamicus is a neotropical freshwater fish. It is one of the most important species farmed in areas of the Parana and Paraguay Rivers basins. The effects of different rearing protocols on growth, survival and incidence of skeletal malformations in pacu larvae were analyzed. A total of six experimental treatments were considered, consisting of: a semi-intensive larviculture (LS in ponds; intensive larviculture (LIn in laboratory (both LS and LIn until 60 days of life; and mixed larviculture, with 20 days of semi-intensive larviculture into cages in ponds after 14 (L1, 21 (L2, 33 (L3 or 40 (L4 days of laboratory larviculture. At the end of the experimental period, LSlarvae showed higher growth rate, with average weight values (2.28g and total length (TL-48.20mm statistically higher than the rest (P1 to L4 treatments showed intermediate growth values, without differences between them (P>0.05, while LIn presented the lowest growth (PS, that presented a significantly lower value (17.5%, PIn and L1 presented the lowest incidence. In no case, visible morphological alterations were found. This study shows that prolonging pacu rearing under laboratory conditions at high densities improves temporal availability and survival of juvenile without affecting growth or subsequent osteological development of fish.

Is the standard compliance check protocol a valid measure of the accessibility of tobacco to underage smokers?

Science.gov (United States)

DiFranza, J.; Savageau, J.; Bouchard, J.

2001-01-01

OBJECTIVE—To determine if the standard compliance check protocol is a valid measure of the experience of underage smokers when purchasing tobacco in unfamiliar communities.
SETTING—160 tobacco outlets in eight Massachusetts communities where underage tobacco sales laws are vigorously enforced.
PROCEDURE—Completed purchase rates were compared between underage smokers who behaved normally and inexperienced non-smoking youths who were not allowed to lie or present proof of age (ID).
RESULTS—The "smoker protocol" increased the likelihood of a sale nearly sixfold over that for the non-smokers (odds ratio (OR) 5.7, 95% confidence interval (CI) 1.5 to 22). When the youths presented an ID with an underage birth date, the odds of a completed sale increased dramatically (OR 27, 95% CI 3.4 to 212). Clerks judged to be under 21 years of age were seven times more likely to make an illegal sale (OR 7.6, 95% CI 2.4 to 24.0).
CONCLUSIONS—Commonly used compliance check protocols are too artificial to reflect accurately the experience of underage smokers. The validity of compliance checks might be improved by having youths present ID, and by employing either tobacco users, or non-tobacco users who are sufficiently experienced to mimic the self confidence exhibited by tobacco users in this situation. Consideration should be given to prohibiting the sale of tobacco by individuals under 21 years of age.


Keywords: compliance check protocol; underage smokers PMID:11544386

Validation of low-volume enrichment protocols for detection of Escherichia coli O157 in raw ground beef components, using commercial kits.

Science.gov (United States)

Ahmed, Imtiaz; Hughes, Denise; Jenson, Ian; Karalis, Tass

2009-03-01

Testing of beef destined for use in ground beef products for the presence of Escherichia coli O157:H7 has become an important cornerstone of control and verification activities within many meat supply chains. Validation of the ability of methods to detect low levels of E. coli O157:H7 is critical to confidence in test systems. Many rapid methods have been validated against standard cultural methods for 25-g samples. In this study, a number of previously validated enrichment broths and commercially available test kits were validated for the detection of low numbers of E. coli O157:H7 in 375-g samples of raw ground beef component matrices using 1 liter of enrichment broth (large-sample:low-volume enrichment protocol). Standard AOAC International methods for 25-g samples in 225 ml of enrichment broth, using the same media, incubation conditions, and test kits, were used as reference methods. No significant differences were detected in the ability of any of the tests to detect low levels of E. coli O157:H7 in samples of raw ground beef components when enriched according to standard or large-sample:low-volume enrichment protocols. The use of large-sample:low-volume enrichment protocols provides cost savings for media and logistical benefits when handling and incubating large numbers of samples.

A Concise Protocol for the Validation of Language ENvironment Analysis (LENA) Conversational Turn Counts in Vietnamese

Science.gov (United States)

Ganek, Hillary V.; Eriks-Brophy, Alice

2018-01-01

The aim of this study was to present a protocol for the validation of the Language ENvironment Analysis (LENA) System's conversational turn count (CTC) for Vietnamese speakers. Ten families of children aged between 22 and 42 months, recruited near Ho Chi Minh City, participated in this project. Each child wore the LENA audio recorder for a full…

Improving the accuracy of blood pressure measurement: the influence of the European Society of Hypertension International Protocol (ESH-IP) for the validation of blood pressure measuring devices and future perspectives.

Science.gov (United States)

Stergiou, George S; Asmar, Roland; Myers, Martin; Palatini, Paolo; Parati, Gianfranco; Shennan, Andrew; Wang, Jiguang; O'Brien, Eoin

2018-03-01

The European Society of Hypertension (ESH) International Protocol (ESH-IP) for the validation of blood pressure (BP) measuring devices was published in 2002, with the main objective of simplifying the validation procedures, so that more BP monitors would be subjected to independent validation. This article provides an overview of the international impact of the ESH-IP and of the lessons learned from its use, to be able to justify further developments in validation protocols. A review of published (PubMed) validation studies from 2002 to 2017 was performed. One hundred and seventy-seven validation studies using the ESH-IP, 59 using the British Hypertension Society protocol, 46 using the Association for the Advancement of Medical Instrumentation (AAMI) standard and 23 using the International Organization for Standardization (ISO) standard were identified. Lists of validated office-clinic, home and ambulatory BP monitors are provided. Of the ESH-IP studies, 93% tested oscillometric devices, 80% upper arm, 71% home, 25% office and 7% ambulatory monitors (some had more than one function). The original goal of the ESH-IP has been fulfilled in that in the last decade the number of published validation studies has more than doubled. It is now recognized that the provision of accurate devices would be best served by having a universal protocol. An international initiative has been put in place by AAMI, ESH and ISO experts aiming to reach consensus for a universal validation protocol to be accepted worldwide, which will allow a more thorough evaluation of the accuracy and performance of future BP monitors.

Validation of the custo screen pediatric blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Beime, Beate; Deutsch, Cornelia; Krüger, Ralf; Wolf, Andreas; Müller, Peter; Hammel, Gertrud; Bramlage, Peter

2017-05-01

The purpose of the study was to validate the ambulatory blood pressure monitoring (ABPM) device custo screen pediatric in children aged 3 to 12 years according to the International Protocol of the European Society of Hypertension (ESH-IP revision 2010). Thirty-three children were included and systolic and diastolic blood pressure measurements were performed according to the ESH-IP. The protocol was modified for children considering data from the German Health Interview and Examination Survey for Children and Adolescents (KIGGS). The custo screen pediatric met all the requirements of the ESH-IP. The mean difference between the test device and the reference was -1.4 ± 3.0 mmHg for systolic blood pressure (SBP) and -0.7 ± 3.2 mmHg for diastolic blood pressure (DBP). For SBP and DBP, all 99 measurements were within the absolute difference of 10 mmHg between the test device and the reference. As to part 2 of the protocol, for DBP in all subjects, two out of three measurements were within 5 mmHg between the device and the standard, whereas for SBP in 32 of 33 subjects, two out of three measurements were within this range. The custo screen pediatric met all criteria of the ESH-IP review 2010, modified for children from 3 to about 12 years, and can be recommended for ABPM in children. What is Known: • Validation of blood pressure measuring devices is essential to provide patients with an accurate blood pressure measuring device. • The majority of devices has not been validated in children. What is New: • Prior to the present validation, study protocol adjustments of ESH-IP review 2010 for children were defined according to German Health Interview and Examination Survey for Children and Adolescents 2013 (KIGGS). • The custo screen pediatric test device met all criteria of ESH-IP revision 2010, modified for children, and can be recommended for ABPM in children aged 3 to about 12 years.

Erratum: Development, appraisal, validation and implementation of a consensus protocol for the assessment of cerebral amyloid angiopathy in post-mortem brain tissue.

Science.gov (United States)

Love, Seth; Chalmers, Katy; Ince, Paul; Esiri, Margaret; Attems, Johannes; Kalaria, Raj; Jellinger, Kurt; Yamada, Masahito; McCarron, Mark; Minett, Thais; Matthews, Fiona; Greenberg, Steven; Mann, David; Kehoe, Patrick Gavin

2015-01-01

In a collaboration involving 11 groups with research interests in cerebral amyloid angiopathy (CAA), we used a two-stage process to develop and in turn validate a new consensus protocol and scoring scheme for the assessment of CAA and associated vasculopathic abnormalities in post-mortem brain tissue. Stage one used an iterative Delphi-style survey to develop the consensus protocol. The resultant scoring scheme was tested on a series of digital images and paraffin sections that were circulated blind to a number of scorers. The scoring scheme and choice of staining methods were refined by open-forum discussion. The agreed protocol scored parenchymal and meningeal CAA on a 0-3 scale, capillary CAA as present/absent and vasculopathy on 0-2 scale, in the 4 cortical lobes that were scored separately. A further assessment involving three centres was then undertaken. Neuropathologists in three centres (Bristol, Oxford and Sheffield) independently scored sections from 75 cases (25 from each centre) and high inter-rater reliability was demonstrated. Stage two used the results of the three-centre assessment to validate the protocol by investigating previously described associations between APOE genotype (previously determined), and both CAA and vasculopathy. Association of capillary CAA with or without arteriolar CAA with APOE ε4 was confirmed. However APOE ε2 was also found to be a strong risk factor for the development of CAA, not only in AD but also in elderly non-demented controls. Further validation of this protocol and scoring scheme is encouraged, to aid its wider adoption to facilitate collaborative and replication studies of CAA.[This corrects the article on p. 19 in vol. 3, PMID: 24754000.].

Development and validation of risk prediction equations to estimate survival in patients with colorectal cancer: cohort study

OpenAIRE

Hippisley-Cox, Julia; Coupland, Carol

2017-01-01

Objective: To develop and externally validate risk prediction equations to estimate absolute and conditional survival in patients with colorectal cancer. \\ud \\ud Design: Cohort study.\\ud \\ud Setting: General practices in England providing data for the QResearch database linked to the national cancer registry.\\ud \\ud Participants: 44 145 patients aged 15-99 with colorectal cancer from 947 practices to derive the equations. The equations were validated in 15 214 patients with colorectal cancer ...

Split Course Hyperfractionated Accelerated Radio-Chemotherapy (SCHARC) for patients with advanced head and neck cancer: Influence of protocol deviations and hemoglobin on overall survival, a retrospective analysis

OpenAIRE

Stadler, Peter; Putnik, Kurt; Kreimeyer, Thore; Sprague, Lisa D; Koelbl, Oliver; Schäfer, Christof

2006-01-01

Abstract Background The advantage of hyperfractionated accelerated radiation therapy for advanced head and neck cancer has been reported. Furthermore, randomized trials and meta-analyses have confirmed the survival benefit of additional chemotherapy to radiotherapy. We retrospectively analyzed the efficiency and toxicity of the Regensburg standard therapy protocol "SCHARC" and the overall survival of our patients. Methods From 1997 to 2004, 64 patients suffering from advanced head and neck ca...

Validation of the Artsana CSI 610 automated blood pressure monitor in adults according to the International Protocol of the European Society of Hypertension.

Science.gov (United States)

Pini, Claudio; Pastori, Marco; Baccheschi, Jordan; Omboni, Stefano; Parati, Gianfranco

2007-06-01

There is evidence that blood pressure measurement outside the doctor's office can provide valuable information for the diagnostic evaluation of hypertensive patients and for monitoring their response to treatment. Home blood pressure monitoring devices have a major role in this setting, provided that their accuracy in measuring blood pressure is demonstrated by validation studies. This study aimed at verifying whether the automatic electronic oscillometric blood pressure measuring device Artsana CSI 610 complied with the standard of accuracy indicated by the ESH International Protocol. Sequential measurements of systolic and diastolic blood pressure were obtained in 33 participants using the mercury sphygmomanometer (two observers) and the test device (one supervisor). A standard adult cuff was always employed during the study. According to the ESH validation protocol, 99 couples of test device and reference blood pressure measurements were obtained during the two phases of the study (three pairs for each of the 33 participants). The Artsana CSI 610 device successfully passed phase 1 of study validation with the number of absolute differences between test and reference device never validation study with a mean (+/-SD) device-observer difference of -1.4+/-4.8 mmHg for systolic and -0.9+/-3.5 mmHg for diastolic blood pressure. According to the results of the validation study on the basis of the ESH International Protocol, the Artsana CSI 610 can be recommended for clinical use in adults.

Validation of Autoclave Protocols for Successful Decontamination of Category A Medical Waste Generated from Care of Patients with Serious Communicable Diseases.

Science.gov (United States)

Garibaldi, Brian T; Reimers, Mallory; Ernst, Neysa; Bova, Gregory; Nowakowski, Elaine; Bukowski, James; Ellis, Brandon C; Smith, Chris; Sauer, Lauren; Dionne, Kim; Carroll, Karen C; Maragakis, Lisa L; Parrish, Nicole M

2017-02-01

In response to the Ebola outbreak in 2014, many hospitals designated specific areas to care for patients with Ebola and other highly infectious diseases. The safe handling of category A infectious substances is a unique challenge in this environment. One solution is on-site waste treatment with a steam sterilizer or autoclave. The Johns Hopkins Hospital (JHH) installed two pass-through autoclaves in its biocontainment unit (BCU). The JHH BCU and The Johns Hopkins biosafety level 3 (BSL-3) clinical microbiology laboratory designed and validated waste-handling protocols with simulated patient trash to ensure adequate sterilization. The results of the validation process revealed that autoclave factory default settings are potentially ineffective for certain types of medical waste and highlighted the critical role of waste packaging in successful sterilization. The lessons learned from the JHH validation process can inform the design of waste management protocols to ensure effective treatment of highly infectious medical waste. Copyright © 2017 American Society for Microbiology.

Multiprofissional electronic protocol in ophtalmology with enfasis in strabismus

Directory of Open Access Journals (Sweden)

CHRISTIE GRAF RIBEIRO

Full Text Available ABSTRACT Objective: to create and validate an electronic database in ophthalmology focused on strabismus, to computerize this database in the form of a systematic data collection software named Electronic Protocol, and to incorporate this protocol into the Integrated System of Electronic Protocols (SINPE(c. Methods: this is a descriptive study, with the methodology divided into three phases: (1 development of a theoretical ophthalmologic database with emphasis on strabismus; (2 computerization of this theoretical ophthalmologic database using SINPE(c and (3 interpretation of the information with demonstration of results to validate the protocol. We inputed data from the charts of fifty patients with known strabismus through the Electronic Protocol for testing and validation. Results: the new electronic protocol was able to store information regarding patient history, physical examination, laboratory exams, imaging results, diagnosis and treatment of patients with ophthalmologic diseases, with emphasis on strabismus. We included 2,141 items in this master protocol and created 20 new specific electronic protocols for strabismus, each with its own specifics. Validation was achieved through correlation and corroboration of the symptoms and confirmed diagnoses of the fifty included patients with the diagnostic criteria for the twenty new strabismus protocols. Conclusion: a new, validated electronic database focusing on ophthalmology, with emphasis on strabismus, was successfully created through the standardized collection of information, and computerization of the database using proprietary software. This protocol is ready for deployment to facilitate data collection, sorting and application for practitioners and researchers in numerous specialties.

Simulation Fidelity Issues for Nuclear Survivability Validation Protocols.

Science.gov (United States)

1992-11-01

PM/TO ATTN: AMCPM-GARS-TMD AUlN: AMCPM-JS-TM U S ARMY MISSILE COMMAND ATTN: AMCPM-MS-PM ATTN: AMCPM-MSCS-PM ATUN : MAJ R LUSHBOUGH ATTN: AMCPM-PL...TETI JAYCOR ATTN: D WALTERS HONEYWELL INC ATTN: DR B C PASSENHEIM ATUN : F PELTON ATTN: E WENAAS ATTN: SHIRLEY KREIGER ATTN: W SEIDLER HONEYWELL INC

Development and External Validation of Prognostic Model for 2-Year Survival of Non-Small-Cell Lung Cancer Patients Treated With Chemoradiotherapy

International Nuclear Information System (INIS)

Dehing-Oberije, Cary; Yu Shipeng; De Ruysscher, Dirk; Meersschout, Sabine; Van Beek, Karen; Lievens, Yolande; Van Meerbeeck, Jan; De Neve, Wilfried; Rao, Bharat Ph.D.; Weide, Hiska van der; Lambin, Philippe

2009-01-01

Purpose: Radiotherapy, combined with chemotherapy, is the treatment of choice for a large group of non-small-cell lung cancer (NSCLC) patients. Recent developments in the treatment of these patients have led to improved survival. However, the clinical TNM stage is highly inaccurate for the prediction of survival, and alternatives are lacking. The objective of this study was to develop and validate a prediction model for survival of NSCLC patients, treated with chemoradiotherapy. Patients and Methods: The clinical data from 377 consecutive inoperable NSCLC patients, Stage I-IIIB, treated radically with chemoradiotherapy were collected. A prognostic model for 2-year survival was developed, using 2-norm support vector machines. The performance of the model was expressed as the area under the curve of the receiver operating characteristic and assessed using leave-one-out cross-validation, as well as two external data sets. Results: The final multivariate model consisted of gender, World Health Organization performance status, forced expiratory volume in 1 s, number of positive lymph node stations, and gross tumor volume. The area under the curve, assessed by leave-one-out cross-validation, was 0.74, and application of the model to the external data sets yielded an area under the curve of 0.75 and 0.76. A high- and low-risk group could be clearly identified using a risk score based on the model. Conclusion: The multivariate model performed very well and was able to accurately predict the 2-year survival of NSCLC patients treated with chemoradiotherapy. The model could support clinicians in the treatment decision-making process.

Improved survival with an innovative approach to the treatment of severely burned patients: development of a burn treatment manual

OpenAIRE

Morisada, S.; Nosaka, N.; Tsukahara, K.; Ugawa, T.; Sato, K.; Ujike, Y.

2015-01-01

The management of severely burned patients remains a major issue worldwide as indicated by the high incidence of permanent debilitating complications and poor survival rates. In April 2012, the Advanced Emergency & Critical Care Medical Center of the Okayama University Hospital began implementing guidelines for severely burned patients, distributed as a standard burn treatment manual. The protocol, developed in-house, was validated by comparing the outcomes of patients with severe extensive b...

Analyzing security protocols in hierarchical networks

DEFF Research Database (Denmark)

Zhang, Ye; Nielson, Hanne Riis

2006-01-01

Validating security protocols is a well-known hard problem even in a simple setting of a single global network. But a real network often consists of, besides the public-accessed part, several sub-networks and thereby forms a hierarchical structure. In this paper we first present a process calculus...... capturing the characteristics of hierarchical networks and describe the behavior of protocols on such networks. We then develop a static analysis to automate the validation. Finally we demonstrate how the technique can benefit the protocol development and the design of network systems by presenting a series...

Prognostic nomograms for predicting survival and distant metastases in locally advanced rectal cancers.

Directory of Open Access Journals (Sweden)

Junjie Peng

Full Text Available To develop prognostic nomograms for predicting outcomes in patients with locally advanced rectal cancers who do not receive preoperative treatment.A total of 883 patients with stage II-III rectal cancers were retrospectively collected from a single institution. Survival analyses were performed to assess each variable for overall survival (OS, local recurrence (LR and distant metastases (DM. Cox models were performed to develop a predictive model for each endpoint. The performance of model prediction was validated by cross validation and on an independent group of patients.The 5-year LR, DM and OS rates were 22.3%, 32.7% and 63.8%, respectively. Two prognostic nomograms were successfully developed to predict 5-year OS and DM-free survival rates, with c-index of 0.70 (95% CI = [0.66, 0.73] and 0.68 (95% CI = [0.64, 0.72] on the original dataset, and 0.76 (95% CI = [0.67, 0.86] and 0.73 (95% CI = [0.63, 0.83] on the validation dataset, respectively. Factors in our models included age, gender, carcinoembryonic antigen value, tumor location, T stage, N stage, metastatic lymph nodes ratio, adjuvant chemotherapy and chemoradiotherapy. Predicted by our nomogram, substantial variability in terms of 5-year OS and DM-free survival was observed within each TNM stage category.The prognostic nomograms integrated demographic and clinicopathological factors to account for tumor and patient heterogeneity, and thereby provided a more individualized outcome prognostication. Our individualized prediction nomograms could help patients with preoperatively under-staged rectal cancer about their postoperative treatment strategies and follow-up protocols.

The EADC-ADNI Harmonized Protocol for manual hippocampal segmentation on magnetic resonance: Evidence of validity

Science.gov (United States)

Frisoni, Giovanni B.; Jack, Clifford R.; Bocchetta, Martina; Bauer, Corinna; Frederiksen, Kristian S.; Liu, Yawu; Preboske, Gregory; Swihart, Tim; Blair, Melanie; Cavedo, Enrica; Grothe, Michel J.; Lanfredi, Mariangela; Martinez, Oliver; Nishikawa, Masami; Portegies, Marileen; Stoub, Travis; Ward, Chadwich; Apostolova, Liana G.; Ganzola, Rossana; Wolf, Dominik; Barkhof, Frederik; Bartzokis, George; DeCarli, Charles; Csernansky, John G.; deToledo-Morrell, Leyla; Geerlings, Mirjam I.; Kaye, Jeffrey; Killiany, Ronald J.; Lehéricy, Stephane; Matsuda, Hiroshi; O'Brien, John; Silbert, Lisa C.; Scheltens, Philip; Soininen, Hilkka; Teipel, Stefan; Waldemar, Gunhild; Fellgiebel, Andreas; Barnes, Josephine; Firbank, Michael; Gerritsen, Lotte; Henneman, Wouter; Malykhin, Nikolai; Pruessner, Jens C.; Wang, Lei; Watson, Craig; Wolf, Henrike; deLeon, Mony; Pantel, Johannes; Ferrari, Clarissa; Bosco, Paolo; Pasqualetti, Patrizio; Duchesne, Simon; Duvernoy, Henri; Boccardi, Marina

2015-01-01

Background An international Delphi panel has defined a harmonized protocol (HarP) for the manual segmentation of the hippocampus on MR. The aim of this study is to study the concurrent validity of the HarP toward local protocols, and its major sources of variance. Methods Fourteen tracers segmented 10 Alzheimer's Disease Neuroimaging Initiative (ADNI) cases scanned at 1.5 T and 3T following local protocols, qualified for segmentation based on the HarP through a standard web-platform and resegmented following the HarP. The five most accurate tracers followed the HarP to segment 15 ADNI cases acquired at three time points on both 1.5 T and 3T. Results The agreement among tracers was relatively low with the local protocols (absolute left/right ICC 0.44/0.43) and much higher with the HarP (absolute left/right ICC 0.88/0.89). On the larger set of 15 cases, the HarP agreement within (left/right ICC range: 0.94/0.95 to 0.99/0.99) and among tracers (left/right ICC range: 0.89/0.90) was very high. The volume variance due to different tracers was 0.9% of the total, comparing favorably to variance due to scanner manufacturer (1.2), atrophy rates (3.5), hemispheric asymmetry (3.7), field strength (4.4), and significantly smaller than the variance due to atrophy (33.5%, P < .001), and physiological variability (49.2%, P < .001). Conclusions The HarP has high measurement stability compared with local segmentation protocols, and good reproducibility within and among human tracers. Hippocampi segmented with the HarP can be used as a reference for the qualification of human tracers and automated segmentation algorithms. PMID:25267715

Validation of the Oregon Scientific BPU 330 for self-monitoring of blood pressure according to the International Protocol

Directory of Open Access Journals (Sweden)

Li Li

2008-10-01

Full Text Available Li Li1, XinYu Zhang1, ChunHong Yan1, QingXiang Liang21Biomedical Engineering Lab, Faculty of Information Engineering, ShenZhen University, ShenZhen, China; 2Bao An People’s Hospital, ShenZhen, ChinaObjective: Extensive marketing of devices for self-measurement of blood pressure has created a need for purchasers to be able to satisfy themselves that such devices have been evaluated according to agreed criteria. The Oregon Scientific BPU 330 blood pressure monitor is an electronic device for upper arm measurement. This study assessed the accuracy of the Oregon Scientific BPU 330 blood pressure monitor according to the International Protocol by the Working Group on Blood Pressure Monitoring of the European Society of Hypertension for validation of blood pressure measuring devices.Method: 52 participants over 30 years of age were studied in the validation. Nine blood pressure measurements were taken alternately with a mercury sphygmomanometer by two observers, and by the supervisor, using the BPU 330 device. A total of 33 participants were selected for the analysis. The validation was divided into two phases. Phase 1 included 15 participants. If the device passed phase 1, 18 more participants were included. The 99 pairs of measurements were compared according to the International Protocol. The device was given a pass/fail recommendation based on its accuracy compared with the mercury standard (within 5, 10, and 15 mmHg, as well as the number met in the ranges specified by the International Protocol.Results: The mean and standard deviation of the difference between the mean of the observers and the BPU 330 device were 1.7 ± 4.7 mmHg and 2.8 ± 3.9 mmHg for systolic blood pressure (SBP and diastolic blood pressure (DBP, respectively. In phase 1, the device passed with a total of 33, 43, and 44 SBP readings; 38, 44, and 45 DBP readings were within 5, 10, and 15 mmHg, respectively. In phase 2.1, 81, 95, and 96 for SBP, and 83, 95, and 98 for DBP

Lactate minimum in a ramp protocol and its validity to estimate the maximal lactate steady state

Directory of Open Access Journals (Sweden)

Emerson Pardono

2009-01-01

Full Text Available http://dx.doi.org/10.5007/1980-0037.2009v11n2p174   The objectives of this study were to evaluate the validity of the lactate minimum (LM using a ramp protocol for the determination of LM intensity (LMI, and to estimate the exercise intensity corresponding to maximal blood lactate steady state (MLSS. In addition, the possibility of determining aerobic and anaerobic fitness was investigated. Fourteen male cyclists of regional level performed one LM protocol on a cycle ergometer (Excalibur–Lode consisting of an incremental test at an initial workload of 75 Watts, with increments of 1 Watt every 6 seconds. Hyperlactatemia was induced by a 30-second Wingate anaerobic test (WAT (Monark–834E at a workload corresponding to 8.57% of the volunteer’s body weight. Peak power (11.5±2 Watts/kg, mean power output (9.8±1.7 Watts/kg, fatigue index (33.7±2.3% and lactate 7 min after WAT (10.5±2.3 mmol/L were determined. The incremental test identified LMI (207.8±17.7 Watts and its respective blood lactate concentration (2.9±0.7 mmol/L, heart rate (153.6±10.6 bpm, and also maximal aerobic power (305.2±31.0 Watts. MLSS intensity was identified by 2 to 4 constant exercise tests (207.8±17.7 Watts, with no difference compared to LMI and good agreement between the two parameters. The LM test using a ramp protocol seems to be a valid method for the identification of LMI and estimation of MLSS intensity in regional cyclists. In addition, both anaerobic and aerobic fitness parameters were identified during a single session.

Predicting survival of de novo metastatic breast cancer in Asian women: systematic review and validation study.

Science.gov (United States)

Miao, Hui; Hartman, Mikael; Bhoo-Pathy, Nirmala; Lee, Soo-Chin; Taib, Nur Aishah; Tan, Ern-Yu; Chan, Patrick; Moons, Karel G M; Wong, Hoong-Seam; Goh, Jeremy; Rahim, Siti Mastura; Yip, Cheng-Har; Verkooijen, Helena M

2014-01-01

In Asia, up to 25% of breast cancer patients present with distant metastases at diagnosis. Given the heterogeneous survival probabilities of de novo metastatic breast cancer, individual outcome prediction is challenging. The aim of the study is to identify existing prognostic models for patients with de novo metastatic breast cancer and validate them in Asia. We performed a systematic review to identify prediction models for metastatic breast cancer. Models were validated in 642 women with de novo metastatic breast cancer registered between 2000 and 2010 in the Singapore Malaysia Hospital Based Breast Cancer Registry. Survival curves for low, intermediate and high-risk groups according to each prognostic score were compared by log-rank test and discrimination of the models was assessed by concordance statistic (C-statistic). We identified 16 prediction models, seven of which were for patients with brain metastases only. Performance status, estrogen receptor status, metastatic site(s) and disease-free interval were the most common predictors. We were able to validate nine prediction models. The capacity of the models to discriminate between poor and good survivors varied from poor to fair with C-statistics ranging from 0.50 (95% CI, 0.48-0.53) to 0.63 (95% CI, 0.60-0.66). The discriminatory performance of existing prediction models for de novo metastatic breast cancer in Asia is modest. Development of an Asian-specific prediction model is needed to improve prognostication and guide decision making.

Predicting survival of de novo metastatic breast cancer in Asian women: systematic review and validation study.

Directory of Open Access Journals (Sweden)

Hui Miao

Full Text Available BACKGROUND: In Asia, up to 25% of breast cancer patients present with distant metastases at diagnosis. Given the heterogeneous survival probabilities of de novo metastatic breast cancer, individual outcome prediction is challenging. The aim of the study is to identify existing prognostic models for patients with de novo metastatic breast cancer and validate them in Asia. MATERIALS AND METHODS: We performed a systematic review to identify prediction models for metastatic breast cancer. Models were validated in 642 women with de novo metastatic breast cancer registered between 2000 and 2010 in the Singapore Malaysia Hospital Based Breast Cancer Registry. Survival curves for low, intermediate and high-risk groups according to each prognostic score were compared by log-rank test and discrimination of the models was assessed by concordance statistic (C-statistic. RESULTS: We identified 16 prediction models, seven of which were for patients with brain metastases only. Performance status, estrogen receptor status, metastatic site(s and disease-free interval were the most common predictors. We were able to validate nine prediction models. The capacity of the models to discriminate between poor and good survivors varied from poor to fair with C-statistics ranging from 0.50 (95% CI, 0.48-0.53 to 0.63 (95% CI, 0.60-0.66. CONCLUSION: The discriminatory performance of existing prediction models for de novo metastatic breast cancer in Asia is modest. Development of an Asian-specific prediction model is needed to improve prognostication and guide decision making.

Validation of a protocol for the estimation of three-dimensional body center of mass kinematics in sport.

Science.gov (United States)

Mapelli, Andrea; Zago, Matteo; Fusini, Laura; Galante, Domenico; Colombo, Andrea; Sforza, Chiarella

2014-01-01

Since strictly related to balance and stability control, body center of mass (CoM) kinematics is a relevant quantity in sport surveys. Many methods have been proposed to estimate CoM displacement. Among them, segmental method appears to be suitable to investigate CoM kinematics in sport: human body is assumed as a system of rigid bodies, hence the whole-body CoM is calculated as the weighted average of the CoM of each segment. The number of landmarks represents a crucial choice in the protocol design process: one have to find the proper compromise between accuracy and invasivity. In this study, using a motion analysis system, a protocol based upon the segmental method is validated, adopting an anatomical model comprising 14 landmarks. Two sets of experiments were conducted. Firstly, our protocol was compared to the ground reaction force method (GRF), accounted as a standard in CoM estimation. In the second experiment, we investigated the aerial phase typical of many disciplines, comparing our protocol with: (1) an absolute reference, the parabolic regression of the vertical CoM trajectory during the time of flight; (2) two common approaches to estimate CoM kinematics in gait, known as sacrum and reconstructed pelvis methods. Recognized accuracy indexes proved that the results obtained were comparable to the GRF; what is more, during the aerial phases our protocol showed to be significantly more accurate than the two other methods. The protocol assessed can therefore be adopted as a reliable tool for CoM kinematics estimation in further sport researches. Copyright © 2013 Elsevier B.V. All rights reserved.

Validation of the FAST skating protocol to predict aerobic power in ice hockey players.

Science.gov (United States)

Petrella, Nicholas J; Montelpare, William J; Nystrom, Murray; Plyley, Michael; Faught, Brent E

2007-08-01

Few studies have reported a sport-specific protocol to measure the aerobic power of ice hockey players using a predictive process. The purpose of our study was to validate an ice hockey aerobic field test on players of varying ages, abilities, and levels. The Faught Aerobic Skating Test (FAST) uses an on-ice continuous skating protocol on a course measuring 160 feet (48.8 m) using a CD to pace the skater with a beep signal to cross the starting line at each end of the course. The FAST incorporates the principle of increasing workload at measured time intervals during a continuous skating exercise. Step-wise multiple regression modelling was used to determine the estimate of aerobic power. Participants completed a maximal aerobic power test using a modified Bruce incremental treadmill protocol, as well as the on-ice FAST. Normative data were collected on 406 ice hockey players (291 males, 115 females) ranging in age from 9 to 25 y. A regression to predict maximum aerobic power was developed using body mass (kg), height (m), age (y), and maximum completed lengths of the FAST as the significant predictors of skating aerobic power (adjusted R2 = 0.387, SEE = 7.25 mL.kg-1.min-1, p < 0.0001). These results support the application of the FAST in estimating aerobic power among male and female competitive ice hockey players between the ages of 9 and 25 years.

Impact of applying the more stringent validation criteria of the revised European Society of Hypertension International Protocol 2010 on earlier validation studies.

Science.gov (United States)

Stergiou, George S; Karpettas, Nikos; Atkins, Neil; O'Brien, Eoin

2011-04-01

Since 2002 when the European Society of Hypertension International Protocol (ESH-IP) was published it has become the preferred protocol for validating blood pressure monitors worldwide. In 2010, a revised version of the ESH-IP with more stringent criteria was published. This study assesses the impact of applying the revised ESH-IP criteria. A systematic literature review of ESH-IP studies reported between 2002 and 2010 was conducted. The impact of applying the ESH-IP 2010 criteria retrospectively on the data reported in these studies was investigated. The performance of the oscillometric devices in the last decade was also investigated on the basis of the ESH-IP criteria. Among 119 published studies, 112 with sufficient data were analyzed. According to ESH-IP 2002, the test device failed in 19 studies, whereas by applying the ESH-IP 2010 criteria in 28 additional studies increased the failure rate from 17 to 42%. Of these 28 studies, in 20 (71%) the test device failed at part 1 (accuracy per measurement) and in 22 (79%) at part 2 (accuracy per subject). Most of the failures involved the '5 mmHg or less' criterion. In the last decade there has been a consistent trend toward improved performance of oscillometric devices assessed on the basis of the ESH-IP criteria. This retrospective analysis shows that the stricter revised ESH-IP 2010 criteria will noticeably increase the failure rate of devices being validated. Oscillometric devices are becoming more accurate, and the revised ESH-IP by acknowledging this trend will allow more accurate devices to enter the market.

Development and internal validation of a prognostic model to predict recurrence free survival in patients with adult granulosa cell tumors of the ovary

NARCIS (Netherlands)

van Meurs, Hannah S.; Schuit, Ewoud; Horlings, Hugo M.; van der Velden, Jacobus; van Driel, Willemien J.; Mol, Ben Willem J.; Kenter, Gemma G.; Buist, Marrije R.

2014-01-01

Models to predict the probability of recurrence free survival exist for various types of malignancies, but a model for recurrence free survival in individuals with an adult granulosa cell tumor (GCT) of the ovary is lacking. We aimed to develop and internally validate such a prognostic model. We

NVN 5694 intra laboratory validation. Feasibility study for interlaboratory- validation

International Nuclear Information System (INIS)

Voors, P.I.; Baard, J.H.

1998-11-01

Within the project NORMSTAR 2 a number of Dutch prenormative protocols have been defined for radioactivity measurements. Some of these protocols, e.g. the Dutch prenormative protocol NVN 5694, titled Methods for radiochemical determination of polonium-210 and lead-210, have not been validated, neither by intralaboratory nor interlaboratory studies. Validation studies are conducted within the framework of the programme 'Normalisatie and Validatie van Milieumethoden 1993-1997' (Standardization and Validation of test methods for environmental parameters) of the Dutch Ministry of Housing, Physical Planning and the Environment (VROM). The aims of this study were (a) a critical evaluation of the protocol, (b) investigation on the feasibility of an interlaboratory study, and (c) the interlaboratory validation of NVN 5694. The evaluation of the protocol resulted in a list of deficiencies varying from missing references to incorrect formulae. From the survey by interview it appeared that for each type of material, there are 4 to 7 laboratories willing to participate in a interlaboratory validation study. This reflects the situation in 1997. Consequently, if 4 or 6 (the minimal number) laboratories are participating and each laboratory analyses 3 subsamples, the uncertainty in the repeatability standard deviation is 49 or 40 %, respectively. If the ratio of reproducibility standard deviation to the repeatability standard deviation is equal to 1 or 2, then the uncertainty in the reproducibility standard deviation increases from 42 to 67 % and from 34 to 52 % for 4 or 6 laboratories, respectively. The intralaboratory validation was established on four different types of materials. Three types of materials (milkpowder condensate and filter) were prepared in the laboratory using the raw material and certified Pb-210 solutions, and one (sediment) was obtained from the IAEA. The ECN-prepared reference materials were used after testing on homogeneity. The pre-normative protocol can

[Effect of nutritional support on survival in patients with amyotrophic lateral sclerosis].

Science.gov (United States)

López Gómez, J J; Ballesteros Pomar, Ma D; Vázquez Sánchez, F; Vidal Casariego, A; Calleja Fernández, A; Cano Rodríguez, I

2011-01-01

Malnutrition affects morbidity and mortality of patients with ALS. The nutrition unit should evaluate these patients early and regularly providing the necessary steps in the evolution of the disease. A retrospective cohort study in which we analyzed 46 patients diagnosed with ALS, 21 of them received nutritional therapy. We studied age, mode of onset, date of entry into a nutritional protocol, placement of PEG and survival. We performed a test of Breslow comparing patients who were at nutritional protocol with those not receiving nutritional support, and those who received early nutritional therapy with those with delayed nutrition. There was an increase in median survival for patients in nutritional therapy in bulbar ALS (452 vs 55 days) and in spinal ALS (1,798 vs 357 days) (p = 0.002). The median delay in the initiation of nutritional therapy in spinal ALS was 557 days while in bulbar ALS was 230 days. The survival in the spinal ALS of those who entered into nutritional protocol before the median survival was 325 days to 181 days (p = 0.09) while in bulbar ALS those who entered before had a median survival of 435 days to 177 days (p = 0.38). The entry of patients with ALS in a nutritional protocol increases survival. There is an advantage in the evolution of patients with early nutritional treatment.

Event-by-event simulation of quantum cryptography protocols

NARCIS (Netherlands)

Zhao, S.; Raedt, H. De

We present a new approach to simulate quantum cryptography protocols using event-based processes. The method is validated by simulating the BB84 protocol and the Ekert protocol, both without and with the presence of an eavesdropper.

TH-CD-BRA-11: Implementation and Evaluation of a New 3D Dosimetry Protocol for Validating MRI Guided Radiation Therapy Treatments

International Nuclear Information System (INIS)

Mein, S; Rankine, L; Adamovics, J; Li, H; Oldham, M

2016-01-01

Purpose: To develop, evaluate and apply a novel high-resolution 3D remote dosimetry protocol for validation of MRI guided radiation therapy treatments (MRIdian by ViewRay™). We demonstrate the first application of the protocol (including two small but required new correction terms) utilizing radiochromic 3D plastic PRESAGE™ with optical-CT readout. Methods: A detailed study of PRESAGE™ dosimeters (2kg) was conducted to investigate the temporal and spatial stability of radiation induced optical density change (ΔOD) over 8 days. Temporal stability was investigated on 3 dosimeters irradiated with four equally-spaced square 6MV fields delivering doses between 10cGy and 300cGy. Doses were imaged (read-out) by optical-CT at multiple intervals. Spatial stability of ΔOD response was investigated on 3 other dosimeters irradiated uniformly with 15MV extended-SSD fields with doses of 15cGy, 30cGy and 60cGy. Temporal and spatial (radial) changes were investigated using CERR and MATLAB’s Curve Fitting Tool-box. A protocol was developed to extrapolate measured ΔOD readings at t=48hr (the typical shipment time in remote dosimetry) to time t=1hr. Results: All dosimeters were observed to gradually darken with time (<5% per day). Consistent intra-batch sensitivity (0.0930±0.002 ΔOD/cm/Gy) and linearity (R2=0.9996) was observed at t=1hr. A small radial effect (<3%) was observed, attributed to curing thermodynamics during manufacture. The refined remote dosimetry protocol (including polynomial correction terms for temporal and spatial effects, CT and CR) was then applied to independent dosimeters irradiated with MR-IGRT treatments. Excellent line profile agreement and 3D-gamma results for 3%/3mm, 10% threshold were observed, with an average passing rate 96.5%± 3.43%. Conclusion: A novel 3D remote dosimetry protocol is presented capable of validation of advanced radiation treatments (including MR-IGRT). The protocol uses 2kg radiochromic plastic dosimeters read-out by

TH-CD-BRA-11: Implementation and Evaluation of a New 3D Dosimetry Protocol for Validating MRI Guided Radiation Therapy Treatments

Energy Technology Data Exchange (ETDEWEB)

Mein, S [Duke University Medical Physics Graduate Program (United States); Rankine, L [Department of Radiation Oncology, University of North Carolina in Chapel Hill (United States); Department of Radiation Oncology, Washington University School of Medicine (United States); Adamovics, J [Department of Chemistry and Biology, Rider University, Lawrenceville, NJ (United States); Li, H [Department of Radiation Oncology, Washington University School of Medicine (United States); Oldham, M [Department of Radiation Oncology, Duke University Medical Center (United States)

2016-06-15

Purpose: To develop, evaluate and apply a novel high-resolution 3D remote dosimetry protocol for validation of MRI guided radiation therapy treatments (MRIdian by ViewRay™). We demonstrate the first application of the protocol (including two small but required new correction terms) utilizing radiochromic 3D plastic PRESAGE™ with optical-CT readout. Methods: A detailed study of PRESAGE™ dosimeters (2kg) was conducted to investigate the temporal and spatial stability of radiation induced optical density change (ΔOD) over 8 days. Temporal stability was investigated on 3 dosimeters irradiated with four equally-spaced square 6MV fields delivering doses between 10cGy and 300cGy. Doses were imaged (read-out) by optical-CT at multiple intervals. Spatial stability of ΔOD response was investigated on 3 other dosimeters irradiated uniformly with 15MV extended-SSD fields with doses of 15cGy, 30cGy and 60cGy. Temporal and spatial (radial) changes were investigated using CERR and MATLAB’s Curve Fitting Tool-box. A protocol was developed to extrapolate measured ΔOD readings at t=48hr (the typical shipment time in remote dosimetry) to time t=1hr. Results: All dosimeters were observed to gradually darken with time (<5% per day). Consistent intra-batch sensitivity (0.0930±0.002 ΔOD/cm/Gy) and linearity (R2=0.9996) was observed at t=1hr. A small radial effect (<3%) was observed, attributed to curing thermodynamics during manufacture. The refined remote dosimetry protocol (including polynomial correction terms for temporal and spatial effects, CT and CR) was then applied to independent dosimeters irradiated with MR-IGRT treatments. Excellent line profile agreement and 3D-gamma results for 3%/3mm, 10% threshold were observed, with an average passing rate 96.5%± 3.43%. Conclusion: A novel 3D remote dosimetry protocol is presented capable of validation of advanced radiation treatments (including MR-IGRT). The protocol uses 2kg radiochromic plastic dosimeters read-out by

Ocean Optics Protocols for Satellite Ocean Color Sensor Validation. Revised

Science.gov (United States)

Fargion, Giulietta S.; Mueller, James L.

2000-01-01

The 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. This document supersedes the earlier version (Mueller and Austin 1995) published as Volume 25 in the SeaWiFS Technical Report Series. This document marks a significant departure from, and improvement on, theformat and content of Mueller and Austin (1995). The authorship of the protocols has been greatly broadened to include experts specializing in some key areas. New chapters have been added to provide detailed and comprehensive protocols for stability monitoring of radiometers using portable sources, abovewater measurements of remote-sensing reflectance, spectral absorption measurements for discrete water samples, HPLC pigment analysis and fluorometric pigment analysis. Protocols were included in Mueller and Austin (1995) for each of these areas, but the new treatment makes significant advances in each topic area. There are also new chapters prescribing protocols for calibration of sun photometers and sky radiance sensors, sun photometer and sky radiance measurements and analysis, and data archival. These topic areas were barely mentioned in Mueller and Austin (1995).

Association of radiotherapy and chemotherapy in limited small cell lung cancers: interest of alternating protocols

International Nuclear Information System (INIS)

Le Chevalier, T.; Arriagada, R.; Ruffie, P.; Cremoux, H. de; Douillard, J.Y.; Tuchais, C.; Chomy, P.; Riviere, A.; Tarayre, M.

1992-01-01

From 1980, alternating protocols of chemotherapy and thorax radiotherapy in limited small cell lung cancers have been elaborated in order to control locally the disease, to improve the total survival and to reduce the toxicity that are bound the simultaneous treatments of chemotherapy and radiotherapy. Thanks to these protocols, the two-year survival rate is 27% and the five-year survival rate, 16%

Development and validation of a protocol for field validation of passive dosimeters for ethylene oxide excursion limit monitoring

Energy Technology Data Exchange (ETDEWEB)

Puskar, M.A.; Szopinski, F.G.; Hecker, L.H. (Corporate Industrial Hygiene Laboratory, Abbott Laboratories, North Chicago, IL (USA))

1991-04-01

An exposure and analysis protocol is described for the field validation of passive dosimeters for ethylene oxide (EtO) excursion limit monitoring. The protocol calls for the use of a field exposure chamber with concurrent sampling using Tedlar air-sampling bags. The bags are analyzed immediately after sampling by gas chromatography with flame ionization detection (GC-FID). The chamber design allows all monitors to be exposed for the exact same time in the field. The sampling and analysis procedure not only determines the actual concentration of EtO present during the monitor's exposure but estimates if concentrations of EtO vary from point to point in the monitor array during the exposure. In chamber operation, the accuracy of the standard generator used to calibrate the GC-FID was independently verified in the field by the standard additions method. The sampling bias of the sampling train was determined to be -3.5% in the 2.4 ppm to 14.3 ppm concentration range. To estimate the stability of collected EtO samples in Tedlar bags, the rate of EtO loss in the bags was determined to be 0.011 ppm/hr at 2.57 ppm and 0.066 ppm/hr at 8.07 ppm. Sampling bias of the passive methods by additional EtO exposure of the monitors in the closed chamber after sampling and during purging was determined to be +1.5%. The Tedlar bag sampling method with subsequent GC-FID determination demonstrated a coefficient of variation of 1.8% at 2.43 ppm.

A Protocol for Advanced Psychometric Assessment of Surveys

Science.gov (United States)

Squires, Janet E.; Hayduk, Leslie; Hutchinson, Alison M.; Cranley, Lisa A.; Gierl, Mark; Cummings, Greta G.; Norton, Peter G.; Estabrooks, Carole A.

2013-01-01

Background and Purpose. In this paper, we present a protocol for advanced psychometric assessments of surveys based on the Standards for Educational and Psychological Testing. We use the Alberta Context Tool (ACT) as an exemplar survey to which this protocol can be applied. Methods. Data mapping, acceptability, reliability, and validity are addressed. Acceptability is assessed with missing data frequencies and the time required to complete the survey. Reliability is assessed with internal consistency coefficients and information functions. A unitary approach to validity consisting of accumulating evidence based on instrument content, response processes, internal structure, and relations to other variables is taken. We also address assessing performance of survey data when aggregated to higher levels (e.g., nursing unit). Discussion. In this paper we present a protocol for advanced psychometric assessment of survey data using the Alberta Context Tool (ACT) as an exemplar survey; application of the protocol to the ACT survey is underway. Psychometric assessment of any survey is essential to obtaining reliable and valid research findings. This protocol can be adapted for use with any nursing survey. PMID:23401759

Establishment and intra-/inter-laboratory validation of a standard protocol of reactive oxygen species assay for chemical photosafety evaluation.

Science.gov (United States)

Onoue, Satomi; Hosoi, Kazuhiro; Wakuri, Shinobu; Iwase, Yumiko; Yamamoto, Toshinobu; Matsuoka, Naoko; Nakamura, Kazuichi; Toda, Tsuguto; Takagi, Hironori; Osaki, Naoto; Matsumoto, Yasuhiro; Kawakami, Satoru; Seto, Yoshiki; Kato, Masashi; Yamada, Shizuo; Ohno, Yasuo; Kojima, Hajime

2013-11-01

A reactive oxygen species (ROS) assay was previously developed for photosafety evaluation of pharmaceuticals, and the present multi-center study aimed to establish and validate a standard protocol for ROS assay. In three participating laboratories, two standards and 42 coded chemicals, including 23 phototoxins and 19 nonphototoxic drugs/chemicals, were assessed by the ROS assay according to the standardized protocol. Most phototoxins tended to generate singlet oxygen and/or superoxide under UV-vis exposure, but nonphototoxic chemicals were less photoreactive. In the ROS assay on quinine (200 µm), a typical phototoxic drug, the intra- and inter-day precisions (coefficient of variation; CV) were found to be 1.5-7.4% and 1.7-9.3%, respectively. The inter-laboratory CV for quinine averaged 15.4% for singlet oxygen and 17.0% for superoxide. The ROS assay on 42 coded chemicals (200 µm) provided no false negative predictions upon previously defined criteria as compared with the in vitro/in vivo phototoxicity, although several false positives appeared. Outcomes from the validation study were indicative of satisfactory transferability, intra- and inter-laboratory variability, and predictive capacity of the ROS assay. Copyright © 2012 John Wiley & Sons, Ltd.

Concurrent validation of a neurocognitive assessment protocol for clients with mental illness in job matching as shop sales in supported employment.

Science.gov (United States)

Ng, S S W; Lak, D C C; Lee, S C K; Ng, P P K

2015-03-01

Occupational therapists play a major role in the assessment and referral of clients with severe mental illness for supported employment. Nonetheless, there is scarce literature about the content and predictive validity of the process. In addition, the criteria of successful job matching have not been analysed and job supervisors have relied on experience rather than objective standards in recruitment. This study aimed to explore the profile of successful clients working in 'shop sales' in a supportive environment using a neurocognitive assessment protocol, and to validate the protocol against 'internal standards' of the job supervisors. This was a concurrent validation study of criterion-related scales for a single job type. The subjective ratings from the supervisors were concurrently validated against the results of neurocognitive assessment of intellectual function and work-related cognitive behaviour. A regression model was established for clients who succeeded and failed in employment using supervisor's ratings and a cutoff value of 10.5 for the Performance Fitness Rating Scale (R(2) = 0.918, F[41] = 3.794, p = 0.003). Classification And Regression Tree was also plotted to identify the profile of cases, with an overall accuracy of 0.861 (relative error, 0.26). Use of both inference statistics and data mining techniques enables the decision tree of neurocognitive assessments to be more readily applied by therapists in vocational rehabilitation, and thus directly improve the efficiency and efficacy of the process.

Rapid detection of Salmonella in meat: Comparative and collaborative validation of a non-complex and cost effective pre-PCR protocol

DEFF Research Database (Denmark)

Löfström, Charlotta; Hansen, F.; Mansdal, S.

2011-01-01

samples using a real-time PCR method. The protocol included incubation in buffered peptone water, centrifugation of an aliquot and a boiling procedure. The validation study included comparative and collaborative trials recommended by the Nordic Organization for Validation of Alternative Methods (NordVal......). The comparative trial was performed against a culture based reference method (NMKL187, 2007) and a previously NordVal approved PCR method with a semi-automated magnetic bead-based DNA extraction step using 122 artificially contaminated samples. The limit of detection (LOD50) was found to be 3.0, 3.2 and 3.4 CFU...

Communicating systems with UML 2 modeling and analysis of network protocols

CERN Document Server

Barrera, David Garduno

2013-01-01

This book gives a practical approach to modeling and analyzing communication protocols using UML 2. Network protocols are always presented with a point of view focusing on partial mechanisms and starting models. This book aims at giving the basis needed for anybody to model and validate their own protocols. It follows a practical approach and gives many examples for the description and analysis of well known basic network mechanisms for protocols.The book firstly shows how to describe and validate the main protocol issues (such as synchronization problems, client-server interactions, layer

Long-Term Survival Prediction for Coronary Artery Bypass Grafting: Validation of the ASCERT Model Compared With The Society of Thoracic Surgeons Predicted Risk of Mortality.

Science.gov (United States)

Lancaster, Timothy S; Schill, Matthew R; Greenberg, Jason W; Ruaengsri, Chawannuch; Schuessler, Richard B; Lawton, Jennifer S; Maniar, Hersh S; Pasque, Michael K; Moon, Marc R; Damiano, Ralph J; Melby, Spencer J

2018-05-01

The recently developed American College of Cardiology Foundation-Society of Thoracic Surgeons (STS) Collaboration on the Comparative Effectiveness of Revascularization Strategy (ASCERT) Long-Term Survival Probability Calculator is a valuable addition to existing short-term risk-prediction tools for cardiac surgical procedures but has yet to be externally validated. Institutional data of 654 patients aged 65 years or older undergoing isolated coronary artery bypass grafting between 2005 and 2010 were reviewed. Predicted survival probabilities were calculated using the ASCERT model. Survival data were collected using the Social Security Death Index and institutional medical records. Model calibration and discrimination were assessed for the overall sample and for risk-stratified subgroups based on (1) ASCERT 7-year survival probability and (2) the predicted risk of mortality (PROM) from the STS Short-Term Risk Calculator. Logistic regression analysis was performed to evaluate additional perioperative variables contributing to death. Overall survival was 92.1% (569 of 597) at 1 year and 50.5% (164 of 325) at 7 years. Calibration assessment found no significant differences between predicted and actual survival curves for the overall sample or for the risk-stratified subgroups, whether stratified by predicted 7-year survival or by PROM. Discriminative performance was comparable between the ASCERT and PROM models for 7-year survival prediction (p validated for prediction of long-term survival after coronary artery bypass grafting in all risk groups. The widely used STS PROM performed comparably as a predictor of long-term survival. Both tools provide important information for preoperative decision making and patient counseling about potential outcomes after coronary artery bypass grafting. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Discriminating real victims from feigners of psychological injury in gender violence: Validating a protocol for forensic setting

Directory of Open Access Journals (Sweden)

Ramon Arce

2009-07-01

Full Text Available Standard clinical assessment of psychological injury does not provide valid evidence in forensic settings, and screening of genuine from feigned complaints must be undertaken prior to the diagnosis of mental state (American Psychological Association, 2002. Whereas psychological injury is Post-traumatic Stress Disorder (PTSD, a clinical diagnosis may encompass other nosologies (e.g., depression and anxiety. The assessment of psychological injury in forensic contexts requires a multimethod approach consisting of a psychometric measure and an interview. To assess the efficacy of the multimethod approach in discriminating real from false victims, 25 real victims of gender violence and 24 feigners were assessed using a the Symptom Checklist-90-Revised (SCL-90-R, a recognition task; and a forensic clinical interview, a knowledge task. The results revealed that feigners reported more clinical symptoms on the SCL-90-R than real victims. Moreover, the feigning indicators on the SCL-90-R, GSI, PST, and PSDI were higher in feigners, but not sufficient to provide a screening test for invalidating feigning protocols. In contrast, real victims reported more clinical symptoms related to PTSD in the forensic clinical interview than feigners. Notwithstanding, in the forensic clinical interview feigners were able to feign PTSD which was not detected by the analysis of feigning strategies. The combination of both measures and their corresponding validity controls enabled the discrimination of real victims from feigners. Hence, a protocol for discriminating the psychological sequelae of real victims from feigners of gender violence is described.

IMPLEMENTATION AND VALIDATION OF STATISTICAL TESTS IN RESEARCH'S SOFTWARE HELPING DATA COLLECTION AND PROTOCOLS ANALYSIS IN SURGERY.

Science.gov (United States)

Kuretzki, Carlos Henrique; Campos, Antônio Carlos Ligocki; Malafaia, Osvaldo; Soares, Sandramara Scandelari Kusano de Paula; Tenório, Sérgio Bernardo; Timi, Jorge Rufino Ribas

2016-03-01

The use of information technology is often applied in healthcare. With regard to scientific research, the SINPE(c) - Integrated Electronic Protocols was created as a tool to support researchers, offering clinical data standardization. By the time, SINPE(c) lacked statistical tests obtained by automatic analysis. Add to SINPE(c) features for automatic realization of the main statistical methods used in medicine . The study was divided into four topics: check the interest of users towards the implementation of the tests; search the frequency of their use in health care; carry out the implementation; and validate the results with researchers and their protocols. It was applied in a group of users of this software in their thesis in the strict sensu master and doctorate degrees in one postgraduate program in surgery. To assess the reliability of the statistics was compared the data obtained both automatically by SINPE(c) as manually held by a professional in statistics with experience with this type of study. There was concern for the use of automatic statistical tests, with good acceptance. The chi-square, Mann-Whitney, Fisher and t-Student were considered as tests frequently used by participants in medical studies. These methods have been implemented and thereafter approved as expected. The incorporation of the automatic SINPE (c) Statistical Analysis was shown to be reliable and equal to the manually done, validating its use as a research tool for medical research.

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

Science.gov (United States)

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.

Development and external validation of a risk-prediction model to predict 5-year overall survival in advanced larynx cancer.

Science.gov (United States)

Petersen, Japke F; Stuiver, Martijn M; Timmermans, Adriana J; Chen, Amy; Zhang, Hongzhen; O'Neill, James P; Deady, Sandra; Vander Poorten, Vincent; Meulemans, Jeroen; Wennerberg, Johan; Skroder, Carl; Day, Andrew T; Koch, Wayne; van den Brekel, Michiel W M

2018-05-01

TNM-classification inadequately estimates patient-specific overall survival (OS). We aimed to improve this by developing a risk-prediction model for patients with advanced larynx cancer. Cohort study. We developed a risk prediction model to estimate the 5-year OS rate based on a cohort of 3,442 patients with T3T4N0N+M0 larynx cancer. The model was internally validated using bootstrapping samples and externally validated on patient data from five external centers (n = 770). The main outcome was performance of the model as tested by discrimination, calibration, and the ability to distinguish risk groups based on tertiles from the derivation dataset. The model performance was compared to a model based on T and N classification only. We included age, gender, T and N classification, and subsite as prognostic variables in the standard model. After external validation, the standard model had a significantly better fit than a model based on T and N classification alone (C statistic, 0.59 vs. 0.55, P statistic to 0.68. A risk prediction model for patients with advanced larynx cancer, consisting of readily available clinical variables, gives more accurate estimations of the estimated 5-year survival rate when compared to a model based on T and N classification alone. 2c. Laryngoscope, 128:1140-1145, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

Emmprin Expression Predicts Response and Survival following Cisplatin Containing Chemotherapy for Bladder Cancer: A Validation Study.

Science.gov (United States)

Hemdan, Tammer; Malmström, Per-Uno; Jahnson, Staffan; Segersten, Ulrika

2015-12-01

Neoadjuvant chemotherapy before cystectomy is recommended. To our knowledge the subset of patients likely to benefit has not been identified. We validate emmprin and survivin as markers of chemotherapy response. Tumor specimens were obtained before therapy from a total of 250 patients with T1-T4 bladder cancer enrolled in 2 randomized trials comparing neoadjuvant chemotherapy before cystectomy with a surgery only arm. Protein expression was determined by immunohistochemistry. Expression was categorized according to predefined cutoffs reported in the literature. Data were analyzed with the Kaplan-Meier method and Cox models. Patients in the chemotherapy cohort with negative emmprin expression had significantly higher down staging overall survival than those with positive expression (71% vs 38%, pemmprin expression was not associated with overall survival (46% vs 35%, p=0.23) or cancer specific survival (55% vs 51%, p=0.64). Emmprin negative patients had an absolute risk reduction of 25% in overall survival (95% CI 11-40) and a number needed to treat of 4 (95% CI 2.5-9.3). Survivin expression was not useful as a biomarker in this study. Limitations were the retrospective design and heterogeneity coupled with the time difference between the trials. Patients with emmprin negative tumors have a better response to neoadjuvant chemotherapy before cystectomy than those with positive expression. Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Protocol for Validation of the Land Surface Reflectance Fundamental Climate Data Record using AERONET: Application to the Global MODIS and VIIRS Data Records

Science.gov (United States)

Roger, J. C.; Vermote, E.; Holben, B. N.

2014-12-01

The land surface reflectance is a fundamental climate data record at the basis of the derivation of other climate data records (Albedo, LAI/Fpar, Vegetation indices) and a key parameter in the understanding of the land-surface-climate processes. It is essential that a careful validation of its uncertainties is performed on a global and continuous basis. One approach is the direct comparison of this product with ground measurements but that approach presents several issues related to scale, the episodic nature of ground measurements and the global representativeness. An alternative is to compare the surface reflectance product to reference reflectance determined from Top of atmosphere reflectance corrected using accurate radiative transfer code and very detailed measurements of the atmosphere obtained over the AERONET sites (Vermote and al, 2014, RSE) which allows to test for a large range of aerosol characteristics; formers being important inputs for atmospheric corrections. However, the application of this method necessitates the definition of a very detailed protocol for the use of AERONET data especially as far as size distribution and absorption are concerned, so that alternative validation methods or protocols could be compared. This paper describes the protocol we have been working on based on our experience with the AERONET data and its application to the MODIS and VIIRS record.

Blockchain Consensus Protocols in the Wild

OpenAIRE

Cachin, Christian; Vukolić, Marko

2017-01-01

A blockchain is a distributed ledger for recording transactions, maintained by many nodes without central authority through a distributed cryptographic protocol. All nodes validate the information to be appended to the blockchain, and a consensus protocol ensures that the nodes agree on a unique order in which entries are appended. Consensus protocols for tolerating Byzantine faults have received renewed attention because they also address blockchain systems. This work discusses the process o...

