Cryotherapy for Primary Treatment of Prostate Cancer: Intermediate Term Results of a Prospective Study from a Single Institution

PubMed Central

Rodríguez, S. Alvarez; Arias Fúnez, F.; Bueno Bravo, C.; Rodríguez-Patrón Rodríguez, R.; Sanz Mayayo, E.; Palacios, V. Hevia; Burgos Revilla, F. J.

2014-01-01

Purpose. Published data about cryotherapy for prostate cancer (PC) treatment are based on case series with a lack of clinical trials and the inexistence of a validated definition of biochemical failure. A prospective study with standardized followup protocol was conducted in our institution. Material and Methods. Prospective study of a series of cases including 108 patients diagnosed with localized PC at clinical stage T1c-T2c treated by primary cryoablation and median followup of 61 months. Criteria of biochemical recurrence were unified according to the American Society for Therapeutic Radiology and Oncology (ASTRO). End points were biochemical progression-free survival (BPFS), cancer-specific survival, and overall survival. Rate of complications was reported. Results. The BPFS for low-, medium-, and high-risk patients was 96.4%, 91.2%, and 62.2%, respectively. Cancer-specific survival was 98.1%. Overall survival reached 94.4%. Complications included incontinence in 5.6%, urinary tract obstruction in 1.9%, urethral sloughing in 5.6%, haematuria in 1.9%, perineal pain in 11.1%, and prostatorectal fistula in 0.9%. Erectile disfunction was found in 98.1%. Conclusions. Cryotherapy is an effective and minimally invasive treatment for primary PC in well-selected cases, with low surgical risk and good results in terms of BPFS, cancer-specific survival, and overall survival. PMID:24693437

Evaluation of a multidrug chemotherapy protocol with mitoxantrone based maintenance (CHOP-MA) for the treatment of canine lymphoma.

PubMed

Daters, A T; Mauldin, G E; Mauldin, G N; Brodsky, E M; Post, G S

2010-03-01

The purpose of this study was to evaluate the efficacy of adding mitoxantrone to a cyclophosphamide, doxorubicin, vincristine, L-asparaginase and prednisone containing protocol. Sixty-five dogs with multicentric lymphoma were evaluated for overall remission and survival times. Remission and survival time versus stage, substage, pretreatment hypercalcaemia and pretreatment steroid administration were also evaluated. Overall median remission for dogs with multicentric lymphoma was 302 days and overall median survival was 622 days. Of the dogs with multicentric lymphoma, 23 (35%) received all scheduled mitoxantrone doses. Only median survival versus substage was found to be significant (substage a median survival was 679 days and substage b median survival was 302 days, P = 0.025). Increasing the total combined dose of doxorubicin and mitoxantrone may improve remission times when compared with historical controls, and further studies are needed to determine how best to utilize mitoxantrone in multidrug chemotherapy protocols for canine multicentric lymphoma.

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

PubMed

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

2018-04-24

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

Renal Transplants from Older Deceased Donors: Use of Preimplantation Biopsy and Differential Allocation to Dual or Single Kidney Transplant according to Histological Score Has No Advantages over Allocation to Single Kidney Transplant by Simple Clinical Indication.

PubMed

Casati, Costanza; Colombo, Valeriana Giuseppina; Perrino, Marialuisa; Rossetti, Ornella Marina; Querques, Marialuisa; Giacomoni, Alessandro; Binaggia, Agnese; Colussi, Giacomo

2018-01-01

Grafts from elderly donors (ECD) are increasingly allocated to single (SKT) or dual (DKT) kidney transplantation according to biopsy score. Indications and benefits of either procedure lack universal agreement. A total of 302 ECD-transplants in period from Jan 1, 2000, to Dec 31, 2015, were allocated to SKT (SKT pre ) on clinical grounds alone (before Dec 2010, pre-DKT era, n = 170) or according to a clinical-histological protocol (after Dec 2010, DKT era, n = 132) to DKT ( n = 48), SKT biopsy-based protocol ("high-risk", SKT hr , n = 51), or SKT clinically based protocol ("low-risk", SKT lr , n = 33). Graft and patient survival were compared between the two periods and between different transplant categories. Graft and overall survival in recipients from ECD in pre-DKT and DKT era did not differ (5-year graft survival 87.7% and 84.2%, resp.); equal survival in the 2 ECD periods was shown in both donor age ranges of 60-69 and >70-years, and in low-risk or high-risk ECD categories. Within the DKT protocol SKT hr showed worst graft and overall survival in the 60-69 donor age range; DKT did not result in significantly better outcome than SKT from ECD in either era. One-year posttransplant creatinine clearance in recipients did not differ between any ECD transplant category. At 3 and 5 years after transplantation there were significantly higher total dialysis-free recipient life years from an equal donor number in the pre-DKT era than in the DKT protocol. Use of a biopsy-based protocol to allocate grafts from aged donors to SKT or DKT did not result in better short term graft survival than a clinically based protocol with allocation only to SKT and reduced overall recipient dialysis-free life years in time.

Renal Transplants from Older Deceased Donors: Use of Preimplantation Biopsy and Differential Allocation to Dual or Single Kidney Transplant according to Histological Score Has No Advantages over Allocation to Single Kidney Transplant by Simple Clinical Indication

PubMed Central

Casati, Costanza; Colombo, Valeriana Giuseppina; Perrino, Marialuisa; Rossetti, Ornella Marina; Querques, Marialuisa; Giacomoni, Alessandro; Binaggia, Agnese

2018-01-01

Background Grafts from elderly donors (ECD) are increasingly allocated to single (SKT) or dual (DKT) kidney transplantation according to biopsy score. Indications and benefits of either procedure lack universal agreement. Methods A total of 302 ECD-transplants in period from Jan 1, 2000, to Dec 31, 2015, were allocated to SKT (SKTpre) on clinical grounds alone (before Dec 2010, pre-DKT era, n = 170) or according to a clinical-histological protocol (after Dec 2010, DKT era, n = 132) to DKT (n = 48), SKT biopsy-based protocol (“high-risk”, SKThr, n = 51), or SKT clinically based protocol (“low-risk”, SKTlr, n = 33). Graft and patient survival were compared between the two periods and between different transplant categories. Results Graft and overall survival in recipients from ECD in pre-DKT and DKT era did not differ (5-year graft survival 87.7% and 84.2%, resp.); equal survival in the 2 ECD periods was shown in both donor age ranges of 60–69 and >70-years, and in low-risk or high-risk ECD categories. Within the DKT protocol SKThr showed worst graft and overall survival in the 60–69 donor age range; DKT did not result in significantly better outcome than SKT from ECD in either era. One-year posttransplant creatinine clearance in recipients did not differ between any ECD transplant category. At 3 and 5 years after transplantation there were significantly higher total dialysis-free recipient life years from an equal donor number in the pre-DKT era than in the DKT protocol. Conclusions Use of a biopsy-based protocol to allocate grafts from aged donors to SKT or DKT did not result in better short term graft survival than a clinically based protocol with allocation only to SKT and reduced overall recipient dialysis-free life years in time. PMID:29862061

[Our experiences in the treatment of acute leukemias in children].

PubMed

Stojimirović, E; Cvetković, P

1976-01-01

43 children suffering of acute leucaemia were treated in University Children's Hospital Belgrade during the period of 1969- april 1975. 39 patients were treated as acute lymphoblastic leucaemia (90,7%), and 4 patients as acute nonlymphoblastic leucaemia (9,3%). Complete remission of 34 patients treated as ALL by protocol PARIS 06 was established in 94,1%. All 5 patients suffering of ALL, treated by protocol PARIS 01 LA 72 had complete remission. 85,7 patients treated by protocol 06 AL 66 survived one year. 53,5% patients survived two years, 14,2% three years, and 3,5% survived four years. These facts are not final, because 35% patients are still alive. From 5 patients treated by protocol 01 AL 72 4 patinets are in complete remission, but this period is too short to per mit any conclusion. Meadle survival time for patients suffering of ANLL is 7,5 months. One patient is in complete remission for already 9 months.

Modeling of Receptor Tyrosine Kinase Signaling: Computational and Experimental Protocols.

PubMed

Fey, Dirk; Aksamitiene, Edita; Kiyatkin, Anatoly; Kholodenko, Boris N

2017-01-01

The advent of systems biology has convincingly demonstrated that the integration of experiments and dynamic modelling is a powerful approach to understand the cellular network biology. Here we present experimental and computational protocols that are necessary for applying this integrative approach to the quantitative studies of receptor tyrosine kinase (RTK) signaling networks. Signaling by RTKs controls multiple cellular processes, including the regulation of cell survival, motility, proliferation, differentiation, glucose metabolism, and apoptosis. We describe methods of model building and training on experimentally obtained quantitative datasets, as well as experimental methods of obtaining quantitative dose-response and temporal dependencies of protein phosphorylation and activities. The presented methods make possible (1) both the fine-grained modeling of complex signaling dynamics and identification of salient, course-grained network structures (such as feedback loops) that bring about intricate dynamics, and (2) experimental validation of dynamic models.

Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition.

PubMed

Harris, P N A; McNamara, J F; Lye, D C; Davis, J S; Bernard, L; Cheng, A C; Doi, Y; Fowler, V G; Kaye, K S; Leibovici, L; Lipman, J; Llewelyn, M J; Munoz-Price, S; Paul, M; Peleg, A Y; Rodríguez-Baño, J; Rogers, B A; Seifert, H; Thamlikitkul, V; Thwaites, G; Tong, S Y C; Turnidge, J; Utili, R; Webb, S A R; Paterson, D L

2017-08-01

To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI). Prospective studies, randomized trials or registered protocols comparing antibiotic therapies for BSI, published from 2005 to 2016, were reviewed. Consensus endpoints for BSI studies were defined using a modified Delphi process. Different primary and secondary endpoints were defined for pilot (small-scale studies designed to evaluate protocol design, feasibility and implementation) and definitive trials (larger-scale studies designed to test hypotheses and influence clinical practice), as well as for Staphylococcus aureus and Gram-negative BSI. For pilot studies of S. aureus BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever, stable/improved Sequential Organ Failure Assessment (SOFA) score and clearance of blood cultures, with no microbiologically confirmed failure up to 90 days. For definitive S. aureus BSI studies, a primary outcome of success at 90 days was defined by survival and no microbiologically confirmed failure. For pilot studies of Gram-negative BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever and symptoms related to BSI source, stable or improved SOFA score and negative blood cultures. For definitive Gram-negative BSI studies, a primary outcome of survival at 90 days supported by a secondary outcome of success at day 7 (as previously defined) was agreed. These endpoints provide a framework to aid future trial design. Further work will be required to validate these endpoints with respect to patient-centred clinical outcomes. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

Survival times for canine intranasal sarcomas treated with radiation therapy: 86 cases (1996-2011).

PubMed

Sones, Evan; Smith, Annette; Schleis, Stephanie; Brawner, William; Almond, Gregory; Taylor, Kathryn; Haney, Siobhan; Wypij, Jackie; Keyerleber, Michele; Arthur, Jennifer; Hamilton, Terrance; Lawrence, Jessica; Gieger, Tracy; Sellon, Rance; Wright, Zack

2013-01-01

Sarcomas comprise approximately one-third of canine intranasal tumors, however few veterinary studies have described survival times of dogs with histologic subtypes of sarcomas separately from other intranasal tumors. One objective of this study was to describe median survival times for dogs treated with radiation therapy for intranasal sarcomas. A second objective was to compare survival times for dogs treated with three radiation therapy protocols: daily-fractionated radiation therapy; Monday, Wednesday, and Friday fractionated radiation therapy; and palliative radiation therapy. Medical records were retrospectively reviewed for dogs that had been treated with radiation therapy for confirmed intranasal sarcoma. A total of 86 dogs met inclusion criteria. Overall median survival time for included dogs was 444 days. Median survival time for dogs with chondrosarcoma (n = 42) was 463 days, fibrosarcoma (n = 12) 379 days, osteosarcoma (n = 6) 624 days, and undifferentiated sarcoma (n = 22) 344 days. Dogs treated with daily-fractionated radiation therapy protocols; Monday, Wednesday and Friday fractionated radiation therapy protocols; and palliative radiation therapy protocols had median survival times of 641, 347, and 305 days, respectively. A significant difference in survival time was found for dogs receiving curative intent radiation therapy vs. palliative radiation therapy (P = 0.032). A significant difference in survival time was also found for dogs receiving daily-fractionated radiation therapy vs. Monday, Wednesday and Friday fractionated radiation therapy (P = 0.0134). Findings from this study support the use of curative intent radiation therapy for dogs with intranasal sarcoma. Future prospective, randomized trials are needed for confirmation of treatment benefits. © 2012 Veterinary Radiology & Ultrasound.

Genomic profiling of thousands of candidate polymorphisms predicts risk of relapse in 778 Danish and German childhood acute lymphoblastic leukemia patients.

PubMed

Wesołowska-Andersen, A; Borst, L; Dalgaard, M D; Yadav, R; Rasmussen, K K; Wehner, P S; Rasmussen, M; Ørntoft, T F; Nordentoft, I; Koehler, R; Bartram, C R; Schrappe, M; Sicheritz-Ponten, T; Gautier, L; Marquart, H; Madsen, H O; Brunak, S; Stanulla, M; Gupta, R; Schmiegelow, K

2015-02-01

Childhood acute lymphoblastic leukemia survival approaches 90%. New strategies are needed to identify the 10-15% who evade cure. We applied targeted, sequencing-based genotyping of 25 000 to 34 000 preselected potentially clinically relevant single-nucleotide polymorphisms (SNPs) to identify host genome profiles associated with relapse risk in 352 patients from the Nordic ALL92/2000 protocols and 426 patients from the German Berlin-Frankfurt-Munster (BFM) ALL2000 protocol. Patients were enrolled between 1992 and 2008 (median follow-up: 7.6 years). Eleven cross-validated SNPs were significantly associated with risk of relapse across protocols. SNP and biologic pathway level analyses associated relapse risk with leukemia aggressiveness, glucocorticosteroid pharmacology/response and drug transport/metabolism pathways. Classification and regression tree analysis identified three distinct risk groups defined by end of induction residual leukemia, white blood cell count and variants in myeloperoxidase (MPO), estrogen receptor 1 (ESR1), lamin B1 (LMNB1) and matrix metalloproteinase-7 (MMP7) genes, ATP-binding cassette transporters and glucocorticosteroid transcription regulation pathways. Relapse rates ranged from 4% (95% confidence interval (CI): 1.6-6.3%) for the best group (72% of patients) to 76% (95% CI: 41-90%) for the worst group (5% of patients, P<0.001). Validation of these findings and similar approaches to identify SNPs associated with toxicities may allow future individualized relapse and toxicity risk-based treatments adaptation.

USE OF BROMOERGOCRYPTINE IN THE VALIDATION OF PROTOCOLS FOR THE ASSESSMENT OF MECHANISMS OF EARLY PREGNANCY LOSS IN THE RAT

EPA Science Inventory

Validated protocols for evaluating maternally mediated mechanisms of early pregnancy failure in rodents are needed for use in the risk assessment process. To supplement previous efforts in the validation of a panel of protocols assembled for this purpose, bromoergocryptine (BEC) ...

Cross-Validation of Survival Bump Hunting by Recursive Peeling Methods.

PubMed

Dazard, Jean-Eudes; Choe, Michael; LeBlanc, Michael; Rao, J Sunil

2014-08-01

We introduce a survival/risk bump hunting framework to build a bump hunting model with a possibly censored time-to-event type of response and to validate model estimates. First, we describe the use of adequate survival peeling criteria to build a survival/risk bump hunting model based on recursive peeling methods. Our method called "Patient Recursive Survival Peeling" is a rule-induction method that makes use of specific peeling criteria such as hazard ratio or log-rank statistics. Second, to validate our model estimates and improve survival prediction accuracy, we describe a resampling-based validation technique specifically designed for the joint task of decision rule making by recursive peeling (i.e. decision-box) and survival estimation. This alternative technique, called "combined" cross-validation is done by combining test samples over the cross-validation loops, a design allowing for bump hunting by recursive peeling in a survival setting. We provide empirical results showing the importance of cross-validation and replication.

Cross-Validation of Survival Bump Hunting by Recursive Peeling Methods

PubMed Central

Dazard, Jean-Eudes; Choe, Michael; LeBlanc, Michael; Rao, J. Sunil

2015-01-01

We introduce a survival/risk bump hunting framework to build a bump hunting model with a possibly censored time-to-event type of response and to validate model estimates. First, we describe the use of adequate survival peeling criteria to build a survival/risk bump hunting model based on recursive peeling methods. Our method called “Patient Recursive Survival Peeling” is a rule-induction method that makes use of specific peeling criteria such as hazard ratio or log-rank statistics. Second, to validate our model estimates and improve survival prediction accuracy, we describe a resampling-based validation technique specifically designed for the joint task of decision rule making by recursive peeling (i.e. decision-box) and survival estimation. This alternative technique, called “combined” cross-validation is done by combining test samples over the cross-validation loops, a design allowing for bump hunting by recursive peeling in a survival setting. We provide empirical results showing the importance of cross-validation and replication. PMID:26997922

[Long term results of exclusive chemotherapy for glottic squamous cell carcinoma complete clinical responders after induction chemotherapy].

PubMed

Vachin, F; Hans, S; Atlan, D; Brasnu, D; Menard, M; Laccourreye, O

2004-06-01

To evaluate the long-term results of exclusive chemotherapy for T1-T3N0M0 glottic squamous cell carcinoma complete clinical responders after induction chemotherapy. Between 1985 and 2000, 69 patients with glottic squamous cell carcinoma complete clinical responders after induction chemotherapy were managed with exclusive chemotherapy at our department. Chemotherapy associated platinum and fluorouracil. This retrospective analysis evaluated actuarial survival, treatment morbidity, oncologic events and laryngeal preservation. Various independent factors were tested for potential correlation with survival and local recurrence. The 5-year Kaplan-Meier actuarial survival, local control, lymph node control estimate were 83,6%, 64,8%, 98,6% respectively. Chemotherapy never resulted in death. The 10-year actuarial metachronous second primary tumors estimate was 32%. The overall laryngeal preservation rate was 98,6%. Altogether our data and the review of the literature suggest that in patients achieving a complete clinical response after and induction based chemotherapy regimen, the completion of an exclusive chemotherapy regimen appears to be a valid alternative to the conventional use of radiotherapy or chemo-radiation protocols.

Randomized trial for answers to clinical questions: evaluating a pre-appraised versus a MEDLINE search protocol.

PubMed

Patel, Manesh R; Schardt, Connie M; Sanders, Linda L; Keitz, Sheri A

2006-10-01

The paper compares the speed, validity, and applicability of two different protocols for searching the primary medical literature. A randomized trial involving medicine residents was performed. An inpatient general medicine rotation was used. Thirty-two internal medicine residents were block randomized into four groups of eight. Success rate of each search protocol was measured by perceived search time, number of questions answered, and proportion of articles that were applicable and valid. Residents randomized to the MEDLINE-first (protocol A) group searched 120 questions, and residents randomized to the MEDLINE-last (protocol B) searched 133 questions. In protocol A, 104 answers (86.7%) and, in protocol B, 117 answers (88%) were found to clinical questions. In protocol A, residents reported that 26 (25.2%) of the answers were obtained quickly or rated as "fast" (<5 minutes) as opposed to 55 (51.9%) in protocol B, (P = 0.0004). A subset of questions and articles (n = 79) were reviewed by faculty who found that both protocols identified similar numbers of answer articles that addressed the questions and were felt to be valid using critical appraisal criteria. For resident-generated clinical questions, both protocols produced a similarly high percentage of applicable and valid articles. The MEDLINE-last search protocol was perceived to be faster. However, in the MEDLINE-last protocol, a significant portion of questions (23%) still required searching MEDLINE to find an answer.

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

USGS Publications Warehouse

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.

A standardised protocol for the validation of banking methodologies for arterial allografts.

PubMed

Lomas, R J; Dodd, P D F; Rooney, P; Pegg, D E; Hogg, P A; Eagle, M E; Bennett, K E; Clarkson, A; Kearney, J N

2013-09-01

The objective of this study was to design and test a protocol for the validation of banking methodologies for arterial allografts. A series of in vitro biomechanical and biological assessments were derived, and applied to paired fresh and banked femoral arteries. The ultimate tensile stress and strain, suture pullout stress and strain, expansion/rupture under hydrostatic pressure, histological structure and biocompatibility properties of disinfected and cryopreserved femoral arteries were compared to those of fresh controls. No significant differences were detected in any of the test criteria. This validation protocol provides an effective means of testing and validating banking protocols for arterial allografts.

Comparison of COAP and UW-19 protocols for dogs with multicentric lymphoma.

PubMed

Hosoya, Kenji; Kisseberth, William C; Lord, Linda K; Alvarez, Francisco J; Lara-Garcia, Ana; Kosarek, Carrie E; London, Cheryl A; Couto, C Guillermo

2007-01-01

Various chemotherapy protocols for treating lymphoma in dogs have been published; however, comparison of protocols from different studies is difficult, especially when evaluating survival time and toxicoses. The choice of COAP (C, cyclophosphamide; O, vincristine; A, cytosine arabinoside; P, prednisone) and a modified University of Wisconsin 19-week (UW-19) induction protocol has no influence on overall survival times in dogs with lymphoma. One hundred and one dogs with multicentric lymphoma. Retrospective study (2001-2006). Dogs induced with either an 8-week COP-based protocol (C, cyclophosphamide; O, vincristine; and P, prednisone) with maintenance therapy (COAP group) or a 19-week CHOP (C, cyclophosphamide; H, doxorubicin; O, vincristine; and P, prednisone) based protocol (UW-19 group) were compared in terms of the duration of first remission, survival time, toxicoses, and cost. There were 71 dogs in the COAP group and 30 dogs in the UW-19 group. Various protocols were used after the first relapse. The median duration of the first remission for the COAP and UW-19 groups were 94 days (range, 6-356 days) and 174 days (28-438 days), respectively (P < .01). The median survival times for dogs in the COAP and UW-19 groups were 309 days (6-620 days) and 275 days (70-1102+ days), respectively (P = .09). Dogs in the COAP group had a hazard ratio of 1.9 (95% CI 1.1-3.4) for death relative to the UW-19 group (P = .03), after controlling for the confounders (World Health Organization clinical stage, age, sex, use of doxorubicin during reinduction). The severity of neutropenia and gastrointestinal toxicoses were significantly higher in the UW-19 group than in the COAP group (P = .01 and P < .01, respectively). Use of a long-term doxorubicin-containing sequential combination chemotherapy protocol is associated with a decreased risk of relapse and death relative to a non-doxorubicin-containing protocol.

iSAFT Protocol Validation Platform for On-Board Data Networks

NASA Astrophysics Data System (ADS)

Tavoularis, Antonis; Kollias, Vangelis; Marinis, Kostas

2014-08-01

iSAFT is an integrated powerful HW/SW environmentfor the simulation, validation & monitoring of satellite/spacecraft on-board data networks supporting simultaneously a wide range of protocols (RMAP, PTP, CCSDS Space Packet, TM/TC, CANopen, etc.) and network interfaces (SpaceWire, ECSS MIL-STD-1553, ECSS CAN). It is based on over 20 years of TELETEL's experience in the area of protocol validation in the telecommunications and aeronautical sectors, and it has been fully re-engineered in cooperation of TELETEL with ESA & space Primes, to comply with space on-board industrial validation requirements (ECSS, EGSE, AIT, AIV, etc.). iSAFT is highly modular and expandable to support new network interfaces & protocols and it is based on the powerful iSAFT graphical tool chain (Protocol Analyser / Recorder, TestRunner, Device Simulator, Traffic Generator, etc.).

Heme oxygenase-1, carbon monoxide, and bilirubin induce tolerance in recipients toward islet allografts by modulating T regulatory cells.

PubMed

Lee, Soo Sun; Gao, Wenda; Mazzola, Silvia; Thomas, Michael N; Csizmadia, Eva; Otterbein, Leo E; Bach, Fritz H; Wang, Hongjun

2007-11-01

Heme oxygenase-1 (HO-1) induction in, or carbon monoxide (CO), or bilirubin administration to, donors and/or recipients frequently lead to long-term survival (>100 days) of DBA/2 islets into B6AF1 recipients. We tested here whether similar treatments show value in a stronger immunogenetic combination, i.e., BALB/c to C57BL/6, and attempted to elucidate the mechanism accounting for tolerance. Induction of HO-1, administering CO or bilirubin to the donor, the islets or the recipient, prolonged islet allograft survival to different extents. Combining all the above treatments (the "combined" protocol) led to survival for >100 days and antigen-specific tolerance to 60% of the transplanted grafts. A high level of forkhead box P3 (Foxp3) and transforming growth factor beta (TGF-beta) expression was detected in the long-term surviving grafts. With the combined protocol, significantly more T regulatory cells (Tregs) were observed surrounding islets 7 days following transplantation. No prolongation of graft survival was observed using the combined protocol when CD4+ CD25+ T cells were predepleted from the recipients before transplantation. In conclusion, our combined protocol led to long-term survival and tolerance to islets in the BALB/c to C57BL/6 combination by promoting Foxp3+ Tregs; these cells played a critical role in the induction and maintenance of tolerance in the recipient.

External-beam Co-60 radiotherapy for canine nasal tumors: a comparison of survival by treatment protocol.

PubMed

Yoon, J H; Feeney, D A; Jessen, C R; Walter, P A

2008-02-01

A retrospective analysis of survival times in dogs with intranasal tumors was performed comparing those treated using hypofractionated or full course Co-60 radiotherapy protocols alone or with surgical adjuvant therapy and those receiving no radiation treatment. One hundred thirty-nine dogs presented to the University of Minnesota Veterinary Medical Center for treatment of histologically-confirmed nasal neoplasia between July 1983 and October 2001 met the criteria for review. Statistically analyzed parameters included age at diagnosis, tumor histologic classification, fractionation schedule (number of treatments, and number of treatment days/week) (classified as hypofractionated if 2 or less treatments/week); calculated minimum tumor dose/fraction; calculated total minimum tumor dose (classified as hypofractionated if less than 37 Gy in six or fewer fractions); number of radiotherapy portals, a treatment gap of more than 7 days in a full course (3-5 treatments/week, 3-3.5 week treatment time) radiotherapy protocol, the influence of eye shields on survival following single portal DV fields, the survey radiographic extent of the disease, and the presence or absence of cytoreductive surgery. There was a significant relationship only between protocols using 3 or more treatments/week and at least 37 Gy cumulative minimum tumor dose and survival. However, there was no significant relationship between either total minimum tumor dose or dose/fraction and survival and there were no significant relationships between survival and any of the other variables analyzed including tumor histologic type.

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

PubMed

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 (68

A new MRI rating scale for progressive supranuclear palsy and multiple system atrophy: validity and reliability

PubMed Central

Rolland, Yan; Vérin, Marc; Payan, Christine A; Duchesne, Simon; Kraft, Eduard; Hauser, Till K; Jarosz, Josef; Deasy, Neil; Defevbre, Luc; Delmaire, Christine; Dormont, Didier; Ludolph, Albert C; Bensimon, Gilbert

2011-01-01

Aim To evaluate a standardised MRI acquisition protocol and a new image rating scale for disease severity in patients with progressive supranuclear palsy (PSP) and multiple systems atrophy (MSA) in a large multicentre study. Methods The MRI protocol consisted of two-dimensional sagittal and axial T1, axial PD, and axial and coronal T2 weighted acquisitions. The 32 item ordinal scale evaluated abnormalities within the basal ganglia and posterior fossa, blind to diagnosis. Among 760 patients in the study population (PSP=362, MSA=398), 627 had per protocol images (PSP=297, MSA=330). Intra-rater (n=60) and inter-rater (n=555) reliability were assessed through Cohen's statistic, and scale structure through principal component analysis (PCA) (n=441). Internal consistency and reliability were checked. Discriminant and predictive validity of extracted factors and total scores were tested for disease severity as per clinical diagnosis. Results Intra-rater and inter-rater reliability were acceptable for 25 (78%) of the items scored (≥0.41). PCA revealed four meaningful clusters of covarying parameters (factor (F) F1: brainstem and cerebellum; F2: midbrain; F3: putamen; F4: other basal ganglia) with good to excellent internal consistency (Cronbach α 0.75–0.93) and moderate to excellent reliability (intraclass coefficient: F1: 0.92; F2: 0.79; F3: 0.71; F4: 0.49). The total score significantly discriminated for disease severity or diagnosis; factorial scores differentially discriminated for disease severity according to diagnosis (PSP: F1–F2; MSA: F2–F3). The total score was significantly related to survival in PSP (p<0.0007) or MSA (p<0.0005), indicating good predictive validity. Conclusions The scale is suitable for use in the context of multicentre studies and can reliably and consistently measure MRI abnormalities in PSP and MSA. Clinical Trial Registration Number The study protocol was filed in the open clinical trial registry (http://www.clinicaltrials.gov) with ID No NCT00211224. PMID:21386111

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

PubMed

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.

Molecular cloning of Brevundimonas diminuta for efficacy assessment of reverse osmosis devices.

PubMed

Donofrio, Robert; Saha, Ratul; Bestervelt, Lori; Bagley, Susan

2012-06-01

Brevundimonas diminuta is the test organism specified in the United States Environmental Protection Agency's (USEPA) reverse osmosis (RO) treatment device verification protocol. As non-selective growth medium is employed, enumeration of B. diminuta may be impaired due to interference by indigenous heterotrophic bacteria. Thus the microbial removal capability of the filtration system may be incorrectly assessed. As these treatment devices are used in emergency situations, the health of the public could be compromised. The objective of this study was to develop selective approaches for enumerating viable B. diminuta in test water. Two molecular approaches were investigated: expression of a kanamycin resistance gene and expression of a fluorescent protein gene. The USEPA protocol specifies a 0.3 μm cell size, so the expression of the selective markers were assessed following growth on media designed to induce this small cell diameter. The kan(R) strain was demonstrated to be equivalent to the wild type in cell dimension and survival following exposure to the test water. The kan(R) strain showed equivalent performance to the wild type in the RO protocol indicating that it is a viable alternative surrogate. By utilizing this strain, a more accurate validation of the RO system can be achieved.

The macular degeneration and aging study: Design and research protocol of a randomized trial for a psychosocial intervention with macular degeneration patients.

PubMed

Sörensen, Silvia; White, Katherine; Mak, Wingyun; Zanibbi, Katherine; Tang, Wan; O'Hearn, Amanda; Hegel, Mark T

2015-05-01

Age-related Macular Degeneration (AMD) is the leading cause of irreversible and predictable blindness among older adults with serious physical and mental health consequences. Visual impairment is associated with negative future outlook and depression and has serious consequences for older adults' quality of life and, by way of depression, on long-term survival. Psychosocial interventions have the potential to alleviate and prevent depression symptoms among older AMD patients. We describe the protocol of the Macular Degeneration and Aging Study, a randomized clinical trial of a psychosocial Preventive Problem-Solving Intervention. The intervention is aimed at enhancing well-being and future planning among older adults with macular degeneration by increasing preparation for future care. Adequate randomization and therapeutic fidelity were achieved. Current retention rates were acceptable, given the vulnerability of the population. Acceptability (adherence and satisfaction) was high. Given the high public health significance and impact on quality of life among older adults with vision loss, this protocol contributes a valid test of a promising intervention for maintaining mental and physical health in this population. Copyright © 2015 Elsevier Inc. All rights reserved.

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

PubMed

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

2017-03-01

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

Survival time of dogs with splenic hemangiosarcoma treated by splenectomy with or without adjuvant chemotherapy: 208 cases (2001-2012).

PubMed

Wendelburg, Kristin M; Price, Lori Lyn; Burgess, Kristine E; Lyons, Jeremiah A; Lew, Felicia H; Berg, John

2015-08-15

To determine survival time for dogs with splenic hemangiosarcoma treated with splenectomy alone, identify potential prognostic factors, and evaluate the efficacy of adjuvant chemotherapy. Retrospective case series. 208 dogs. Medical records were reviewed, long-term follow-up information was obtained, and survival data were analyzed statistically. 154 dogs were treated with surgery alone, and 54 were treated with surgery and chemotherapy. Twenty-eight dogs received conventional chemotherapy, 13 received cyclophosphamide-based metronomic chemotherapy, and 13 received both conventional and metronomic chemotherapy. Median survival time of dogs treated with splenectomy alone was 1.6 months. Clinical stage was the only prognostic factor significantly associated with survival time. When the entire follow-up period was considered, there was no significant difference in survival time between dogs treated with surgery alone and dogs treated with surgery and chemotherapy. However, during the first 4 months of follow-up, after adjusting for the effects of clinical stage, survival time was significantly prolonged among dogs receiving any type of chemotherapy (hazard ratio, 0.6) and among dogs receiving both conventional and metronomic chemotherapy (hazard ratio, 0.4). Clinical stage was strongly associated with prognosis for dogs with splenic hemangiosarcoma. Chemotherapy was effective in prolonging survival time during the early portion of the follow-up period. Combinations of doxorubicin-based conventional protocols and cyclophosphamide-based metronomic protocols appeared to be more effective than either type of chemotherapy alone, but prolongations in survival time resulting from current protocols were modest.

Using Colored Stochastic Petri Net (CS-PN) software for protocol specification, validation, and evaluation

NASA Technical Reports Server (NTRS)

Zenie, Alexandre; Luguern, Jean-Pierre

1987-01-01

The specification, verification, validation, and evaluation, which make up the different steps of the CS-PN software are outlined. The colored stochastic Petri net software is applied to a Wound/Wait protocol decomposable into two principal modules: request or couple (transaction, granule) treatment module and wound treatment module. Each module is specified, verified, validated, and then evaluated separately, to deduce a verification, validation and evaluation of the complete protocol. The colored stochastic Petri nets tool is shown to be a natural extension of the stochastic tool, adapted to distributed systems and protocols, because the color conveniently takes into account the numerous sites, transactions, granules and messages.

Improvement of Cell Survival During Human Pluripotent Stem Cell Definitive Endoderm Differentiation

PubMed Central

Wang, Han; Luo, Xie; Yao, Li; Lehman, Donna M.

2015-01-01

Definitive endoderm (DE) is a vital precursor for internal organs such as liver and pancreas. Efficient protocol to differentiate human embryonic stem cells (hESCs) or induced pluripotent stem cells (iPSCs) to DE is essential for regenerative medicine and for modeling diseases; yet, poor cell survival during DE differentiation remains unsolved. In this study, our use of B27 supplement in modified differentiation protocols has led to a substantial improvement. We used an SOX17-enhanced green fluorescent protein (eGFP) reporter hESC line to compare and modify established DE differentiation protocols. Both total live cell numbers and the percentages of eGFP-positive cells were used to assess differentiation efficiency. Among tested protocols, three modified protocols with serum-free B27 supplement were developed to generate a high number of DE cells. Massive cell death was avoided during DE differentiation and the percentage of DE cells remained high. When the resulting DE cells were further differentiated toward the pancreatic lineage, the expression of pancreatic-specific markers was significantly increased. Similar high DE differentiation efficiency was observed in H1 hESCs and iPSCs through the modified protocols. In B27 components, bovine serum albumin was found to facilitate DE differentiation and cell survival. Using our modified DE differentiation protocols, satisfactory quantities of quality DE can be produced as primary material for further endoderm lineage differentiation. PMID:26132288

Sub-millisecond ligand probing of cell receptors with multiple solution exchange

PubMed Central

Sylantyev, Sergiy; Rusakov, Dmitri A

2013-01-01

The accurate knowledge of receptor kinetics is crucial to our understanding of cell signal transduction in general and neural function in particular. The classical technique of probing membrane receptors on a millisecond scale involves placing a recording micropipette with a membrane patch in front of a double-barrel (θ-glass) application pipette mounted on a piezo actuator. Driven by electric pulses, the actuator can rapidly shift the θ-glass pipette tip, thus exposing the target receptors to alternating ligand solutions. However, membrane patches survive for only a few minutes, thus normally restricting such experiments to a single-application protocol. In order to overcome this deficiency, we have introduced pressurized supply microcircuits in the θ-glass channels, thus enabling repeated replacement of application solutions within 10–15 s. this protocol, which has been validated in our recent studies and takes 20–60 min to implement, allows the characterization of ligand-receptor interactions with high sensitivity, thereby also enabling a powerful paired-sample statistical design. PMID:23744290

Outcome and toxicity associated with a dose-intensified, maintenance-free CHOP-based chemotherapy protocol in canine lymphoma: 130 cases.

PubMed

Sorenmo, Karin; Overley, B; Krick, E; Ferrara, T; LaBlanc, A; Shofer, F

2010-09-01

A dose-intensified/dose-dense chemotherapy protocol for canine lymphoma was designed and implemented at the Veterinary Hospital of the University of Pennsylvania. In this study, we describe the clinical characteristics, prognostic factors, efficacy and toxicity in 130 dogs treated with this protocol. The majority of the dogs had advanced stage disease (63.1% stage V) and sub-stage b (58.5%). The median time to progression (TTP) and lymphoma-specific survival were 219 and 323 days, respectively. These results are similar to previous less dose-intense protocols. Sub-stage was a significant negative prognostic factor for survival. The incidence of toxicity was high; 53.9 and 45% of the dogs needed dose reductions and treatment delays, respectively. Dogs that required dose reductions and treatment delays had significantly longer TTP and lymphoma-specific survival times. These results suggest that dose density is important, but likely relative, and needs to be adjusted according to the individual patient's toxicity for optimal outcome.

Computer-Guided Implant Surgery in Fresh Extraction Sockets and Immediate Loading of a Full Arch Restoration: A 2-Year Follow-Up Study of 14 Consecutively Treated Patients

PubMed Central

Daas, M.; Assaf, A.; Dada, K.; Makzoumé, J.

2015-01-01

Statement of Problem. Low scientific evidence is identified in the literature for combining implant placement in fresh extraction sockets with immediate function. Moreover, the few studies available on immediate implants in postextraction sites supporting immediate full-arch rehabilitation clearly lack comprehensive protocols. Purpose. The purpose of this study is to report outcomes of a comprehensive protocol using CAD-CAM technology for surgical planning and fabrication of a surgical template and to demonstrate that immediate function can be easily performed with immediate implants in postextraction sites supporting full-arch rehabilitation. Material and Methods. 14 subjects were consecutively rehabilitated (13 maxillae and 1 mandible) with 99 implants supporting full-arch fixed prostheses followed between 6 and 24 months (mean of 16 months). Outcome measures were prosthesis and implant success, biologic and prosthetic complications, pain, oedema evaluation, and radiographic marginal bone levels at surgery and then at 6, 12, 18, and 24 months. Data were analyzed with descriptive statistics. Results. The overall cumulative implant survival rate at mean follow-up time of 16 months was 97.97%. The average marginal bone loss was 0,9 mm. Conclusions. Within the limitations of this study, the results validate this treatment modality for full-arch rehabilitations with predictable outcomes and high survival rate after 2 years. PMID:26064119

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.

PubMed

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.

Strategies to assess the validity of recommendations: a study protocol

PubMed Central

2013-01-01

Background Clinical practice guidelines (CPGs) become quickly outdated and require a periodic reassessment of evidence research to maintain their validity. However, there is little research about this topic. Our project will provide evidence for some of the most pressing questions in this field: 1) what is the average time for recommendations to become out of date?; 2) what is the comparative performance of two restricted search strategies to evaluate the need to update recommendations?; and 3) what is the feasibility of a more regular monitoring and updating strategy compared to usual practice?. In this protocol we will focus on questions one and two. Methods The CPG Development Programme of the Spanish Ministry of Health developed 14 CPGs between 2008 and 2009. We will stratify guidelines by topic and by publication year, and include one CPG by strata. We will develop a strategy to assess the validity of CPG recommendations, which includes a baseline survey of clinical experts, an update of the original exhaustive literature searches, the identification of key references (reference that trigger a potential recommendation update), and the assessment of the potential changes in each recommendation. We will run two alternative search strategies to efficiently identify important new evidence: 1) PLUS search based in McMaster Premium LiteratUre Service (PLUS) database; and 2) a Restrictive Search (ReSe) based on the least number of MeSH terms and free text words needed to locate all the references of each original recommendation. We will perform a survival analysis of recommendations using the Kaplan-Meier method and we will use the log-rank test to analyse differences between survival curves according to the topic, the purpose, the strength of recommendations and the turnover. We will retrieve key references from the exhaustive search and evaluate their presence in the PLUS and ReSe search results. Discussion Our project, using a highly structured and transparent methodology, will provide guidance of when recommendations are likely to be at risk of being out of date. We will also assess two novel restrictive search strategies which could reduce the workload without compromising rigour when CPGs developers check for the need of updating. PMID:23967896

Evaluation of Shape and Textural Features from CT as Prognostic Biomarkers in Non-small Cell Lung Cancer.

PubMed

Bianconi, Francesco; Fravolini, Mario Luca; Bello-Cerezo, Raquel; Minestrini, Matteo; Scialpi, Michele; Palumbo, Barbara

2018-04-01

We retrospectively investigated the prognostic potential (correlation with overall survival) of 9 shape and 21 textural features from non-contrast-enhanced computed tomography (CT) in patients with non-small-cell lung cancer. We considered a public dataset of 203 individuals with inoperable, histologically- or cytologically-confirmed NSCLC. Three-dimensional shape and textural features from CT were computed using proprietary code and their prognostic potential evaluated through four different statistical protocols. Volume and grey-level run length matrix (GLRLM) run length non-uniformity were the only two features to pass all four protocols. Both features correlated negatively with overall survival. The results also showed a strong dependence on the evaluation protocol used. Tumour volume and GLRLM run-length non-uniformity from CT were the best predictor of survival in patients with non-small-cell lung cancer. We did not find enough evidence to claim a relationship with survival for the other features. Copyright© 2018, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

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

NASA Technical Reports Server (NTRS)

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

2003-01-01

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

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

NASA Technical Reports Server (NTRS)

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

2003-01-01

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

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

NASA Technical Reports Server (NTRS)

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

2003-01-01

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

An Argument Approach to Observation Protocol Validity

ERIC Educational Resources Information Center

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

2012-01-01

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

Study protocol: systematic review and meta-analysis of randomized controlled trials in first-line treatment of squamous non-small cell lung cancer

PubMed Central

2014-01-01

Background There is a high unmet need for effective treatments for patients with squamous non-small cell lung cancer (NSCLC). Eli Lilly and Company is conducting a phase III, randomized, multicenter, open-label study of gemcitabine plus cisplatin plus necitumumab (GC + N) versus gemcitabine plus cisplatin (GC) for the first-line treatment of patients with stage IV squamous NSCLC. Given GC is not the only treatment commonly used for the treatment of squamous NSCLC, this study was designed to compare the survival, toxicity, and quality of life outcomes of current treatment strategies for squamous NSCLC in the first-line setting. Methods/Design A systematic review and meta-analysis (including indirect comparisons) of treatments used in squamous NSCLC will be conducted to assess the clinical efficacy (overall and progression-free survival), health-related quality of life (HRQoL), and safety (grade 3–4 toxicity) of GC + N compared to other treatments used in squamous NSCLC. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines will be followed for all aspects of this study. A systematic literature review will be conducted to identify randomized controlled trials evaluating chemotherapy treatment in first-line NSCLC. Eligible articles will be restricted to randomized controlled trials (RCTs) among chemotherapy-naïve advanced NSCLC cancer patients that report outcome data (survival, toxicity, or quality of life) for patients with squamous histology. Following data extraction and validation, data consistency and study heterogeneity will be assessed. A network meta-analysis will be conducted based on the available hazard ratios for overall and progression-free survival, odds ratios for published toxicity data, and mean difference of HRQoL scales. Sensitivity analyses will be conducted. Discussion This is a presentation of the study protocol only. Results and conclusions are pending completion of this study. Systematic review registration PROSPERO CRD42014008968 PMID:25227571

Esophageal Cancer: New Insights into a Heterogenous Disease.

PubMed

Krug, Sebastian; Michl, Patrick

2017-01-01

Esophageal cancer represents a heterogeneous malignancy mostly diagnosed in advanced stages. Worldwide, squamous cell carcinomas (SCCs) continue to be the most prevalent subtype; however, in the Western countries, the incidence of adenocarcinomas is increasing and will exceed that of SCC in the near future. During the last decade, several landmark trials contributed to a better understanding of the disease and emphasized the importance of multimodal treatment protocols. With the introduction of perioperative or neoadjuvant approaches, the survival of both subtypes of esophageal cancer has significantly improved. Several trials confirmed a survival benefit for perioperative chemotherapy or neoadjuvant chemoradiation, respectively, for patients with resectable locally advanced adenocarcinomas. However, the question of whether perioperative chemotherapy or neoadjuvant chemoradiation is more effective for the long-term survival in this population has yet to be fully elucidated. In SCCs, neoadjuvant chemoradiation followed by surgery or definitive chemoradiation in case of functional inoperability represent the preferred treatment options. Compared to neoadjuvant protocols, adjuvant chemotherapy or chemoradiation have only minor effects and are associated with enhanced toxicities. Current preclinical and clinical trials investigate efficacy and tolerability of novel drugs aiming to modulate immune check-points and dual inhibition of HER2. In this "to-the-point" article, we review the current standard and summarize the most recent and encouraging therapeutic advances in esophageal cancer. Multimodal treatment approaches for esophageal cancer should be discussed in a multidisciplinary team based on histology, tumor localization, and patient performance status. Neoadjuvant chemoradiation is beneficial for patients with locally advanced SCC and adenocarcinomas of the esophagus and the gastroesophageal junction (GEJ), with perioperative chemotherapy representing a valid alternative for GEJ adenocarcinomas. Combination therapies are indicated for metastatic adenocarcinomas, while the benefit of palliative chemotherapy in SCC remains controversial. Trastuzumab is indicated in HER2+ metastatic adenocarcinomas. © 2017 S. Karger AG, Basel.

Survival of Mexican children with acute myeloid leukaemia who received early intensification chemotherapy and an autologous transplant.

PubMed

Jiménez-Hernández, Elva; Dueñas-González, María Teresa; Arellano-Galindo, José; Medrano-Ortíz-De-Zárate, María Elena; Bekker-Méndez, Vilma Carolina; Berges-García, Adolfina; Solís-Labastida, Karina; Sánchez-Jara, Berenice; Tiznado-García, Héctor Manuel; Jaimes-Reyes, Ethel Zulie; García-Jiménez, Xochiketzalli; Espinoza-Hernández, Laura; Núñez-Villegas, Nora Nancy; Franco-Ornelas, Sergio; Pérez-Casillas, Ruy Xavier; Villegas, Octavio Martínez; Palomares, Teresa Marin; Mejía-Aranguré, Juan Manuel

2015-01-01

In Mexico and other developing countries, few reports of the survival of children with acute leukaemia exist. Objective. We aimed at comparing the disease-free survival of children with acute myeloid leukaemia who, in addition to being treated with the Latin American protocol of chemotherapy and an autologous transplant, either underwent early intensified chemotherapy or did not undergo such treatment. This was a cohort study with a historical control group, forty patients, less than 16 years old. Group A (20 patients), diagnosed in the period 2005-2007, was treated with the Latin American protocol of chemotherapy with an autologous transplant plus early intensified chemotherapy: high doses of cytarabine and mitoxantrone. Group B (20 patients), diagnosed in the period 1999-2004, was treated as Group A, but without the early intensified chemotherapy. Relapse-free survival for Group A was 90% whereas that for Group B it was 60% (P = 0.041). Overall survival for Group A (18, 90%) was higher than that for Group B (60%). Complete remission continued for two years of follow-up. Relapse-free survival for paediatric patients treated with the Latin American protocol of chemotherapy with an autologous transplant plus early intensified chemotherapy was higher than that for those who did not receive early intensified chemotherapy.

Response rates and survival times for cats with lymphoma treated with the University of Wisconsin-Madison chemotherapy protocol: 38 cases (1996-2003).

PubMed

Milner, Rowan J; Peyton, Jamie; Cooke, Kirsten; Fox, Leslie E; Gallagher, Alexander; Gordon, Patti; Hester, Juli

2005-10-01

To determine response rates and survival times for cats with lymphoma treated with the University of Wisconsin-Madison chemotherapy protocol. Retrospective study. 38 cats with lymphoma. Medical records were reviewed, and information on age, sex, breed, FeLV and FIV infection status, anatomic form, clinical stage, and survival time was obtained. Immunophenotyping was not performed. Mean +/- SD age of the cats was 10.9 +/- 4.4 years. Overall median survival time was 210 days (interquartile range, 90 to 657 days), and overall duration of first remission was 156 days (interquartile range, 87 to 316 days). Age, sex, anatomic form, and clinical stage were not significantly associated with duration of first remission or survival time. Eighteen of the 38 (47%) cats had complete remission, 14 (37%) had partial remission, and 6 (16%) had no response. Duration of first remission was significantly longer for cats with complete remission (654 days) than for cats with partial remission (114 days). Median survival time for cats with complete remission (654 days) was significantly longer than median survival time for cats with partial remission (122 days) and for cats with no response (11 days). Results suggested that a high percentage of cats with lymphoma will respond to treatment with the University of Wisconsin-Madison chemotherapy protocol. Age, sex, anatomic form, and clinical stage were not significantly associated with duration of first response or survival time, but initial response to treatment was.

The NINDS-Canadian stroke network vascular cognitive impairment neuropsychology protocols in Chinese.

PubMed

Wong, Adrian; Xiong, Yun-yun; Wang, Defeng; Lin, Shi; Chu, Winnie W C; Kwan, Pauline W K; Nyenhuis, David; Black, Sandra E; Wong, Ka Sing Lawrence; Mok, Vincent

2013-05-01

Vascular cognitive impairment (VCI) affects up to half of stroke survivors and predicts poor outcomes. Valid and reliable assessement for VCI is lacking, especially for the Chinese population. In 2005, the National Institute of Neurological Disorders and Stroke and Canadian Stroke Network (NINDS-CSN) Harmonisation workshop proposed a set of three neuropsychology protocols for VCI evaluation. This paper is to introduce the protocol design and to report the psychometric properties of the Chinese NINDS-CSN VCI protocols. Fifty patients with mild stroke (mean National Institute of Health Stroke Scale 2.2 (SD=3.2)) and 50 controls were recruited. The NINDS-CSN VCI protocols were adapted into Chinese. We assessed protocols' (1) external validity, defined by how well the protocol summary scores differentiated patients from controls using receiver operating characteristics (ROC) curve analysis; (2) concurrent validity, by correlations with functional measures including Stroke Impact Scale memory score and Chinese Disability Assessment for Dementia; (3) internal consistency; and (4) ease of administration. All three protocols differentiated patients from controls (area under ROC for the three protocols between 0.77 to 0.79, p<0.001), and significantly correlated with the functional measures (Pearson r ranged from 0.37 to 0.51). A cut-off of 19/20 on MMSE identified only one-tenth of patients classified as impaired on the 5-min protocol. Cronbach's α across the four cognitive domains of the 60-min protocol was 0.78 for all subjects and 0.76 for stroke patients. The Chinese NINDS-CSN VCI protocols are valid and reliable for cognitive assessment in Chinese patients with mild stroke.