A Selected Reaction Monitoring Mass Spectrometry Protocol for Validation of Proteomic Biomarker Candidates in Studies of Psychiatric Disorders.

Science.gov (United States)

Reis-de-Oliveira, Guilherme; Garcia, Sheila; Guest, Paul C; Cassoli, Juliana S; Martins-de-Souza, Daniel

2017-01-01

Most biomarker candidates arising from proteomic studies of psychiatric disorders have not progressed for use in clinical studies due to insufficient validation steps. Here we describe a selective reaction monitoring mass spectrometry (SRM-MS) approach that could be used as a follow-up validation tool of proteins identified in blood serum or plasma. This protocol specifically covers the stages of peptide selection and optimization. The increasing application of SRM-MS should enable fast, sensitive, and robust methods with the potential for use in clinical studies involving sampling of serum or plasma. Understanding the molecular mechanisms and identifying potential biomarkers for risk assessment, diagnosis, prognosis, and prediction of drug response goes toward the implementation of translational medicine strategies for improved treatment of patients with psychiatric disorders and other debilitating diseases.

Validation of the A&D UM-211 device for office blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Fania, Claudio; Albertini, Federica; Palatini, Paolo

2017-10-01

The aim of this study was to define the accuracy of UM-211, an automated oscillometric device for office use coupled to several cuffs for different arm sizes, according to the International Protocol of the European Society of Hypertension. The validation was performed in 33 individuals. Their mean age was 59.6±12.9 years, systolic blood pressure (BP) was 144.3±21.5 mmHg (range: 96-184 mmHg), diastolic BP was 86.8±18.5 mmHg (range: 48-124 mmHg), and arm circumference was 30.2±4.3 cm (range: 23-39 cm). Four sequential readings were taken by observers 1 and 2 using a double-headed stethoscope and a mercury sphygmomanometer, whereas three BP readings were taken by the supervisor using the test instrument. The differences between the readings provided by the device and the mean observer measurements were calculated. Therefore, each device measurement was compared with the previous and the next mean observer measurement. The validation results fulfilled all the 2010 European Society of Hypertension revision Protocol criteria for the general population and passed all validation grades. On average, the device overestimated systolic BP by 1.7±2.4 mmHg and diastolic BP by 1.7±2.5 mmHg. These data show that the UM-211 device coupled to several cuffs for different ranges of arm circumference met the requirements for validation according to the International Protocol and can be recommended for clinical use in the adult population. However, these results mainly apply to the use of the 22-32 and the 31-45 cm cuffs.

Validation of the Medisana MTP Plus upper arm blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Erdem, Emre; Aydogdu, Türkan; Akpolat, Tekin

2011-02-01

Standard validation protocols are objective guides for healthcare providers, physicians, and patients. The purpose of this study was to test validation of the Medisana MTP Plus upper arm blood pressure (BP) measuring monitor for self-measurement according to the European Society of Hypertension International Protocol (ESH-IP2) in adults. The Medisana MTP Plus monitor is an automated and oscillometric upper arm device for home BP monitoring. Nine consecutive measurements were made according to the ESH-IP2. Overseen by an independent supervisor, measurements were recorded by two observers blinded from both each other's readings and from the device readings. The Medisana MTP Plus device fulfills the validation criteria of the ESH-IP2 for the general population. The mean (standard deviation) of the difference between the observers and the device measurements was 0.6 mmHg (5.1 mmHg) for systolic and 2.7 mmHg (3.4 mmHg) for diastolic pressures, respectively. As the Medisana MTP Plus device has achieved the required standards, it is recommended for home BP monitoring in an adult population.

Validation of the G.LAB MD2200 wrist blood pressure monitor according to the European Society of Hypertension, the British Hypertension Society, and the International Organization for Standardization Protocols.

Science.gov (United States)

Liu, Ze-Yu; Zhang, Qing-Han; Ye, Xiao-Lei; Liu, Da-Peng; Cheng, Kang; Zhang, Chun-Hai; Wan, Yi

2017-04-01

To validate the G.LAB MD2200 automated wrist blood pressure (BP) monitors according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010, the British Hypertension Society (BHS), and the International Organization for Standardization (ISO) 81060-2:2013 protocols. The device was assessed on 33 participants according to the ESH requirements and was then tested on 85 participants according to the BHS and ISO 81060-2:2013 criteria. The validation procedures and data analysis followed the protocols precisely. The G.LAB MD2200 devices passed all parts of ESH-IP revision 2010 for both systolic and diastolic BP, with a device-observer difference of 2.15±5.51 and 1.51±5.16 mmHg, respectively. The device achieved A/A grading for the BHS protocol and it also fulfilled the criteria of ISO 81060-2:2013, with mean differences of systolic and diastolic BP between the device and the observer of 2.19±5.21 and 2.11±4.70 mmHg, respectively. The G.LAB MD2200 automated wrist BP monitor passed the ESH-IP revision 2010 and the ISO 81060-2:2013 protocol, and achieved the A/A grade of the BHS protocol, which can be recommended for self-measurement in the general population.

Implant loading protocols for edentulous patients with fixed prostheses: a systematic review and meta-analysis.

Science.gov (United States)

Papaspyridakos, Panos; Chen, Chun-Jung; Chuang, Sung-Kiang; Weber, Hans-Peter

2014-01-01

To report on the effect of immediate implant loading with fixed prostheses compared to early and conventional loading on implant and prosthesis survival, failure, and complications. An electronic and manual search was conducted to identify randomized controlled clinical trials (RCTs) as well as prospective and retrospective studies involving rough surface implants and implant fixed complete dental prostheses for edentulous patients. The 62 studies that fulfilled the inclusion criteria featured 4 RCTs, 2 prospective case-control studies, 34 prospective cohort studies, and 22 retrospective cohort studies. These studies yielded data from 2,695 patients (2,757 edentulous arches) with 13,653 implants. Studies were grouped according to the loading protocol applied; 45 studies reported on immediate loading, 8 on early loading, and 11 on conventional loading. For the immediate loading protocol with flap surgery, the implant and prosthesis survival rates ranged from 90.1% to 100% and 93.75% to 100%, respectively (range of follow-up, 1 to 10 years). When immediate loading was combined with guided flapless implant placement, the implant survival rates ranged from 90% to 99.4%. For the early loading protocol, the implant and prosthesis survival rates ranged from 94.74% to 100% and 93.75% to 100%, respectively (range of follow-up, 1 to 10 years). For the conventional loading protocol, the implant and prosthesis survival rates ranged from 94.95% to 100% and 87.5% to 100%, respectively (range of follow-up, 2 to 15 years). No difference was identified between maxilla and mandible. When selecting cases carefully and using dental implants with a rough surface, immediate loading with fixed prostheses in edentulous patients results in similar implant and prosthesis survival and failure rates as early and conventional loading. For immediate loading, most of the studies recommended a minimal insertion torque of 30 Ncm. The estimated 1-year implant survival was above 99% with all three

Implementing an online tool for genome-wide validation of survival-associated biomarkers in ovarian-cancer using microarray data from 1287 patients

DEFF Research Database (Denmark)

Győrffy, Balázs; Lánczky, András; Szállási, Zoltán

2012-01-01

was set up using gene expression data and survival information of 1287 ovarian cancer patients downloaded from Gene Expression Omnibus and The Cancer Genome Atlas (Affymetrix HG-U133A, HG-U133A 2.0, and HG-U133 Plus 2.0 microarrays). After quality control and normalization, only probes present on all......). A Kaplan–Meier survival plot was generated and significance was computed. The tool can be accessed online at www.kmplot.com/ovar. We used this integrative data analysis tool to validate the prognostic power of 37 biomarkers identified in the literature. Of these, CA125 (MUC16; P=3.7x10–5, hazard ratio (HR...... biomarker validation platform that mines all available microarray data to assess the prognostic power of 22 277 genes in 1287 ovarian cancer patients. We specifically used this tool to evaluate the effect of 37 previously published biomarkers on ovarian cancer prognosis....

Calf-raise senior: a new test for assessment of plantar flexor muscle strength in older adults: protocol, validity, and reliability.

Science.gov (United States)

André, Helô-Isa; Carnide, Filomena; Borja, Edgar; Ramalho, Fátima; Santos-Rocha, Rita; Veloso, António P

2016-01-01

This study aimed to develop a new field test protocol with a standardized measurement of strength and power in plantar flexor muscles targeted to functionally independent older adults, the calf-raise senior (CRS) test, and also evaluate its reliability and validity. Forty-one subjects aged 65 years and older of both sexes participated in five different cross-sectional studies: 1) pilot (n=12); 2) inter- and intrarater agreement (n=12); 3) construct (n=41); 4) criterion validity (n=33); and 5) test-retest reliability (n=41). Different motion parameters were compared in order to define a specifically designed protocol for seniors. Two raters evaluated each participant twice, and the results of the same individual were compared between raters and participants to assess the interrater and intrarater agreement. The validity and reliability studies involved three testing sessions that lasted 2 weeks, including a battery of functional fitness tests, CRS test in two occasions, accelerometry, and strength assessments in an isokinetic dynamometer. The CRS test presented an excellent test-retest reliability (intraclass correlation coefficient [ICC] =0.90, standard error of measurement =2.0) and interrater reliability (ICC =0.93-0.96), as well as a good intrarater agreement (ICC =0.79-0.84). Participants with better results in the CRS test were younger and presented higher levels of physical activity and functional fitness. A significant association between test results and all strength parameters (isometric, r =0.87, r 2 =0.75; isokinetic, r =0.86, r 2 =0.74; and rate of force development, r =0.77, r 2 =0.59) was shown. This study was successful in demonstrating that the CRS test can meet the scientific criteria of validity and reliability. The test can be a good indicator of ankle strength in older adults and proved to discriminate significantly between individuals with improved functionality and levels of physical activity.

Survival of captive-reared Hispaniolan Parrots released in Parque Nacional del Este, Dominican Republic

Science.gov (United States)

Collazo, J.A.; White, T.H.; Vilella, F.J.; Guerrero, S.A.

2003-01-01

We report first-year survival rates of 49 captive-reared Hispaniolan Parrots (Amazona ventralis) released in Parque Nacional del Este, Dominican Republic. Our goal was to learn about factors affecting postrelease survival. Specifically, we tested if survival was related to movements and whether modifying prerelease protocols influenced survival rates. We also estimated survival in the aftermath of Hurricane Georges (22 September 1998). Twenty-four parrots, fitted with radio-transmitters, were released between 14 September and 12 December 1997. Twenty-five more were released between 29 June and 16 September 1998. First-year survival rates were 30% in 1997 and 29% in 1998. Survival probability was related to bird mobility. In contrast to birds released in 1997, none of the 25 parrots released in 1998 suffered early postrelease mortality (i.e., 3-5 days after release). Two adjustments to prerelease protocols (increased exercise and reduced blood sampling) made in 1998 may have contributed to differences in mobility and survival between years. The reduction of early postrelease mortality in 1998 was encouraging, as was the prospect for higher first-year survival (e.g., 30% to 65%). Only one death was attributed to the immediate impact of the hurricane. Loss of foraging resources was likely a major contributor to ensuing mortality. Birds increased their mobility, presumably in search of food. Survival rates dropped 23% in only eight weeks posthurricane. This study underscores the value of standardized prerelease protocols, and of estimating survival and testing for factors that might influence it. Inferences from such tests will provide the best basis to make adjustments to a release program.

Validating Animal Models

Directory of Open Access Journals (Sweden)

Nina Atanasova

2015-06-01

Full Text Available In this paper, I respond to the challenge raised against contemporary experimental neurobiology according to which the field is in a state of crisis because of the multiple experimental protocols employed in different laboratories and strengthening their reliability that presumably preclude the validity of neurobiological knowledge. I provide an alternative account of experimentation in neurobiology which makes sense of its experimental practices. I argue that maintaining a multiplicity of experimental protocols and strengthening their reliability are well justified and they foster rather than preclude the validity of neurobiological knowledge. Thus, their presence indicates thriving rather than crisis of experimental neurobiology.

Improved survival with an innovative approach to the treatment of severely burned patients: development of a burn treatment manual.

Science.gov (United States)

Morisada, S; Nosaka, N; Tsukahara, K; Ugawa, T; Sato, K; Ujike, Y

2015-09-30

The management of severely burned patients remains a major issue worldwide as indicated by the high incidence of permanent debilitating complications and poor survival rates. In April 2012, the Advanced Emergency & Critical Care Medical Center of the Okayama University Hospital began implementing guidelines for severely burned patients, distributed as a standard burn treatment manual. The protocol, developed in-house, was validated by comparing the outcomes of patients with severe extensive burns (SEB) treated before and after implementation of these new guidelines at this institution. The patients included in this study had a burn index (BI) ≥30 or a prognostic burn index (PBI = BI + patient's age) ≥100. The survival rate of the patients with BI ≥30 was 65.2% with the traditional treatment and 100% with the new guidelines. Likewise, the survival rate of the patients with PBI ≥100 was 61.1% with the traditional treatment compared to 100% with the new guidelines. Together, these data demonstrate that the new treatment guidelines dramatically improved the treatment outcome and survival of SEB patients.

The Dutch Linguistic Intraoperative Protocol: a valid linguistic approach to awake brain surgery.

Science.gov (United States)

De Witte, E; Satoer, D; Robert, E; Colle, H; Verheyen, S; Visch-Brink, E; Mariën, P

2015-01-01

Intraoperative direct electrical stimulation (DES) is increasingly used in patients operated on for tumours in eloquent areas. Although a positive impact of DES on postoperative linguistic outcome is generally advocated, information about the neurolinguistic methods applied in awake surgery is scarce. We developed for the first time a standardised Dutch linguistic test battery (measuring phonology, semantics, syntax) to reliably identify the critical language zones in detail. A normative study was carried out in a control group of 250 native Dutch-speaking healthy adults. In addition, the clinical application of the Dutch Linguistic Intraoperative Protocol (DuLIP) was demonstrated by means of anatomo-functional models and five case studies. A set of DuLIP tests was selected for each patient depending on the tumour location and degree of linguistic impairment. DuLIP is a valid test battery for pre-, intraoperative and postoperative language testing and facilitates intraoperative mapping of eloquent language regions that are variably located. Copyright © 2014 Elsevier Inc. All rights reserved.

Metabolic therapy with Deanna Protocol supplementation delays disease progression and extends survival in amyotrophic lateral sclerosis (ALS mouse model.

Directory of Open Access Journals (Sweden)

Csilla Ari

Full Text Available Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease, is a neurodegenerative disorder of motor neurons causing progressive muscle weakness, paralysis, and eventual death from respiratory failure. There is currently no cure or effective treatment for ALS. Besides motor neuron degeneration, ALS is associated with impaired energy metabolism, which is pathophysiologically linked to mitochondrial dysfunction and glutamate excitotoxicity. The Deanna Protocol (DP is a metabolic therapy that has been reported to alleviate symptoms in patients with ALS. In this study we hypothesized that alternative fuels in the form of TCA cycle intermediates, specifically arginine-alpha-ketoglutarate (AAKG, the main ingredient of the DP, and the ketogenic diet (KD, would increase motor function and survival in a mouse model of ALS (SOD1-G93A. ALS mice were fed standard rodent diet (SD, KD, or either diets containing a metabolic therapy of the primary ingredients of the DP consisting of AAKG, gamma-aminobutyric acid, Coenzyme Q10, and medium chain triglyceride high in caprylic triglyceride. Assessment of ALS-like pathology was performed using a pre-defined criteria for neurological score, accelerated rotarod test, paw grip endurance test, and grip strength test. Blood glucose, blood beta-hydroxybutyrate, and body weight were also monitored. SD+DP-fed mice exhibited improved neurological score from age 116 to 136 days compared to control mice. KD-fed mice exhibited better motor performance on all motor function tests at 15 and 16 weeks of age compared to controls. SD+DP and KD+DP therapies significantly extended survival time of SOD1-G93A mice by 7.5% (p = 0.001 and 4.2% (p = 0.006, respectively. Sixty-three percent of mice in the KD+DP and 72.7% of the SD+DP group lived past 125 days, while only 9% of the control animals survived past that point. Targeting energy metabolism with metabolic therapy produces a therapeutic effect in ALS mice which

Metabolic therapy with Deanna Protocol supplementation delays disease progression and extends survival in amyotrophic lateral sclerosis (ALS) mouse model.

Science.gov (United States)

Ari, Csilla; Poff, Angela M; Held, Heather E; Landon, Carol S; Goldhagen, Craig R; Mavromates, Nicholas; D'Agostino, Dominic P

2014-01-01

Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease, is a neurodegenerative disorder of motor neurons causing progressive muscle weakness, paralysis, and eventual death from respiratory failure. There is currently no cure or effective treatment for ALS. Besides motor neuron degeneration, ALS is associated with impaired energy metabolism, which is pathophysiologically linked to mitochondrial dysfunction and glutamate excitotoxicity. The Deanna Protocol (DP) is a metabolic therapy that has been reported to alleviate symptoms in patients with ALS. In this study we hypothesized that alternative fuels in the form of TCA cycle intermediates, specifically arginine-alpha-ketoglutarate (AAKG), the main ingredient of the DP, and the ketogenic diet (KD), would increase motor function and survival in a mouse model of ALS (SOD1-G93A). ALS mice were fed standard rodent diet (SD), KD, or either diets containing a metabolic therapy of the primary ingredients of the DP consisting of AAKG, gamma-aminobutyric acid, Coenzyme Q10, and medium chain triglyceride high in caprylic triglyceride. Assessment of ALS-like pathology was performed using a pre-defined criteria for neurological score, accelerated rotarod test, paw grip endurance test, and grip strength test. Blood glucose, blood beta-hydroxybutyrate, and body weight were also monitored. SD+DP-fed mice exhibited improved neurological score from age 116 to 136 days compared to control mice. KD-fed mice exhibited better motor performance on all motor function tests at 15 and 16 weeks of age compared to controls. SD+DP and KD+DP therapies significantly extended survival time of SOD1-G93A mice by 7.5% (p = 0.001) and 4.2% (p = 0.006), respectively. Sixty-three percent of mice in the KD+DP and 72.7% of the SD+DP group lived past 125 days, while only 9% of the control animals survived past that point. Targeting energy metabolism with metabolic therapy produces a therapeutic effect in ALS mice which may prolong

Routing protocol extension for resilient GMPLS multi-domain networks

DEFF Research Database (Denmark)

Manolova, Anna Vasileva; Ruepp, Sarah Renée; Romeral, Ricardo

2010-01-01

This paper evaluates the performance of multi-domain networks under the Generalized Multi-Protocol Label Switching control framework in case of a single inter-domain link failure. We propose and evaluate a routing protocol extension for the Border Gateway Protocol, which allows domains to obtain...... two Autonomous System disjoint paths and use them efficiently under failure conditions. Three main applications for the protocol extension are illustrated: reducing traffic loss on existing connections by xploiting pre-selected backup paths derived with our proposal, applying multi-domain restoration...... as survivability mechanism in case of single link failure, and employing proper failure notification mechanisms for routing of future connection requests under routing protocol re-convergence. Via simulations we illustrate the benefits of utilizing the proposed routing protocol extension for networks employing...

Radiotherapy QA of the DAHANCA 19 protocol

DEFF Research Database (Denmark)

Samsøe, E.; Andersen, E.; Hansen, C. R.

2015-01-01

Purpose/Objective: It has been demonstrated that nonadherence to protocol-specified radiotherapy (RT) requirements is associated with reduced survival, local control and potentially increased toxicity [1]. Thus, quality assurance (QA) of RT is important when evaluating the results of clinical...

Desensitization protocols and their outcome.

Science.gov (United States)

Marfo, Kwaku; Lu, Amy; Ling, Min; Akalin, Enver

2011-04-01

In the last decade, transplantation across previously incompatible barriers has increasingly become popular because of organ donor shortage, availability of better methods of detecting and characterizing anti-HLA antibodies, ease of diagnosis, better understanding of antibody-mediated rejection, and the availability of effective regimens. This review summarizes all manuscripts published since the first publication in 2000 on desensitized patients and discusses clinical outcomes including acute and chronic antibody-mediated rejection rate, the new agents available, kidney paired exchange programs, and the future directions in sensitized patients. There were 21 studies published between 2000 and 2010, involving 725 patients with donor-specific anti-HLA antibodies (DSAs) who underwent kidney transplantation with different desensitization protocols. All studies were single center and retrospective. The patient and graft survival were 95% and 86%, respectively, at a 2-year median follow-up. Despite acceptable short-term patient and graft survivals, acute rejection rate was 36% and acute antibody-mediated rejection rate was 28%, which is significantly higher than in nonsensitized patients. Recent studies with longer follow-up of those patients raised concerns about long-term success of desensitization protocols. The studies utilizing protocol biopsies in desensitized patients also reported higher subclinical and chronic antibody-mediated rejection. An association between the strength of DSAs determined by median fluorescence intensity values of Luminex single-antigen beads and risk of rejection was observed. Two new agents, bortezomib, a proteasome inhibitor, and eculizumab, an anti-complement C5 antibody, were recently introduced to desensitization protocols. An alternative intervention is kidney paired exchange, which should be considered first for sensitized patients. © 2011 by the American Society of Nephrology

Proton Beam Therapy for Hepatocellular Carcinoma: A Comparison of Three Treatment Protocols

Energy Technology Data Exchange (ETDEWEB)

Mizumoto, Masashi; Okumura, Toshiyuki; Hashimoto, Takayuki [Proton Medical Research Center, University of Tsukuba, Tsukuba, Ibaraki (Japan); Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Fukuda, Kuniaki [Department of Gastroenterology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Oshiro, Yoshiko; Fukumitsu, Nobuyoshi [Proton Medical Research Center, University of Tsukuba, Tsukuba, Ibaraki (Japan); Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Abei, Masato [Department of Gastroenterology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Kawaguchi, Atsushi [Biostatistics Center, Kurume University, Fukuoka (Japan); Hayashi, Yasutaka; Ookawa, Ayako; Hashii, Haruko; Kanemoto, Ayae [Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Moritake, Takashi [Proton Medical Research Center, University of Tsukuba, Tsukuba, Ibaraki (Japan); Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Tohno, Eriko [Department of Diagnostic Radiology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Tsuboi, Koji [Proton Medical Research Center, University of Tsukuba, Tsukuba, Ibaraki (Japan); Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki (Japan); Sakae, Takeji [Proton Medical Research Center, University of Tsukuba, Tsukuba, Ibaraki (Japan); Sakurai, Hideyuki, E-mail: hsakurai@pmrc.tsukuba.ac.jp [Proton Medical Research Center, University of Tsukuba, Tsukuba, Ibaraki (Japan); Department of Radiation Oncology, University of Tsukuba, Tsukuba, Ibaraki (Japan)

2011-11-15

Background: Our previous results for treatment of hepatocellular carcinoma (HCC) with proton beam therapy revealed excellent local control with low toxicity. Three protocols were used to avoid late complications such as gastrointestinal ulceration and bile duct stenosis. In this study, we examined the efficacy of these protocols. Methods and Materials: The subjects were 266 patients (273 HCCs) treated by proton beam therapy at University of Tsukuba between January 2001 and December 2007. Three treatment protocols (A, 66 GyE in 10 fractions; B, 72.6 GyE in 22 fractions; and C, 77 GyE in 35 fractions) were used, depending on the tumor location. Results: Of the 266 patients, 104, 95, and 60 patients were treated with protocols A, B, and C, respectively. Seven patients with double lesions underwent two different protocols. The overall survival rates after 1, 3 and 5 years were 87%, 61%, and 48%, respectively (median survival, 4.2 years). Multivariate analysis showed that better liver function, small clinical target volume, and no prior treatment (outside the irradiated field) were associated with good survival. The local control rates after 1, 3, and 5 years were 98%, 87%, and 81%, respectively. Multivariate analysis did not identify any factors associated with good local control. Conclusions: This study showed that proton beam therapy achieved good local control for HCC using each of three treatment protocols. This suggests that selection of treatment schedules based on tumor location may be used to reduce the risk of late toxicity and maintain good treatment efficacy.

Validation of the Somnotouch-NIBP noninvasive continuous blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Bilo, Grzegorz; Zorzi, Cristina; Ochoa Munera, Juan E; Torlasco, Camilla; Giuli, Valentina; Parati, Gianfranco

2015-10-01

The present study aimed to evaluate the accuracy of the Somnotouch-NIBP noninvasive continuous blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adults (11 women, mean age 63.5±11.9 years) using a mercury sphygmomanometer (two observers) and the Somnotouch-NIBP device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. All the validation requirements were fulfilled. The Somnotouch-NIBP device fulfilled the requirements of the part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 75/99, 90/99, and 96/99, respectively, for systolic blood pressure and 90/99, 99/99, and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Twenty-seven and 31 participants had at least two of the three device-observers differences less than or equal to 5 mmHg for systolic and diastolic blood pressure, respectively. All three device-observer differences were greater than 5 mmHg in two participants for systolic and in one participant for diastolic blood pressure. The Somnotouch-NIBP noninvasive continuous blood pressure monitor has passed the requirements of the International Protocol revision 2010, and hence can be recommended for blood pressure monitoring in adults, at least under conditions corresponding to those investigated in our study.

Validation of the BPLab® 24-hour blood pressure monitoring system in a pediatric population according to the 1993 British Hypertension Society protocol

Directory of Open Access Journals (Sweden)

Ledyaev MY

2015-02-01

Full Text Available Mikhail Y Ledyaev, Olga V Stepanova, Anastasia M Ledyaeva Department of Pediatric Disease, Volgograd State Medical University, Volgograd, Russian Federation Background: Automatic 24-hour ambulatory blood pressure (BP monitoring (ABPM is a basic procedure performed in adults with arterial hypertension, but ABPM monitors have become widely used in pediatric practice only recently. The main problem is the lack of common normative data sets for ABPM in children and the small number of appropriate monitors that can be used for analysis of the 24-hour BP profile in this age group. The aim of this study was to validate the BPLab® ABPM monitor according to the 1993 British Hypertension Society (BHS-93 protocol, as well as to work out solutions regarding the feasibility of this device in pediatric practice. Methods: Our study included 30 children of both sexes and aged 5–15 years, ie, “older” children according to the BHS-93 protocol. Before starting the study, we obtained ethical approval from the regional scientific ethics committee. All participants and their parents signed their written consent for participation in the study. The data were simultaneously obtained by three experts, who had completed a noninvasive BP measurement training course. BP values were measured using the Korotkoff auscultatory method (Phase I for systolic BP and Phase V for diastolic BP. Discrepancies in the systolic and diastolic BP measurements (n=180; 90 for each expert were analyzed according to the criteria specified in the BHS-93 protocol. Results: The device was graded “A” for both systolic BP and diastolic BP according to the criteria of the BHS-93 protocol. Conclusion: The BPLab ABPM device may be recommended for extensive pediatric use. Keywords: ambulatory blood pressure monitoring, children, device, validation 

[Impact of the chemotherapy protocols for metastatic breast cancer on the treatment cost and the survival time of 371 patients treated in three hospitals of the Rhone-Alpes region].

Science.gov (United States)

Paviot, B Trombert; Bachelot, T; Clavreul, G; Jacquin, J-P; Mille, D; Rodrigues, J-M

2009-10-01

The chemotherapy of the metastatic breast cancer is characterized by the diversity of the treatment protocols and the utilisation of new expensive molecules posing the double problem of outcomes for the patients and financial effects for the hospitals. This survey describes the different chemotherapy treatments prescribed in the metastatic breast cancer and the direct costs supported by the hospitals according to the patient survival time. A cohort of 371 patients treated for a metastatic breast cancer was followed in three hospitals of the Rhone-Alpes region between 2001 and 2006. The detail of their different antineoplasic treatments, as well as the purchase cost of the drugs and their cost of hospital administration, the cost of the other hospital stays are presented in relation with the survival. The median survival time (35,8 months; CI 95%: [31.7-39.1]) since the first metastasis does not differ significantly according to the hospital. Ninety-three different chemotherapy protocols are observed combining from one to five molecules. Thirty-two different molecules are identified. In first line treatment, there is a significant difference in the use of the new molecules according to hospital (Chi(2) test; P cost of a chemotherapy treatment is 3,919 euro (+/- 8,069 euro), the higher cost is observed for trastuzumab (23,443 euro). The average time period before the beginning of a new chemotherapy line is 212 days (+/- 237 days) and the mean cost of hospital stay during this period is 3,903 euro (+/- 4,097 euro). If no impact of the chemotherapy treatment strategy is observed on the survival time of the patient, it is the opposite for the hospital treatment cost. These results are asking for a better control system of the authorization procedure of new molecules marketing and the harmonization of the practices.

Technical Analysis of SSP-21 Protocol

Energy Technology Data Exchange (ETDEWEB)

Bromberger, S. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)

2017-06-09

As part of the California Energy Systems for the Twenty-First Century (CES-21) program, in December 2016 San Diego Gas and Electric (SDG&E) contracted with Lawrence Livermore National Laboratory (LLNL) to perform an independent verification and validation (IV&V) of a white paper describing their Secure SCADA Protocol for the Twenty-First Century (SSP-21) in order to analyze the effectiveness and propriety of cryptographic protocol use within the SSP-21 specification. SSP-21 is designed to use cryptographic protocols to provide (optional) encryption, authentication, and nonrepudiation, among other capabilities. The cryptographic protocols to be used reflect current industry standards; future versions of SSP-21 will use other advanced technologies to provide a subset of security services.

Validation of Progression‐Free Survival as a Surrogate Endpoint for Overall Survival in Malignant Mesothelioma: Analysis of Cancer and Leukemia Group B and North Central Cancer Treatment Group (Alliance) Trials

Science.gov (United States)

Wang, Xiaoyi; Hodgson, Lydia; George, Stephen L.; Sargent, Daniel J.; Foster, Nate R.; Ganti, Apar Kishor; Stinchcombe, Thomas E.; Crawford, Jeffrey; Kratzke, Robert; Adjei, Alex A.; Kindler, Hedy L.; Vokes, Everett E.; Pang, Herbert

2017-01-01

Abstract Purpose. The aim of this study was to investigate whether progression‐free survival (PFS) can be considered a surrogate endpoint for overall survival (OS) in malignant mesothelioma. Materials and Methods. Individual data were collected from 15 Cancer and Leukemia Group B (615 patients) and 2 North Central Cancer Treatment Group (101 patients) phase II trials. The effects of 5 risk factors for OS and PFS, including age, histology, performance status (PS), white blood cell count, and European Organisation for Research and Treatment of Cancer (EORTC) risk score, were used in the analysis. Individual‐level surrogacy was assessed by Kendall's tau through a Clayton bivariate Copula survival (CBCS) model. Summary‐level surrogacy was evaluated via the association between logarithms of the hazard ratio (log HR)—log HROS and log HRPFS—measured in R2 from a weighted least‐square (WLS) regression model and the CBCS model. Results. The median PFS for all patients was 3.0 months (95% confidence interval [CI], 2.8–3.5 months) and the median OS was 7.2 months (95% CI, 6.5–8.0 months). Moderate correlations between PFS and OS were observed across all risk factors at the individual level, with Kendall's tau ranging from 0.46 to 0.47. The summary‐level surrogacy varied among risk factors. The Copula R2 ranged from 0.51 for PS to 0.78 for histology. The WLS R2 ranged from 0.26 for EORTC and PS to 0.67 for age. Conclusions. The analyses demonstrated low to moderate individual‐level surrogacy between PFS and OS. At the summary level, the surrogacy between PFS and OS varied significantly across different risk factors. With a short postprogression survival and a moderate correlation between PFS and OS, there is no evidence that PFS is a valid surrogate endpoint for OS in malignant mesothelioma. Implications for Practice. For better disease management and for more efficient clinical trial designs, it is important to know if progression‐free survival (PFS) is

Validation of HPLC-ESI-MS/MS Protocol to Analyze EtG in Hair for Assessment of Chronic Excessive Alcohol Use in Thailand in Conjunction with AUDIT.

Science.gov (United States)

Thananchai, Thiwaphorn; Junkuy, Anongphan; Kittirattanapaiboon, Phunnapa; Sribanditmongkol, Pongruk

2016-06-01

Hair analysis for chronic excessive alcohol (ethanol) use has focused on ethyl glucuronide (EtG), a minor metabolite of ethanol. Preferred methods have involved high-performance liquid chromatography (HPLC) combined with tandem mass spectrometry (MS/MS) in line with an electrospray ionization (ESI) source. EtG analysis in hair has not yet been introduced to Thailand To validate an in-house HPLC-ESI-MS/MS hair analysis protocol for EtG and to apply it to a field sample of alcohol drinkers to assess different risk levels of alcohol consumption as measured by the Alcohol Use Disorders Identification Test (AUDIT). Validation procedures followed guidelines of the US Food and Drug Administration, the European Medicines Agency, and the Scientific Working Group for Forensic Toxicology. One hundred twenty subjects reported consuming alcohol during a 3-month period prior to enrollment. After taking the Thai-language version of AUDIT, subjects were divided on the basis of test scores into low, medium, and high-risk groups for chronic excessive alcohol use. The protocol satisfied the international standards for selectivity, specificity, accuracy, precision, and calibration curve. There was no significant matrix effect. Limits of detection and quantification (LOD/LOQ) were set at 15 pg of EtG per mg of hair. The protocol was not able to detect EtG in low-risk subjects (n = 38). Detection rates for medium-risk (n = 42) and high-risk subjects (n = 40) were 14.3% and 85%, respectively. The median of EtG concentration between these two groups were significantly different. Sensitivity and specificity were both more than 90% when EtG concentrations of high-risk subjects were compared with the 30 pg/mg cutoff recommended by the Society of Hair Testing (SoHT) for diagnosing chronic excessive alcohol consumption, based on an average ethanol daily intake greater than 60 g. The in-house protocol for EtG analysis in hair was validated according to international standards. The protocol is a

A Novel and Validated Protocol for Performing MIC Tests to Determine the Susceptibility of Piscirickettsia salmonis Isolates to Florfenicol and Oxytetracycline

Directory of Open Access Journals (Sweden)

Sergio Contreras-Lynch

2017-07-01

Full Text Available This paper presents a validated protocol, using a novel, specifically formulated medium, to perform broth microdilution antimicrobial susceptibility assays of the salmonid bacterial pathogen Piscirickettsia salmonis. The minimum inhibitory concentrations (MIC for florfenicol and oxytetracycline against 58 P. salmonis isolates recovered from various outbreaks occurred in Chilean salmonid farms were determined using this protocol. Normalized resistance interpretation (NRI analysis was applied to these data to calculate appropriate protocol-specific epidemiological cut-off values. These cut-off values allow the isolates to be categorized as either fully susceptible wild type (WT members of this species, or as manifesting reduced susceptibility non-wild type (NWT. The distribution of MIC values of florfenicol was bimodal and the distribution of the normalized values for the putative WT observation had a standard deviation of 0.896 log2 μg mL-1. This analysis calculated a cut-off value of ≤0.25 μg mL-1 and categorized 33 (56% of the isolates as manifesting reduced susceptibility to florfenicol. For the oxytetracycline MIC data the NRI analysis also treated the distribution as bimodal. The distribution of the normalized values for the putative WT observation had a standard deviation of 0.951 log2 μg mL-1. This analysis gave a cut-off value of ≤0.5 μg mL-1 and categorized five isolates (9% as manifesting reduced susceptibility to oxytetracycline. The susceptibility testing protocol developed in this study was capable of generating MIC data from all the isolates tested. On the basis of the precision of the data it generated, and the degree of separation of values for WT and NWT it achieved, it is argued that this protocol has the performance characteristics necessary for it to be considered as a standard protocol.

Blockchain Consensus Protocols in the Wild (Keynote Talk)

OpenAIRE

Cachin, Christian; Vukolic, Marko

2017-01-01

A blockchain is a distributed ledger for recording transactions, maintained by many nodes without central authority through a distributed cryptographic protocol. All nodes validate the information to be appended to the blockchain, and a consensus protocol ensures that the nodes agree on a unique order in which entries are appended. Consensus protocols for tolerating Byzantine faults have received renewed attention because they also address blockchain systems. This work discusses the process o...

Model description and evaluation of the mark-recapture survival model used to parameterize the 2012 status and threats analysis for the Florida manatee (Trichechus manatus latirostris)

Science.gov (United States)

Langtimm, Catherine A.; Kendall, William L.; Beck, Cathy A.; Kochman, Howard I.; Teague, Amy L.; Meigs-Friend, Gaia; Peñaloza, Claudia L.

2016-11-30

This report provides supporting details and evidence for the rationale, validity and efficacy of a new mark-recapture model, the Barker Robust Design, to estimate regional manatee survival rates used to parameterize several components of the 2012 version of the Manatee Core Biological Model (CBM) and Threats Analysis (TA).  The CBM and TA provide scientific analyses on population viability of the Florida manatee subspecies (Trichechus manatus latirostris) for U.S. Fish and Wildlife Service’s 5-year reviews of the status of the species as listed under the Endangered Species Act.  The model evaluation is presented in a standardized reporting framework, modified from the TRACE (TRAnsparent and Comprehensive model Evaluation) protocol first introduced for environmental threat analyses.  We identify this new protocol as TRACE-MANATEE SURVIVAL and this model evaluation specifically as TRACE-MANATEE SURVIVAL, Barker RD version 1. The longer-term objectives of the manatee standard reporting format are to (1) communicate to resource managers consistent evaluation information over sequential modeling efforts; (2) build understanding and expertise on the structure and function of the models; (3) document changes in model structures and applications in response to evolving management objectives, new biological and ecological knowledge, and new statistical advances; and (4) provide greater transparency for management and research review.

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.

Science.gov (United States)

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

Optimization and validation of the protocol used to analyze the taste of traditional Chinese medicines using an electronic tongue.

Science.gov (United States)

Li, Xuelin; Gao, Xiaojie; Liu, Ruixin; Wang, Junming; Wu, Zidan; Zhang, Lu; Li, Huiling; Gui, Xinjing; Kang, Bingya; Shi, Junhan

2016-11-01

Tools to define the active ingredients and flavors of Traditional Chinese Medicines (TCMs) are limited by long analysis times, complex sample preparation and a lack of multiplexed analysis. The aim of the present study was to optimize and validate an electronic tongue (E-tongue) methodology to analyze the bitterness of TCMs. To test the protocol, 35 different TCM concoctions were measured using an E-tongue, and seven replicate measurements of each sample were taken to evaluate reproducibility and precision. E-tongue sensor information was identified and classified using analysis approaches including least squares support vector machine (LS-SVM), support vector machine (SVM), discriminant analysis (DA) and partial least squares (PLS). A benefit of this analytical protocol was that the analysis of a single sample took <15 min for all seven sensors. The results identified that the LS-SVM approach provided the best bitterness classification accuracy (binary classification accuracy, 100%; ternary classification accuracy, 89.66%). The E-tongue protocol developed showed good reproducibility and high precision within a 6 h measurement cycle. To the best of our knowledge, this is the first study of an E-tongue being applied to assay the bitterness of TCMs. This approach could be applied in the classification of the taste of TCMs, and serve important roles in other fields, including foods and beverages.

DockBench: An Integrated Informatic Platform Bridging the Gap between the Robust Validation of Docking Protocols and Virtual Screening Simulations

Directory of Open Access Journals (Sweden)

Alberto Cuzzolin

2015-05-01

Full Text Available Virtual screening (VS is a computational methodology that streamlines the drug discovery process by reducing costs and required resources through the in silico identification of potential drug candidates. Structure-based VS (SBVS exploits knowledge about the three-dimensional (3D structure of protein targets and uses the docking methodology as search engine for novel hits. The success of a SBVS campaign strongly depends upon the accuracy of the docking protocol used to select the candidates from large chemical libraries. The identification of suitable protocols is therefore a crucial step in the setup of SBVS experiments. Carrying out extensive benchmark studies, however, is usually a tangled task that requires users’ proficiency in handling different file formats and philosophies at the basis of the plethora of existing software packages. We present here DockBench 1.0, a platform available free of charge that eases the pipeline by automating the entire procedure, from docking benchmark to VS setups. In its current implementation, DockBench 1.0 handles seven docking software packages and offers the possibility to test up to seventeen different protocols. The main features of our platform are presented here and the results of the benchmark study of human Checkpoint kinase 1 (hChk1 are discussed as validation test.

VALIDATION OF THE MECG-DP-NS-01 MONITOR IN OSCILLOMETRY AND AUSCULTATION MODES IN CHILDREN AND ADOLESCENTS, ACCORDING TO ESH-IP2, BHS AND AAMI PROTOCOLS

Directory of Open Access Journals (Sweden)

S. I. Fedorova

2015-01-01

Full Text Available Background: High blood pressure in childhood and adolescence is associated with a 2 to 3-fold increase of the risk of arterial hypertension. According to the Russian guidelines, only devices that have been tested by international protocols can be used for the main diagnostic method of arterial hypertension in children and adolescents, i.e. ambulatory 24-hour blood pressure monitoring.Aim: To validate the MECG-DP-NS-01 upper arm BP monitor in oscillometry and auscultation modes within the “Soyuz” complex, in children and adolescents aged from 5 to 15 years according to the international protocol of the European Society of Hypertension (ESH from 2010 (ESH-IP2, the protocol of the British Hypertension Society (BHS from 1993 and the standard of the Association for the Advancement of Medical Instrumentation (AAMI.Materials and methods: We recruited 99 children and adolescents (49 male, 50 female aged from 5 to 15 years (33 children, from 5 to 7 years, 33, from 8 to 11 years, 33, from 12 to 15 years. Expert and device blood pressure measurements were performed in each patient according to the protocols.Results: The MECG-DP-NS-01 upper arm blood pressure monitor was validated and its accuracy in blood pressure measurement in children and adolescents according to ESH-IP2, BHS and AAMI protocols confirmed. According to BHS 1993 protocol, its accuracy corresponded to A/A both in the oscillometry and auscultation modes.Conclusion: According to ESH-IP2, BHS and AAMI protocols, MEGC-DP-NS-01 within the “Soyuz” complex could be recommended for 24-hour ambulatory blood pressure monitoring in children and adolescents aged from 5 to 15 years, both in the oscillometry and auscultation modes. According to the Declaration of blood pressure Measuring Device Equivalence signed by the manufacturer for the devices MDP-NS-02s “Voshod” and MEGCDPNS-01, and to the equivalence criteria for blood pressure measuring devices, the results of testing and its

Validation of the Konsung QD217A for clinical use and self-measurement according to the European Society of Hypertension International Protocol.

Science.gov (United States)

Wu, Ning; Zhang, Xuezhong; Wang, Wen; Zhang, Hongye

2015-08-01

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor Konsung QD217A for home BP monitoring according to the European Society of Hypertension International Protocol revision 2010. Three trained observers validated the performance of these devices by comparing the measurements obtained from these devices with those taken using a standard mercury sphygmomanometer. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using a standard mercury sphygmomanometer and the Konsung QD217A device. A total of 99 pairs of comparisons were obtained from 33 participants. The QD217A device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10 and 15 mmHg was 70/99, 92/99 and 96/99, respectively, for SBP and 80/99, 94/99 and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. A total of 27 and 31 participants for SBP and DBP, respectively, showed at least two of the three device-observers differences within 5 mmHg (required≥24). The number of participants without device-observer difference within 5 mmHg was one for SBP and one for DBP (required≤3). The Konsung upper arm BP monitor QD217A has passed the International Protocol requirements and it can be recommended for clinical use and self-measurement in adults. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.

Simulation and Validation of Cisco Lethal Conditions in Minnesota Lakes under Past and Future Climate Scenarios Using Constant Survival Limits

Directory of Open Access Journals (Sweden)

Liping Jiang

2016-07-01

Full Text Available Fish habitat in lakes is strongly constrained by water temperature (T and available dissolved oxygen (DO that are changed under climate warming. A one dimensional, dynamic water quality model MINLAKE2012 was used for T and DO simulation over 48 years. A fish habitat model FishHabitat2013 using simulated T and DO profiles as input was developed to determine lethal conditions of cisco Corgenous artedi in Minnesota lakes. Twenty-three lakes that had observations of cisco mortality or survival in the unusually warm summer of 2006 were used for model validation. The cisco habitat model used a lethal temperature of 22.1 °C and DO survival limit of 3 mg/L determined through model validation and sensitivity analysis. Cisco lethal conditions in 12 shallow, 16 medium-depth, and 30 deep virtual lakes were then simulated. Isopleths of total number of years with cisco kill and average cisco kill days for the years with kills under past (1961–2008 and future climate were generated to understand/extrapolate climate impacts on cisco in 620 Minnesota lakes. Shallow and medium-depth lakes are projected to not be good candidates for cisco refuge lakes, but deep lakes are possible cisco refuge lakes based on lethal condition projection under future warmer climate.

Validation of the Andon KD595 for clinical use and self-measurement according to the European Society of Hypertension International Protocol.

Science.gov (United States)

Wu, Ning; Zhang, Xuezhong; Wang, Wen; Zhang, Hongye

2016-04-01

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor Andon KD595 for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using the standard mercury sphygmomanometer and the Andon KD595 device. Ninety-nine pairs of comparisons were obtained from 33 participants for analysis. The KD595 device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10, and 15 mmHg was 72/99, 93/99, and 96/99, respectively, for SBP and 72/99, 96/99, and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. A total of 28 and 25 participants had at least two of the three device-observer differences within 5 mmHg (required≥24) for SBP and DBP, respectively. The number of participants without device-observer difference within 5 mmHg was two for SBP and two for DBP (required≤3). The Andon upper arm blood pressure monitor KD595 has passed the International Protocol requirements and it can be recommended for clinical use and self-measurement in adults.

Validation of the Andon KD5031 for clinical use and self-measurement according to the European Society of Hypertension International Protocol.

Science.gov (United States)

Wu, Ning; Zhang, Xuezhong; Wang, Wen; Zhang, Hongye

2016-10-01

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor Andon KD5031 for home BP monitoring according to the European Society of Hypertension International Protocol revision 2010. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using the standard mercury sphygmomanometer and the Andon KD5031 device. Ninety-nine pairs of comparisons were obtained from 33 participants for analysis. The KD5031 device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10, and 15 mmHg was 66/99, 93/99, and 98/99, respectively, for SBP and 72/99, 94/99, and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. Twenty-six participants for both SBP and DBP had at least two of the three device-observer differences within 5 mmHg (required ≥24). The number of participants without a device-observer difference within 5 mmHg was one for SBP and three for DBP (required ≤3). The Andon upper arm BP monitor KD5031 has passed the International Protocol requirements, and it can be recommended for clinical use and self-measurement in adults.

Diagnosing subtle palatal anomalies: Validation of video-analysis and assessment protocol for diagnosing occult submucous cleft palate.

Science.gov (United States)

Rourke, Ryan; Weinberg, Seth M; Marazita, Mary L; Jabbour, Noel

2017-09-01

Submucous cleft palate (SMCP) classically involves bifid uvula, zona pellucida, and notched hard palate. However, patients may present with more subtle anatomic abnormalities. The ability to detect these abnormalities is important for surgeons managing velopharyngeal dysfunction (VPD) or considering adenoidectomy. Validate an assessment protocol for diagnosis of occult submucous cleft palate (OSMCP) and identify physical examination features present in patients with OSMCP in the relaxed and activated palate positions. Study participants included patients referred to a pediatric VPD clinic with concern for hypernasality or SMCP. Using an appropriately encrypted iPod touch, transoral video was obtained for each patient with the palate in the relaxed and activated positions. The videos were reviewed by two otolaryngologists in normal speed and slow-motion, as needed, and a questionnaire was completed by each reviewer pertaining to the anatomy and function of the palate. 47 patients, with an average age of 4.6 years, were included in the study over a one-year period. Four videos were unusable due to incomplete view of the palate. The most common palatal abnormality noted was OSMCP, diagnosed by each reviewer in 26/43 and 30/43 patients respectively. Using the assessment protocol, agreement on palatal diagnosis was 83.7% (kappa = 0.68), indicating substantial agreement, with the most prevalent anatomic features being vaulted palate elevation (96%) and visible notching of hard palate (75%). The diagnosis of subtle palatal anomalies is difficult and can be subjective. Using the proposed video-analysis method and assessment protocol may improve reliability of diagnosis of OSMCP. Copyright © 2017 Elsevier B.V. All rights reserved.

Validation of the A&D UM-201 device for office blood pressure measurement according to the European Society of Hypertension International Protocol Revision 2010.

Science.gov (United States)

Fania, Claudio; Albertini, Federica; Palatini, Paolo

2017-08-01

The aim of this study was to determine the accuracy of the A&D UM-201 device coupled to several cuffs for different arm sizes for office blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension. Evaluation was carried out in 33 individuals. The mean age of the individuals was 59.3±13.2 years, systolic BP was 145.4±20.6 mmHg (range: 109-186 mmHg), diastolic BP was 87.3±18.0 mmHg (range: 50-124 mmHg), and arm circumference was 30.4±4.2 cm (range: 23-39 cm). The protocol requirements were followed precisely. The UM-201 monitor passed all requirements, fulfilling the standards of the protocol. On average, the device overestimated systolic BP by 3.0±2.1 mmHg and diastolic BP by 2.6±2.0 mmHg. These data show that the A&D UM-201 device coupled to several cuffs for different ranges of arm circumference fulfilled the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

Multiprofissional electronic protocol in ophtalmology with enfasis in strabismus

OpenAIRE

RIBEIRO, CHRISTIE GRAF; MOREIRA, ANA TEREZA RAMOS; PINTO, JOSÉ SIMÃO DE PAULA; MALAFAIA, OSVALDO

2016-01-01

ABSTRACT Objective: to create and validate an electronic database in ophthalmology focused on strabismus, to computerize this database in the form of a systematic data collection software named Electronic Protocol, and to incorporate this protocol into the Integrated System of Electronic Protocols (SINPE(c)). Methods: this is a descriptive study, with the methodology divided into three phases: (1) development of a theoretical ophthalmologic database with emphasis on strabismus; (2) compute...

Development and validation of simple RP-HPLC-PDA analytical protocol for zileuton assisted with Design of Experiments for robustness determination

OpenAIRE

Saurabh B. Ganorkar; Dinesh M. Dhumal; Atul A. Shirkhedkar

2017-01-01

A simple, rapid, sensitive, robust, stability-indicating RP-HPLC-PDA analytical protocol was developed and validated for the analysis of zileuton racemate in bulk and in tablet formulation. Development of method and resolution of degradation products from forced; hydrolytic (acidic, basic, neutral), oxidative, photolytic (acidic, basic, neutral, solid state) and thermal (dry heat) degradation was achieved on a LC – GC Qualisil BDS C18 column (250 mm × 4.6 mm × 5 μm) by isocratic mode at ambie...

Validation of Transtek blood pressure monitor TMB-1491 for self-measurement according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Tian, Huiyong; Zeng, Sijian; Zhong, Xiaoyan; Gong, Wei; Liu, Wenjun

2015-10-01

Transtek blood pressure monitor TMB-1491 is an automatic upper arm device designed for self/home measurement in adult populations. This study aimed to evaluate its accuracy according to the European Society of Hypertension International Protocol revision 2010. The protocol requirements were followed precisely with the recruitment of 33 adult individuals on whom same-left-arm sequential systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. According to the validation protocol, 99 pairs of test device and reference blood pressure measurements were obtained in this study (three pairs for each of the 33 participants). The device produced 74, 95 and 99 measurements within 5, 10, and 15 mmHg for SBP and 85, 97, and 99 for DBP, respectively. The mean±SD device-observer difference was -0.6±4.4 mmHg for SBP and -0.6±3.4 mmHg for DBP. The number of participants with two or three device-observer difference within 5 mmHg was 24 for SBP and 29 for DBP. In addition, none of the participants had a device-observer difference within 5 mmHg for SBP, and three of the participants had the same for DBP. Transtek TMB-1491 has passed all phases of European Society of Hypertension International Protocol revision 2010 and can be recommended for self/home measurement in adult populations.

Ocean Optics Protocols for Satellite Ocean Color Sensor Validation. Volume 2; Revised

Science.gov (United States)

Mueller, James L. (Editor); Fargion, Giulietta S. (Editor); Trees, C.; Austin, R. W.; Pietras, C. (Editor); Hooker, S.; Holben, B.; McClain, Charles R.; Clark, D. K.; Yuen, M.

2002-01-01

This document stipulates protocols for measuring bio-optical and radiometric data for the SIMBIOS Project. It supersedes the earlier version, and is organized into four parts: Introductory Background, Instrument Characteristics, Field Measurements and Data Analysis, Data Reporting and Archival. Changes in this revision include the addition of three new chapters: (1) Fundamental Definitions, Relationships and Conventions; (2) MOBY, A Radiometric Buoy for Performance Monitoring and Vicarious Calibration of Satellite Ocean Color Sensors: Measurement and Data Analysis Protocols; and (3) Normalized Water-Leaving Radiance and Remote Sensing Reflectance: Bidirectional Reflectance and Other Factors. Although the present document represents another significant, incremental improvement in the ocean optics protocols, there are several protocols that have either been overtaken by recent technological progress, or have been otherwise identified as inadequate. Revision 4 is scheduled for completion sometime in 2003. This technical report is not meant as a substitute for scientific literature. Instead, it will provide a ready and responsive vehicle for the multitude of technical reports issued by an operational Project. The contributions are published as submitted, after only minor editing to correct obvious grammatical or clerical errors.

Ocean Optics Protocols for Satellite Ocean Color Sensor Validation. Volume 1; Revised

Science.gov (United States)

Mueller, James L. (Editor); Fargion, Giulietta (Editor); Mueller, J. L.; Trees, C.; Austin, R. W.; Pietras, C.; Hooker, S.; Holben, B.; McClain, Charles R.; Clark, D. K.;

Hair cortisol detection in dairy cattle by using EIA: protocol validation and correlation with faecal cortisol metabolites.

Science.gov (United States)

Tallo-Parra, O; Manteca, X; Sabes-Alsina, M; Carbajal, A; Lopez-Bejar, M

2015-06-01

Hair may be a useful matrix to detect cumulative cortisol concentrations in studies of animal welfare and chronic stress. The aim of this study was to validate a protocol for cortisol detection in hair from dairy cattle by enzyme immunoassay (EIA). Seventeen adult Holstein-Friesian dairy cows were used during the milking period. Hair cortisol concentration was assessed in 25-day-old hair samples taken from the frontal region of the head, analysing black and white coloured hair separately. Concentrations of cortisol metabolites were determined in faeces collected twice a week during the same period of time. There was a high correlation between cortisol values in faeces and cortisol in white colour hair samples but such correlation was not significant with the black colour hair samples. The intra- and inter-assay coefficients of variation were 4.9% and 10.6%, respectively. The linearity showed R 2=0.98 and mean percentage error of -10.8 ± 1.55%. The extraction efficiency was 89.0 ± 23.52% and the parallelism test showed similar slopes. Cortisol detection in hair by using EIA seems to be a valid method to represent long-term circulating cortisol levels in dairy cattle.

Fiber Laser Component Testing for Space Qualification Protocol Development

Science.gov (United States)

Falvey, S.; Buelow, M.; Nelson, B.; Starcher, Y.; Thienel, L.; Rhodes, C.; Tull, Jackson; Drape, T.; Westfall, C.

A test protocol for the space qualifying of Ytterbium-doped diode-pumped fiber laser (DPFL) components was developed under the Bright Light effort, sponsored by AFRL/VSE. A literature search was performed and summarized in an AMOS 2005 conference paper that formed the building blocks for the development of the test protocol. The test protocol was developed from the experience of the Bright Light team, the information in the literature search, and the results of a study of the Telcordia standards. Based on this protocol developed, test procedures and acceptance criteria for a series of vibration, thermal/vacuum, and radiation exposure tests were developed for selected fiber laser components. Northrop Grumman led the effort in vibration and thermal testing of these components at the Aerospace Engineering Facility on Kirtland Air Force Base, NM. The results of the tests conducted have been evaluated. This paper discusses the vibration and thermal testing that was executed to validate the test protocol. The lessons learned will aid in future assessments and definition of space qualification protocols. Components representative of major items within a Ytterbium-doped diode-pumped fiber laser were selected for testing; including fibers, isolators, combiners, fiber Bragg gratings, and laser diodes. Selection of the components was based on guidelines to test multiple models of typical fiber laser components. A goal of the effort was to test two models (i.e. different manufacturers) of each type of article selected, representing different technologies for the same type of device. The test articles did not include subsystems or systems. These components and parts may not be available commercial-off-the-shelf (COTS), and, in fact, many are custom articles, or newly developed by the manufacturer. The primary goal for this effort is a completed taxonomy that lists all relevant laser components, modules, subsystems, and interfaces, and cites the documentation for space

Validation of the OMRON M7 (HEM-780-E) blood pressure measuring device in a population requiring large cuff use according to the International Protocol of the European Society of Hypertension.

Science.gov (United States)

El Feghali, Ramzi N; Topouchian, Jirar A; Pannier, Bruno M; El Assaad, Hiba A; Asmar, Roland G

2007-06-01

A high percentage of hypertensive patients present an arm circumference of over 32 cm; the use of a large cuff is therefore recommended. Validation studies are usually performed in the general population using a standard-size cuff. The aim of this study was to assess the accuracy of the Omron M7 device in a population with an arm circumference ranging from 32 to 42 cm. A validation study was performed according to the International Protocol of the European Society of Hypertension. This protocol is divided into two phases: the first phase is performed on 15 selected participants (45 pairs of blood-pressure measurements); if the device passes this phase, 18 supplementary participants are included (54 pairs of blood-pressure measurements), making a total number of 33 participants (99 pairs of blood-pressure measurements), on whom the analysis is performed. For each participant, four blood-pressure measurements were performed simultaneously by two trained observers, using mercury sphygmomanometers fitted with a Y tube; the measurements alternated with three by the test device. The difference between the blood-pressure value given by the device and that obtained by the two observers (mean of the two observations) was calculated for each measure. The 99 pairs of blood-pressure differences were classified into three categories (Society of Hypertension protocol. The Omron M7 device passed the first and the second phases of the validation process. The average differences between the two observers were 1.5+/-3.2 and -0.5+/-2.2 mmHg for systolic blood pressure and diastolic blood pressure, and those between the device and the mercury sphygmomanometer were -1.6+/-6.7 for systolic blood pressure and -0.12+/-4.0 mmHg for diastolic blood pressure Readings that differ by less than 5, 10 and 15 mmHg for systolic blood-pressure and diastolic blood-pressure values fulfill the recommendation criteria of the European Society of Hypertension protocol. The Omron M7 (HEM-780-E) device

Prediction of overall survival for metastatic pancreatic cancer: Development and validation of a prognostic nomogram with data from open clinical trial and real-world study.

Science.gov (United States)

Hang, Junjie; Wu, Lixia; Zhu, Lina; Sun, Zhiqiang; Wang, Ge; Pan, Jingjing; Zheng, Suhua; Xu, Kequn; Du, Jiadi; Jiang, Hua

2018-06-01

It is necessary to develop prognostic tools of metastatic pancreatic cancer (MPC) for optimizing therapeutic strategies. Thus, we tried to develop and validate a prognostic nomogram of MPC. Data from 3 clinical trials (NCT00844649, NCT01124786, and NCT00574275) and 133 Chinese MPC patients were used for analysis. The former 2 trials were taken as the training cohort while NCT00574275 was used as the validation cohort. In addition, 133 MPC patients treated in China were taken as the testing cohort. Cox regression model was used to investigate prognostic factors in the training cohort. With these factors, we established a nomogram and verified it by Harrell's concordance index (C-index) and calibration plots. Furthermore, the nomogram was externally validated in the validation cohort and testing cohort. In the training cohort (n = 445), performance status, liver metastasis, Carbohydrate antigen 19-9 (CA19-9) log-value, absolute neutrophil count (ANC), and albumin were independent prognostic factors for overall survival (OS). A nomogram was established with these factors to predict OS and survival probabilities. The nomogram showed an acceptable discrimination ability (C-index: .683) and good calibration, and was further externally validated in the validation cohort (n = 273, C-index: .699) and testing cohort (n = 133, C-index: .653).The nomogram total points (NTP) had the potential to stratify patients into 3-risk groups with median OS of 11.7, 7.0 and 3.7 months (P < .001), respectively. In conclusion, the prognostic nomogram with NTP can predict OS for patients with MPC with considerable accuracy. © 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Measurement of Survival Time in Brachionus Rotifers: Synchronization of Maternal Conditions.

Science.gov (United States)

Kaneko, Gen; Yoshinaga, Tatsuki; Gribble, Kristin E; Welch, David M; Ushio, Hideki

2016-07-22

Rotifers are microscopic cosmopolitan zooplankton used as models in ecotoxicological and aging studies due to their several advantages such as short lifespan, ease of culture, and parthenogenesis that enables clonal culture. However, caution is required when measuring their survival time as it is affected by maternal age and maternal feeding conditions. Here we provide a protocol for powerful and reproducible measurement of the survival time in Brachionus rotifers following a careful synchronization of culture conditions over several generations. Empirically, poor synchronization results in early mortality and a gradual decrease in survival rate, thus resulting in weak statistical power. Indeed, under such conditions, calorie restriction (CR) failed to significantly extend the lifespan of B. plicatilis although CR-induced longevity has been demonstrated with well-synchronized rotifer samples in past and present studies. This protocol is probably useful for other invertebrate models, including the fruitfly Drosophila melanogaster and the nematode Caenorhabditis elegans, because maternal age effects have also been reported in these species.