CAPTIONALS: A computer aided testing environment for the verification and validation of communication protocols

NASA Technical Reports Server (NTRS)

Feng, C.; Sun, X.; Shen, Y. N.; Lombardi, Fabrizio

1992-01-01

This paper covers the verification and protocol validation for distributed computer and communication systems using a computer aided testing approach. Validation and verification make up the so-called process of conformance testing. Protocol applications which pass conformance testing are then checked to see whether they can operate together. This is referred to as interoperability testing. A new comprehensive approach to protocol testing is presented which address: (1) modeling for inter-layer representation for compatibility between conformance and interoperability testing; (2) computational improvement to current testing methods by using the proposed model inclusive of formulation of new qualitative and quantitative measures and time-dependent behavior; (3) analysis and evaluation of protocol behavior for interactive testing without extensive simulation.

Validation of nomograms for overall survival, cancer-specific survival, and recurrence in carcinoma of the major salivary glands.

PubMed

Hay, Ashley; Migliacci, Jocelyn; Zanoni, Daniella Karassawa; Patel, Snehal; Yu, Changhong; Kattan, Michael W; Ganly, Ian

2018-05-01

The purpose of this study was to investigate the performance of the Memorial Sloan Kettering Cancer Center salivary carcinoma nomograms predicting overall survival, cancer-specific survival, and recurrence with an external validation dataset. The validation dataset comprised 123 patients treated between 2010 and 2015 at our institution. They were evaluated by assessing discrimination (concordance index [C-index]) and calibration (plotting predicted vs actual probabilities for quintiles). The validation cohort (n = 123) showed some differences to the original cohort (n = 301). The validation cohort had less high-grade cancers (P = .006), less lymphovascular invasion (LVI; P < .001) and shorter follow-up of 19 months versus 45.6 months. Validation showed a C-index of 0.833 (95% confidence interval [CI] 0.758-0.908), 0.807 (95% CI 0.717-0.898), and 0.844 (95% CI 0.768-0.920) for overall survival, cancer-specific survival, and recurrence, respectively. The 3 salivary gland nomograms performed well using a contemporary validation dataset, despite limitations related to sample size, follow-up, and differences in clinical and pathology characteristics between the original and validation cohorts. © 2018 Wiley Periodicals, Inc.

Risk-Benefit Analysis of Pediatric-Inspired Versus Hyperfractionated Cyclophosphamide, Vincristine, Doxorubicin, and Dexamethasone Protocols for Acute Lymphoblastic Leukemia in Adolescents and Young Adults.

PubMed

Guzauskas, Gregory F; Villa, Kathleen F; Vanhove, Geertrui F; Fisher, Vicki L; Veenstra, David L

2017-03-01

To estimate the risk-benefit trade-off of a pediatric-inspired regimen versus hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (hyper-CVAD) for first-line treatment of adolescents/young adult (AYA; ages 16-39 years) patients with Philadelphia-negative acute lymphoblastic leukemia. Patient outcomes were simulated using a 6-state Markov model, including complete response (CR), no CR, first relapse, second CR, second relapse, and death. A Weibull distribution was fit to the progression-free survival curve of hyper-CVAD-treated AYA patients from a single-center study, and comparable patient data from a retrospective study of pediatric regimen-treated AYA patients were utilized to estimate a relative progression difference (hazard ratio = 0.51) and model survival differences. Health-state utilities were estimated based on treatment stage, with an assumption that the pediatric protocol had 0.10 disutility compared with hyper-CVAD before the maintenance phase of treatment. Total life-years and quality-adjusted life-years (QALYs) were compared between treatment protocols at 1, 5, and 10 years, with additional probabilistic sensitivity analyses. Treatment with the pediatric-inspired protocol was associated with a 0.04 increase in life-years, but a 0.01 decrease in QALYs at 1 year. By years 5 and 10, the pediatric-inspired protocol resulted in 0.18 and 0.24 increase in life-years and 0.25 and 0.32 increase in QALYs, respectively, relative to hyper-CVAD. The lower quality of life associated with the induction and intensification phases of pediatric treatment was offset by more favorable progression-free survival and overall survival relative to hyper-CVAD. Our exploratory analysis suggests that, compared with hyper-CVAD, pediatric-inspired protocols may increase life-years throughout treatment stages and QALYs in the long term.

Comparison of efficacy and toxicity of doxorubicin and mitoxantrone in combination chemotherapy for canine lymphoma

PubMed Central

Wang, Shang-Lin; Lee, Jih-Jong; Liao, Albert Taiching

2016-01-01

Forty-four dogs with multicentric lymphoma were treated using a cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) induction protocol or treated using a cyclophosphamide, mitoxantrone, vincristine, and prednisolone (CMOP) induction protocol. There was no statistical difference in signalment and the presence of historical negative prognostic factors between the groups. The median progression-free survival (PFS) in the CHOP and CMOP groups were 222 d and 162 d, respectively (P = 0.75). The median survival time (MST) of dogs in CHOP and CMOP groups were 318 d and 242 d, respectively (P = 0.63). Anorexia and diarrhea episodes were significantly higher in the CHOP group than in the CMOP group (P = 0.02 and P = 0.01, respectively). These results suggest that the CMOP protocol provides similar PFS, MST and causes fewer side effects compared to the CHOP protocol. Therefore, the CMOP protocol may be another treatment choice for canine multicentric lymphoma. PMID:26933263

Comparison of efficacy and toxicity of doxorubicin and mitoxantrone in combination chemotherapy for canine lymphoma.

PubMed

Wang, Shang-Lin; Lee, Jih-Jong; Liao, Albert Taiching

2016-03-01

Forty-four dogs with multicentric lymphoma were treated using a cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) induction protocol or treated using a cyclophosphamide, mitoxantrone, vincristine, and prednisolone (CMOP) induction protocol. There was no statistical difference in signalment and the presence of historical negative prognostic factors between the groups. The median progression-free survival (PFS) in the CHOP and CMOP groups were 222 d and 162 d, respectively (P = 0.75). The median survival time (MST) of dogs in CHOP and CMOP groups were 318 d and 242 d, respectively (P = 0.63). Anorexia and diarrhea episodes were significantly higher in the CHOP group than in the CMOP group (P = 0.02 and P = 0.01, respectively). These results suggest that the CMOP protocol provides similar PFS, MST and causes fewer side effects compared to the CHOP protocol. Therefore, the CMOP protocol may be another treatment choice for canine multicentric lymphoma.

Optimization of wireless sensor networks based on chicken swarm optimization algorithm

NASA Astrophysics Data System (ADS)

Wang, Qingxi; Zhu, Lihua

2017-05-01

In order to reduce the energy consumption of wireless sensor network and improve the survival time of network, the clustering routing protocol of wireless sensor networks based on chicken swarm optimization algorithm was proposed. On the basis of LEACH agreement, it was improved and perfected that the points on the cluster and the selection of cluster head using the chicken group optimization algorithm, and update the location of chicken which fall into the local optimum by Levy flight, enhance population diversity, ensure the global search capability of the algorithm. The new protocol avoided the die of partial node of intensive using by making balanced use of the network nodes, improved the survival time of wireless sensor network. The simulation experiments proved that the protocol is better than LEACH protocol on energy consumption, also is better than that of clustering routing protocol based on particle swarm optimization algorithm.

Subclinical rejection associated with chronic allograft nephropathy in protocol biopsies as a risk factor for late graft loss.

PubMed

Moreso, F; Ibernon, M; Gomà, M; Carrera, M; Fulladosa, X; Hueso, M; Gil-Vernet, S; Cruzado, J M; Torras, J; Grinyó, J M; Serón, D

2006-04-01

Chronic allograft nephropathy (CAN) in protocol biopsies is associated with graft loss while the association between subclinical rejection (SCR) and outcome has yielded contradictory results. We analyze the predictive value of SCR and/or CAN in protocol biopsies on death-censored graft survival. Since 1988, a protocol biopsy was done during the first 6 months in stable grafts with serum creatinine <300 micromol/L and proteinuria <1 g/day. Biopsies were evaluated according to Banff criteria. Borderline changes and acute rejection were grouped as SCR. CAN was defined as presence of interstitial fibrosis and tubular atrophy. Mean follow-up was 91 +/- 46 months. Sufficient tissue was obtained in 435 transplants. Biopsies were classified as normal (n = 186), SCR (n = 74), CAN (n = 110) and SCR with CAN (n = 65). Presence of SCR with CAN was associated with old donors, percentage of panel reactive antibodies and presence of acute rejection before protocol biopsy. Cox regression analysis showed that SCR with CAN (relative risk [RR]: 1.86, 95% confidence interval [CI]: 1.11-3.12; p = 0.02) and hepatitis C virus (RR: 2.27, 95% CI: 1.38-3.75; p = 0.01) were independent predictors of graft survival. In protocol biopsies, the detrimental effect of interstitial fibrosis/tubular atrophy on long-term graft survival is modulated by SCR.

Institutional resuscitation protocols: do they affect cardiopulmonary resuscitation outcomes? A 6-year study in a single tertiary-care centre.

PubMed

Sodhi, Kanwalpreet; Singla, Manender Kumar; Shrivastava, Anupam

2015-02-01

Despite advances in cardiopulmonary resuscitation and widespread life-support trainings, the outcomes of resuscitation are variable. There is a definitive need for organizational inputs to strengthen the resuscitation process. Our hospital authorities introduced certain changes at the organizational level in our in-house resuscitation protocol. We aimed to study the impact of these changes on the outcomes of resuscitation. The hospital code blue committee decided to reformulate the resuscitation protocols and reframe the code blue team. Various initiatives were taken in the form of infrastructural changes, procurement of equipment, organising certified training programs, conduct of mock code and simulation drills etc. A prospective and retrospective observational study was made over 6 years: a pre-intervention period, which included all cardiac arrests from January 2007 to December 2009, before the implementation of the program, and a post-intervention period from January 2010 to December 2012, after the implementation of the program. The outcomes of interest were response time, immediate survival, day/night survival and survival to discharge ratio. 2,164 in-hospital cardiac arrests were included in the study, 1,042 during the pre-intervention period and 1,122 during the post-intervention period. The survival percentage increased from 26.7 to 40.8 % (p < 0.05), and the survival to discharge ratio increased from 23.4 to 66.6 % (p < 0.05). Both day- and night-time survival improved (p < 0.05) and response time improved from 4 to 1.5 min. A strong hospital-based resuscitation policy with well-defined protocols and infrastructure has potential synergistic effect and plays a big role in improving the outcomes of resuscitation.

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.

PubMed

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 < or = MRL), tetracyclines (< or = MRL and < or = 2.5 MRL), macrolides (2 MRL), quinolones (< or = 2 MRL), some sulphonamides (< or = 3 MRL), and trimethoprim (2 MRL). However, the sensitivity of the STAR protocol towards aminoglycosides (> 8 MRL) and florfenicol (< or = 10 MRL) was unsatisfactory (>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.

Multicenter Prospective Study of Angiogenesis Polymorphism Validation in HCC Patients Treated with Sorafenib. An INNOVATE Study Protocol.

PubMed

Casadei Gardini, Andrea; Faloppi, Luca; Aprile, Giuseppe; Brunetti, Oronzo; Caparello, Chiara; Corbelli, Jody; Chessa, Luchino; Bruno, Daniele; Ercolani, Giorgio; Leonetti, Alessandro; de Stefano, Giorgio; Farella, Nunzia; Foschi, Francesco Giuseppe; Lanzi, Arianna; Dadduzio, Vincenzo; Marisi, Giorgia; Masi, Gianluca; Negri, Francesca V; Pagan, Flavia; Santini, Daniele; Scarpi, Emanuela; Silletta, Marianna; Silvestris, Nicola; Tamburini, Emiliano; Tassinari, Davide; Vivaldi, Caterina; Gentilucci, Umberto Vespasiani; Zagonel, Vittorina; Calvetti, Lorenzo; Cascinu, Stefano; Frassineti, Giovanni Luca; Scartozzi, Mario

2017-12-01

Introduction Although sorafenib is the upfront standard of care for advanced hepatocellular carcinoma (HCC), molecular predictors of efficacy have not been identified yet. In the ALICE-1 study, rs2010963 of VEGF-A and VEGF-C proved to be independent predictive factors for progression-free survival (PFS) and overall survival (OS) in multivariate analysis. The ALICE-1 study results were confirmed in the ALICE-2 study, in which VEGF and VEGFR SNPs were analyzed. In the ePHAS study we analyzed the SNPs of eNOS. In univariate analysis, patients homozygous for an eNOS haplotype (HT1: T-4b at eNOS-786/eNOS VNTR) had significantly shorter median PFS and OS than those with other haplotypes. These data were confirmed in the validation set. Methods This nonpharmacological, interventional, prospective multicenter study aims to determine whether eNOS, HIF-1, VEGF, Ang2 and VEGFR polymorphisms play a role in predicting the objective response rate, PFS, and OS of advanced HCC patients treated with sorafenib. The study will involve 160 advanced HCC patients with Child-Pugh class A disease. The primary aim is to validate the prognostic or predictive roles of eNOS, Ang2, HIF-1, VEGF and VEGFR polymorphisms in relation to the clinical outcome (PFS) of HCC patients treated with sorafenib. Conclusions Overall, our data may suggest that polymorphism analysis of the VEGF, VEGFR-2, HIF and eNOS genes can identify HCC patients who are more likely to benefit from sorafenib.

Cladribine in a weekly versus daily schedule for untreated active hairy cell leukemia: final report from the Polish Adult Leukemia Group (PALG) of a prospective, randomized, multicenter trial.

PubMed

Robak, Tadeusz; Jamroziak, Krzysztof; Gora-Tybor, Joanna; Blonski, Jerzy Z; Kasznicki, Marek; Dwilewicz-Trojaczek, Jadwiga; Wiater, Elzbieta; Zdunczyk, Andrzej; Dybowicz, Jacek; Dmoszynska, Anna; Wojtaszko, Maria; Zdziarska, Barbara; Calbecka, Malgorzata; Kostyra, Aleksandra; Hellmann, Andrzej; Lewandowski, Krzysztof; Stella-Holowiecka, Beata; Sulek, Kazimierz; Gawronski, Krzysztof; Skotnicki, Aleksander B; Nowak, Wieslaw; Zawilska, Krystyna; Molendowicz-Portala, Lucyna; Kloczko, Janusz; Sokolowski, Jaroslaw; Warzocha, Krzysztof; Seferynska, Ilona; Ceglarek, Bernardeta; Konopka, Lech

2007-05-01

Cladribine (2-chlorodeoxyadenosine, 2-CdA) treatment-associated infections may shorten potentially long-term survival in hairy cell leukemia (HCL). In search of the optimal mode of 2-CdA administration, 132 patients with untreated HCL were randomized to receive either standard 5-day 2-CdA protocol or a novel schedule of 6 weekly 2-CdA infusions suggested to be less toxic. Analysis of treatment response confirmed similar complete remission rates, overall response rates, progression-free survival, and overall survival in both 2-CdA protocols. However, we did not observe lower toxicity in the weekly schedule. Of special interest, no significant differences were found in the rate of grade 3/4 infections (18% for daily and 26% for weekly protocol, difference -8.2%; 95% confidence interval [CI] -23.2% to 6.9%; P = .28) and the rate of septic deaths (3% for daily and 2% for weekly protocol, difference 1.4%; 95% CI -4.3% to 7.0%; P = .64). In conclusion, HCL treatment with weekly 2-CdA infusions is equally effective but no safer than the standard 5-day 2-CdA protocol.

Survival of Mexican Children with Acute Myeloid Leukaemia Who Received Early Intensification Chemotherapy and an Autologous Transplant

PubMed Central

Jiménez-Hernández, Elva; Dueñas-González, María Teresa; Arellano-Galindo, José; Medrano-Ortíz-De-Zárate, María Elena; Bekker-Méndez, Vilma Carolina; Berges-García, Adolfina; Solís-Labastida, Karina; Sánchez-Jara, Berenice; Tiznado-García, Héctor Manuel; Jaimes-Reyes, Ethel Zulie; García-Jiménez, Xochiketzalli; Espinoza-Hernández, Laura; Núñez-Villegas, Nora Nancy; Franco-Ornelas, Sergio; Pérez-Casillas, Ruy Xavier; Martínez Villegas, Octavio; Palomares, Teresa Marin; Mejía-Aranguré, Juan Manuel

2015-01-01

Background. In Mexico and other developing countries, few reports of the survival of children with acute leukaemia exist. Objective. We aimed at comparing the disease-free survival of children with acute myeloid leukaemia who, in addition to being treated with the Latin American protocol of chemotherapy and an autologous transplant, either underwent early intensified chemotherapy or did not undergo such treatment. Procedure. This was a cohort study with a historical control group, forty patients, less than 16 years old. Group A (20 patients), diagnosed in the period 2005–2007, was treated with the Latin American protocol of chemotherapy with an autologous transplant plus early intensified chemotherapy: high doses of cytarabine and mitoxantrone. Group B (20 patients), diagnosed in the period 1999–2004, was treated as Group A, but without the early intensified chemotherapy. Results. Relapse-free survival for Group A was 90% whereas that for Group B it was 60% (P = 0.041). Overall survival for Group A (18, 90%) was higher than that for Group B (60%). Complete remission continued for two years of follow-up. Conclusions. Relapse-free survival for paediatric patients treated with the Latin American protocol of chemotherapy with an autologous transplant plus early intensified chemotherapy was higher than that for those who did not receive early intensified chemotherapy. PMID:25821830

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

PubMed

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.

Prognostic significance of clinical presentation, induction and rescue treatment in 42 cases of canine centroblastic diffuse large B-cell multicentric lymphoma in the United Kingdom.

PubMed

Davies, O; Szladovits, B; Polton, G; Garden, O A; Leo, C; Lara-Garcia, A

2018-06-01

Canine lymphoma is a heterogeneous group of diseases and many previous studies have evaluated the response of a mixed population of lymphoma cases to one specific treatment protocol. The aim of this retrospective study was to describe the outcome and prognostic factors in 42 cases of multicentric centroblastic diffuse large B-cell lymphoma treated with either a COP-type (35%) or CHOP-type (64%) induction chemotherapy. The objective response rate to induction therapy was 94%; entire dogs had a greater rate of complete vs partial remissions than neutered dogs (P = .017). Median progression-free survival for the first remission (PFS1) was 182 days; absence of anaemia at diagnosis (P = .002) and pretreatment neutrophil:lymphocyte ratio (NLR) below 9.44 (P = .015) were independently predictive of longer PFS1. Fifty-eight percent of dogs received rescue protocols with an objective response rate of 81%; 31% of dogs received further rescue protocols (up to a total of 5) and the median number of protocols administered were 2. Median overall survival (OS) was 322 days, the 1-year survival rate was 38% and the 2-year survival rate was 9%. Lymphocyte:monocyte ratio above 1.43 (P = .031), NLR below 11.44 (P = .009), the combination of induction and rescue therapy (P = .030) and the total number of doxorubicin doses used (P = .002) were independently predictive of longer OS. Use of a COP-type protocol induction compared with CHOP did not undermine OS providing doxorubicin was used as rescue therapy. © 2017 John Wiley & Sons Ltd.

Validation protocols for blood pressure-measuring devices: status quo and development needs.

PubMed

Beime, Beate; Deutsch, Cornelia; Gomez, Timothy; Zwingers, Thomas; Mengden, Thomas; Bramlage, Peter

2016-02-01

Hypertension is a major risk factor for cardiovascular morbidity and mortality. Therefore, blood pressure self-measuring devices have emerged as valuable tools in patient care and the accuracy of these instruments is of fundamental importance. For this reason, several validation procedures for assessing the efficacy of blood pressure monitoring devices have been developed, including protocols by the Association for the Advancement of Medical Instrumentation, the British Hypertension Society, the German Hypertension League (Prüfsiegelprotokoll), and the International Protocol of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. In the past, most of the protocols have been reviewed and modified because of experiences gained during the validation studies carried out. However, each shows distinct differences, that is number and characteristics of patients required, blood pressure ranges, and the length of the validation procedure, which may result in unique advantages and/or limitations associated with their use. The continued standardization and evolution of these guidelines is essential to ensure the efficacy of blood pressure-measuring devices marketed for clinical and home use. Here, we aimed to compare four currently used validation protocols and to initiate a discussion on potential future improvements.

Development and validation of polar RP-HPLC method for screening for ectoine high-yield strains in marine bacteria with green chemistry.

PubMed

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.

A Unified Fault-Tolerance Protocol

NASA Technical Reports Server (NTRS)

Miner, Paul; Gedser, Alfons; Pike, Lee; Maddalon, Jeffrey

2004-01-01

Davies and Wakerly show that Byzantine fault tolerance can be achieved by a cascade of broadcasts and middle value select functions. We present an extension of the Davies and Wakerly protocol, the unified protocol, and its proof of correctness. We prove that it satisfies validity and agreement properties for communication of exact values. We then introduce bounded communication error into the model. Inexact communication is inherent for clock synchronization protocols. We prove that validity and agreement properties hold for inexact communication, and that exact communication is a special case. As a running example, we illustrate the unified protocol using the SPIDER family of fault-tolerant architectures. In particular we demonstrate that the SPIDER interactive consistency, distributed diagnosis, and clock synchronization protocols are instances of the unified protocol.

Retrospective analysis for treatment of naïve canine multicentric lymphoma with a 15-week, maintenance-free CHOP protocol.

PubMed

Curran, K; Thamm, D H

2016-08-01

Standard of care treatment of dogs with multicentric lymphoma includes combination chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP); however, owners may be hesitant to commit the resources necessary to complete a lengthy, multi-drug protocol. One hundred thirty-four client-owned dogs with multicentric lymphoma were treated with a 15-week CHOP chemotherapy protocol. The overall response rate was 98% with 104 dogs experiencing a complete response (CR). The median progression-free survival (PFS) time for all dogs was 176 days, and the median disease-specific overall survival time was 311 days. Prognostic factors identified on multivariate analysis as significant for PFS included substage, immunophenotype, hospitalization for adverse events, need for dose reduction, presence of neutrophilia at diagnosis, presence of anemia and experiencing a CR as best response to therapy. In conclusion, this protocol may be a viable alternative to CHOP protocols using a larger number of treatments. © 2015 John Wiley & Sons Ltd.

Implementation of Pit Crew Approach and Cardiopulmonary Resuscitation Metrics for Out-of-Hospital Cardiac Arrest Improves Patient Survival and Neurological Outcome.

PubMed

Hopkins, Christy L; Burk, Chris; Moser, Shane; Meersman, Jack; Baldwin, Clair; Youngquist, Scott T

2016-01-11

Survival from out-of-hospital cardiac arrest (OHCA) varies by community and emergency medical services (EMS) system. We hypothesized that the adoption of multiple best practices to focus EMS crews on high-quality, minimally interrupted cardiopulmonary resuscitation (CPR) would improve survival of OHCA patients in Salt Lake City. In September 2011, Salt Lake City Fire Department EMS providers underwent a systemwide restructuring of care for OHCA patients that focused on the adoption of high-quality CPR with minimal interruptions and offline medical review of defibrillator data and feedback on CPR metrics. Victims were directed to ST-elevation myocardial infarction receiving centers. Prospectively collected data on patient survival and neurological outcome for all OHCAs were compared. In the postintervention period, there were 407 cardiac arrests with 65 neurologically intact survivors (16%), compared with 330 cardiac arrests with 25 neurologically intact survivors (8%) in the preintervention period. Among patients who survived to hospital admission, a higher proportion in the postintervention period survived to hospital discharge (71/141 [50%] versus 36/98 [37%], P=0.037) and had a favorable neurological outcome (65 [46%] versus 25 [26%], P=0.0005) compared with patients treated before the protocol changes. The univariate odds ratio or the association between neurologically intact survival (cerebral performance category 1 and 2) and protocol implementation was 2.3 (95% CI 1.4 to 3.7, P=0.001). Among discharged patients, the distribution of cerebral performance category scores was more favorable in the postintervention period (P<0.0001). A multifaceted protocol, including several American Heart Assocation best practices for the resuscitation of patients with OHCA, was associated with improved survival and neurological outcome. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Determination of the exercise intensity that elicits maximal fat oxidation in individuals with obesity.

PubMed

Dandanell, Sune; Præst, Charlotte Boslev; Søndergård, Stine Dam; Skovborg, Camilla; Dela, Flemming; Larsen, Steen; Helge, Jørn Wulff

2017-04-01

Maximal fat oxidation (MFO) and the exercise intensity that elicits MFO (Fat Max ) are commonly determined by indirect calorimetry during graded exercise tests in both obese and normal-weight individuals. However, no protocol has been validated in individuals with obesity. Thus, the aims were to develop a graded exercise protocol for determination of Fat Max in individuals with obesity, and to test validity and inter-method reliability. Fat oxidation was assessed over a range of exercise intensities in 16 individuals (age: 28 (26-29) years; body mass index: 36 (35-38) kg·m -2 ; 95% confidence interval) on a cycle ergometer. The graded exercise protocol was validated against a short continuous exercise (SCE) protocol, in which Fat Max was determined from fat oxidation at rest and during 10 min of continuous exercise at 35%, 50%, and 65% of maximal oxygen uptake. Intraclass and Pearson correlation coefficients between the protocols were 0.75 and 0.72 and within-subject coefficient of variation (CV) was 5 (3-7)%. A Bland-Altman plot revealed a bias of -3% points of maximal oxygen uptake (limits of agreement: -12 to 7). A tendency towards a systematic difference (p = 0.06) was observed, where Fat Max occurred at 42 (40-44)% and 45 (43-47)% of maximal oxygen uptake with the graded and the SCE protocol, respectively. In conclusion, there was a high-excellent correlation and a low CV between the 2 protocols, suggesting that the graded exercise protocol has a high inter-method reliability. However, considerable intra-individual variation and a trend towards systematic difference between the protocols reveal that further optimization of the graded exercise protocol is needed to improve validity.

Validation protocol of analytical procedures for quantification of drugs in polymeric systems for parenteral administration: dexamethasone phosphate disodium microparticles.

PubMed

Martín-Sabroso, Cristina; Tavares-Fernandes, Daniel Filipe; Espada-García, Juan Ignacio; Torres-Suárez, Ana Isabel

2013-12-15

In this work a protocol to validate analytical procedures for the quantification of drug substances formulated in polymeric systems that comprise both drug entrapped into the polymeric matrix (assay:content test) and drug released from the systems (assay:dissolution test) is developed. This protocol is applied to the validation two isocratic HPLC analytical procedures for the analysis of dexamethasone phosphate disodium microparticles for parenteral administration. Preparation of authentic samples and artificially "spiked" and "unspiked" samples is described. Specificity (ability to quantify dexamethasone phosphate disodium in presence of constituents of the dissolution medium and other microparticle constituents), linearity, accuracy and precision are evaluated, in the range from 10 to 50 μg mL(-1) in the assay:content test procedure and from 0.25 to 10 μg mL(-1) in the assay:dissolution test procedure. The robustness of the analytical method to extract drug from microparticles is also assessed. The validation protocol developed allows us to conclude that both analytical methods are suitable for their intended purpose, but the lack of proportionality of the assay:dissolution analytical method should be taken into account. The validation protocol designed in this work could be applied to the validation of any analytical procedure for the quantification of drugs formulated in controlled release polymeric microparticles. Copyright © 2013 Elsevier B.V. All rights reserved.

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

PubMed

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.

Field validation of protocols developed to evaluate in-line mastitis detection systems.

PubMed

Kamphuis, C; Dela Rue, B T; Eastwood, C R

2016-02-01

This paper reports on a field validation of previously developed protocols for evaluating the performance of in-line mastitis-detection systems. The protocols outlined 2 requirements of these systems: (1) to detect cows with clinical mastitis (CM) promptly and accurately to enable timely and appropriate treatment and (2) to identify cows with high somatic cell count (SCC) to manage bulk milk SCC levels. Gold standard measures, evaluation tests, performance measures, and performance targets were proposed. The current study validated the protocols on commercial dairy farms with automated in-line mastitis-detection systems using both electrical conductivity (EC) and SCC sensor systems that both monitor at whole-udder level. The protocol for requirement 1 was applied on 3 commercial farms. For requirement 2, the protocol was applied on 6 farms; 3 of them had low bulk milk SCC (128×10(3) cells/mL) and were the same farms as used for field evaluation of requirement 1. Three farms with high bulk milk SCC (270×10(3) cells/mL) were additionally enrolled. The field evaluation methodology and results were presented at a workshop including representation from 7 international suppliers of in-line mastitis-detection systems. Feedback was sought on the acceptance of standardized performance evaluation protocols and recommended refinements to the protocols. Although the methodology for requirement 1 was relatively labor intensive and required organizational skills over an extended period, no major issues were encountered during the field validation of both protocols. The validation, thus, proved the protocols to be practical. Also, no changes to the data collection process were recommended by the technology supplier representatives. However, 4 recommendations were made to refine the protocols: inclusion of an additional analysis that ignores small (low-density) clot observations in the definition of CM, extension of the time window from 4 to 5 milkings for timely alerts for CM, setting a maximum number of 10 milkings for the time window to detect a CM episode, and presentation of sensitivity for a larger range of false alerts per 1,000 milkings replacing minimum performance targets. The recommended refinements are discussed with suggested changes to the original protocols. The information presented is intended to inform further debate toward achieving international agreement on standard protocols to evaluate performance of in-line mastitis-detection systems. Copyright © 2016 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Test of Gross Motor Development-3 (TGMD-3) with the Use of Visual Supports for Children with Autism Spectrum Disorder: Validity and Reliability.

PubMed

Allen, K A; Bredero, B; Van Damme, T; Ulrich, D A; Simons, J

2017-03-01

The validity and reliability of the Test of Gross Motor Development-3 (TGMD-3) were measured, taking into consideration the preference for visual learning of children with autism spectrum disorder (ASD). The TGMD-3 was administered to 14 children with ASD (4-10 years) and 21 age-matched typically developing children under two conditions: TGMD-3 traditional protocol, and TGMD-3 visual support protocol. Excellent levels of internal consistency, test-retest, interrater and intrarater reliability were achieved for the TGMD-3 visual support protocol. TGMD-3 raw scores of children with ASD were significantly lower than typically developing peers, however, significantly improved using the TGMD-3 visual support protocol. This demonstrates that the TGMD-3 visual support protocol is a valid and reliable assessment of gross motor performance for children with ASD.

Validity of the modified back-saver sit-and-reach test: a comparison with other protocols.

PubMed

Hui, S S; Yuen, P Y

2000-09-01

Studies have shown that the classical sit-and-reach (CSR) test, the modified sit-and-reach (MSR), and the newly developed back-saver sit-and-reach (BS) test have poor criterion-related validity in estimating low-back flexibility but yielded moderate criterion-related validity in hamstring flexibility. The V sit-and-reach (VSR) test was found to be practical but the validity has not been established. The purpose of this study was to propose a modified back-saver sit-and-reach (MBS) test, which incorporated all advantages of the various protocols, and to compare the criterion-related validity and reliability of all these tests. 158 college students (F = 96, and M = 62; age = 20.77 +/- 2.51) performed CSR, VSR, BS (left and right leg), and MBS (left and right leg) tests in a randomized order. Scores from each test were then correlated with the criterion measures. For all sit-reach tests, intraclass reliability (single trial) was very high (r = 0.89-0.98). MBS yielded significant and highest r with low-back and hamstring criterion for men (r = 0.47-0.67) and women (r = 0.23-0.54). The low-back and right hamstring validity of MBS for men were significantly (P < 0.01) higher than those from BS and CSR, whereas no differences in criterion-related validity were found between the MBS and other protocols in women. The ratings of perceived comfort among the sit-and-reach protocols were significantly different (P < 0.001) from each other. The rating for MBS was observed the most comfortable test as compared with other protocols. The MBS test is not only a reliable test for hamstring and low-back flexibility, it is also a more practical with improved validity for hamstring and low-back flexibility in men than previous protocols.

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.

PubMed

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 last 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 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.

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.

PubMed

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.

Impact of Sonic Hedgehog Pathway Expression on Outcome in HPV Negative Head and Neck Carcinoma Patients after Surgery and Adjuvant Radiotherapy

PubMed Central

Enzenhofer, Elisabeth; Parzefall, Thomas; Haymerle, Georg; Schneider, Sven; Kadletz, Lorenz; Heiduschka, Gregor; Pammer, Johannes; Oberndorfer, Felicitas; Wrba, Fritz; Loader, Benjamin; Grasl, Matthäus Christoph; Perisanidis, Christos; Erovic, Boban M.

2016-01-01

Introduction HPV positive patients suffering from head and neck cancer benefit from intensified radiotherapy when applied as a primary as well as an adjuvant treatment strategy. However, HPV negative patients treated with surgery and adjuvant radiotherapy lack validated prognostic biomarkers. It is therefore important to define prognostic biomarkers in this particular patient population. Especially, ´high-risk groups´ need to be defined in order to adapt treatment protocols. Since dysregulation of the sonic hedgehog pathway plays an important role in carcinogenesis, we aimed to assess whether members of the sonic hedgehog-signaling pathway may act as prognostic factors in patients with HPV negative head and neck squamous cell carcinoma. Materials and Methods In this prospective study, pretreatment tumor biopsies of patients with head and neck squamous cell carcinoma were taken during panendoscopy (2005 to 2008). All patients were treated with surgery and postoperative radiotherapy. After assessment of HPV and p16 status, protein expression profiles of the Sonic hedgehog-signaling pathway were determined by immunohistochemistry and tissue microarray analyses in 36 HPV negative tumor biopsies. Expression profiles of Sonic hedgehog, Indian hedgehog, Patched, Smoothened, Gli-1, Gli-2 and Gli-3 were correlated with patients´ clinical data, local-control rate, disease-free as well as overall survival. Data from The Cancer Genome Atlas databank were used for external validation of our results. Results Gli-1 (p = 0.04) and Gli-2 (p = 0.02) overexpression was significantly linked to improved overall survival of HPV negative patients. Gli-2 (p = 0.04) overexpression correlated significantly with prolonged disease-free survival. Cox-multivariate analysis showed that overexpression of Gli-2 correlated independently (HR 0.40, 95% CI 0.16–0.95, p = 0.03) with increased overall survival. Discussion Gli-1 and Gli-2 overexpression represents a substantial prognostic factor for overall and disease-free survival in patients with locally advanced HPV negative head and neck cancer undergoing surgery and postoperative radiotherapy. PMID:27918595

Cumulative cisplatin dose in concurrent chemoradiotherapy for head and neck cancer: A systematic review.

PubMed

Strojan, Primož; Vermorken, Jan B; Beitler, Jonathan J; Saba, Nabil F; Haigentz, Missak; Bossi, Paolo; Worden, Francis P; Langendijk, Johannes A; Eisbruch, Avraham; Mendenhall, William M; Lee, Anne W M; Harrison, Louis B; Bradford, Carol R; Smee, Robert; Silver, Carl E; Rinaldo, Alessandra; Ferlito, Alfio

2016-04-01

The optimal cumulative dose and timing of cisplatin administration in various concurrent chemoradiotherapy protocols for nonmetastatic head and neck squamous cell carcinoma (HNSCC) has not been determined. The absolute survival benefit at 5 years of concurrent chemoradiotherapy protocols versus radiotherapy alone observed in prospective randomized trials reporting on the use of cisplatin monochemotherapy for nonnasopharyngeal HNSCC was extracted. In the case of nonrandomized studies, the outcome results at 2 years were compared between groups of patients receiving different cumulative cisplatin doses. Eleven randomized trials and 7 nonrandomized studies were identified. In 6 definitive radiotherapy phase III trials, a statistically significant association (p = .027) between cumulative cisplatin dose, independent of the schedule, and overall survival benefit was observed for higher doses. Results support the conclusion that the cumulative dose of cisplatin in concurrent chemoradiation protocols for HNSCC has a significant positive correlation with survival. © 2015 Wiley Periodicals, Inc. Head Neck 38: E2151-E2158, 2016. © 2015 Wiley Periodicals, Inc.

Incidence of C4d stain in protocol biopsies from renal allografts: results from a multicenter trial.

PubMed

Mengel, Michael; Bogers, Johannes; Bosmans, Jean-Louis; Serón, Daniel; Moreso, Francesc; Carrera, Marta; Gwinner, Wilfried; Schwarz, Anke; De Broe, Marc; Kreipe, Hans; Haller, Hermann

2005-05-01

C4d staining of renal allografts is regarded as an in situ marker of active humoral rejection. Few data are available about the incidence of C4d deposition in protocol biopsies compared to indication biopsies. To evaluate whether center-specific factors influence the incidence of C4d detection, we performed a multicenter study. From three European centers, 551 protocol and 377 indication biopsies were reclassified according to the updated Banff criteria and stained for C4d. C4d results were recorded as diffuse or focal positive and statistically correlated to clinical parameters, morphology and graft survival. In the protocol biopsies, a diffuse C4d stain was found in 2.0%, and a focal stain in 2.4%. In indication biopsies, 12.2% were diffusely and 8.5% focally C4d positive (protocol:indication p < 0.0001). The incidence of C4d deposition varied significantly between centers, attributable to variable numbers of presensitized patients with more C4d positive indication and protocol biopsies. Diffuse and focal C4d stain correlated with morphology of humoral rejection in protocol as well as in indication biopsies. Protocol biopsies show a significantly lower incidence of C4d deposition than indication biopsies. Subclinical C4d detection in protocol biopsies had no significant impact on allograft survival in our series.

A randomized controlled trial of the effect of prednisone omission from a multidrug chemotherapy protocol on treatment outcome in dogs with peripheral nodal lymphomas.

PubMed

Childress, Michael O; Ramos-Vara, José A; Ruple, Audrey

2016-11-01

OBJECTIVE To determine the effect of prednisone omission from a multidrug chemotherapy protocol on outcome in dogs with peripheral nodal lymphomas. DESIGN Single-center, nonblinded, parallel-group, randomized, controlled trial. ANIMALS 40 client-owned dogs with a histopathologically confirmed diagnosis of peripheral nodal lymphoma and an expected survival time of > 4 weeks with treatment. PROCEDURES Treatment consisted of a combination of L-asparaginase, cyclophosphamide, doxorubicin, vincristine, and prednisone (L-CHOP) or an identical protocol except for the omission of prednisone (L-CHO). The primary outcome of interest was progression-free survival time. Veterinary caregivers and assessors of outcome were not blinded to treatment assignment. Treatment assignment was concealed from the owners of study dogs prior to enrollment, but was revealed after written informed consent was provided. RESULTS The trial was terminated early because of slow enrollment. The 40 dogs successfully enrolled in the study were randomly assigned to the L-CHOP (n = 18) or L-CHO (22) group; results for all 40 dogs were analyzed with respect to the primary outcome. Median progression-free survival time was 142.5 days for dogs receiving L-CHO and 292 days for dogs receiving L-CHOP (hazard ratio, 1.79; 95% confidence interval, 0.85 to 3.75). Serious adverse events were more common among dogs receiving L-CHO. However, this difference was not significant. CONCLUSIONS AND CLINICAL RELEVANCE The exclusion of prednisone from the L-CHOP protocol did not appear to result in improved progression-free survival time for dogs with peripheral nodal lymphomas. However, the present trial was likely underpowered to detect a clinically meaningful difference in progression-free survival time between groups.

Permeability Surface Area Product Using Perfusion Computed Tomography Is a Valuable Prognostic Factor in Glioblastomas Treated with Radiotherapy Plus Concomitant and Adjuvant Temozolomide.

PubMed

Saito, Taiichi; Sugiyama, Kazuhiko; Ikawa, Fusao; Yamasaki, Fumiyuki; Ishifuro, Minoru; Takayasu, Takeshi; Nosaka, Ryo; Nishibuchi, Ikuno; Muragaki, Yoshihiro; Kawamata, Takakazu; Kurisu, Kaoru

2017-01-01

The current standard treatment protocol for patients with newly diagnosed glioblastoma (GBM) includes surgery, radiotherapy, and concomitant and adjuvant temozolomide (TMZ). We hypothesized that the permeability surface area product (PS) from a perfusion computed tomography (PCT) study is associated with sensitivity to TMZ. The aim of this study was to determine whether PS values were correlated with prognosis of GBM patients who received the standard treatment protocol. This study included 36 patients with GBM that were newly diagnosed between October 2005 and September 2014 and who underwent preoperative PCT study and the standard treatment protocol. We measured the maximum value of relative cerebral blood volume (rCBVmax) and the maximum PS value (PSmax). We statistically examined the relationship between PSmax and prognosis using survival analysis, including other clinicopathologic factors (age, Karnofsky performance status [KPS], extent of resection, O6-methylguanine-DNA methyltransferase [MGMT] status, second-line use of bevacizumab, and rCBVmax). Log-rank tests revealed that age, KPS, MGMT status, and PSmax were significantly correlated with overall survival. Multivariate analysis using the Cox regression model showed that PSmax was the most significant prognostic factor. Receiver operating characteristic curve analysis showed that PSmax had the highest accuracy in differentiating longtime survivors (LTSs) (surviving more than 2 years) from non-LTSs. At a cutoff point of 8.26 mL/100 g/min, sensitivity and specificity were 90% and 70%, respectively. PSmax from PCT study can help predict survival time in patients with GBM receiving the standard treatment protocol. Survival may be related to sensitivity to TMZ. Copyright © 2016 Elsevier Inc. All rights reserved.

DNA variants in DHFR gene and response to treatment in children with childhood B ALL: revisited in AIEOP-BFM protocol.

PubMed

Ceppi, Francesco; Gagné, Vincent; Douyon, Laurance; Quintin, Camille J; Colombini, Antonella; Parasole, Rosanna; Buldini, Barbara; Basso, Giuseppe; Conter, Valentino; Cazzaniga, Giovanni; Krajinovic, Maja

2018-01-01

We have previously reported an association of dihydrofolate reductase promoter polymorphisms with reduced event-free survival in childhood acute lymphoblastic leukemia (ALL) patients treated with Dana Farber Cancer Institute protocol. Here, we assessed whether these associations are applicable to other protocol, based on different methotrexate doses. Genotypes for six tag polymorphisms and resulting haplotypes were analyzed for an association with ALL outcome. The association was found with the polymorphisms A-680C, A-317G and C-35T in high-risk group patients. Carriers of haplotype *1 had a remarkably higher risk of events compared with noncarriers and a lower probability of event-free survival (21.4 vs 81.3%). The role of DHFR variants in predicting the outcome of childhood ALL extends beyond single-treatment protocol and can be useful biomarker in personalizing treatment.

Global Land Product Validation Protocols: An Initiative of the CEOS Working Group on Calibration and Validation to Evaluate Satellite-derived Essential Climate Variables

NASA Astrophysics Data System (ADS)

Guillevic, P. C.; Nickeson, J. E.; Roman, M. O.; camacho De Coca, F.; Wang, Z.; Schaepman-Strub, G.

2016-12-01

The Global Climate Observing System (GCOS) has specified the need to systematically produce and validate Essential Climate Variables (ECVs). The Committee on Earth Observation Satellites (CEOS) Working Group on Calibration and Validation (WGCV) and in particular its subgroup on Land Product Validation (LPV) is playing a key coordination role leveraging the international expertise required to address actions related to the validation of global land ECVs. The primary objective of the LPV subgroup is to set standards for validation methods and reporting in order to provide traceable and reliable uncertainty estimates for scientists and stakeholders. The Subgroup is comprised of 9 focus areas that encompass 10 land surface variables. The activities of each focus area are coordinated by two international co-leads and currently include leaf area index (LAI) and fraction of absorbed photosynthetically active radiation (FAPAR), vegetation phenology, surface albedo, fire disturbance, snow cover, land cover and land use change, soil moisture, land surface temperature (LST) and emissivity. Recent additions to the focus areas include vegetation indices and biomass. The development of best practice validation protocols is a core activity of CEOS LPV with the objective to standardize the evaluation of land surface products. LPV has identified four validation levels corresponding to increasing spatial and temporal representativeness of reference samples used to perform validation. Best practice validation protocols (1) provide the definition of variables, ancillary information and uncertainty metrics, (2) describe available data sources and methods to establish reference validation datasets with SI traceability, and (3) describe evaluation methods and reporting. An overview on validation best practice components will be presented based on the LAI and LST protocol efforts to date.

Safety and Outcomes in 100 Consecutive Donation After Circulatory Death Liver Transplants Using a Protocol That Includes Thrombolytic Therapy.

PubMed

Bohorquez, H; Seal, J B; Cohen, A J; Kressel, A; Bugeaud, E; Bruce, D S; Carmody, I C; Reichman, T W; Battula, N; Alsaggaf, M; Therapondos, G; Bzowej, N; Tyson, G; Joshi, S; Nicolau-Raducu, R; Girgrah, N; Loss, G E

2017-08-01

Donation after circulatory death (DCD) liver transplantation (LT) reportedly yields inferior survival and increased complication rates compared with donation after brain death (DBD). We compare 100 consecutive DCD LT using a protocol that includes thrombolytic therapy (late DCD group) to an historical DCD group (early DCD group n = 38) and a cohort of DBD LT recipients (DBD group n = 435). Late DCD LT recipients had better 1- and 3-year graft survival rates than early DCD LT recipients (92% vs. 76.3%, p = 0.03 and 91.4% vs. 73.7%, p = 0.01). Late DCD graft survival rates were comparable to those of the DBD group (92% vs. 93.3%, p = 0.24 and 91.4% vs. 88.2%, p = 0.62). Re-transplantation occurred in 18.4% versus 1% for the early and late DCD groups, respectively (p = 0.001). Patient survival was similar in all three groups. Ischemic-type biliary lesions (ITBL) occurred in 5%, 3%, and 0.2% for early DCD, late DCD, and DBD groups, respectively, but unlike in the early DCD group, in the late DCD group ITBL was endoscopically managed and resolved in each case. Using a protocol that includes a thrombolytic therapy, DCD LT yielded patient and graft survival rates comparable to DBD LT. © 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.

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

PubMed

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

2016-01-01

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

Development and validation of a remote home safety protocol.

PubMed

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

2018-02-01

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

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

PubMed

Topouchian, Jirar; Agnoletti, Davide; Blacher, Jacques; Youssef, Ahmed; Ibanez, Isabel; Khabouth, Jose; Khawaja, Salwa; Beaino, Layale; Asmar, Roland

2011-01-01

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. 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. 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. 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.

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

PubMed

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

2013-12-01

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

A new survival score for patients with brain metastases who received whole-brain radiotherapy (WBRT) alone.

PubMed

Rades, Dirk; Dziggel, Liesa; Nagy, Viorica; Segedin, Barbara; Lohynska, Radka; Veninga, Theo; Khoa, Mai T; Trang, Ngo T; Schild, Steven E

2013-07-01

Survival scores for patients with brain metastasis exist. However, the treatment regimens used to create these scores were heterogeneous. This study aimed to develop and validate a survival score in homogeneously treated patients. Eight-hundred-and-eighty-two patients receiving 10 × 3Gy of WBRT alone were randomly assigned to a test group (N=441) or a validation group (N=441). In the multivariate analysis of the test group, age, performance status, extracranial metastasis, and systemic treatment prior to WBRT were independent predictors of survival. The score for each factor was determined by dividing the 6-month survival rate (in %) by 10. Scores were summed and total scores ranged from 6 to 19 points. Patients were divided into four prognostic groups. The 6-month survival rates were 4% for 6-9 points, 29% for 10-14 points, 62% for 15-17 points, and 93% for 17-18 points (p<0.001) in the test group. The survival rates were 3%, 28%, 54% and 96%, respectively (p<0.001) in the validation group. Since the 6-month survival rates in the validation group were very similar to the test group, this new score (WBRT-30) appears valid and reproducible. It can help making treatment choices and stratifying patients in future trials. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

A Protocol for Advanced Psychometric Assessment of Surveys

PubMed Central

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

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

ERIC Educational Resources Information Center

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

2009-01-01

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

Waveform analysis-guided treatment versus a standard shock-first protocol for the treatment of out-of-hospital cardiac arrest presenting in ventricular fibrillation: results of an international randomized, controlled trial.

PubMed

Freese, John P; Jorgenson, Dawn B; Liu, Ping-Yu; Innes, Jennifer; Matallana, Luis; Nammi, Krishnakant; Donohoe, Rachael T; Whitbread, Mark; Silverman, Robert A; Prezant, David J

2013-08-27

Ventricular fibrillation (VF) waveform properties have been shown to predict defibrillation success and outcomes among patients treated with immediate defibrillation. We postulated that a waveform analysis algorithm could be used to identify VF unlikely to respond to immediate defibrillation, allowing selective initial treatment with cardiopulmonary resuscitation in an effort to improve overall survival. In a multicenter, double-blind, randomized study, out-of-hospital cardiac arrest patients in 2 urban emergency medical services systems were treated with automated external defibrillators using either a VF waveform analysis algorithm or the standard shock-first protocol. The VF waveform analysis used a predefined threshold value below which return of spontaneous circulation (ROSC) was unlikely with immediate defibrillation, allowing selective treatment with a 2-minute interval of cardiopulmonary resuscitation before initial defibrillation. The primary end point was survival to hospital discharge. Secondary end points included ROSC, sustained ROSC, and survival to hospital admission. Of 6738 patients enrolled, 987 patients with VF of primary cardiac origin were included in the primary analysis. No immediate or long-term survival benefit was noted for either treatment algorithm (ROSC, 42.5% versus 41.2%, P=0.70; sustained ROSC, 32.4% versus 33.4%, P=0.79; survival to admission, 34.1% versus 36.4%, P=0.46; survival to hospital discharge, 15.6% versus 17.2%, P=0.55, respectively). Use of a waveform analysis algorithm to guide the initial treatment of out-of-hospital cardiac arrest patients presenting in VF did not improve overall survival compared with a standard shock-first protocol. Further study is recommended to examine the role of waveform analysis for the guided management of VF.

Population estimates and monitoring guidelines for endangered Laysan Teal, Anas Laysanensis, at Midway Atoll: Pilot study results 2008-2010.

USGS Publications Warehouse

Reynolds, Michelle H.; Brinck, Kevin W.; Laniawe, Leona

2011-01-01

To improve the Laysan Teal population estimates, we recommend changes to the monitoring protocol. Additional years of data are needed to quantify inter-annual seasonal detection probabilities, which may allow the use of standardized direct counts as an unbiased index of population size. Survey protocols should be enhanced through frequent resights, regular survey intervals, and determining reliable standards to detect catastrophic declines and annual changes in adult abundance. In late 2009 to early 2010, 68% of the population was marked with unique color band combinations. This allowed for potentially accurate adult population estimates and survival estimates without the need to mark new birds in 2010, 2011, and possibly 2012. However, efforts should be made to replace worn or illegible bands so birds can be identified in future surveys. It would be valuable to develop more sophisticated population size and survival models using Program MARK, a state-of-the-art software package which uses likelihood models to analyze mark-recapture data. This would allow for more reliable adult population and survival estimates to compare with the ―source‖ Laysan Teal population on Laysan Island. These models will require additional years of resight data (> 1 year) and, in some cases, an intensive annual effort of marking and recapture. Because data indicate standardized all-wetland counts are a poor index of abundance, monitoring efforts could be improved by expanding resight surveys to include all wetlands, discontinuing the all-wetland counts, and reallocating some of the wetland count effort to collect additional opportunistic resights. Approximately two years of additional bimonthly surveys are needed to validate the direct count as an appropriate index of population abundance. Additional years of individual resight data will allow estimates of adult population size, as specified in recovery criteria, and to track species population dynamics at Midway Atoll.