Validation of the Beurer BM 44 upper arm blood pressure monitor for home measurement, according to the European Society of Hypertension International Protocol 2002.

Science.gov (United States)

Lüders, Stephan; Krüger, Ralf; Zemmrich, Claudia; Forstner, Klaus; Sturm, Claus-Dieter; Bramlage, Peter

2012-12-01

The present study aimed to validate the automated upper arm blood pressure (BP) measuring device BM 44 for home BP monitoring according to the 2002 Protocol of the European Society of Hypertension. The most important new feature of the new device was an integrated 'WHO indicator', which categorizes the patient's individual result within the WHO recommendations for target BP by a coloured scale. Systolic and diastolic BPs were measured sequentially in 35 adult participants (16 men, 19 women) using a standard mercury y-tubed reference sphygmomanometer (two observers) and the BM 44 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 15 participants in phase 1 and a further 18 participants in phase 2 of the validation study. The BM 44 device passed phase 1 of the validation study successfully with a number of absolute differences between device and observers of 5, 10 and 15 mmHg for at least 28 out of 25, 35 out of 35 and 40 out of 40 measurements, respectively. The device also achieved the targets for phases 2.1 and 2.2, with 23 and 26 participants having had at least two of three device-observers differences within 5 mmHg for systolic and diastolic BP, respectively. The Beurer BM 44 upper arm BP monitor has passed the International Protocol requirements, and hence can be recommended for home use in adults. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Predicting environmental aspects of CCSR leachates through the application of scientifically valid leaching protocols

International Nuclear Information System (INIS)

Hassett, D.J.

1993-01-01

The disposal of solid wastes from energy production, particularly solid wastes from coal conversion processes, requires a thorough understanding of the waste material as well as the disposal environment. Many coal conversion solid residues (CCSRs) have chemical, mineralogical, and physical properties advantageous for use as engineering construction materials and in other industrial applications. If disposal is to be the final disposition of CCSRs from any source, the very properties that can make ash useful also contribute to behavior that must be understood for scientifically logical and environmentally responsible disposal. This paper describes the application of scientifically valid leaching and characterization tests designed to predict field phenomena. The key to proper characterization of these unique materials is the recognition of and compensation for the hydration reactions that can occur during long-term leaching. Many of these reactions, such as the formation of the mineral ettringite, can have a profound effect on the concentration of potentially problematic trace elements such as boron, chromium, and selenium. The mobility of these elements, which may be concentrated in CCSRs due to the conversion process, must be properly evaluated for the formation of informed and scientifically sound decisions regarding safe disposal. Groundwater is an extremely important and relatively scarce resource. Contamination of this resource is a threat to life, which is highly dependent on it, so management of materials that can impact groundwater must be carefully planned and executed. The application of scientifically valid leaching protocols and complete testing are critical to proper waste management

Cancer survival for Aboriginal and Torres Strait Islander Australians: a national study of survival rates and excess mortality.

Science.gov (United States)

Condon, John R; Zhang, Xiaohua; Baade, Peter; Griffiths, Kalinda; Cunningham, Joan; Roder, David M; Coory, Michael; Jelfs, Paul L; Threlfall, Tim

2014-01-31

National cancer survival statistics are available for the total Australian population but not Indigenous Australians, although their cancer mortality rates are known to be higher than those of other Australians. We aimed to validate analysis methods and report cancer survival rates for Indigenous Australians as the basis for regular national reporting. We used national cancer registrations data to calculate all-cancer and site-specific relative survival for Indigenous Australians (compared with non-Indigenous Australians) diagnosed in 2001-2005. Because of limited availability of Indigenous life tables, we validated and used cause-specific survival (rather than relative survival) for proportional hazards regression to analyze time trends and regional variation in all-cancer survival between 1991 and 2005. Survival was lower for Indigenous than non-Indigenous Australians for all cancers combined and for many cancer sites. The excess mortality of Indigenous people with cancer was restricted to the first three years after diagnosis, and greatest in the first year. Survival was lower for rural and remote than urban residents; this disparity was much greater for Indigenous people. Survival improved between 1991 and 2005 for non-Indigenous people (mortality decreased by 28%), but to a much lesser extent for Indigenous people (11%) and only for those in remote areas; cancer survival did not improve for urban Indigenous residents. Cancer survival is lower for Indigenous than other Australians, for all cancers combined and many individual cancer sites, although more accurate recording of Indigenous status by cancer registers is required before the extent of this disadvantage can be known with certainty. Cancer care for Indigenous Australians needs to be considerably improved; cancer diagnosis, treatment, and support services need to be redesigned specifically to be accessible and acceptable to Indigenous people.

Validation of the Pangao PG-800A36 automatic wrist blood pressure monitor according to the European Society of Hypertension and the British Hypertension Society protocols.

Science.gov (United States)

Zhao, Hairong; Qiao, Weichang; Zhang, Rui; Cui, Peng; Hou, Fanglin; Zhang, Wenli

2018-02-01

The aim of this study was to validate the PG-800A36 automatic wrist blood pressure monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010 and the British Hypertension Society (BHS) protocols. A total of 33 participants were initially included on the basis of the ESH-IP, followed by examination of 85 participants according to the BHS protocol. The procedures and analysis methods of the protocols were followed precisely with left arm/wrist sequential measurements by two trained observers using a mercury sphygmomanometer and one supervisor using the device. The device passed the ESH-IP with an average difference of 1.45±6.46 mmHg for systolic blood pressure and 1.25±5.10 mmHg for diastolic blood pressure. Furthermore, the A/A grade of the BHS protocol was achieved with an average difference of 1.84±6.94 mmHg for systolic blood pressure and 1.15±6.49 mmHg for diastolic blood pressure, and thus, the device also fulfilled the requirements of the Association for the Advancement of Medical Instrumentation. The Pangao PG-800A36 passed the requirements of the ESH-IP revision 2010 and achieved the A/A grade of the BHS protocol, which can be recommended for self-measurement in the general population.

Multiparametric multidetector computed tomography scanning on suspicion of hyperacute ischemic stroke: validating a standardized protocol

Directory of Open Access Journals (Sweden)

Felipe Torres Pacheco

2013-06-01

Full Text Available Multidetector computed tomography (MDCT scanning has enabled the early diagnosis of hyperacute brain ischemia. We aimed at validating a standardized protocol to read and report MDCT techniques in a series of adult patients. The inter-observer agreement among the trained examiners was tested, and their results were compared with a standard reading. No false positives were observed, and an almost perfect agreement (Kappa>0.81 was documented when the CT angiography (CTA and cerebral perfusion CT (CPCT map data were added to the noncontrast CT (NCCT analysis. The inter-observer agreement was higher for highly trained readers, corroborating the need for specific training to interpret these modern techniques. The authors recommend adding CTA and CPCT to the NCCT analysis in order to clarify the global analysis of structural and hemodynamic brain abnormalities. Our structured report is suitable as a script for the reproducible analysis of the MDCT of patients on suspicion of ischemic stroke.

Method validation in pharmaceutical analysis: from theory to practical optimization

Directory of Open Access Journals (Sweden)

Jaqueline Kaleian Eserian

2015-01-01

Full Text Available The validation of analytical methods is required to obtain high-quality data. For the pharmaceutical industry, method validation is crucial to ensure the product quality as regards both therapeutic efficacy and patient safety. The most critical step in validating a method is to establish a protocol containing well-defined procedures and criteria. A well planned and organized protocol, such as the one proposed in this paper, results in a rapid and concise method validation procedure for quantitative high performance liquid chromatography (HPLC analysis.   Type: Commentary

Validation of the A&D BP UA-651 device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Benetti, Elisabetta; Fania, Claudio; Palatini, Paolo

2014-02-01

The objective of this study was to determine the accuracy of the A&D BP UA-651 device for home blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension. Device evaluation was carried out in 33 patients. The mean age of the patients was 48.3±15.5 years, the mean systolic BP was 138.3±24.9 mmHg (range 90-180), the mean diastolic BP was 88.3±13.8 mmHg (range 60-108), and the mean arm circumference was 28.6±3.4 cm (range 23-36). The protocol requirements were followed precisely. The device passed all requirements, fulfilling the standards of the protocol. On average, the device underestimated the systolic BP by 0.4±4.4 mmHg and diastolic BP by 1.3±3.5 mmHg. The device-observer discrepancies were unrelated to patients' clinical characteristics. These data show that the A&D BP UA-651 device fulfilled the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

Development of a standard communication protocol for an emergency situation management in nuclear power plants

Energy Technology Data Exchange (ETDEWEB)

Kim, Man Cheol, E-mail: charleskim@kaeri.re.k [Integrated Risk Assessment Center, Korea Atomic Energy Research Institute, 150, Deokjin-dong, Yuseong-gu, Daejeon 305-353 (Korea, Republic of); Park, Jinkyun; Jung, Wondea [Integrated Risk Assessment Center, Korea Atomic Energy Research Institute, 150, Deokjin-dong, Yuseong-gu, Daejeon 305-353 (Korea, Republic of); Kim, Hanjeom; Kim, Yoon Joong [YGN Nuclear Power Division Training Center, Korea Hydro and Nuclear Power Company, 517 Kyemari, Hongnong-eup, Yeongkwang-gun, Chonnam 513-880 (Korea, Republic of)

2010-06-15

Correct communication between main control room (MCR) operators is an important factor in the management of emergency situations in nuclear power plants (NPPs). For this reason, a standard communication protocol for the management of emergency situations in NPPs has been developed, with the basic direction of enhancing the safety of NPPs and the standardization of communication protocols. To validate the newly developed standard communication protocol, validation experiments with 10 licensed NPP MCR operator teams was performed. From the validation experiments, it was found that the use of the standard communication protocol required more time, but it can contribute to the enhancement of the safety of NPPs by an operators' better grasp of the safety-related parameters and a more efficient and clearer communication between NPP operators, while imposing little additional workloads on the NPP MCR operators. The standard communication protocol is expected to be used to train existing NPP MCR operators without much aversion, as well as new operators.

Therapeutic efficacy and toxicity of bolus application of chemotherapy protocol in the treatment of metastatic colorectal cancer.

Science.gov (United States)

Šišić, Ibrahim; Pojskić, Belma; Mekić Abazović, Alma; Kovčin, Vladimir

2015-08-01

To compare efficacy and toxicity of bolus application of chemotherapy protocol, oxaliplatin, fluorouracil (bolus), leucovorin (folfox) between two groups of patients in the therapy of metastatic colorectal carcinoma (mCRC). A total of 63 patients were treated for mCRC in the period January 2009 - January 2010 at the Department of Oncology of the Cantonal Hospital Zenica, Bosnia and Herzegovina (first group, 30 patients) and at the Department of Oncology of the Clinical Hospital Centre Bežanijska kosa in Belgrade, Serbia, in the period January 2005 - January 2006 (second group, 33 patients). The patients were treated according the same protocol, i.v. bolus infusion, but in different day intervals (D), 1, 8, 15/28 days or D1-D5/28 days, respectively. In all patients the following factors were analyzed: tumor response, overall survival (OS), progression free survival, hematological and non-hematological toxicity . Colon was the primary localization in almost two thirds of patients. There was no statistically significant difference between the groups according to the age, hematological and non-hematological toxicity, as well as in achieved OS. Progression free survival expressed in months was in average 5 months though with a large range between minimal and maximal survival time. Both groups have shown equivalent efficacy to applied chemotherapy protocols. Overall survival in the two groups matched data from the literature. Further research should confirm success of the combination of chemotherapy protocols and their combination with the biological therapy. Copyright© by the Medical Assotiation of Zenica-Doboj Canton.

Therapeutic efficacy and toxicity of bolus application of chemotherapy protocol in the treatment of metastatic colorectal cancer

Directory of Open Access Journals (Sweden)

Ibrahim Šišić

2015-08-01

Full Text Available Aim To compare efficacy and toxicity of bolus application of chemotherapy protocol, oxaliplatin, fluorouracil (bolus, leucovorin (folfox between two groups of patients in the therapy of metastatic colorectal carcinoma (mCRC. Methods A total of 63 patients were treated for mCRC in the period January 2009 – January 2010 at the Department of Oncology of the Cantonal Hospital Zenica, Bosnia and Herzegovina (first group, 30 patients and at the Department of Oncology of the Clinical Hospital Centre Bežanijska kosa in Belgrade, Serbia, in the period January 2005 – January 2006 (second group, 33 patients. The patients were treated according the same protocol, i.v. bolus infusion, but in different day intervals (D, 1, 8, 15/28 days or D1-D5/28 days, respectively. In all patients the following factors were analyzed: tumor response, overall survival (OS, progression free survival, hematological and non-hematological toxicity. Results Colon was the primary localization in almost two thirds of patients. There was no statistically significant difference between the groups according to the age, hematological and non-hematological toxicity, as well as in achieved OS. Progression free survival expressed in months was in average 5 months though with a large range between minimal and maximal survival time. Conclusion Both groups have shown equivalent efficacy to applied chemotherapy protocols. Overall survival in the two groups matched data from the literature. Further research should confirm success of the combination of chemotherapy protocols and their combination with the biological therapy.

Field Monitoring Protocol. Heat Pump Water Heaters

Energy Technology Data Exchange (ETDEWEB)

Sparn, B. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Earle, L. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Christensen, D. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Maguire, J. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Wilson, E. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Hancock, C. E. [Mountain Energy Partnership, Longmont, CO (United States)

2013-02-01

This document provides a standard field monitoring protocol for evaluating the installed performance of Heat Pump Water Heaters in residential buildings. The report is organized to be consistent with the chronology of field test planning and execution. Research questions are identified first, followed by a discussion of analysis methods, and then the details of measuring the required information are laid out. A field validation of the protocol at a house near the NREL campus is included for reference.

Field Monitoring Protocol: Heat Pump Water Heaters

Energy Technology Data Exchange (ETDEWEB)

Sparn, B.; Earle, L.; Christensen, D.; Maguire, J.; Wilson, E.; Hancock, E.

2013-02-01

This document provides a standard field monitoring protocol for evaluating the installed performance of Heat Pump Water Heaters in residential buildings. The report is organized to be consistent with the chronology of field test planning and execution. Research questions are identified first, followed by a discussion of analysis methods, and then the details of measuring the required information are laid out. A field validation of the protocol at a house near the NREL campus is included for reference.

Comparison of the BPLab® sphygmomanometer for ambulatory blood pressure monitoring with mercury sphygmomanometry in pregnant women: validation study according to the British Hypertension Society protocol

Directory of Open Access Journals (Sweden)

Dorogova IV

2015-04-01

Full Text Available Inna V Dorogova, Elena S Panina Penza Institute of Advanced Training for Physicians, Penza, RussiaAbstract: The purpose of this study was to validate the automated BPLab® sphygmomanometer for ambulatory blood pressure monitoring (ABPM in pregnant women according to Part II of the 1993 British Hypertension Society protocol. Pregnant women attending the antenatal clinic were randomly asked to participate (n=30. The BPLab sphygmomanometer was tested on pregnant women in this study and achieved A/A ratings according to the BHS protocol when compared with the “gold” standard of mercury sphygmomanometry. The device can therefore be recommended for use in pregnancy.Keywords: pregnancy, BPLab, blood pressure measuring

Validation of the A&D BP UB-542 wrist device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Saladini, Francesca; Benetti, Elisabetta; Fania, Claudio; Palatini, Paolo

2013-08-01

The objective of this study was to determine the accuracy of the A&D BP UB-542 wrist device for home blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension (ESH). Device evaluation was carried out in 33 patients. The mean age was 50.9±10.1 years, the mean systolic BP was 141.6±22.8 mmHg (range 92 : 189), the mean diastolic BP was 89.2±11.4 mmHg (range 62 : 120), the mean arm circumference was 28.8±3.2 cm (range 23-35), and the mean wrist circumference was 17.1±1.4 cm (range 14-19.5). The protocol requirements were followed precisely. The device passed all requirements, fulfilling the standards of the protocol. On average, the device overestimated the systolic BP by 1.8±7.2 mmHg and diastolic BP by 1.6±5.7 mmHg. These data show that the A&D BP UB-542 wrist device met the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

Validation of the Andon KD-5917 automatic upper arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Guo, Wan-Gang; Li, Bing-Ling; He, Yong; Xue, Yu-Sheng; Wang, Hai-Yan; Zheng, Qiang-Sun; Xiang, Ding-Cheng

2014-08-01

To validate the Andon KD-5917 automatic upper arm blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. Sequential same-left-arm measurements of systolic blood pressure (SBP) and diastolic blood pressure (DBP) were obtained in 33 participants using the mercury sphygmomanometer and the test device. According to the validation protocol, 99 pairs of test device and reference blood pressure measurements (three pairs for each of the 33 participants) were obtained in the study. The device produced 73, 98, and 99 measurements within 5, 10, and 15 mmHg for SBP and 86, 98, and 99 for DBP, respectively. The mean ± SD device-observer difference was 3.07 ± 3.68 mmHg for SBP and -0.89 ± 3.72 mmHg for DBP. The number of patients with two or three of the device-observer difference within 5 mmHg was 26 for SBP and 29 for DBP, and no patient had a device-observer difference within 5 mmHg. The Andon KD-5917 automatic upper arm blood pressure monitor can be recommended for clinical use and self-measurement in an adult population on the basis of the European Society of Hypertension International Protocol revision 2010.

Bounding the per-protocol effect in randomized trials: An application to colorectal cancer screening

NARCIS (Netherlands)

S.A. Swanson (Sonja); Holme (Øyvind); M. Løberg (Magnus); M. Kalager (Mette); M. Bretthauer (Michael); G. Hoff (G.); E. Aas (Eline); M.A. Hernán (M.)

2015-01-01

textabstractBackground: The per-protocol effect is the effect that would have been observed in a randomized trial had everybody followed the protocol. Though obtaining a valid point estimate for the per-protocol effect requires assumptions that are unverifiable and often implausible, lower and upper

Simulation, calibration and validation protocols for the model 3D-CMCC-CNR-FEM: a case study in the Bonis’ watershed (Calabria, Italy

Directory of Open Access Journals (Sweden)

Collalti A

2017-08-01

Full Text Available Simulation, calibration and validation protocols for the model 3D-CMCC-CNR-FEM: a case study in the Bonis’ watershed (Calabria, Italy. At present, the climate changes issue is perhaps the greatest threat that is affecting people and the environment. Forest ecosystems have a key role in the mitigation of climate change. In this context, the prediction of the evolution and growth dynamics of the forests including carbon and water fluxes, and in relation to forest management has become a primary objective. The present study aims at defining a protocol for data collection and the workflow for using the 3D-CMCC-CNR-FEM model in a small mountain watershed in the Calabria region. Within this work we synergistically integrate data coming from different methods (e.g., LiDAR, eddy covariance and sample area to predict forest dynamics (growth, carbon and water fluxes. Carbon and water fluxes will be simulated considering also the effects of forest management.

Multiprofissional electronic protocol in ophtalmology with enfasis in strabismus.

Science.gov (United States)

Ribeiro, Christie Graf; Moreira, Ana Tereza Ramos; Pinto, José Simão DE Paula; Malafaia, Osvaldo

2016-01-01

to create and validate an electronic database in ophthalmology focused on strabismus, to computerize this database in the form of a systematic data collection software named Electronic Protocol, and to incorporate this protocol into the Integrated System of Electronic Protocols (SINPE(c)). this is a descriptive study, with the methodology divided into three phases: (1) development of a theoretical ophthalmologic database with emphasis on strabismus; (2) computerization of this theoretical ophthalmologic database using SINPE(c) and (3) interpretation of the information with demonstration of results to validate the protocol. We inputed data from the charts of fifty patients with known strabismus through the Electronic Protocol for testing and validation. the new electronic protocol was able to store information regarding patient history, physical examination, laboratory exams, imaging results, diagnosis and treatment of patients with ophthalmologic diseases, with emphasis on strabismus. We included 2,141 items in this master protocol and created 20 new specific electronic protocols for strabismus, each with its own specifics. Validation was achieved through correlation and corroboration of the symptoms and confirmed diagnoses of the fifty included patients with the diagnostic criteria for the twenty new strabismus protocols. a new, validated electronic database focusing on ophthalmology, with emphasis on strabismus, was successfully created through the standardized collection of information, and computerization of the database using proprietary software. This protocol is ready for deployment to facilitate data collection, sorting and application for practitioners and researchers in numerous specialties. criar uma base eletrônica de dados em oftalmologia com ênfase em estrabismo através da coleta padronizada de informações. Informatizar esta base sob a forma de software para a coleta sistemática de dados chamado "Protocolo Eletrônico" e incorporar este

Automatic Traffic-Based Internet Control Message Protocol (ICMP) Model Generation for ns-3

Science.gov (United States)

2015-12-01

more protocols (especially at different layers of the OSI model ), implementing an inference engine to extract inter- and intrapacket dependencies, and...ARL-TR-7543 ● DEC 2015 US Army Research Laboratory Automatic Traffic-Based Internet Control Message Protocol (ICMP) Model ...ICMP) Model Generation for ns-3 by Jaime C Acosta and Felipe Jovel Survivability/Lethality Analysis Directorate, ARL Felipe Sotelo and Caesar

Validation of a novel protocol for calculating estimated energy requirements and average daily physical activity ratio for the US population: 2005-2006.

Science.gov (United States)

Archer, Edward; Hand, Gregory A; Hébert, James R; Lau, Erica Y; Wang, Xuewen; Shook, Robin P; Fayad, Raja; Lavie, Carl J; Blair, Steven N

2013-12-01

To validate the PAR protocol, a novel method for calculating population-level estimated energy requirements (EERs) and average physical activity ratio (APAR), in a nationally representative sample of US adults. Estimates of EER and APAR values were calculated via a factorial equation from a nationally representative sample of 2597 adults aged 20 and 74 years (US National Health and Nutrition Examination Survey; data collected between January 1, 2005, and December 31, 2006). Validation of the PAR protocol-derived EER (EER(PAR)) values was performed via comparison with values from the Institute of Medicine EER equations (EER(IOM)). The correlation between EER(PAR) and EER(IOM) was high (0.98; Pmen to 148 kcal/d (5.7% higher) in obese women. The 2005-2006 EERs for the US population were 2940 kcal/d for men and 2275 kcal/d for women and ranged from 3230 kcal/d in obese (BMI ≥30) men to 2026 kcal/d in normal weight (BMI women. There were significant inverse relationships between APAR and both obesity and age. For men and women, the APAR values were 1.53 and 1.52, respectively. Obese men and women had lower APAR values than normal weight individuals (P¼.023 and P¼.015, respectively) [corrected], and younger individuals had higher APAR values than older individuals (Pphysical activity and health. Copyright © 2013 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

Entanglement distillation protocols and number theory

International Nuclear Information System (INIS)

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

2005-01-01

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 Z D n associated with Bell diagonal states is a module rather than a vector space. We find that a partition of Z D n 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

Quench detection electronics testing protocol for SST-1 magnets

International Nuclear Information System (INIS)

Banaudha, Moni; Varmora, Pankaj; Parghi, Bhadresh; Prasad, Upendra

2017-01-01

Quench Detection (QD) system consisting 204 signal channels has been successfully installed and working well during plasma experiment of SST-1 Tokamak. QD system requires testing, validation and maintenance in every SST-1 campaign for better reliability and maintainability of the system. Standalone test of each channel of the system is essential for hard-ware validation. The standard Testing Protocol follow in every campaign which validate each section of QD electronics as well as voltage tap signal cables which are routed inside the cryostat and then extended outside of the SST-1 machine up-to the magnet control room. Fiber link for Quench signal transmission to the SST-1 magnet power supply is also test and validate before every plasma campaign. Precise instrument used as a dummy source of quench signal and for manual quench generation to test the each channel and Master Quench Logic. Each signal Integrated with the magnet DAQ system, signal observed at 1Hz and 50Hz configuration to validate the logging data, compare with actual and previous test data. This paper describes the testing protocol follow in every campaign to validate functionality of QD electronics, limitation of testing, test results and overall integration of the quench detection system for SST-1 magnet. (author)

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.

Science.gov (United States)

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.

Survival in amyotrophic lateral sclerosis with home mechanical ventilation: the impact of systematic respiratory assessment and bulbar involvement.

Science.gov (United States)

Farrero, Eva; Prats, Enric; Povedano, Mónica; Martinez-Matos, J Antonio; Manresa, Frederic; Escarrabill, Joan

2005-06-01

To analyze (1) the impact of a protocol of early respiratory evaluation of the indications for home mechanical ventilation (HMV) in patients with amyotrophic lateral sclerosis (ALS), and (2) the effects of the protocol and of bulbar involvement on the survival of patients receiving noninvasive ventilation (NIV). Retrospective study in a tertiary care referral center. HMV was indicated in 86 patients with ALS, with 22 patients (25%) presenting with intolerance to treatment associated with bulbar involvement. Treatment with HMV had been initiated in 15 of 64 patients prior to initiating the protocol (group A) and in the remaining 49 patients after protocol initiation (group B). In group A, the majority of patients began treatment with HMV during an acute episode requiring ICU admission (p = 0.001) and tracheal ventilation (p = 0.025), with a lower percentage of patients beginning HMV treatment without respiratory insufficiency (p = 0.013). No significant differences in survival rates were found between groups A and B among patients treated with NIV. Greater survival was observed in group B (p = 0.03) when patients with bulbar involvement were excluded (96%). Patients without bulbar involvement at the start of therapy with NIV presented a significantly better survival rate (p = 0.03). Multivariate analysis showed bulbar involvement to be an independent prognostic factor for survival (relative risk, 1.6; 95% confidence interval, 1.01 to 2.54; p = 0.04). No significant differences in survival were observed between patients with bulbar involvement following treatment with NIV and those with intolerance, except for the subgroup of patients who began NIV treatment with hypercapnia (p = 0.0002). Early systematic respiratory evaluation in patients with ALS is necessary to improve the results of HMV. Further studies are required to confirm the benefits of NIV treatment in patients with bulbar involvement, especially in the early stages.

External Validation Study of First Trimester Obstetric Prediction Models (Expect Study I): Research Protocol and Population Characteristics.

Science.gov (United States)

Meertens, Linda Jacqueline Elisabeth; Scheepers, Hubertina Cj; De Vries, Raymond G; Dirksen, Carmen D; Korstjens, Irene; Mulder, Antonius Lm; Nieuwenhuijze, Marianne J; Nijhuis, Jan G; Spaanderman, Marc Ea; Smits, Luc Jm

2017-10-26

A number of first-trimester prediction models addressing important obstetric outcomes have been published. However, most models have not been externally validated. External validation is essential before implementing a prediction model in clinical practice. The objective of this paper is to describe the design of a study to externally validate existing first trimester obstetric prediction models, based upon maternal characteristics and standard measurements (eg, blood pressure), for the risk of pre-eclampsia (PE), gestational diabetes mellitus (GDM), spontaneous preterm birth (PTB), small-for-gestational-age (SGA) infants, and large-for-gestational-age (LGA) infants among Dutch pregnant women (Expect Study I). The results of a pilot study on the feasibility and acceptability of the recruitment process and the comprehensibility of the Pregnancy Questionnaire 1 are also reported. A multicenter prospective cohort study was performed in The Netherlands between July 1, 2013 and December 31, 2015. First trimester obstetric prediction models were systematically selected from the literature. Predictor variables were measured by the Web-based Pregnancy Questionnaire 1 and pregnancy outcomes were established using the Postpartum Questionnaire 1 and medical records. Information about maternal health-related quality of life, costs, and satisfaction with Dutch obstetric care was collected from a subsample of women. A pilot study was carried out before the official start of inclusion. External validity of the models will be evaluated by assessing discrimination and calibration. Based on the pilot study, minor improvements were made to the recruitment process and online Pregnancy Questionnaire 1. The validation cohort consists of 2614 women. Data analysis of the external validation study is in progress. This study will offer insight into the generalizability of existing, non-invasive first trimester prediction models for various obstetric outcomes in a Dutch obstetric population

In vitro protocol for validating interface pressure sensors for therapeutic compression garments: Importance of sphygmomanometer placement and initial cuff diameter

Directory of Open Access Journals (Sweden)

Inhwa Jung

2018-02-01

Full Text Available An optimal protocol is needed to validate the performance of future interface pressure sensors for compression garments when using a sphygmomanometer. PicoPress® was used on a rigid plastic cylinder (r=4 cm. An FDA-cleared aneroid sphygmomanometer was used to apply pressures from 10-60 mmHg with a diameter of 8 cm or 12 cm placed either beneath the sphygmomanometer’s airbag or fabric cuff. A two-tail t-test was performed (P<0.05 for significance for all applied pressures. PicoPress® outputs vary with sensor placement (airbag vs fabric cuff and the initial cuff diameter. Sensor placement overlying the sphygmomanometer’s fabric cuff compared to the airbag led to significantly higher pressures (37%-135% depending on the cuff diameter size. These differences were nearly all statistically significant (P<0.05. Validation of new interface pressure sensors deploying a sphygmomanometer for calibration should specify the location of sensor placement location and initial diameter with a preference for placement under the airbag.

Validation of the Grandway MD2301 digital automatic blood pressure monitor according to the European Society of Hypertension International Protocol.

Science.gov (United States)

Chen, Wan; Zeng, Zhao-Lin; Bing, Sen; Li, Lin-Yi; Wang, Rui; Wan, Yi

2016-08-01

The aim of the present study was to validate the Grandway MD2301 digital automatic blood pressure monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. The ESH-IP revision 2010 for the validation of blood pressure-measuring devices in adults was followed precisely. Systolic and diastolic blood pressure (SBP and DBP, respectively) were measured sequentially in 33 adult patients and compared with a standard mercury sphygmomanometer (two observers). A total of 99 comparison pairs were obtained. The device produced 78, 95 and 99 measurements within 5, 10, and 15 mmHg for SBP and 83, 96, and 99 for DBP, respectively. The average device-observer difference was -1.81±4.22 mmHg for SBP and -0.15±3.93 mmHg for DBP. All of the data were within the standards requirements to pass the testing. The Grandway MD2301 digital automatic blood pressure monitor meets the standards of the ESH-IP revision 2010 and can be recommended for self/home measurement in the general population.

Specification and Validation of an Edge Router Discovery Protocol for Mobile Ad Hoc Networks

DEFF Research Database (Denmark)

Kristensen, Lars Michael; Jensen, Kurt

2004-01-01

We present an industrial project at Ericsson Telebit A/S where Coloured Petri Nets (CP-nets or CPNs) have been used for the design and specification of an edge router discovery protocol for mobile ad-hoc networks. The Edge Router Discovery Protocol (ERDP) supports an edge router in a stationary...

Validation of two automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension: the Omron M6 (HEM-7001-E) and the Omron R7 (HEM 637-IT).

Science.gov (United States)

Topouchian, Jirar A; El Assaad, Mohamed A; Orobinskaia, Ludmila V; El Feghali, Ramzi N; Asmar, Roland G

2006-06-01

Two electronic devices for self-measurement of blood pressure - a brachial monitor, the Omron M6, and a wrist monitor, the Omron R7 - were evaluated in two separate studies according to the International Protocol of the European Society of Hypertension. The International Validation Protocol is divided into two phases: the first phase is performed on 15 selected participants (45 pairs of blood pressure measurements); if the device passes this phase, 18 supplementary participants are included (54 pairs of blood pressure measurements) making a total number of 33 participants (99 pairs of blood pressure measurements) on whom the final validation is performed. The same methodology recommended by the European Society of Hypertension protocol was applied for both studies. In each study and for each participant, four blood pressure measurements were taken simultaneously by two trained observers using mercury sphygmomanometers alternately with three measurements taken by the tested device. The difference between the blood pressure value given by the device and that obtained by the two observers (mean of the two observers) was calculated for each measure. The 99 pairs of blood pressure differences were classified into three categories (M6 device, and 0.2+/-4.2 and 0.2+/-2.9 mmHg for systolic and diastolic blood pressure, respectively, for the Omron R7 device. For both devices, readings differing by less than 5, 10 and 15 mmHg for systolic and diastolic blood pressure values fulfill the recommendation criteria of the International Protocol as well as the individual analysis. The Omron M6 (HEM-7001-E) and the Omron R7 (HEM 637-IT) devices fulfilled the validation recommendations of the International Protocol.

A Weak Value Based QKD Protocol Robust Against Detector Attacks

Science.gov (United States)

Troupe, James

2015-03-01

We propose a variation of the BB84 quantum key distribution protocol that utilizes the properties of weak values to insure the validity of the quantum bit error rate estimates used to detect an eavesdropper. The protocol is shown theoretically to be secure against recently demonstrated attacks utilizing detector blinding and control and should also be robust against all detector based hacking. Importantly, the new protocol promises to achieve this additional security without negatively impacting the secure key generation rate as compared to that originally promised by the standard BB84 scheme. Implementation of the weak measurements needed by the protocol should be very feasible using standard quantum optical techniques.

Non-invasive transcranial ultrasound therapy based on a 3D CT scan: protocol validation and in vitro results

International Nuclear Information System (INIS)

Marquet, F; Pernot, M; Aubry, J-F; Montaldo, G; Tanter, M; Fink, M; Marsac, L

2009-01-01

A non-invasive protocol for transcranial brain tissue ablation with ultrasound is studied and validated in vitro. The skull induces strong aberrations both in phase and in amplitude, resulting in a severe degradation of the beam shape. Adaptive corrections of the distortions induced by the skull bone are performed using a previous 3D computational tomography scan acquisition (CT) of the skull bone structure. These CT scan data are used as entry parameters in a FDTD (finite differences time domain) simulation of the full wave propagation equation. A numerical computation is used to deduce the impulse response relating the targeted location and the ultrasound therapeutic array, thus providing a virtual time-reversal mirror. This impulse response is then time-reversed and transmitted experimentally by a therapeutic array positioned exactly in the same referential frame as the one used during CT scan acquisitions. In vitro experiments are conducted on monkey and human skull specimens using an array of 300 transmit elements working at a central frequency of 1 MHz. These experiments show a precise refocusing of the ultrasonic beam at the targeted location with a positioning error lower than 0.7 mm. The complete validation of this transcranial adaptive focusing procedure paves the way to in vivo animal and human transcranial HIFU investigations.

Non-invasive transcranial ultrasound therapy based on a 3D CT scan: protocol validation and in vitro results

Energy Technology Data Exchange (ETDEWEB)

Marquet, F; Pernot, M; Aubry, J-F; Montaldo, G; Tanter, M; Fink, M [Laboratoire Ondes et Acoustique, ESPCI, Universite Paris VII, UMR CNRS 7587, 10 rue Vauquelin, 75005 Paris (France); Marsac, L [Supersonic Imagine, Les Jardins de la Duranne, 510 rue Rene Descartes, 13857 Aix-en-Provence (France)], E-mail: fabrice.marquet@espci.org

2009-05-07

A non-invasive protocol for transcranial brain tissue ablation with ultrasound is studied and validated in vitro. The skull induces strong aberrations both in phase and in amplitude, resulting in a severe degradation of the beam shape. Adaptive corrections of the distortions induced by the skull bone are performed using a previous 3D computational tomography scan acquisition (CT) of the skull bone structure. These CT scan data are used as entry parameters in a FDTD (finite differences time domain) simulation of the full wave propagation equation. A numerical computation is used to deduce the impulse response relating the targeted location and the ultrasound therapeutic array, thus providing a virtual time-reversal mirror. This impulse response is then time-reversed and transmitted experimentally by a therapeutic array positioned exactly in the same referential frame as the one used during CT scan acquisitions. In vitro experiments are conducted on monkey and human skull specimens using an array of 300 transmit elements working at a central frequency of 1 MHz. These experiments show a precise refocusing of the ultrasonic beam at the targeted location with a positioning error lower than 0.7 mm. The complete validation of this transcranial adaptive focusing procedure paves the way to in vivo animal and human transcranial HIFU investigations.

A dose-surviving fraction curve for mouse colonic mucosa

International Nuclear Information System (INIS)

Tucker, S.L.; Thames, H.D. Jr.; Withers, H.R.; Mason, K.A.

1983-01-01

A dose-surviving fraction curve representing the response of the mouse colonic mucosa to single doses of 137 Cs gamma radiation was obtained from the results of a multifraction in vivo colony assay. Construction of the curve required an estimated of the average number of clonogens initially present per colonic crypt. The estimated clonogen count (88) was determined by a statistical method based on the use of doses per fraction common to different fractionation protocols. Parameters for the LQ and TC models of cell survival were obtained by weighted least-squares fits to the data. A comparison of the survival characteristics of cells from the mouse colonic and jejunal crypts suggested that the epithelium of the colon is less radiosensitive than that of the jejunum. (author)

Intelligent QoS routing algorithm based on improved AODV protocol for Ad Hoc networks

Science.gov (United States)

Huibin, Liu; Jun, Zhang

2016-04-01

Mobile Ad Hoc Networks were playing an increasingly important part in disaster reliefs, military battlefields and scientific explorations. However, networks routing difficulties are more and more outstanding due to inherent structures. This paper proposed an improved cuckoo searching-based Ad hoc On-Demand Distance Vector Routing protocol (CSAODV). It elaborately designs the calculation methods of optimal routing algorithm used by protocol and transmission mechanism of communication-package. In calculation of optimal routing algorithm by CS Algorithm, by increasing QoS constraint, the found optimal routing algorithm can conform to the requirements of specified bandwidth and time delay, and a certain balance can be obtained among computation spending, bandwidth and time delay. Take advantage of NS2 simulation software to take performance test on protocol in three circumstances and validate the feasibility and validity of CSAODV protocol. In results, CSAODV routing protocol is more adapt to the change of network topological structure than AODV protocol, which improves package delivery fraction of protocol effectively, reduce the transmission time delay of network, reduce the extra burden to network brought by controlling information, and improve the routing efficiency of network.

The EADC-ADNI Harmonized Protocol for manual hippocampal segmentation on magnetic resonance

DEFF Research Database (Denmark)

Frisoni, Giovanni B; Jack, Clifford R; Bocchetta, Martina

2015-01-01

BACKGROUND: An international Delphi panel has defined a harmonized protocol (HarP) for the manual segmentation of the hippocampus on MR. The aim of this study is to study the concurrent validity of the HarP toward local protocols, and its major sources of variance. METHODS: Fourteen tracers segme...

A feeding protocol for delivery of agents to assess development in Varroa mites.

Directory of Open Access Journals (Sweden)

Ana R Cabrera

Full Text Available A novel feeding protocol for delivery of bio-active agents to Varroa mites was developed by providing mites with honey bee larva hemolymph supplemented with cultured insect cells and selected materials delivered on a fibrous cotton substrate. Mites were starved, fed on treated hemolymph to deliver selected agents and then returned to bee larvae. Transcript levels of two reference genes, actin and glyceraldehyde 3-phosphate dehydrogenase (GAPDH, as well as for nine selected genes involved in reproductive processes showed that the starvation and feeding protocol periods did not pose a high level of stress to the mites as transcript levels remained comparable between phoretic mites and those completing the protocol. The feeding protocol was used to deliver molecules such as hormone analogs or plasmids. Mites fed with Tebufenozide, an ecdysone analog, had higher transcript levels of shade than untreated or solvent treated mites. In order to extend this feeding protocol, cultured insect cells were incorporated to a final ratio of 1 part cells and 2 parts hemolymph. Although supplementation with Bombyx mori Bm5 cells increased the amount of hemolymph consumed per mite, there was a significant decrease in the percentage of mites that fed and survived. On the other hand, Drosophila melanogaster S2 cells reduced significantly the percentage of mites that fed and survived as well as the amount of hemolymph consumed. The feeding protocol provides a dynamic platform with which to challenge the Varroa mite to establish efficacy of control agents for this devastating honey bee pest.

Validation of the Pangao PG-800B5 for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Chen, Wan; Zeng, Zhaolin; Li, Lizhi; Wan, Xiaofen; Wan, Yi

2014-10-01

This study aimed to validate the Pangao PG-800B5 upper arm blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. A total of 33 participants, 16 men and 17 women, were included in the device evaluation. The protocol requirements were followed precisely. The mean age of the participants was 56.4±21.0 years (range 22-84 years). The mean systolic blood pressure was 143.6±25.5 mmHg (range 98-188 mmHg), the mean diastolic blood pressure was 85.7±17.2 mmHg (range 49-125 mmHg), and the mean arm circumference was 26.1±2.2 cm (range 23-32 cm). On average, the device overestimated the systolic blood pressure by 0.9±4.2 mmHg and diastolic blood pressure by 0.7±4.5 mmHg. The device passed all requirements, fulfilling the standards of the protocol. Therefore, the Pangao PG-800B5 upper arm blood pressure monitor can be recommended for clinical use and self-measurement in an adult population.

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

Science.gov (United States)

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…

Improving the quality of adult mortality data collected in demographic surveys: validation study of a new siblings' survival questionnaire in Niakhar, Senegal.

Science.gov (United States)

Helleringer, Stéphane; Pison, Gilles; Masquelier, Bruno; Kanté, Almamy Malick; Douillot, Laetitia; Duthé, Géraldine; Sokhna, Cheikh; Delaunay, Valérie

2014-05-01

In countries with limited vital registration, adult mortality is frequently estimated using siblings' survival histories (SSHs) collected during Demographic and Health Surveys (DHS). These data are affected by reporting errors. We developed a new SSH questionnaire, the siblings' survival calendar (SSC). It incorporates supplementary interviewing techniques to limit omissions of siblings and uses an event history calendar to improve reports of dates and ages. We hypothesized that the SSC would improve the quality of adult mortality data. We conducted a retrospective validation study among the population of the Niakhar Health and Demographic Surveillance System in Senegal. We randomly assigned men and women aged 15-59 y to an interview with either the DHS questionnaire or the SSC. We compared SSHs collected in each group to prospective data on adult mortality collected in Niakhar. The SSC reduced respondents' tendency to round reports of dates and ages to the nearest multiple of five or ten ("heaping"). The SSC also had higher sensitivity in recording adult female deaths: among respondents whose sister(s) had died at an adult age in the past 15 y, 89.6% reported an adult female death during SSC interviews versus 75.6% in DHS interviews (p = 0.027). The specificity of the SSC was similar to that of the DHS questionnaire, i.e., it did not increase the number of false reports of deaths. However, the SSC did not improve the reporting of adult deaths among the brothers of respondents. Study limitations include sample selectivity, limited external validity, and multiple testing. The SSC has the potential to collect more accurate SSHs than the questionnaire used in DHS. Further research is needed to assess the effects of the SSC on estimates of adult mortality rates. Additional validation studies should be conducted in different social and epidemiological settings. Controlled-Trials.com ISRCTN06849961

Patients undergoing radical prostatectomy have a better survival than the background population

DEFF Research Database (Denmark)

Andreas Røder, Martin; Brasso, Klaus; Drimer Berg, Kasper

2013-01-01

underwent radical prostatectomy. Patients were followed prospectively per protocol. No patients were lost to follow-up. Overall and cause-specific survival were described using Kaplan-Meier plots. Standardized relative survival and mortality ratio were calculated based on expected survival in the age......INTRODUCTION: The objective of this study was to investigate standardised relative survival and mortality ratio for patients undergoing radical prostatectomy for localized prostate cancer at our institution. MATERIAL AND METHODS: Between 1995 and 2010, a total of 1,350 consecutive patients......-matched Danish population using the methods and macros described by Dickmann. The country-specific population mortality rates used for calculation of the expected survival were based on data from The Human Mortality Database. RESULTS: The median follow-up was 3.4 years (range: 0-14.3 years). A total of 59 (4...

Validation of the CPS + EG Staging System for Disease-Specific Survival in Breast Cancer Patients Treated with Neoadjuvant Chemotherapy.

Science.gov (United States)

Abdelsattar, Jad M; Al-Hilli, Zahraa; Hoskin, Tanya L; Heins, Courtney N; Boughey, Judy C

2016-10-01

CPS + EG staging, which incorporates estrogen receptor (ER) status and tumor grade with pretreatment clinical stage (CS) and post-treatment pathologic stage (PS), has been reported to have better correlation with outcome than classic TNM staging for patients treated with neoadjuvant chemotherapy (NAC). Our goal was to evaluate the performance of CPS + EG staging system in an external cohort treated with NAC. We reviewed patients with stages I-IIIC breast cancer treated with NAC and surgery at our institution between 1988 and 2014. ER status, Nottingham grade, treatment, American Joint Committee on Cancer (AJCC) CS before NAC and PS after NAC, and follow-up data were collected. The discrimination of CPS + EG and pathologic AJCC stage were assessed using area under the curve (AUC) for survival data. A total of 769 patients were analyzed with a median follow-up of 2.6 (range 0.0-19.4) years; 103 patients died of breast cancer. Overall, the 5-year breast cancer cause-specific survival was 81.5 % [95 % confidence interval (CI) 77.6-85.5]. The 5-year, cause-specific survival by CPS + EG score was 93.8 % score 0, 89.9 % score 1, 90.7 % score 2, 84.8 % score 3, 67.7 % score 4, and 43.4 % score 5/6. CPS + EG score was significantly associated with cause-specific survival (p < 0.001) with an AUC of 0.69 (95 % CI 0.62-0.77) at 5 years. This was higher than the AUC of 0.63 (95 % CI 0.56-0.70) for AJCC PS (p = 0.10). This study validates the CPS + EG staging system using Nottingham grade in an external cohort. Addition of tumor biology and treatment response shows promise in improving survival estimates for patients treated with NAC.

The Surviving Sepsis Campaign: Where have we been and where are we going?

Science.gov (United States)

Dellinger, R Phillip

2015-04-01

The Surviving Sepsis Campaign develops and promotes evidence-based guidelines and performance-improvement practices aimed at reducing deaths from sepsis worldwide. The most recent guidelines, published in 2013, provide detailed management strategies for acute care, fluid resuscitation, and vasopressor use. In addition, the campaign has developed simple, short protocols for what to do within 3 and 6 hours of recognition of sepsis. These protocols are associated with reduced mortality rates. Copyright © 2015 Cleveland Clinic.

Long-term outcome of intensive initial immunosuppression protocol in pediatric deceased donor renal transplantation.

LENUS (Irish Health Repository)

Olaitan, Oyedolamu K

2010-02-01

To report the long-term outcome of deceased donor kidney transplantation in children with emphasis on the use of an intensive initial immunosuppression protocol using R-ATG as antibody induction. Between January 1991 and December 1997, 82 deceased donor kidney transplantations were performed in 75 pediatric recipients. Mean recipient age at transplantation was 12.9 yr and the mean follow-up period was 12.6 yr. All patients received quadruple immunosuppression with steroid, cyclosporine, azathioprine, and antibody induction using R-ATG-Fresenius. Actual one, five, and 10 yr patient survival rates were 99%, 97%, and 94%, respectively; only one patient (1.2%) developed PTLD. Actual one, five, and 10 yr overall graft survival rates were 84%, 71%, and 50%, respectively; there were five cases (6%) of graft thrombosis and the actual immunological graft survival rates were 91%, 78%, and 63% at one, five, and 10 yr, respectively. The use of an intensive initial immunosuppression protocol with R-ATG as antibody induction is safe and effective in pediatric recipients of deceased donor kidneys with excellent immunological graft survival without an increase in PTLD or other neoplasms over a minimum 10-yr follow up.

Efficacy of post operative adjuvant therapy with human interferon beta, MCNU and radiation (IMR) for malignant glioma: comparison among three protocols

International Nuclear Information System (INIS)

Hatano, N.; Wakabayashi, T.; Kajita, Y.; Mizuno, M.; Ohno, T.; Nakayashiki, N.; Takemura, A.; Yoshida, J.

2000-01-01

In order to develop ultimate adjuvant therapy for malignant gliomas, we analyzed 77 patients with malignant gliomas (29 anaplastic astrocytomas (AAs) and 48 glioblastoma multiformes (GMs)) treated by three protocols of IMR therapy (human interferon-beta (HuIFN-β), MCNU and radiation). In protocol 1 (n = 45 : AA = 13, GM = 32), 1 x 10 6 IU of HuIFN-β was administrated intravenously once a day for 7 days. On day 2, MCNU was administrated at a dose of 2 mg/kg b.w. intravenously and from day 3, radiation was started in five weekly fractions of 2 Gy for 6 weeks. Total dose was 60 Gy. Protocol 2 (n = 19 : AA = 11, GM = 8) was comparable with protocol 1 except HuIFN-β was administrated twice a day at a dose of 1 x 10 6 IU each. Protocol 3 (n = 13 : AA = 5, GM = 8) differed from protocol 2 only in a high dose-hyperfractionated radiation which was given twice a day at a dose of 1.5 Gy each and for a total dose of 66 Gy. Antitumor effects were evaluated by survival and response rate determined by decrease of tumor size. Significant improvement was obtained in patients with AAs by protocol 2 and 3. Response rates of patients with AAs and GMs were 46.2 % and 50 % in protocol 1, 63.6 % and 50 % in protocol 2, and 80 % and 50 % in protocol 3, respectively. One and two year survival rates in AAs were 46.4 % and 34.8 % in protocol 1, both 75 % in protocol 2, and both 100 % in protocol 3. Survival rates in GMs were not different among them. Except of radiation necrosis, which was observed in 38.5 % of the patients under protocol 3, there was no significant difference in the adverse effects among the three protocols. In the present study, the efficacy of IMR therapy for patients with malignant gliomas, especially for AAs, was confirmed. We conclude that twice a day administrations of HuIFN-β in combination with a high dose-hyperfractionated radiation provide increased efficacy in IMR therapy. (author)

Predicting Overall Survival After Stereotactic Ablative Radiation Therapy in Early-Stage Lung Cancer: Development and External Validation of the Amsterdam Prognostic Model

Energy Technology Data Exchange (ETDEWEB)

Louie, Alexander V., E-mail: Dr.alexlouie@gmail.com [Department of Radiation Oncology, VU University Medical Center, Amsterdam (Netherlands); Department of Radiation Oncology, London Regional Cancer Program, University of Western Ontario, London, Ontario (Canada); Department of Epidemiology, Harvard School of Public Health, Harvard University, Boston, Massachusetts (United States); Haasbeek, Cornelis J.A. [Department of Radiation Oncology, VU University Medical Center, Amsterdam (Netherlands); Mokhles, Sahar [Department of Cardio-Thoracic Surgery, Erasmus University Medical Center, Rotterdam (Netherlands); Rodrigues, George B. [Department of Radiation Oncology, London Regional Cancer Program, University of Western Ontario, London, Ontario (Canada); Stephans, Kevin L. [Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio (United States); Lagerwaard, Frank J. [Department of Radiation Oncology, VU University Medical Center, Amsterdam (Netherlands); Palma, David A. [Department of Radiation Oncology, London Regional Cancer Program, University of Western Ontario, London, Ontario (Canada); Videtic, Gregory M.M. [Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio (United States); Warner, Andrew [Department of Radiation Oncology, London Regional Cancer Program, University of Western Ontario, London, Ontario (Canada); Takkenberg, Johanna J.M. [Department of Cardio-Thoracic Surgery, Erasmus University Medical Center, Rotterdam (Netherlands); Reddy, Chandana A. [Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio (United States); Maat, Alex P.W.M. [Department of Cardio-Thoracic Surgery, Erasmus University Medical Center, Rotterdam (Netherlands); Woody, Neil M. [Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio (United States); Slotman, Ben J.; Senan, Suresh [Department of Radiation Oncology, VU University Medical Center, Amsterdam (Netherlands)

2015-09-01

Purpose: A prognostic model for 5-year overall survival (OS), consisting of recursive partitioning analysis (RPA) and a nomogram, was developed for patients with early-stage non-small cell lung cancer (ES-NSCLC) treated with stereotactic ablative radiation therapy (SABR). Methods and Materials: A primary dataset of 703 ES-NSCLC SABR patients was randomly divided into a training (67%) and an internal validation (33%) dataset. In the former group, 21 unique parameters consisting of patient, treatment, and tumor factors were entered into an RPA model to predict OS. Univariate and multivariate models were constructed for RPA-selected factors to evaluate their relationship with OS. A nomogram for OS was constructed based on factors significant in multivariate modeling and validated with calibration plots. Both the RPA and the nomogram were externally validated in independent surgical (n=193) and SABR (n=543) datasets. Results: RPA identified 2 distinct risk classes based on tumor diameter, age, World Health Organization performance status (PS) and Charlson comorbidity index. This RPA had moderate discrimination in SABR datasets (c-index range: 0.52-0.60) but was of limited value in the surgical validation cohort. The nomogram predicting OS included smoking history in addition to RPA-identified factors. In contrast to RPA, validation of the nomogram performed well in internal validation (r{sup 2}=0.97) and external SABR (r{sup 2}=0.79) and surgical cohorts (r{sup 2}=0.91). Conclusions: The Amsterdam prognostic model is the first externally validated prognostication tool for OS in ES-NSCLC treated with SABR available to individualize patient decision making. The nomogram retained strong performance across surgical and SABR external validation datasets. RPA performance was poor in surgical patients, suggesting that 2 different distinct patient populations are being treated with these 2 effective modalities.

DESCQA: Synthetic Sky Catalog Validation Framework

Science.gov (United States)

Mao, Yao-Yuan; Uram, Thomas D.; Zhou, Rongpu; Kovacs, Eve; Ricker, Paul M.; Kalmbach, J. Bryce; Padilla, Nelson; Lanusse, François; Zu, Ying; Tenneti, Ananth; Vikraman, Vinu; DeRose, Joseph

2018-04-01

The DESCQA framework provides rigorous validation protocols for assessing the quality of high-quality simulated sky catalogs in a straightforward and comprehensive way. DESCQA enables the inspection, validation, and comparison of an inhomogeneous set of synthetic catalogs via the provision of a common interface within an automated framework. An interactive web interface is also available at portal.nersc.gov/project/lsst/descqa.

External validation and newly development of a nomogram to predict overall survival of abiraterone-treated, castration-resistant patients with metastatic prostate cancer

Directory of Open Access Journals (Sweden)

Yun-Jie Yang

2018-01-01

Full Text Available Abiraterone acetate is approved for the treatment of castration-resistant prostate cancer (CRPC; however, its effects vary. An accurate prediction model to identify patient groups that will benefit from abiraterone treatment is therefore urgently required. The Chi model exhibits a good profile for risk classification, although its utility for the chemotherapy-naive group is unclear. This study aimed to externally validate the Chi model and develop a new nomogram to predict overall survival (OS. We retrospectively analyzed a cohort of 110 patients. Patients were distributed among good-, intermediate-, and poor-risk groups, according to the Chi model. The good-, intermediate-, and poor-risk groups had a sample size of 59 (53.6%, 34 (30.9%, and 17 (15.5% in our dataset, and a median OS of 48.4, 29.1, and 10.5 months, respectively. The C-index of external validation of Chi model was 0.726. Univariate and multivariate analyses identified low hemoglobin concentrations (<110 g l−1, liver metastasis, and a short time interval from androgen deprivation therapy to abiraterone initiation (<36 months as predictors of OS. Accordingly, a new nomogram was developed with a C-index equal to 0.757 (95% CI, 0.678–0.836. In conclusion, the Chi model predicted the prognosis of abiraterone-treated, chemotherapy-naive patients with mCRPC, and we developed a new nomogram to predict the overall survival of this group of patients with less parameters.

A calibration protocol for population-specific accelerometer cut-points in children.

Science.gov (United States)

Mackintosh, Kelly A; Fairclough, Stuart J; Stratton, Gareth; Ridgers, Nicola D

2012-01-01

To test a field-based protocol using intermittent activities representative of children's physical activity behaviours, to generate behaviourally valid, population-specific accelerometer cut-points for sedentary behaviour, moderate, and vigorous physical activity. Twenty-eight children (46% boys) aged 10-11 years wore a hip-mounted uniaxial GT1M ActiGraph and engaged in 6 activities representative of children's play. A validated direct observation protocol was used as the criterion measure of physical activity. Receiver Operating Characteristics (ROC) curve analyses were conducted with four semi-structured activities to determine the accelerometer cut-points. To examine classification differences, cut-points were cross-validated with free-play and DVD viewing activities. Cut-points of ≤ 372, >2160 and >4806 counts • min(-1) representing sedentary, moderate and vigorous intensity thresholds, respectively, provided the optimal balance between the related needs for sensitivity (accurately detecting activity) and specificity (limiting misclassification of the activity). Cross-validation data demonstrated that these values yielded the best overall kappa scores (0.97; 0.71; 0.62), and a high classification agreement (98.6%; 89.0%; 87.2%), respectively. Specificity values of 96-97% showed that the developed cut-points accurately detected physical activity, and sensitivity values (89-99%) indicated that minutes of activity were seldom incorrectly classified as inactivity. The development of an inexpensive and replicable field-based protocol to generate behaviourally valid and population-specific accelerometer cut-points may improve the classification of physical activity levels in children, which could enhance subsequent intervention and observational studies.

A calibration protocol for population-specific accelerometer cut-points in children.

Directory of Open Access Journals (Sweden)

Kelly A Mackintosh

Full Text Available To test a field-based protocol using intermittent activities representative of children's physical activity behaviours, to generate behaviourally valid, population-specific accelerometer cut-points for sedentary behaviour, moderate, and vigorous physical activity.Twenty-eight children (46% boys aged 10-11 years wore a hip-mounted uniaxial GT1M ActiGraph and engaged in 6 activities representative of children's play. A validated direct observation protocol was used as the criterion measure of physical activity. Receiver Operating Characteristics (ROC curve analyses were conducted with four semi-structured activities to determine the accelerometer cut-points. To examine classification differences, cut-points were cross-validated with free-play and DVD viewing activities.Cut-points of ≤ 372, >2160 and >4806 counts • min(-1 representing sedentary, moderate and vigorous intensity thresholds, respectively, provided the optimal balance between the related needs for sensitivity (accurately detecting activity and specificity (limiting misclassification of the activity. Cross-validation data demonstrated that these values yielded the best overall kappa scores (0.97; 0.71; 0.62, and a high classification agreement (98.6%; 89.0%; 87.2%, respectively. Specificity values of 96-97% showed that the developed cut-points accurately detected physical activity, and sensitivity values (89-99% indicated that minutes of activity were seldom incorrectly classified as inactivity.The development of an inexpensive and replicable field-based protocol to generate behaviourally valid and population-specific accelerometer cut-points may improve the classification of physical activity levels in children, which could enhance subsequent intervention and observational studies.

Validation of the Andon KD-5965 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Huang, Jinhua; Li, Zhijie; Li, Guimei; Liu, Zhaoying

2015-10-01

This study aimed to evaluate the accuracy of the Andon KD-5965 upper-arm blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adults, with 20 women using a mercury sphygmomanometer (two observers) and the Andon KD-5965 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and observers within 5, 10, and 15 mmHg was 70/99, 91/99, and 98/99, respectively, for systolic blood pressure and 81/99, 99/99, and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Twenty-five and 29 participants, for systolic and diastolic blood pressure, respectively, had at least two of the three device-observers differences within 5 mmHg (required≥24). Two and one participants for systolic and diastolic blood pressure, respectively, had all three device-observers comparisons greater than 5 mmHg. According to the validation results, with better performance for diastolic blood pressure than that for systolic blood pressure, the Andon automated oscillometric upper-arm blood pressure monitor KD-5965 fulfilled the requirements of the European Society of Hypertension International Protocol revision 2010, and hence can be recommended for blood pressure measurement in adults.

Analytical validation of a flow cytometric protocol for quantification of platelet microparticles in dogs.

Science.gov (United States)

Cremer, Signe E; Krogh, Anne K H; Hedström, Matilda E K; Christiansen, Liselotte B; Tarnow, Inge; Kristensen, Annemarie T

2018-06-01

Platelet microparticles (PMPs) are subcellular procoagulant vesicles released upon platelet activation. In people with clinical diseases, alterations in PMP concentrations have been extensively investigated, but few canine studies exist. This study aims to validate a canine flow cytometric protocol for PMP quantification and to assess the influence of calcium on PMP concentrations. Microparticles (MP) were quantified in citrated whole blood (WB) and platelet-poor plasma (PPP) using flow cytometry. Anti-CD61 antibody and Annexin V (AnV) were used to detect platelets and phosphatidylserine, respectively. In 13 healthy dogs, CD61 + /AnV - concentrations were analyzed with/without a calcium buffer. CD61 + /AnV - , CD61 + /AnV + , and CD61 - /AnV + MP quantification were validated in 10 healthy dogs. The coefficient of variation (CV) for duplicate (intra-assay) and parallel (inter-assay) analyses and detection limits (DLs) were calculated. CD61 + /AnV - concentrations were higher in calcium buffer; 841,800 MP/μL (526,000-1,666,200) vs without; 474,200 MP/μL (278,800-997,500), P < .05. In WB, PMP were above DLs and demonstrated acceptable (<20%) intra-assay and inter-assay CVs in 9/10 dogs: 1.7% (0.5-8.9) and 9.0% (0.9-11.9), respectively, for CD61 + /AnV - and 2.4% (0.2-8.7) and 7.8% (0.0-12.8), respectively, for CD61 + /AnV + . Acceptable CVs were not seen for the CD61 - /AnV + MP. In PPP, quantifications were challenged by high inter-assay CV, overlapping DLs and hemolysis and lipemia interfered with quantification in 5/10 dogs. Calcium induced higher in vitro PMP concentrations, likely due to platelet activation. PMP concentrations were reliably quantified in WB, indicating the potential for clinical applications. PPP analyses were unreliable due to high inter-CV and DL overlap, and not obtainable due to hemolysis and lipemia interference. © 2018 American Society for Veterinary Clinical Pathology.

Molecular Signature for Lymphatic Invasion Associated with Survival of Epithelial Ovarian Cancer.

Science.gov (United States)

Paik, E Sun; Choi, Hyun Jin; Kim, Tae-Joong; Lee, Jeong-Won; Kim, Byoung-Gie; Bae, Duk-Soo; Choi, Chel Hun

2018-04-01

We aimed to develop molecular classifier that can predict lymphatic invasion and their clinical significance in epithelial ovarian cancer (EOC) patients. We analyzed gene expression (mRNA, methylated DNA) in data from The Cancer Genome Atlas. To identify molecular signatures for lymphatic invasion, we found differentially expressed genes. The performance of classifier was validated by receiver operating characteristics analysis, logistic regression, linear discriminant analysis (LDA), and support vector machine (SVM). We assessed prognostic role of classifier using random survival forest (RSF) model and pathway deregulation score (PDS). For external validation,we analyzed microarray data from 26 EOC samples of Samsung Medical Center and curatedOvarianData database. We identified 21 mRNAs, and seven methylated DNAs from primary EOC tissues that predicted lymphatic invasion and created prognostic models. The classifier predicted lymphatic invasion well, which was validated by logistic regression, LDA, and SVM algorithm (C-index of 0.90, 0.71, and 0.74 for mRNA and C-index of 0.64, 0.68, and 0.69 for DNA methylation). Using RSF model, incorporating molecular data with clinical variables improved prediction of progression-free survival compared with using only clinical variables (p < 0.001 and p=0.008). Similarly, PDS enabled us to classify patients into high-risk and low-risk group, which resulted in survival difference in mRNA profiles (log-rank p-value=0.011). In external validation, gene signature was well correlated with prediction of lymphatic invasion and patients' survival. Molecular signature model predicting lymphatic invasion was well performed and also associated with survival of EOC patients.

Hyperfractionated Accelerated Radiotherapy (HART) for Anaplastic Thyroid Carcinoma: Toxicity and Survival Analysis

Energy Technology Data Exchange (ETDEWEB)

Dandekar, Prasad [Head and Neck/Thyroid Unit, Royal Marsden NHS Foundation Trust, Sutton, Surrey (United Kingdom); Harmer, Clive; Barbachano, Yolanda [Department of Clinical Research and Development, Royal Marsden NHS Foundation Trust, Sutton, Surrey (United Kingdom); Rhys-Evans, Peter; Harrington, Kevin; Nutting, Christopher [Head and Neck-Thyroid Unit, Royal Marsden NHS Foundation Trust, Chelsea, London (United Kingdom); Newbold, Kate [Head and Neck/Thyroid Unit, Royal Marsden NHS Foundation Trust, Sutton, Surrey (United Kingdom); Consultant Clinical Oncologist, Royal Marsden NHS Foundation Trust, Chelsea, London (United Kingdom)

2009-06-01

Purpose: Anaplastic thyroid carcinoma (ATC) is one of the most aggressive cancers, and the current protocol of hyperfractionated accelerated radiotherapy was initiated to improve survival while limiting toxicities. Methods and Materials: All patients with ATC from 1991 to 2002 were accrued and received megavoltage radiotherapy from the mastoid processes to the carina up to 60 Gy in twice-daily fractions of 1.8 and 2 Gy, 6 hours apart. Results: Thirty-one patients were accrued with a median age of 69 years, and 55% were women. Debulking was performed in 26%, and total thyroidectomy, in 6%, whereas 68% received radical radiotherapy alone. Local control data were available for 27 patients: 22% had a complete response, 26% had a partial response, 15% showed progressive disease, and 37% showed static disease. Median overall survival for all 31 patients was 70 days (95% confidence interval, 40-99). There was no significant difference in median survival between patients younger (70 days) and older than 70 years (42 days), between men (70 days) and women (49days), and between patients receiving postoperative radiotherapy (77 days) and radical radiotherapy alone (35 days). Grade III or higher skin erythema was seen in 56% patients; desquamation in 21%; dysphagia in 74%; and esophagitis in 79%. Conclusion: The current protocol failed to offer a significant survival benefit, was associated with severe toxicities, and thus was discontinued. There is a suggestion that younger patients with operable disease have longer survival, but this would require a larger study to confirm it.

A differential centrifugation protocol and validation criterion for enhancing mass spectrometry (MALDI-TOF) results in microbial identification using blood culture growth bottles.

Science.gov (United States)

March-Rosselló, G A; Muñoz-Moreno, M F; García-Loygorri-Jordán de Urriés, M C; Bratos-Pérez, M A

2013-05-01

Matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry (MALDI-TOF) is a widely used tool in clinical microbiology for rapidly identifying microorganisms. This technique can be applied directly on positive blood cultures without the need for its culturing, thereby, reducing the time required for microbiological diagnosis. The present study proposes an innovative identification protocol applied to positive blood culture bottles using MALDI-TOF. We have processed 100 positive blood culture bottles, of which 36 of 37 Gram-negative bacteria (97.3 %) were correctly identified directly with 100 % of Enterobacteriaceae and other Gram-negative rods and 87.5 % of non-fermenting Gram-negative rods. We also correctly identified directly 62 of 63 of Gram-positive bacteria (98.4 %) with 100 % of Streptococcus, Enterococcus, and Gram-positive bacilli and 98 % of Staphylococcus. Applying the differential centrifugation protocol at the moment the automatic blood culture incubation system gives a positive reading together with the proposed validation criterion offers 98 % sensitivity (95 % confidence interval: 95.2-100 %). The MALDI-TOF system, thus, provides a rapid and reliable system for identifying microorganisms from blood culture growth bottles.

Performance of an easy-to-use prediction model for renal patient survival: an external validation study using data from the ERA-EDTA Registry.

Science.gov (United States)

Hemke, Aline C; Heemskerk, Martin B A; van Diepen, Merel; Kramer, Anneke; de Meester, Johan; Heaf, James G; Abad Diez, José Maria; Torres Guinea, Marta; Finne, Patrik; Brunet, Philippe; Vikse, Bjørn E; Caskey, Fergus J; Traynor, Jamie P; Massy, Ziad A; Couchoud, Cécile; Groothoff, Jaap W; Nordio, Maurizio; Jager, Kitty J; Dekker, Friedo W; Hoitsma, Andries J

2018-01-16

An easy-to-use prediction model for long-term renal patient survival based on only four predictors [age, primary renal disease, sex and therapy at 90 days after the start of renal replacement therapy (RRT)] has been developed in The Netherlands. To assess the usability of this model for use in Europe, we externally validated the model in 10 European countries. Data from the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Registry were used. Ten countries that reported individual patient data to the registry on patients starting RRT in the period 1995-2005 were included. Patients prediction model was evaluated for the 10- (primary endpoint), 5- and 3-year survival predictions by assessing the calibration and discrimination outcomes. We used a data set of 136 304 patients from 10 countries. The calibration in the large and calibration plots for 10 deciles of predicted survival probabilities showed average differences of 1.5, 3.2 and 3.4% in observed versus predicted 10-, 5- and 3-year survival, with some small variation on the country level. The concordance index, indicating the discriminatory power of the model, was 0.71 in the complete ERA-EDTA Registry cohort and varied according to country level between 0.70 and 0.75. A prediction model for long-term renal patient survival developed in a single country, based on only four easily available variables, has a comparably adequate performance in a wide range of other European countries. © The Author(s) 2018. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Monitoring System with Two Central Facilities Protocol

Directory of Open Access Journals (Sweden)

Caesar Firdaus

2017-03-01

Full Text Available The security of data and information on government’s information system required proper way of defending against threat. Security aspect can be achieved by using cryptography algorithm, applying information hiding concept, and implementing security protocol. In this research, two central facilities protocol was implemented on Research and Development Center of Mineral and Coal Technology’s Cooperation Contract Monitoring System by utilizing AES and whitespace manipulation algorithm. Adjustment on the protocol by creating several rule of validation ID’s generation and checking processes could fulfill two of four cryptography objectives, consist of authentication and non-repudiation. The solid collaboration between central legitimization agency (CLA, central tabulating facility (CTF, and client is the main idea in two central facilities protocol. The utilization of AES algorithm could defend the data on transmission from man in the middle attack scenario. On the other hand, whitespace manipulation algorithm provided data integrity aspect of the document that is uploaded to the system itself. Both of the algorithm fulfill confidentiality, data integrity, and authentication.

Improving an Anonymous and Provably Secure Authentication Protocol for a Mobile User

Directory of Open Access Journals (Sweden)

Jongho Moon

2017-01-01

Full Text Available Recently many authentication protocols using an extended chaotic map were suggested for a mobile user. Many researchers demonstrated that authentication protocol needs to provide key agreement, mutual authentication, and user anonymity between mobile user and server and resilience to many possible attacks. In this paper, we cautiously analyzed chaotic-map-based authentication scheme and proved that it is still insecure to off-line identity guessing, user and server impersonation, and on-line identity guessing attacks. To address these vulnerabilities, we proposed an improved protocol based on an extended chaotic map and a fuzzy extractor. We proved the security of the proposed protocol using a random oracle and AVISPA (Automated Validation of Internet Security Protocols and Applications tool. Furthermore, we present an informal security analysis to make sure that the improved protocol is invulnerable to possible attacks. The proposed protocol is also computationally efficient when compared to other previous protocols.

Validation of the Kingyield BP210 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension-International Protocol.

Science.gov (United States)

Zeng, Wei-Fang; Huang, Qi-Fang; Sheng, Chang-Sheng; Li, Yan; Wang, Ji-Guang

2012-02-01

The present study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor BP210 for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese participants (21 women, 51 years of mean age) using a mercury sphygmomanometer (two observers) and the BP210 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 15 participants in phase 1 and a further 18 participants in phase 2 of the validation study. Data analysis was conducted using the ESHIP analyzer. The BP210 device successfully passed phase 1 of the validation study with a number of absolute differences between device and observers within 5, 10, and 15 mmHg for at least 33/45, 44/45, and 44/45 measurements, respectively. The device also achieved the targets for phase 2.1, with 77/99, 95/99, and 97/99 differences within 5, 10, and 15 mmHg, respectively for systolic blood pressure, and with 78/99, 97/99, and 99/99 within 5, 10, and 15 mmHg, respectively for diastolic blood pressure. In phase 2.2, 29 and 25 participants had at least two of the three device-observers differences within 5 mmHg (required≥22) for systolic blood pressure and diastolic blood pressure, respectively. The Kingyield wrist blood pressure monitor BP210 has passed the International Protocol requirements, and hence can be recommended for home use in adults.

The effects of sequential versus concurrent chemotherapy and radiotherapy on survival and toxicity in patients with newly diagnosed high-grade astrocytoma

International Nuclear Information System (INIS)

Kleinberg, Lawrence; Grossman, Stuart A.; Piantadosi, Steven; Zeltzman, Michel; Wharam, Moody

1999-01-01

Purpose: To determine the effects of sequential versus concurrent administration of cranial radiotherapy and cisplatin/carmustine (BCNU) chemotherapy on survival and toxicity in newly diagnosed high-grade astrocytomas. Methods and Materials: From 1988 to 1996, 101 patients were treated on 2 therapeutic protocols for malignant glioma that used the identical chemotherapy regimen but differed in the timing of cranial radiotherapy. The eligibility criteria for the 2 protocols were identical. In the first protocol (1988-1991, 52 patients), cisplatin 120 mg/BCNU 120 mg i.v. over 72 h, was given for 3 monthly cycles prior to cranial radiotherapy. After a response rate of 42%, with a median survival of 13 months was achieved with this sequential regimen, a successor protocol (1992-1996, 49 patients) was developed in which cranial radiotherapy began concurrently with the start of the identical chemotherapy regimen. Chemotherapy was delayed but not discontinued if prolonged grade III/IV hematologic toxicity was experienced, but protocol therapy was discontinued if disease progression or thromboembolic events occurred. Survival outcome and hematologic toxicity were compared for the patients treated on these protocols. Results: Seventy-seven percent of sequentially-treated patients and 68% of concurrently-treated patients completed all planned therapy. Kaplan-Meier survival was similar to concurrent or sequential administration of chemotherapy and radiotherapy (median 12.8 months vs. 13.8 months, respectively). Hematologic toxicity was significantly less in sequentially- versus concurrently-treated patients, with median nadir per cycle (2.9 vs. 1.8 x 10 3 /mm 3 ) (p < 0.001), and incidence of grade 3/4 leukopenia 40% versus 77% (p = 0.002). There was also an increase in platelet transfusion requirements in concurrently-treated patients, but no significant worsening of anemia. We postulate that the worsened leukopenia results from the effects of concurrent radiotherapy on

Validation of the iHealth BP7 wrist blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Wang, Qing; Zhao, Huadong; Chen, Wan; Li, Ni; Wan, Yi

2014-02-01

The aim of this study was to validate the iHealth BP7 wireless wrist blood pressure monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. A total of 99 pairs of test device and reference blood pressure measurements (three pairs for each of the 33 participants) were obtained for validation. The ESH-IP revision 2010 for the validation of blood pressure measuring devices in adults was followed precisely. The device produced 66, 87, and 97 measurements within 5, 10, and 15 mmHg for systolic blood pressure (SBP) and 72, 93, and 99 mmHg for diastolic blood pressure (DBP), respectively. The mean±SD device-observer difference was -0.7±6.9 mmHg for SBP and -1.0±5.1 mmHg for DBP. The number of participants with two or three device-observer differences within 5 mmHg was 25 for SBP and 26 for DBP; furthermore, there were three participants for SBP and one participant for DBP, with none of the device-observer differences within 5 mmHg. On the basis of the validation results, the iHealth BP7 wireless wrist blood pressure monitor can be recommended for self-measurement in an adult population.

Energy-Aware Routing Protocol for Ad Hoc Wireless Sensor Networks

Directory of Open Access Journals (Sweden)

Mann Raminder P

2005-01-01

Full Text Available Wireless ad hoc sensor networks differ from wireless ad hoc networks from the following perspectives: low energy, lightweight routing protocols, and adaptive communication patterns. This paper proposes an energy-aware routing protocol (EARP suitable for ad hoc wireless sensor networks and presents an analysis for its energy consumption in various phases of route discovery and maintenance. Based on the energy consumption associated with route request processing, EARP advocates the minimization of route requests by allocating dynamic route expiry times. This paper introduces a unique mechanism for estimation of route expiry time based on the probability of route validity, which is a function of time, number of hops, and mobility parameters. In contrast to AODV, EARP reduces the repeated flooding of route requests by maintaining valid routes for longer durations.

A Secure Simplification of the PKMv2 Protocol in IEEE 802.16e-2005

DEFF Research Database (Denmark)

Yuksel, Ender; Nielson, Hanne Riis; Nielsen, Christoffer Rosenkilde

2007-01-01

Static analysis is successfully used for automatically validating security properties of classical cryptographic protocols. In this paper, we shall employ the same technique to a modern security protocol for wireless networks, namely the latest version of the Privacy and Key Management protocol...... for IEEE 802.16e, PKMv2. This protocol seems to have an exaggerated mixture of security features. Thus, we iteratively investigate which components are necessary for upholding the security properties and which can be omitted safely. This approach is based on the LySa process calculus and employs...

Improving the Quality of Adult Mortality Data Collected in Demographic Surveys: Validation Study of a New Siblings' Survival Questionnaire in Niakhar, Senegal

Science.gov (United States)

Helleringer, Stéphane; Pison, Gilles; Masquelier, Bruno; Kanté, Almamy Malick; Douillot, Laetitia; Duthé, Géraldine; Sokhna, Cheikh; Delaunay, Valérie

2014-01-01

Background In countries with limited vital registration, adult mortality is frequently estimated using siblings' survival histories (SSHs) collected during Demographic and Health Surveys (DHS). These data are affected by reporting errors. We developed a new SSH questionnaire, the siblings' survival calendar (SSC). It incorporates supplementary interviewing techniques to limit omissions of siblings and uses an event history calendar to improve reports of dates and ages. We hypothesized that the SSC would improve the quality of adult mortality data. Methods and Findings We conducted a retrospective validation study among the population of the Niakhar Health and Demographic Surveillance System in Senegal. We randomly assigned men and women aged 15–59 y to an interview with either the DHS questionnaire or the SSC. We compared SSHs collected in each group to prospective data on adult mortality collected in Niakhar. The SSC reduced respondents' tendency to round reports of dates and ages to the nearest multiple of five or ten (“heaping”). The SSC also had higher sensitivity in recording adult female deaths: among respondents whose sister(s) had died at an adult age in the past 15 y, 89.6% reported an adult female death during SSC interviews versus 75.6% in DHS interviews (p = 0.027). The specificity of the SSC was similar to that of the DHS questionnaire, i.e., it did not increase the number of false reports of deaths. However, the SSC did not improve the reporting of adult deaths among the brothers of respondents. Study limitations include sample selectivity, limited external validity, and multiple testing. Conclusions The SSC has the potential to collect more accurate SSHs than the questionnaire used in DHS. Further research is needed to assess the effects of the SSC on estimates of adult mortality rates. Additional validation studies should be conducted in different social and epidemiological settings. Trial Registration Controlled-Trials.com ISRCTN06849961

Validation of Land Surface Temperature from Sentinel-3

Science.gov (United States)

Ghent, D.

2017-12-01

One of the main objectives of the Sentinel-3 mission is to measure sea- and land-surface temperature with high-end accuracy and reliability in support of environmental and climate monitoring in an operational context. Calibration and validation are thus key criteria for operationalization within the framework of the Sentinel-3 Mission Performance Centre (S3MPC). Land surface temperature (LST) has a long heritage of satellite observations which have facilitated our understanding of land surface and climate change processes, such as desertification, urbanization, deforestation and land/atmosphere coupling. These observations have been acquired from a variety of satellite instruments on platforms in both low-earth orbit and in geostationary orbit. Retrieval accuracy can be a challenge though; surface emissivities can be highly variable owing to the heterogeneity of the land, and atmospheric effects caused by the presence of aerosols and by water vapour absorption can give a bias to the underlying LST. As such, a rigorous validation is critical in order to assess the quality of the data and the associated uncertainties. Validation of the level-2 SL_2_LST product, which became freely available on an operational basis from 5th July 2017 builds on an established validation protocol for satellite-based LST. This set of guidelines provides a standardized framework for structuring LST validation activities. The protocol introduces a four-pronged approach which can be summarised thus: i) in situ validation where ground-based observations are available; ii) radiance-based validation over sites that are homogeneous in emissivity; iii) intercomparison with retrievals from other satellite sensors; iv) time-series analysis to identify artefacts on an interannual time-scale. This multi-dimensional approach is a necessary requirement for assessing the performance of the LST algorithm for the Sea and Land Surface Temperature Radiometer (SLSTR) which is designed around biome

Validation of the Omron M6 (HEM-7001-E) upper-arm blood pressure measuring device according to the International Protocol in adults and obese adults.

Science.gov (United States)

Altunkan, Sekip; Ilman, Nevzat; Kayatürk, Nur; Altunkan, Erkan

2007-08-01

Electronic blood pressure (BP) measurement devices are the preferred choice of patients owing to their user-friendly nature; however, there is a requirement to investigate the accuracy and reliability of these devices. The objective of this study is to evaluate the accuracy of the Omron M6 upper-arm BP device against the mercury sphygmomanometer in adults and obese adults according to the International Protocol criteria. One hundred and twenty-one patients, older than 30 years of age, were studied and classified on the basis of the range of the International Protocol. BP measurements at the upper arm with the Omron M6 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential BP measurements were taken. A total of 33 participants were selected for each validation study. During the validation study, 99 measurements were performed on 33 participants for comparison. The first phase was performed on 15 participants, and if the device passed this phase, 18 more participants were selected. Having a two-fold purpose, this study was conducted on both adult and obese adult patients. Mean discrepancies and standard deviations of the monitor-mercury sphygmomanometer were 1.1+/-4.0 mmHg for systolic BP (SBP) and -0.5+/-3.5 mmHg for diastolic BP (DBP) in the adult group. The device passed phase 1 in 15 participants. In phase 2.1, out of a total of 99 comparisons, 88, 96, and 97 for SBP, and 88, 98, and 99 for DBP were M6 automatic monitor, which measures BP at the upper arm, produced results in accordance with the criteria of phases 2.1 and 2.2 in both SBP and DBP, when applied to adults and to obese adults. It was concluded that the Omron M6 device, which measures BP at the upper arm, was deemed to be in accordance with the International Protocol criteria and can be recommended for use by adults and obese adults.

The reliability and validity of fatigue measures during multiple-sprint work: an issue revisited.

Science.gov (United States)

Glaister, Mark; Howatson, Glyn; Pattison, John R; McInnes, Gill

2008-09-01

The ability to repeatedly produce a high-power output or sprint speed is a key fitness component of most field and court sports. The aim of this study was to evaluate the validity and reliability of eight different approaches to quantify this parameter in tests of multiple-sprint performance. Ten physically active men completed two trials of each of two multiple-sprint running protocols with contrasting recovery periods. Protocol 1 consisted of 12 x 30-m sprints repeated every 35 seconds; protocol 2 consisted of 12 x 30-m sprints repeated every 65 seconds. All testing was performed in an indoor sports facility, and sprint times were recorded using twin-beam photocells. All but one of the formulae showed good construct validity, as evidenced by similar within-protocol fatigue scores. However, the assumptions on which many of the formulae were based, combined with poor or inconsistent test-retest reliability (coefficient of variation range: 0.8-145.7%; intraclass correlation coefficient range: 0.09-0.75), suggested many problems regarding logical validity. In line with previous research, the results support the percentage decrement calculation as the most valid and reliable method of quantifying fatigue in tests of multiple-sprint performance.

Formal Specification and Description Language and Message Sequence Chart to Model and Validate Session Initiation Protocol Services

OpenAIRE

Sa'ed Abed; Mohammad H. Al Shayeji; Ovais Ahmed; Sahel Alouneh

2016-01-01

Session Initiation Protocol (SIP) is a signaling layer protocol for building, adjusting and ending sessions among participants including Internet conferences, telephone calls and multimedia distribution. SIP facilitates user movement by proxying and forwarding requests to the present location of the user. In this paper, we provide a formal Specification and Description Language (SDL) and Message Sequence Chart (MSC) to model and define the Internet Engineering Task Force (IETF) SIP protocol a...

A new score predicting the survival of patients with spinal cord compression from myeloma

International Nuclear Information System (INIS)

Douglas, Sarah; Schild, Steven E; Rades, Dirk

2012-01-01

This study was performed to create and validate a scoring system for the survival of patients with malignant spinal cord compression (SCC) from myeloma. Of the entire cohort (N = 216), 108 patients were assigned to a test group and 108 patients to a validation group. In the test group, nine pre-treatment factors including age, gender, Eastern Cooperative Oncology Group performance status (ECOG-PS), number of involved vertebrae, ambulatory status prior to radiotherapy, other bone lesions, extraosseous lesions, interval from first diagnosis of myeloma to radiotherapy of SCC, and the time developing motor deficits were retrospectively analyzed. On univariate analysis, improved survival was associated with ECOG-PS 1–2 (p = 0.006), being ambulatory (p = 0.005), and absence of other bone lesions (p = 0.019). On multivariate analysis, ECOG-PS (p = 0.036) and ambulatory status (p = 0.037) were significant; other bone lesions showed a strong trend (p = 0.06). These factors were included in the score. The score for each factor was determined by dividing the 12-month survival rate (in%) by 10. The total risk score was the sum of the three factor scores and ranged from 19 to 24 points. Three prognostic groups were designed with the following 12-month survival rates: 49% for 19–20 points, 74% for 21–23 points, and 93% for 24 points (p = 0.002). In the validation group, the 12-month survival rates were 51%, 80%, and 90%, respectively (p < 0.001). This score appears reproducible, because the 12-month survival rates of both the test and the validation group were very similar. This new survival score can help personalize the treatment of patients with SCC from myeloma and can be of benefit when counseling patients

A Robust PCR Protocol for HIV Drug Resistance Testing on Low-Level Viremia Samples

Directory of Open Access Journals (Sweden)

Shivani Gupta

2017-01-01

Full Text Available The prevalence of drug resistance (DR mutations in people with HIV-1 infection, particularly those with low-level viremia (LLV, supports the need to improve the sensitivity of amplification methods for HIV DR genotyping in order to optimize antiretroviral regimen and facilitate HIV-1 DR surveillance and relevant research. Here we report on a fully validated PCR-based protocol that achieves consistent amplification of the protease (PR and reverse transcriptase (RT regions of HIV-1 pol gene across many HIV-1 subtypes from LLV plasma samples. HIV-spiked plasma samples from the External Quality Assurance Program Oversight Laboratory (EQAPOL, covering various HIV-1 subtypes, as well as clinical specimens were used to optimize and validate the protocol. Our results demonstrate that this protocol has a broad HIV-1 subtype coverage and viral load span with high sensitivity and reproducibility. Moreover, the protocol is robust even when plasma sample volumes are limited, the HIV viral load is unknown, and/or the HIV subtype is undetermined. Thus, the protocol is applicable for the initial amplification of the HIV-1 PR and RT genes required for subsequent genotypic DR assays.

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

Science.gov (United States)

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.

ARQ Protocols in Cognitive Decode-and-Forward Relay Networks: Opportunities Gain

Directory of Open Access Journals (Sweden)

Zongsheng Zhang

2015-04-01

Full Text Available In this paper, two novel automatic-repeat-request (ARQ based protocols were proposed, which exploit coop- eration opportunity inherent in secondary retransmission to create access opportunities. If the signal was not decoded correctly in destination, another user can be acted as a relay to reduce retransmission rounds by relaying the signal. For comparison, we also propose a Direct ARQ Protocol. Specif- ically, we derive the exact closed-form outage probability of three protocols, which provides an effective means to evalu- ate the effects of several parameters. Moreover, we propose a new metric to evaluate the performance improvement for cognitive networks. Finally, Monte Carlo simulations were presented to validate the theory analysis, and a comparison is made among the three protocols.

Wireless Power Transfer Protocols in Sensor Networks: Experiments and Simulations

Directory of Open Access Journals (Sweden)

Sotiris Nikoletseas

2017-04-01

Full Text Available Rapid technological advances in the domain of Wireless Power Transfer pave the way for novel methods for power management in systems of wireless devices, and recent research works have already started considering algorithmic solutions for tackling emerging problems. In this paper, we investigate the problem of efficient and balanced Wireless Power Transfer in Wireless Sensor Networks. We employ wireless chargers that replenish the energy of network nodes. We propose two protocols that configure the activity of the chargers. One protocol performs wireless charging focused on the charging efficiency, while the other aims at proper balance of the chargers’ residual energy. We conduct detailed experiments using real devices and we validate the experimental results via larger scale simulations. We observe that, in both the experimental evaluation and the evaluation through detailed simulations, both protocols achieve their main goals. The Charging Oriented protocol achieves good charging efficiency throughout the experiment, while the Energy Balancing protocol achieves a uniform distribution of energy within the chargers.

Development of a likelihood of survival scoring system for hospitalized equine neonates using generalized boosted regression modeling.

Directory of Open Access Journals (Sweden)

Katarzyna A Dembek

Full Text Available BACKGROUND: Medical management of critically ill equine neonates (foals can be expensive and labor intensive. Predicting the odds of foal survival using clinical information could facilitate the decision-making process for owners and clinicians. Numerous prognostic indicators and mathematical models to predict outcome in foals have been published; however, a validated scoring method to predict survival in sick foals has not been reported. The goal of this study was to develop and validate a scoring system that can be used by clinicians to predict likelihood of survival of equine neonates based on clinical data obtained on admission. METHODS AND RESULTS: Data from 339 hospitalized foals of less than four days of age admitted to three equine hospitals were included to develop the model. Thirty seven variables including historical information, physical examination and laboratory findings were analyzed by generalized boosted regression modeling (GBM to determine which ones would be included in the survival score. Of these, six variables were retained in the final model. The weight for each variable was calculated using a generalized linear model and the probability of survival for each total score was determined. The highest (7 and the lowest (0 scores represented 97% and 3% probability of survival, respectively. Accuracy of this survival score was validated in a prospective study on data from 283 hospitalized foals from the same three hospitals. Sensitivity, specificity, positive and negative predictive values for the survival score in the prospective population were 96%, 71%, 91%, and 85%, respectively. CONCLUSIONS: The survival score developed in our study was validated in a large number of foals with a wide range of diseases and can be easily implemented using data available in most equine hospitals. GBM was a useful tool to develop the survival score. Further evaluations of this scoring system in field conditions are needed.

Evaluation of the efficacy and toxicity of protocol cisplatin, 5-fluorouracil, leucovorin compared to protocol fluorouracil, doxorubicin and mitomycin C in locally advanced and metastatic gastric cancer

Directory of Open Access Journals (Sweden)

Andrić Zoran

2012-01-01

Full Text Available Introduction. Still there is no consensus on the choice of the most efficient and the least toxic chemotherapy regimen in the treatment of advanced gastric cancer. Nowadays few therapy protocols are available for treating this disease. Objective. Study was conducted to compare the efficacy and toxicity of FAM (flurouracil, doxorubicin, mitomycin C with CDDP and FU/FA (cisplatin, 5-fluorouracil, leucovorin protocols in patients with locally advanced and metastatic gastric cancer. Methods. This randomized study involved a group of 50 patients with locally advanced or metastatic gastric cancer, who had not previously undergone chemotherapy treatment. Progression free survival, overall survival and drug toxicity were evaluated. For statistical analysis chi-square test, Kaplan-Meier curve and the log rank test were used. Results. The overall response rate was 20% in the group treated with FAM and 24% in the group treated with CDDP, FU/FA (4% of patients from each group had complete response, but without significant statistical difference. Median survival was 10.9 months in the FAM group and 11.8 months in CDDP, FU/FA group, with no statistically significant difference. Non-haematological and haematological toxicities of CDDP, FU/FA were considerably less frequent than of FAM, and there was no treatment related deaths in any of the groups. Conclusion. Both investigated regimens demonstrated moderate efficacy. The study shows in favour of justified application of both protocols, while in regard to toxicity CDDP and FU/FA can be recommended as preferable treatment for locally advanced and metastatic gastric cancer. New strategies should be considered for better efficacy in the treatment of advanced gastric cancer. New strategies are necessary with the goal to achieve a better therapeutic effect.

Validation of the SCIAN LD-735 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Kang, Yuan-Yuan; Chen, Qi; Li, Yan; Wang, Ji-Guang

2016-08-01

This study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor SCIAN LD-735 for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were measured sequentially in 33 adult Chinese participants (10 women, mean age 44.8 years) using a mercury sphygmomanometer (two observers) and the SCIAN LD-735 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The SCIAN LD-735 device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 86/99, 97/99, and 98/99, respectively, for systolic blood pressure and 85/99, 98/99, and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. In total, 30 and 33 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observer differences within 5 mmHg (required ≥24). No participant had all of the three device-observer comparisons greater than 5 mmHg for systolic or diastolic blood pressure. The SCIAN wrist blood pressure monitor LD-735 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.

Validation of the AVITA BPM17 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Kang, Yuan-Yuan; Chen, Qi; Liu, Chang-Yuan; Li, Yan; Wang, Ji-Guang

2017-08-01

The aim of the present study was to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor AVITA BPM17 for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese (19 men, 45.7 years of mean age) using a mercury sphygmomanometer (two observers) and the AVITA BPM17 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The AVITA BPM17 device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 94/99, 98/99, and 98/99, respectively, for systolic blood pressure and 92/99, 99/99, and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Overall, 32 participants for both systolic and diastolic blood pressure, respectively, had at least two of the three device-observerss differences within 5 mmHg (required ≥24). None had all the three device-observers comparisons greater than 5 mmHg for systolic and diastolic blood pressure. The AVITA wrist blood pressure monitor BPM17 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.

Evaluating the predictive accuracy and the clinical benefit of a nomogram aimed to predict survival in node-positive prostate cancer patients: External validation on a multi-institutional database.

Science.gov (United States)

Bianchi, Lorenzo; Schiavina, Riccardo; Borghesi, Marco; Bianchi, Federico Mineo; Briganti, Alberto; Carini, Marco; Terrone, Carlo; Mottrie, Alex; Gacci, Mauro; Gontero, Paolo; Imbimbo, Ciro; Marchioro, Giansilvio; Milanese, Giulio; Mirone, Vincenzo; Montorsi, Francesco; Morgia, Giuseppe; Novara, Giacomo; Porreca, Angelo; Volpe, Alessandro; Brunocilla, Eugenio

2018-04-06

To assess the predictive accuracy and the clinical value of a recent nomogram predicting cancer-specific mortality-free survival after surgery in pN1 prostate cancer patients through an external validation. We evaluated 518 prostate cancer patients treated with radical prostatectomy and pelvic lymph node dissection with evidence of nodal metastases at final pathology, at 10 tertiary centers. External validation was carried out using regression coefficients of the previously published nomogram. The performance characteristics of the model were assessed by quantifying predictive accuracy, according to the area under the curve in the receiver operating characteristic curve and model calibration. Furthermore, we systematically analyzed the specificity, sensitivity, positive predictive value and negative predictive value for each nomogram-derived probability cut-off. Finally, we implemented decision curve analysis, in order to quantify the nomogram's clinical value in routine practice. External validation showed inferior predictive accuracy as referred to in the internal validation (65.8% vs 83.3%, respectively). The discrimination (area under the curve) of the multivariable model was 66.7% (95% CI 60.1-73.0%) by testing with receiver operating characteristic curve analysis. The calibration plot showed an overestimation throughout the range of predicted cancer-specific mortality-free survival rates probabilities. However, in decision curve analysis, the nomogram's use showed a net benefit when compared with the scenarios of treating all patients or none. In an external setting, the nomogram showed inferior predictive accuracy and suboptimal calibration characteristics as compared to that reported in the original population. However, decision curve analysis showed a clinical net benefit, suggesting a clinical implication to correctly manage pN1 prostate cancer patients after surgery. © 2018 The Japanese Urological Association.

The Verex Blockchain: A Non-Anonymous Decentralized Ledger with an Assigned-Majority-Validation Consensus Protocol

OpenAIRE

Jill, Deane E.

2018-01-01

A useful blockchain should possess the following properties, one or more of which many existing blockchain systems lack: 1) A sound consensus protocol. 2) An efficient transaction-processing system. 3) Immutability of history. 4) Decentralization. 5) An effective avenue for hard-forks and rule changes. We propose a system named the “Verex Blockchain” that will fulfill these requirements. This system employs an “Assigned-Majority-Validation” consensus protocol whereby only nodes within a speci...

Performance Analysis of Untraceability Protocols for Mobile Agents Using an Adaptable Framework

OpenAIRE

LESZCZYNA RAFAL; GORSKI Janusz Kazimierz

2006-01-01

Recently we had proposed two untraceability protocols for mobile agents and began investigating their quality. We believe that quality evaluation of security protocols should extend a sole validation of their security and cover other quality aspects, primarily their efficiency. Thus after conducting a security analysis, we wanted to complement it with a performance analysis. For this purpose we developed a performance evaluation framework, which, as we realised, with certain adjustments, can ...

Development and validation of an OECD reproductive toxicity test guideline with the pond snail Lymnaea stagnalis (Mollusca, Gastropoda).

Science.gov (United States)

Ducrot, Virginie; Askem, Clare; Azam, Didier; Brettschneider, Denise; Brown, Rebecca; Charles, Sandrine; Coke, Maïra; Collinet, Marc; Delignette-Muller, Marie-Laure; Forfait-Dubuc, Carole; Holbech, Henrik; Hutchinson, Thomas; Jach, Arne; Kinnberg, Karin L; Lacoste, Cédric; Le Page, Gareth; Matthiessen, Peter; Oehlmann, Jörg; Rice, Lynsey; Roberts, Edward; Ruppert, Katharina; Davis, Jessica Elphinstone; Veauvy, Clemence; Weltje, Lennart; Wortham, Ruth; Lagadic, Laurent

2014-12-01

The OECD test guideline development program has been extended in 2011 to establish a partial life-cycle protocol for assessing the reproductive toxicity of chemicals to several mollusk species, including the great pond snail Lymnaea stagnalis. In this paper, we summarize the standard draft protocol for a reproduction test with this species, and present inter-comparison results obtained in a 56-day prevalidation ring-test using this protocol. Seven European laboratories performed semi-static tests with cultured snails of the strain Renilys® exposed to nominal concentrations of cadmium chloride (from 53 to 608μgCdL(-1)). Cd concentrations in test solutions were analytically determined to confirm accuracy in the metal exposure concentrations in all laboratories. Physico-chemical and biological validity criteria (namely dissolved oxygen content >60% ASV, water temperature 20±1°C, control snail survival >80% and control snail fecundity >8 egg-masses per snail over the test period) were met in all laboratories which consistently demonstrated the reproductive toxicity of Cd in snails using the proposed draft protocol. Effect concentrations for fecundity after 56days were reproducible between laboratories (68validation ring-test involving 14 laboratories in Europe, North- and South-America is currently being implemented using four chemicals (Cd, prochloraz, trenbolone

Diagnostic PCR: validation and sample preparation are two sides of the same coin

DEFF Research Database (Denmark)

Hoorfar, Jeffrey; Wolffs, Petra; Radstrøm, Peter

2004-01-01

Increased use of powerful PCR technology for the routine detection of pathogens has focused attention on the need for international validation and preparation of official non-commercial guidelines. Bacteria of epidemiological importance should be the prime focus, although a "validation...... of quantitative reference DNA material and reagents, production of stringent protocols and tools for thermal cycler performance testing, uncomplicated sample preparation techniques, and extensive ring trials for assessment of the efficacy of selected matrix/pathogen detection protocols....

Outcomes of Optimized over Standard Protocol of Rabbit Antithymocyte Globulin for Severe Aplastic Anemia: A Single-Center Experience

Science.gov (United States)

Ge, Meili; Shao, Yingqi; Huang, Jinbo; Huang, Zhendong; Zhang, Jing; Nie, Neng; Zheng, Yizhou

2013-01-01

Background Previous reports showed that outcome of rabbit antithymocyte globulin (rATG) was not satisfactory as the first-line therapy for severe aplastic anemia (SAA). We explored a modifying schedule of administration of rATG. Design and Methods Outcomes of a cohort of 175 SAA patients, including 51 patients administered with standard protocol (3.55 mg/kg/d for 5 days) and 124 cases with optimized protocol (1.97 mg/kg/d for 9 days) of rATG plus cyclosporine (CSA), were analyzed retrospectively. Results Of all 175 patients, response rates at 3 and 6 months were 36.6% and 56.0%, respectively. 51 cases received standard protocol had poor responses at 3 (25.5%) and 6 months (41.2%). However, 124 patients received optimized protocol had better responses at 3 (41.1%, P = 0.14) and 6 (62.1%, P = 0.01). Higher incidences of infection (57.1% versus 37.9%, P = 0.02) and early mortality (17.9% versus 0.8%, P<0.001) occurred in patients received standard protocol compared with optimized protocol. The 5-year overall survival in favor of the optimized over standard rATG protocol (76.0% versus. 50.3%, P<0.001) was observed. By multivariate analysis, optimized protocol (RR = 2.21, P = 0.04), response at 3 months (RR = 10.31, P = 0.03) and shorter interval (<23 days) between diagnosis and initial dose of rATG (RR = 5.35, P = 0.002) were independent favorable predictors of overall survival. Conclusions Optimized instead of standard rATG protocol in combination with CSA remained efficacious as a first-line immunosuppressive regimen for SAA. PMID:23554855

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

Science.gov (United States)

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.

Development of a protocol that allows safe consumption of the hypoallergenic apple cultivar Santana

OpenAIRE

Maas, van der, M.P.; Schenk, M.F.

2009-01-01

The apple (Malus ×domestica) cultivar Santana was shown to have a low allergenicity in a previously reported clinical trial. A protocol was developed to validate these results outside a clinical setting and to market the Santana as a hypoallergenic apple for large-scale consumption. This protocol was designed to ensure safe consumption of the Santana by consumers suffering from apple allergy. We tested the protocol in a pilot in 100 supermarket stores and evaluated in an internet-based survey...

A guideline for the validation of likelihood ratio methods used for forensic evidence evaluation.

Science.gov (United States)

Meuwly, Didier; Ramos, Daniel; Haraksim, Rudolf

2017-07-01

This Guideline proposes a protocol for the validation of forensic evaluation methods at the source level, using the Likelihood Ratio framework as defined within the Bayes' inference model. In the context of the inference of identity of source, the Likelihood Ratio is used to evaluate the strength of the evidence for a trace specimen, e.g. a fingermark, and a reference specimen, e.g. a fingerprint, to originate from common or different sources. Some theoretical aspects of probabilities necessary for this Guideline were discussed prior to its elaboration, which started after a workshop of forensic researchers and practitioners involved in this topic. In the workshop, the following questions were addressed: "which aspects of a forensic evaluation scenario need to be validated?", "what is the role of the LR as part of a decision process?" and "how to deal with uncertainty in the LR calculation?". The questions: "what to validate?" focuses on the validation methods and criteria and "how to validate?" deals with the implementation of the validation protocol. Answers to these questions were deemed necessary with several objectives. First, concepts typical for validation standards [1], such as performance characteristics, performance metrics and validation criteria, will be adapted or applied by analogy to the LR framework. Second, a validation strategy will be defined. Third, validation methods will be described. Finally, a validation protocol and an example of validation report will be proposed, which can be applied to the forensic fields developing and validating LR methods for the evaluation of the strength of evidence at source level under the following propositions. Copyright © 2016. Published by Elsevier B.V.

The INCA trial (Impact of NOD2 genotype-guided antibiotic prevention on survival in patients with liver Cirrhosis and Ascites): study protocol for a randomized controlled trial.

Science.gov (United States)

Casper, Markus; Mengel, Martin; Fuhrmann, Christine; Herrmann, Eva; Appenrodt, Beate; Schiedermaier, Peter; Reichert, Matthias; Bruns, Tony; Engelmann, Cornelius; Grünhage, Frank; Lammert, Frank

2015-03-08

Patients with liver cirrhosis have a highly elevated risk of developing bacterial infections that significantly decrease survival rates. One of the most relevant infections is spontaneous bacterial peritonitis (SBP). Recently, NOD2 germline variants were found to be potential predictors of the development of infectious complications and mortality in patients with cirrhosis. The aim of the INCA (Impact of NOD2 genotype-guided antibiotic prevention on survival in patients with liver Cirrhosis and Ascites) trial is to investigate whether survival of this genetically defined high-risk group of patients with cirrhosis defined by the presence of NOD2 variants is improved by primary antibiotic prophylaxis of SBP. The INCA trial is a double-blind, placebo-controlled clinical trial with two parallel treatment arms (arm 1: norfloxacin 400 mg once daily; arm 2: placebo once daily; 12-month treatment and observational period). Balanced randomization of 186 eligible patients with stratification for the protein content of the ascites (INCA trial is first in the field of hepatology aimed at rapidly transferring and validating information on individual genetic risk into clinical decision algorithms. German Clinical Trials Register DRKS00005616 . Registered 22 January 2014. EU Clinical Trials Register EudraCT 2013-001626-26 . Registered 26 January 2015.

A new scoring system for predicting survival in patients with non-small cell lung cancer

International Nuclear Information System (INIS)

Schild, Steven E; Tan, Angelina D; Wampfler, Jason A; Ross, Helen J; Yang, Ping; Sloan, Jeff A

2015-01-01

This analysis was performed to create a scoring system to estimate the survival of patients with non-small cell lung cancer (NSCLC). Data from 1274 NSCLC patients were analyzed to create and validate a scoring system. Univariate (UV) and multivariate (MV) Cox models were used to evaluate the prognostic importance of each baseline factor. Prognostic factors that were significant on both UV and MV analyses were used to develop the score. These included quality of life, age, performance status, primary tumor diameter, nodal status, distant metastases, and smoking cessation. The score for each factor was determined by dividing the 5-year survival rate (%) by 10 and summing these scores to form a total score. MV models and the score were validated using bootstrapping with 1000 iterations from the original samples. The score for each prognostic factor ranged from 1 to 7 points with higher scores reflective of better survival. Total scores (sum of the scores from each independent prognostic factor) of 32–37 correlated with a 5-year survival of 8.3% (95% CI = 0–17.1%), 38–43 correlated with a 5-year survival of 20% (95% CI = 13–27%), 44–47 correlated with a 5-year survival of 48.3% (95% CI = 41.5–55.2%), 48–49 correlated to a 5-year survival of 72.1% (95% CI = 65.6–78.6%), and 50–52 correlated to a 5-year survival of 84.7% (95% CI = 79.6–89.8%). The bootstrap method confirmed the reliability of the score. Prognostic factors significantly associated with survival on both UV and MV analyses were used to construct a valid scoring system that can be used to predict survival of NSCLC patients. Optimally, this score could be used when counseling patients, and designing future trials

Treatment of feline lymphoma using a 12-week, maintenance-free combination chemotherapy protocol in 26 cats.

Science.gov (United States)

Limmer, S; Eberle, N; Nerschbach, V; Nolte, I; Betz, D

2016-08-01

The aim of this prospective clinical trial was to investigate the efficacy and toxicity of a short-term, maintenance-free chemotherapy protocol in feline lymphoma. Twenty-six cats with confirmed diagnosis of high-/intermediate-grade lymphoma were treated with a 12-week protocol consisting of cyclic administration of l-asparaginase, vincristine, cyclophosphamide, doxorubicin and prednisolone. Complete (CR) and partial remission (PR) rates were 46 and 27%, respectively. Median duration of first CR was 394 days compared with a median PR duration of 41 days. No factor was identified to significantly influence the likelihood to reach CR. Overall survival amounted to 78 days (range: 9-2230 days). Median survival in CR cats was 454 days and in PR cats was 82 days. Toxicosis was mainly low grade with anorexia seen most frequently. In cats achieving CR, maintenance-free chemotherapy may be sufficient to attain long-term remission and survival. Factors aiding in prognosticating the likelihood for CR, strategies enhancing response and targeting chemotherapy-induced anorexia need to be identified in future. © 2014 John Wiley & Sons Ltd.

Prediction of survival after surgery due to skeletal metastases in the extremities

DEFF Research Database (Denmark)

Sørensen, M S; Gerds, T A; Hindsø, K

2016-01-01

metastases and American Society of Anaesthesiologist's score were included into a series of logistic regression models. The outcome was the survival status at three, six and 12 months respectively. Results were internally validated based on 1000 cross-validations and reported as time-dependent area under...

Hopping control channel MAC protocol for opportunistic spectrum access networks

Institute of Scientific and Technical Information of China (English)

FU Jing-tuan; JI Hong; MAO Xu

2010-01-01

Opportunistic spectrum access （OSA） is considered as a promising approach to mitigate spectrum scarcity by allowing unlicensed users to exploit spectrum opportunities in licensed frequency bands. Derived from the existing channel-hopping multiple access （CHMA） protocol,we introduce a hopping control channel medium access control （MAC） protocol in the context of OSA networks. In our proposed protocol,all nodes in the network follow a common channel-hopping sequence; every frequency channel can be used as control channel and data channel. Considering primary users＇ occupancy of the channel,we use a primary user （PU） detection model to calculate the channel availability for unlicensed users＇ access. Then,a discrete Markov chain analytical model is applied to describe the channel states and deduce the system throughput. Through simulation,we present numerical results to demonstrate the throughput performance of our protocol and thus validate our work.

Validity of selected cardiovascular field-based test among Malaysian ...

African Journals Online (AJOL)

Based on emerge obese problem among Malaysian, this research is formulated to validate published tests among healthy female adult. Selected test namely; 20 meter multi-stage shuttle run, 2.4km run test, 1 mile walk test and Harvard Step test were correlated with laboratory test (Bruce protocol) to find the criterion validity ...

Population-based cancer survival in the United States: Data, quality control, and statistical methods.

Science.gov (United States)

Allemani, Claudia; Harewood, Rhea; Johnson, Christopher J; Carreira, Helena; Spika, Devon; Bonaventure, Audrey; Ward, Kevin; Weir, Hannah K; Coleman, Michel P

2017-12-15

Robust comparisons of population-based cancer survival estimates require tight adherence to the study protocol, standardized quality control, appropriate life tables of background mortality, and centralized analysis. The CONCORD program established worldwide surveillance of population-based cancer survival in 2015, analyzing individual data on 26 million patients (including 10 million US patients) diagnosed between 1995 and 2009 with 1 of 10 common malignancies. In this Cancer supplement, we analyzed data from 37 state cancer registries that participated in the second cycle of the CONCORD program (CONCORD-2), covering approximately 80% of the US population. Data quality checks were performed in 3 consecutive phases: protocol adherence, exclusions, and editorial checks. One-, 3-, and 5-year age-standardized net survival was estimated using the Pohar Perme estimator and state- and race-specific life tables of all-cause mortality for each year. The cohort approach was adopted for patients diagnosed between 2001 and 2003, and the complete approach for patients diagnosed between 2004 and 2009. Articles in this supplement report population coverage, data quality indicators, and age-standardized 5-year net survival by state, race, and stage at diagnosis. Examples of tables, bar charts, and funnel plots are provided in this article. Population-based cancer survival is a key measure of the overall effectiveness of services in providing equitable health care. The high quality of US cancer registry data, 80% population coverage, and use of an unbiased net survival estimator ensure that the survival trends reported in this supplement are robustly comparable by race and state. The results can be used by policymakers to identify and address inequities in cancer survival in each state and for the United States nationally. Cancer 2017;123:4982-93. Published 2017. This article is a U.S. Government work and is in the public domain in the USA. Published 2017. This article is a U

Validation of the Microlife BP A3 PC upper arm blood pressure monitor in patients with diabetes mellitus according to the ANSI/AAMI/ISO 81060-2: 2013 protocol.

Science.gov (United States)

Beime, Beate; Krüger, Ralf; Hammel, Gertrud; Bramlage, Peter; Deutsch, Cornelia

2018-02-01

The aim of the present study was to validate the blood pressure (BP) measurement device, Microlife BP A3 PC, in patients with diabetes mellitus, according to the ANSI/AAMI/ISO 81060-2:2013 protocol. In 85 individuals aged 56-88 years, with predefined criteria for diabetes mellitus, BP measurements on the upper arm were performed alternately using the Microlife BP A3 PC and a standard mercury reference sphygmomanometer. A total of 333 comparisons were included for analysis. The mean difference between the Microlife BP A3 PC and the reference was -1.5±6.3 mmHg for systolic BP (SBP) and -1.3±5.2 mmHg for diastolic BP (DBP) according to criterion 1 of the protocol. For SBP, a total of 209 of the 333 measurements were within the range of 5 mmHg (62.8%), whereas the corresponding numbers for DBP were 232 of 333 (69.7%). For criterion 2, the intraindividual differences for the test device and the reference were -1.50±4.73 mmHg for SBP and -1.30±4.55 mmHg for DBP, thus being within the defined ranges provided by the protocol. The Microlife BP A3 PC fulfilled the requirements of criteria 1 and 2 of the ANSI/AAMI/ISO 81060-2:2013 protocol and can also be recommended for BP measurement in diabetic patients.

Development of a multi-fraction radiation protocol for intracerebral human glioblastoma xenografts

International Nuclear Information System (INIS)

Ozawa, T.; Santos, R.A.; Hu, L.H.; Faddegon, B.A.; Lamborn, K.R.; Deen, D.F.

2003-01-01

Patients with malignant gliomas are typically treated by surgery, radiation therapy and chemotherapy. Fractionated radiotherapy consists of 30 daily doses of 1.8 to 2 Gy given over a 6-week period. We have investigated a multi-fraction radiation protocol in which rats bearing intracerebral tumors are irradiated once daily for 10 days with a 2-day break in the middle. This scheme simulates the first third of a typical human radiation protocol, and it is a practical scheme to conduct in the laboratory. U-87 MG or U-251 MG human glioblastoma cells were implanted into the right caudate-putamens of male athymic rats. We irradiated rats using an irradiation jig that allowed us to deliver Cesium-137 photons at a dose rate of 280 cGy/minute selectively to the portion of the head containing the tumor. This device adequately shields all other parts of rat, including the critically sensitive oropharynx. Animals received the first radiation dose when intracerebral tumors were ∼20 mg in size. Untreated U-87 MG tumor-bearing rats died with a median survival of 23 days, while tumor bearing rats that were given ten 1-Gy doses died with a median survival of 28.5 days. Untreated U-251 MG tumor-bearing rats died with a median survival of 34.5 days, while tumor-bearing rats that were given ten 1-Gy doses died with a median survival of 58 days. However, 5 of 14 of these rats had a lifespan >68 days and were considered cured. A daily dose of 0.75 Gy produced a median survival of 43 days, but again 2 rats had a lifespan >70 days. Currently, we are seeking a dose that causes reproducible tumor growth delay of 1 to 2 weeks, without curing any animals, to use in future studies that combine radiation with other anti-tumor agents

Development and validation of simple RP-HPLC-PDA analytical protocol for zileuton assisted with Design of Experiments for robustness determination

Directory of Open Access Journals (Sweden)

Saurabh B. Ganorkar

2017-02-01

Full Text Available A simple, rapid, sensitive, robust, stability-indicating RP-HPLC-PDA analytical protocol was developed and validated for the analysis of zileuton racemate in bulk and in tablet formulation. Development of method and resolution of degradation products from forced; hydrolytic (acidic, basic, neutral, oxidative, photolytic (acidic, basic, neutral, solid state and thermal (dry heat degradation was achieved on a LC – GC Qualisil BDS C18 column (250 mm × 4.6 mm × 5 μm by isocratic mode at ambient temperature, employing a mobile phase methanol and (0.2%, v/v orthophosphoric acid in ratio of (80:20, v/v at a flow rate of 1.0 mL min−1 and detection at 260 nm. ‘Design of Experiments’ (DOE employing ‘Central Composite Design’ (CCD and ‘Response Surface Methodology’ (RSM were applied as an advancement to traditional ‘One Variable at Time’ (OVAT approach to evaluate the effects of variations in selected factors (methanol content, flow rate, concentration of orthophosphoric acid as graphical interpretation for robustness and statistical interpretation was achieved with Multiple Linear Regression (MLR and ANOVA. The method succeeded over the validation parameters: linearity, precision, accuracy, limit of detection and limit of quantitation, and robustness. The method was applied effectively for analysis of in-house zileuton tablets.

MAC-layer protocol for TCP fairness in Wireless Mesh Networks

KAUST Repository

Nawab, Faisal

2012-08-01

In this paper we study the interactions of TCP and IEEE 802.11 MAC in Wireless Mesh Networks (WMNs). We use a Markov chain to capture the behavior of TCP sessions, particularly the impact on network throughput performance due to the effect of queue utilization and packet relaying. A closed form solution is derived to numerically determine the throughput. Based on the developed model, we propose a distributed MAC protocol to alleviate the unfairness problem in WMNs. Our protocol uses the age of packet as a priority metric for packet scheduling. Simulation is conducted to validate our model and to illustrate the fairness characteristics of our proposed MAC protocol. We conclude that we can achieve fairness with only little impact on network capacity.

An Authentication Protocol for Future Sensor Networks.

Science.gov (United States)

Bilal, Muhammad; Kang, Shin-Gak

2017-04-28

Authentication is one of the essential security services in Wireless Sensor Networks (WSNs) for ensuring secure data sessions. Sensor node authentication ensures the confidentiality and validity of data collected by the sensor node, whereas user authentication guarantees that only legitimate users can access the sensor data. In a mobile WSN, sensor and user nodes move across the network and exchange data with multiple nodes, thus experiencing the authentication process multiple times. The integration of WSNs with Internet of Things (IoT) brings forth a new kind of WSN architecture along with stricter security requirements; for instance, a sensor node or a user node may need to establish multiple concurrent secure data sessions. With concurrent data sessions, the frequency of the re-authentication process increases in proportion to the number of concurrent connections. Moreover, to establish multiple data sessions, it is essential that a protocol participant have the capability of running multiple instances of the protocol run, which makes the security issue even more challenging. The currently available authentication protocols were designed for the autonomous WSN and do not account for the above requirements. Hence, ensuring a lightweight and efficient authentication protocol has become more crucial. In this paper, we present a novel, lightweight and efficient key exchange and authentication protocol suite called the Secure Mobile Sensor Network (SMSN) Authentication Protocol. In the SMSN a mobile node goes through an initial authentication procedure and receives a re-authentication ticket from the base station. Later a mobile node can use this re-authentication ticket when establishing multiple data exchange sessions and/or when moving across the network. This scheme reduces the communication and computational complexity of the authentication process. We proved the strength of our protocol with rigorous security analysis (including formal analysis using the BAN

Validation of the AVITA BPM64 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Kang, Yuan-Yuan; Chen, Qi; Liu, Chang-Yuan; Li, Yan; Wang, Ji-Guang

2018-02-01

The aim of this study was to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor AVITA BPM64 for home BP monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic BPs were measured sequentially in 33 adult Chinese (14 women, mean age 47.0 years) using a mercury sphygmomanometer (two observers) and the AVITA BPM64 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The AVITA BPM64 device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 91/99, 98/99, and 98/99, respectively, for systolic BP and 92/99, 99/99, and 99/99, respectively, for diastolic BP. The device also fulfilled the criteria in part 2 of the validation study. Thirty-two participants for both systolic and diastolic BP had at least two of the three device-observer differences within 5 mmHg (required ≥24). Only one participant for systolic BP had all three device-observer comparisons greater than 5 mmHg. The AVITA upper arm BP monitor BPM64 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.

Validation of the Rossmax CF175 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Zhang, Lu; Kang, Yuan-Yuan; Zeng, Wei-Fang; Li, Yan; Wang, Ji-Guang

2015-04-01

The present study aimed to evaluate the accuracy of the Rossmax CF175 upper-arm blood pressure monitor for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese (17 women, mean age 46 years) using a mercury sphygmomanometer (two observers) and the Rossmax CF175 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. All the blood pressure requirements were fulfilled. The Rossmax CF175 device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and observers within 5, 10, and 15 mmHg was 78/99, 94/99, and 98/99, respectively, for systolic blood pressure, and 81/99, 96/99, and 97/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Twenty-nine participants, for both of systolic and diastolic blood pressure, had at least two of the three device-observers differences within 5 mmHg (required ≥24). Only one participant for diastolic blood pressure had all three device-observers comparisons greater than 5 mmHg. The Rossmax automated oscillometric upper-arm blood pressure monitor CF175 fulfilled the requirements of the International Protocol revision 2010, and hence can be recommended for blood pressure measurement in adults.

Validation of the AVITA BPM15S wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Kang, Yuan-Yuan; Zeng, Wei-Fang; Zhang, Lu; Li, Yan; Wang, Ji-Guang

2014-06-01

The present study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor AVITA BPM15S for home blood pressure monitoring according to the International Protocol revision 2010 of the European Society of Hypertension. Systolic and diastolic blood pressures were sequentially measured in 33 Chinese adults (15 women, mean age 51 years) using a mercury sphygmomanometer (two observers) and the AVITA BPM15S device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The AVITA BPM15S device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and observers within 5, 10, and 15 mmHg were 85/99, 94/99, and 98/99, respectively, for systolic blood pressure, and 82/99, 96/99, and 98/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Thirty-two and 28 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observer differences within 5 mmHg (required ≥ 24). No participant had all of the three device-observer comparisons greater than 5 mmHg for systolic or diastolic blood pressure. The AVITA wrist blood pressure monitor BPM15S fulfilled the requirements of the International Protocol revision 2010 and hence can be recommended for home use in an adult population.

Development and validation of technique for in-vivo 3D analysis of cranial bone graft survival

Science.gov (United States)

Bernstein, Mark P.; Caldwell, Curtis B.; Antonyshyn, Oleh M.; Ma, Karen; Cooper, Perry W.; Ehrlich, Lisa E.

1997-05-01

Bone autografts are routinely employed in the reconstruction of facial deformities resulting from trauma, tumor ablation or congenital malformations. The combined use of post- operative 3D CT and SPECT imaging provides a means for quantitative in vivo evaluation of bone graft volume and osteoblastic activity. The specific objectives of this study were: (1) Determine the reliability and accuracy of interactive computer-assisted analysis of bone graft volumes based on 3D CT scans; (2) Determine the error in CT/SPECT multimodality image registration; (3) Determine the error in SPECT/SPECT image registration; and (4) Determine the reliability and accuracy of CT-guided SPECT uptake measurements in cranial bone grafts. Five human cadaver heads served as anthropomorphic models for all experiments. Four cranial defects were created in each specimen with inlay and onlay split skull bone grafts and reconstructed to skull and malar recipient sites. To acquire all images, each specimen was CT scanned and coated with Technetium doped paint. For purposes of validation, skulls were landmarked with 1/16-inch ball-bearings and Indium. This study provides a new technique relating anatomy and physiology for the analysis of cranial bone graft survival.

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

Science.gov (United States)

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

2008-10-01

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

Validation of the Omron M6 (HEM-7001-E) upper arm blood pressure measuring device according to the International Protocol in elderly patients.