Young investigator challenge: Validation and optimization of immunohistochemistry protocols for use on cellient cell block specimens.

PubMed

Sauter, Jennifer L; Grogg, Karen L; Vrana, Julie A; Law, Mark E; Halvorson, Jennifer L; Henry, Michael R

2016-02-01

The objective of the current study was to establish a process for validating immunohistochemistry (IHC) protocols for use on the Cellient cell block (CCB) system. Thirty antibodies were initially tested on CCBs using IHC protocols previously validated on formalin-fixed, paraffin-embedded tissue (FFPE). Cytology samples were split to generate thrombin cell blocks (TCB) and CCBs. IHC was performed in parallel. Antibody immunoreactivity was scored, and concordance or discordance in immunoreactivity between the TCBs and CCBs for each sample was determined. Criteria for validation of an antibody were defined as concordant staining in expected positive and negative cells, in at least 5 samples each, and concordance in at least 90% of the samples total. Antibodies that failed initial validation were retested after alterations in IHC conditions. Thirteen of the 30 antibodies (43%) did not meet initial validation criteria. Of those, 8 antibodies (calretinin, clusters of differentiation [CD] 3, CD20, CDX2, cytokeratin 20, estrogen receptor, MOC-31, and p16) were optimized for CCBs and subsequently validated. Despite several alterations in conditions, 3 antibodies (Ber-EP4, D2-40, and paired box gene 8 [PAX8]) were not successfully validated. Nearly one-half of the antibodies tested in the current study failed initial validation using IHC conditions that were established in the study laboratory for FFPE material. Although some antibodies subsequently met validation criteria after optimization of conditions, a few continued to demonstrate inadequate immunoreactivity. These findings emphasize the importance of validating IHC protocols for methanol-fixed tissue before clinical use and suggest that optimization for alcohol fixation may be needed to obtain adequate immunoreactivity on CCBs. © 2016 American Cancer Society.

The specification-based validation of reliable multicast protocol: Problem Report. M.S. Thesis

NASA Technical Reports Server (NTRS)

Wu, Yunqing

1995-01-01

Reliable Multicast Protocol (RMP) is a communication protocol that provides an atomic, totally ordered, reliable multicast service on top of unreliable IP multicasting. In this report, we develop formal models for RMP using existing automated verification systems, and perform validation on the formal RMP specifications. The validation analysis help identifies some minor specification and design problems. We also use the formal models of RMP to generate a test suite for conformance testing of the implementation. Throughout the process of RMP development, we follow an iterative, interactive approach that emphasizes concurrent and parallel progress of implementation and verification processes. Through this approach, we incorporate formal techniques into our development process, promote a common understanding for the protocol, increase the reliability of our software, and maintain high fidelity between the specifications of RMP and its implementation.

Assessment and risk classification protocol for patients in emergency units1

PubMed Central

Silva, Michele de Freitas Neves; Oliveira, Gabriela Novelli; Pergola-Marconato, Aline Maino; Marconato, Rafael Silva; Bargas, Eliete Boaventura; Araujo, Izilda Esmenia Muglia

2014-01-01

Objective to develop, validate the contents and verify the reliability of a risk classification protocol for an Emergency Unit. Method the content validation was developed in a University Hospital in a country town located in the state of Sao Paulo and was carried out in two stages: the first with the individual assessment of specialists and the second with the meeting between the researchers and the specialists. The use of the protocol followed a specific guide. Concerning reliability, the concordance or equivalent method among observers was used. Results the protocol developed showed to have content validity and, after the suggested changes were made, there were excellent results concerning reliability. Conclusion the assistance flow chart was shown to be easy to use, and facilitate the search for the complaint in each assistance priority. PMID:26107828

Validating Analytical Protocols to Determine Selected Pesticides and PCBs Using Routine Samples.

PubMed

Pindado Jiménez, Oscar; García Alonso, Susana; Pérez Pastor, Rosa María

2017-01-01

This study aims at providing recommendations concerning the validation of analytical protocols by using routine samples. It is intended to provide a case-study on how to validate the analytical methods in different environmental matrices. In order to analyze the selected compounds (pesticides and polychlorinated biphenyls) in two different environmental matrices, the current work has performed and validated two analytical procedures by GC-MS. A description is given of the validation of the two protocols by the analysis of more than 30 samples of water and sediments collected along nine months. The present work also scopes the uncertainty associated with both analytical protocols. In detail, uncertainty of water sample was performed through a conventional approach. However, for the sediments matrices, the estimation of proportional/constant bias is also included due to its inhomogeneity. Results for the sediment matrix are reliable, showing a range 25-35% of analytical variability associated with intermediate conditions. The analytical methodology for the water matrix determines the selected compounds with acceptable recoveries and the combined uncertainty ranges between 20 and 30%. Analyzing routine samples is rarely applied to assess trueness of novel analytical methods and up to now this methodology was not focused on organochlorine compounds in environmental matrices.

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

PubMed

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.

Early Access to the Cardiac Catheterization Laboratory for Patients Resuscitated From Cardiac Arrest Due to a Shockable Rhythm: The Minnesota Resuscitation Consortium Twin Cities Unified Protocol.

PubMed

Garcia, Santiago; Drexel, Todd; Bekwelem, Wobo; Raveendran, Ganesh; Caldwell, Emily; Hodgson, Lucinda; Wang, Qi; Adabag, Selcuk; Mahoney, Brian; Frascone, Ralph; Helmer, Gregory; Lick, Charles; Conterato, Marc; Baran, Kenneth; Bart, Bradley; Bachour, Fouad; Roh, Steven; Panetta, Carmelo; Stark, Randall; Haugland, Mark; Mooney, Michael; Wesley, Keith; Yannopoulos, Demetris

2016-01-07

In 2013 the Minnesota Resuscitation Consortium developed an organized approach for the management of patients resuscitated from shockable rhythms to gain early access to the cardiac catheterization laboratory (CCL) in the metro area of Minneapolis-St. Paul. Eleven hospitals with 24/7 percutaneous coronary intervention capabilities agreed to provide early (within 6 hours of arrival at the Emergency Department) access to the CCL with the intention to perform coronary revascularization for outpatients who were successfully resuscitated from ventricular fibrillation/ventricular tachycardia arrest. Other inclusion criteria were age >18 and <76 and presumed cardiac etiology. Patients with other rhythms, known do not resuscitate/do not intubate, noncardiac etiology, significant bleeding, and terminal disease were excluded. The primary outcome was survival to hospital discharge with favorable neurological outcome. Patients (315 out of 331) who were resuscitated from VT/VF and transferred alive to the Emergency Department had complete medical records. Of those, 231 (73.3%) were taken to the CCL per the Minnesota Resuscitation Consortium protocol while 84 (26.6%) were not taken to the CCL (protocol deviations). Overall, 197 (63%) patients survived to hospital discharge with good neurological outcome (cerebral performance category of 1 or 2). Of the patients who followed the Minnesota Resuscitation Consortium protocol, 121 (52%) underwent percutaneous coronary intervention, and 15 (7%) underwent coronary artery bypass graft. In this group, 151 (65%) survived with good neurological outcome, whereas in the group that did not follow the Minnesota Resuscitation Consortium protocol, 46 (55%) survived with good neurological outcome (adjusted odds ratio: 1.99; [1.07-3.72], P=0.03). Early access to the CCL after cardiac arrest due to a shockable rhythm in a selected group of patients is feasible in a large metropolitan area in the United States and is associated with a 65% survival rate to hospital discharge with a good neurological outcome. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Hatching, survival and deformities of piracanjuba (Brycon orbignyanus) embryos subjected to different cooling protocols.

PubMed

Paes, Maria do Carmo Faria; da Silva, Regiane Cristina; do Nascimento, Nivaldo Ferreira; Valentin, Fernanda Nogueira; Senhorini, José Augusto; Nakaghi, Laura Satiko Okada

2014-12-01

Groups of one hundred Brycon orbignyanus embryos at the stage of blastopore closure were subjected to different cooling protocols. Different combinations and concentrations of cryoprotectants were tested: sucrose, methanol, ethylene glycol and dimethyl sulfoxide (Me2SO); at different temperatures (0.0±2.0°C and 8.0±2.0°C) and refrigeration times (6, 10, 24, 72 and 168 h), with the exception of the positive control (incubation without previous cooling). At the end of each refrigeration time, the embryos were acclimatized, rehydrated and incubated to determine hatching, survival and deformity rates. Morphological analysis of embryos was also carried out. The results showed that temperature and refrigeration time are critical factors for embryo survival. No embryos survived after 24, 72 and 168 h of refrigeration. Furthermore, when the refrigeration time increased from 6 to 10h and the temperature decreased from 8.0±2.0°C to 0.0±2.0°C, mortality rates increased significantly. It was also found that in all protocols dead eggs and/or larvae with some degree of deformity were present. The main larval deformities observed were the malformation of the head, tail, yolk sac, vertebral column and eyes. Copyright © 2014 Elsevier Inc. All rights reserved.

SeaWiFS technical report series. Volume 5: Ocean optics protocols for SeaWiFS validation

NASA Technical Reports Server (NTRS)

Mueller, James L.; Austin, Roswell W.; Hooker, Stanford B. (Editor); Firestone, Elaine R. (Editor)

1992-01-01

Protocols are presented for measuring optical properties, and other environmental variables, to validate the radiometric performance of the Sea-viewing Wide Field-of-view Sensor (SeaWiFS), and to develop and validate bio-optical algorithms for use with SeaWiFS data. The protocols are intended to establish foundations for a measurement strategy to verify the challenging SeaWiFS accuracy goals of 5 percent in water-leaving radiances and 35 percent in chlorophyll alpha concentration. The protocols first specify the variables which must be measured, and briefly review rationale. Subsequent chapters cover detailed protocols for instrument performance specifications, characterizing and calibration instruments, methods of making measurements in the field, and methods of data analysis. These protocols were developed at a workshop sponsored by the SeaWiFS Project Office (SPO) and held at the Naval Postgraduate School in Monterey, California (9-12 April, 1991). This report is the proceedings of that workshop, as interpreted and expanded by the authors and reviewed by workshop participants and other members of the bio-optical research community. The protocols are a first prescription to approach unprecedented measurement accuracies implied by the SeaWiFS goals, and research and development are needed to improve the state-of-the-art in specific areas. The protocols should be periodically revised to reflect technical advances during the SeaWiFS Project cycle.

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

PubMed

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.

Development and validation of response markers to predict survival and pleurodesis success in patients with malignant pleural effusion (PROMISE): a multicohort analysis.

PubMed

Psallidas, Ioannis; Kanellakis, Nikolaos I; Gerry, Stephen; Thézénas, Marie Laëtitia; Charles, Philip D; Samsonova, Anastasia; Schiller, Herbert B; Fischer, Roman; Asciak, Rachelle; Hallifax, Robert J; Mercer, Rachel; Dobson, Melissa; Dong, Tao; Pavord, Ian D; Collins, Gary S; Kessler, Benedikt M; Pass, Harvey I; Maskell, Nick; Stathopoulos, Georgios T; Rahman, Najib M

2018-06-13

The prevalence of malignant pleural effusion is increasing worldwide, but prognostic biomarkers to plan treatment and to understand the underlying mechanisms of disease progression remain unidentified. The PROMISE study was designed with the objectives to discover, validate, and prospectively assess biomarkers of survival and pleurodesis response in malignant pleural effusion and build a score that predicts survival. In this multicohort study, we used five separate and independent datasets from randomised controlled trials to investigate potential biomarkers of survival and pleurodesis. Mass spectrometry-based discovery was used to investigate pleural fluid samples for differential protein expression in patients from the discovery group with different survival and pleurodesis outcomes. Clinical, radiological, and biological variables were entered into least absolute shrinkage and selection operator regression to build a model that predicts 3-month mortality. We evaluated the model using internal and external validation. 17 biomarker candidates of survival and seven of pleurodesis were identified in the discovery dataset. Three independent datasets (n=502) were used for biomarker validation. All pleurodesis biomarkers failed, and gelsolin, macrophage migration inhibitory factor, versican, and tissue inhibitor of metalloproteinases 1 (TIMP1) emerged as accurate predictors of survival. Eight variables (haemoglobin, C-reactive protein, white blood cell count, Eastern Cooperative Oncology Group performance status, cancer type, pleural fluid TIMP1 concentrations, and previous chemotherapy or radiotherapy) were validated and used to develop a survival score. Internal validation with bootstrap resampling and external validation with 162 patients from two independent datasets showed good discrimination (C statistic values of 0·78 [95% CI 0·72-0·83] for internal validation and 0·89 [0·84-0·93] for external validation of the clinical PROMISE score). To our knowledge, the PROMISE score is the first prospectively validated prognostic model for malignant pleural effusion that combines biological and clinical parameters to accurately estimate 3-month mortality. It is a robust, clinically relevant prognostic score that can be applied immediately, provide important information on patient prognosis, and guide the selection of appropriate management strategies. European Respiratory Society, Medical Research Funding-University of Oxford, Slater & Gordon Research Fund, and Oxfordshire Health Services Research Committee Research Grants. Copyright © 2018 Elsevier Ltd. All rights reserved.

External validation of the diffuse intrinsic pontine glioma survival prediction model: a collaborative report from the International DIPG Registry and the SIOPE DIPG Registry.

PubMed

Veldhuijzen van Zanten, Sophie E M; Lane, Adam; Heymans, Martijn W; Baugh, Joshua; Chaney, Brooklyn; Hoffman, Lindsey M; Doughman, Renee; Jansen, Marc H A; Sanchez, Esther; Vandertop, William P; Kaspers, Gertjan J L; van Vuurden, Dannis G; Fouladi, Maryam; Jones, Blaise V; Leach, James

2017-08-01

We aimed to perform external validation of the recently developed survival prediction model for diffuse intrinsic pontine glioma (DIPG), and discuss its utility. The DIPG survival prediction model was developed in a cohort of patients from the Netherlands, United Kingdom and Germany, registered in the SIOPE DIPG Registry, and includes age <3 years, longer symptom duration and receipt of chemotherapy as favorable predictors, and presence of ring-enhancement on MRI as unfavorable predictor. Model performance was evaluated by analyzing the discrimination and calibration abilities. External validation was performed using an unselected cohort from the International DIPG Registry, including patients from United States, Canada, Australia and New Zealand. Basic comparison with the results of the original study was performed using descriptive statistics, and univariate- and multivariable regression analyses in the validation cohort. External validation was assessed following a variety of analyses described previously. Baseline patient characteristics and results from the regression analyses were largely comparable. Kaplan-Meier curves of the validation cohort reproduced separated groups of standard (n = 39), intermediate (n = 125), and high-risk (n = 78) patients. This discriminative ability was confirmed by similar values for the hazard ratios across these risk groups. The calibration curve in the validation cohort showed a symmetric underestimation of the predicted survival probabilities. In this external validation study, we demonstrate that the DIPG survival prediction model has acceptable cross-cohort calibration and is able to discriminate patients with short, average, and increased survival. We discuss how this clinico-radiological model may serve a useful role in current clinical practice.

Development of a cross-disciplinary continuous insulin infusion protocol for non-critically ill patients in a French university hospital.

PubMed

Bernard, Lise; Roche, Béatrice; Batisse, Marie; Maqdasy, Salwan; Terral, Daniel; Sautou, Valérie; Tauveron, Igor

2016-10-01

In non-critically ill patients, the use of an insulin syringe pump allows the management of temporary situations during which other therapies cannot be used (failure of subcutaneous injections, awaiting advice from the diabetes team, emergency situations, prolonged corticosteroid therapy, initiation of an artificial nutrition, need for a fasting status, etc.). To manage the risks related to this «never event», the use of a standard validated protocol for insulin administration and monitoring is an essential prerequisite. To this end, a multidisciplinary approach is recommended. With the support of our subcommission «Endocrinology-Diabetology», we proceeded with a «step-by-step process» to create such a standardized protocol: (1) review of all existing protocols in our hospital; (2) overview of the literature data concerning insulin infusion protocols developed by multidisciplinary teams in France and abroad; (3) development of a standardized protocol for non-intensive care unit patients, respecting the current recommendations and adapting it to the working habits of health teams; and (4) validation of the protocol Two protocols based on the same structure but adapted to the health status of the patient have been developed. The protocols are divided in to three parts: (1) golden rules to make the use of the protocol appropriate and safe; (2) the algorithm (a double entry table) corresponding to a dynamic adaptation of insulin doses, clearly defining the target and the 'at risk situations'; and (3) practical aspects of the protocol: preparation of the syringe, treatment initiation and traceability. The protocols have been validated by the institution. Our standardized insulin infusion protocol is simple, easy to implement, safe and is likely to be applicable in diverse care units. However, the efficiency, safety and the workability of our protocols have to be clinically evaluated. © 2016 John Wiley & Sons, Ltd.

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

PubMed

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

2015-01-01

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

Optimizing the design of a reproduction toxicity test with the pond snail Lymnaea stagnalis.

PubMed

Charles, Sandrine; Ducrot, Virginie; Azam, Didier; Benstead, Rachel; Brettschneider, Denise; De Schamphelaere, Karel; Filipe Goncalves, Sandra; Green, John W; Holbech, Henrik; Hutchinson, Thomas H; Faber, Daniel; Laranjeiro, Filipe; Matthiessen, Peter; Norrgren, Leif; Oehlmann, Jörg; Reategui-Zirena, Evelyn; Seeland-Fremer, Anne; Teigeler, Matthias; Thome, Jean-Pierre; Tobor Kaplon, Marysia; Weltje, Lennart; Lagadic, Laurent

2016-11-01

This paper presents the results from two ring-tests addressing the feasibility, robustness and reproducibility of a reproduction toxicity test with the freshwater gastropod Lymnaea stagnalis (RENILYS strain). Sixteen laboratories (from inexperienced to expert laboratories in mollusc testing) from nine countries participated in these ring-tests. Survival and reproduction were evaluated in L. stagnalis exposed to cadmium, tributyltin, prochloraz and trenbolone according to an OECD draft Test Guideline. In total, 49 datasets were analysed to assess the practicability of the proposed experimental protocol, and to estimate the between-laboratory reproducibility of toxicity endpoint values. The statistical analysis of count data (number of clutches or eggs per individual-day) leading to ECx estimation was specifically developed and automated through a free web-interface. Based on a complementary statistical analysis, the optimal test duration was established and the most sensitive and cost-effective reproduction toxicity endpoint was identified, to be used as the core endpoint. This validation process and the resulting optimized protocol were used to consolidate the OECD Test Guideline for the evaluation of reproductive effects of chemicals in L. stagnalis. Copyright © 2016 Elsevier Inc. All rights reserved.

Validation of an imageable surgical resection animal model of Glioblastoma (GBM).

PubMed

Sweeney, Kieron J; Jarzabek, Monika A; Dicker, Patrick; O'Brien, Donncha F; Callanan, John J; Byrne, Annette T; Prehn, Jochen H M

2014-08-15

Glioblastoma (GBM) is the most common and malignant primary brain tumour having a median survival of just 12-18 months following standard therapy protocols. Local recurrence, post-resection and adjuvant therapy occurs in most cases. U87MG-luc2-bearing GBM xenografts underwent 4.5mm craniectomy and tumour resection using microsurgical techniques. The cranial defect was repaired using a novel modified cranial window technique consisting of a circular microscope coverslip held in place with glue. Immediate post-operative bioluminescence imaging (BLI) revealed a gross total resection rate of 75%. At censor point 4 weeks post-resection, Kaplan-Meier survival analysis revealed 100% survival in the surgical group compared to 0% in the non-surgical cohort (p=0.01). No neurological defects or infections in the surgical group were observed. GBM recurrence was reliably imaged using facile non-invasive optical bioluminescence (BLI) imaging with recurrence observed at week 4. For the first time, we have used a novel cranial defect repair method to extend and improve intracranial surgical resection methods for application in translational GBM rodent disease models. Combining BLI and the cranial window technique described herein facilitates non-invasive serial imaging follow-up. Within the current context we have developed a robust methodology for establishing a clinically relevant imageable GBM surgical resection model that appropriately mimics GBM recurrence post resection in patients. Copyright © 2014 Elsevier B.V. All rights reserved.

NEDD9, an independent good prognostic factor in intermediate-risk acute myeloid leukemia patients

PubMed Central

Pallarès, Victor; Hoyos, Montserrat; Chillón, M. Carmen; Barragán, Eva; Conde, M. Isabel Prieto; Llop, Marta; Céspedes, María Virtudes; Nomdedeu, Josep F.; Brunet, Salut; Sanz, Miguel Ángel; González-Díaz, Marcos; Sierra, Jorge; Casanova, Isolda; Mangues, Ramon

2017-01-01

Intermediate-risk acute myeloid leukemia (IR-AML) is the largest subgroup of AML patients and is highly heterogeneous. Whereas adverse and favourable risk patients have well-established treatment protocols, IR-AML patients have not. It is, therefore, crucial to find novel factors that stratify this subgroup to implement risk-adapted strategies. The CAS (Crk-associated substrate) adaptor protein family regulates cell proliferation, survival, migration and adhesion. Despite its association with metastatic dissemination and prognosis of different solid tumors, the role of these proteins in hematological malignancies has been scarcely evaluated. Nevertheless, previous work has established an important role for the CAS family members NEDD9 or BCAR1 in the migratory and dissemination capacities of myeloid cells. On this basis, we hypothesized that NEDD9 or BCAR1 expression levels could associate with survival in IR-AML patients and become new prognostic markers. To that purpose, we assessed BCAR1 and NEDD9 gene expression in a cohort of 73 adult AML patients validating the results in an independent cohort (n = 206). We have identified NEDD9, but not BCAR1, as a new a marker for longer overall and disease-free survival, and for lower cumulative incidence of relapse. In summary, NEDD9 gene expression is an independent prognostic factor for favourable prognosis in IR-AML patients. PMID:29100287

Proposal and validation of a new model to estimate survival for hepatocellular carcinoma patients.

PubMed

Liu, Po-Hong; Hsu, Chia-Yang; Hsia, Cheng-Yuan; Lee, Yun-Hsuan; Huang, Yi-Hsiang; Su, Chien-Wei; Lee, Fa-Yauh; Lin, Han-Chieh; Huo, Teh-Ia

2016-08-01

The survival of hepatocellular carcinoma (HCC) patients is heterogeneous. We aim to develop and validate a simple prognostic model to estimate survival for HCC patients (MESH score). A total of 3182 patients were randomised into derivation and validation cohort. Multivariate analysis was used to identify independent predictors of survival in the derivation cohort. The validation cohort was employed to examine the prognostic capabilities. The MESH score allocated 1 point for each of the following parameters: large tumour (beyond Milan criteria), presence of vascular invasion or metastasis, Child-Turcotte-Pugh score ≥6, performance status ≥2, serum alpha-fetoprotein level ≥20 ng/ml, and serum alkaline phosphatase ≥200 IU/L, with a maximal of 6 points. In the validation cohort, significant survival differences were found across all MESH scores from 0 to 6 (all p < 0.01). The MESH system was associated with the highest homogeneity and lowest corrected Akaike information criterion compared with Barcelona Clínic Liver Cancer, Hong Kong Liver Cancer (HKLC), Cancer of the Liver Italian Program, Taipei Integrated Scoring and model to estimate survival in ambulatory HCC Patients systems. The prognostic accuracy of the MESH scores remained constant in patients with hepatitis B- or hepatitis C-related HCC. The MESH score can also discriminate survival for patients from early to advanced stages of HCC. This newly proposed simple and accurate survival model provides enhanced prognostic accuracy for HCC. The MESH system is a useful supplement to the BCLC and HKLC classification schemes in refining treatment strategies. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

PubMed Central

Landrine, Hope; Klonoff, Elizabeth A.

2003-01-01

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

Basic research supported developments of chemotherapy in nonresectable isolated colorectal liver metastases to a protocol of hepatic artery infusion using mitoxantrone, 5-FU + folinic acid and mitomycin C.