Science.gov (United States)

Altunkan, Sekip; Iliman, Nevzat; Altunkan, Erkan

2008-04-01

Despite the widespread use of automated self-measurement monitors, there is limited published evidence on their accuracy and reliability on different patient groups. The objective of this study was to evaluate the accuracy and reliability of the Omron M6 (HEM-7001-E) upper-arm blood pressure (BP) device against mercury sphygmomanometer on elderly patients according to the criteria of the International Protocol. Thirty-three patients above 65 years of age, who were classified based on the BP categories of the International Protocol, were recruited for the study. BP measurements at the upper arm with the Omron M6 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential BP measurements were taken. During the validation study, 99 measurements were obtained from 33 patients for comparison. The first phase was carried out on 15 patients and if the device passed this phase, 18 more patients were selected. Mean discrepancies and standard deviations of the device sphygmomanometer were 1.4+/-5.3 mmHg for systolic BP (SBP) and -1.4+/-4.5 mmHg for diastolic BP (DBP) in the study group. The device passed phase 1 in 15 patients. In phase 2.1, from the total 99 comparisons, 76, 92, and 97 for SBP and 77, 94, and 99 for DBP were less than 5, 10, and 15 mmHg, respectively. The Omron M6 passed phases 2.1 and 2.2 in the elderly group of patients. The Omron M6 (HEM-7001-E) upper-arm BP monitor passed according to the International Protocol criteria and can be recommended for use in elderly patients.

Nasa's International Space Station: A Testbed for Planetary Protection Protocol Development

Science.gov (United States)

Bell, M. S.; Rucker, M.; Love, S.; Johnson, J.; Chambliss, J.; Pierson, D.; Ott, M.; Mary, N.; Glass, B.; Lupisella, M.;

Recurrence of Ewing sarcoma: Is detection by imaging follow-up protocol associated with survival advantage?

NARCIS (Netherlands)

Heinemann, Melina; Ranft, Andreas; Langer, Thorsten; Jürgens, Herbert; Kreyer, Justus; Vieth, Volker; Schäfers, Michael; Weckesser, Matthias; Simon, Thorsten; Hassenpflug, Wolf; Corbacioglu, Selim; Bielack, Stefan; Mayer-Steinacker, Regina; Kühne, Thomas; van den Berg, Henk; Gelderblom, Hans; Bauer, Sebastian; Stegger, Lars; Dirksen, Uta

2018-01-01

The Cooperative Ewing Sarcoma Study and the Late Effects Surveillance System of the Society for Paediatric Oncology and Haematology recommend a structured follow-up imaging protocol (FUIP) for patients with Ewing sarcoma (EwS) with decreasing frequency of imaging over the first 5 years. The present

Persistent RCSMA: A MAC Protocol for a Distributed Cooperative ARQ Scheme in Wireless Networks

Directory of Open Access Journals (Sweden)

J. Alonso-Zárate

2008-05-01

Full Text Available The persistent relay carrier sensing multiple access (PRCSMA protocol is presented in this paper as a novel medium access control (MAC protocol that allows for the execution of a distributed cooperative automatic retransmission request (ARQ scheme in IEEE 802.11 wireless networks. The underlying idea of the PRCSMA protocol is to modify the basic rules of the IEEE 802.11 MAC protocol to execute a distributed cooperative ARQ scheme in wireless networks in order to enhance their performance and to extend coverage. A closed formulation of the distributed cooperative ARQ average packet transmission delay in a saturated network is derived in the paper. The analytical equations are then used to evaluate the performance of the protocol under different network configurations. Both the accuracy of the analysis and the performance evaluation of the protocol are supported and validated through computer simulations.

[Chinese Protocol of Diagnosis and Treatment of Colorectal Cancer].

Science.gov (United States)

2018-04-01

Colorectal cancer is one of the most common malignant tumors in China. In 2012 one million thirty six thousand cases of colorectal cancer were diagnosed all over the world, two hundred fifty three thousand cases were diagnosed in China (accounted for 18.6%). China has the largest number of new cases of colorectal cancer in the world. Colorectal cancer has becoming a serious threat of Chinese residents' health. In 2010, the National Ministry of Health organized colorectal cancer expertise of the Chinese Medical Association to write the "Chinese Protocol of Diagnosis and Treatment of Colorectal Cancer" (2010edition), and publish it publicly. In recent years, the National Health and Family Planning Commission has organized experts to revised the protocol 2 times: the first time in 2015, the second time in 2017. The revised part of "Chinese Protocol of Diagnosis and Treatment of Colorectal Cancer" (2017 edition) involves new progress in the field of imaging examination, pathological evaluation, surgery, chemotherpy and radiotherapy. The 2017 edition of the protocol not only referred to the contents of the international guidelines, but also combined with the specific national conditions and clinical practice in China, and also included many evidence-based clinical data in China recently. The 2017 edition of the protocol would further promote the standardization of diagnosis and treatment of colorectal cancer in China, improve the survival and prognosis of patients, and benefit millions of patients with colorectal cancer and their families.

Fluid resuscitation for major burn patients with the TMMU protocol.

Science.gov (United States)

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.

Post-treatment surveillance testing of patients with colorectal cancer and the association with survival: protocol for a retrospective cohort study of the Surveillance, Epidemiology, and End Results (SEER)-Medicare database.

Science.gov (United States)

Hines, Robert B; Jiban, Md Jibanul Haque; Choudhury, Kanak; Loerzel, Victoria; Specogna, Adrian V; Troy, Steven P; Zhang, Shunpu

2018-04-28

Although the colorectal cancer (CRC) mortality rate has significantly improved over the past several decades, many patients will have a recurrence following curative treatment. Despite this high risk of recurrence, adherence to CRC surveillance testing guidelines is poor which increases cancer-related morbidity and potentially, mortality. Several randomised controlled trials (RCTs) with varying surveillance strategies have yielded conflicting evidence regarding the survival benefit associated with surveillance testing. However, due to differences in study protocols and limitations of sample size and length of follow-up, the RCT may not be the best study design to evaluate this relationship. An observational comparative effectiveness research study can overcome the sample size/follow-up limitations of RCT designs while assessing real-world variability in receipt of surveillance testing to provide much needed evidence on this important clinical issue. The gap in knowledge that this study will address concerns whether adherence to National Comprehensive Cancer Network CRC surveillance guidelines improves survival. Patients with colon and rectal cancer aged 66-84 years, who have been diagnosed between 2002 and 2008 and have been included in the Surveillance, Epidemiology, and End Results-Medicare database, are eligible for this retrospective cohort study. To minimise bias, patients had to survive at least 12 months following the completion of treatment. Adherence to surveillance testing up to 5 years post-treatment will be assessed in each year of follow-up and overall. Binomial regression will be used to assess the association between patients' characteristics and adherence. Survival analysis will be conducted to assess the association between adherence and 5-year survival. This study was approved by the National Cancer Institute and the Institutional Review Board of the University of Central Florida. The results of this study will be disseminated by publishing in

A protocol avoiding allogeneic transfusion in joint arthroplasties.

Science.gov (United States)

Suh, You-Sung; Nho, Jae-Hwi; Choi, Hyung-Suk; Ha, Yong-Chan; Park, Jong-Seok; Koo, Kyung-Hoi

2016-09-01

Arthroplasties of hip and knee are associated with blood loss, which may lead to adverse patient outcome. Performing arthroplasties in Jehovah's Witness patients who do not accept transfusion has been a matter of concern. We developed a protocol, which avoids transfusion in arthroplasties of Jehovah's Witness patients, and evaluated the feasibility and safety of the protocol. The target of preoperative hemoglobin was more than 10 g/dL. When preoperative hemoglobin was lower than 10 g/dL, 4000 U erythropoietin (3 times a week) and 100 mg iron supplement (every day) were administered until the hemoglobin reached 10 g/dL. When the preoperative hemoglobin was higher than 10 g/dL, 4000 U erythropoietin and 100 mg iron supplement were administered once, before operation. During the operation, cell saver was used. Postoperatively, erythropoietin and iron supplements were administered until the hemoglobin reached 10 g/dL, similar to the preoperative protocol. We evaluated the feasibility of our protocol, perioperative complications and hematologic changes. From 2002 to 2014, 186 Witness patients visited our department. In 179 patients (96.2 %), 77 total knee arthroplasties, 69 bipolar hemiarthroplasties and 33 total hip arthroplasties were performed. The mean hemoglobin level was 12.3 g/dL preoperatively, 9.4 g/dL on postoperative day 3 and 10.3 g/dL on postoperative day 7. One patient died immediately after the arthroplasty and the remaining 178 patients survived. Total joint arthroplasty could be done without transfusion using this protocol in most of our patients. The rates of infection and mortality were similar with known infection and mortality rates of arthroplasties. In patients who do not want allogeneic transfusions, our protocol is a safe alternative to perform joint arthroplasties.

Validation of the iHealth BP3 upper-arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Chen, Can; Shang, Fujun; Wang, Jiepin; Chen, Jianghong; Ji, Na; Wan, Yi

2012-12-01

This study aimed to evaluate the performance of the iHealth BP3 upper-arm blood pressure monitor, which is designed for clinic use and self-measurement of blood pressure using Apple touch devices as an interface. The European Society of Hypertension International Protocol (ESH-IP) revision 2010 for the validation of blood pressure measuring devices in adults was followed precisely. Ninty-nine couples of test device and reference blood pressure measurements were obtained during the study (three pairs for each of the 33 participants). The 33 participants, age 47.1±12.3 years (age range 27-69 years) and arm circumference 30.0±4.4 cm, had a mean systolic blood pressure (SBP) of 143.9±27.4 mmHg and a mean diastolic blood pressure (DBP) of 90.1±18.3 mmHg. The device passed all of the requirements fulfilling the standards of the protocol, and the mean±SD device-observer difference was 2.8±4.2 mmHg for SBP and -0.4±3.5 mmHg for DBP. According to the results of the validation study on the basis of the ESH-IP revision 2010, the iHealth BP3 can be recommended for clinic use and self-measurement in an adult population. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Validating visual disturbance types and classes used for forest soil monitoring protocols

Science.gov (United States)

D. S. Page-Dumroese; A. M. Abbott; M. P. Curran; M. F. Jurgensen

2012-01-01

We describe several methods for validating visual soil disturbance classes used during forest soil monitoring after specific management operations. Site-specific vegetative, soil, and hydrologic responses to soil disturbance are needed to identify sensitive and resilient soil properties and processes; therefore, validation of ecosystem responses can provide information...

Repetitive transarterial chemoembolization (TACE) of liver metastases from gastric cancer: Local control and survival results

Energy Technology Data Exchange (ETDEWEB)

Vogl, Thomas J., E-mail: T.Vogl@em.uni-frankfurt.de [Institute for Diagnostic and Interventional Radiology, Johann Wolfgang Goethe-University Frankfurt (Germany); Gruber-Rouh, Tatjana; Eichler, Katrin [Institute for Diagnostic and Interventional Radiology, Johann Wolfgang Goethe-University Frankfurt (Germany); Nour-Eldin, Nour-Eldin A. [Institute for Diagnostic and Interventional Radiology, Johann Wolfgang Goethe-University Frankfurt (Germany); Department of Radiology, Faculty of Medicine, Cairo University, Cairo (Egypt); Trojan, Jörg [Department of Internal Medicine I, Johann Wolfgang Goethe-University Frankfurt (Germany); Zangos, Stephan [Institute for Diagnostic and Interventional Radiology, Johann Wolfgang Goethe-University Frankfurt (Germany); Naguib, Nagy N.N. [Institute for Diagnostic and Interventional Radiology, Johann Wolfgang Goethe-University Frankfurt (Germany); Radiology Department, Faculty of Medicine, Alexandria University, Alexandria (Egypt)

2013-02-15

Objective: To evaluate the local tumor control and survival data after transarterial chemoembolization with different drug combinations in the palliative treatment of patients with liver metastases of gastric cancer. Materials and methods: The study was retrospectively performed. 56 patients (mean age, 52.4) with unresectable liver metastases of gastric cancer who did not respond to systemic chemotherapy were repeatedly treated with TACE in 4-week intervals. In total, 310 chemoembolization procedures were performed (mean, 5.5 sessions per patient). The local chemotherapy protocol consisted of mitomycin alone (30.4%), mitomycin and gemcitabine (33.9%), or mitomycin, gemcitabine and cisplatin (35.7%). Embolization was performed with lipiodol and starch microspheres. Local tumor response was evaluated by MRI according to RECIST. Survival data from first chemoembolization were calculated according to the Kaplan–Meier method. Results: The local tumor control was: complete response in 1.8% (n = 1), partial response in 1.8% (n = 1), stable disease in 51.8% (n = 29) and progressive disease in 44.6% (n = 25) of patients. The 1-, 2-, and 3-year survival rate from the start of chemoembolization were 58%, 38%, and 23% respectively. The median and mean survival times were 13 and 27.1 months. A Statistically significant difference between patients treated with different chemotherapy protocols was noted (ρ = 0.045) with the best survival time in the mitomycin, gemcitabine and cisplatin group. Conclusion: Transarterial chemoembolization is a minimally invasive therapy option for palliative treatment of liver metastases in patients with gastric cancer.

USING CFD TO ANALYZE NUCLEAR SYSTEMS BEHAVIOR: DEFINING THE VALIDATION REQUIREMENTS

Energy Technology Data Exchange (ETDEWEB)

Richard Schultz

2012-09-01

A recommended protocol to formulate numeric tool specifications and validation needs in concert with practices accepted by regulatory agencies for advanced reactors is described. The protocol is based on the plant type and perceived transient and accident envelopes that translates to boundary conditions for a process that gives the: (a) key phenomena and figures-of-merit which must be analyzed to ensure that the advanced plant can be licensed, (b) specification of the numeric tool capabilities necessary to perform the required analyses—including bounding calculational uncertainties, and (c) specification of the validation matrices and experiments--including the desired validation data. The result of applying the process enables a complete program to be defined, including costs, for creating and benchmarking transient and accident analysis methods for advanced reactors. By following a process that is in concert with regulatory agency licensing requirements from the start to finish, based on historical acceptance of past licensing submittals, the methods derived and validated have a high probability of regulatory agency acceptance.

Minimal sampling protocol for accurate estimation of urea production: a study with oral [13C]urea in fed and fasted piglets

NARCIS (Netherlands)

Oosterveld, Michiel J. S.; Gemke, Reinoud J. B. J.; Dainty, Jack R.; Kulik, Willem; Jakobs, Cornelis; de Meer, Kees

2005-01-01

An oral [13C]urea protocol may provide a simple method for measurement of urea production. The validity of single pool calculations in relation to a reduced sampling protocol was assessed. In eight fed and five fasted piglets, plasma urea enrichments from a 10 h sampling protocol were measured

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

Science.gov (United States)

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.

Effect of a low fat versus a low carbohydrate weight loss dietary intervention on biomarkers of long term survival in breast cancer patients ('CHOICE'): study protocol.

Science.gov (United States)

Sedlacek, Scot M; Playdon, Mary C; Wolfe, Pamela; McGinley, John N; Wisthoff, Mark R; Daeninck, Elizabeth A; Jiang, Weiqin; Zhu, Zongjian; Thompson, Henry J

2011-07-06

Weight loss in overweight or obese breast cancer patients is associated with an improved prognosis for long term survival. However, it is not clear whether the macronutrient composition of the chosen weight loss dietary plan imparts further prognostic benefit. A study protocol is presented for a dietary intervention to investigate the effects of weight loss dietary patterns that vary markedly in fat and carbohydrate contents on biomarkers of exposure to metabolic processes that may promote tumorigenesis and that are predictive of long term survival. The study will also determine how much weight must be lost for biomarkers to change in a favorable direction. Approximately 370 overweight or obese postmenopausal breast cancer survivors (body mass index: 25.0 to 34.9 kg/m²) will be accrued and assigned to one of two weight loss intervention programs or a non-intervention control group. The dietary intervention is implemented in a free living population to test the two extremes of popular weight loss dietary patterns: a high carbohydrate, low fat diet versus a low carbohydrate, high fat diet. The effects of these dietary patterns on biomarkers for glucose homeostasis, chronic inflammation, cellular oxidation, and steroid sex hormone metabolism will be measured. Participants will attend 3 screening and dietary education visits, and 7 monthly one-on-one dietary counseling and clinical data measurement visits in addition to 5 group visits in the intervention arms. Participants in the control arm will attend two clinical data measurement visits at baseline and 6 months. The primary outcome is high sensitivity C-reactive protein. Secondary outcomes include interleukin-6, tumor necrosis factor-α, insulin-like growth factor-1 (IGF), IGF binding protein-3, 8-isoprostane-F2-alpha, estrone, estradiol, progesterone, sex hormone binding globulin, adiponectin, and leptin. While clinical data indicate that excess weight for height is associated with poor prognosis for long term

Effect of a low fat versus a low carbohydrate weight loss dietary intervention on biomarkers of long term survival in breast cancer patients ('CHOICE': study protocol

Directory of Open Access Journals (Sweden)

Daeninck Elizabeth A

2011-07-01

Full Text Available Abstract Background Weight loss in overweight or obese breast cancer patients is associated with an improved prognosis for long term survival. However, it is not clear whether the macronutrient composition of the chosen weight loss dietary plan imparts further prognostic benefit. A study protocol is presented for a dietary intervention to investigate the effects of weight loss dietary patterns that vary markedly in fat and carbohydrate contents on biomarkers of exposure to metabolic processes that may promote tumorigenesis and that are predictive of long term survival. The study will also determine how much weight must be lost for biomarkers to change in a favorable direction. Methods/Design Approximately 370 overweight or obese postmenopausal breast cancer survivors (body mass index: 25.0 to 34.9 kg/m2 will be accrued and assigned to one of two weight loss intervention programs or a non-intervention control group. The dietary intervention is implemented in a free living population to test the two extremes of popular weight loss dietary patterns: a high carbohydrate, low fat diet versus a low carbohydrate, high fat diet. The effects of these dietary patterns on biomarkers for glucose homeostasis, chronic inflammation, cellular oxidation, and steroid sex hormone metabolism will be measured. Participants will attend 3 screening and dietary education visits, and 7 monthly one-on-one dietary counseling and clinical data measurement visits in addition to 5 group visits in the intervention arms. Participants in the control arm will attend two clinical data measurement visits at baseline and 6 months. The primary outcome is high sensitivity C-reactive protein. Secondary outcomes include interleukin-6, tumor necrosis factor-α, insulin-like growth factor-1 (IGF, IGF binding protein-3, 8-isoprostane-F2-alpha, estrone, estradiol, progesterone, sex hormone binding globulin, adiponectin, and leptin. Discussion While clinical data indicate that excess weight

Institutional clinical trial accrual volume and survival of patients with head and neck cancer.

Science.gov (United States)

Wuthrick, Evan J; Zhang, Qiang; Machtay, Mitchell; Rosenthal, David I; Nguyen-Tan, Phuc Felix; Fortin, André; Silverman, Craig L; Raben, Adam; Kim, Harold E; Horwitz, Eric M; Read, Nancy E; Harris, Jonathan; Wu, Qian; Le, Quynh-Thu; Gillison, Maura L

2015-01-10

National Comprehensive Cancer Network guidelines recommend patients with head and neck cancer (HNC) receive treatment at centers with expertise, but whether provider experience affects survival is unknown. The effect of institutional experience on overall survival (OS) in patients with stage III or IV HNC was investigated within a randomized trial of the Radiation Therapy Oncology Group (RTOG 0129), which compared cisplatin concurrent with standard versus accelerated fractionation radiotherapy. As a surrogate for experience, institutions were classified as historically low- (HLACs) or high-accruing centers (HHACs) based on accrual to 21 RTOG HNC trials (1997 to 2002). The effect of accrual volume on OS was estimated by Cox proportional hazards models. Median RTOG accrual (1997 to 2002) at HLACs was four versus 65 patients at HHACs. Analysis included 471 patients in RTOG 0129 (2002 to 2005) with known human papillomavirus and smoking status. Patients at HLACs versus HHACs had better performance status (0: 62% v 52%; P = .04) and lower T stage (T4: 26.5% v 35.3%; P = .002) but were otherwise similar. Radiotherapy protocol deviations were higher at HLACs versus HHACs (18% v 6%; P accounting for radiotherapy protocol deviations. Institutional experience substantially influences survival in locally advanced HNC. © 2014 by American Society of Clinical Oncology.

Validation of a standard forensic anthropology examination protocol by measurement of applicability and reliability on exhumed and archive samples of known biological attribution.

Science.gov (United States)

Francisco, Raffaela Arrabaça; Evison, Martin Paul; Costa Junior, Moacyr Lobo da; Silveira, Teresa Cristina Pantozzi; Secchieri, José Marcelo; Guimarães, Marco Aurelio

2017-10-01

Forensic anthropology makes an important contribution to human identification and assessment of the causes and mechanisms of death and body disposal in criminal and civil investigations, including those related to atrocity, disaster and trafficking victim identification. The methods used are comparative, relying on assignment of questioned material to categories observed in standard reference material of known attribution. Reference collections typically originate in Europe and North America, and are not necessarily representative of contemporary global populations. Methods based on them must be validated when applied to novel populations. This study describes the validation of a standardized forensic anthropology examination protocol by application to two contemporary Brazilian skeletal samples of known attribution. One sample (n=90) was collected from exhumations following 7-35 years of burial and the second (n=30) was collected following successful investigations following routine case work. The study presents measurement of (1) the applicability of each of the methods: used and (2) the reliability with which the biographic parameters were assigned in each case. The results are discussed with reference to published assessments of methodological reliability regarding sex, age and-in particular-ancestry estimation. Copyright © 2017 Elsevier B.V. All rights reserved.

On Tradeoffs between Trust and Survivability using a Game Theoretic Approach

Science.gov (United States)

2016-04-13

given group protocol. That is, the entire system is penalized or rewarded regardless of which individual entity misbehaved or behaved, so that group...study the tradeoff between group trust and system survivability in the presence of misbehaving nodes and under resource constraints. Lastly, we...threshold. However, in this case, the system penalizes the misbehaving node by evicting it, ultimately eliminating any chance of participation in any group

Learned helplessness: validity and reliability of depressive-like states in mice.

Science.gov (United States)

Chourbaji, S; Zacher, C; Sanchis-Segura, C; Dormann, C; Vollmayr, B; Gass, P

2005-12-01

The learned helplessness paradigm is a depression model in which animals are exposed to unpredictable and uncontrollable stress, e.g. electroshocks, and subsequently develop coping deficits for aversive but escapable situations (J.B. Overmier, M.E. Seligman, Effects of inescapable shock upon subsequent escape and avoidance responding, J. Comp. Physiol. Psychol. 63 (1967) 28-33 ). It represents a model with good similarity to the symptoms of depression, construct, and predictive validity in rats. Despite an increased need to investigate emotional, in particular depression-like behaviors in transgenic mice, so far only a few studies have been published using the learned helplessness paradigm. One reason may be the fact that-in contrast to rats (B. Vollmayr, F.A. Henn, Learned helplessness in the rat: improvements in validity and reliability, Brain Res. Brain Res. Protoc. 8 (2001) 1-7)--there is no generally accepted learned helplessness protocol available for mice. This prompted us to develop a reliable helplessness procedure in C57BL/6N mice, to exclude possible artifacts, and to establish a protocol, which yields a consistent fraction of helpless mice following the shock exposure. Furthermore, we validated this protocol pharmacologically using the tricyclic antidepressant imipramine. Here, we present a mouse model with good face and predictive validity that can be used for transgenic, behavioral, and pharmacological studies.

Survival effect of first- and second-line treatments for patients with primary glioblastoma: a cohort study from a prospective registry, 1997-2010.

Science.gov (United States)

Nava, Francesca; Tramacere, Irene; Fittipaldo, Andrea; Bruzzone, Maria Grazia; Dimeco, Francesco; Fariselli, Laura; Finocchiaro, Gaetano; Pollo, Bianca; Salmaggi, Andrea; Silvani, Antonio; Farinotti, Mariangela; Filippini, Graziella

2014-05-01

Prospective follow-up studies of large cohorts of patients with glioblastoma (GBM) are needed to assess the effectiveness of conventional treatments in clinical practice. We report GBM survival data from the Brain Cancer Register of the Fondazione Istituto Neurologico Carlo Besta (INCB) in Milan, Italy, which collected longitudinal data for all consecutive patients with GBM from 1997 to 2010. Survival data were obtained from 764 patients (aged>16 years) with histologically confirmed primary GBM who were diagnosed and treated over a 7-year period (2004-2010) with follow-up to April 2012 (cohort II). Equivalent data from 490 GBM patients diagnosed and treated over the preceding 7 years (1997-2003) with follow-up to April 2005 (cohort I) were available for comparison. Progression-free survival (PFS) was available from 361 and 219 patients actively followed up at INCB in cohorts II and I, respectively. Survival probabilities were 54% at 1 year, 21% at 2 years, and 11% at 3 years, respectively, in cohort II compared with 47%, 11%, and 5%, respectively, in cohort I. PFS was 22% and 12% at 1 year in cohorts II and I. Better survival and PFS in cohort II was significantly associated with introduction of the Stupp protocol into clinical practice, with adjusted hazard ratios (HRs) of 0.78 for survival and 0.73 for PFS, or a 22% relative decrease in the risk of death and a 27% relative decrease in the risk of recurrence. After recurrence, reoperation was performed in one-fifth of cohort I and in one-third of cohort II but was not effective (HR, 1.05 in cohort I and 1.02 in cohort II). Second-line chemotherapy, mainly consisting of nitrosourea-based chemotherapy, temozolomide, mitoxantrone, fotemustine, and bevacizumab, improved survival in both cohorts (HR, 0.57 in cohort I and 0.74 in cohort II). Radiosurgery was also effective (HR, 0.52 in cohort II). We found a significant increase in overall survival, PFS, and survival after recurrence after 2004, likely due to

Development of a waste management protocol based on assessment of knowledge and practice of healthcare personnel in surgical departments.

Science.gov (United States)

Mostafa, Gehan M A; Shazly, Mona M; Sherief, Wafaa I

2009-01-01

Good healthcare waste management in a hospital depends on a dedicated waste management team, good administration, careful planning, sound organization, underpinning legislation, adequate financing, and full participation by trained staff. Hence, waste management protocols must be convenient and sensible. To assess the knowledge and practice related to waste management among doctors, nurses, and housekeepers in the surgical departments at Al-Mansoura University Hospital, and to design and validate a waste management protocol for the health team in these settings. This cross-sectional study was carried out in the eight surgical departments at Al-Mansoura University Hospital. All health care personnel and their assistants were included: 38 doctors, 106 nurses, and 56 housekeepers. Two groups of jury were included for experts' opinions validation of the developed protocol, one from academia (30 members) and the other from service providers (30 members). Data were collected using a self-administered knowledge questionnaire for nurses and doctors, and an interview questionnaire for housekeepers. Observation checklists were used for assessment of performance. The researchers developed the first draft of the waste management protocol according to the results of the analysis of the data collected in the assessment phase. Then, the protocol was presented to the jury group for validation, and then was implemented. Only 27.4% of the nurses, 32.1% of the housekeepers, and 36.8% of the doctors had satisfactory knowledge. Concerning practice, 18.9% of the nurses, 7.1% of the housekeepers, and none of the doctors had adequate practice. Nurses' knowledge score had a statistically significant weak positive correlation with the attendance of training courses (r=0.23, pwaste management. The knowledge among nurses is positively affected by attendance of training programs. Based on the findings, a protocol for healthcare waste management was developed and validated. It is recommended to

Consensus problem in directed networks of multi-agents via nonlinear protocols

International Nuclear Information System (INIS)

Liu Xiwei; Chen Tianping; Lu Wenlian

2009-01-01

In this Letter, the consensus problem via distributed nonlinear protocols for directed networks is investigated. Its dynamical behaviors are described by ordinary differential equations (ODEs). Based on graph theory, matrix theory and the Lyapunov direct method, some sufficient conditions of nonlinear protocols guaranteeing asymptotical or exponential consensus are presented and rigorously proved. The main contribution of this work is that for nonlinearly coupled networks, we generalize the results for undirected networks to directed networks. Consensus under pinning control technique is also developed here. Simulations are also given to show the validity of the theories.

A Call for sting treatment protocol: Case report of a 3 year old with ...

African Journals Online (AJOL)

Acute Kidney Injury in children following bee sting envenomation is rare and survival is hinged on early recognition and prompt appropriate management. This report is aimed at raising awareness among healthcare workers, of one of the systemic effects of massive bee sting and the need to develop sting treatment protocol.

Static validation of licence conformance policies

DEFF Research Database (Denmark)

Hansen, Rene Rydhof; Nielson, Flemming; Nielson, Hanne Riis

2008-01-01

Policy conformance is a security property gaining importance due to commercial interest like Digital Rights Management. It is well known that static analysis can be used to validate a number of more classical security policies, such as discretionary and mandatory access control policies, as well...... as communication protocols using symmetric and asymmetric cryptography. In this work we show how to develop a Flow Logic for validating the conformance of client software with respect to a licence conformance policy. Our approach is sufficiently flexible that it extends to fully open systems that can admit new...

Clinical applicability and cutoff values for an unstructured neuropsychological assessment protocol for older adults with low formal education.

Science.gov (United States)

de Paula, Jonas Jardim; Bertola, Laiss; Ávila, Rafaela Teixeira; Moreira, Lafaiete; Coutinho, Gabriel; de Moraes, Edgar Nunes; Bicalho, Maria Aparecida Camargos; Nicolato, Rodrigo; Diniz, Breno Satler; Malloy-Diniz, Leandro Fernandes

2013-01-01

The neuropsychological exam plays a central role in the assessment of elderly patients with cognitive complaints. It is particularly relevant to differentiate patients with mild dementia from those subjects with mild cognitive impairment. Formal education is a critical factor in neuropsychological performance; however, there are few studies that evaluated the psychometric properties, especially criterion related validity, neuropsychological tests for patients with low formal education. The present study aims to investigate the validity of an unstructured neuropsychological assessment protocol for this population and develop cutoff values for clinical use. A protocol composed by the Rey-Auditory Verbal Learning Test, Frontal Assessment Battery, Category and Letter Fluency, Stick Design Test, Clock Drawing Test, Digit Span, Token Test and TN-LIN was administered to 274 older adults (96 normal aging, 85 mild cognitive impairment and 93 mild Alzheimer`s disease) with predominantly low formal education. Factor analysis showed a four factor structure related to Executive Functions, Language/Semantic Memory, Episodic Memory and Visuospatial Abilities, accounting for 65% of explained variance. Most of the tests showed a good sensitivity and specificity to differentiate the diagnostic groups. The neuropsychological protocol showed a significant ecological validity as 3 of the cognitive factors explained 31% of the variance on Instrumental Activities of Daily Living. The study presents evidence of the construct, criteria and ecological validity for this protocol. The neuropsychological tests and the proposed cutoff values might be used for the clinical assessment of older adults with low formal education.

An enhanced password authentication scheme for session initiation protocol with perfect forward secrecy.

Science.gov (United States)

Qiu, Shuming; Xu, Guoai; Ahmad, Haseeb; Guo, Yanhui

2018-01-01

The Session Initiation Protocol (SIP) is an extensive and esteemed communication protocol employed to regulate signaling as well as for controlling multimedia communication sessions. Recently, Kumari et al. proposed an improved smart card based authentication scheme for SIP based on Farash's scheme. Farash claimed that his protocol is resistant against various known attacks. But, we observe some accountable flaws in Farash's protocol. We point out that Farash's protocol is prone to key-compromise impersonation attack and is unable to provide pre-verification in the smart card, efficient password change and perfect forward secrecy. To overcome these limitations, in this paper we present an enhanced authentication mechanism based on Kumari et al.'s scheme. We prove that the proposed protocol not only overcomes the issues in Farash's scheme, but it can also resist against all known attacks. We also provide the security analysis of the proposed scheme with the help of widespread AVISPA (Automated Validation of Internet Security Protocols and Applications) software. At last, comparing with the earlier proposals in terms of security and efficiency, we conclude that the proposed protocol is efficient and more secure.

An enhanced password authentication scheme for session initiation protocol with perfect forward secrecy

Science.gov (United States)

2018-01-01

The Session Initiation Protocol (SIP) is an extensive and esteemed communication protocol employed to regulate signaling as well as for controlling multimedia communication sessions. Recently, Kumari et al. proposed an improved smart card based authentication scheme for SIP based on Farash’s scheme. Farash claimed that his protocol is resistant against various known attacks. But, we observe some accountable flaws in Farash’s protocol. We point out that Farash’s protocol is prone to key-compromise impersonation attack and is unable to provide pre-verification in the smart card, efficient password change and perfect forward secrecy. To overcome these limitations, in this paper we present an enhanced authentication mechanism based on Kumari et al.’s scheme. We prove that the proposed protocol not only overcomes the issues in Farash’s scheme, but it can also resist against all known attacks. We also provide the security analysis of the proposed scheme with the help of widespread AVISPA (Automated Validation of Internet Security Protocols and Applications) software. At last, comparing with the earlier proposals in terms of security and efficiency, we conclude that the proposed protocol is efficient and more secure. PMID:29547619

Impact of Socioeconomic Status on Timing of Relapse and Overall Survival for Children Treated on Dana-Farber Cancer Institute ALL Consortium Protocols (2000-2010).

Science.gov (United States)

Bona, Kira; Blonquist, Traci M; Neuberg, Donna S; Silverman, Lewis B; Wolfe, Joanne

2016-06-01

Population-based evidence suggests that lower socioeconomic status (SES) negatively impacts the overall survival (OS) of children with leukemia; however, the relationships between SES and treatment-related mortality, relapse, and timing of relapse remain unclear. We examined OS, event-free survival (EFS) and cumulative incidence (CI) and timing of relapse by community-level poverty for 575 children aged 1-18 years with newly diagnosed acute lymphoblastic leukemia (ALL) treated on consecutive phase III multicenter Dana-Farber Cancer Institute ALL Consortium Protocols between 2000 and 2010. Children were categorized into high- and low-poverty areas for the analysis using aggregate U.S. Census data linked to zip code. Children living in high-poverty areas experienced a 5-year OS of 85% as compared with 92% for those in low-poverty areas (P = 0.02); poverty remained marginally significant (P = 0.07) after adjustment for immunophenotype, age, and white blood cell count. There were no differences detected in EFS or CI relapse by poverty area. However, 92% of the relapses observed in children from high-poverty areas occurred <36 months from complete remission, compared to 48% of those in children from low-poverty areas (P = 0.008). U.S. children with ALL living in high-poverty areas have a higher risk of early relapse when compared with those living in low-poverty areas despite uniform treatment. This may in part explain decreased OS observed in these children. This finding highlights disparities in childhood cancer outcomes by SES despite uniform treatment. Further investigations of the mechanistic pathways underlying this finding are needed. © 2016 Wiley Periodicals, Inc.

Prehospital cardiac arrest survival and neurologic recovery.

Science.gov (United States)

Hillis, M; Sinclair, D; Butler, G; Cain, E

1993-01-01

Many studies of prehospital defibrillation have been conducted but the effects of airway intervention are unknown and neurologic follow-up has been incomplete. A non-randomized cohort prospective study was conducted to determine the effectiveness of defibrillation in prehospital cardiac arrest. Two ambulance companies in the study area developed a defibrillation protocol and they formed the experimental group. A subgroup of these patients received airway management with an esophageal obturator airway (EOA) or endotracheal intubation (ETT). The control group was composed of patients who suffered a prehospital cardiac arrest and did not receive prehospital defibrillation. All survivors were assessed for residual deficits using the Sickness Impact Profile (SIP) and the Dementia Rating Scale (DRS). A total of 221 patients were studied over a 32-month period. Both the experimental group (N = 161) and the control group (N = 60) were comparable with respect to age, sex distribution, and ambulance response time. Survival to hospital discharge was 2/60 (3.3%) in the control group and 12/161 (6.3%) in the experimental group. This difference is not statistically significant. Survival in the experimental group by airway management technique was basic airway support (3/76 3.9%), EOA (3/67 4.5%), and ETT (6/48 12.5%). The improved effect on survival by ETT management was statistically significant. Survivors had minor differences in memory, work, and recreation as compared to ischemic heart disease patients as measured by the SIP and DRS. No effect of defibrillation was found on survival to hospital discharge. However, endotracheal intubation improved survival in defibrillated patients. Survivors had a good functional outcome.

SURVIVAL OF CAPTIVE-REARED PUERTO RICAN PARROTS RELEASED IN THE CARIBBEAN NATIONAL FOREST

Science.gov (United States)

THOMAS H. WHITE; JAIME A. COLLAZO; FRANCISCO J. VILELLA

2005-01-01

We report first-year survival for 34 captive-reared Puerto Rican Parrots (Amazona vittata) released in the Caribbean National Forest, Puerto Rico between 2000 and 2002. The purpose of the releases were to increase population size and the potential number of breeding individuals of the sole extant wild population, and to refine release protocols for eventual...

Validation of the Andon KD-5851 upper arm blood pressure monitor, for self-measurement according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Wu, Lili; Jiao, Yinghui; Wang, Chengdong; Chen, Lei; Di, Dalin; Zhang, Haiyan

2015-08-01

This study aimed to validate the Andon KD-5851 upper arm blood pressure (BP) monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. A total of 33 eligible participants were included in the study. Sequential measurements of BPs were performed using a mercury sphygmomanometer and the device, and the data analysis was carried out following precisely the ESH-IP revision 2010. The device had 82, 98, and 99 measurements within 5, 10, and 15 mmHg for systolic blood pressure and 85, 95, and 99 measurements for diastolic blood pressure, respectively. The average device-observer difference was -0.53±4.00 mmHg for systolic blood pressure and -1.15±4.06 mmHg for diastolic blood pressure. The device passed all the criteria according to the ESH-IP revision 2010. According to the validation results on the basis of the ESH-IP revision 2010, the Andon KD-5851 upper arm BP monitor can be recommended for self/home measurement in adults. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.

Validation of the Omron HEM-7201 upper arm blood pressure monitor, for self-measurement in a high-altitude environment, according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Cho, K; Tian, M; Lan, Y; Zhao, X; Yan, L L

2013-08-01

Few studies have been conducted on blood pressure monitors and their use at high altitude. This study is the first to evaluate the accuracy of an automatic blood pressure monitor in a high-altitude environment following a standard validation protocol. The Omron HEM-7201 upper arm blood pressure monitor was tested for accuracy in Lhasa, Tibet, China (3650 m above sea level) according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP2). Thirty-three participants received 9-10 sequential blood pressure measurements alternating between a mercury sphygmomanometer and the device. The mean device-observer measurement difference was 1.0±5.9 mm Hg for systolic blood pressure (SBP) and -3.1±4.6 mm Hg for diastolic blood pressure (DBP). Of the 99 measurement pairs analyzed, 72, 90 and 97 device readings were within 5, 10 and 15 mm Hg, respectively, of the observer measurements for SBP, and 68, 92 and 99 readings for DBP. The number of participants with at least two out of three measurements within 5 mm Hg was 27 for SBP and 25 for DBP. Three participants had no measurements within 5 mm Hg for either SBP or DBP. As a result, the Omron HEM-7201 passes the ESH-IP2 validation criteria and can therefore be recommended for use in adults in this setting.

Validation of the SEJOY BP-1307 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Lei, Lei; Chen, Yi; Chen, Qi; Li, Yan; Wang, Ji-Guang

2017-12-01

The present study aimed to evaluate the accuracy of the automated oscillometric upper-arm blood pressure monitor SEJOY BP-1307 (also called JOYTECH DBP-1307) for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese individuals (13 women, 45.1 years of mean age) using a mercury sphygmomanometer (two observers) and the SEJOY BP-1307 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The average±SD of the device-observer differences was 0.2±4.1 and -1.7±4.7 mmHg for systolic and diastolic blood pressure, respectively. The SEJOY BP-1307 device achieved the criteria in both part 1 and part 2 of the validation study. The SEJOY upper-arm blood pressure monitor BP-1307 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.

Validation of the Medipro MediCare 100f upper arm blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Yi, Jun; Wan, Yi; Pan, Feng; Yu, Xiaorong; Zhao, Huadong; Shang, Fujun; Xu, Yongyong

2011-08-01

The validation of sphygmomanometer is important in accurate blood pressure measurement. This study presents the validation results by the Medipro MediCare 100f upper arm blood pressure monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. The ESH-IP revision 2010 for the validation of blood pressure measuring devices in adults was followed precisely. A total of 99 couples of test device and reference blood pressure measurements were obtained during the study (three pairs for each of the 33 participants). The device produced 73, 93, and 98 measurements within 5, 10, and 15 mmHg for systolic blood pressure (SBP) and 79, 93, and 96 for diastolic blood pressure (DBP), respectively. The mean standard deviation device-observer difference was 1.4 ± 5.2 mmHg for SBP and 0.02±5.8 mmHg for DBP. The number of participants with two or three of the device-observer differences within 5 mmHg was 24 for SBP and 30 for DBP, whereas there was no participant with none of the device-observer differences within 5 mmHg. According to the results of the validation study based on the ESH-IP revision 2010, the Medipro MediCare 100f can be recommended for self-measurement in an adult population.

[Prognostic estimation in critical patients. Validation of a new and very simple system of prognostic estimation of survival in an intensive care unit].

Science.gov (United States)

Abizanda, R; Padron, A; Vidal, B; Mas, S; Belenguer, A; Madero, J; Heras, A

2006-04-01

To make the validation of a new system of prognostic estimation of survival in critical patients (EPEC) seen in a multidisciplinar Intensive care unit (ICU). Prospective analysis of a patient cohort seen in the ICU of a multidisciplinar Intensive Medicine Service of a reference teaching hospital with 19 beds. Four hundred eighty four patients admitted consecutively over 6 months in 2003. Data collection of a basic minimum data set that includes patient identification data (gender, age), reason for admission and their origin, prognostic estimation of survival by EPEC, MPM II 0 and SAPS II (the latter two considered as gold standard). Mortality was evaluated on hospital discharge. EPEC validation was done with analysis of its discriminating capacity (ROC curve), calibration of its prognostic capacity (Hosmer Lemeshow C test), resolution of the 2 x 2 Contingency tables around different probability values (20, 50, 70 and mean value of prognostic estimation). The standardized mortality rate (SMR) for each one of the methods was calculated. Linear regression of the EPEC regarding the MPM II 0 and SAPS II was established and concordance analyses were done (Bland-Altman test) of the prediction of mortality by the three systems. In spite of an apparently good linear correlation, similar accuracy of prediction and discrimination capacity, EPEC is not well-calibrated (no likelihood of death greater than 50%) and the concordance analyses show that more than 10% of the pairs were outside the 95% confidence interval. In spite of its ease of application and calculation and of incorporating delay of admission in ICU as a variable, EPEC does not offer any predictive advantage on MPM II 0 or SAPS II, and its predictions adapt to reality worse.

Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves.

Science.gov (United States)

Guyot, Patricia; Ades, A E; Ouwens, Mario J N M; Welton, Nicky J

2012-02-01

The results of Randomized Controlled Trials (RCTs) on time-to-event outcomes that are usually reported are median time to events and Cox Hazard Ratio. These do not constitute the sufficient statistics required for meta-analysis or cost-effectiveness analysis, and their use in secondary analyses requires strong assumptions that may not have been adequately tested. In order to enhance the quality of secondary data analyses, we propose a method which derives from the published Kaplan Meier survival curves a close approximation to the original individual patient time-to-event data from which they were generated. We develop an algorithm that maps from digitised curves back to KM data by finding numerical solutions to the inverted KM equations, using where available information on number of events and numbers at risk. The reproducibility and accuracy of survival probabilities, median survival times and hazard ratios based on reconstructed KM data was assessed by comparing published statistics (survival probabilities, medians and hazard ratios) with statistics based on repeated reconstructions by multiple observers. The validation exercise established there was no material systematic error and that there was a high degree of reproducibility for all statistics. Accuracy was excellent for survival probabilities and medians, for hazard ratios reasonable accuracy can only be obtained if at least numbers at risk or total number of events are reported. The algorithm is a reliable tool for meta-analysis and cost-effectiveness analyses of RCTs reporting time-to-event data. It is recommended that all RCTs should report information on numbers at risk and total number of events alongside KM curves.

Predicting implementation from organizational readiness for change: a study protocol

Directory of Open Access Journals (Sweden)

Kelly P Adam

2011-07-01

Full Text Available Abstract Background There is widespread interest in measuring organizational readiness to implement evidence-based practices in clinical care. However, there are a number of challenges to validating organizational measures, including inferential bias arising from the halo effect and method bias - two threats to validity that, while well-documented by organizational scholars, are often ignored in health services research. We describe a protocol to comprehensively assess the psychometric properties of a previously developed survey, the Organizational Readiness to Change Assessment. Objectives Our objective is to conduct a comprehensive assessment of the psychometric properties of the Organizational Readiness to Change Assessment incorporating methods specifically to address threats from halo effect and method bias. Methods and Design We will conduct three sets of analyses using longitudinal, secondary data from four partner projects, each testing interventions to improve the implementation of an evidence-based clinical practice. Partner projects field the Organizational Readiness to Change Assessment at baseline (n = 208 respondents; 53 facilities, and prospectively assesses the degree to which the evidence-based practice is implemented. We will conduct predictive and concurrent validities using hierarchical linear modeling and multivariate regression, respectively. For predictive validity, the outcome is the change from baseline to follow-up in the use of the evidence-based practice. We will use intra-class correlations derived from hierarchical linear models to assess inter-rater reliability. Two partner projects will also field measures of job satisfaction for convergent and discriminant validity analyses, and will field Organizational Readiness to Change Assessment measures at follow-up for concurrent validity (n = 158 respondents; 33 facilities. Convergent and discriminant validities will test associations between organizational readiness and

Validating an Observation Protocol to Measure Special Education Teacher Effectiveness

Science.gov (United States)

Johnson, Evelyn S.; Semmelroth, Carrie L.

2015-01-01

This study used Kane's (2013) Interpretation/Use Argument (IUA) to measure validity on the Recognizing Effective Special Education Teachers (RESET) observation tool. The RESET observation tool is designed to evaluate special education teacher effectiveness using evidence-based instructional practices as the basis for evaluation. In alignment with…

A gene expression signature associated with survival in metastatic melanoma

Science.gov (United States)

Mandruzzato, Susanna; Callegaro, Andrea; Turcatel, Gianluca; Francescato, Samuela; Montesco, Maria C; Chiarion-Sileni, Vanna; Mocellin, Simone; Rossi, Carlo R; Bicciato, Silvio; Wang, Ena; Marincola, Francesco M; Zanovello, Paola

2006-01-01

Background Current clinical and histopathological criteria used to define the prognosis of melanoma patients are inadequate for accurate prediction of clinical outcome. We investigated whether genome screening by means of high-throughput gene microarray might provide clinically useful information on patient survival. Methods Forty-three tumor tissues from 38 patients with stage III and stage IV melanoma were profiled with a 17,500 element cDNA microarray. Expression data were analyzed using significance analysis of microarrays (SAM) to identify genes associated with patient survival, and supervised principal components (SPC) to determine survival prediction. Results SAM analysis revealed a set of 80 probes, corresponding to 70 genes, associated with survival, i.e. 45 probes characterizing longer and 35 shorter survival times, respectively. These transcripts were included in a survival prediction model designed using SPC and cross-validation which allowed identifying 30 predicting probes out of the 80 associated with survival. Conclusion The longer-survival group of genes included those expressed in immune cells, both innate and acquired, confirming the interplay between immunological mechanisms and the natural history of melanoma. Genes linked to immune cells were totally lacking in the poor-survival group, which was instead associated with a number of genes related to highly proliferative and invasive tumor cells. PMID:17129373

A gene expression signature associated with survival in metastatic melanoma

Directory of Open Access Journals (Sweden)

Rossi Carlo R

2006-11-01

Full Text Available Abstract Background Current clinical and histopathological criteria used to define the prognosis of melanoma patients are inadequate for accurate prediction of clinical outcome. We investigated whether genome screening by means of high-throughput gene microarray might provide clinically useful information on patient survival. Methods Forty-three tumor tissues from 38 patients with stage III and stage IV melanoma were profiled with a 17,500 element cDNA microarray. Expression data were analyzed using significance analysis of microarrays (SAM to identify genes associated with patient survival, and supervised principal components (SPC to determine survival prediction. Results SAM analysis revealed a set of 80 probes, corresponding to 70 genes, associated with survival, i.e. 45 probes characterizing longer and 35 shorter survival times, respectively. These transcripts were included in a survival prediction model designed using SPC and cross-validation which allowed identifying 30 predicting probes out of the 80 associated with survival. Conclusion The longer-survival group of genes included those expressed in immune cells, both innate and acquired, confirming the interplay between immunological mechanisms and the natural history of melanoma. Genes linked to immune cells were totally lacking in the poor-survival group, which was instead associated with a number of genes related to highly proliferative and invasive tumor cells.

Sensitivity Analysis of Per-Protocol Time-to-Event Treatment Efficacy in Randomized Clinical Trials

Science.gov (United States)

Gilbert, Peter B.; Shepherd, Bryan E.; Hudgens, Michael G.

2013-01-01

Summary Assessing per-protocol treatment effcacy on a time-to-event endpoint is a common objective of randomized clinical trials. The typical analysis uses the same method employed for the intention-to-treat analysis (e.g., standard survival analysis) applied to the subgroup meeting protocol adherence criteria. However, due to potential post-randomization selection bias, this analysis may mislead about treatment efficacy. Moreover, while there is extensive literature on methods for assessing causal treatment effects in compliers, these methods do not apply to a common class of trials where a) the primary objective compares survival curves, b) it is inconceivable to assign participants to be adherent and event-free before adherence is measured, and c) the exclusion restriction assumption fails to hold. HIV vaccine efficacy trials including the recent RV144 trial exemplify this class, because many primary endpoints (e.g., HIV infections) occur before adherence is measured, and nonadherent subjects who receive some of the planned immunizations may be partially protected. Therefore, we develop methods for assessing per-protocol treatment efficacy for this problem class, considering three causal estimands of interest. Because these estimands are not identifiable from the observable data, we develop nonparametric bounds and semiparametric sensitivity analysis methods that yield estimated ignorance and uncertainty intervals. The methods are applied to RV144. PMID:24187408

SURVEY OF ENERGY COMPETENCE ROUTING PROTOCOL IN UTILIZING AODV IN MANETS (20150471)

OpenAIRE

TUSHAR SINGH RAJPUT; RAJ KUMAR PAUL

2018-01-01

In MANETs (Mobile unintentional Networks) communication at the mobile nodes will be achieved by mistreatment multihop wireless links. The aim of every protocol, in Associate in Nursing ad-hoc network, is to seek out valid routes between 2 communication nodes.

Survival outcomes and prognostic factors in mycosis fungoides/Sézary syndrome: validation of the revised International Society for Cutaneous Lymphomas/European Organisation for Research and Treatment of Cancer staging proposal.

Science.gov (United States)

Agar, Nita Sally; Wedgeworth, Emma; Crichton, Siobhan; Mitchell, Tracey J; Cox, Michael; Ferreira, Silvia; Robson, Alistair; Calonje, Eduardo; Stefanato, Catherine M; Wain, Elizabeth Mary; Wilkins, Bridget; Fields, Paul A; Dean, Alan; Webb, Katherine; Scarisbrick, Julia; Morris, Stephen; Whittaker, Sean J

2010-11-01

We have analyzed the outcome of mycosis fungoides (MF) and Sézary syndrome (SS) patients using the recent International Society for Cutaneous Lymphomas (ISCL)/European Organisation for Research and Treatment of Cancer (EORTC) revised staging proposal. Overall survival (OS), disease-specific survival (DSS), and risk of disease progression (RDP) were calculated for a cohort of 1,502 patients using univariate and multivariate models. The mean age at diagnosis was 54 years, and 71% of patients presented with early-stage disease. Disease progression occurred in 34%, and 26% of patients died due to MF/SS. A significant difference in survival and progression was noted for patients with early-stage disease having patches alone (T1a/T2a) compared with those having patches and plaques (T1b/T2b). Univariate analysis established that (1) advanced skin and overall clinical stage, increased age, male sex, increased lactate dehydrogenase (LDH), and large-cell transformation were associated with reduced survival and increased RDP; (2) hypopigmented MF, MF with lymphomatoid papulosis, and poikilodermatous MF were associated with improved survival and reduced RDP; and (3) folliculotropic MF was associated with an increased RDP. Multivariate analysis established that (1) advanced skin (T) stage, the presence in peripheral blood of the tumor clone without Sézary cells (B0b), increased LDH, and folliculotropic MF were independent predictors of poor survival and increased RDP; (2) large-cell transformation and tumor distribution were independent predictors of increased RDP only; and (3) N, M, and B stages; age; male sex; and poikilodermatous MF were only significant for survival. This study has validated the recently proposed ISCL/EORTC staging system and identified new prognostic factors.

Evaluation factors for verification and validation of low-level waste disposal site models

International Nuclear Information System (INIS)

Moran, M.S.; Mezga, L.J.

1982-01-01

The purpose of this paper is to identify general evaluation factors to be used to verify and validate LLW disposal site performance models in order to assess their site-specific applicability and to determine their accuracy and sensitivity. It is intended that the information contained in this paper be employed by model users involved with LLW site performance model verification and validation. It should not be construed as providing protocols, but rather as providing a framework for the preparation of specific protocols or procedures. A brief description of each evaluation factor is provided. The factors have been categorized according to recommended use during either the model verification or the model validation process. The general responsibilities of the developer and user are provided. In many cases it is difficult to separate the responsibilities of the developer and user, but the user is ultimately accountable for both verification and validation processes. 4 refs

Improvement in High-Grade Osteosarcoma Survival: Results from 202 Patients Treated at a Single Institution in Taiwan.

Science.gov (United States)

Hung, Giun-Yi; Yen, Hsiu-Ju; Yen, Chueh-Chuan; Wu, Po-Kuei; Chen, Cheng-Fong; Chen, Paul C-H; Wu, Hung-Ta H; Chiou, Hong-Jen; Chen, Wei-Ming

2016-04-01

The aim of this study was to compare survival before and after 2004 and define the prognostic factors for high-grade osteosarcomas beyond those of typical young patients with localized extremity disease. Few studies have reported the long-term treatment outcomes of high-grade osteosarcoma in Taiwan. A total of 202 patients with primary high-grade osteosarcoma who received primary chemotherapy at Taipei Veterans General Hospital between January 1995 and December 2011 were retrospectively evaluated and compared by period (1995-2003 vs 2004-2011). Patients of all ages and tumor sites and those following or not following controlled protocols were included in analysis of demographic, tumor-related, and treatment-related variables and survival. Overall survival and progression-free survival at 5 years were, respectively, 67.7% and 48% for all patients (n = 202), 77.3% and 57.1% for patients without metastasis (n = 157), and 33.9% and 14.8% for patients with metastasis (n = 45). The survival rates of patients treated after 2004 were significantly higher (by 13%-16%) compared with those of patients treated before 2004, with an accompanying 30% increase in histological good response rate (P = .002). Factors significantly contributing to inferior survival in univariate and multivariate analyses were diagnosis before 2004, metastasis at diagnosis, and being a noncandidate for a controlled treatment protocol. By comparison with the regimens used at our institution before 2004, the current results support the effectiveness of the post-2004 regimens, which consisted of substantially reduced cycles of high-dose methotrexate and a higher dosage of ifosfamide per cycle, cisplatin, and doxorubicin, for treating high-grade osteosarcoma in Asian patients.

A track-event theory of cell survival

Energy Technology Data Exchange (ETDEWEB)

Besserer, Juergen; Schneider, Uwe [Zuerich Univ. (Switzerland). Inst. of Physics; Radiotherapy Hirslanden, Zuerich (Switzerland)

2015-09-01

When fractionation schemes for hypofractionation and stereotactic body radiotherapy are considered, a reliable cell survival model at high dose is needed for calculating doses of similar biological effectiveness. In this work a simple model for cell survival which is valid also at high dose is developed from Poisson statistics. An event is defined by two double strand breaks (DSB) on the same or different chromosomes. An event is always lethal due to direct lethal damage or lethal binary misrepair by the formation of chromosome aberrations. Two different mechanisms can produce events: one-track events (OTE) or two-track-events (TTE). The target for an OTE is always a lethal event, the target for an TTE is one DSB. At least two TTEs on the same or different chromosomes are necessary to produce an event. Both, the OTE and the TTE are statistically independent. From the stochastic nature of cell kill which is described by the Poisson distribution the cell survival probability was derived. It was shown that a solution based on Poisson statistics exists for cell survival. It exhibits exponential cell survival at high dose and a finite gradient of cell survival at vanishing dose, which is in agreement with experimental cell studies. The model fits the experimental data nearly as well as the three-parameter formula of Hug-Kellerer and is only based on two free parameters. It is shown that the LQ formalism is an approximation of the model derived in this work. It could be also shown that the derived model predicts a fractionated cell survival experiment better than the LQ-model. It was shown that cell survival can be described with a simple analytical formula on the basis of Poisson statistics. This solution represents in the limit of large dose the typical exponential behavior and predicts cell survival after fractionated dose application better than the LQ-model.

A track-event theory of cell survival

International Nuclear Information System (INIS)

Besserer, Juergen; Schneider, Uwe

2015-01-01

When fractionation schemes for hypofractionation and stereotactic body radiotherapy are considered, a reliable cell survival model at high dose is needed for calculating doses of similar biological effectiveness. In this work a simple model for cell survival which is valid also at high dose is developed from Poisson statistics. An event is defined by two double strand breaks (DSB) on the same or different chromosomes. An event is always lethal due to direct lethal damage or lethal binary misrepair by the formation of chromosome aberrations. Two different mechanisms can produce events: one-track events (OTE) or two-track-events (TTE). The target for an OTE is always a lethal event, the target for an TTE is one DSB. At least two TTEs on the same or different chromosomes are necessary to produce an event. Both, the OTE and the TTE are statistically independent. From the stochastic nature of cell kill which is described by the Poisson distribution the cell survival probability was derived. It was shown that a solution based on Poisson statistics exists for cell survival. It exhibits exponential cell survival at high dose and a finite gradient of cell survival at vanishing dose, which is in agreement with experimental cell studies. The model fits the experimental data nearly as well as the three-parameter formula of Hug-Kellerer and is only based on two free parameters. It is shown that the LQ formalism is an approximation of the model derived in this work. It could be also shown that the derived model predicts a fractionated cell survival experiment better than the LQ-model. It was shown that cell survival can be described with a simple analytical formula on the basis of Poisson statistics. This solution represents in the limit of large dose the typical exponential behavior and predicts cell survival after fractionated dose application better than the LQ-model.

Bit Level Synchronized MAC Protocol for Multireader RFID Networks

Directory of Open Access Journals (Sweden)

Namboodiri Vinod

2010-01-01

Full Text Available The operation of multiple RFID readers in close proximity results in interference between the readers. This issue is termed the reader collision problem and cannot always be solved by assigning them to different frequency channels due to technical and regulatory limitations. The typical solution is to separate the operation of such readers across time. This sequential operation, however, results in a long delay to identify all tags. We present a bit level synchronized (BLSync MAC protocol for multi-reader RFID networks that allows multiple readers to operate simultaneously on the same frequency channel. The BLSync protocol solves the reader collision problem by allowing all readers to transmit the same query at the same time. We analyze the performance of using the BLSync protocol and demonstrate benefits of 40%–50% in terms of tag reading delay for most settings. The benefits of BLSync, first demonstrated through analysis, are then validated and quantified through simulations on realistic reader-tag layouts.

Review of epidemiological and clinical characteristics and overall survival in patients with colorectal cancer

Directory of Open Access Journals (Sweden)

Michelle Eisenhardt

2013-10-01

Full Text Available Backgound and Objectives: Colorectal cancer (CRC has high incidence, is often treatable and curable if diagnosed early. This study aimed to identify the epidemiological characteristic and assess overall survival in patients with CRC treated at a center specializing in oncology. Methods: Medical records of 127 patients with CRC were retrospectively evaluated. Clinical and epidemiological characteristics, in addition to treatment protocols and adverse reactions presented by patients were reviewed. The association of significance was assessed by chi-square and Fisher exact tests. The survival analyses were performed using the Kaplan-Meier method. The confidence interval was of 95% (p

Identification of a research protocol to study orthodontic tooth movement

Directory of Open Access Journals (Sweden)

Annalisa Dichicco

2014-06-01

Full Text Available Aim: The orthodontic movement is associated with a process of tissue remodeling together with the release of several chemical mediators in periodontal tissues. Each mediator is a potential marker of tooth movement and expresses biological processes as: tissue inflammation and bone remodeling. Different amounts of every mediator are present in several tissues and fluids of the oral cavity. Therefore, there are different methods that allow sampling with several degrees of invasiveness. Chemical mediators are also substances of different molecular nature, and multiple kind of analysis methods allow detection. The purpose of this study was to draft the best research protocol for an optimal study on orthodontic movement efficiency. Methods: An analysis of the international literature have been made, to identify the gold standard of each aspect of the protocol: type of mediator, source and method of sampling and analysis method. Results: From the analysis of the international literature was created an original research protocol for the study and the assessment of the orthodontic movement, by using the biomarkers of the tooth movement. Conclusions: The protocol created is based on the choice of the gold standard of every aspect already analyzed in the literature and in existing protocols for the monitoring of orthodontic tooth movement through the markers of tooth movement. Clinical trials re required for the evaluation and validation of the protocol created.

IEEE 802.11 Wireless LANs: Performance Analysis and Protocol Refinement

Directory of Open Access Journals (Sweden)

Chatzimisios P.

2005-01-01

Full Text Available The IEEE 802.11 protocol is emerging as a widely used standard and has become the most mature technology for wireless local area networks (WLANs. In this paper, we focus on the tuning of the IEEE 802.11 protocol parameters taking into consideration, in addition to throughput efficiency, performance metrics such as the average packet delay, the probability of a packet being discarded when it reaches the maximum retransmission limit, the average time to drop a packet, and the packet interarrival time. We present an analysis, which has been validated by simulation that is based on a Markov chain model commonly used in the literature. We further study the improvement on these performance metrics by employing suitable protocol parameters according to the specific communication needs of the IEEE 802.11 protocol for both basic access and RTS/CTS access schemes. We show that the use of a higher initial contention window size does not considerably degrade performance in small networks and performs significantly better in any other scenario. Moreover, we conclude that the combination of a lower maximum contention window size and a higher retry limit considerably improves performance. Results indicate that the appropriate adjustment of the protocol parameters enhances performance and improves the services that the IEEE 802.11 protocol provides to various communication applications.