PubMed

Link, K H; Kornmann, M; Leder, G; Pillasch, A F; Sunelaitis, E; Schatz, M; Pressmar, J; Beger, H G

1999-02-01

Since the developments in systemic chemotherapy of metastasized colorectal cancer have not resulted in substantial gains in survival times, we wished to improve the course of isolated nonresectable colorectal liver metastases (CPLM) by hepatic arterial infusion treatment. Patients (pts) with CRLM have a worse fate than those pts whose liver metastases could be resected. Systemic (i.v.) chemotherapy for CRLM/colorectal metastases does not improve survival to a relevant level (median survival time (med. surv.) after 5-Fluorouracil + Folinic Acid (5-FU + FA) i.v.: 6.4-14.3 months (m)). Hepatic artery infusion (HAI) with 5-Fluorode-oxyuridine (5-FUDR) has been demonstrated in a metaanalysis of randomized trials to be superior to i.v. treatment/palliative care (med. surv.: 15 vs. 10 m). The benefit of HAI with 5-FUDR, although recommended as treatment for CRLM, is severely compromised by the 5-FUDR induced hepatotoxicity, leading eventually to sclerosing cholangitis (SC)/liver scirrhosis. We have stepwise developed a protocol for HAI of CRLM, which is superior to HAI with 5-FUDR, and, most evidently, to systemic chemotherapy. Between 1982-1997, 222 CR (L) M patients were treated within subsequent protocols (Table). In protocol A, 68 CRLM pts received HAI with 5-FUDR (A1: nonrandomized pts; A2: randomized pts). In protocol B (randomized pts.), 46 pts received 5-FUDR i.a. (via HAI) + i.v. In protocol C, systemic chemotherapy with 5-FU + FA was conducted in 34 pts with metastasized colorectal cancers, including CRLM. In protocol D 5-FU + FA was delivered via HAI in 25 pts with CRLM. In protocol E, based on in vitro phase II studies and the results of protocol D, Mitoxantrone and Mitomycin C were added to 5-FU + FA (MFFM). Fifty (50) CRLM pts received HAI with MFFM. The response rates, med. surv. times, systemic toxicity and SC rates are shown in the table. HAI with MFFM produced objective responses in 66%, the med. surv. was 27.4 m, and no SC occurred. The ports surgically placed for HAI, e.g., in protocols D and E, functioned in 90%, 82%, and 76% 6, 9, and 11 m after start of the HAI. Quality of life in protocol E was high. Nine pts from protocols D + E with either partial (PR, 7 pts) or complete (CR, 2 pts) remissions received a secondary liver resection without hospital mortality, and 7/9 pts are living 2-58 m after liver resection, 2/9 pts died 11 and 22 m after resection. [table: see text] Our learning curve to achieve optimal treatment of CRLM resulted in a protocol using HAI with MFFM. The results of this protocol (E) including the high remission rate, long median survival time, good port function, high quality of life, and, most interestingly, the possibility to downstage and resect primarily nonresectable metastases, seem to be superior to HAI with 5-FUDR of 5-FU + FA and to systemic chemotherapy with 5-FU + FA. This hypothesis is currently examined in a phase III study (HAI with MFFM vs. 5-FU + FA i.v.).

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

PubMed

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.

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

PubMed Central

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

2016-01-01

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. PMID:27500471

Treatment of patients with multiple myeloma over 65 yr: more tolerability or better response?

PubMed

Tarkun, Pinar; Atalay, Figen; Atesoglu, Elif Birtas; Mehtap, Ozgur; Simsek, Melih; Terzi, Esra; Geduk, Ayfer; Balli, Fatih; Batman, Adnan; Baydemir, Canan; Hacihanefioglu, Abdullah

2015-05-01

Two-thirds of newly diagnosed patients with multiple myeloma (MM) are over 65 yr and/or physically unfit. Such patients are not eligible for high-dose chemotherapy or stem cell transplantation. The treatment aims in these patients should be to prolong survival by obtaining the best possible response, while maintaining good tolerability. The aim of our study was to evaluate the response to treatment and treatment-related toxicities in patients treated with conventional and novel protocols. The records of 138 elderly (≥65 yr) patients with MM were retrospectively evaluated. The median overall survival(OS) of the patients was 46 months. The median progression-free survival (PFS) was 18 months. The OS and PFS of the patients treated with the conventional protocols did not differ significantly from those treated with the novel protocols. The statistical analysis of the quality of the response to the treatment with the conventional and novel therapies showed that complete remission (CR), combined with a very good partial response (VGPR), was significantly higher in the latter. However, the toxicities were higher in the novel treatment group. The novel drug protocols significantly increased the quality of the responses of elderly patients with MM to therapy, but they did not increase the patients' tolerability. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

PubMed

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.

In vitro Dermal Absorption of Hydroquinone: Protocol Validation and Applicability on Illegal Skin-Whitening Cosmetics.

PubMed

Desmedt, Bart; Ates, Gamze; Courselle, Patricia; De Beer, Jacques O; Rogiers, Vera; Hendrickx, Benoit; Deconinck, Eric; De Paepe, Kristien

2016-01-01

In Europe, hydroquinone is a forbidden cosmetic ingredient. It is, however, still abundantly used because of its effective skin-whitening properties. The question arises as to whether the quantities of hydroquinone used become systemically available and may cause damage to human health. Dermal absorption studies can provide this information. In the EU, dermal absorption has to be assessed in vitro since the Cosmetic Regulation 1223/2009/EC forbids the use of animals. To obtain human-relevant data, a Franz diffusion cell protocol was validated using human skin. The results obtained were comparable to those from a multicentre validation study. The protocol was applied to hydroquinone and the dermal absorption ranged between 31 and 44%, which is within the range of published in vivo human values. This shows that a well-validated in vitro dermal absorption study using human skin provides relevant human data. The validated protocol was used to determine the dermal absorption of illegal skin-whitening cosmetics containing hydroquinone. All samples gave high dermal absorption values, rendering them all unsafe for human health. These results add to our knowledge of illegal cosmetics on the EU market, namely that they exhibit a negative toxicological profile and are likely to induce health problems. © 2017 S. Karger AG, Basel.

Evaluation of clinical and histologic factors associated with survival time in dogs with stage II splenic hemangiosarcoma treated by splenectomy and adjuvant chemotherapy: 30 cases (2011-2014).

PubMed

Moore, Antony S; Rassnick, Kenneth M; Frimberger, Angela E

2017-09-01

OBJECTIVE To determine histologic and clinical factors associated with survival time in dogs with stage II splenic hemangiosarcoma treated by splenectomy and a chemotherapy protocol in which an anthracycline was alternated with lomustine. DESIGN Retrospective case series. ANIMALS 30 dogs with stage II splenic hemangiosarcoma. PROCEDURES Medical records of 3 facilities were reviewed to identify dogs treated for stage II splenic hemangiosarcoma between June 2011 and October 2014. Information collected included signalment, disease staging data, whether anemia was present, date of splenectomy, chemotherapy protocol, adverse effects, and date of death or last follow-up. Histologic slides were reviewed and scored by pathologists. Associations between variables of interest and survival data were evaluated statistically. RESULTS Median survival time for all dogs was 158 days (range, 55 to 560 days), and the 1-year survival rate was 16%. On multivariate analysis, only the histologically determined mitotic score was significantly associated with survival time. The median survival time of 292 days for dogs with a mitotic score of 0 (< 11 mitoses/10 hpf; n = 9) was significantly longer than that for dogs with higher scores (indicating higher mitotic rates); the 1-year survival rate for these dogs was 42%. CONCLUSIONS AND CLINICAL RELEVANCE Results suggested that future studies should take histologic factors, particularly mitotic rate, as well as tumor stage into account when assessing treatment effects on survival time of dogs with splenic hemangiosarcoma.

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

PubMed Central

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.

PubMed

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

2014-01-01

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

The Reliability and Validity of Protocols for the Assessment of Endurance Sports Performance: An Updated Review

ERIC Educational Resources Information Center

Stevens, Christopher John; Dascombe, Ben James

2015-01-01

Sports performance testing is one of the most common and important measures used in sport science. Performance testing protocols must have high reliability to ensure any changes are not due to measurement error or inter-individual differences. High validity is also important to ensure test performance reflects true performance. Time-trial…

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

PubMed Central

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 recurrence after 2004, likely due to improvements in surgical techniques, introduction of the Stupp protocol as a first-line treatment, and new standard protocols for second-line chemotherapy and radiosurgery after tumor recurrence. In both cohorts, reoperation after tumor recurrence did not improve survival. PMID:24463354

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

PubMed

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 improvements in surgical techniques, introduction of the Stupp protocol as a first-line treatment, and new standard protocols for second-line chemotherapy and radiosurgery after tumor recurrence. In both cohorts, reoperation after tumor recurrence did not improve survival.

SAVAH: Source Address Validation with Host Identity Protocol

NASA Astrophysics Data System (ADS)

Kuptsov, Dmitriy; Gurtov, Andrei

Explosive growth of the Internet and lack of mechanisms that validate the authenticity of a packet source produced serious security and accounting issues. In this paper, we propose validating source addresses in LAN using Host Identity Protocol (HIP) deployed in a first-hop router. Compared to alternative solutions such as CGA, our approach is suitable both for IPv4 and IPv6. We have implemented SAVAH in Wi-Fi access points and evaluated its overhead for clients and the first-hop router.

SeaWiFS technical report series. Volume 25: Ocean optics protocols for SeaWiFS validation, revision 1

NASA Technical Reports Server (NTRS)

Hooker, Stanford B. (Editor); Firestone, Elaine R. (Editor); Acker, James G. (Editor); Mueller, James L.; Austin, Roswell W.

1995-01-01

This report presents protocols for measuring optical properties, and other environmental variables, to validate the radiometric performance of the Sea-viewing Wide Field-of-view Sensor (SeaWiFS), and to develop and validate bio-optical algorithms for use with SeaWiFS data. The protocols are intended to establish foundations for a measurement strategy to verify the challenging SeaWiFS uncertainty goals of 5 percent in water-leaving radiances and 35 percent in chlorophyll alpha concentration. The protocols first specify the variables which must be measured, and briefly review the rationale for measuring each variable. Subsequent chapters cover detailed protocols for instrument performance specifications, characterizing and calibrating instruments, methods of making measurements in the field, and methods of data analysis. These protocols were developed at a workshop sponsored by the SeaWiFS Project Office (SPO) and held at the Naval Postgraduate School in Monterey, California (9-12 April 1991). This report began as the proceedings of the workshop, as interpreted and expanded by the authors and reviewed by workshop participants and other members of the bio-optical research community. The protocols are an evolving prescription to allow the research community to approach the unprecedented measurement uncertainties implied by the SeaWiFS goals; research and development are needed to improve the state-of-the-art in specific areas. These protocols should be periodically revised to reflect technical advances during the SeaWiFS Project cycle. The present edition (Revision 1) incorporates new protocols in several areas, including expanded protocol descriptions for Case-2 waters and other improvements, as contributed by several members of the SeaWiFS Science Team.

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.

PubMed

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.

[High dosage therapy and autologous peripheral stem cell transplantation in breast carcinoma].

PubMed

Kier, P; Ruckser, R; Buxhofer, V; Habertheuer, K H; Zelenka, P; Tatzreiter, G; Hübl, G; Kittl, E; Hauser, A; Sebesta, C; Hinterberger, W

2000-01-01

42 breast cancer patients were treated by high-dose chemotherapy (HDC) and autologous peripheral stem-cell transplantation (ASTx) in the Donauspital between 1992 and 1999. 24 patients had stage II/III breast cancer with high risk for relapse. The other 18 patients underwent HDC and ASTx in chemosensitive stage IV. After previous conventional chemotherapy peripheral stem-cells were harvested by one cycle of mobilisation chemotherapy (epirubicin/taxol, FEC 120 or cyclophosphamide) followed by cytokine stimulation. 16 patients were treated by a tandem transplantation (conditioning protocol for 1st ASTx was melphalan 200 mg/m2 and for 2nd transplant it was CTC: cyclophosphamide 6 g/m2; thiotepa 500 mg/m2; carboplatin 800 mg/m2). The other 26 patients received one HDC with CTC as conditioning protocol. The HDC was well tolerated by all patients, there was no transplant-related mortality. The median survival and the progression-free survival (PFS) after HDC and ASTx in stage IV breast cancer patients were 28 and 11 months, respectively. The median survival and PFS were not yet reached in stage II/III patients after 55 months. The actuarial survival and PFS in that patient group were 70% after 55 months. Our data confirm the low risk and good efficacy of HDC and ASTx in breast cancer patients. Nevertheless randomised studies are necessary to evaluate the importance of HDC compared to intensified conventional protocols without ASTx.

Highly active antiretroviral therapy and outcome of AIDS-related Burkitt's lymphoma or leukemia. Results of the PETHEMA-LAL3/97 study.

PubMed

Oriol, Albert; Ribera, Josep-Maria; Brunet, Salut; del Potro, Eloy; Abella, Eugènia; Esteve, Jordi

2005-07-01

Short, intensive cycles of chemotherapy have resulted in improved survival in BurkittOs lymphoma/leukemia (BL) in adults. The prognosis of patients with immunodeficiency virus (HIV)-associated BL is considered to be poor, but these patients have seldom been treated with BL-specific protocols. However, a study (PETHEMA-LAL3/97) in which patients with BL were treated regardless of their HIV status failed to find differences between HIV-infected and immunocompetent individuals. Furthermore, patients who received highly active antiretroviral therapy (HAART) seemed to have a slightly better disease-free survival than those who did not (p=0.051). We extended the follow-up analysis to elucidate the role of HAART in the survival of HIV-infected patients included in the PETHEMA-LAL3/97 protocol.

Cross-validation and Peeling Strategies for Survival Bump Hunting using Recursive Peeling Methods

PubMed Central

Dazard, Jean-Eudes; Choe, Michael; LeBlanc, Michael; Rao, J. Sunil

2015-01-01

We introduce a framework to build a survival/risk bump hunting model with a censored time-to-event response. Our Survival Bump Hunting (SBH) method is based on a recursive peeling procedure that uses a specific survival peeling criterion derived from non/semi-parametric statistics such as the hazards-ratio, the log-rank test or the Nelson--Aalen estimator. To optimize the tuning parameter of the model and validate it, we introduce an objective function based on survival or prediction-error statistics, such as the log-rank test and the concordance error rate. We also describe two alternative cross-validation techniques adapted to the joint task of decision-rule making by recursive peeling and survival estimation. Numerical analyses show the importance of replicated cross-validation and the differences between criteria and techniques in both low and high-dimensional settings. Although several non-parametric survival models exist, none addresses the problem of directly identifying local extrema. We show how SBH efficiently estimates extreme survival/risk subgroups unlike other models. This provides an insight into the behavior of commonly used models and suggests alternatives to be adopted in practice. Finally, our SBH framework was applied to a clinical dataset. In it, we identified subsets of patients characterized by clinical and demographic covariates with a distinct extreme survival outcome, for which tailored medical interventions could be made. An R package PRIMsrc (Patient Rule Induction Method in Survival, Regression and Classification settings) is available on CRAN (Comprehensive R Archive Network) and GitHub. PMID:27034730

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

PubMed

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, p<0.05). Validation of the developed protocol was done, and the percent of agreement ranged between 60.0% and 96.7% for the service group, and 60.0% and 90.0% for the academia group. The majority of the doctors, nurses, and housekeepers have unsatisfactory knowledge and inadequate practice related to health care waste 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 implement the developed waste management protocol for the surgical departments in the designed hospital, with establishment of waste management audits.

Reversible Causes in Cardiovascular Collapse at the Emergency Department Using Ultrasonography (REVIVE-US).

PubMed

Chua, Mui Teng; Chan, Gene Wh; Kuan, Win Sen

2017-08-01

Ultrasonographic evaluation of patients in cardiac arrest is currently not protocolised in the advanced cardiac life support (ACLS) algorithm. Potentially reversible causes may be identified using bedside ultrasonography that is ubiquitous in most emergency departments (EDs). This study aimed to evaluate the incidence of sonographically detectable reversible causes of cardiac arrest by incorporating an ultrasonography protocol into the ACLS algorithm. Secondary objectives include rates of survival to hospital admission, hospital discharge, and 30-day mortality. We conducted a prospective study using bedside ultrasonography to evaluate for potentially reversible causes in patients with cardiac arrest at the ED of National University Hospital, Singapore, regardless of the initial electrocardiogram rhythm. A standardised ultrasonography protocol was performed during the 10-second pulse check window. Between June 2015 and April 2016, 104 patients were recruited, corresponding to 65% of all out-of-hospital cardiac arrest patients conveyed to the ED. Median age was 71 years (interquartile range, 55 to 80) and 71 (68.3%) patients were male. The most common rhythm on arrival was asystole (45.2%). Four (3.8%) patients had ultrasonographic findings suggestive of massive pulmonary embolism while 1 received intravenous thrombolysis and survived until discharge. Pericardial effusion without tamponade was detected in 4 (3.8%) patients and 6 (5.8%) patients had intra-abdominal free fluid. Twenty (19.2%) patients survived until admission, 2 of whom (1.9%) survived to discharge and beyond 30 days. Bedside ultrasonography can be safely incorporated into the ACLS protocol. Detection of any reversible causes may alter management and improve survival in selected patients.

Rationally optimized cryopreservation of multiple mouse embryonic stem cell lines: II—Mathematical prediction and experimental validation of optimal cryopreservation protocols☆

PubMed Central

Kashuba, Corinna M.; Benson, James D.; Critser, John K.

2014-01-01

In Part I, we documented differences in cryopreservation success measured by membrane integrity in four mouse embryonic stem cell (mESC) lines from different genetic backgrounds (BALB/c, CBA, FVB, and 129R1), and we demonstrated a potential biophysical basis for these differences through a comparative study characterizing the membrane permeability characteristics and osmotic tolerance limits of each cell line. Here we use these values to predict optimal cryoprotectants, cooling rates, warming rates, and plunge temperatures. We subsequently verified these predictions experimentally for their effects on post-thaw recovery. From this study, we determined that a cryopreservation protocol utilizing 1 M propylene glycol, a cooling rate of 1 °C/minute, and plunging into liquid nitrogen at −41 °C, combined with subsequent warming in a 22 °C water bath with agitation, significantly improved post-thaw recovery for three of the four mESC lines, and did not diminish post-thaw recovery for our single exception. It is proposed that this protocol can be successfully applied to most mESC lines beyond those included within this study once the effect of propylene glycol on mESC gene expression, growth characteristics, and germ-line transmission has been determined. Mouse ESC lines with poor survival using current standard cryopreservation protocols or our proposed protocol can be optimized on a case-by-case basis using the method we have outlined over two papers. For our single exception, the CBA cell line, a cooling rate of 5 °C/minute in the presence of 1.0 M dimethyl sulfoxide or 1.0 M propylene glycol, combined with plunge temperature of −80 °C was optimal. PMID:24560712

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

PubMed Central

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

2015-01-01

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

External validation of a 5-year survival prediction model after elective abdominal aortic aneurysm repair.

PubMed

DeMartino, Randall R; Huang, Ying; Mandrekar, Jay; Goodney, Philip P; Oderich, Gustavo S; Kalra, Manju; Bower, Thomas C; Cronenwett, Jack L; Gloviczki, Peter

2018-01-01

The benefit of prophylactic repair of abdominal aortic aneurysms (AAAs) is based on the risk of rupture exceeding the risk of death from other comorbidities. The purpose of this study was to validate a 5-year survival prediction model for patients undergoing elective repair of asymptomatic AAA <6.5 cm to assist in optimal selection of patients. All patients undergoing elective repair for asymptomatic AAA <6.5 cm (open or endovascular) from 2002 to 2011 were identified from a single institutional database (validation group). We assessed the ability of a prior published Vascular Study Group of New England (VSGNE) model (derivation group) to predict survival in our cohort. The model was assessed for discrimination (concordance index), calibration (calibration slope and calibration in the large), and goodness of fit (score test). The VSGNE derivation group consisted of 2367 patients (70% endovascular). Major factors associated with survival in the derivation group were age, coronary disease, chronic obstructive pulmonary disease, renal function, and antiplatelet and statin medication use. Our validation group consisted of 1038 patients (59% endovascular). The validation group was slightly older (74 vs 72 years; P < .01) and had a higher proportion of men (76% vs 68%; P < .01). In addition, the derivation group had higher rates of advanced cardiac disease, chronic obstructive pulmonary disease, and baseline creatinine concentration (1.2 vs 1.1 mg/dL; P < .01). Despite slight differences in preoperative patient factors, 5-year survival was similar between validation and derivation groups (75% vs 77%; P = .33). The concordance index of the validation group was identical between derivation and validation groups at 0.659 (95% confidence interval, 0.63-0.69). Our validation calibration in the large value was 1.02 (P = .62, closer to 1 indicating better calibration), calibration slope of 0.84 (95% confidence interval, 0.71-0.97), and score test of P = .57 (>.05 indicating goodness of fit). Across different populations of patients, assessment of age and level of cardiac, pulmonary, and renal disease can accurately predict 5-year survival in patients with AAA <6.5 cm undergoing repair. This risk prediction model is a valid method to assess mortality risk in determining potential overall survival benefit from elective AAA repair. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Metabolic Tumor Volume as a Prognostic Imaging-Based Biomarker for Head-and-Neck Cancer: Pilot Results From Radiation Therapy Oncology Group Protocol 0522

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

Schwartz, David L., E-mail: david.schwartz@utsw.edu; Harris, Jonathan; Yao, Min

2015-03-15

Purpose: To evaluate candidate fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) imaging biomarkers for head-and-neck chemoradiotherapy outcomes in the cooperative group trial setting. Methods and Materials: Radiation Therapy Oncology Group (RTOG) protocol 0522 patients consenting to a secondary FDG-PET/CT substudy were serially imaged at baseline and 8 weeks after radiation. Maximum standardized uptake value (SUVmax), SUV peak (mean SUV within a 1-cm sphere centered on SUVmax), and metabolic tumor volume (MTV) using 40% of SUVmax as threshold were obtained from primary tumor and involved nodes. Results: Of 940 patients entered onto RTOG 0522, 74 were analyzable for this substudy. Neither high baselinemore » SUVmax nor SUVpeak from primary or nodal disease were associated with poor treatment outcomes. However, primary tumor MTV above the cohort median was associated with worse local-regional control (hazard ratio 4.01, 95% confidence interval 1.28-12.52, P=.02) and progression-free survival (hazard ratio 2.34, 95% confidence interval 1.02-5.37, P=.05). Although MTV and T stage seemed to correlate (mean MTV 6.4, 13.2, and 26.8 for T2, T3, and T4 tumors, respectively), MTV remained a strong independent prognostic factor for progression-free survival in bivariate analysis that included T stage. Primary MTV remained prognostic in p16-associated oropharyngeal cancer cases, although sample size was limited. Conclusion: High baseline primary tumor MTV was associated with worse treatment outcomes in this limited patient subset of RTOG 0522. Additional confirmatory work will be required to validate primary tumor MTV as a prognostic imaging biomarker for patient stratification in future trials.« less

MiRNA-181d Expression Significantly Affects Treatment Responses to Carmustine Wafer Implantation.

PubMed

Sippl, Christoph; Ketter, Ralf; Bohr, Lisa; Kim, Yoo Jin; List, Markus; Oertel, Joachim; Urbschat, Steffi

2018-05-26

Standard therapeutic protocols for glioblastoma, the most aggressive type of brain cancer, include surgery followed by chemoradiotherapy. Additionally, carmustine-eluting wafers can be implanted locally into the resection cavity. To evaluate microRNA (miRNA)-181d as a prognostic marker of responses to carmustine wafer implantation. A total of 80 glioblastoma patients (40/group) were included in a matched pair analysis. One group (carmustine wafer group) received concomitant chemoradiotherapy with carmustine wafer implantation (Stupp protocol). The second group (control group) received only concomitant chemoradiotherapy. All tumor specimens were subjected to evaluations of miRNA-181d expression, results were correlated with further individual clinical data. The Cancer Genome Atlas (TCGA) dataset of 149 patients was used as an independent cohort to validate the results. Patients in the carmustine wafer group with low miRNA-181d expression had significantly longer overall (hazard ratio [HR], 35.03, [95% confidence interval (CI): 3.50-350.23], P = .002) and progression-free survival (HR, 20.23, [95% CI: 2.19-186.86], P = .008) than patients of the same group with a high miRNA-181d expression. These correlations were not observed in the control group. The nonsignificance in the control group was confirmed in the independent TCGA dataset. The carmustine wafer group patients with low miRNA-181d expression also had a significantly longer progression-free (P = .049) and overall survival (OS) (P = .034), compared with control group patients. Gross total resection correlated significantly with longer OS (P = .023). MiRNA-181d expression significantly affects treatment responses to carmustine wafer implantation.

Towards an improved LAI collection protocol via simulated field-based PAR sensing

DOE PAGES

Yao, Wei; Van Leeuwen, Martin; Romanczyk, Paul; ...

2016-07-14

In support of NASA’s next-generation spectrometer—the Hyperspectral Infrared Imager (HyspIRI)—we are working towards assessing sub-pixel vegetation structure from imaging spectroscopy data. Of particular interest is Leaf Area Index (LAI), which is an informative, yet notoriously challenging parameter to efficiently measure in situ. While photosynthetically-active radiation (PAR) sensors have been validated for measuring crop LAI, there is limited literature on the efficacy of PAR-based LAI measurement in the forest environment. This study (i) validates PAR-based LAI measurement in forest environments, and (ii) proposes a suitable collection protocol, which balances efficiency with measurement variation, e.g., due to sun flecks and various-sized canopymore » gaps. A synthetic PAR sensor model was developed in the Digital Imaging and Remote Sensing Image Generation (DIRSIG) model and used to validate LAI measurement based on first-principles and explicitly-known leaf geometry. Simulated collection parameters were adjusted to empirically identify optimal collection protocols. Furthermore, these collection protocols were then validated in the field by correlating PAR-based LAI measurement to the normalized difference vegetation index (NDVI) extracted from the “classic” Airborne Visible Infrared Imaging Spectrometer (AVIRIS-C) data (R 2 was 0.61). The results indicate that our proposed collecting protocol is suitable for measuring the LAI of sparse forest (LAI < 3–5 ( m 2/m 2)).« less

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

PubMed

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.

External validation of a Cox prognostic model: principles and methods

PubMed Central

2013-01-01

Background A prognostic model should not enter clinical practice unless it has been demonstrated that it performs a useful role. External validation denotes evaluation of model performance in a sample independent of that used to develop the model. Unlike for logistic regression models, external validation of Cox models is sparsely treated in the literature. Successful validation of a model means achieving satisfactory discrimination and calibration (prediction accuracy) in the validation sample. Validating Cox models is not straightforward because event probabilities are estimated relative to an unspecified baseline function. Methods We describe statistical approaches to external validation of a published Cox model according to the level of published information, specifically (1) the prognostic index only, (2) the prognostic index together with Kaplan-Meier curves for risk groups, and (3) the first two plus the baseline survival curve (the estimated survival function at the mean prognostic index across the sample). The most challenging task, requiring level 3 information, is assessing calibration, for which we suggest a method of approximating the baseline survival function. Results We apply the methods to two comparable datasets in primary breast cancer, treating one as derivation and the other as validation sample. Results are presented for discrimination and calibration. We demonstrate plots of survival probabilities that can assist model evaluation. Conclusions Our validation methods are applicable to a wide range of prognostic studies and provide researchers with a toolkit for external validation of a published Cox model. PMID:23496923

Prospective Validation of Pooled Prognostic Factors in Women with Advanced Cervical Cancer Treated with Chemotherapy with/without Bevacizumab: NRG Oncology/GOG Study

PubMed Central

Tewari, Krishnansu S.; Sill, Michael W.; Monk, Bradley J.; Penson, Richard T.; Long, Harry J.; Poveda, Andrés; Landrum, Lisa M.; Leitao, Mario M.; Brown, Jubilee; Reid, Thomas J.A.; Michael, Helen E.; Moore, David H.

2016-01-01

Purpose In the randomized phase III trial, Gynecologic Oncology Group protocol 240, the incorporation of bevacizumab with chemotherapy significantly increased overall survival (OS) in women with advanced cervical cancer. A major objective of GOG-240 was to prospectively analyze previously identified pooled clinical prognostic factors known as the Moore criteria. Experimental Design Potential negative factors included black race, performance status 1, pelvic disease, prior cisplatin, and progression-free interval <365 days. Risk categories included low-risk (0-1 factor); intermediate-risk (2-3 factors); high-risk (4-5 factors). Each test of association was conducted at the 5% level of significance. Logistic regression and survival analysis was used to determine whether factors were prognostic or could be used to guide therapy. Results For the entire population (n=452), high-risk patients had significantly worse OS (p<0.0001). The hazard ratios of death for treating with topotecan in low-risk, mid-risk, and high-risk subsets are 1.18 (95% CI 0.63-2.24), 1.11 (95% CI 0.82-1.5), and 0.84 (95% CI 0.50-1.42), respectively. The hazard ratios of death for treating with bevacizumab in low-risk, mid-risk, and high-risk subsets are 0.96 (95% CI 0.51-1.83; p=0.9087), 0.673 (95% CI 0.5-0.91; p=0.0094), and 0.536 (95% CI 0.32-0.905; p=0.0196), respectively. Conclusions This is the first prospectively validated scoring system in cervical cancer. The Moore criteria have real world clinical applicability. Toxicity concerns may justify omission of bevacizumab in some low-risk patients where survival benefit is small. The benefit to receiving bevacizumab appears to be greatest in the moderate- and high-risk subgroups (5.8 month increase in median OS). PMID:26672085

Comparison of a CHOP-LAsp-based protocol with and without maintenance for canine multicentric lymphoma.

PubMed

Lautscham, E M; Kessler, M; Ernst, T; Willimzig, L; Neiger, R

2017-03-25

The recommendation to treat canine lymphoma with a discontinuous protocol is based on small case numbers and mostly historic controls. This study compares duration of first remission (DFR) and overall survival time (ST) with a discontinuous protocol to the same protocol with maintenance phase. 408 dogs were treated with a CHOP-LAsp (C=cyclophosphamide; H=hydroxydaunorubicin; O=Oncovin; P=prednisolone; LAsp=l-asparaginase)-based 28-week induction protocol. In 75 dogs (cohort 1), this was followed by a maintenance phase consisting of vincristine, chlorambucil and actinomycin-D with a total treatment duration of two years. In the subsequent 333 dogs, therapy was discontinued after induction (cohort 2). Median DFR and ST in cohort 1 were 216 and 375 days and 184 and 304 days in cohort 2. 6-Month, 1-year and 2-year survival rates in cohort 1 were 73 per cent, 50 per cent, 24 per cent and 67 per cent, 39 per cent, 21 per cent in cohort 2. There was no significant difference between the two protocols (P=0.291 for ST, P=0.071 for DFR). On multivariate analysis, corticosteroid pretreatment (P=0.005), thrombocytopenia at diagnosis (P=0.019), stage (P=0.009), substage b at relapse (P<0.001), age (P=0.002) and incomplete or unstable remission necessitating intensification of therapy (P=0.004) were negatively correlated with ST in both groups. This study supports the use of a discontinuous protocol for canine multicentric lymphoma. British Veterinary Association.

Optimal Outcomes in Young Class 3 Patients With Thalassemia Undergoing HLA-Identical Sibling Bone Marrow Transplantation.

PubMed

Gaziev, Javid; Isgrò, Antonella; Sodani, Pietro; Marziali, Marco; Paciaroni, Katia; Gallucci, Cristiano; De Angelis, Gioia; Andreani, Marco; Testi, Manuela; Alfieri, Cecilia; Ribersani, Michela; Galluccio, Tiziana; Battarra, Maria Rosa; Morrone, Aldo; Lucarelli, Guido

2016-04-01

Bone marrow transplantation (BMT) for class 3 patients with thalassemia is challenging due to high rates of graft rejection and transplant-related mortality. Since the first studies of BMT in the late 1980s, a number of conditioning regimens have been designed to improve outcomes, but with suboptimal results. Here we report the outcome of transplantation in class 3 patients using a modified protocol. Sixty-three patients between 5 and 16.7 years of age with class 3 thalassemia received HLA-matched sibling BMT following either the original protocol (26 patients) or the modified protocol (37 patients). Both regimens comprised preconditioning cytoreduction with hydroxyurea and azathioprine starting at -45 days pretransplant, and fludarabine from days -16 to -12. Conditioning was performed with busulfan and cyclophosphamide (original protocol) or with busulfan, thiotepa, and cyclophosphamide (modified protocol). The 2 groups showed similar patient demographics. At day 0, the degree of cytoreduction (lymphopenia, neuthropenia, and thrombocytopenia) achieved by the modified protocol was greater than the original protocol. The incidence of graft failure/rejection was significantly higher in the original group (15%; 95% confidence interval [95% CI], 5-32%) compared with the modified group (0%) (P = 0.014). The respective 5-year thalassemia-free survival rates were 73% (95% CI, 51-86%) and 92% (95% CI, 77-97%) (P = 0.047). Both groups showed similar incidences of grades II to IV acute graft-versus host disease. Modified protocol did not increase nonhematological toxicity or infectious complications. The modified treatment protocol effectively and safely prevented graft failure/rejection and significantly increased thalassemia-free survival of class 3 patients with thalassemia.

A Public-Key Based Authentication and Key Establishment Protocol Coupled with a Client Puzzle.

ERIC Educational Resources Information Center

Lee, M. C.; Fung, Chun-Kan

2003-01-01

Discusses network denial-of-service attacks which have become a security threat to the Internet community and suggests the need for reliable authentication protocols in client-server applications. Presents a public-key based authentication and key establishment protocol coupled with a client puzzle protocol and validates it through formal logic…

Validating Vegetable Production Unit (VPU) Plants, Protocols, Procedures and Requirements (P3R) using Currently Existing Flight Resources

NASA Technical Reports Server (NTRS)

Bingham, Gail; Bates, Scott; Bugbee, Bruce; Garland, Jay; Podolski, Igor; Levinskikh, Rita; Sychev, Vladimir; Gushin, Vadim

2009-01-01

Validating Vegetable Production Unit (VPU) Plants, Protocols, Procedures and Requirements (P3R) Using Currently Existing Flight Resources (Lada-VPU-P3R) is a study to advance the technology required for plant growth in microgravity and to research related food safety issues. Lada-VPU-P3R also investigates the non-nutritional value to the flight crew of developing plants on-orbit. The Lada-VPU-P3R uses the Lada hardware on the ISS and falls under a cooperative agreement between National Aeronautics and Space Administration (NASA) and the Russian Federal Space Association (FSA). Research Summary: Validating Vegetable Production Unit (VPU) Plants, Protocols, Procedures and Requirements (P3R) Using Currently Existing Flight Resources (Lada-VPU-P3R) will optimize hardware and

The impact of routine surveillance screening with magnetic resonance imaging (MRI) to detect tumour recurrence in children with central nervous system (CNS) tumours: protocol for a systematic review and meta-analysis.

PubMed

Main, Caroline; Stevens, Simon P; Bailey, Simon; Phillips, Robert; Pizer, Barry; Wheatley, Keith; Kearns, Pamela R; English, Martin; Wilne, Sophie; Wilson, Jayne S

2016-08-31

The aim of this study is to assess the impact of routine MRI surveillance to detect tumour recurrence in children with no new neurological signs or symptoms compared with alternative follow-up practices, including periodic clinical and physical examinations and the use of non-routine imaging upon presentation with disease signs or symptoms. Standard systematic review methods aimed at minimising bias will be employed for study identification, selection and data extraction. Ten electronic databases have been searched, and further citation searching and reference checking will be employed. Randomised and non-randomised controlled trials assessing the impact of routine surveillance MRI to detect tumour recurrence in children with no new neurological signs or symptoms compared to alternative follow-up schedules including imaging upon presentation with disease signs or symptoms will be included. The primary outcome is time to change in therapeutic intervention. Secondary outcomes include overall survival, surrogate survival outcomes, response rates, diagnostic yield per set of images, adverse events, quality of survival and validated measures of family psychological functioning and anxiety. Two reviewers will independently screen and select studies for inclusion. Quality assessment will be undertaken using the Cochrane Collaboration's tools for assessing risk of bias. Where possible, data will be summarised using combined estimates of effect for time to treatment change, survival outcomes and response rates using assumption-free methods. Further sub-group analyses and meta-regression models will be specified and undertaken to explore potential sources of heterogeneity between studies within each tumour type if necessary. Assessment of the impact of surveillance imaging in children with CNS tumours is methodologically complex. The evidence base is likely to be heterogeneous in terms of imaging protocols, definitions of radiological response and diagnostic accuracy of tumour recurrence due to changes in imaging technology over time. Furthermore, the delineation of tumour recurrence from either pseudo-progression or radiation necrosis after radiotherapy is potentially problematic and linked to the timing of follow-up assessments. However, given the current routine practice of MRI surveillance in the follow-up of children with CNS tumours in the UK and the resource implications, it is important to evaluate the cost-benefit profile of this practice. PROSPERO CRD42016036802.

Wound-healing outcomes using standardized assessment and care in clinical practice.

PubMed

Bolton, Laura; McNees, Patrick; van Rijswijk, Lia; de Leon, Jean; Lyder, Courtney; Kobza, Laura; Edman, Kelly; Scheurich, Anne; Shannon, Ron; Toth, Michelle

2004-01-01

Wound-healing outcomes applying standardized protocols have typically been measured within controlled clinical trials, not natural settings. Standardized protocols of wound care have been validated for clinical use, creating an opportunity to measure the resulting outcomes. Wound-healing outcomes were explored during clinical use of standardized validated protocols of care based on patient and wound assessments. This was a prospective multicenter study of wound-healing outcomes management in real-world clinical practice. Healing outcomes from March 26 to October 31, 2001, were recorded on patients in 3 long-term care facilities, 1 long-term acute care hospital, and 12 home care agencies for wounds selected by staff to receive care based on computer-generated validated wound care algorithms. After diagnosis, wound dimensions and status were assessed using a tool adapted from the Pressure Sore Status Toolfor use on all wounds. Wound, ostomy, and continence nursing professionals accessed consistent protocols of care, via telemedicine in home care or paper forms in long-term care. A physician entered assessments into a desktop computer in the wound clinic. Based on evidence that healing proceeds faster with fewer infections in environments without gauze, the protocols generally avoided gauze dressings. Most of the 767 wounds selected to receive the standardized-protocols of care were stage III-IV pressure ulcers (n = 373; mean healing time 62 days) or full-thickness venous ulcers (n = 124; mean healing time 57 days). Partial-thickness wounds healed faster than same-etiology full-thickness wounds. These results provide benchmarks for natural-setting healing outcomes and help to define and address wound care challenges. Outcomes primarily using nongauze protocols of care matched or surpassed best previously published results on similar wounds using gauze-based protocols of care, including protocols applying gauze impregnated with growth factors or other agents.

Association of Adjuvant Chemotherapy With Survival in Patients With Stage II or III Gastric Cancer

PubMed Central

Jiang, Yuming; Li, Tuanjie; Liang, Xiaoling; Hu, Yanfeng; Huang, Lei; Liao, Zhenchen; Zhao, Liying; Han, Zhen; Zhu, Shuguang; Wang, Menglan; Xu, Yangwei; Qi, Xiaolong; Liu, Hao; Yang, Yang; Yu, Jiang; Liu, Wei; Cai, Shirong

2017-01-01

Importance The current staging system of gastric cancer is not adequate for defining a prognosis and predicting the patients most likely to benefit from chemotherapy. Objective To construct a survival prediction model based on specific tumor and patient characteristics that enables individualized predictions of the net survival benefit of adjuvant chemotherapy for patients with stage II or stage III gastric cancer. Design, Setting, and Participants In this multicenter retrospective analysis, a survival prediction model was constructed using data from a training cohort of 746 patients with stage II or stage III gastric cancer who satisfied the study’s inclusion criteria and underwent surgery between January 1, 2004, and December 31, 2012, at Nanfang Hospital in Guangzhou, China. Patient and tumor characteristics were included as covariates, and their association with overall survival and disease-free survival with and without adjuvant chemotherapy was assessed. The model was internally validated for discrimination and calibration using bootstrap resampling. To externally validate the model, data were included from a validation cohort of 973 patients with stage II or stage III gastric cancer who met the inclusion criteria and underwent surgery at First Affiliated Hospital in Guangzhou, China, and at West China Hospital of Sichuan Hospital in Chendu, China, between January 1, 2000, and June 30, 2009. Data were analyzed from July 10, 2016, to September 1, 2016. Main Outcomes and Measures Concordance index and decision curve analysis for each measure associated with postoperative overall survival and disease-free survival. Results Of the 1719 patients analyzed, 1183 (68.8%) were men and 536 (31.2%) were women and the median (interquartile range) age was 57 (49-66) years. Age, location, differentiation, carcinoembryonic antigen, cancer antigen 19-9, depth of invasion, lymph node metastasis, and adjuvant chemotherapy were significantly associated with overall survival and disease-free survival, with P < .05. The survival prediction model demonstrated good calibration and discrimination, with relatively high bootstrap-corrected concordance indexes in the training and validation cohorts. In the validation cohort, the concordance index for overall survival was 0.693 (95% CI, 0.671-0.715) and for disease-free survival was 0.704 (95% CI, 0.681-0.728). Two nomograms and a calculating tool were built on the basis of specific input variables to estimate an individual’s net survival gain attributable to adjuvant chemotherapy. Conclusions and Relevance The survival prediction model can be used to make individualized predictions of the expected survival benefit from the addition of adjuvant chemotherapy for patients with stage II or stage III gastric cancer. PMID:28538950

The impact of perioperative fluid therapy on short-term outcomes and 5-year survival among patients undergoing colorectal cancer surgery - A prospective cohort study within an ERAS protocol.

PubMed

Asklid, D; Segelman, J; Gedda, C; Hjern, F; Pekkari, K; Gustafsson, U O

2017-08-01

Restricted perioperative fluid therapy is one of several interventions in the enhanced recovery after surgery (ERAS) protocol, designed to reduce morbidity and hospital stay after surgery. The impact of this single intervention on short and long term outcome after colorectal surgery is unknown. This cohort study includes all consecutive patients operated with abdominal resection of colorectal cancer 2002-2007 at Ersta Hospital, Stockholm, Sweden. All patients were treated within an ERAS protocol and registered in the ERAS-database. Compliance to interventions in the ERAS protocol was analysed. The impact of a restrictive perioperative fluid therapy (≤3000 ml on the day of surgery) protocol on short-term outcomes as well as 5-year survival was assessed with multivariable analysis adjusted for confounding factors. Nine hundred and eleven patients were included. Patients receiving ≤3000 ml of intravenous fluids on the day of surgery had a lower risk of complications OR 0.44 (95% C I 0.28-0.71), symptoms delaying discharge OR 0.47(95% C I 0.32-0.70) and shorter length of stay compared with patients receiving >3000 ml. In cox regression analysis, the risk of cancer specific death was reduced with 55% HR 0.45(95% C I 0.25-0.81) for patients receiving ≤ 3000 ml compared with patients receiving >3000 ml. A restrictive compared with a non-restrictive perioperative fluid therapy on the day of surgery may be associated with lower short-term complication rates, faster recovery, shorter length of stay and improved 5-year survival. Copyright © 2017 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

Recommendations for standardizing validation procedures assessing physical activity of older persons by monitoring body postures and movements.

PubMed

Lindemann, Ulrich; Zijlstra, Wiebren; Aminian, Kamiar; Chastin, Sebastien F M; de Bruin, Eling D; Helbostad, Jorunn L; Bussmann, Johannes B J

2014-01-10

Physical activity is an important determinant of health and well-being in older persons and contributes to their social participation and quality of life. Hence, assessment tools are needed to study this physical activity in free-living conditions. Wearable motion sensing technology is used to assess physical activity. However, there is a lack of harmonisation of validation protocols and applied statistics, which make it hard to compare available and future studies. Therefore, the aim of this paper is to formulate recommendations for assessing the validity of sensor-based activity monitoring in older persons with focus on the measurement of body postures and movements. Validation studies of body-worn devices providing parameters on body postures and movements were identified and summarized and an extensive inter-active process between authors resulted in recommendations about: information on the assessed persons, the technical system, and the analysis of relevant parameters of physical activity, based on a standardized and semi-structured protocol. The recommended protocols can be regarded as a first attempt to standardize validity studies in the area of monitoring physical activity.

Improved Outcome of Enteric Peritonitis in Peritoneal Dialysis Patients Aged 50 Years and Older with Temporary Discontinuation of Peritoneal Dialysis and Intravenous Meropenem.

PubMed

Abrahams, Alferso C; Rüger, Wim; Ter Wee, Pieter M; van Ittersum, Frans J; Boer, Walther H

2017-01-01

♦ BACKGROUND: Peritonitis is a major cause of morbidity, mortality, and technique failure in peritoneal dialysis (PD) patients, especially when caused by enteric microorganisms (EM). We have implemented a treatment protocol specifically aimed at improving the outcome in EM peritonitis. The adapted protocol was applied in all PD patients 50 years and older presenting with peritonitis who were considered to be at risk of EM peritonitis and involves 3 interventions: 1) temporary discontinuation of PD without removing the catheter (peritoneal rest), 2) intravenous meropenem, and 3) meropenem intracatheter as lock (Mero-PerRest protocol). ♦ METHODS: In this observational study, we compared the outcome of 203 peritonitis episodes in 71 patients treated with the Mero-PerRest protocol, with 217 episodes in 104 patients treated with a more traditional intraperitoneal gentamicin-rifampicin-based regimen. ♦ RESULTS: In EM peritonitis episodes, the Mero-PerRest protocol resulted in a higher primary cure rate (90.0% vs 65.3%, adjusted odds ratio [OR] 4.54 [95% confidence interval (CI) 1.46 - 14.15]) and better technique survival (90.0% vs 69.4%, adjusted OR 3.41 [95% CI 1.07 - 10.87]). This effect was most distinct in patients with polymicrobial EM peritonitis (cure rate 87.5% vs 34.8%, p = 0.0003). Interestingly, primary cure rate (95.6% vs 84.7%, adjusted OR 3.92 [95% CI 1.37 - 11.19]) and technique survival (95.6% vs 85.6%, adjusted OR 3.60 [95% CI 1.25 - 10.32]) were also excellent in non-EM peritonitis episodes. Patient survival did not differ significantly. ♦ CONCLUSION: The poor outcome of peritonitis caused by EM in PD patients aged 50 years and older could be improved by applying a treatment protocol involving temporary discontinuation of PD without catheter removal and intravenous and intracatheter meropenem. Copyright © 2017 International Society for Peritoneal Dialysis.

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

PubMed

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.

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

ERIC Educational Resources Information Center

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…

Telemetry Standards, RCC Standard 106-17. Chapter 26. TmNSDataMessage Transfer Protocol

DTIC Science & Technology

2017-07-01

Channel (RTSPDataChannel) ............................................ 26-13 26.4.3 Reliability Critical (RC) Delivery Protocol...error status code specified in RFC 2326 for "Request-URI Too Large" is 虮". 26.4.1.5 Request Types RTSPDataSources shall return valid ...to the following requirements. • Valid TmNSDataMessages shall be delivered containing the original Packages matching the requested

A double candidate survivable routing protocol for HAP network

NASA Astrophysics Data System (ADS)

He, Panfeng; Li, Chunyue; Ni, Shuyan

2016-11-01

To improve HAP network invulnerability, and at the same time considering the quasi-dynamic topology in HAP network, a simple and reliable routing protocol is proposed in the paper. The protocol firstly uses a double-candidate strategy for the next-node select to provide better robustness. Then during the maintenance stage, short hello packets instead of long routing packets are used only to check link connectivity in the quasi-dynamic HAP network. The route maintenance scheme based on short hello packets can greatly reduce link spending. Simulation results based on OPNET demonstrate the effectiveness of the proposed routing protocol.

Standards for Environmental Measurement Using GIS: Toward a Protocol for Protocols.

PubMed

Forsyth, Ann; Schmitz, Kathryn H; Oakes, Michael; Zimmerman, Jason; Koepp, Joel

2006-02-01

Interdisciplinary research regarding how the built environment influences physical activity has recently increased. Many research projects conducted jointly by public health and environmental design professionals are using geographic information systems (GIS) to objectively measure the built environment. Numerous methodological issues remain, however, and environmental measurements have not been well documented with accepted, common definitions of valid, reliable variables. This paper proposes how to create and document standardized definitions for measures of environmental variables using GIS with the ultimate goal of developing reliable, valid measures. Inherent problems with software and data that hamper environmental measurement can be offset by protocols combining clear conceptual bases with detailed measurement instructions. Examples demonstrate how protocols can more clearly translate concepts into specific measurement. This paper provides a model for developing protocols to allow high quality comparative research on relationships between the environment and physical activity and other outcomes of public health interest.

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

PubMed Central

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.

2016-01-01

ABSTRACT 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. PMID:27927920

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

PubMed

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.

Effect of a blood transfusion protocol and low dose steroid regime on renal transplant survival.

PubMed

Notghi, A; Anderton, J L; Chisholm, G D; Hamer-Hodges, D; Wilkinson, S; Smith, G; Galloway, N T; Yap, P L; Winney, R J

1986-04-01

The effects of introduction of a low steroid regime and pre-transplant blood transfusion were evaluated. The kidney and patient survival rates for the period before such a policy was adopted were compared with the period after this policy. There has been a highly significant rise in patient survival rates to the present level of 95 per cent at three years. There was a similar rise in three year graft survival rates from less than 40 per cent to 66 per cent.

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

NASA Astrophysics Data System (ADS)

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.

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

PubMed

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.

"May I Buy a Pack of Marlboros, Please?" A Systematic Review of Evidence to Improve the Validity and Impact of Youth Undercover Buy Inspections.

PubMed

Lee, Joseph G L; Gregory, Kyle R; Baker, Hannah M; Ranney, Leah M; Goldstein, Adam O

2016-01-01

Most smokers become addicted to tobacco products before they are legally able to purchase these products. We systematically reviewed the literature on protocols to assess underage purchase and their ecological validity. We conducted a systematic search in May 2015 in PubMed and PsycINFO. We independently screened records for inclusion. We conducted a narrative review and examined implications of two types of legal authority for protocols that govern underage buy enforcement in the United States: criminal (state-level laws prohibiting sales to youth) and administrative (federal regulations prohibiting sales to youth). Ten studies experimentally assessed underage buy protocols and 44 studies assessed the association between youth characteristics and tobacco sales. Protocols that mimicked real-world youth behaviors were consistently associated with substantially greater likelihood of a sale to a youth. Many of the tested protocols appear to be designed for compliance with criminal law rather than administrative enforcement in ways that limited ecological validity. This may be due to concerns about entrapment. For administrative enforcement in particular, entrapment may be less of an issue than commonly thought. Commonly used underage buy protocols poorly represent the reality of youths' access to tobacco from retailers. Compliance check programs should allow youth to present themselves naturally and attempt to match the community's demographic makeup.

"May I Buy a Pack of Marlboros, Please?" A Systematic Review of Evidence to Improve the Validity and Impact of Youth Undercover Buy Inspections

PubMed Central

Lee, Joseph G. L.; Gregory, Kyle R.; Baker, Hannah M.; Ranney, Leah M.; Goldstein, Adam O.

2016-01-01

Most smokers become addicted to tobacco products before they are legally able to purchase these products. We systematically reviewed the literature on protocols to assess underage purchase and their ecological validity. We conducted a systematic search in May 2015 in PubMed and PsycINFO. We independently screened records for inclusion. We conducted a narrative review and examined implications of two types of legal authority for protocols that govern underage buy enforcement in the United States: criminal (state-level laws prohibiting sales to youth) and administrative (federal regulations prohibiting sales to youth). Ten studies experimentally assessed underage buy protocols and 44 studies assessed the association between youth characteristics and tobacco sales. Protocols that mimicked real-world youth behaviors were consistently associated with substantially greater likelihood of a sale to a youth. Many of the tested protocols appear to be designed for compliance with criminal law rather than administrative enforcement in ways that limited ecological validity. This may be due to concerns about entrapment. For administrative enforcement in particular, entrapment may be less of an issue than commonly thought. Commonly used underage buy protocols poorly represent the reality of youths' access to tobacco from retailers. Compliance check programs should allow youth to present themselves naturally and attempt to match the community’s demographic makeup. PMID:27050671

Feasibility of objectively measured physical activity and sedentary behavior in patients with malignant pleural effusion.