Evaluating Psychometric Characteristics of Detection Protocol of Malingering Stuttering

Directory of Open Access Journals (Sweden)

Arsia Thaghva

2017-07-01

Conclusion According to the results, the detection protocol of malingering stuttering is of good internal consistency and concurrent validity. However, considering that the sample population was not large in the present study, it can be said that this study is a preliminary evaluation to find the psychometric features of the instruments, with the aim of laying the groundwork for further studies.

RESULTS OF ACUTE LYMPHOBLASTIC LEUKEMIA TREATMENT WITH INTENSIVE CHEMOTHERAPY IN CHILDREN IN ST.-PETERSBURG: RETROSPECTIVE EVALUATION OF TWO VERSIONS OF COALL-92 PROTOCOL

Directory of Open Access Journals (Sweden)

E.G. Boichenko

2011-01-01

Full Text Available Regardless the success gained in treatment of acute lymphoblastic leukaemia, several problems still remain to be solved, such as: overcoming primary drug resistance and minimizing the amount of relapses as well as decreasing of chemotherapy toxicity without detriment to the final outcome of the treatment. Development of an optimal chemotherapeutical strategy still remains a hot issue. Objective: to evaluate an efficacy of two modifications of German protocol COALL-92 in treatment of ALL in children in St.-Petersburg. Methods: the retrospective analysis of results of treatment in patients under 18 years old with ALL was performed. The diagnosis was confirmed according to international criteria. The treatment was performed via protocols PECO-92 and COALL-St.-Petersburg-92. Results: 438 initial patients with ALL were treated in St.-Petersburg clinics during the period from 01.01.1993 to 01.01.2007. At the time of analysis the probability of event-free survival (pEFS was 60% in group of PECO-92 protocol and 70% — in COALL group (plog-rank = 0,048, probability of relapse-free survival (рRFS was 65 and 74% (plog-rank = 0,002, probability of overall survival was (pOS 78 and 70%, correspondingly (plog-rank = 0,079. Conclusion: inclusion of protocol treatment in practice of St.-Petersburg hospitals resulted in significant improvement of treatment results in children with ALL. The problem of both versions of COALL protocol is high rate of postremission mortality due to high toxicity of intensive stage if chemotherapy.Key words: children, acute lymphoblastic leukemia, intensive chemotherapy.(Voprosy sovremennoi pediatrii — Current Pediatrics. 2011; 10 (3: 33–42

Validation of the AVITA BPM63S upper arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Kang, Yuan-Yuan; Zeng, Wei-Fang; Liu, Ming; Li, Yan; Wang, Ji-Guang

2014-02-01

The present study aimed to evaluate the accuracy of the AVITA BPM63S upper arm blood pressure monitor for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese (14 women, mean age of 47 years) using a mercury sphygmomanometer (two observers) and the AVITA BPM63S device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. All the blood pressure requirements were fulfilled. The AVITA BPM63S device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 68/99, 89/99, and 96/99, respectively, for systolic blood pressure, and 75/99, 95/99, and 97/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Twenty-four and 25 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observers differences within 5 mmHg (required ≥24). One and two participants for systolic and diastolic blood pressure, respectively, had all three device-observers differences greater than 5 mmHg. The AVITA BPM63S automated oscillometric upper arm blood pressure monitor has passed the requirements of the International Protocol revision 2010, and hence can be recommended for blood pressure measurement at home in adults.

Validation of four devices: Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 for home blood pressure measurement according to the European Society of Hypertension International Protocol

Directory of Open Access Journals (Sweden)

Topouchian J

2014-01-01

Full Text Available Jirar Topouchian,1 Davide Agnoletti,1 Jacques Blacher,1 Ahmed Youssef,1 Mirna N Chahine,2,3 Isabel Ibanez,3 Nathalie Assemani,3 Roland Asmar1–31Centre de Diagnostic, Hôpital Hôtel-Dieu, Paris, France; 2Faculty of Medicine of the Lebanese University, 3Foundation-Medical Research Institutes, Beirut, LebanonBackground: Four oscillometric devices, including the Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670, designed for self-blood pressure measurement (SBPM were evaluated according to the European Society of Hypertension (ESH International Protocol Revision 2010 in four separate studies.Methods: The four devices measure brachial blood pressure (BP using the oscillometric method. The Withings BP-800 has to be connected to an Apple® iOS device such as an iPhone®, iPad®, or iPod®. The ESH International Protocol Revision 2010 includes a total number of 33 subjects. The difference between observer and device BP values was calculated for each measure. Ninety-nine pairs of BP differences were classified into three categories (≤5 mmHg, ≤10 mmHg, ≤15 mmHg. The protocol procedures were followed precisely in each of the four studies.Results: All four tested devices passed the validation process. The mean differences between the device and mercury readings were: −1.8±5.1 mmHg and −0.4±2.8 mmHg for systolic and diastolic BP, respectively, using the Omron M6 Comfort device; 2.5±4.6 mmHg and −1.2±4.3 mmHg for the Omron HEM-7420 device; −0.2±5.0 mmHg and 0.4±4.2 mmHg for the Withings BP-800 device; and 3.0±5.3 mmHg and 0.3±5.2 mmHg for the Polygreen KP-7670 device.Conclusion: Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 readings differing by less than 5 mmHg, 10 mmHg, and 15 mmHg fulfill the ESH International Protocol Revision 2010 requirements, and therefore are suitable for use by patients for SBPM, if used correctly.Keywords: Omron M6 Comfort, Omron HEM-7420, Withings BP-800

A Protocol Layer Trust-Based Intrusion Detection Scheme for Wireless Sensor Networks

Directory of Open Access Journals (Sweden)

Jian Wang

2017-05-01

Full Text Available This article proposes a protocol layer trust-based intrusion detection scheme for wireless sensor networks. Unlike existing work, the trust value of a sensor node is evaluated according to the deviations of key parameters at each protocol layer considering the attacks initiated at different protocol layers will inevitably have impacts on the parameters of the corresponding protocol layers. For simplicity, the paper mainly considers three aspects of trustworthiness, namely physical layer trust, media access control layer trust and network layer trust. The per-layer trust metrics are then combined to determine the overall trust metric of a sensor node. The performance of the proposed intrusion detection mechanism is then analyzed using the t-distribution to derive analytical results of false positive and false negative probabilities. Numerical analytical results, validated by simulation results, are presented in different attack scenarios. It is shown that the proposed protocol layer trust-based intrusion detection scheme outperforms a state-of-the-art scheme in terms of detection probability and false probability, demonstrating its usefulness for detecting cross-layer attacks.

Distributed synchronization of networked drive-response systems: A nonlinear fixed-time protocol.

Science.gov (United States)

Zhao, Wen; Liu, Gang; Ma, Xi; He, Bing; Dong, Yunfeng

2017-11-01

The distributed synchronization of networked drive-response systems is investigated in this paper. A novel nonlinear protocol is proposed to ensure that the tracking errors converge to zeros in a fixed-time. By comparison with previous synchronization methods, the present method considers more practical conditions and the synchronization time is not dependent of arbitrary initial conditions but can be offline pre-assign according to the task assignment. Finally, the feasibility and validity of the presented protocol have been illustrated by a numerical simulation. Copyright © 2017. Published by Elsevier Ltd.

Determine the Influence of Time Held in “Knockdown” Anesthesia on Survival and Stress of Surgically Implanted Juvenile Salmonids

Energy Technology Data Exchange (ETDEWEB)

Woodley, Christa M.; Wagner, Katie A.; Knox, Kasey M.

2012-01-31

The Juvenile Salmon Acoustic Telemetry System (JSATS) was developed for the U.S. Army Corp of Engineers Portland District (USACE) to address questions related to survival and performance measures of juvenile salmonids as they pass through the Federal Columbia River Power System (FCRPS). Researchers using JSATS acoustic transmitters (ATs) were tasked with standardizing the surgical implantation procedure to ensure that the stressors of handling and surgery on salmonids were consistent and less likely to cause effects of tagging in survival studies. Researchers questioned whether the exposure time in 'knockdown' anesthesia (or induction) to prepare fish for surgery could influence the survival of study fish (CBSPSC 2011). Currently, fish are held in knockdown anesthesia after they reach Stage 4 anesthesia until the completion of the surgical implantation of a transmitter, varies from 5 to 15 minutes for studies conducted in the Columbia Basin. The Columbia Basin Surgical Protocol Steering Committee (CBSPSC ) expressed concern that its currently recommended 10-minute maximum time limit during which fish are held in anesthetic - tricaine methanesulfonate (MS-222, 80 mg L-1 water) - could increase behavioral and physiological costs, and/or decrease survival of outmigrating juvenile salmonids. In addition, the variability in the time fish are held at Stage 4 could affect the data intended for direct comparison of fish within or among survival studies. Under the current recommended protocol, if fish exceed the 10-minute time limit, they are to be released without surgical implantation, thereby increasing the number of fish handled and endangered species 'take' at the bypass systems for FCRPS survival studies.

Applications of Multi-Channel Safety Authentication Protocols in Wireless Networks.

Science.gov (United States)

Chen, Young-Long; Liau, Ren-Hau; Chang, Liang-Yu

2016-01-01

People can use their web browser or mobile devices to access web services and applications which are built into these servers. Users have to input their identity and password to login the server. The identity and password may be appropriated by hackers when the network environment is not safe. The multiple secure authentication protocol can improve the security of the network environment. Mobile devices can be used to pass the authentication messages through Wi-Fi or 3G networks to serve as a second communication channel. The content of the message number is not considered in a multiple secure authentication protocol. The more excessive transmission of messages would be easier to collect and decode by hackers. In this paper, we propose two schemes which allow the server to validate the user and reduce the number of messages using the XOR operation. Our schemes can improve the security of the authentication protocol. The experimental results show that our proposed authentication protocols are more secure and effective. In regard to applications of second authentication communication channels for a smart access control system, identity identification and E-wallet, our proposed authentication protocols can ensure the safety of person and property, and achieve more effective security management mechanisms.

[Validation of the Omron HEM-650 wrist blood pressure device using the British Hypertension Society protocol in emergency patients in Hong Kong].

Science.gov (United States)

Hung, Kevin KC; Lai, W Y; Cocks, Robert A; Rainer, Timothy H; Graham, Colin A

2015-10-01

Automated wrist cuff blood pressure (BP) devices are more compact and easier to use, particularly when access to the upper arm is restricted, for example in emergencies. We tested the Omron HEM-650 wrist device using the validation criteria of the British Hypertension Society (BHS) protocol in a major emergency department (ED) in Hong Kong. 85 patients had three measurements each by both the Omron HEM-650 wrist device and the mercury sphygmomanometer. The conventional automated BP with arm cuff was also measured using an oscillometric (Colin BP-88S NXT) device for comparison. The Omron HEM-650 achieved a grade B for both systolic and diastolic BP and demonstrated acceptable accuracy and reliability in Chinese patients in the emergency setting. The Omron HEM 650 wrist device can be recommended for use in adult emergency patients. Further research is warranted for its use in pregnant women and critically ill patients.

Digital correction of magnification in pelvic x rays for preoperative planning of hip joint replacements: Theoretical development and clinical results of a new protocol

International Nuclear Information System (INIS)

The, B.; Diercks, R.L.; Stewart, R.E.; Ooijen, P.M.A. van; Horn, J.R. van

2005-01-01

The introduction of digital radiological facilities leads to the necessity of digital preoperative planning, which is an essential part of joint replacement surgery. To avoid errors in the preparation and execution of hip surgery, reliable correction of the magnification of the projected hip is a prerequisite. So far, no validated method exists to accomplish this. We present validated geometrical models of the x-ray projection of spheres, relevant for the calibration procedure to correct for the radiographic magnification. With help of these models a new calibration protocol was developed. The validity and precision of this procedure was determined in clinical practice. Magnification factors could be predicted with a maximal margin of error of 1.5%. The new calibration protocol is valid and reliable. The clinical tests revealed that correction of magnification has a 95% margin of error of -3% to +3%. Future research might clarify if a strict calibration protocol, as presented in this study, results in more accurate preoperative planning of hip joint replacements

Clinical prediction of 5-year survival in systemic sclerosis

DEFF Research Database (Denmark)

Fransen, Julie Munk; Popa-Diaconu, D; Hesselstrand, R

2011-01-01

Systemic sclerosis (SSc) is associated with a significant reduction in life expectancy. A simple prognostic model to predict 5-year survival in SSc was developed in 1999 in 280 patients, but it has not been validated in other patients. The predictions of a prognostic model are usually less accura...

Validation of asthma recording in electronic health records: protocol for a systematic review.

Science.gov (United States)

Nissen, Francis; Quint, Jennifer K; Wilkinson, Samantha; Mullerova, Hana; Smeeth, Liam; Douglas, Ian J

2017-05-29

Asthma is a common, heterogeneous disease with significant morbidity and mortality worldwide. It can be difficult to define in epidemiological studies using electronic health records as the diagnosis is based on non-specific respiratory symptoms and spirometry, neither of which are routinely registered. Electronic health records can nonetheless be valuable to study the epidemiology, management, healthcare use and control of asthma. For health databases to be useful sources of information, asthma diagnoses should ideally be validated. The primary objectives are to provide an overview of the methods used to validate asthma diagnoses in electronic health records and summarise the results of the validation studies. EMBASE and MEDLINE will be systematically searched for appropriate search terms. The searches will cover all studies in these databases up to October 2016 with no start date and will yield studies that have validated algorithms or codes for the diagnosis of asthma in electronic health records. At least one test validation measure (sensitivity, specificity, positive predictive value, negative predictive value or other) is necessary for inclusion. In addition, we require the validated algorithms to be compared with an external golden standard, such as a manual review, a questionnaire or an independent second database. We will summarise key data including author, year of publication, country, time period, date, data source, population, case characteristics, clinical events, algorithms, gold standard and validation statistics in a uniform table. This study is a synthesis of previously published studies and, therefore, no ethical approval is required. The results will be submitted to a peer-reviewed journal for publication. Results from this systematic review can be used to study outcome research on asthma and can be used to identify case definitions for asthma. CRD42016041798. © Article author(s) (or their employer(s) unless otherwise stated in the text of the

Compact Modbus TCP/IP protocol for data acquisition systems based on limited hardware resources

Science.gov (United States)

Bai, Q.; Jin, B.; Wang, D.; Wang, Y.; Liu, X.

2018-04-01

The Modbus TCP/IP has been a standard industry communication protocol and widely utilized for establishing sensor-cloud platforms on the Internet. However, numerous existing data acquisition systems built on traditional single-chip microcontrollers without sufficient resources cannot support it, because the complete Modbus TCP/IP protocol always works dependent on a full operating system which occupies abundant hardware resources. Hence, a compact Modbus TCP/IP protocol is proposed in this work to make it run efficiently and stably even on a resource-limited hardware platform. Firstly, the Modbus TCP/IP protocol stack is analyzed and the refined protocol suite is rebuilt by streamlining the typical TCP/IP suite. Then, specific implementation of every hierarchical layer is respectively presented in detail according to the protocol structure. Besides, the compact protocol is implemented in a traditional microprocessor to validate the feasibility of the scheme. Finally, the performance of the proposed scenario is assessed. The experimental results demonstrate that message packets match the frame format of Modbus TCP/IP protocol and the average bandwidth reaches to 1.15 Mbps. The compact protocol operates stably even based on a traditional microcontroller with only 4-kB RAM and 12-MHz system clock, and no communication congestion or frequent packet loss occurs.

Do thallium myocardial perfusion scan abnormalities predict survival in sarcoid patients without cardiac symptoms

International Nuclear Information System (INIS)

Kinney, E.L.; Caldwell, J.W.

1990-01-01

Whereas the total mortality rate for sarcoidosis is 0.2 per 100,000, the prognosis, when the heart is involved, is very much worse. The authors used the difference in mortality rate to infer whether thallium 201 myocardial perfusion scan abnormalities correspond to myocardial sarcoid by making the simplifying assumption that if they do, then patients with abnormal scans will be found to have a death rate similar to patients with sarcoid heart disease. The authors therefore analyzed complete survival data on 52 sarcoid patients without cardiac symptoms an average of eighty-nine months after they had been scanned as part of a protocol. By use of survival analysis (the Cox proportional hazards model), the only variable that was significantly associated with survival was age. The patients' scan pattern, treatment status, gender, and race were not significantly related to survival. The authors conclude that thallium myocardial perfusion scans cannot reliably be used to diagnose sarcoid heart disease in sarcoid patients without cardiac symptoms

Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves

Directory of Open Access Journals (Sweden)

Guyot Patricia

2012-02-01

Full Text Available Abstract Background The results of Randomized Controlled Trials (RCTs on time-to-event outcomes that are usually reported are median time to events and Cox Hazard Ratio. These do not constitute the sufficient statistics required for meta-analysis or cost-effectiveness analysis, and their use in secondary analyses requires strong assumptions that may not have been adequately tested. In order to enhance the quality of secondary data analyses, we propose a method which derives from the published Kaplan Meier survival curves a close approximation to the original individual patient time-to-event data from which they were generated. Methods We develop an algorithm that maps from digitised curves back to KM data by finding numerical solutions to the inverted KM equations, using where available information on number of events and numbers at risk. The reproducibility and accuracy of survival probabilities, median survival times and hazard ratios based on reconstructed KM data was assessed by comparing published statistics (survival probabilities, medians and hazard ratios with statistics based on repeated reconstructions by multiple observers. Results The validation exercise established there was no material systematic error and that there was a high degree of reproducibility for all statistics. Accuracy was excellent for survival probabilities and medians, for hazard ratios reasonable accuracy can only be obtained if at least numbers at risk or total number of events are reported. Conclusion The algorithm is a reliable tool for meta-analysis and cost-effectiveness analyses of RCTs reporting time-to-event data. It is recommended that all RCTs should report information on numbers at risk and total number of events alongside KM curves.

Validation and Development of a Modified Breast Graded Prognostic Assessment As a Tool for Survival in Patients With Breast Cancer and Brain Metastases.

Science.gov (United States)

Subbiah, Ishwaria M; Lei, Xiudong; Weinberg, Jeffrey S; Sulman, Erik P; Chavez-MacGregor, Mariana; Tripathy, Debu; Gupta, Rohan; Varma, Ankur; Chouhan, Jay; Guevarra, Richard P; Valero, Vicente; Gilbert, Mark R; Gonzalez-Angulo, Ana M

2015-07-10

Several indices have been developed to predict overall survival (OS) in patients with breast cancer with brain metastases, including the breast graded prognostic assessment (breast-GPA), comprising age, tumor subtype, and Karnofsky performance score. However, number of brain metastases-a highly relevant clinical variable-is less often incorporated into the final model. We sought to validate the existing breast-GPA in an independent larger cohort and refine it integrating number of brain metastases. Data were retrospectively gathered from a prospectively maintained institutional database. Patients with newly diagnosed brain metastases from 1996 to 2013 were identified. After validating the breast-GPA, multivariable Cox regression and recursive partitioning analysis led to the development of the modified breast-GPA. The performances of the breast-GPA and modified breast-GPA were compared using the concordance index. In our cohort of 1,552 patients, the breast-GPA was validated as a prognostic tool for OS (P three v ≤ three), both were independent predictors of OS. We therefore developed the modified breast-GPA integrating a fourth clinical parameter. Recursive partitioning analysis reinforced the prognostic significance of these four factors. Concordance indices were 0.78 (95% CI, 0.77 to 0.80) and 0.84 (95% CI, 0.83 to 0.85) for the breast-GPA and modified breast-GPA, respectively (P formative part of the clinician's discussion of prognosis and direction of care and as a potential patient selection tool for clinical trials. © 2015 by American Society of Clinical Oncology.

ABO-Incompatible Adult Living Donor Liver Transplantation Under the Desensitization Protocol With Rituximab.

Science.gov (United States)

Song, G-W; Lee, S-G; Hwang, S; Kim, K-H; Ahn, C-S; Moon, D-B; Ha, T-Y; Jung, D-H; Park, G-C; Kim, W-J; Sin, M-H; Yoon, Y-I; Kang, W-H; Kim, S-H; Tak, E-Y

2016-01-01

ABO incompatibility is no longer considered a contraindication for adult living donor liver transplantation (ALDLT) due to various strategies to overcome the ABO blood group barrier. We report the largest single-center experience of ABO-incompatible (ABOi) ALDLT in 235 adult patients. The desensitization protocol included a single dose of rituximab and total plasma exchange. In addition, local graft infusion therapy, cyclophosphamide, or splenectomy was used for a certain time period, but these treatments were eventually discontinued due to adverse events. There were three cases (1.3%) of in-hospital mortality. The cumulative 3-year graft and patient survival rates were 89.2% and 92.3%, respectively, and were comparable to those of the ABO-compatible group (n = 1301). Despite promising survival outcomes, 17 patients (7.2%) experienced antibody-mediated rejection that manifested as diffuse intrahepatic biliary stricture; six cases required retransplantation, and three patients died. ABOi ALDLT is a feasible method for expanding a living liver donor pool, but the efficacy of the desensitization protocol in targeting B cell immunity should be optimized. © Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.

Effect of a low fat versus a low carbohydrate weight loss dietary intervention on biomarkers of long term survival in breast cancer patients ('CHOICE'): study protocol

International Nuclear Information System (INIS)

Sedlacek, Scot M; Playdon, Mary C; Wolfe, Pamela; McGinley, John N; Wisthoff, Mark R; Daeninck, Elizabeth A; Jiang, Weiqin; Zhu, Zongjian; Thompson, Henry J

2011-01-01

Weight loss in overweight or obese breast cancer patients is associated with an improved prognosis for long term survival. However, it is not clear whether the macronutrient composition of the chosen weight loss dietary plan imparts further prognostic benefit. A study protocol is presented for a dietary intervention to investigate the effects of weight loss dietary patterns that vary markedly in fat and carbohydrate contents on biomarkers of exposure to metabolic processes that may promote tumorigenesis and that are predictive of long term survival. The study will also determine how much weight must be lost for biomarkers to change in a favorable direction. Approximately 370 overweight or obese postmenopausal breast cancer survivors (body mass index: 25.0 to 34.9 kg/m 2 ) will be accrued and assigned to one of two weight loss intervention programs or a non-intervention control group. The dietary intervention is implemented in a free living population to test the two extremes of popular weight loss dietary patterns: a high carbohydrate, low fat diet versus a low carbohydrate, high fat diet. The effects of these dietary patterns on biomarkers for glucose homeostasis, chronic inflammation, cellular oxidation, and steroid sex hormone metabolism will be measured. Participants will attend 3 screening and dietary education visits, and 7 monthly one-on-one dietary counseling and clinical data measurement visits in addition to 5 group visits in the intervention arms. Participants in the control arm will attend two clinical data measurement visits at baseline and 6 months. The primary outcome is high sensitivity C-reactive protein. Secondary outcomes include interleukin-6, tumor necrosis factor-α, insulin-like growth factor-1 (IGF), IGF binding protein-3, 8-isoprostane-F2-alpha, estrone, estradiol, progesterone, sex hormone binding globulin, adiponectin, and leptin. While clinical data indicate that excess weight for height is associated with poor prognosis for long term

Development and external validation of nomograms to predict the risk of skeletal metastasis at the time of diagnosis and skeletal metastasis-free survival in nasopharyngeal carcinoma.

Science.gov (United States)

Yang, Lin; Xia, Liangping; Wang, Yan; He, Shasha; Chen, Haiyang; Liang, Shaobo; Peng, Peijian; Hong, Shaodong; Chen, Yong

2017-09-06

The skeletal system is the most common site of distant metastasis in nasopharyngeal carcinoma (NPC); various prognostic factors have been reported for skeletal metastasis, though most studies have focused on a single factor. We aimed to establish nomograms to effectively predict skeletal metastasis at initial diagnosis (SMAD) and skeletal metastasis-free survival (SMFS) in NPC. A total of 2685 patients with NPC who received bone scintigraphy (BS) and/or 18F-deoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) and 2496 patients without skeletal metastasis were retrospectively assessed to develop individual nomograms for SMAD and SMFS. The models were validated externally using separate cohorts of 1329 and 1231 patients treated at two other institutions. Five independent prognostic factors were included in each nomogram. The SMAD nomogram had a significantly higher c-index than the TNM staging system (training cohort, P = 0.005; validation cohort, P system (P skeletal metastasis, which may improve counseling and facilitate individualized management of patients with NPC.

Neuroanatomy-based matrix-guided trimming protocol for the rat brain.

Science.gov (United States)

Defazio, Rossella; Criado, Ana; Zantedeschi, Valentina; Scanziani, Eugenio

2015-02-01

Brain trimming through defined neuroanatomical landmarks is recommended to obtain consistent sections in rat toxicity studies. In this article, we describe a matrix-guided trimming protocol that uses channels to reproduce coronal levels of anatomical landmarks. Both setup phase and validation study were performed on Han Wistar male rats (Crl:WI(Han)), 10-week-old, with bodyweight of 298 ± 29 (SD) g, using a matrix (ASI-Instruments(®), Houston, TX) fitted for brains of rats with 200 to 400 g bodyweight. In the setup phase, we identified eight channels, that is, 6, 8, 10, 12, 14, 16, 19, and 21, matching the recommended landmarks midway to the optic chiasm, frontal pole, optic chiasm, infundibulum, mamillary bodies, midbrain, middle cerebellum, and posterior cerebellum, respectively. In the validation study, we trimmed the immersion-fixed brains of 60 rats using the selected channels to determine how consistently the channels reproduced anatomical landmarks. Percentage of success (i.e., presence of expected targets for each level) ranged from 89 to 100%. Where 100% success was not achieved, it was noted that the shift in brain trimming was toward the caudal pole. In conclusion, we developed and validated a trimming protocol for the rat brain that allow comparable extensiveness, homology, and relevance of coronal sections as the landmark-guided trimming with the advantage of being quickly learned by technicians. © 2014 by The Author(s).

An Enhanced Reservation-Based MAC Protocol for IEEE 802.15.4 Networks

Science.gov (United States)

Afonso, José A.; Silva, Helder D.; Macedo, Pedro; Rocha, Luis A.

2011-01-01

The IEEE 802.15.4 Medium Access Control (MAC) protocol is an enabling standard for wireless sensor networks. In order to support applications requiring dedicated bandwidth or bounded delay, it provides a reservation-based scheme named Guaranteed Time Slot (GTS). However, the GTS scheme presents some drawbacks, such as inefficient bandwidth utilization and support to a maximum of only seven devices. This paper presents eLPRT (enhanced Low Power Real Time), a new reservation-based MAC protocol that introduces several performance enhancing features in comparison to the GTS scheme. This MAC protocol builds on top of LPRT (Low Power Real Time) and includes various mechanisms designed to increase data transmission reliability against channel errors, improve bandwidth utilization and increase the number of supported devices. A motion capture system based on inertial and magnetic sensors has been used to validate the protocol. The effectiveness of the performance enhancements introduced by each of the new features is demonstrated through the provision of both simulation and experimental results. PMID:22163826

Method validation for preparing serum and plasma samples from human blood for downstream proteomic, metabolomic, and circulating nucleic acid-based applications.

Science.gov (United States)

Ammerlaan, Wim; Trezzi, Jean-Pierre; Lescuyer, Pierre; Mathay, Conny; Hiller, Karsten; Betsou, Fay

2014-08-01

Formal method validation for biospecimen processing in the context of accreditation in laboratories and biobanks is lacking. Serum and plasma processing protocols were validated for fitness-for-purpose in terms of key downstream endpoints, and this article demonstrates methodology for biospecimen processing method validation. Serum and plasma preparation from human blood was optimized for centrifugation conditions with respect to microparticle counts. Optimal protocols were validated for methodology and reproducibility in terms of acceptance criteria based on microparticle counts, DNA and hemoglobin concentration, and metabolomic and proteomic profiles. These parameters were also used to evaluate robustness for centrifugation temperature (4°C versus room temperature [RT]), deceleration (low, medium, high) and blood stability (after a 2-hour delay). Optimal protocols were 10-min centrifugation for serum and 20-min for plasma at 2000 g, medium brake, RT. Methodology and reproducibility acceptance criteria were met for both protocols except for reproducibility of plasma metabolomics. Overall, neither protocol was robust for centrifugation at 4°C versus RT. RT gave higher microparticles and free DNA yields in serum, and fewer microparticles with less hemolysis in plasma. Overall, both protocols were robust for fast, medium, and low deceleration, with a medium brake considered optimal. Pre-centrifugation stability after a 2-hour delay was seen at both temperatures for hemoglobin concentration and proteomics, but not for microparticle counts. We validated serum and plasma collection methods suitable for downstream protein, metabolite, or free nucleic acid-based applications. Temperature and pre-centrifugation delay can influence analytic results, and laboratories and biobanks should systematically record these conditions in the scope of accreditation.

A nomogram to predict the survival of stage IIIA-N2 non-small cell lung cancer after surgery.

Science.gov (United States)

Mao, Qixing; Xia, Wenjie; Dong, Gaochao; Chen, Shuqi; Wang, Anpeng; Jin, Guangfu; Jiang, Feng; Xu, Lin

2018-04-01

Postoperative survival of patients with stage IIIA-N2 non-small cell lung cancer (NSCLC) is highly heterogeneous. Here, we aimed to identify variables associated with postoperative survival and develop a tool for survival prediction. A retrospective review was performed in the Surveillance, Epidemiology, and End Results database from January 2004 to December 2009. Significant variables were selected by use of the backward stepwise method. The nomogram was constructed with multivariable Cox regression. The model's performance was evaluated by concordance index and calibration curve. The model was validated via an independent cohort from the Jiangsu Cancer Hospital Lung Cancer Center. A total of 1809 patients with stage IIIA-N2 NSCLC who underwent surgery were included in the training cohort. Age, sex, grade, histology, tumor size, visceral pleural invasion, positive lymph nodes, lymph nodes examined, and surgery type (lobectomy vs pneumonectomy) were identified as significant prognostic variables using backward stepwise method. A nomogram was developed from the training cohort and validated using an independent Chinese cohort. The concordance index of the model was 0.673 (95% confidence interval, 0.654-0.692) in training cohort and 0.664 in validation cohort (95% confidence interval, 0.614-0.714). The calibration plot showed optimal consistency between nomogram predicted survival and observed survival. Survival analyses demonstrated significant differences between different subgroups stratified by prognostic scores. This nomogram provided the individual survival prediction for patients with stage IIIA-N2 NSCLC after surgery, which might benefit survival counseling for patients and clinicians, clinical trial design and follow-up, as well as postoperative strategy-making. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

A protocol for classifying ecologically relevant marine zones, a statistical approach

Science.gov (United States)

Verfaillie, Els; Degraer, Steven; Schelfaut, Kristien; Willems, Wouter; Van Lancker, Vera

2009-06-01

Mapping ecologically relevant zones in the marine environment has become increasingly important. Biological data are however often scarce and alternatives are being sought in optimal classifications of abiotic variables. The concept of 'marine landscapes' is based on a hierarchical classification of geological, hydrographic and other physical data. This approach is however subject to many assumptions and subjective decisions. An objective protocol for zonation is being proposed here where abiotic variables are subjected to a statistical approach, using principal components analysis (PCA) and a cluster analysis. The optimal number of clusters (or zones) is being defined using the Calinski-Harabasz criterion. The methodology has been applied on datasets of the Belgian part of the North Sea (BPNS), a shallow sandy shelf environment with a sandbank-swale topography. The BPNS was classified into 8 zones that represent well the natural variability of the seafloor. The internal cluster consistency was validated with a split-run procedure, with more than 99% correspondence between the validation and the original dataset. The ecological relevance of 6 out of the 8 zones was demonstrated, using indicator species analysis. The proposed protocol, as exemplified for the BPNS, can easily be applied to other areas and provides a strong knowledge basis for environmental protection and management of the marine environment. A SWOT-analysis, showing the strengths, weaknesses, opportunities and threats of the protocol was performed.

Validation of the Tensoval Duo Control II blood pressure monitor for clinic use and self-measurement according to the British Hypertension Society protocol and the European Society of Hypertension International Protocol Revision 2010.

Science.gov (United States)

de Greeff, Annemarie; Shennan, Andrew H

2013-06-01

The Tensoval Duo Control II is an automated upper arm device that uses a combination of oscillometric and auscultatory technology to determine blood pressure noninvasively. The accuracy of this device was assessed according to the British Hypertension Society (BHS) protocol and the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) in an adult population. Ethical approval was obtained. Eighty-five and 33 adult individuals, respectively, were recruited to fulfil the requirements of each protocol. Trained observers took nine sequential same-arm measurements alternating between a mercury sphygmomanometer and the device. The device had to achieve at least a B grade for both systolic and diastolic pressures to pass the BHS protocol and had to fulfil the criteria of all three phases of the ESH-IP2 protocol to receive recommendation. The device achieved an A/A grading for the BHS protocol and passed all three phases of the ESH-IP2 protocol. The mean difference±SD for the BHS/ESH protocols, respectively, was -1.8±6.5/-0.7±5.7 mmHg for systolic pressure and 1.9±5.1/2.4±4.5 mmHg for diastolic pressure. The device maintained its A/A grading throughout the low-pressure, medium-pressure and high-pressure ranges. The Tensoval Duo Control II device is recommended for clinical and home use according to both the BHS and the ESH-IP2 standard.

Development and validation of a prognostic model using blood biomarker information for prediction of survival of non-small-cell lung cancer patients treated with combined chemotherapy and radiation or radiotherapy alone (NCT00181519, NCT00573040, and NCT00572325).

Science.gov (United States)

Dehing-Oberije, Cary; Aerts, Hugo; Yu, Shipeng; De Ruysscher, Dirk; Menheere, Paul; Hilvo, Mika; van der Weide, Hiska; Rao, Bharat; Lambin, Philippe

2011-10-01

Currently, prediction of survival for non-small-cell lung cancer patients treated with (chemo)radiotherapy is mainly based on clinical factors. The hypothesis of this prospective study was that blood biomarkers related to hypoxia, inflammation, and tumor load would have an added prognostic value for predicting survival. Clinical data and blood samples were collected prospectively (NCT00181519, NCT00573040, and NCT00572325) from 106 inoperable non-small-cell lung cancer patients (Stages I-IIIB), treated with curative intent with radiotherapy alone or combined with chemotherapy. Blood biomarkers, including lactate dehydrogenase, C-reactive protein, osteopontin, carbonic anhydrase IX, interleukin (IL) 6, IL-8, carcinoembryonic antigen (CEA), and cytokeratin fragment 21-1, were measured. A multivariate model, built on a large patient population (N = 322) and externally validated, was used as a baseline model. An extended model was created by selecting additional biomarkers. The model's performance was expressed as the area under the curve (AUC) of the receiver operating characteristic and assessed by use of leave-one-out cross validation as well as a validation cohort (n = 52). The baseline model consisted of gender, World Health Organization performance status, forced expiratory volume, number of positive lymph node stations, and gross tumor volume and yielded an AUC of 0.72. The extended model included two additional blood biomarkers (CEA and IL-6) and resulted in a leave-one-out AUC of 0.81. The performance of the extended model was significantly better than the clinical model (p = 0.004). The AUC on the validation cohort was 0.66 and 0.76, respectively. The performance of the prognostic model for survival improved markedly by adding two blood biomarkers: CEA and IL-6. Copyright © 2011 Elsevier Inc. All rights reserved.

Validation of computed tomography protocols for simulated mandibular lesions: a comparison study Validação de protocolos de tomografia computadorizada para lesões simuladas em mandíbula: estudo comparativo

Directory of Open Access Journals (Sweden)

Andréia Perrella

2007-06-01

Full Text Available Computed tomography is the choice technique to assess oral and maxillofacial osseous lesions because it provides hard and soft tissues visualization in one examination without superimposition of surrounding structures. This examination offers a significant advance in maxillofacial lesions detection with an excellent anatomic resolution. The aim of this research was to evaluate the validity of two protocols, in axial sections, in simulated mandibular lesions. Two CT protocols were obtained in dry mandibles in which perforations were done simulating lesions. Two observers, previously calibrated, evaluated the images according to different parameters. The results indicated that the sensitivity and specificity in lesion detection were 100% for both protocols, but the detection of loci number of multilocular lesions and the location and detection of medullar invasion obtained reduced validity values, which were influenced by the acquisition protocol. We concluded that thinner axial slices and reconstructions were more effective in detecting early medullar invasion and loci number. Thicker protocols were not considered appropriate to detect multilocular lesions and early stages of medullar invasion.A tomografia Computadorizada é a técnica de escolha no exame de lesões ósseas orais e maxilo-faciais porque proporciona a visualização de tecidos duros e moles em aquisição única e sem sobreposição de estruturas adjacentes. Este exame oferece um avanço significativo na detecção de lesões maxilo-faciais, com excelente resolução anatômica. O objetivo desta pesquisa foi avaliar a validade de dois protocolos, em secções axiais, em lesões simuladas de mandíbula. Dois protocolos de TC foram obtidos em mandíbulas secas em que foram feitas perfurações, simulando lesões. Dois observadores previamente calibrados avaliaram as imagens seguindo parâmetros diversos. Como resultados pudemos observar que a sensibilidade e a especificidade foram

Evaluation of the Efficiency of Two Different Freezing Media and Two Different Protocols to Preserve Human Spermatozoa from Cryoinjury

Directory of Open Access Journals (Sweden)

Gemma Fabozzi

2016-01-01

Full Text Available It is universally recognized that cryopreservation impairs sperm quality. In order to improve postthawing sperm survival and motility, media of different composition and different protocols have been proposed. However, no clear evidence is available to understand which are the most efficient protocol and medium for sperm cryopreservation. The present study evaluates the efficiency of two different cryopreservation protocols and two common freezing media (FM containing different cryoprotectants (CPs, TEST Yolk Buffer (TYB and Sperm Freeze (SF, to preserve human sperm quality. Our data suggest that TYB is better than SF both in terms of postthaw viability and in terms of progressive motility, while the direct addition of FM to the sperm sample resulted in the most efficient protocol in terms of postthaw viability but not in terms of progressive motility.

Unified Protocol for psychiatric and psychological assessment of candidates for transplantation of organs and tissues, PSI-CAT.

Science.gov (United States)

Fidel Kinori, Sara Guila; Alcántara Tadeo, Antonio; Castan Campanera, Esther; Costa Requena, Gemma; Diez Quevedo, Crisanto; Lligoña Garreta, Anna; Lopez Lazcano, Ana; Martínez del Pozo, Montserrat; Rangil Muñoz, Teresa; Peri Nogués, Josep María

2015-01-01

Transplantation is the treatment option that offers improved survival and quality of life as compared to organ failure. Psychiatric and psychological aspects of transplant candidates are important, especially in the pre-assessment stage, as the influence of these factors can hinder post-surgical outcome in both the implanted organ survival and the quality of life of the transplanted person. Of particular importance, are the factors related to pathology due to substance use, psychopathology, and psychosocial support. There are currently few guidelines on the correct evaluation of patients eligible for these complex procedures. Nineteen psychiatrists and clinical psychologists from six public hospitals in Catalonia conducted a systematic consensus to determine the design of a Unified Protocol psychological and psychiatric evaluation. An annual work plan was implemented, during which; the objectives were defined, a literature review was conducted, the inclusion and exclusion criteria were discussed, questionnaires were selected, and a structured interview was developed. With the implementation of the work plan, the Assessment Protocol presented in this article was designed. systematic work and improving cooperation between psychiatrists and clinical psychologists, has led to homogeneity and consensus on a unified evaluation protocol. Copyright © 2013 SEP y SEPB. Published by Elsevier España. All rights reserved.

Prognosis of atypical teratoid rhabdoid tumors (AT/RT) treated with multimodal therapy protocols. Report of our series.

Science.gov (United States)

Valencia-Moya, Alfonso; González-García, Laura; Ros-López, Bienvenido; Acha-García, Tomás; Weil-Lara, Bernardo; Obando-Pacheco, Pablo; Arráez-Sánchez, Miguel Ángel

2016-01-01

Atypical teratoid rhabdoid tumors (AT/RT) of the central nervous system are rare, very aggressive embryological tumors, typically diagnosed in young patients and having a low survival rate after diagnosis. The aim of this study was to emphasize, based on the latest results in the literature, the need for protocols for multidisciplinary treatment in these patients. We report our series of 3 cases treated, diagnosed and followed up between 2009 and 2014. They were treated with multimodal therapy protocols (Rhabdoid SIOP-2007 and European Rhabdoid Registry EU-RHAB-2010). In addition, we carried out a literature review. Two of our 3 cases (supratentorial and spinal tumors) did not show any progression of the disease after long follow-up, in contrast with most of the cases available in the literature. The second patient had a shorter survival. Patient age at the time of diagnosis, supratentorial location of the mass and fewer complications with adjuvant treatments seem to be factors yielding good prognosis for AT/RT tumors. In agreement with the latest international protocols, multidisciplinary treatment is the ideal treatment, consisting of radiotherapy and chemotherapy after complete tumor resection. Copyright © 2014 Sociedad Española de Neurocirugía. Published by Elsevier España. All rights reserved.

Survival effect of first- and second-line treatments for patients with primary glioblastoma: a cohort study from a prospective registry, 1997–2010

Science.gov (United States)

Nava, Francesca; Tramacere, Irene; Fittipaldo, Andrea; Bruzzone, Maria Grazia; DiMeco, Francesco; Fariselli, Laura; Finocchiaro, Gaetano; Pollo, Bianca; Salmaggi, Andrea; Silvani, Antonio; Farinotti, Mariangela; Filippini, Graziella

2014-01-01

Background Prospective follow-up studies of large cohorts of patients with glioblastoma (GBM) are needed to assess the effectiveness of conventional treatments in clinical practice. We report GBM survival data from the Brain Cancer Register of the Fondazione Istituto Neurologico Carlo Besta (INCB) in Milan, Italy, which collected longitudinal data for all consecutive patients with GBM from 1997 to 2010. Methods Survival data were obtained from 764 patients (aged>16 years) with histologically confirmed primary GBM who were diagnosed and treated over a 7-year period (2004–2010) with follow-up to April 2012 (cohort II). Equivalent data from 490 GBM patients diagnosed and treated over the preceding 7 years (1997–2003) with follow-up to April 2005 (cohort I) were available for comparison. Progression-free survival (PFS) was available from 361 and 219 patients actively followed up at INCB in cohorts II and I, respectively. Results Survival probabilities were 54% at 1 year, 21% at 2 years, and 11% at 3 years, respectively, in cohort II compared with 47%, 11%, and 5%, respectively, in cohort I. PFS was 22% and 12% at 1 year in cohorts II and I. Better survival and PFS in cohort II was significantly associated with introduction of the Stupp protocol into clinical practice, with adjusted hazard ratios (HRs) of 0.78 for survival and 0.73 for PFS, or a 22% relative decrease in the risk of death and a 27% relative decrease in the risk of recurrence. After recurrence, reoperation was performed in one-fifth of cohort I and in one-third of cohort II but was not effective (HR, 1.05 in cohort I and 1.02 in cohort II). Second-line chemotherapy, mainly consisting of nitrosourea-based chemotherapy, temozolomide, mitoxantrone, fotemustine, and bevacizumab, improved survival in both cohorts (HR, 0.57 in cohort I and 0.74 in cohort II). Radiosurgery was also effective (HR, 0.52 in cohort II). Conclusions We found a significant increase in overall survival, PFS, and survival after

Validation of the Samsung SBM-100A and Microlife BP 3BU1-5 wrist blood pressure measuring devices in adults according to the International Protocol.

Science.gov (United States)

Altunkan, Sekip; Ilman, Nevzat; Altunkan, Erkan

2007-04-01

A variety of automatic blood measurement devices with diverse features have been introduced to the medical markets recently. Among these devices, models that measure at the wrist have become increasingly popular in self measurements. The objective of this study was to evaluate the accuracy of the Samsung SBM-100A and Microlife BP 3BU1-5 wrist blood pressure devices against the mercury sphygmomanometer in adults according to the International Protocol criteria. Fifty-four patients over 30 years of age were studied and classified based on the International Protocol range. Blood pressure measurements at the wrist with the Samsung SBM-100A and Microlife BP 3BU1-5 were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential blood pressure measurements were taken. A total of 33 participants with randomly distributed arm circumferences were selected for both of the validation studies. During each validation study, 99 measurements were obtained for comparison from 33 participants. The first phase was performed on 15 participants and if the device passed this phase, 18 more participants were selected. Mean discrepancies and standard deviations of the device-sphygmomanometer were 0.9+/-9.2 and -2.7+/-9.3 mmHg for systolic blood pressure and -1.4+/-8.0 mmHg and 1.4+/-5.7 for diastolic blood pressure in the Samsung and Microlife study groups, respectively. The Samsung SBM-100A passed Phase 1 in 15 participants. Despite the fact that Microlife BP 3BU1-5 passed Phase 1 for diastolic pressure, it failed according to the systolic pressure criteria. Eighteen patients were added and Phase 2 was continued, in which Samsung SBM-100A failed to meet the criteria of Phases 2.1 and 2.2 for adults in systolic and diastolic blood pressure. It was found that the Microlife BP 3BU1-5 does not meet the criteria of either of Phases 2.1 and 2.2 for systolic blood pressure and Phase 2.2 for diastolic blood pressure. In this study, Samsung SBM

Survival and ultrastructural features of peach palm (Bactris gasipaes, Kunth) somatic embryos submitted to cryopreservation through vitrification.

Science.gov (United States)

Heringer, Angelo Schuabb; Steinmacher, Douglas André; Schmidt, Éder Carlos; Bouzon, Zenilda Laurita; Guerra, Miguel Pedro

2013-10-01

Bactris gasipaes (Arecaceae), also known as peach palm, was domesticated by Amazonian Indians and is cultivated for its fruit and heart-of-palm, a vegetable grown in the tree's inner core. Currently, the conservation of this species relies on in situ conditions and field gene banks. Complementary conservation strategies, such as those based on in vitro techniques, are indicated in such cases. To establish an appropriate cryopreservation protocol, this study aimed to evaluate the ultrastructural features of B. gasipaes embryogenic cultures submitted to vitrification and subsequent cryogenic temperatures. Accordingly, somatic embryo clusters were submitted to Plant Vitrification Solution 3 (PVS3). In general, cells submitted to PVS3 had viable cell characteristics associated with apparently many mitochondria, prominent nucleus, and preserved cell walls. Cells not incubated in PVS3 did not survive after the cryogenic process in liquid nitrogen. The best incubation time for the vitrification technique was 240 min, resulting in a survival rate of 37 %. In these cases, several features were indicative of quite active cell metabolism, including intact nuclei and preserved cell walls, an apparently many of mitochondria and lipid bodies, and the presence of many starch granules and condensed chromatin. Moreover, ultrastructure analysis revealed that overall cellular structures had been preserved after cryogenic treatment, thus validating the use of vitrification in conjunction with cryopreservation of peach palm elite genotypes, as well as wild genotypes, which carry a rich pool of genes that must be conserved.

Reperfusion injury protection during Basic Life Support improves circulation and survival outcomes in a porcine model of prolonged cardiac arrest.

Science.gov (United States)

Debaty, Guillaume; Lurie, Keith; Metzger, Anja; Lick, Michael; Bartos, Jason A; Rees, Jennifer N; McKnite, Scott; Puertas, Laura; Pepe, Paul; Fowler, Raymond; Yannopoulos, Demetris

2016-08-01

Ischemic postconditioning (PC) using three intentional pauses at the start of cardiopulmonary resuscitation (CPR) improves outcomes after cardiac arrest in pigs when epinephrine (epi) is used before defibrillation. We hypothesized PC, performed during basic life support (BLS) in the absence of epinephrine, would reduce reperfusion injury and enhance 24h functional recovery. Prospective animal investigation. Animal laboratory Female farm pigs (n=46, 39±1kg). Protocol A: After 12min of ventricular fibrillation (VF), 28 pigs were randomized to four groups: (A) Standard CPR (SCPR), (B) active compression-decompression CPR with an impedance threshold device (ACD-ITD), (C) SCPR+PC (SCPR+PC) and (D) ACD-ITD CPR+PC. Protocol B: After 15min of VF, 18 pigs were randomized to ACD-ITD CPR or ACD-ITD+PC. The BLS duration was 2.75min in Protocol A and 5min in Protocol B. Following BLS, up to three shocks were delivered. Without return of spontaneous circulation (ROSC), CPR was resumed and epi (0.5mg) and defibrillation delivered. The primary end point was survival without major adverse events. Hemodynamic parameters and left ventricular ejection fraction (LVEF) were also measured. Data are presented as mean±SEM. Protocol A: ACD-ITD+PC (group D) improved coronary perfusion pressure after 3min of BLS versus the three other groups (28±6, 35±7, 23±5 and 47±7 for groups A, B, C, D respectively, p=0.05). There were no significant differences in 24h survival between groups. LVEF 4h post ROSC was significantly higher with ACD-ITD+PC vs ACD-ITD alone (52.5±3% vs. 37.5±6.6%, p=0.045). Survival rates were significantly higher with ACD-ITD+PC vs. ACD-ITD alone (p=0.027). BLS using ACD-ITD+PC reduced post resuscitation cardiac dysfunction and improved functional recovery after prolonged untreated VF in pigs. 12-11. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Effect of Concurrent High-Dose Cisplatin Chemotherapy and Conformal Radiotherapy on Cervical Esophageal Cancer Survival

International Nuclear Information System (INIS)

Huang Shaohui; Lockwood, Gina; Brierley, James; Cummings, Bernard; Kim, John; Wong, Rebecca; Bayley, Andrew; Ringash, Jolie

2008-01-01

Purpose: To determine whether a change in treatment policy to conformal, elective nodal radiotherapy and concurrent high-dose cisplatin improved survival for cervical esophageal cancer patients. Methods and Materials: All cervical esophageal cancer patients treated between 1997 and 2005 were restaged (1983 American Joint Committee on Cancer criteria). Patients treated before 2001 (previous cohort [PC]) were compared with those treated from 2001 onward (recent cohort [RC]). The PC institutional chemoradiotherapy protocol was 54 Gy in 20 fractions within 4 weeks, with 5-fluorouracil (1,000 mg/m 2 ) on Days 1-4 and either mitomycin C (10 mg/m 2 ) or cisplatin (75 mg/m 2 ) on Day 1. The RC institutional chemoradiotherapy protocol was conformal radiotherapy, 70 Gy in 35 fractions within 7 weeks, to the primary tumor and elective nodes, with high-dose cisplatin (100 mg/m 2 ) on Days 1, 22, and 43. Results: The median follow-up was 3.1 years (PC, 8.1 and RC, 2.3). Of 71 patients (25 women and 46 men), 21 of 29 in the PC and 29 of 42 in the RC were treated curatively (curative subgroup, n = 50). Between the two groups, no differences in overall survival or locoregional relapse-free survival were seen. The overall survival rate at 2 and 5 years was 35% (range, 24-47%) and 21% (range, 12-32%) in the whole group and 46% (range 32-60%) and 28% (range, 15-42%) in the curative group, respectively. In the curative group, no statistically significant prognostic factors were found. Trends toward better locoregional relapse-free survival were seen in women (2-year rate, 73% vs. for men, 36%; p = 0.08) and in patients aged >64 years (2-year rate, 68% vs. age ≤64 years, 34%; p = 0.10). Conclusion: No survival improvement could be demonstrated after changing the treatment policy to high-dose cisplatin-based, conventionally fractionated conformal chemoradiotherapy. Female gender and older age might predict for better outcomes

Using Frankencerts for Automated Adversarial Testing of Certificate Validation in SSL/TLS Implementations

OpenAIRE

Brubaker, Chad; Jana, Suman; Ray, Baishakhi; Khurshid, Sarfraz; Shmatikov, Vitaly

2014-01-01

Modern network security rests on the Secure Sockets Layer (SSL) and Transport Layer Security (TLS) protocols. Distributed systems, mobile and desktop applications, embedded devices, and all of secure Web rely on SSL/TLS for protection against network attacks. This protection critically depends on whether SSL/TLS clients correctly validate X.509 certificates presented by servers during the SSL/TLS handshake protocol.

[Effect of a multidisciplinar protocol on the clinical results obtained after bariatric surgery].

Science.gov (United States)

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 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.

DIFFERENTIAL IMPACT OF HLA-A, HLA-B AND HLA-DR COMPATIBILITY ON THE RENAL ALLOGRAFT SURVIVAL

Directory of Open Access Journals (Sweden)

V. Y. Abramov

2012-01-01

Full Text Available We studied the long-term results of 532 deceased donor kidney transplantations to investigate the impact of HLA match on the survival of renal allograft. All transplants were performed in our center in 1996–2009 and moni- tored prospectively for 1–14 years. We found, the survival of 58 kidneys grafted with 0–2 mismatch for HLA- ABDR to be significantly better (Plogrank = 0,016 than the survival of the kidneys grafted with 3–6 HLA-ABDR mismatch. The full compatibility for HLA-A (n = 75 did not influence the long-term survival (Plogrank = 0,48. The absence of HLA-DR mismatch had a beneficial effect for survival of 68 kidneys (Plogrank = 0,07. Eighteen cases with the full HLA-B compatibility between graft and recipient demonstrated excellent long-term survival (Plogrank = 0,007. HLA-B compatibility influenced significantly (P = 0,042 the survival of transplanted kidney in the Cox regression model adjusted for donor and recipient age, panel-reactive antibody level, re-transplant, and immunosuppression protocol. The data obtained support the conclusion, that HLA compatibility should be one of the criteria of deceased donor kidney allocation. 

Software Validation in ATLAS

International Nuclear Information System (INIS)

Hodgkinson, Mark; Seuster, Rolf; Simmons, Brinick; Sherwood, Peter; Rousseau, David

2012-01-01

The ATLAS collaboration operates an extensive set of protocols to validate the quality of the offline software in a timely manner. This is essential in order to process the large amounts of data being collected by the ATLAS detector in 2011 without complications on the offline software side. We will discuss a number of different strategies used to validate the ATLAS offline software; running the ATLAS framework software, Athena, in a variety of configurations daily on each nightly build via the ATLAS Nightly System (ATN) and Run Time Tester (RTT) systems; the monitoring of these tests and checking the compilation of the software via distributed teams of rotating shifters; monitoring of and follow up on bug reports by the shifter teams and periodic software cleaning weeks to improve the quality of the offline software further.

Progression-free survival, post-progression survival, and tumor response as surrogate markers for overall survival in patients with extensive small cell lung cancer

Directory of Open Access Journals (Sweden)

Hisao Imai

2015-01-01

Full Text Available Objectives: The effects of first-line chemotherapy on overall survival (OS might be confounded by subsequent therapies in patients with small cell lung cancer (SCLC. We examined whether progression-free survival (PFS, post-progression survival (PPS, and tumor response could be valid surrogate endpoints for OS after first-line chemotherapies for patients with extensive SCLC using individual-level data. Methods: Between September 2002 and November 2012, we analyzed 49 cases of patients with extensive SCLC who were treated with cisplatin and irinotecan as first-line chemotherapy. The relationships of PFS, PPS, and tumor response with OS were analyzed at the individual level. Results: Spearman rank correlation analysis and linear regression analysis showed that PPS was strongly correlated with OS (r = 0.97, p < 0.05, R 2 = 0.94, PFS was moderately correlated with OS (r = 0.58, p < 0.05, R 2 = 0.24, and tumor shrinkage was weakly correlated with OS (r = 0.37, p < 0.05, R 2 = 0.13. The best response to second-line treatment, and the number of regimens employed after progression beyond first-line chemotherapy were both significantly associated with PPS ( p ≤ 0.05. Conclusion: PPS is a potential surrogate for OS in patients with extensive SCLC. Our findings also suggest that subsequent treatment after disease progression following first-line chemotherapy may greatly influence OS.

Development and validation of an UHPLC-HRMS protocol for the analysis of flavan-3-ol metabolites and catabolites in urine, plasma and feces of rats fed a red wine proanthocyanidin extract.

Science.gov (United States)

Pereira-Caro, Gema; Ordóñez, José Luis; Ludwig, Iziar; Gaillet, Sylvie; Mena, Pedro; Del Rio, Daniele; Rouanet, Jean-Max; Bindon, Keren A; Moreno-Rojas, José Manuel; Crozier, Alan

2018-06-30

This study developed, optimized and validated an ultra-high-performance liquid chromatography-high-resolution mass spectrometry (UHPLC-HRMS) method to identify and quantify metabolites and microbial-derived catabolites in urine, plasma and feces of rats following ingestion of 50 mg of a red wine proanthocyanidin-rich extract. The method was validated for specificity, linearity, limit of detection (LD) and quantification (LQ), intra-day and inter-day precision, recovery and matrix effects, which were determined for 34 compounds in the three biological matrices. After method validation, three parent flavan-3-ols, four 5-carbon side chain ring fission metabolites, and 27 phenolic acid and aromatic catabolites were quantified in plasma, urine and feces after red wine proanthocyanidin intake. These results establish the value of the UHPLC-HRMS protocol in obtaining a detailed picture of proanthocyanidin metabolites and their microbial-derived catabolites, along with their phase II metabolites, in biological fluids of rat, and potentially in human clinical studies designed to evaluate the bioavailability of dietary flavan-3-ols. Copyright © 2018 Elsevier Ltd. All rights reserved.

Survival-related profile, pathways, and transcription factors in ovarian cancer.

Directory of Open Access Journals (Sweden)

Anne P G Crijns

2009-02-01

Full Text Available BACKGROUND: Ovarian cancer has a poor prognosis due to advanced stage at presentation and either intrinsic or acquired resistance to classic cytotoxic drugs such as platinum and taxoids. Recent large clinical trials with different combinations and sequences of classic cytotoxic drugs indicate that further significant improvement in prognosis by this type of drugs is not to be expected. Currently a large number of drugs, targeting dysregulated molecular pathways in cancer cells have been developed and are introduced in the clinic. A major challenge is to identify those patients who will benefit from drugs targeting these specific dysregulated pathways.The aims of our study were (1 to develop a gene expression profile associated with overall survival in advanced stage serous ovarian cancer, (2 to assess the association of pathways and transcription factors with overall survival, and (3 to validate our identified profile and pathways/transcription factors in an independent set of ovarian cancers. METHODS AND FINDINGS: According to a randomized design, profiling of 157 advanced stage serous ovarian cancers was performed in duplicate using approximately 35,000 70-mer oligonucleotide microarrays. A continuous predictor of overall survival was built taking into account well-known issues in microarray analysis, such as multiple testing and overfitting. A functional class scoring analysis was utilized to assess pathways/transcription factors for their association with overall survival. The prognostic value of genes that constitute our overall survival profile was validated on a fully independent, publicly available dataset of 118 well-defined primary serous ovarian cancers. Furthermore, functional class scoring analysis was also performed on this independent dataset to assess the similarities with results from our own dataset. An 86-gene overall survival profile discriminated between patients with unfavorable and favorable prognosis (median survival, 19

An improved method for preparing Agrobacterium cells that simplifies the Arabidopsis transformation protocol

Directory of Open Access Journals (Sweden)

Ülker Bekir

2006-10-01

Full Text Available Abstract Background The Agrobacterium vacuum (Bechtold et al 1993 and floral-dip (Clough and Bent 1998 are very efficient methods for generating transgenic Arabidopsis plants. These methods allow plant transformation without the need for tissue culture. Large volumes of bacterial cultures grown in liquid media are necessary for both of these transformation methods. This limits the number of transformations that can be done at a given time due to the need for expensive large shakers and limited space on them. Additionally, the bacterial colonies derived from solid media necessary for starting these liquid cultures often fail to grow in such large volumes. Therefore the optimum stage of plant material for transformation is often missed and new plant material needs to be grown. Results To avoid problems associated with large bacterial liquid cultures, we investigated whether bacteria grown on plates are also suitable for plant transformation. We demonstrate here that bacteria grown on plates can be used with similar efficiency for transforming plants even after one week of storage at 4°C. This makes it much easier to synchronize Agrobacterium and plants for transformation. DNA gel blot analysis was carried out on the T1 plants surviving the herbicide selection and demonstrated that the surviving plants are indeed transgenic. Conclusion The simplified method works as efficiently as the previously reported protocols and significantly reduces the workload, cost and time. Additionally, the protocol reduces the risk of large scale contaminations involving GMOs. Most importantly, many more independent transformations per day can be performed using this modified protocol.

Reliability and concurrent validity of an alternative method of lateral ...

African Journals Online (AJOL)

1 University of Northern Iowa, Division of Athletic Training, 003C Human. Performance Center, Cedar ... concurrent validity of the fingertip-to-floor distance test (FFD) ... in these protocols are spinal and extremity range of motion, pelvic control ...

An Enhanced Biometric Based Authentication with Key-Agreement Protocol for Multi-Server Architecture Based on Elliptic Curve Cryptography.

Science.gov (United States)

Reddy, Alavalapati Goutham; Das, Ashok Kumar; Odelu, Vanga; Yoo, Kee-Young

2016-01-01

Biometric based authentication protocols for multi-server architectures have gained momentum in recent times due to advancements in wireless technologies and associated constraints. Lu et al. recently proposed a robust biometric based authentication with key agreement protocol for a multi-server environment using smart cards. They claimed that their protocol is efficient and resistant to prominent security attacks. The careful investigation of this paper proves that Lu et al.'s protocol does not provide user anonymity, perfect forward secrecy and is susceptible to server and user impersonation attacks, man-in-middle attacks and clock synchronization problems. In addition, this paper proposes an enhanced biometric based authentication with key-agreement protocol for multi-server architecture based on elliptic curve cryptography using smartcards. We proved that the proposed protocol achieves mutual authentication using Burrows-Abadi-Needham (BAN) logic. The formal security of the proposed protocol is verified using the AVISPA (Automated Validation of Internet Security Protocols and Applications) tool to show that our protocol can withstand active and passive attacks. The formal and informal security analyses and performance analysis demonstrates that the proposed protocol is robust and efficient compared to Lu et al.'s protocol and existing similar protocols.

Significant prolongation of hamster liver transplant survival in Lewis rats by total-lymphoid irradiation, cyclosporine, and splenectomy

International Nuclear Information System (INIS)

Yamaguchi, Y.; Halperin, E.C.; Harland, R.C.; Wyble, C.; Bollinger, R.R.

1990-01-01

The effects of total lymphoid irradiation, cyclosporine and splenectomy alone and in combination have been studied in liver transplants from the LVG hamster to the LEW rat. Neither CsA alone, splenectomy alone, nor TLI alone prolonged graft survival. CsA/splenectomy and TLI/CsA produced significant prolongation of graft survival. TLI/CsA/splenectomy prolonged graft survival by over sixfold compared with controls. While CsA alone was ineffective in reducing lymphocytotoxic antidonor antibody, splenectomy alone or CsA/splenectomy did significantly suppress production of antibody. Only very low levels of antibody could be detected in animals treated with TLI/CsA/splenectomy. TLI/CsA/splenectomy has an immunosuppressive effect sufficient to significantly prolong liver graft survival in the LVG hamster to LEW rat combination and may represent a promising treatment protocol in experimental cross-species transplantation

Protocol Implementation Generator

DEFF Research Database (Denmark)

Carvalho Quaresma, Jose Nuno; Probst, Christian W.

2010-01-01

Users expect communication systems to guarantee, amongst others, privacy and integrity of their data. These can be ensured by using well-established protocols; the best protocol, however, is useless if not all parties involved in a communication have a correct implementation of the protocol and a...... Generator framework based on the LySatool and a translator from the LySa language into C or Java....... necessary tools. In this paper, we present the Protocol Implementation Generator (PiG), a framework that can be used to add protocol generation to protocol negotiation, or to easily share and implement new protocols throughout a network. PiG enables the sharing, verification, and translation...

Finding Risk Groups by Optimizing Artificial Neural Networks on the Area under the Survival Curve Using Genetic Algorithms.

Science.gov (United States)

Kalderstam, Jonas; Edén, Patrik; Ohlsson, Mattias

2015-01-01

We investigate a new method to place patients into risk groups in censored survival data. Properties such as median survival time, and end survival rate, are implicitly improved by optimizing the area under the survival curve. Artificial neural networks (ANN) are trained to either maximize or minimize this area using a genetic algorithm, and combined into an ensemble to predict one of low, intermediate, or high risk groups. Estimated patient risk can influence treatment choices, and is important for study stratification. A common approach is to sort the patients according to a prognostic index and then group them along the quartile limits. The Cox proportional hazards model (Cox) is one example of this approach. Another method of doing risk grouping is recursive partitioning (Rpart), which constructs a decision tree where each branch point maximizes the statistical separation between the groups. ANN, Cox, and Rpart are compared on five publicly available data sets with varying properties. Cross-validation, as well as separate test sets, are used to validate the models. Results on the test sets show comparable performance, except for the smallest data set where Rpart's predicted risk groups turn out to be inverted, an example of crossing survival curves. Cross-validation shows that all three models exhibit crossing of some survival curves on this small data set but that the ANN model manages the best separation of groups in terms of median survival time before such crossings. The conclusion is that optimizing the area under the survival curve is a viable approach to identify risk groups. Training ANNs to optimize this area combines two key strengths from both prognostic indices and Rpart. First, a desired minimum group size can be specified, as for a prognostic index. Second, the ability to utilize non-linear effects among the covariates, which Rpart is also able to do.

The reliability and validity of fatigue measures during short-duration maximal-intensity intermittent cycling.

Science.gov (United States)

Glaister, Mark; Stone, Michael H; Stewart, Andrew M; Hughes, Michael; Moir, Gavin L

2004-08-01

The purpose of the present study was to assess the reliability and validity of fatigue measures, as derived from 4 separate formulae, during tests of repeat sprint ability. On separate days over a 3-week period, 2 groups of 7 recreationally active men completed 6 trials of 1 of 2 maximal (20 x 5 seconds) intermittent cycling tests with contrasting recovery periods (10 or 30 seconds). All trials were conducted on a friction-braked cycle ergometer, and fatigue scores were derived from measures of mean power output for each sprint. Apart from formula 1, which calculated fatigue from the percentage difference in mean power output between the first and last sprint, all remaining formulae produced fatigue scores that showed a reasonably good level of test-retest reliability in both intermittent test protocols (intraclass correlation range: 0.78-0.86; 95% likely range of true values: 0.54-0.97). Although between-protocol differences in the magnitude of the fatigue scores suggested good construct validity, within-protocol differences highlighted limitations with each formula. Overall, the results support the use of the percentage decrement score as the most valid and reliable measure of fatigue during brief maximal intermittent work.

Five-year survival in 309 patients with colorectal liver metastases treated with radiofrequency ablation

International Nuclear Information System (INIS)

Gillams, A.R.; Lees, W.R.

2009-01-01

There is little published long-term survival data for patients with colorectal liver metastases treated with radiofrequency ablation (RFA). We present a multivariate analysis of 5-year survival in 309 patients (198 male, aged 64 (24-92)) treated at 617 sessions. Our standard protocol used internally cooled electrodes introduced percutaneously under combined US and CT guidance/monitoring. The number and size of liver metastases, the presence and location of extrahepatic disease, primary resection, clinical, chemotherapy and follow-up data were recorded. Data analysis was performed using SPSS v.10. On multivariate analysis, significant survival factors were the presence of extrahepatic disease (p < 0.001) and liver tumour volume (p = 0.001). For 123 patients with five or less metastases of 5 cm or less maximum diameter and no extrahepatic disease median survival was 46 and 36 months from liver metastasis diagnosis and ablation, respectively; corresponding 3- and 5-year survival rates were 63%, 34% and 49%, 24%. Sixty-nine patients had three or less tumours of below 3.5 cm in diameter and their 5-year survival from ablation was 33%. There were 23/617(3.7%) local complications requiring intervention. Five-year survival of 24-33% post ablation in selected patients is superior to any published chemotherapy data and approaches the results of liver resection. (orig.)

Vertical Protocol Composition

DEFF Research Database (Denmark)

Groß, Thomas; Mödersheim, Sebastian Alexander

2011-01-01

The security of key exchange and secure channel protocols, such as TLS, has been studied intensively. However, only few works have considered what happens when the established keys are actually used—to run some protocol securely over the established “channel”. We call this a vertical protocol.......e., that the combination cannot introduce attacks that the individual protocols in isolation do not have. In this work, we prove a composability result in the symbolic model that allows for arbitrary vertical composition (including self-composition). It holds for protocols from any suite of channel and application...

Immunotherapy for recurrent malignant glioma: an interim report on survival.

Science.gov (United States)

Ingram, M; Buckwalter, J G; Jacques, D B; Freshwater, D B; Abts, R M; Techy, G B; Miyagi, K; Shelden, C H; Rand, R W; English, L W

1990-12-01

We present interim survival data for a group of 83 adult patients with recurrent malignant glioma treated by implanting stimulated autologous lymphocytes into the tumour bed following surgical debulking. The patients were treated 6 months or more prior to data analysis. Fifty-nine patients were male and 24 female. The mean age for the entire group was 48.4 years and the mean Karnofsky rating (KR) was 67.2. Eight of the patients had grade II tumours, 33 had grade III tumours and 42 had grade IV tumours. Statistical analysis focuses on tumour grade, KR and patient age, factors that have been shown to affect survival in previous studies. Multifactorial analyses are employed to identify interrelationships among factors related to survival. Seven patients (8%) did not respond to immunotherapy, 76 (92%) had a good initial response. Twenty-five patients (30.1%) are living and 18 (22%) have shown no evidence of recurrence. Results are evaluated in the light of those obtained in trials of other experimental therapies for recurrent malignant gliomas. It is concluded that the present protocol offers a safe and comparatively effective treatment option.

Validation of the iHealth BP5 wireless upper arm blood pressure monitor for self-measurement according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Shang, Fujun; Zhu, Yizheng; Zhu, Zhenlai; Liu, Lei; Wan, Yi

2013-10-01

The aim of this study was to validate the iHealth BP5 wireless upper arm blood pressure (BP) monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. The ESH-IP revision 2010 for validation of BP measuring devices in adults was followed precisely. A total of 99 pairs of test device and reference BP measurements (three pairs for each of the 33 participants) were obtained in the study. The device produced 71, 89, and 97 measurements within 5, 10, and 15 mmHg for systolic blood pressure (SBP) and 73, 90, and 99 mmHg for diastolic blood pressure (DBP), respectively. The mean ± SD device-observer difference was -1.21 ± 5.87 mmHg for SBP and -1.04 ± 5.28 mmHg for DBP. The number of participants with two or three device-observer differences within 5 mmHg was 25 for SBP and 28 for DBP. In addition, three participants had no device-observer difference within 5 mmHg for SBP and none of the participants had the same for DBP. According to the validation results on the basis of the ESH-IP revision 2010, the iHealth BP5 wireless upper arm BP monitor can be recommended for self/home measurement in an adult population.

Validation of the YuWell YE690A upper-arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Chen, Qi; Lei, Lei; Li, Yan; Wang, Ji-Guang

2017-10-01

The present study aimed to evaluate the accuracy of the automated oscillometric upper-arm blood pressure monitor YuWell YE690A for blood pressure measurement according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were measured sequentially in 33 adult Chinese (12 women, 44.2 years of mean age) using a mercury sphygmomanometer (two observers) and the YE690A device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. All the blood pressure requirements were fulfilled. The YuWell YE690A device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 79/99, 96/99, and 97/99, respectively, for systolic blood pressure and 72/99, 95/99, and 98/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Thirty-one and 25 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observer differences within 5 mmHg (required ≥24). No participant for systolic and two participants for diastolic blood pressure had all the three device-observer comparisons greater than 5 mmHg. The YuWell blood pressure monitor YE690A has passed the requirements of the International Protocol revision 2010 and hence can be recommended for blood pressure measurement in adults.

Extraction and analysis of intact glucosinolates--a validated pressurized liquid extraction/liquid chromatography-mass spectrometry protocol for Isatis tinctoria, and qualitative analysis of other cruciferous plants.

Science.gov (United States)

Mohn, Tobias; Cutting, Brian; Ernst, Beat; Hamburger, Matthias

2007-09-28

Glucosinolates have attracted significant interest due to the chemopreventive properties of some of their transformation products. Numerous protocols for the extraction and analysis of glucosinolates have been published, but limited effort has been devoted to optimize and validate crucial extraction parameters and sample preparation steps. We carried out a systematic optimization and validation of a quantitative assay for the direct analysis of intact glucosinolates in Isatis tinctoria leaves (woad, Brassicaceae). Various parameters such as solvent composition, particle size, temperature, and number of required extraction steps were optimized using pressurized liquid extraction (PLE). We observed thermal degradation of glucosinolates at temperatures above 50 degrees C, and loss of >60% within 10min at 100 degrees C, but no enzymatic degradation in the leaf samples at ambient temperature. Excellent peak shape and resolution was obtained by reversed-phase chromatography on a Phenomenex Aqua column using 10mM ammonium formate as ion-pair reagent. Detection was carried out by electrospray ionisation mass spectrometry in the negative ion mode. Analysis of cruciferous vegetables and spices such as broccoli (Brassica oleracea L. var. italica), garden cress (Lepidium sativum L.) and black mustard (Sinapis nigra L.) demonstrated the general applicability of the method.

The PRECIS-2 tool has good interrater reliability and modest discriminant validity.

Science.gov (United States)

Loudon, Kirsty; Zwarenstein, Merrick; Sullivan, Frank M; Donnan, Peter T; Gágyor, Ildikó; Hobbelen, Hans J S M; Althabe, Fernando; Krishnan, Jerry A; Treweek, Shaun

2017-08-01

PRagmatic Explanatory Continuum Indicator Summary (PRECIS)-2 is a tool that could improve design insight for trialists. Our aim was to validate the PRECIS-2 tool, unlike its predecessor, testing the discriminant validity and interrater reliability. Over 80 international trialists, methodologists, clinicians, and policymakers created PRECIS-2 helping to ensure face validity and content validity. The interrater reliability of PRECIS-2 was measured using 19 experienced trialists who used PRECIS-2 to score a diverse sample of 15 randomized controlled trial protocols. Discriminant validity was tested with two raters to independently determine if the trial protocols were more pragmatic or more explanatory, with scores from the 19 raters for the 15 trials as predictors of pragmatism. Interrater reliability was generally good, with seven of nine domains having an intraclass correlation coefficient over 0.65. Flexibility (adherence) and recruitment had wide confidence intervals, but raters found these difficult to rate and wanted more information. Each of the nine PRECIS-2 domains could be used to differentiate between trials taking more pragmatic or more explanatory approaches with better than chance discrimination for all domains. We have assessed the validity and reliability of PRECIS-2. An elaboration study and web site provide guidance to help future users of the tool which is continuing to be tested by trial teams, systematic reviewers, and funders. Copyright © 2017 Elsevier Inc. All rights reserved.

A Lightweight Continuous Authentication Protocol for the Internet of Things

Directory of Open Access Journals (Sweden)

Yo-Hsuan Chuang

2018-04-01

Full Text Available Modern societies are moving toward an information-oriented environment. To gather and utilize information around people’s modern life, tiny devices with all kinds of sensing devices and various sizes of gateways need to be deployed and connected with each other through the Internet or proxy-based wireless sensor networks (WSNs. Within this kind of Internet of Things (IoT environment, how to authenticate each other between two communicating devices is a fundamental security issue. As a lot of IoT devices are powered by batteries and they need to transmit sensed data periodically, it is necessary for IoT devices to adopt a lightweight authentication protocol to reduce their energy consumption when a device wants to authenticate and transmit data to its targeted peer. In this paper, a lightweight continuous authentication protocol for sensing devices and gateway devices in general IoT environments is introduced. The concept of valid authentication time period is proposed to enhance robustness of authentication between IoT devices. To construct the proposed lightweight continuous authentication protocol, token technique and dynamic features of IoT devices are adopted in order to reach the design goals: the reduction of time consumption for consecutive authentications and energy saving for authenticating devices through by reducing the computation complexity during session establishment of continuous authentication. Security analysis is conducted to evaluate security strength of the proposed protocol. In addition, performance analysis has shown the proposed protocol is a strong competitor among existing protocols for device-to-device authentication in IoT environments.

A Lightweight Continuous Authentication Protocol for the Internet of Things

Science.gov (United States)

Chuang, Yo-Hsuan; Yang, Cheng-Ying; Tang, Ssu-Wei

2018-01-01

Modern societies are moving toward an information-oriented environment. To gather and utilize information around people’s modern life, tiny devices with all kinds of sensing devices and various sizes of gateways need to be deployed and connected with each other through the Internet or proxy-based wireless sensor networks (WSNs). Within this kind of Internet of Things (IoT) environment, how to authenticate each other between two communicating devices is a fundamental security issue. As a lot of IoT devices are powered by batteries and they need to transmit sensed data periodically, it is necessary for IoT devices to adopt a lightweight authentication protocol to reduce their energy consumption when a device wants to authenticate and transmit data to its targeted peer. In this paper, a lightweight continuous authentication protocol for sensing devices and gateway devices in general IoT environments is introduced. The concept of valid authentication time period is proposed to enhance robustness of authentication between IoT devices. To construct the proposed lightweight continuous authentication protocol, token technique and dynamic features of IoT devices are adopted in order to reach the design goals: the reduction of time consumption for consecutive authentications and energy saving for authenticating devices through by reducing the computation complexity during session establishment of continuous authentication. Security analysis is conducted to evaluate security strength of the proposed protocol. In addition, performance analysis has shown the proposed protocol is a strong competitor among existing protocols for device-to-device authentication in IoT environments. PMID:29621168

A Lightweight Continuous Authentication Protocol for the Internet of Things.

Science.gov (United States)

Chuang, Yo-Hsuan; Lo, Nai-Wei; Yang, Cheng-Ying; Tang, Ssu-Wei

2018-04-05

Modern societies are moving toward an information-oriented environment. To gather and utilize information around people's modern life, tiny devices with all kinds of sensing devices and various sizes of gateways need to be deployed and connected with each other through the Internet or proxy-based wireless sensor networks (WSNs). Within this kind of Internet of Things (IoT) environment, how to authenticate each other between two communicating devices is a fundamental security issue. As a lot of IoT devices are powered by batteries and they need to transmit sensed data periodically, it is necessary for IoT devices to adopt a lightweight authentication protocol to reduce their energy consumption when a device wants to authenticate and transmit data to its targeted peer. In this paper, a lightweight continuous authentication protocol for sensing devices and gateway devices in general IoT environments is introduced. The concept of valid authentication time period is proposed to enhance robustness of authentication between IoT devices. To construct the proposed lightweight continuous authentication protocol, token technique and dynamic features of IoT devices are adopted in order to reach the design goals: the reduction of time consumption for consecutive authentications and energy saving for authenticating devices through by reducing the computation complexity during session establishment of continuous authentication. Security analysis is conducted to evaluate security strength of the proposed protocol. In addition, performance analysis has shown the proposed protocol is a strong competitor among existing protocols for device-to-device authentication in IoT environments.

A slotted access control protocol for metropolitan WDM ring networks

Science.gov (United States)

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

2009-03-01

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

Validation of Bosch' Mobile Communication NetworkArchitecture with SPIN

NARCIS (Netherlands)

Ruys, T.C.; Langerak, Romanus

This paper discusses validation projects carried out for the Mobile Communication Division of Robert Bosch GmbH. We verified parts of their Mobile Communication Network (MCNet), a communication system which is to be used in infotainment systems of future cars. The protocols of the MCNet have been

I-123 IBZM-SPECT: improved acquisition protocol with HR-collimator

International Nuclear Information System (INIS)

Sandrock, D.; Ivancevic, V.; Dopichaj-Menge, U.; Gruber, D.; Munz, D.

2002-01-01

protocol A and 3 patients with protocol B. These could not properly staged as normal or abnormal. Conclusion: The acquisition protocol using a HR collimator and a 128 x 128 matrix in I-123 IBZM-SPECT leads to a more valid determination of the dopamine D2 receptor status

Markedly improved outcomes and acceptable toxicity in adolescents and young adults with acute lymphoblastic leukemia following treatment with a pediatric protocol: a phase II study by the Japan Adult Leukemia Study Group

International Nuclear Information System (INIS)

Hayakawa, F; Sakura, T; Yujiri, T; Kondo, E; Fujimaki, K; Sasaki, O; Miyatake, J; Handa, H; Ueda, Y; Aoyama, Y; Takada, S; Tanaka, Y; Usui, N; Miyawaki, S; Suenobu, S; Horibe, K; Kiyoi, H; Ohnishi, K; Miyazaki, Y; Ohtake, S; Kobayashi, Y; Matsuo, K; Naoe, T

2014-01-01

The superiority of the pediatric protocol for adolescents with acute lymphoblastic leukemia (ALL) has already been demonstrated, however, its efficacy in young adults remains unclear. The ALL202-U protocol was conducted to examine the efficacy and feasibility of a pediatric protocol in adolescents and young adults (AYAs) with BCR–ABL-negative ALL. Patients aged 15–24 years (n=139) were treated with the same protocol used for pediatric B-ALL. The primary objective of this study was to assess the disease-free survival (DFS) rate and its secondary aims were to assess toxicity, the complete remission (CR) rate and the overall survival (OS) rate. The CR rate was 94%. The 5-year DFS and OS rates were 67% (95% confidence interval (CI) 58–75%) and 73% (95% CI 64–80%), respectively. Severe adverse events were observed at a frequency that was similar to or lower than that in children treated with the same protocol. Only insufficient maintenance therapy significantly worsened the DFS (hazard ratio 5.60, P<0.001). These results indicate that this protocol may be a feasible and highly effective treatment for AYA with BCR–ABL-negative ALL

An enzyme-linked immunoabsorbent assay for estimating red cell survival of transfused red cells-validation using CR-51 labeling

International Nuclear Information System (INIS)

Drew, H.; Kickler, T.; Smith, B.; LaFrance, N.

1984-01-01

The survival time of transfused red cells antigenically distinct from the recipient's red cells was determined using an indirect enzyme linked antiglobulin test. These results were then compared to those determined by Cr-51 labeling. Three patients with hypoproliferative anemias and one patient (2 studies) with traumatic hemolytic anemia caused by a prosthetic heart valve were studied. Survival times were performed by transfusing a 5cc aliquot of Cr-51 labeled cells along with the remaining unit. One hour post transfusion, a blood sample was drawn and used as the 100% value. Subsequent samples drawn over a 2-3 week period were then compared to the initial sample to determine percent survival for both methods. The ELISA method for measuring red cell survival in antigenically distinct cells is in close agreement with the Cr-51 method. Although CR-51 labeling is the accepted method for red cell survival determination the ELISA method can be used when radioisotopes are unavailable or contraindicated or when the decision to estimate red cell survival is made after transfusion

Multivariable model development and internal validation for prostate cancer specific survival and overall survival after whole-gland salvage Iodine-125 prostate brachytherapy

NARCIS (Netherlands)

Peters, Max; van der Voort van Zyp, Jochem R N; Moerland, Marinus A; Hoekstra, Carel J; van de Pol, Sandrine; Westendorp, Hendrik; Maenhout, Metha; Kattevilder, Rob; Verkooijen, Helena M; van Rossum, Peter S N; Ahmed, Hashim U; Shah, Taimur T; Emberton, Mark; van Vulpen, Marco

BACKGROUND: Whole-gland salvage Iodine-125-brachytherapy is a potentially curative treatment strategy for localised prostate cancer (PCa) recurrences after radiotherapy. Prognostic factors influencing PCa-specific and overall survival (PCaSS & OS) are not known. The objective of this study was to

Survival chance in papillary thyroid cancer in Hungary: individual survival probability estimation using the Markov method

International Nuclear Information System (INIS)

Esik, Olga; Tusnady, Gabor; Daubner, Kornel; Nemeth, Gyoergy; Fuezy, Marton; Szentirmay, Zoltan

1997-01-01

Purpose: The typically benign, but occasionally rapidly fatal clinical course of papillary thyroid cancer has raised the need for individual survival probability estimation, to tailor the treatment strategy exclusively to a given patient. Materials and methods: A retrospective study was performed on 400 papillary thyroid cancer patients with a median follow-up time of 7.1 years to establish a clinical database for uni- and multivariate analysis of the prognostic factors related to survival (Kaplan-Meier product limit method and Cox regression). For a more precise prognosis estimation, the effect of the most important clinical events were then investigated on the basis of a Markov renewal model. The basic concept of this approach is that each patient has an individual disease course which (besides the initial clinical categories) is affected by special events, e.g. internal covariates (local/regional/distant relapses). On the supposition that these events and the cause-specific death are influenced by the same biological processes, the parameters of transient survival probability characterizing the speed of the course of the disease for each clinical event and their sequence were determined. The individual survival curves for each patient were calculated by using these parameters and the independent significant clinical variables selected from multivariate studies, summation of which resulted in a mean cause-specific survival function valid for the entire group. On the basis of this Markov model, prediction of the cause-specific survival probability is possible for extrastudy cases, if it is supposed that the clinical events occur within new patients in the same manner and with the similar probability as within the study population. Results: The patient's age, a distant metastasis at presentation, the extent of the surgical intervention, the primary tumor size and extent (pT), the external irradiation dosage and the degree of TSH suppression proved to be

Shortened screening method for phosphorus fractionation in sediments A complementary approach to the standards, measurements and testing harmonised protocol

International Nuclear Information System (INIS)

Pardo, Patricia; Rauret, Gemma; Lopez-Sanchez, Jose Fermin

2004-01-01

The SMT protocol, a sediment phosphorus fractionation method harmonised and validated in the frame of the standards, measurements and testing (SMT) programme (European Commission), establishes five fractions of phosphorus according to their extractability. The determination of phosphate extracted is carried out spectrophotometrically. This protocol has been applied to 11 sediments of different origin and characteristics and the phosphorus extracted in each fraction was determined not only by UV-Vis spectrophotometry, but also by inductively coupled plasma-atomic emission spectrometry. The use of these two determination techniques allowed the differentiation between phosphorus that was present in the extracts as soluble reactive phosphorus and as total phosphorus. From the comparison of data obtained with both determination techniques a shortened screening method, for a quick evaluation of the magnitude and importance of the fractions given by the SMT protocol, is proposed and validated using two certified reference materials

Momentary Assessment of Adults’ Physical Activity and Sedentary Behavior: Feasibility and Validity

OpenAIRE

Dunton, Genevieve Fridlund; Liao, Yue; Kawabata, Keito; Intille, Stephen

2012-01-01

Introduction: Mobile phones are ubiquitous and easy to use, and thus have the capacity to collect real-time data from large numbers of people. Research tested the feasibility and validity of an Ecological Momentary Assessment (EMA) self-report protocol using electronic surveys on mobile phones to assess adults’ physical activity and sedentary behaviors. Methods: Adults (N = 110) (73% female, 30% Hispanic, 62% overweight/obese) completed a four-day signal-contingent EMA protocol (Sat. - Tues.)...

Validation and modification of dried blood spot-based glycosylated hemoglobin assay for the longitudinal aging study in India.

Science.gov (United States)

Hu, Peifeng; Edenfield, Michael; Potter, Alan; Kale, Varsha; Risbud, Arun; Williams, Sharon; Lee, Jinkook; Bloom, David E; Crimmins, Eileen; Seeman, Teresa

2015-01-01

This study aims to validate a modified dried blood spot (DBS)-based glycosylated hemoglobin (HbA1c) assay protocol, after a pretest in India showed poor correlation between the original DBS-based protocol and venous results. The original protocol was tested on different chemistry analyzers and then simplified at the University of Washington (UW). A second pretest was conducted in India to validate the modified assay protocol, using 44 quality control specimens. Data from UW indicated that, using the original protocol, the correlation coefficients between DBS and venous results were above 0.98 on both Bio-Rad and Olympus chemistry analyzers. The protocol worked equally well on filter paper, with or without pre-treatment, and when the recommended amount of blood spot material, or less, was used. A second pretest of the modified protocol confirmed that DBS-based levels from both Olympus and Roche chemistry analyzers were well correlated with DBS results from UW (correlation coefficients were above 0.96), as well as with venous values (correlation coefficients were above 0.94). The DBS-based HbA1c values are highly correlated with venous results. The pre-treatment of filter paper does not appear to be necessary. The poor results from the first pretest are probably due to factors unrelated to the protocol, such as problems with the chemistry analyzer or assay reagents. © 2015 Wiley Periodicals, Inc.

Protocol design and analysis for cooperative wireless networks

CERN Document Server

Song, Wei; Jin, A-Long

2017-01-01

This book focuses on the design and analysis of protocols for cooperative wireless networks, especially at the medium access control (MAC) layer and for crosslayer design between the MAC layer and the physical layer. It highlights two main points that are often neglected in other books: energy-efficiency and spatial random distribution of wireless devices. Effective methods in stochastic geometry for the design and analysis of wireless networks are also explored. After providing a comprehensive review of existing studies in the literature, the authors point out the challenges that are worth further investigation. Then, they introduce several novel solutions for cooperative wireless network protocols that reduce energy consumption and address spatial random distribution of wireless nodes. For each solution, the book offers a clear system model and problem formulation, details of the proposed cooperative schemes, comprehensive performance analysis, and extensive numerical and simulation results that validate th...

Rapid learning in practice: A lung cancer survival decision support system in routine patient care data

International Nuclear Information System (INIS)

Dekker, Andre; Vinod, Shalini; Holloway, Lois; Oberije, Cary; George, Armia; Goozee, Gary; Delaney, Geoff P.; Lambin, Philippe; Thwaites, David

2014-01-01

Background and purpose: A rapid learning approach has been proposed to extract and apply knowledge from routine care data rather than solely relying on clinical trial evidence. To validate this in practice we deployed a previously developed decision support system (DSS) in a typical, busy clinic for non-small cell lung cancer (NSCLC) patients. Material and methods: Gender, age, performance status, lung function, lymph node status, tumor volume and survival were extracted without review from clinical data sources for lung cancer patients. With these data the DSS was tested to predict overall survival. Results: 3919 lung cancer patients were identified with 159 eligible for inclusion, due to ineligible histology or stage, non-radical dose, missing tumor volume or survival. The DSS successfully identified a good prognosis group and a medium/poor prognosis group (2 year OS 69% vs. 27/30%, p < 0.001). Stage was less discriminatory (2 year OS 47% for stage I–II vs. 36% for stage IIIA–IIIB, p = 0.12) with most good prognosis patients having higher stage disease. The DSS predicted a large absolute overall survival benefit (∼40%) for a radical dose compared to a non-radical dose in patients with a good prognosis, while no survival benefit of radical radiotherapy was predicted for patients with a poor prognosis. Conclusions: A rapid learning environment is possible with the quality of clinical data sufficient to validate a DSS. It uses patient and tumor features to identify prognostic groups in whom therapy can be individualized based on predicted outcomes. Especially the survival benefit of a radical versus non-radical dose predicted by the DSS for various prognostic groups has clinical relevance, but needs to be prospectively validated

30 : 2: A Game Designed to Promote the Cardiopulmonary Resuscitation Protocol

Directory of Open Access Journals (Sweden)

Imma Boada

2016-01-01

Full Text Available Cardiopulmonary resuscitation (CPR is a first-aid key survival technique used to stimulate breathing and keep blood flowing to the heart. Its effective administration can significantly increase the survival chances of cardiac arrest victims. We propose 30 : 2, a videogame designed to introduce the main steps of the CPR protocol. It is not intended for certification and training purpose. Driven by the 2010 European Resuscitation Council guidelines we have designed a game composed of eight mini games corresponding to the main steps of the protocol. The player acts as a helper and has to solve a different challenge. We present a detailed description of the game creation process presenting the requirements, the design decisions, and the implementation details. In addition, we present some first impressions of our testing users (25 children, five of each age from 8 to 12 years old and 12 males and 13 females. We evaluated clarity of instructions and three settings of the game: the aesthetics of scenarios, the playability, and the enjoyability of each mini game. All games were well punctuated, and there are no significantly differences between their sex. The proposed game can be a suitable tool to disseminate and promote CPR knowledge.

Trial of validation of two devices for self-measurement of blood pressure according to the European Society of Hypertension International Protocol: the Citizen CH-432B and the Citizen CH-656C.

Science.gov (United States)

Cotte, Uwe V; Faltenbacher, Verena H; von Willich, Werner; Bogner, Johannes R

2008-02-01

Two devices for self-measurement of blood pressure, one at the upper arm (Citizen CH-432B) and one at the wrist (Citizen CH-656C), were evaluated according to the International Protocol of the European Society of Hypertension. The International Protocol is divided into two phases: the first phase is performed on 15 selected participants with five participants in three different blood pressure ranges. If the devices passed this phase, 18 additional participants selected on the basis of the same criteria as in phase 1 were included. Two skilled observers performed the following blood pressure measurements: five measurements were performed with the mercury standard alternating with four measurements with each of the test devices per participant. The first measurement result from each device instrument was not included in the analysis. The difference between the blood pressure value given by the devices and that obtained by the two observers (mean of the two observers) was calculated for each pair of measurements and classified into three categories (within 5, 10 and 15 mmHg). The results were compared to the pass criteria established by the European Society of Hypertension. Afterwards the number of measurement differences falling within 5 mmHg was determined for every person. At least 22 of the 33 participants should have two of their three comparisons within 5 mmHg and there should be a maximum of three participants without a measurement difference within the 5 mmHg range. Both tested devices passed the first phase of the validation process by exceeding the required number of comparisons falling within the 5, 10 and 15 mmHg error zones. Even the second phase confirmed the validation criteria with average differences between the device and the mercury sphygmomanometer of 0.7+/-4.4 and -3.6+/-4.0 mmHg for systolic blood pressure and diastolic blood pressure, respectively, for the Citizen CH-432B device and -0.7+/-6.0 and -1.2+/-4.5 mmHg for the Citizen CH-656C device

Deployment Strategies and Clustering Protocols Efficiency

Directory of Open Access Journals (Sweden)

Chérif Diallo

2017-06-01

Full Text Available Wireless sensor networks face significant design challenges due to limited computing and storage capacities and, most importantly, dependence on limited battery power. Energy is a critical resource and is often an important issue to the deployment of sensor applications that claim to be omnipresent in the world of future. Thus optimizing the deployment of sensors becomes a major constraint in the design and implementation of a WSN in order to ensure better network operations. In wireless networking, clustering techniques add scalability, reduce the computation complexity of routing protocols, allow data aggregation and then enhance the network performance. The well-known MaxMin clustering algorithm was previously generalized, corrected and validated. Then, in a previous work we have improved MaxMin by proposing a Single- node Cluster Reduction (SNCR mechanism which eliminates single-node clusters and then improve energy efficiency. In this paper, we show that MaxMin, because of its original pathological case, does not support the grid deployment topology, which is frequently used in WSN architectures. The unreliability feature of the wireless links could have negative impacts on Link Quality Indicator (LQI based clustering protocols. So, in the second part of this paper we show how our distributed Link Quality based d- Clustering Protocol (LQI-DCP has good performance in both stable and high unreliable link environments. Finally, performance evaluation results also show that LQI-DCP fully supports the grid deployment topology and is more energy efficient than MaxMin.

Chemoradiotherapy, with adjuvant surgery for local control, confers a durable survival advantage in adenocarcinoma and squamous cell carcinoma of the oesophagus.

LENUS (Irish Health Repository)

Bass, G A

2014-04-01

Oesophageal cancer usually presents with systemic disease, necessitating systemic therapy. Neo-adjuvant chemoradiotherapy improves short-term survival, but its long-term impact is disputed because of limited accrual, treatment-protocol heterogeneity and a short follow-up of randomised trials.

Survival of very young children with medulloblastoma (primitive neuroectodermal tumor of the posterior fossa) treated with craniospinal irradiation

International Nuclear Information System (INIS)

Saran, Frank H.; Driever, Pablo Herniz; Thilmann, Christoph; Mose, Stephan; Wilson, Paula; Sharpe, Geoff; Adamietz, Irenaeus A.; Boettcher, Heinz D.

1998-01-01

Purpose: Very young children with medulloblastoma are considered to have a worse prognosis than older children. As radiotherapy remains an important part of the treatment, the adverse prognosis could be due to inadequate radiation treatment rather than biological factors. We analyzed the published literature to examine the impact of radiotherapy on survival in this group. Methods and Materials: A Medline search was performed and we reviewed studies of treatment of medulloblastoma where radiotherapy was delivered using megavoltage equipment and the minimum follow-up allowed the calculation of 5-year survival rates. Results: Thirty-nine studies were published between 1979 and 1996 with a treatment including craniospinal irradiation and boost to the posterior fossa. Eleven studies comprising 1366 patients analyzed survival by age at diagnosis. Eight of 11 studies showed a worse 5-year survival for the younger patient group which reached statistical significance in two. There is also a suggestion of a higher proportion of children with metastatic disease at presentation in the very young age group. The usual policy in younger children was to give a lower dose of radiotherapy to the craniospinal axis (CSA) and posterior fossa (PF) with reduction of dose in the range of 15 to 25% compared to standard treatment. As dose reduction to the posterior fossa is associated with worse survival and local recurrence is the predominant site of failure, the major determinant of worse survival in very young children with medulloblastoma may be suboptimal radiotherapy. Protocols including postoperative chemotherapy with delayed, omitted, or only local tumor irradiation do not reach survival rates of protocols with standard radiotherapy, also suggesting a continued importance for irradiation. Conclusion: Very young children with medulloblastoma have a worse prognosis than older children. Inadequate radiation dose and technique to the primary tumor region may be a major contributing

Protocol for Usability Testing and Validation of the ISO Draft International Standard 19223 for Lung Ventilators

Science.gov (United States)

2017-01-01

Background Clinicians, such as respiratory therapists and physicians, are often required to set up pieces of medical equipment that use inconsistent terminology. Current lung ventilator terminology that is used by different manufacturers contributes to the risk of usage errors, and in turn the risk of ventilator-associated lung injuries and other conditions. Human factors and communication issues are often associated with ventilator-related sentinel events, and inconsistent ventilator terminology compounds these issues. This paper describes our proposed protocol, which will be implemented at the University of Waterloo, Canada when this project is externally funded. Objective We propose to determine whether a standardized vocabulary improves the ease of use, safety, and utility as it relates to the usability of medical devices, compared to legacy medical devices from multiple manufacturers, which use different terms. Methods We hypothesize that usage errors by clinicians will be lower when standardization is consistently applied by all manufacturers. The proposed study will experimentally examine the impact of standardized nomenclature on performance declines in the use of an unfamiliar ventilator product in clinically relevant scenarios. Participants will be respiratory therapy practitioners and trainees, and we propose studying approximately 60 participants. Results The work reported here is in the proposal phase. Once the protocol is implemented, we will report the results in a follow-up paper. Conclusions The proposed study will help us better understand the effects of standardization on medical device usability. The study will also help identify any terms in the International Organization for Standardization (ISO) Draft International Standard (DIS) 19223 that may be associated with recurrent errors. Amendments to the standard will be proposed if recurrent errors are identified. This report contributes a protocol that can be used to assess the effect of

An Enhanced Biometric Based Authentication with Key-Agreement Protocol for Multi-Server Architecture Based on Elliptic Curve Cryptography

Science.gov (United States)

Reddy, Alavalapati Goutham; Das, Ashok Kumar; Odelu, Vanga; Yoo, Kee-Young

2016-01-01

Biometric based authentication protocols for multi-server architectures have gained momentum in recent times due to advancements in wireless technologies and associated constraints. Lu et al. recently proposed a robust biometric based authentication with key agreement protocol for a multi-server environment using smart cards. They claimed that their protocol is efficient and resistant to prominent security attacks. The careful investigation of this paper proves that Lu et al.’s protocol does not provide user anonymity, perfect forward secrecy and is susceptible to server and user impersonation attacks, man-in-middle attacks and clock synchronization problems. In addition, this paper proposes an enhanced biometric based authentication with key-agreement protocol for multi-server architecture based on elliptic curve cryptography using smartcards. We proved that the proposed protocol achieves mutual authentication using Burrows-Abadi-Needham (BAN) logic. The formal security of the proposed protocol is verified using the AVISPA (Automated Validation of Internet Security Protocols and Applications) tool to show that our protocol can withstand active and passive attacks. The formal and informal security analyses and performance analysis demonstrates that the proposed protocol is robust and efficient compared to Lu et al.’s protocol and existing similar protocols. PMID:27163786

An Enhanced Biometric Based Authentication with Key-Agreement Protocol for Multi-Server Architecture Based on Elliptic Curve Cryptography.

Directory of Open Access Journals (Sweden)

Alavalapati Goutham Reddy

Full Text Available Biometric based authentication protocols for multi-server architectures have gained momentum in recent times due to advancements in wireless technologies and associated constraints. Lu et al. recently proposed a robust biometric based authentication with key agreement protocol for a multi-server environment using smart cards. They claimed that their protocol is efficient and resistant to prominent security attacks. The careful investigation of this paper proves that Lu et al.'s protocol does not provide user anonymity, perfect forward secrecy and is susceptible to server and user impersonation attacks, man-in-middle attacks and clock synchronization problems. In addition, this paper proposes an enhanced biometric based authentication with key-agreement protocol for multi-server architecture based on elliptic curve cryptography using smartcards. We proved that the proposed protocol achieves mutual authentication using Burrows-Abadi-Needham (BAN logic. The formal security of the proposed protocol is verified using the AVISPA (Automated Validation of Internet Security Protocols and Applications tool to show that our protocol can withstand active and passive attacks. The formal and informal security analyses and performance analysis demonstrates that the proposed protocol is robust and efficient compared to Lu et al.'s protocol and existing similar protocols.

Validation of the fully automated A&D TM-2656 blood pressure monitor according to the British Hypertension Society Protocol.

Science.gov (United States)

Zeng, Wei-Fang; Liu, Ming; Kang, Yuan-Yuan; Li, Yan; Wang, Ji-Guang

2013-08-01

The present study aimed to evaluate the accuracy of the fully automated oscillometric upper-arm blood pressure monitor TM-2656 according to the British Hypertension Society (BHS) Protocol 1993. We recruited individuals until there were 85 eligible participants and their blood pressure could meet the blood pressure distribution requirements specified by the BHS Protocol. For each individual, we sequentially measured the systolic and diastolic blood pressures using a mercury sphygmomanometer (two observers) and the TM-2656 device (one supervisor). Data analysis was carried out according to the BHS Protocol. The device achieved grade A. The percentage of blood pressure differences within 5, 10, and 15 mmHg was 62, 85, and 96%, respectively, for systolic blood pressure, and 71, 93, and 99%, respectively, for diastolic blood pressure. The average (±SD) of the device-observer differences was -2.1±7.8 mmHg (P<0.0001) and -1.1±5.8 mmHg (P<0.0001) for systolic and diastolic blood pressures, respectively. The A&D upper-arm blood pressure monitor TM-2656 has passed the requirements of the BHS Protocol, and can thus be recommended for blood pressure measurement.

Is there a hierarchy of survival reflexes?

Science.gov (United States)

Macphail, Kieran

2013-10-01

A hierarchy of survival reflexes for prioritising assessment and treatment in patients with pain of insidious onset is hypothesised. The hierarchy asserts that some systems are more vital than others and that the central nervous system (CNS) prioritises systems based on their significance to survival. The hypothesis suggests that dysfunction in more important systems will cause compensation in less important systems. This paper presents studies examining these effects for each system, arguing that each section of the hierarchy may have effects on other systems within the hierarchy. This concept is untested empirically, highly speculative and substantial research is required to validate the suggested hierarchical prioritisation by the CNS. Nonetheless, the hierarchy does provide a theoretical framework to use to exclude contributing systems in patients with pain of insidious onset. Copyright © 2013 Elsevier Ltd. All rights reserved.

Validation of a new strength measurement device for amyotrophic lateral sclerosis clinical trials.

Science.gov (United States)

Andres, Patricia L; Skerry, Linda M; Munsat, Theodore L; Thornell, Brenda J; Szymonifka, Jackie; Schoenfeld, David A; Cudkowicz, Merit E

2012-01-01

Strength measures with reduced variability and higher sensitivity could improve efficiency in clinical trials of amyotrophic lateral sclerosis (ALS). The Accurate Test of Limb Isometric Strength (ATLIS) was developed to precisely and conveniently measure force in 12 muscle groups. In this study we evaluate the reliability and validity of the ATLIS testing protocol. Twenty healthy adults and 10 patients with ALS were tested twice by the same or by different evaluators to determine test-retest and interrater reliability. Twenty healthy adults were examined using ATLIS and a well-validated strength testing protocol (TQNE) to assess criterion-based validity. Mean absolute variation between tests was 8.6%, and intraclass correlation coefficients for each muscle group were high (range 0.82-0.99). The Pearson correlation coefficient of mean ATLIS and TQNE scores was 0.90. A subject survey demonstrated high user acceptance of ATLIS. ATLIS is convenient for patients and evaluators, produces precise strength measurements, and is easily moved between examining rooms. Copyright © 2011 Wiley Periodicals, Inc.

Protocol for Uniformly Measuring and Expressing the Performance of Energy Storage Systems

Energy Technology Data Exchange (ETDEWEB)

Conover, David R. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Crawford, Alasdair J. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Fuller, Jason [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Gourisetti, Sri Nikhil [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Viswanathan, Vilayanur [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Ferreira, Summer Rhodes [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Schoenwald, David A. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Rosewater, David Martin [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

2016-04-01

This Protocol provides a set of “best practices” for characterizing energy storage systems (ESSs) and measuring and reporting their performance. It serves as a basis for assessing how an ESS will perform with respect to key performance attributes relevant to different applications. It is intended to provide a valid and accurate basis for the comparison of different ESSs. By achieving the stated purpose, the Protocol will enable more informed decision-making in the selection of ESSs for various stationary applications. The Protocol identifies general information and technical specifications relevant in describing an ESS and also defines a set of test, measurement, and evaluation criteria with which to express the performance of ESSs that are intended for energy-intensive and/or power-intensive stationary applications. An ESS includes a storage device, battery management system, and any power conversion systems installed with the storage device. The Protocol is agnostic with respect to the storage technology and the size and rating of the ESS. The Protocol does not apply to single-use storage devices and storage devices that are not coupled with power conversion systems, nor does it address safety, security, or operations and maintenance of ESSs, or provide any pass/fail criteria.

TP53 gene status affects survival in advanced mycosis fungoides

Directory of Open Access Journals (Sweden)

Gitte Wooler

2016-11-01

Full Text Available TP53 is frequently mutated in different types of neoplasms including leukemia and lymphomas. Mutations of TP53 have also been reported in mycosis fungoides (MF, the most common type of cutaneous lymphoma. However, little is known about the frequency, spectrum of mutations and their prognostic significance in MF. In this study we have optimized the protocol for Sanger sequencing of TP53 using DNA extracted from archival paraffin-embedded biopsies. Of 19 samples from patients with stage IIB MF or higher, 31% harboured mutations in TP53. Overall survival of the patients with mutated TP53 was significantly shorter than median survival in the age- and stage-matched patients treated in our Institution. Distribution of mutations was heterogenous in TP53 exons, however C>T transitions were common suggesting the causal role of ultraviolet radiation. We propose that TP53 mutation status would be useful for risk stratification of patients with advanced MF.

Validation of the HONSUN LD-578 blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol.

Science.gov (United States)

Zhang, Yi; Wang, Jie; Huang, Qi-Fang; Sheng, Chang-Sheng; Li, Yan; Wang, Ji-Guang

2009-06-01

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor LD-578 (HONSUN Group, Shanghai, China) for home blood pressure monitoring according to the International Protocol. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese using a mercury sphygmomanometer (two observers) and the LD-578 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 15 participants in phase 1 and a further 18 participants in phase 2 of the validation study. Data analysis was performed using the ESHIP Analyzer. The LD-578 device successfully passed phase 1 of the validation study with a number of absolute differences between device and observers within 5, 10, and 15 mmHg for at least 32 of 45, 41 of 45, and 45 of 45 measurements (required 25, 35, and 40), respectively. The device also achieved the targets for phase 2.1, with 67 of 99, 90 of 99, and 98 of 99 differences within 5, 10, and 15 mmHg, respectively, for systolic blood pressure, and with 69 of 99, 95 of 99, and 98 of 99 within 5, 10, and 15 mmHg, respectively, for diastolic blood pressure. In phase 2.2, 24 participants had at least two of the three device-observers differences within 5 mmHg (required >or=22) for systolic and diastolic blood pressure. The HONSUN upper arm blood pressure monitor LD-578 can be recommended for home use in adults.

Survival analysis of a treatment data for cancer of the larynx

International Nuclear Information System (INIS)

Khan, K.

2002-01-01

In this paper a survival analysis of the survival time is done. The Cox regression model is fitted to the survival time with the assumption of proportional hazard. A model is selected after inclusion and exclusion of factors and variables as explanatory variables. The assumption of proportional hazards is tested in the manner suggested by Harrell (1986). The assumption of proportional hazards is supported by these tests. However the plot of Schoenfeld residuals against dose gave a little evidence of non validity of the proportional hazard assumption. The assumption seems to be satisfied for variable time. The martingale residuals suggest no pattern for variable age. The functional form of dose is not linear. Hence the quadratic dose is used as an explanatory variable. A comparison of logistic regression analysis and survival analysis is also made in this paper. It can be concluded that Cox proportional hazards model is a better model than the logistic model as it is more parsimonious and utilizes more information. (author)

Survival analysis of heart failure patients: A case study.

Science.gov (United States)

Ahmad, Tanvir; Munir, Assia; Bhatti, Sajjad Haider; Aftab, Muhammad; Raza, Muhammad Ali

2017-01-01

This study was focused on survival analysis of heart failure patients who were admitted to Institute of Cardiology and Allied hospital Faisalabad-Pakistan during April-December (2015). All the patients were aged 40 years or above, having left ventricular systolic dysfunction, belonging to NYHA class III and IV. Cox regression was used to model mortality considering age, ejection fraction, serum creatinine, serum sodium, anemia, platelets, creatinine phosphokinase, blood pressure, gender, diabetes and smoking status as potentially contributing for mortality. Kaplan Meier plot was used to study the general pattern of survival which showed high intensity of mortality in the initial days and then a gradual increase up to the end of study. Martingale residuals were used to assess functional form of variables. Results were validated computing calibration slope and discrimination ability of model via bootstrapping. For graphical prediction of survival probability, a nomogram was constructed. Age, renal dysfunction, blood pressure, ejection fraction and anemia were found as significant risk factors for mortality among heart failure patients.

An Easy Tool to Predict Survival in Patients Receiving Radiation Therapy for Painful Bone Metastases

Energy Technology Data Exchange (ETDEWEB)

Westhoff, Paulien G., E-mail: p.g.westhoff@umcutrecht.nl [Department of Radiotherapy, University Medical Center Utrecht, Utrecht (Netherlands); Graeff, Alexander de [Department of Medical Oncology, University Medical Center Utrecht, Utrecht (Netherlands); Monninkhof, Evelyn M. [Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht (Netherlands); Bollen, Laurens; Dijkstra, Sander P. [Department of Orthopedic Surgery, Leiden University Medical Center (Netherlands); Steen-Banasik, Elzbieta M. van der [ARTI Institute for Radiation Oncology Arnhem, Arnhem (Netherlands); Vulpen, Marco van [Department of Radiotherapy, University Medical Center Utrecht, Utrecht (Netherlands); Leer, Jan Willem H. [Department of Radiotherapy, University Medical Center Nijmegen, Nijmegen (Netherlands); Marijnen, Corrie A.; Linden, Yvette M. van der [Department of Clinical Oncology, Leiden University Medical Center, Leiden (Netherlands)

2014-11-15

Purpose: Patients with bone metastases have a widely varying survival. A reliable estimation of survival is needed for appropriate treatment strategies. Our goal was to assess the value of simple prognostic factors, namely, patient and tumor characteristics, Karnofsky performance status (KPS), and patient-reported scores of pain and quality of life, to predict survival in patients with painful bone metastases. Methods and Materials: In the Dutch Bone Metastasis Study, 1157 patients were treated with radiation therapy for painful bone metastases. At randomization, physicians determined the KPS; patients rated general health on a visual analogue scale (VAS-gh), valuation of life on a verbal rating scale (VRS-vl) and pain intensity. To assess the predictive value of the variables, we used multivariate Cox proportional hazard analyses and C-statistics for discriminative value. Of the final model, calibration was assessed. External validation was performed on a dataset of 934 patients who were treated with radiation therapy for vertebral metastases. Results: Patients had mainly breast (39%), prostate (23%), or lung cancer (25%). After a maximum of 142 weeks' follow-up, 74% of patients had died. The best predictive model included sex, primary tumor, visceral metastases, KPS, VAS-gh, and VRS-vl (C-statistic = 0.72, 95% CI = 0.70-0.74). A reduced model, with only KPS and primary tumor, showed comparable discriminative capacity (C-statistic = 0.71, 95% CI = 0.69-0.72). External validation showed a C-statistic of 0.72 (95% CI = 0.70-0.73). Calibration of the derivation and the validation dataset showed underestimation of survival. Conclusion: In predicting survival in patients with painful bone metastases, KPS combined with primary tumor was comparable to a more complex model. Considering the amount of variables in complex models and the additional burden on patients, the simple model is preferred for daily use. In addition, a risk table for survival is

Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: the protocol of the KLASS-02 multicenter randomized controlled clinical trial

International Nuclear Information System (INIS)

Hur, Hoon; Lee, Hyun Yong; Lee, Hyuk-Joon; Kim, Min Chan; Hyung, Woo Jin; Park, Young Kyu; Kim, Wook; Han, Sang-Uk

2015-01-01

Despite the well-described benefits of laparoscopic surgery such as lower operative blood loss and enhanced postoperative recovery in gastric cancer surgery, the application of laparoscopic surgery in patients with locally advanced gastric cancer (AGC) remains elusive owing to a lack of clinical evidence. Recently, the Korean Laparoscopic Surgical Society Group launched a new multicenter randomized clinical trial (RCT) to compare laparoscopic and open D2 lymphadenectomy for patients with locally AGC. Here, we introduce the protocol of this clinical trial. This trial is an investigator-initiated, randomized, controlled, parallel group, non-inferiority trial. Gastric cancer patients diagnosed with primary tumors that have invaded into the muscle propria and not into an adjacent organ (cT2–cT4a) in preoperative studies are recruited. Another criterion for recruitment is no lymph node metastasis or limited perigastric lymph node (including lymph nodes around the left gastric artery) metastasis. A total 1,050 patients in both groups are required to statistically show non-inferiority of the laparoscopic approach with respect to the primary end-point, relapse-free survival of 3 years. Secondary outcomes include postoperative morbidity and mortality, postoperative recovery, quality of life, and overall survival. Surgeons who are validated through peer-review of their surgery videos can participate in this clinical trial. This clinical trial was designed to maintain the principles of a surgical clinical trial with internal validity for participating surgeons. Through the KLASS-02 RCT, we hope to show the efficacy of laparoscopic D2 lymphadenectomy in AGC patients compared with the open procedure. ClinicalTrial.gov, https://www.clinicaltrials.gov/ct2/show/NCT01456598?term

Validation of the Omron HEM-7320-LA, upper arm blood pressure monitor with Intelli Wrap Technology Cuff HEM-FL1 for self-measurement and clinic use according to the European Society of Hypertension International Protocol revision 2010 in the Mexican population.

Science.gov (United States)

Grover-Páez, Fernando; Cardona-Muñoz, Ernesto G; Cardona-Müller, David; Guzmán-Saldívar, Víctor H; Rodríguez-De la Cerda, Mariana; Jiménez-Cázarez, Mayra B; Totsuka-Sutto, Sylvia E; Alanis-Sánchez, Guillermo A; Ramos-Becerra, Carlos G

2017-12-01

The aim of this study was to determine the accuracy of the Omron HEM-7320-LA with Intelli Wrap technology cuff HEM-FL1 for self-measurement and clinic blood pressure (BP) measurement according to the European Society of Hypertension International Protocol revision 2010. The evaluation was performed in 39 individuals. The mean age of the participants was 47.9±14 years; systolic BP was 145.2±24.3 mmHg (range: 97-190), diastolic BP was 90.9±12.9 mmHg (range: 68-120), and arm circumference was 30.8±4 cm (range: 25-38.5). The device successfully fulfilled the established criteria of the validation protocol. The device overestimated systolic BP by 0.6±5.7 mmHg and diastolic BP by 2.2±5.1 mmHg. The specially designed cuff HEM-FL1 to cover a broad range of arm circumferences and self-placement fulfilled the requirements of the International Protocol.

Protocol for the evaluation and validation of Qi Blood Yin Yang deficiency pattern questionnaire: prospective observational study.

Science.gov (United States)

Kim, Jihye; Kim, Keun Ho

2015-12-01

The aim of this study is to validate the pattern identification standard of qi, blood, yin, and yang deficiency patterns diagnosis. The current study will investigate the usefulness of the Qi Blood Yin Yang deficiency pattern questionnaire as a diagnostic tool for qi, blood, yin, and yang deficiencies by assessing the agreement between the scores and a gold standard established by assessors. This protocol is for a single center, prospective, observational study. A total of 248 eligible patients with unexplained chronic fatigue will be assigned to four groups in a 1:1:1:1 ratio as the qi deficiency group, blood deficiency group, yin deficiency group, and yang deficiency group. The primary outcome will be measured using the score of the Qi Blood Yin Yang deficiency pattern questionnaire and the secondary outcomes will be measured using the fatigue severity scale, Korean-translated chalder fatigue scale, computerized tongue image analysis system, and three types of pattern identification questionnaires (cold-heat, food accumulation, and seven emotions patterns). The safety of the clinical study will be assessed after measurements at every visit. All statistical analysis will be performed using the R Statistics program. Statistics experts will analyze the relationship between clinical data using the Pearson's Chi-squared test and independent t -test. This study will provide reference data and good evidence that are applicable to future studies. Furthermore, the results of the present study are useful to improve the care of patients with unexplained chronic fatigue and unexplained chronic fatigue-related disorders.

Synthetic CT: Simulating low dose single and dual energy protocols from a dual energy scan

International Nuclear Information System (INIS)

Wang, Adam S.; Pelc, Norbert J.

2011-01-01

Purpose: The choice of CT protocol can greatly impact patient dose and image quality. Since acquiring multiple scans at different techniques on a given patient is undesirable, the ability to predict image quality changes starting from a high quality exam can be quite useful. While existing methods allow one to generate simulated images of lower exposure (mAs) from an acquired CT exam, the authors present and validate a new method called synthetic CT that can generate realistic images of a patient at arbitrary low dose protocols (kVp, mAs, and filtration) for both single and dual energy scans. Methods: The synthetic CT algorithm is derived by carefully ensuring that the expected signal and noise are accurate for the simulated protocol. The method relies on the observation that the material decomposition from a dual energy CT scan allows the transmission of an arbitrary spectrum to be predicted. It requires an initial dual energy scan of the patient to either synthesize raw projections of a single energy scan or synthesize the material decompositions of a dual energy scan. The initial dual energy scan contributes inherent noise to the synthesized projections that must be accounted for before adding more noise to simulate low dose protocols. Therefore, synthetic CT is subject to the constraint that the synthesized data have noise greater than the inherent noise. The authors experimentally validated the synthetic CT algorithm across a range of protocols using a dual energy scan of an acrylic phantom with solutions of different iodine concentrations. An initial 80/140 kVp dual energy scan of the phantom provided the material decomposition necessary to synthesize images at 100 kVp and at 120 kVp, across a range of mAs values. They compared these synthesized single energy scans of the phantom to actual scans at the same protocols. Furthermore, material decompositions of a 100/120 kVp dual energy scan are synthesized by adding correlated noise to the initial material

Volume of high-risk intratumoral subregions at multi-parametric MR imaging predicts overall survival and complements molecular analysis of glioblastoma

Energy Technology Data Exchange (ETDEWEB)

Cui, Yi; Li, Ruijiang [Stanford University, Department of Radiation Oncology, Palo Alto, CA (United States); Hokkaido University, Global Station for Quantum Medical Science and Engineering, Global Institution for Collaborative Research and Education, Hokkaido (Japan); Ren, Shangjie [Tianjin University, School of Electrical Engineering and Automation, Tianjin Shi (China); Tha, Khin Khin; Shirato, Hiroki [Hokkaido University, Global Station for Quantum Medical Science and Engineering, Global Institution for Collaborative Research and Education, Hokkaido (Japan); Hokkaido University, Department of Radiology and Nuclear Medicine, Hokkaido (Japan); Wu, Jia [Stanford University, Department of Radiation Oncology, Palo Alto, CA (United States)

2017-09-15

To develop and validate a volume-based, quantitative imaging marker by integrating multi-parametric MR images for predicting glioblastoma survival, and to investigate its relationship and synergy with molecular characteristics. We retrospectively analysed 108 patients with primary glioblastoma. The discovery cohort consisted of 62 patients from the cancer genome atlas (TCGA). Another 46 patients comprising 30 from TCGA and 16 internally were used for independent validation. Based on integrated analyses of T1-weighted contrast-enhanced (T1-c) and diffusion-weighted MR images, we identified an intratumoral subregion with both high T1-c and low ADC, and accordingly defined a high-risk volume (HRV). We evaluated its prognostic value and biological significance with genomic data. On both discovery and validation cohorts, HRV predicted overall survival (OS) (concordance index: 0.642 and 0.653, P < 0.001 and P = 0.038, respectively). HRV stratified patients within the proneural molecular subtype (log-rank P = 0.040, hazard ratio = 2.787). We observed different OS among patients depending on their MGMT methylation status and HRV (log-rank P = 0.011). Patients with unmethylated MGMT and high HRV had significantly shorter survival (median survival: 9.3 vs. 18.4 months, log-rank P = 0.002). Volume of the high-risk intratumoral subregion identified on multi-parametric MRI predicts glioblastoma survival, and may provide complementary value to genomic information. (orig.)

A Machine-to-Machine protocol benchmark for eHealth applications - Use case: Respiratory rehabilitation.

Science.gov (United States)

Talaminos-Barroso, Alejandro; Estudillo-Valderrama, Miguel A; Roa, Laura M; Reina-Tosina, Javier; Ortega-Ruiz, Francisco

2016-06-01

M2M (Machine-to-Machine) communications represent one of the main pillars of the new paradigm of the Internet of Things (IoT), and is making possible new opportunities for the eHealth business. Nevertheless, the large number of M2M protocols currently available hinders the election of a suitable solution that satisfies the requirements that can demand eHealth applications. In the first place, to develop a tool that provides a benchmarking analysis in order to objectively select among the most relevant M2M protocols for eHealth solutions. In the second place, to validate the tool with a particular use case: the respiratory rehabilitation. A software tool, called Distributed Computing Framework (DFC), has been designed and developed to execute the benchmarking tests and facilitate the deployment in environments with a large number of machines, with independence of the protocol and performance metrics selected. DDS, MQTT, CoAP, JMS, AMQP and XMPP protocols were evaluated considering different specific performance metrics, including CPU usage, memory usage, bandwidth consumption, latency and jitter. The results obtained allowed to validate a case of use: respiratory rehabilitation of chronic obstructive pulmonary disease (COPD) patients in two scenarios with different types of requirement: Home-Based and Ambulatory. The results of the benchmark comparison can guide eHealth developers in the choice of M2M technologies. In this regard, the framework presented is a simple and powerful tool for the deployment of benchmark tests under specific environments and conditions. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

A new testing protocol for zirconia dental implants.

Science.gov (United States)

Sanon, Clarisse; Chevalier, Jérôme; Douillard, Thierry; Cattani-Lorente, Maria; Scherrer, Susanne S; Gremillard, Laurent

2015-01-01

Based on the current lack of standards concerning zirconia dental implants, we aim at developing a protocol to validate their functionality and safety prior their clinical use. The protocol is designed to account for the specific brittle nature of ceramics and the specific behavior of zirconia in terms of phase transformation. Several types of zirconia dental implants with different surface textures (porous, alveolar, rough) were assessed. The implants were first characterized in their as-received state by Scanning Electron Microscopy (SEM), Focused Ion Beam (FIB), X-Ray Diffraction (XRD). Fracture tests following a method adapted from ISO 14801 were conducted to evaluate their initial mechanical properties. Accelerated aging was performed on the implants, and XRD monoclinic content measured directly at their surface instead of using polished samples as in ISO 13356. The implants were then characterized again after aging. Implants with an alveolar surface presented large defects. The protocol shows that such defects compromise the long-term mechanical properties. Implants with a porous surface exhibited sufficient strength but a significant sensitivity to aging. Even if associated to micro cracking clearly observed by FIB, aging did not decrease mechanical strength of the implants. As each dental implant company has its own process, all zirconia implants may behave differently, even if the starting powder is the same. Especially, surface modifications have a large influence on strength and aging resistance, which is not taken into account by the current standards. Protocols adapted from this work could be useful. Copyright © 2014 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Validating prediction scales of type 2 diabetes mellitus in Spain: the SPREDIA-2 population-based prospective cohort study protocol

Science.gov (United States)

Salinero-Fort, Miguel Ángel; de Burgos-Lunar, Carmen; Mostaza Prieto, José; Lahoz Rallo, Carlos; Abánades-Herranz, Juan Carlos; Gómez-Campelo, Paloma; Laguna Cuesta, Fernando; Estirado De Cabo, Eva; García Iglesias, Francisca; González Alegre, Teresa; Fernández Puntero, Belén; Montesano Sánchez, Luis; Vicent López, David; Cornejo Del Río, Víctor; Fernández García, Pedro J; Sabín Rodríguez, Concesa; López López, Silvia; Patrón Barandío, Pedro

2015-01-01

Introduction The incidence of type 2 diabetes mellitus (T2DM) is increasing worldwide. When diagnosed, many patients already have organ damage or advance subclinical atherosclerosis. An early diagnosis could allow the implementation of lifestyle changes and treatment options aimed at delaying the progression of the disease and to avoid cardiovascular complications. Different scores for identifying undiagnosed diabetes have been reported, however, their performance in populations of southern Europe has not been sufficiently evaluated. The main objectives of our study are: to evaluate the screening performance and cut-off points of the main scores that identify the risk of undiagnosed T2DM and prediabetes in a Spanish population, and to develop and validate our own predictive models of undiagnosed T2DM (screening model), and future T2DM (prediction risk model) after 5-year follow-up. As a secondary objective, we will evaluate the atherosclerotic burden of the population with undiagnosed T2DM. Methods and analysis Population-based prospective cohort study with baseline screening, to evaluate the performance of the FINDRISC, DANISH, DESIR, ARIC and QDScore, against the gold standard tests: Fasting plasma glucose, oral glucose tolerance and/or HbA1c. The sample size will include 1352 participants between the ages of 45 and 74 years. Analysis: sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio positive, likelihood ratio negative and receiver operating characteristic curves and area under curve. Binary logistic regression for the first 700 individuals (derivation) and last 652 (validation) will be performed. All analyses will be calculated with their 95% CI; statistical significance will be p<0.05. Ethics and dissemination The study protocol has been approved by the Research Ethics Committee of the Carlos III Hospital (Madrid). The score performance and predictive model will be presented in medical conferences, workshops

The design and analysis of salmonid tagging studies in the Columbia Basin. Volume 2: Estimating salmonid survival with combined PIT-CWT tagging. Technical report

International Nuclear Information System (INIS)

Newman, K.

1997-06-01

Passive Integrated Transponder (PIT) tags and Coded Wire Tags (CWTs) in combination can provide information about salmonid survival that single tag releases may not. The release and recapture protocol affects which survival and recapture rates can be estimated and the precision of the estimates. For the particular case of Columbia river salmonids tagged with both PIT tags and CWTs, three different release and recapture protocols were evaluated. This report addresses the need to study the fate of salmon smolt in-river and their subsequent return as adults. Double-tagging procedures are investigated where PIT-tags would be used to provide in-river survival data during smolt outmigrations and coded-wire tags (CWT) used to provide adult return information. This report provides statistical models for the analysis of the joint data as well as recommendations on optimal tagging studies. Study costs and stress on smolt can be reduced by only PIT-tagging a subset of all the fish coded-wire-tagged, while retaining the information content and sampling precision

Expression of the DNA repair gene MLH1 correlates with survival in patients who have resected pancreatic cancer and have received adjuvant chemoradiation: NRG Oncology RTOG Study 9704.

Science.gov (United States)

Lawrence, Yaacov R; Moughan, Jennifer; Magliocco, Anthony M; Klimowicz, Alexander C; Regine, William F; Mowat, Rex B; DiPetrillo, Thomas A; Small, William; Simko, Jeffry P; Golan, Talia; Winter, Kathryn A; Guha, Chandan; Crane, Christopher H; Dicker, Adam P

2018-02-01

The majority of patients with pancreatic cancer who undergo curative resection experience rapid disease recurrence. In previous small studies, high expression of the mismatch-repair protein mutL protein homolog 1 (MLH1) in pancreatic cancers was associated with better outcomes. The objective of this study was to validate the association between MLH1 expression and survival in patients who underwent resection of pancreatic cancer and received adjuvant chemoradiation. Samples were obtained from the NRG Oncology Radiation Therapy Oncology Group 9704 prospective, randomized trial (clinicaltrials.gov identifier NCT00003216), which compared 2 adjuvant protocols in patients with pancreatic cancer who underwent resection. Tissue microarrays were prepared from formalin-fixed, paraffin-embedded, resected tumor tissues. MLH1 expression was quantified using fluorescence immunohistochemistry and automated quantitative analysis, and expression was dichotomized above and below the median value. Immunohistochemical staining was successfully performed on 117 patients for MLH1 (60 and 57 patients from the 2 arms). The characteristics of the participants who had tissue samples available were similar to those of the trial population as a whole. At the time of analysis, 84% of participants had died, with a median survival of 17 months. Elevated MLH1 expression levels in tumor nuclei were significantly correlated with longer disease-free and overall survival in each arm individually and in both arms combined. Two-year overall survival was 16% in patients who had low MLH1 expression levels and 53% in those who had high MLH1 expression levels (P MLH1 expression was correlated with long-term survival. Further studies should assess whether MLH1 expression predicts which patients with localized pancreatic cancer may benefit most from aggressive, multimodality treatment. Cancer 2018;124:491-8. © 2017 American Cancer Society. © 2017 American Cancer Society.

Instrumental variable estimation in a survival context

DEFF Research Database (Denmark)

Tchetgen Tchetgen, Eric J; Walter, Stefan; Vansteelandt, Stijn

2015-01-01

for regression analysis in a survival context, primarily under an additive hazards model, for which we describe 2 simple methods for estimating causal effects. The first method is a straightforward 2-stage regression approach analogous to 2-stage least squares commonly used for IV analysis in linear regression....... The IV approach is very well developed in the context of linear regression and also for certain generalized linear models with a nonlinear link function. However, IV methods are not as well developed for regression analysis with a censored survival outcome. In this article, we develop the IV approach....... In this approach, the fitted value from a first-stage regression of the exposure on the IV is entered in place of the exposure in the second-stage hazard model to recover a valid estimate of the treatment effect of interest. The second method is a so-called control function approach, which entails adding...

Survival associated pathway identification with group Lp penalized global AUC maximization

Directory of Open Access Journals (Sweden)

Liu Zhenqiu

2010-08-01

Full Text Available Abstract It has been demonstrated that genes in a cell do not act independently. They interact with one another to complete certain biological processes or to implement certain molecular functions. How to incorporate biological pathways or functional groups into the model and identify survival associated gene pathways is still a challenging problem. In this paper, we propose a novel iterative gradient based method for survival analysis with group Lp penalized global AUC summary maximization. Unlike LASSO, Lp (p 1. We first extend Lp for individual gene identification to group Lp penalty for pathway selection, and then develop a novel iterative gradient algorithm for penalized global AUC summary maximization (IGGAUCS. This method incorporates the genetic pathways into global AUC summary maximization and identifies survival associated pathways instead of individual genes. The tuning parameters are determined using 10-fold cross validation with training data only. The prediction performance is evaluated using test data. We apply the proposed method to survival outcome analysis with gene expression profile and identify multiple pathways simultaneously. Experimental results with simulation and gene expression data demonstrate that the proposed procedures can be used for identifying important biological pathways that are related to survival phenotype and for building a parsimonious model for predicting the survival times.

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

Science.gov (United States)

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.

A Universal Standard for the Validation of Blood Pressure Measuring Devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.

Science.gov (United States)

Stergiou, George S; Alpert, Bruce; Mieke, Stephan; Asmar, Roland; Atkins, Neil; Eckert, Siegfried; Frick, Gerhard; Friedman, Bruce; Graßl, Thomas; Ichikawa, Tsutomu; Ioannidis, John P; Lacy, Peter; McManus, Richard; Murray, Alan; Myers, Martin; Palatini, Paolo; Parati, Gianfranco; Quinn, David; Sarkis, Josh; Shennan, Andrew; Usuda, Takashi; Wang, Jiguang; Wu, Colin O; O'Brien, Eoin

2018-03-01

In the past 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols. © 2018 American Heart Association, Inc., and Wolters Kluwer Health, Inc.

Protocol for Bone Augmentation with Simultaneous Early Implant Placement: A Retrospective Multicenter Clinical Study

Directory of Open Access Journals (Sweden)

Peter Fairbairn

2015-01-01

Full Text Available Purpose. To present a novel protocol for alveolar bone regeneration in parallel to early implant placement. Methods. 497 patients in need of extraction and early implant placement with simultaneous bone augmentation were treated in a period of 10 years. In all patients the same specific method was followed and grafting was performed utilizing in situ hardening fully resorbable alloplastic grafting materials consisting of β-tricalcium phosphate and calcium sulfate. The protocol involved atraumatic extraction, implant placement after 4 weeks with simultaneous bone augmentation, and loading of the implant 12 weeks after placement and grafting. Follow-up periods ranged from 6 months to 10 years (mean of 4 years. Results. A total of 601 postextraction sites were rehabilitated in 497 patients utilizing the novel protocol. Three implants failed before loading and three implants failed one year after loading, leaving an overall survival rate of 99.0%. Conclusions. This standardized protocol allows successful long-term functional results regarding alveolar bone regeneration and implant rehabilitation. The concept of placing the implant 4 weeks after extraction, augmenting the bone around the implant utilizing fully resorbable, biomechanically stable, alloplastic materials, and loading the implant at 12 weeks seems to offer advantages when compared with traditional treatment modalities.

The prediction of progression-free and overall survival in women with an advanced stage of epithelial ovarian carcinoma.

Science.gov (United States)

Gerestein, C G; Eijkemans, M J C; de Jong, D; van der Burg, M E L; Dykgraaf, R H M; Kooi, G S; Baalbergen, A; Burger, C W; Ansink, A C

2009-02-01

Prognosis in women with ovarian cancer mainly depends on International Federation of Gynecology and Obstetrics stage and the ability to perform optimal cytoreductive surgery. Since ovarian cancer has a heterogeneous presentation and clinical course, predicting progression-free survival (PFS) and overall survival (OS) in the individual patient is difficult. The objective of this study was to determine predictors of PFS and OS in women with advanced stage epithelial ovarian cancer (EOC) after primary cytoreductive surgery and first-line platinum-based chemotherapy. Retrospective observational study. Two teaching hospitals and one university hospital in the south-western part of the Netherlands. Women with advanced stage EOC. All women who underwent primary cytoreductive surgery for advanced stage EOC followed by first-line platinum-based chemotherapy between January 1998 and October 2004 were identified. To investigate independent predictors of PFS and OS, a Cox' proportional hazard model was used. Nomograms were generated with the identified predictive parameters. The primary outcome measure was OS and the secondary outcome measures were response and PFS. A total of 118 women entered the study protocol. Median PFS and OS were 15 and 44 months, respectively. Preoperative platelet count (P = 0.007), and residual disease statistic of 0.63. Predictive parameters for OS were preoperative haemoglobin serum concentration (P = 0.012), preoperative platelet counts (P = 0.031) and residual disease statistic of 0.67. PFS could be predicted by postoperative residual disease and preoperative platelet counts, whereas residual disease, preoperative platelet counts and preoperative haemoglobin serum concentration were predictive for OS. The proposed nomograms need to be externally validated.

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

Energy Technology Data Exchange (ETDEWEB)

Barrett, C. L. (Christopher L.); Drozda, M. (Martin); Marathe, A. (Achla); Marathe, M. V. (Madhav V.)

2002-01-01

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

Reliability and validity of the Mywellness Key physical activity monitor

Directory of Open Access Journals (Sweden)

Sieverdes JC

2013-01-01

Full Text Available John C Sieverdes,1 Eric E Wickel,2 Gregory A Hand,3 Marco Bergamin,4 Robert R Moran,5 Steven N Blair3,51Medical University of South Carolina, College of Nursing and Medicine, Charleson, SC, 2University of Tulsa, Exercise and Sport Science, Tulsa, OK, 3University of South Carolina, Department of Exercise Science, Division of Health Aspects of Physical Activity, Arnold School of Public Health, Columbia, SC, USA; 4University of Padova, Department of Medicine, Sports Medicine Division, Padova, Italy; 5University of South Carolina, Department of Epidemiology and Biostatistics, Arnold School of Public Health, Columbia, SC, USABackground: This study evaluated the reliability and criterion validity of the Mywellness Key accelerometer (MWK using treadmill protocols and indirect calorimetry.Methods: Twenty-five participants completed two four-stage 20-minute treadmill protocols while wearing two MWK accelerometers. Reliability was assessed using raw counts. Validity was assessed by comparing the estimated VO2 calculated from the MWK with values from respiratory gas exchange.Results: Good overall and point estimates of reliability were found for the MWK (all intraclass correlations > 0.93. Generalizability theory coefficients showed lower values for running speed (0.70 versus walking speed (all > 0.84, with the majority of the overall percentage of variability derived from the participant (68%–88% of the total 100%. Acceptable validity was found overall (Pearson’s r = 0.895–0.902, P < 0.0001, with an overall mean absolute error of 16.22% and a coefficient of variance of 16.92%. Bland-Altman plots showed an overestimation of energy expenditure during the running speed, but total kilocalories were underestimated during the protocol by approximately 10%.Conclusion: Good validity was found during light and moderate walking, while running was slightly overestimated. The MWK may be useful for clinicians and researchers interested in promotion or assessment

Validation of a real-time wireless telemedicine system, using bluetooth protocol and a mobile phone, for remote monitoring patient in medical practice.

Science.gov (United States)

Yousef, Jasemian; Lars, A N

2005-06-22

This paper validates the integration of a generic real-time wireless telemedicine system utilising Global System for Mobile Communications (GSM), BLUETOOTH protocol and General Packet Radio Service (GPRS) for cellular network in clinical practice. In the first experiment, the system was tested on 24 pacemaker patients at Aalborg Hospital (Denmark), in order to see if the pacemaker implant would be affected by the system. I the second experiment, the system was tested on 15 non risky arrhythmia heart patients, in order to evaluate and validate the system application in clinical practice, for patient monitoring. Electrocardiograms were selected as the continuously monitored parameter in the present study. The results showed that the system had no negative effects on the pacemaker implants. The experiment results showed, that in a realistic environment for the patients, the system had 96.1 % up-time, 3.2 (kbps) throughput, 10(-3) (packet/s) Packet Error Rate and 10(-3) (packet/s) Packet Lost Rate. During 24 hours test the network did not respond for 57 minutes, from which 83.1 % was in the range of 0-3 minutes, 15.4 % was in the range of 3-5 minutes, and only 0.7 % of the down-time was > or = 5 and < or = 6 minutes. By a subjective evaluation, it was demonstrated that the system is applicable and the patients as well as the healthcare personals were highly confident with the system. Moreover, the patients had high degree of mobility and freedom, employing the system. In conclusion, this generic telemedicine system showed a high reliability, quality and performance, and the design can provide a basic principle for real-time wireless remote monitoring systems used in clinical practice.

Validation of the process control system of an automated large scale manufacturing plant.

Science.gov (United States)

Neuhaus, H; Kremers, H; Karrer, T; Traut, R H

1998-02-01

The validation procedure for the process control system of a plant for the large scale production of human albumin from plasma fractions is described. A validation master plan is developed, defining the system and elements to be validated, the interfaces with other systems with the validation limits, a general validation concept and supporting documentation. Based on this master plan, the validation protocols are developed. For the validation, the system is subdivided into a field level, which is the equipment part, and an automation level. The automation level is further subdivided into sections according to the different software modules. Based on a risk categorization of the modules, the qualification activities are defined. The test scripts for the different qualification levels (installation, operational and performance qualification) are developed according to a previously performed risk analysis.

Does colour polymorphism enhance survival of prey populations?

Science.gov (United States)

Wennersten, Lena; Forsman, Anders

2009-01-01

That colour polymorphism may protect prey populations from predation is an old but rarely tested hypothesis. We examine whether colour polymorphic populations of prey exposed to avian predators in an ecologically valid visual context were exposed to increased extinction risk compared with monomorphic populations. We made 2976 artificial pastry prey, resembling Lepidoptera larvae, in four different colours and presented them in 124 monomorphic and 124 tetramorphic populations on tree trunks and branches such that they would be exposed to predation by free-living birds, and monitored their ‘survival’. Among monomorphic populations, there was a significant effect of prey coloration on survival, confirming that coloration influenced susceptibility to visually oriented predators. Survival of polymorphic populations was inferior to that of monomorphic green populations, but did not differ significantly from monomorphic brown, yellow or red populations. Differences in survival within polymorphic populations paralleled those seen among monomorphic populations; the red morph most frequently went extinct first and the green morph most frequently survived the longest. Our findings do not support the traditional protective polymorphism hypothesis and are in conflict with those of earlier studies. As a possible explanation to our findings, we offer a competing ‘giveaway cue’ hypothesis: that polymorphic populations may include one morph that attracts the attention of predators and that polymorphic populations therefore may suffer increased predation compared with some monomorphic populations. PMID:19324729

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

Science.gov (United States)

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.

Protocol for development and validation of a context-appropriate tool for assessing organisational readiness for change in primary health clinics in South Africa.

Science.gov (United States)

Brooke-Sumner, Carrie; Sorsdahl, Katherine; Lombard, Carl; Petersen-Williams, Petal; Myers, Bronwyn

2018-04-09

A large treatment gap for common mental disorders (such as depression) exists in South Africa. Comorbidity with other chronic diseases, including HIV and diseases of lifestyle, is an increasing public health concern globally. Currently, primary health facilities as points of care for those with chronic disease provide limited services for common mental disorders. Assessing organisational readiness for change (ORC) towards adopting health innovations (such as mental health services) using contextually appropriate measures is needed to facilitate implementation of these services. This study aims to investigate the validity of the Texas Christian University Organisational Readiness for Change (TCU-ORC) scale in the South African context. Subsequently, we will develop a shortened version of this scale. This study is nested within Project MIND, a multiyear randomised controlled trial that is testing two different approaches for integrating counselling for common mental disorders into chronic disease care. Although the modified, contextually appropriate ORC measure resulting from the proposed study will be developed in the context of integrating mental health into primary healthcare services, the potential for the tool to be generalised to further understanding barriers to any change being implemented in primary care settings is high. We will establish internal consistency (Cronbach's alpha coefficients), test-retest reliability (intraclass correlation coefficient) and construct validity of the long-form TCU-ORC questionnaire. Survey data will be collected from 288 clinical, management and operational staff from 24 primary health facilities where the Project MIND trial is implemented. A modified Delphi approach will assess the content validity of the TCU-ORC items and identify areas for potential adaptation and item reduction. Ethical approval has been granted by the South African Medical Research Council (Protocol ID EC004-2-2015, amendment of 20 August 2017). Results

A Selective-Awakening MAC Protocol for Energy-Efficient Data Forwarding in Linear Sensor Networks

Directory of Open Access Journals (Sweden)

Iclia Villordo-Jimenez

2018-01-01

Full Text Available We introduce the Selective-Awakening MAC (SA-MAC protocol which is a synchronized duty-cycled protocol with pipelined scheduling for Linear Sensor Networks (LSNs. In the proposed protocol, nodes selectively awake depending on node density and traffic load conditions and on the state of the buffers of the receiving nodes. In order to characterize the performance of the proposed protocol, we present a Discrete-Time Markov Chain-based analysis that is validated through extensive discrete-event simulations. Our results show that SA-MAC significantly outperforms previous proposals in terms of energy consumption, throughput, and packet loss probability. This is particularly true under high node density and high traffic load conditions, which are expected to be common scenarios in the context of IoT applications. We also present an analysis by grade (i.e., the number of hops to the sink, which is located at one end of the LSN that reveals that LSNs exhibit heterogeneous performance depending on the nodes’ grade. Such results can be used as a design guideline for future LSN implementations.

Computationally Developed Sham Stimulation Protocol for Multichannel Desynchronizing Stimulation

Directory of Open Access Journals (Sweden)

Magteld Zeitler

2018-05-01

Full Text Available A characteristic pattern of abnormal brain activity is abnormally strong neuronal synchronization, as found in several brain disorders, such as tinnitus, Parkinson's disease, and epilepsy. As observed in several diseases, different therapeutic interventions may induce a placebo effect that may be strong and hinder reliable clinical evaluations. Hence, to distinguish between specific, neuromodulation-induced effects and unspecific, placebo effects, it is important to mimic the therapeutic procedure as precisely as possibly, thereby providing controls that actually lack specific effects. Coordinated Reset (CR stimulation has been developed to specifically counteract abnormally strong synchronization by desynchronization. CR is a spatio-temporally patterned multichannel stimulation which reduces the extent of coincident neuronal activity and aims at an anti-kindling, i.e., an unlearning of both synaptic connectivity and neuronal synchrony. Apart from acute desynchronizing effects, CR may cause sustained, long-lasting desynchronizing effects, as already demonstrated in pre-clinical and clinical proof of concept studies. In this computational study, we set out to computationally develop a sham stimulation protocol for multichannel desynchronizing stimulation. To this end, we compare acute effects and long-lasting effects of six different spatio-temporally patterned stimulation protocols, including three variants of CR, using a no-stimulation condition as additional control. This is to provide an inventory of different stimulation algorithms with similar fundamental stimulation parameters (e.g., mean stimulation rates but qualitatively different acute and/or long-lasting effects. Stimulation protocols sharing basic parameters, but inducing nevertheless completely different or even no acute effects and/or after-effects, might serve as controls to validate the specific effects of particular desynchronizing protocols such as CR. In particular, based on

Creating and validating GIS measures of urban design for health research.

Science.gov (United States)

Purciel, Marnie; Neckerman, Kathryn M; Lovasi, Gina S; Quinn, James W; Weiss, Christopher; Bader, Michael D M; Ewing, Reid; Rundle, Andrew

2009-12-01

Studies relating urban design to health have been impeded by the unfeasibility of conducting field observations across large areas and the lack of validated objective measures of urban design. This study describes measures for five dimensions of urban design - imageability, enclosure, human scale, transparency, and complexity - created using public geographic information systems (GIS) data from the US Census and city and state government. GIS measures were validated for a sample of 588 New York City block faces using a well-documented field observation protocol. Correlations between GIS and observed measures ranged from 0.28 to 0.89. Results show valid urban design measures can be constructed from digital sources.

Validation of four devices: Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 for home blood pressure measurement according to the European Society of Hypertension International Protocol.

Science.gov (United States)

Topouchian, Jirar; Agnoletti, Davide; Blacher, Jacques; Youssef, Ahmed; Chahine, Mirna N; Ibanez, Isabel; Assemani, Nathalie; Asmar, Roland

2014-01-01

Four oscillometric devices, including the Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670, designed for self-blood pressure measurement (SBPM) were evaluated according to the European Society of Hypertension (ESH) International Protocol Revision 2010 in four separate studies. The four devices measure brachial blood pressure (BP) using the oscillometric method. The Withings BP-800 has to be connected to an Apple® iOS device such as an iPhone®, iPad®, or iPod®. The ESH International Protocol Revision 2010 includes a total number of 33 subjects. The difference between observer and device BP values was calculated for each measure. Ninety-nine pairs of BP differences were classified into three categories (≤5 mmHg, ≤10 mmHg, ≤15 mmHg). The protocol procedures were followed precisely in each of the four studies. All four tested devices passed the validation process. The mean differences between the device and mercury readings were: -1.8±5.1 mmHg and -0.4±2.8 mmHg for systolic and diastolic BP, respectively, using the Omron M6 Comfort device; 2.5±4.6 mmHg and -1.2±4.3 mmHg for the Omron HEM-7420 device; -0.2±5.0 mmHg and 0.4±4.2 mmHg for the Withings BP-800 device; and 3.0±5.3 mmHg and 0.3±5.2 mmHg for the Polygreen KP-7670 device. Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 readings differing by less than 5 mmHg, 10 mmHg, and 15 mmHg fulfill the ESH International Protocol Revision 2010 requirements, and therefore are suitable for use by patients for SBPM, if used correctly.

Validation of A&D TM-2430 upper-arm blood pressure monitor for ambulatory blood pressure monitoring in children and adolescents, according to the British Hypertension Society protocol.

Science.gov (United States)

Yip, Gabriel Wai-Kwok; So, Hung-Kwan; Li, Albert Martin; Tomlinson, Brian; Wong, Sik-Nin; Sung, Rita Yn-Tz

2012-04-01

The A&D TM-2430 ambulatory blood pressure (BP) monitor has been validated in adults but not in a young population. We sought to validate the device monitoring in children and adolescents, according to the British Hypertension Society (BHS) protocol. The A&D TM-2430 is an automated oscillometric upper-arm device for ambulatory BP monitoring. Nine consecutive measurements were taken in 61 children (mean age, 9.8 years; range, 5-15 years) according to the BHS criteria. Overseen by an independent supervisor, measurements were recorded by two observers blinded from each other's readings and from the device readings. The mean difference ± SD between the observers and device measurements was 0.73 ± 1.64 mmHg for systolic blood pressure (SBP) and -1.23 ± 1.65 mmHg for diastolic blood pressure (DBP), respectively, with an interobserver difference of 4 mmHg. The cumulative percentages of differences within 5, 10, and 15 mmHg were 89, 95, and 98% for SBP and 67, 88, and 98% for DBP. The device achieved a grade A rating for SBP and a B grade for DBP. The A&D TM-2430 upper-arm BP monitor has fulfilled the required BHS standards and can be recommended for measuring ambulatory BP in children and adolescent populations.

Validation of Omron RS8, RS6, and RS3 home blood pressure monitoring devices, in accordance with the European Society of Hypertension International Protocol revision 2010.

Science.gov (United States)

Takahashi, Hakuo; Yoshika, Masamichi; Yokoi, Toyohiko

2013-01-01

Allowing patients to measure their blood pressure at home is recognized as being of clinical value. However, it is not known how often these measurements are taken correctly. Blood pressure monitors for home use fall into two types based on the position of the cuff, ie, at the upper arm or the wrist. The latter is particularly convenient, as measurements can be taken fully clothed. This study aimed to evaluate the performance of the wrist-type blood pressure monitors Omron RS8 (HEM-6310F-E), Omron RS6 (HEM-6221-E), and Omron RS3 (HEM-6130-E). A team of three trained doctors validated the performance of these devices by comparing the measurements obtained from these devices with those taken using a standard mercury sphygmomanometer. All the devices met the validation requirements of the European Society of Hypertension International Protocol revision 2010. The difference in blood pressure readings between the tested device and the standard mercury sphygmomanometer was within 3 mmHg, which is acceptable according to the European Society of Hypertension guidelines. All the home devices tested were found to be suitable for measuring blood pressure at home because their performance fulfilled the requirement of the guidelines.

Survival analysis of heart failure patients: A case study.

Directory of Open Access Journals (Sweden)

Tanvir Ahmad

Full Text Available This study was focused on survival analysis of heart failure patients who were admitted to Institute of Cardiology and Allied hospital Faisalabad-Pakistan during April-December (2015. All the patients were aged 40 years or above, having left ventricular systolic dysfunction, belonging to NYHA class III and IV. Cox regression was used to model mortality considering age, ejection fraction, serum creatinine, serum sodium, anemia, platelets, creatinine phosphokinase, blood pressure, gender, diabetes and smoking status as potentially contributing for mortality. Kaplan Meier plot was used to study the general pattern of survival which showed high intensity of mortality in the initial days and then a gradual increase up to the end of study. Martingale residuals were used to assess functional form of variables. Results were validated computing calibration slope and discrimination ability of model via bootstrapping. For graphical prediction of survival probability, a nomogram was constructed. Age, renal dysfunction, blood pressure, ejection fraction and anemia were found as significant risk factors for mortality among heart failure patients.

Antioxidant defenses predict long-term survival in a passerine bird.

Directory of Open Access Journals (Sweden)

Nicola Saino

2011-05-01

Full Text Available Normal and pathological processes entail the production of oxidative substances that can damage biological molecules and harm physiological functions. Organisms have evolved complex mechanisms of antioxidant defense, and any imbalance between oxidative challenge and antioxidant protection can depress fitness components and accelerate senescence. While the role of oxidative stress in pathogenesis and aging has been studied intensively in humans and model animal species under laboratory conditions, there is a dearth of knowledge on its role in shaping life-histories of animals under natural selection regimes. Yet, given the pervasive nature and likely fitness consequences of oxidative damage, it can be expected that the need to secure efficient antioxidant protection is powerful in molding the evolutionary ecology of animals. Here, we test whether overall antioxidant defense varies with age and predicts long-term survival, using a wild population of a migratory passerine bird, the barn swallow (Hirundo rustica, as a model.Plasma antioxidant capacity (AOC of breeding individuals was measured using standard protocols and annual survival was monitored over five years (2006-2010 on a large sample of selection episodes. AOC did not covary with age in longitudinal analyses after discounting the effect of selection. AOC positively predicted annual survival independently of sex. Individuals were highly consistent in their relative levels of AOC, implying the existence of additive genetic variance and/or environmental (including early maternal components consistently acting through their lives.Using longitudinal data we showed that high levels of antioxidant protection positively predict long-term survival in a wild animal population. Present results are therefore novel in disclosing a role for antioxidant protection in determining survival under natural conditions, strongly demanding for more longitudinal eco-physiological studies of life-histories in

Performance modeling of neighbor discovery in proactive routing protocols

Directory of Open Access Journals (Sweden)

Andres Medina

2011-07-01

Full Text Available It is well known that neighbor discovery is a critical component of proactive routing protocols in wireless ad hoc networks. However there is no formal study on the performance of proposed neighbor discovery mechanisms. This paper provides a detailed model of key performance metrics of neighbor discovery algorithms, such as node degree and the distribution of the distance to symmetric neighbors. The model accounts for the dynamics of neighbor discovery as well as node density, mobility, radio and interference. The paper demonstrates a method for applying these models to the evaluation of global network metrics. In particular, it describes a model of network connectivity. Validation of the models shows that the degree estimate agrees, within 5% error, with simulations for the considered scenarios. The work presented in this paper serves as a basis for the performance evaluation of remaining performance metrics of routing protocols, vital for large scale deployment of ad hoc networks.

Development and validation of polar RP-HPLC method for screening for ectoine high-yield strains in marine bacteria with green chemistry.

Science.gov (United States)

Chen, Jun; Chen, Jianwei; Wang, Sijia; Zhou, Guangmin; Chen, Danqing; Zhang, Huawei; Wang, Hong

2018-04-02

A novel, green, rapid, and precise polar RP-HPLC method has been successfully developed and screened for ectoine high-yield strain in marine bacteria. Ectoine is a polar and extremely useful solute which allows microorganisms to survive in extreme environmental salinity. This paper describes a polar-HPLC method employed polar RP-C18 (5 μm, 250 × 4.6 mm) using pure water as the mobile phase and a column temperature of 30 °C, coupled with a flow rate at 1.0 mL/min and detected under a UV detector at wavelength of 210 nm. Our method validation demonstrates excellent linearity (R 2  = 0.9993), accuracy (100.55%), and a limit of detection LOQ and LOD of 0.372 and 0.123 μgmL -1 , respectively. These results clearly indicate that the developed polar RP-HPLC method for the separation and determination of ectoine is superior to earlier protocols.

The Dana Farber consortium protocol (DFCP) vs. classic Hyper-CVAD for treatment of acute lymphoblastic leukemia in patients <50 Y. Single institution experience.

Science.gov (United States)

Alabdulwahab, Amal S; Elsayed, Hussein G; Sherisher, Mohamed A; Zeeneldin, Ahmed; Alghamdi, Khalofa; Elbjeirami, Wafaa M

2017-09-01

The use of intensive pediatric protocols for the treatment of ALL is being extended to older adults. Analysis of the efficacy and toxicity results of pediatric DFCP vs. classic Hyper-CVAD protocol for the treatment of patients with ALL Hyper-CVAD for first line treatment of patients with ALL Hyper-CVAD protocol. CR rate was 90.7% for DFCP vs. 83.7 for Hyper-CVAD (p 0.7). 3 Y Leukemia free survival was 57.4% (70.9% for DFCP vs. 41.6% Hyper-CVAD P 0.1) while 3Y OS was 62.6%% for the whole group, 72.6% DFCP vs. 48.5% Hyper-CVAD, P 0.04. Those with age Hyper-CVAD related to gall stones. Osteonecrosis affected 5 patients on DFCP. pediatric protocols are feasible in patients younger than 50 Y and they are more active than classic adult protocols. Although modifications of adult protocols may improve their results, this had to be investigated in randomized controlled trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

Protocol for the quantification of greenhouse gas emissions from waste management activities

International Nuclear Information System (INIS)

2013-10-01

The Waste Sector GHG Protocol is intended to provide guidelines for calculating and reporting greenhouse gas (GHG) emissions associated with a waste management service, over a specific time period (usually one year) and based on simple operational data. The Protocol itself has evolved with time, going through 4 version updates. The different versions correspond to evolutions initiated by the original Entreprises pour l'Environnement Working Group (Seche Environnement, Suez Environnement and Veolia Environnement) but also to the suggestions and feedback provided by several waste associations that have reviewed and commented on the Protocol. As a result, several worldwide associations have validated and used the Protocol for their own greenhouse gas inventories. The version 5 of the Waste Sector GHG Protocol has received the 'Built on the GHG Protocol' label. With such label, the Waste Sector Protocol reinforces its desire to be the reference tool for the waste sector by ensuring its users of a total and transparent coherence and conformity with the GHG Protocol Corporate Standard's requirements. The Protocol is also available on the following web page: http://www.ghgprotocol.org/Tools-Built-on-GHG-Protocol. The Waste Sector GHG Protocol aims at: Providing a consistent and transparent approach to quantify, report and verify GHG direct (scope 1), indirect (scope 2) and avoided emissions of waste management actors; Establishing best practice across the waste sector for the implementation of coherent and homogeneous GHG emissions inventories; Explaining waste sector's particularities in terms of GHG emissions (diffuse emission from landfills, GHG avoided emissions, carbon sequestration); Helping companies to take proper commitments and stakeholders to understand and verify those commitments. The Protocol consists of a manual with two additional documents: A 'Frequently Asked Questions' document; A 'Follow-up of modifications

African Breast Cancer-Disparities in Outcomes (ABC-DO): protocol of a multicountry mobile health prospective study of breast cancer survival in sub-Saharan Africa.

Science.gov (United States)

McKenzie, Fiona; Zietsman, Annelle; Galukande, Moses; Anele, Angelica; Adisa, Charles; Cubasch, Herbert; Parham, Groesbeck; Anderson, Benjamin O; Abedi-Ardekani, Behnoush; Schuz, Joachim; Dos Santos Silva, Isabel; McCormack, Valerie

2016-08-23

Sub-Saharan African (SSA) women with breast cancer (BC) have low survival rates from this potentially treatable disease. An understanding of context-specific societal, health-systems and woman-level barriers to BC early detection, diagnosis and treatment are needed. The African Breast Cancer-Disparities in Outcomes (ABC-DO) is a prospective hospital-based study of overall survival, impact on quality of life (QOL) and delays along the journey to diagnosis and treatment of BC in SSA. ABC-DO is currently recruiting in Namibia, Nigeria, South Africa, Uganda and Zambia. Women aged 18 years or older who present at participating secondary and tertiary hospitals with a new clinical or histocytological diagnosis of primary BC are invited to participate. For consented women, tumour characteristics, specimen and treatment data are obtained. Over a 2-year enrolment period, we aim to recruit 2000 women who, in the first instance, will be followed for between 1 and 3 years. A face-to-face baseline interview obtains information on socioeconomic, cultural and demographic factors, QOL, health and BC attitudes/knowledge, and timing of all prediagnostic contacts with caregivers in orthodox health, traditional and spiritual systems. Responses are immediately captured on mobile devices that are fed into a tailored mobile health (mHealth) study management system. This system implements the study protocol, by prompting study researchers to phone women on her mobile phone every 3 months and, failing to reach her, prompts contact with her next-of-kin. At follow-up calls, women provide updated information on QOL, care received and disease impacts on family and working life; date of death is asked of her next-of-kin when relevant. The study was approved by ethics committees of all involved institutions. All participants provide written informed consent. The findings from the study will be published in peer-reviewed scientific journals, presented to funders and relevant local

Survival after radiotherapy in gastric cancer: Systematic review and meta-analysis

International Nuclear Information System (INIS)

Valentini, Vincenzo; Cellini, Francesco; Minsky, Bruce D.; Mattiucci, Gian Carlo; Balducci, Mario; D'Agostino, Giuseppe; D'Angelo, Elisa; Dinapoli, Nicola; Nicolotti, Nicola; Valentini, Chiara; La Torre, Giuseppe

2009-01-01

Background and purpose: A systematic review and meta-analysis was performed to assess the impact of radiotherapy on both 3- and 5-year survival in patients with resectable gastric cancer. Methods: Randomized Clinical Trials (RCTs) in which radiotherapy, (preoperative, postoperative and/or intraoperative), was compared with surgery alone or surgery plus chemotherapy in resectable gastric cancer were identified by searching web-based databases and supplemented by manual examination of reference lists. Meta-analysis was performed using Risk Ratios (RRs). Random or fixed effects models were used to combine data. The methodological quality was evaluated by Chalmers' score. Results: Radiotherapy had a significant impact on 5-year survival. Using an intent to treat (ITT) and a Per Protocol (PP) analysis, the overall 5-year RR was 1.26 (95% CI: 1.08-1.48; NNT = 17) and 1.31 (95% CI: 1.04-1.66; NNT = 13), respectively. Although the quality of the studies was variable, the data were consistent and no clear publication bias was found. Conclusion: This meta-analysis showed a statistically significant 5-year survival benefit with the addition of radiotherapy in patients with resectable gastric cancer. Radiotherapy remains a standard component in the treatment of resectable gastric cancer and new RCTs need to address the impact of new conformal radiotherapy technologies.

Survival without sequelae after prolonged cardiopulmonary resuscitation after electric shock.

Science.gov (United States)

Motawea, Mohamad; Al-Kenany, Al-Sayed; Hosny, Mostafa; Aglan, Omar; Samy, Mohamad; Al-Abd, Mohamed

2016-03-01

"Electrical shock is the physiological reaction or injury caused by electric current passing through the human body. It occurs upon contact of a human body part with any source of electricity that causes a sufficient current through the skin, muscles, or hair causing undesirable effects ranging from simple burns to death." Ventricular fibrillation is believed to be the most common cause of death after electrical shock. "The ideal duration of cardiac resuscitation is unknown. Typically prolonged cardiopulmonary resuscitation is associated with poor neurologic outcomes and reduced long term survival. No consensus statement has been made and traditionally efforts are usually terminated after 15-30 minutes." The case under discussion seems worthy of the somewhat detailed description given. It is for a young man who survived after 65 minutes after electrical shock (ES) after prolonged high-quality cardiopulmonary resuscitation (CPR), multiple defibrillations, and artificial ventilation without any sequelae. Early start of adequate chest compressions and close adherence to advanced cardiac life support protocols played a vital role in successful CPR.

A shortened protocol for assessing cognitive bias in rats.

Science.gov (United States)

Brydges, Nichola M; Hall, Lynsey

2017-07-15

Reliable measurement of affective state in animals is a significant goal of animal welfare. Such measurements would also improve the validity of pre-clinical mental health research which relies on animal models. However, at present, affective states in animals are inaccessible to direct measurement. In humans, changes in cognitive processing can give reliable indications of emotional state. Therefore, similar techniques are increasingly being used to gain proxy measures of affective states in animals. In particular, the 'cognitive bias' assay has gained popularity in recent years. Major disadvantages of this technique include length of time taken for animals to acquire the task (typically several weeks), negative experiences associated with task training, and issues of motivation. Here we present a shortened cognitive bias protocol using only positive reinforcers which must actively be responded to. The protocol took an average of 4days to complete, and produced similar results to previous, longer methods (minimum 30days). Specifically, rats housed in standard laboratory conditions demonstrated negative cognitive biases when presented with ambiguous stimuli, and took longer to make a decision when faced with an ambiguous stimulus. Compared to previous methods, this protocol is significantly shorter (average 4days vs. minimum 30days), utilises only positive reinforcers to avoid inducing negative affective states, and requires active responses to all cues, avoiding potential confounds of motivational state. We have successfully developed a shortened cognitive bias protocol, suitable for use with laboratory rats. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

A Prospective Pilot Study to Validate the Management Protocol for Patients Presenting with Acute Urinary Retention: A Community-Based, Nonhospitalised Protocol

Directory of Open Access Journals (Sweden)

Shyamala S. Gopi

2006-01-01

Full Text Available Acute urinary retention (AUR in males is managed conventionally by hospital admission, alpha-adrenergic therapy, and trial without catheter. To reduce inpatient bed pressures, we set up a protocol to manage such patients in the community. We review our results in this paper. We performed a prospective study of male patients presenting to our acute admissions ward and Accident and Emergency department over 6 months. Patients with chronic urinary retention, macroscopic haematuria, sepsis, urinary tract infection, and/or serum creatinine >130 mmol/l were excluded from the study. Those enrolled were catheterised, commenced on alfuzosin (10 mg nocte, and discharged to the community. A trial without catheter (TWOC was performed 5—7 days later. QoL/IPSS, peak flow rate, and residual volume assessment were performed following successful TWOC 3 months later.Thirty-one male patients with a median age of 69 years were studied and the median residual volume following catheterisation was 900 ml. The aetiology of AUR was benign prostatic hyperplasia (BPH in 29 patients and constipation in the remaining 2 patients. TWOC was successful in 19 patients (61.3% following first TWOC, 26 (83.9% following second trial of voiding. The mean peak flow rate was 6.5 ml/sec and postvoid scan 165 ml, following an immediate TWOC. At 3 months follow-up, mean peak flow rate was 13.2 ml/sec, postvoid scan 26.5 ml, IPSS 4.5, and QoL score was 2. This study has shown that AUR can be managed safely and effectively in the community. Effective communication with the nurse urology specialist, general practitioner, and emergency department are crucial for the successful implementation of the protocol.

Long-Term Survival of Dental Implants with Different Prosthetic Loading Times in Healthy Patients: A 5-Year Retrospective Clinical Study.

Science.gov (United States)

Muelas-Jiménez, M Isabel; Olmedo-Gaya, Maria Victoria; Manzano-Moreno, Francisco J; Reyes-Botella, Candela; Vallecillo-Capilla, Manuel

2017-02-01

To compare survival rates among dental implants restored with immediate, early, and conventional loading protocols, also comparing between maxillary and mandibular implants, and to evaluate the influence of implant length and diameter and the type of prosthesis on treatment outcomes. This retrospective cohort study initially included all 52 patients receiving dental implants between July 2006 and February 2008 at a private oral surgery clinic in Granada (Southern Spain). Clinical and radiographic examinations were performed, including periapical or panoramic radiographs, and incidences during completion of the restoration were recorded at 1 week, 3 months, 6 months, and at 1, 2, 3, 4, and 5 years. After a 5-year follow-up, 1 patient had died, 3 were lost to follow-up, and 6 required grafting before implant placement; therefore, the final study sample comprised 42 patients with 164 implants. Variables associated with the survival/failure of the restoration were: number of implants (higher failure rate with fewer implants), bone type (higher failure rate in type III or IV bone), and type of prosthesis (higher failure rate with single crowns). No significant association was found in univariate or multivariate analyses between survival rate and the loading protocol, implant length or diameter, or maxillary/mandibular location. Immediate occlusal loading, immediate provisionalization without occlusal loading, and early loading are viable treatment options with similar survival rates to those obtained with conventional loading. Bone quality and number of implants per patient were the most influential factors. © 2015 by the American College of Prosthodontists.

Post-relapse survival in patients with Ewing sarcoma.

Science.gov (United States)

Ferrari, Stefano; Luksch, Roberto; Hall, Kirsten Sundby; Fagioli, Franca; Prete, Arcangelo; Tamburini, Angela; Tienghi, Amelia; DiGirolamo, Stefania; Paioli, Anna; Abate, Massimo Eraldo; Podda, Marta; Cammelli, Silvia; Eriksson, Mikael; Brach del Prever, Adalberto

2015-06-01

Post-relapse survival (PRS) was evaluated in patients with Ewing sarcoma (EWS) enrolled in chemotherapy protocols based on the use of high-dose chemotherapy with busulfan and melfalan (HDT) as a first-line consolidation treatment in high-risk patients. EWS patients enrolled in ISG/SSG III and IV trials who relapsed after complete remission were included in the analysis. At recurrence, chemotherapy based on high-dose ifosfamide was foreseen, and patients who responded but had not received HDT underwent consolidation therapy with HDT. Data from 107 EWS patients were included in the analysis. Median time to recurrence (RFI) was 18 months, and 45 (42%) patients had multiple sites of recurrence. Patients who had previously been treated with HDT had a significantly (P = 0.02) shorter RFI and were less likely to achieve a second complete remission (CR2). CR2 status was achieved by 42 (39%) patients. Fifty patients received high-dose IFO (20 went to consolidation HDT). The 5-year PRS was 19% (95% CI 11 to 27%). With CR2, the 5-year PRS was 48% (95% CI 31 to 64%). Without CR2, median time to death was six months (range 1-45 months). According to the multivariate analysis, patients younger than 15 years, recurrence to the lung only, and RFI longer than 24 months significantly influenced the probability of PRS. Age, pattern of recurrence, RFI, and response to second-line chemotherapy influence post-relapse survival in patients with recurrent Ewing sarcoma. No survival advantage was observed from chemotherapy consolidation with HDT. © 2015 Wiley Periodicals, Inc.

Methow and Columbia Rivers studies: summary of data collection, comparison of database structure and habitat protocols, and impact of additional PIT tag interrogation systems to survival estimates, 2008-2012

Science.gov (United States)

Martens, Kyle D.; Tibbits, Wesley T.; Watson, Grace A.; Newsom, Michael A.; Connolly, Patrick J.

2014-01-01

designed to show some initial analysis and to disseminate summary information that could potentially be used in ongoing modeling efforts by USGS, Reclamation, and University of Idaho. The second chapter documents the database of fish and habitat data collected by USGS from 2004 through 2012 and compares USGS habitat protocols to the Columbia Habitat Monitoring Program (CHaMP) protocol. The third chapter is a survival analysis of fish moving through Passive Integrated Transponder (PIT) tag interrogation systems in the Methow and Columbia Rivers. It examines the effects of adding PIT tags and/or PIT tag interrogation systems on survival estimates of juvenile steelhead and Chinook salmon.

A Comparison Between Inter-Asterisk eXchange Protocol and Jingle Protocol: Session Time

Directory of Open Access Journals (Sweden)

H. S. Haj Aliwi

2016-08-01

Full Text Available Over the last few years, many multimedia conferencing and Voice over Internet Protocol (VoIP applications have been developed due to the use of signaling protocols in providing video, audio and text chatting services between at least two participants. This paper compares between two widely common signaling protocols: InterAsterisk eXchange Protocol (IAX and the extension of the eXtensible Messaging and Presence Protocol (Jingle in terms of delay time during call setup, call teardown, and media sessions.

Comparison of two imaging protocols for acute stroke: unenhanced cranial CT versus a multimodality cranial CT protocol with perfusion imaging

International Nuclear Information System (INIS)

Langer, R. D.; Gorkom, K. Neidl van.; Kaabi, Ho Al.; Torab, F.; Czechowski, J.; Nagi, M.; Ashish, G. M.

2007-01-01

Full text: The aim of the study was to validate a multimodality cranial computed tomography (CCT) protocol for patients with acute stroke in the United Arab Emirates as a basic imaging procedure for a stroke unit. Therefore, a comparative study was conducted between two groups: retrospective, historical group 1 with early unenhanced CCT and prospective group 2 undergoing a multimodality CCT protocol. Follow-up unenhanced CCT >48 h served as gold standard in both groups. Group 1: Early unenhanced CCT of 50 patients were evaluated retrospectively, using Alberta Stroke Program Early CT Score, and compared with the definite infarction on follow-up CCT. Group 2: 50 patients underwent multimodality CCT (unenhanced CCT, perfusion studies: cerebral blood flow, cerebral blood volume, mean transit time and CT angiography) <8 h after clinical onset and follow-up studies. Modified National Institute of Health Stroke Scale was used clinically in both groups. Group 1 showed 38 men, 12 women, clinical onset 2-8 h before CCT and modified National Institute of Health Stroke Scale 0-28. Group 2 included 38 men, 12 women, onset 3-8 h before CCT, modified National Institute of Health Stroke Scale 0-28. Sensitivity was 58.3% in group 1 and 84.2% in group 2. Computed tomography angiography detected nine intracranial occlusions/stenoses. The higher sensitivity of the multimodality CCT protocol justifies its use as a basic diagnostic tool for the set-up of a first-stroke unit in the United Arab Emirates

Survival analysis

International Nuclear Information System (INIS)

Badwe, R.A.

1999-01-01

The primary endpoint in the majority of the studies has been either disease recurrence or death. This kind of analysis requires a special method since all patients in the study experience the endpoint. The standard method for estimating such survival distribution is Kaplan Meier method. The survival function is defined as the proportion of individuals who survive beyond certain time. Multi-variate comparison for survival has been carried out with Cox's proportional hazard model

Final report for the protocol extensions for ATM Security Laboratory Directed Research and Development Project

Energy Technology Data Exchange (ETDEWEB)

Tarman, T.D.; Pierson, L.G.; Brenkosh, J.P. [and others

1996-03-01

This is the summary report for the Protocol Extensions for Asynchronous Transfer Mode project, funded under Sandia`s Laboratory Directed Research and Development program. During this one-year effort, techniques were examined for integrating security enhancements within standard ATM protocols, and mechanisms were developed to validate these techniques and to provide a basic set of ATM security assurances. Based on our experience during this project, recommendations were presented to the ATM Forum (a world-wide consortium of ATM product developers, service providers, and users) to assist with the development of security-related enhancements to their ATM specifications. As a result of this project, Sandia has taken a leading role in the formation of the ATM Forum`s Security Working Group, and has gained valuable alliances and leading-edge experience with emerging ATM security technologies and protocols.

The role of basiliximab in the evolving renal transplantation immunosuppression protocol

Directory of Open Access Journals (Sweden)

Paola Salis

2008-06-01

Full Text Available Paola Salis, Chiara Caccamo, Roberto Verzaro, Salvatore Gruttadauria, Mary ArteroDivision of Nephrology and Division of Abdominal Transplantation, Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione, Palermo, ItalyAbstract: Basiliximab is a chimeric mouse-human monoclonal antibody directed against the alpha chain of the interleukin-2 (IL-2 receptor on activated T lymphocytes. It was shown in phase III trials to reduce the number and severity of acute rejection episodes in the first year following renal transplantation in adults and children, with a reasonable cost-benefit ratio. The drug does not increase the incidence of opportunistic infections or malignancies above baseline in patients treated with conventional calcineurin inhibitor-based immunosuppression. In the field of renal transplantation, basiliximab does not increase kidney or patient survival, despite the reduction in the number of rejection episodes. Basiliximab may reduce the incidence of delayed graft function. In comparison with lymphocyte-depleting antibodies basiliximab appears to have equal efficacy in standard immunological risk patients. Recently, IL-2 receptor monoclonal antibodies have been used with the objective of reducing or eliminating the more toxic elements of the standard immunosuppression protocol. Several trials have incorporated basiliximab in protocols designed to avoid or withdraw rapidly corticosteroids, as well as protocols which substitute target-of-rapamycin (TOR inhibitors for calcineurin inhibitors.Keywords: basiliximab, renal transplantation, IL-2 receptor antagonists, induction, immunosuppression, corticosteroids, calcineurin inhibitors

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

Science.gov (United States)

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.

Elemental carbon exposure at residence and survival after acute myocardial infarction.

Science.gov (United States)

von Klot, Stephanie; Gryparis, Alexandros; Tonne, Cathryn; Yanosky, Jeffrey; Coull, Brent A; Goldberg, Robert J; Lessard, Darleen; Melly, Steven J; Suh, Helen H; Schwartz, Joel

2009-07-01

Particulate air pollution has been consistently related to cardiovascular mortality. Some evidence suggests that particulate matter may accelerate the atherosclerotic process. Effects of within-city variations of particulate air pollution on survival after an acute cardiovascular event have been little explored. We conducted a cohort study of hospital survivors of acute myocardial infarction (MI) from the Worcester, MA, metropolitan area to investigate the long-term effects of within-city variation in traffic-related air pollution on mortality. The study builds on an ongoing community-wide investigation examining changes over time in MI incidence and case-fatality rates. We included confirmed cases of MI in 1995, 1997, 1999, 2001, and 2003. Long-term survival status was ascertained through 2005. A validated spatiotemporal land use regression model for traffic-related air pollution was developed and annual averages of elemental carbon at residence estimated. The effect of estimated elemental carbon on the long-term mortality of patients discharged after MI was analyzed using a Cox proportional hazards model, controlling for a variety of demographic, medical history, and clinical variables. Of the 3895 patients with validated MI, 44% died during follow-up. Exposure to estimated elemental carbon in the year of entry into the study was 0.44 microg/m on average. All-cause mortality increased by 15% (95% confidence interval = 0.03%-29%) per interquartile range increase in estimated yearly elemental carbon (0.24 microg/m) after the second year of survival. No association between traffic-related pollution and all-cause mortality was observed during the first 2 years of follow-up. Chronic traffic-related particulate air pollution is associated with increased mortality in hospital survivors of acute MI after the second year of survival.

Elaboration and Validation of the Medication Prescription Safety Checklist 1

Science.gov (United States)

Pires, Aline de Oliveira Meireles; Ferreira, Maria Beatriz Guimarães; do Nascimento, Kleiton Gonçalves; Felix, Márcia Marques dos Santos; Pires, Patrícia da Silva; Barbosa, Maria Helena

2017-01-01

ABSTRACT Objective: to elaborate and validate a checklist to identify compliance with the recommendations for the structure of medication prescriptions, based on the Protocol of the Ministry of Health and the Brazilian Health Surveillance Agency. Method: methodological research, conducted through the validation and reliability analysis process, using a sample of 27 electronic prescriptions. Results: the analyses confirmed the content validity and reliability of the tool. The content validity, obtained by expert assessment, was considered satisfactory as it covered items that represent the compliance with the recommendations regarding the structure of the medication prescriptions. The reliability, assessed through interrater agreement, was excellent (ICC=1.00) and showed perfect agreement (K=1.00). Conclusion: the Medication Prescription Safety Checklist showed to be a valid and reliable tool for the group studied. We hope that this study can contribute to the prevention of adverse events, as well as to the improvement of care quality and safety in medication use. PMID:28793128

Implementation of a two-state quantum bit commitment protocol in optical fibers

International Nuclear Information System (INIS)

Almeida, Á J; Stojanovic, A D; Paunković, N; Loura, R; Mateus, P; Muga, N J; Silva, N A; André, P S; Pinto, A N

2016-01-01

We demonstrate experimentally the feasibility of a two-state quantum bit commitment protocol, which is both concealing and partially binding, assuming technological limitations. The security of this protocol is based on the lack of long-term stable quantum memories. We use a polarization-encoding scheme and optical fiber as a quantum channel. The measurement probability for the commitment is obtained and the optimal cheating strategy demonstrated. The average success rates for an honest player in the case where the measurements are performed using equal bases are 93.4%, when the rectilinear basis is measured, and 96.7%, when the diagonal basis is measured. The rates for the case when the measurements are performed in different bases are 52.9%, when the rectilinear basis is measured, and 55.4% when the diagonal basis is measured. The average success rates for the optimal cheating strategy are 80% and 73.8%, which are way below the success rates of an honest player. Using a strict numerical validity criterion, we show that, for these experimental values, the protocol is secure. (paper)

Validation of an open-formula, diagnostic real-time PCR method for 20-hr detection of Salmonella in animal feeds

DEFF Research Database (Denmark)

Löfström, Charlotta; Hoorfar, Jeffrey

2012-01-01

A comparative study of a 20-hr, non-commercial, open-formula PCR method and the standard culture-based method NMKL 187, for detection of Salmonella, was performed according to the validation protocol from the Nordic organization for validation of alternative microbiological methods (NordVal) on 81...

Modelling survival after treatment of intraocular melanoma using artificial neural networks and Bayes theorem

International Nuclear Information System (INIS)

Taktak, Azzam F G; Fisher, Anthony C; Damato, Bertil E

2004-01-01

This paper describes the development of an artificial intelligence (AI) system for survival prediction from intraocular melanoma. The system used artificial neural networks (ANNs) with five input parameters: coronal and sagittal tumour location, anterior tumour margin, largest basal tumour diameter and the cell type. After excluding records with missing data, 2331 patients were included in the study. These were split randomly into training and test sets. Date censorship was applied to the records to deal with patients who were lost to follow-up and patients who died from general causes. Bayes theorem was then applied to the ANN output to construct survival probability curves. A validation set with 34 patients unseen to both training and test sets was used to compare the AI system with Cox's regression (CR) and Kaplan-Meier (KM) analyses. Results showed large differences in the mean 5 year survival probability figures when the number of records with matching characteristics was small. However, as the number of matches increased to >100 the system tended to agree with CR and KM. The validation set was also used to compare the system with a clinical expert in predicting time to metastatic death. The rms error was 3.7 years for the system and 4.3 years for the clinical expert for 15 years survival. For <10 years survival, these figures were 2.7 and 4.2, respectively. We concluded that the AI system can match if not better the clinical expert's prediction. There were significant differences with CR and KM analyses when the number of records was small, but it was not known which model is more accurate

Modelling survival after treatment of intraocular melanoma using artificial neural networks and Bayes theorem

Energy Technology Data Exchange (ETDEWEB)

Taktak, Azzam F G [Department of Clinical Engineering, Duncan Building, Royal Liverpool University Hospital, Liverpool L7 8XP (United Kingdom); Fisher, Anthony C [Department of Clinical Engineering, Duncan Building, Royal Liverpool University Hospital, Liverpool L7 8XP (United Kingdom); Damato, Bertil E [Department of Ophthalmology, Royal Liverpool University Hospital, Liverpool L7 8XP (United Kingdom)

2004-01-07

This paper describes the development of an artificial intelligence (AI) system for survival prediction from intraocular melanoma. The system used artificial neural networks (ANNs) with five input parameters: coronal and sagittal tumour location, anterior tumour margin, largest basal tumour diameter and the cell type. After excluding records with missing data, 2331 patients were included in the study. These were split randomly into training and test sets. Date censorship was applied to the records to deal with patients who were lost to follow-up and patients who died from general causes. Bayes theorem was then applied to the ANN output to construct survival probability curves. A validation set with 34 patients unseen to both training and test sets was used to compare the AI system with Cox's regression (CR) and Kaplan-Meier (KM) analyses. Results showed large differences in the mean 5 year survival probability figures when the number of records with matching characteristics was small. However, as the number of matches increased to >100 the system tended to agree with CR and KM. The validation set was also used to compare the system with a clinical expert in predicting time to metastatic death. The rms error was 3.7 years for the system and 4.3 years for the clinical expert for 15 years survival. For <10 years survival, these figures were 2.7 and 4.2, respectively. We concluded that the AI system can match if not better the clinical expert's prediction. There were significant differences with CR and KM analyses when the number of records was small, but it was not known which model is more accurate.

Institutional Clinical Trial Accrual Volume and Survival of Patients With Head and Neck Cancer