PubMed

Jeffery, Emily; Lee, Yc Gary; McVeigh, Joanne; Straker, Leon; Wooding, Troy; Newton, Robert U; Peddle-McIntyre, Carolyn

2017-10-01

Malignant pleural effusion (MPE) affects 1 million people worldwide annually and can significantly impair physical activity. Accelerometry is a validated method of objectively assessing physical activity. The purpose of this study was to determine the compliance in patients with MPE to accelerometry and describe their activity. Patients with MPE wore an Actigraph GT3X accelerometer over a 7-day continuous wear protocol. Compliance was measured as the percent of patients who had ≥4 valid days (i.e., 8-h/day of waking wear-time). Eastern Cooperative Oncology Group performance status was documented the day of actigraphy initialization. Forty-six patients with MPE received accelerometers; 44 (95.7%) returned their device. No complications were reported on their use. Forty subjects (90.9%) had ≥4 valid days of wear-time. Patients spent most of their waking hours sedentary [mean 11.0 h (SD 1.95)], with limited participation in moderate and vigorous physical activity [mean 9.5 min (SD 14.16)]. Compared to patients with better performance status (n = 32), patients with poorer performance status (n = 11) spent significantly more hours/day sedentary [mean difference 2.1 (CI 0.86-3.32); p = 0.001], as did those who survived <3 months (n = 5) compared to >12 months (n = 27) [mean difference 2.6 (CI 0.49-4.77); p = 0.013). Accelerometry was applied successfully in patients with MPE with high compliance and no adverse events. This is the first reported objectively measured physical activity in patients with MPE and revealed high sedentary behavior and low physical activity. The data reflected patient performance status and discriminated between survival groups. Accelerometry can provide a useful measure for future interventional studies in patients with MPE.

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

PubMed

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

PubMed Central

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. PMID:26807344

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

PubMed Central

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

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

PubMed

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 <35 within 5 mmHg and never <40 within 10 and 15 mmHg. The test device also passed phase 2 of the 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 the Pangao PG-800A11 wrist device assessed according to the European Society of Hypertension and the British Hypertension Society protocols.

PubMed

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

2015-04-01

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

Calibration and validation of toxicokinetic-toxicodynamic models for three neonicotinoids and some aquatic macroinvertebrates.

PubMed

Focks, Andreas; Belgers, Dick; Boerwinkel, Marie-Claire; Buijse, Laura; Roessink, Ivo; Van den Brink, Paul J

2018-05-01

Exposure patterns in ecotoxicological experiments often do not match the exposure profiles for which a risk assessment needs to be performed. This limitation can be overcome by using toxicokinetic-toxicodynamic (TKTD) models for the prediction of effects under time-variable exposure. For the use of TKTD models in the environmental risk assessment of chemicals, it is required to calibrate and validate the model for specific compound-species combinations. In this study, the survival of macroinvertebrates after exposure to the neonicotinoid insecticide was modelled using TKTD models from the General Unified Threshold models of Survival (GUTS) framework. The models were calibrated on existing survival data from acute or chronic tests under static exposure regime. Validation experiments were performed for two sets of species-compound combinations: one set focussed on multiple species sensitivity to a single compound: imidacloprid, and the other set on the effects of multiple compounds for a single species, i.e., the three neonicotinoid compounds imidacloprid, thiacloprid and thiamethoxam, on the survival of the mayfly Cloeon dipterum. The calibrated models were used to predict survival over time, including uncertainty ranges, for the different time-variable exposure profiles used in the validation experiments. From the comparison between observed and predicted survival, it appeared that the accuracy of the model predictions was acceptable for four of five tested species in the multiple species data set. For compounds such as neonicotinoids, which are known to have the potential to show increased toxicity under prolonged exposure, the calibration and validation of TKTD models for survival needs to be performed ideally by considering calibration data from both acute and chronic tests.

Month of birth and survival to age 105+: evidence from the age validation study of German semi-supercentenarians.

PubMed

Doblhammer, Gabriele; Scholz, Rembrandt; Maier, Heiner

2005-10-01

Using data from Germany, we examine if month of birth influences survival up to age 105. Since age reporting at the highest ages is notoriously unreliable we draw on age-validated information from a huge age validation project of 1487 alleged German semi-supercentenarians aged 105+. We use month of birth as an exogenous indicator for seasonal changes in the environment around the time of birth. We find that the seasonal distribution of birth dates changes with age. For 925 age-validated semi-supercentenarians the seasonality is more pronounced than at the time of their birth (1880-1900). Among the December-born the relative risk of survival from birth to age 105+is 16% higher than the average, among the June-born, 23% lower. The month-of-birth pattern in the survival risk of the German semi-supercentenarians resembles closely the month-of-birth pattern in remaining life expectancy at age 50 in Denmark.

Commonly used severity scores are not good predictors of mortality in sepsis from severe leptospirosis: a series of ten patients.

PubMed

Velissaris, Dimitrios; Karanikolas, Menelaos; Flaris, Nikolaos; Fligou, Fotini; Marangos, Markos; Filos, Kriton S

2012-01-01

Introduction. Severe leptospirosis, also known as Weil's disease, can cause multiorgan failure with high mortality. Scoring systems for disease severity have not been validated for leptospirosis, and there is no documented method to predict mortality. Methods. This is a case series on 10 patients admitted to ICU for multiorgan failure from severe leptospirosis. Data were collected retrospectively, with approval from the Institution Ethics Committee. Results. Ten patients with severe leptospirosis were admitted in the Patras University Hospital ICU in a four-year period. Although, based on SOFA scores, predicted mortality was over 80%, seven of 10 patients survived and were discharged from the hospital in good condition. There was no association between SAPS II or SOFA scores and mortality, but survivors had significantly lower APACHE II scores compared to nonsurvivors. Conclusion. Commonly used severity scores do not seem to be useful in predicting mortality in severe leptospirosis. Early ICU admission and resuscitation based on a goal-directed therapy protocol are recommended and may reduce mortality. However, this study is limited by retrospective data collection and small sample size. Data from large prospective studies are needed to validate our findings.

Validation of the Registry to Evaluate Early and Long-Term Pulmonary Arterial Hypertension Disease Management (REVEAL) pulmonary hypertension prediction model in a unique population and utility in the prediction of long-term survival.

PubMed

Cogswell, Rebecca; Kobashigawa, Erin; McGlothlin, Dana; Shaw, Robin; De Marco, Teresa

2012-11-01

The Registry to Evaluate Early and Long-Term Pulmonary Arterial (PAH) Hypertension Disease Management (REVEAL) model was designed to predict 1-year survival in patients with PAH. Multivariate prediction models need to be evaluated in cohorts distinct from the derivation set to determine external validity. In addition, limited data exist on the utility of this model in the prediction of long-term survival. REVEAL model performance was assessed to predict 1-year and 5-year outcomes, defined as survival or composite survival or freedom from lung transplant, in 140 patients with PAH. The validation cohort had a higher proportion of human immunodeficiency virus (7.9% vs 1.9%, p < 0.0001), methamphetamine use (19.3% vs 4.9%, p < 0.0001), and portal hypertension PAH (16.4% vs 5.1%, p < 0.0001) compared with the development cohort. The C-index of the model to predict survival was 0.765 at 1 year and 0.712 at 5 years of follow-up. The C-index of the model to predict composite survival or freedom from lung transplant was 0.805 and 0.724 at 1 and 5 years of follow-up, respectively. Prediction by the model, however, was weakest among patients with intermediate-risk predicted survival. The REVEAL model had adequate discrimination to predict 1-year survival in this small but clinically distinct validation cohort. Although the model also had predictive ability out to 5 years, prediction was limited among patients of intermediate risk, suggesting our prediction methods can still be improved. Copyright © 2012. Published by Elsevier Inc.

The cryopreservation protocol optimal for progenitor recovery is not optimal for preservation of marrow repopulating ability.

PubMed

Balint, B; Ivanović, Z; Petakov, M; Taseski, J; Jovcić, G; Stojanović, N; Milenković, P

1999-03-01

The efficiency of five different cryopreservation protocols (our original controlled-rate and noncontrolled-rate protocols) was evaluated on the basis of the recovery after thawing of very primitive pluripotent hemopoietic stem cells (MRA(CFU-GM), pluripotent progenitors (CFU-Sd12) and committed granulocyte-monocyte progenitors (CFU-GM) in mouse bone marrow. Although the nucleated cell recovery and viability determined immediately after the thawing and washing of the cells were found to be similar, whether controlled-rate or noncontrolled-rate cryopreservation protocols were used, the recovery of MRA(CFU-GM), CFU-Sd12 and CFU-GM varied depending on the type of protocol and the cryoprotector (DMSO) concentrations used. It was shown that the controlled-rate protocol was more efficient, enabling better MRA(CFU-GM), CFU-Sd12 and CFU-GM recovery from frozen samples. The most efficient was the controlled-rate protocol of cryopreservation designed to compensate for the release of fusion heat, which enabled a better survival of CFU-Sd12 and CFU-GM when combined with a lower (5%) DMSO concentration. On the contrary, a satisfactory survival rate of very primitive stem cells (MRA(CFU-GM)) was achieved only when 10% DMSO was included with a five-step protocol of cryopreservation. These results point to adequately used controlled-rate freezing as essential for a highly efficient cryopreservation of some of the categories of hematopoietic stem and progenitor cells. At the same time, it was obvious that a higher DMSO concentration was necessary for the cryopreservation of very primitive stem cells, but not, however, for more mature progenitor cells (CFU-S, CFU-GM). These results imply the existence of a mechanism that decreases the intracellular concentration of DMSO in primitive MRA cells, which is not the case for less primitive progenitors.

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

PubMed Central

2017-01-01

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. PMID:28448606

Reactivating TP53 signaling by the novel MDM2 inhibitor DS-3032b as a therapeutic option for high-risk neuroblastoma

PubMed Central

Arnhold, Viktor; Schmelz, Karin; Proba, Jutta; Winkler, Annika; Wünschel, Jasmin; Toedling, Joern; Deubzer, Hedwig E.; Künkele, Annette; Eggert, Angelika; Schulte, Johannes H.; Hundsdoerfer, Patrick

2018-01-01

Fewer than 50% of patients with high-risk neuroblastoma survive five years after diagnosis with current treatment protocols. Molecular targeted therapies are expected to improve survival. Although MDM2 has been validated as a promising target in preclinical models, no MDM2 inhibitors have yet entered clinical trials for neuroblastoma patients. Toxic side effects, poor bioavailability and low efficacy of the available MDM2 inhibitors that have entered phase I/II trials drive the development of novel MDM2 inhibitors with an improved risk-benefit profile. We investigated the effect of the novel MDM2 small molecular inhibitor, DS-3032b, on viability, proliferation, senescence, migration, cell cycle arrest and apoptosis in a panel of six neuroblastoma cell lines with different TP53 and MYCN genetic backgrounds, and assessed efficacy in a murine subcutaneous model for high-risk neuroblastoma. Re-analysis of existing expression data from 476 primary neuroblastomas showed that high-level MDM2 expression correlated with poor patient survival. DS-3032b treatment enhanced TP53 target gene expression and induced G1 cell cycle arrest, senescence and apoptosis. CRISPR-mediated MDM2 knockout in neuroblastoma cells mimicked DS-3032b treatment. TP53 signaling was selectively activated by DS-3032b in neuroblastoma cells with wildtype TP53, regardless of the presence of MYCN amplification, but was significantly reduced by TP53 mutations or expression of a dominant-negative TP53 mutant. Oral DS-3032b administration inhibited xenograft tumor growth and prolonged mouse survival. Our in vitro and in vivo data demonstrate that DS-3032b reactivates TP53 signaling even in the presence of MYCN amplification in neuroblastoma cells, to reduce proliferative capacity and cause cytotoxicity. PMID:29416773

Stereotactic radiosurgery boost to the resection cavity for cerebral metastases: Report of overall survival, complications, and corticosteroid protocol

PubMed Central

Kellogg, Robert G.; Straus, David C.; Choi, Mehee; Chaudhry, Thymur A.; Diaz, Aidnag Z.; Muñoz, Lorenzo F.

2013-01-01

Background: This report focuses on the overall survival and complications associated with treatment of cerebral metastases with surgical resection followed by stereotactic radiosurgery (SRS). Management and complications of corticosteroid therapy are underreported in the literature but represent an important source of morbidity for patients. Methods: Fifty-nine consecutive patients underwent surgical resection of a cerebral metastasis followed by SRS to the cavity. Patient charts were reviewed retrospectively to ascertain overall survival, local control, surgical complications, SRS complications, and corticosteroid complications. Results: Our mean follow-up was 14.4 months (median 12.0 months, range 0.9-62.9 months). Median overall survival in this series was 15.25 months and local control was 98.3%. There was a statistically significant survival benefit conferred by Radiation Therapy Oncology Group recursive partitioning analysis Classes 1 and 2. The surgical complication rate was 6.8% while the SRS complication rate was 2.4%. Corticosteroid complications are reported and dependence at 1 month was 20.3%, at 3 months 6.8%, at 6 months 1.7%, and at 12 months no patients remained on corticosteroid therapy. Conclusions: Overall survival and local control with this treatment paradigm compare well to the other published literature. Complications associated with this patient population are low. A corticosteroid tapering protocol is proposed and demonstrated lower rates of steroid-related complications and dependence than previously reported. PMID:24349867

Effectiveness of Autologous Fat Grafting in Adherent Scars: Results Obtained by a Comprehensive Scar Evaluation Protocol.

PubMed

Jaspers, Mariëlle E H; Brouwer, Katrien M; van Trier, Antoine J M; Groot, Marloes L; Middelkoop, Esther; van Zuijlen, Paul P M

2017-01-01

Nowadays, patients normally survive severe traumas such as burn injuries and necrotizing fasciitis. Large skin defects can be closed but the scars remain. Scars may become adherent to underlying structures when the subcutical fat layer is damaged. Autologous fat grafting provides the possibility of reconstructing a functional sliding layer underneath the scar. Autologous fat grafting is becoming increasingly popular for scar treatment, although large studies using validated evaluation tools are lacking. The authors therefore objectified the effectiveness of single-treatment autologous fat grafting on scar pliability using validated scar measurement tools. Forty patients with adherent scars receiving single-treatment autologous fat grafting were measured preoperatively and at 3-month follow-up. The primary outcome parameter was scar pliability, measured using the Cutometer. Scar quality was also evaluated by the Patient and Observer Scar Assessment Scale and the DSM II ColorMeter. To prevent selection bias, measurements were performed following a standardized algorithm. The Cutometer parameters elasticity and maximal extension improved 22.5 percent (p < 0.001) and 15.6 percent (p = 0.001), respectively. Total Patient and Observer Scar Assessment Scale scores improved from 3.6 to 2.9 on the observer scale, and from 5.1 to 3.8 on the patient scale (both p < 0.001). Color differences between the scar and normal skin remained unaltered. For the first time, the effect of autologous fat grafting on functional scar parameters was ascertained using a comprehensive scar evaluation protocol. The improved scar pliability supports the authors' hypothesis that the function of the subcutis can be restored to a certain extent by single-treatment autologous fat grafting. Therapeutic, IV.

OSI-compatible protocols for mobile-satellite communications: The AMSS experience

NASA Technical Reports Server (NTRS)

Moher, Michael

1990-01-01

The protocol structure of the international aeronautical mobile satellite service (AMSS) is reviewed with emphasis on those aspects of protocol performance, validation, and conformance which are peculiar to mobile services. This is in part an analysis of what can be learned from the AMSS experience with protocols which is relevant to the design of other mobile satellite data networks, e.g., land mobile.

Montreal Cognitive Assessment 5-minute protocol is a brief, valid, reliable, and feasible cognitive screen for telephone administration.

PubMed

Wong, Adrian; Nyenhuis, David; Black, Sandra E; Law, Lorraine S N; Lo, Eugene S K; Kwan, Pauline W L; Au, Lisa; Chan, Anne Y Y; Wong, Lawrence K S; Nasreddine, Ziad; Mok, Vincent

2015-04-01

The National Institute of Neurological Disorders and Stroke-Canadian Stroke Network Vascular Cognitive Impairment Harmonization working group proposed a brief cognitive protocol for screening of vascular cognitive impairment. We investigated the validity, reliability, and feasibility of the Montreal Cognitive Assessment 5-minute protocol (MoCA 5-minute protocol) administered over the telephone. Four items examining attention, verbal learning and memory, executive functions/language, and orientation were extracted from the MoCA to form the MoCA 5-minute protocol. One hundred four patients with stroke or transient ischemic attack, including 53 with normal cognition (Clinical Dementia Rating, 0) and 51 with cognitive impairment (Clinical Dementia Rating, 0.5 or 1), were administered the MoCA in clinic and a month later, the MoCA 5-minute protocol over the telephone. Administration of the MoCA 5-minute protocol took 5 minutes over the telephone. Total score of the MoCA 5-minute protocol correlated negatively with age (r=-0.36; P<0.001) and positively with years of education (r=0.41; P<0.001) but not with sex (ρ=0.03; P=0.773). Total scores of the MoCA and MoCA 5-minute protocol were highly correlated (r=0.87; P<0.001). The MoCA 5-minute protocol performed equally well as the MoCA in differentiating patients with cognitive impairment from those without (areas under receiver operating characteristics curve for MoCA 5-minute protocol, 0.78; MoCA=0.74; P>0.05 for difference; Cohen d for group difference, 0.80-1.13). It differentiated cognitively impaired patients with executive domain impairment from those without (areas under receiver operating characteristics curve, 0.89; P<0.001; Cohen d=1.7 for group difference). Thirty-day test-retest reliability was excellent (intraclass correlation coefficient, 0.89). The MoCA 5-minute protocol is a free, valid, and reliable cognitive screen for stroke and transient ischemic attack. It is brief and highly feasible for telephone administration. © 2015 American Heart Association, Inc.

Security of a sessional blind signature based on quantum cryptograph

NASA Astrophysics Data System (ADS)

Wang, Tian-Yin; Cai, Xiao-Qiu; Zhang, Rui-Ling

2014-08-01

We analyze the security of a sessional blind signature protocol based on quantum cryptograph and show that there are two security leaks in this protocol. One is that the legal user Alice can change the signed message after she gets a valid blind signature from the signatory Bob, and the other is that an external opponent Eve also can forge a valid blind message by a special attack, which are not permitted for blind signature. Therefore, this protocol is not secure in the sense that it does not satisfy the non-forgeability of blind signatures. We also discuss the methods to prevent the attack strategies in the end.

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

PubMed

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.

Validation of a school-based amblyopia screening protocol in a kindergarten population.

PubMed

Casas-Llera, Pilar; Ortega, Paula; Rubio, Inmaculada; Santos, Verónica; Prieto, María J; Alio, Jorge L

2016-08-04

To validate a school-based amblyopia screening program model by comparing its outcomes to those of a state-of-the-art conventional ophthalmic clinic examination in a kindergarten population of children between the ages of 4 and 5 years. An amblyopia screening protocol, which consisted of visual acuity measurement using Lea charts, ocular alignment test, ocular motility assessment, and stereoacuity with TNO random-dot test, was performed at school in a pediatric 4- to 5-year-old population by qualified healthcare professionals. The outcomes were validated in a selected group by a conventional ophthalmologic examination performed in a fully equipped ophthalmologic center. The ophthalmologic evaluation was used to confirm whether or not children were correctly classified by the screening protocol. The sensitivity and specificity of the test model to detect amblyopia were established. A total of 18,587 4- to 5-year-old children were subjected to the amblyopia screening program during the 2010-2011 school year. A population of 100 children were selected for the ophthalmologic validation screening. A sensitivity of 89.3%, specificity of 93.1%, positive predictive value of 83.3%, negative predictive value of 95.7%, positive likelihood ratio of 12.86, and negative likelihood ratio of 0.12 was obtained for the amblyopia screening validation model. The amblyopia screening protocol model tested in this investigation shows high sensitivity and specificity in detecting high-risk cases of amblyopia compared to the standard ophthalmologic examination. This screening program may be highly relevant for amblyopia screening at schools.

[Ventilatory dysfunction in motor neuron disease: when and how to act?].

PubMed

Rocha, J Afonso; Miranda, M J

2007-01-01

Amyotrophic lateral sclerosis is a devastating progressive neurodegenerative disorder, involving motor neurons in the cerebral cortex, brainstem and spinal cord. Mean duration of survival from the time of diagnosis is around 15 months, being pulmonary complications and respiratory failure responsible for more than 85% of deaths. Albeit the inevitability of respiratory failure and short-term death, standardized intervention protocols have been shown to significantly delay the need for invasive ventilatory support, thus prolonging survival and enhancing quality of life. The authors present an intervention protocol based on clinical progression and respiratory parameters. Decisions regarding initiation of non-invasive positive pressure ventilation (NIPPV) and mechanically assisted coughing, depend on development of symptoms of hypoventilation and on objective deterioration of respiratory parameters especially in what concerns bulbar muscle function. These include maximum inspiratory capacity (MIC), difference between MIC and vital capacity (MIC-VC), and assisted peak cough flow (PCF). These standardized protocols along with patient and caregivers education, allow for improved quality of life, prolonged survival and delay or eventually prevent the need for tracheotomy and invasive ventilatory support. Supplemental oxygen should be avoided in these patients, since it precludes use of oxymetry as feedback for titrating NIPPV and MAC, and is associated with decreased ventilatory drive and aggravated hypercapnia.

A formal protocol test procedure for the Survivable Adaptable Fiber Optic Embedded Network (SAFENET)

NASA Astrophysics Data System (ADS)

High, Wayne

1993-03-01

This thesis focuses upon a new method for verifying the correct operation of a complex, high speed fiber optic communication network. These networks are of growing importance to the military because of their increased connectivity, survivability, and reconfigurability. With the introduction and increased dependence on sophisticated software and protocols, it is essential that their operation be correct. Because of the speed and complexity of fiber optic networks being designed today, they are becoming increasingly difficult to test. Previously, testing was accomplished by application of conformance test methods which had little connection with an implementation's specification. The major goal of conformance testing is to ensure that the implementation of a profile is consistent with its specification. Formal specification is needed to ensure that the implementation performs its intended operations while exhibiting desirable behaviors. The new conformance test method presented is based upon the System of Communicating Machine model which uses a formal protocol specification to generate a test sequence. The major contribution of this thesis is the application of the System of Communicating Machine model to formal profile specifications of the Survivable Adaptable Fiber Optic Embedded Network (SAFENET) standard which results in the derivation of test sequences for a SAFENET profile. The results applying this new method to SAFENET's OSI and Lightweight profiles are presented.

Systemic Chemotherapy using FLOT - Regimen Combined with Cytoreductive Surgery plus HIPEC for Treatment of Peritoneal Metastasized Gastric Cancer. .

PubMed

Müller, H; Hotopp, Th; Tofeili, A; Wutke, K

2014-05-01

The aim was to evaluate the feasibility and the effectiveness of neoadjuvant systemic chemotherapy using FLOT - protocol followed by cytoreductive surgery (CRS), hyperthermic intraperitoneal chemotherapy (HIPEC) followed by systemic chemotherapyand in patients with peritoneal carciriomatosis (PC) from gastric cancer. Twenty six (median age 53 years, range 39 - 71) were scheduled for three cycles of neoadjuvant systemic chemotherapy using bi-weekly FLOT - protocol followed by CRS + HIPEC. Thereafter 3 additional cycles of FLOT were given. During HIPEC in Colliseum technique Oxaliplatin was given in a dosage of 200 mg/m2 and Docetaxel in a dosage of 80 mg/m2. All patients underwent cytoreductive surgery plus HIPEC. Peritoneal Cancer index was > 15 in 3 cases only. Complete resection could be carried out in all cases (CC-O 18, CC-18). Postoperative complication rate was 23% with no mortality within 30 days. Anastomotic leakage rate was 3.2%. Overall survival was 19.0 months with a 2-year survival rate 38%. Regression analysis demonstrated a Peritoneal Cancer Index PCI > 12 as negative factor for survival. Neoadju- vant chemotherapy using FLOT - protocol followed by CRS + HIPEC seems to be associated with prolonged OS in patients with peritoneal carcinomatosis from gastric cancer. This treatment is not recommended for patients with extensive peritoneal involvement and PCI > 12.

How do we estimate survival? External validation of a tool for survival estimation in patients with metastatic bone disease-decision analysis and comparison of three international patient populations.

PubMed

Piccioli, Andrea; Spinelli, M Silvia; Forsberg, Jonathan A; Wedin, Rikard; Healey, John H; Ippolito, Vincenzo; Daolio, Primo Andrea; Ruggieri, Pietro; Maccauro, Giulio; Gasbarrini, Alessandro; Biagini, Roberto; Piana, Raimondo; Fazioli, Flavio; Luzzati, Alessandro; Di Martino, Alberto; Nicolosi, Francesco; Camnasio, Francesco; Rosa, Michele Attilio; Campanacci, Domenico Andrea; Denaro, Vincenzo; Capanna, Rodolfo

2015-05-22

We recently developed a clinical decision support tool, capable of estimating the likelihood of survival at 3 and 12 months following surgery for patients with operable skeletal metastases. After making it publicly available on www.PATHFx.org , we attempted to externally validate it using independent, international data. We collected data from patients treated at 13 Italian orthopaedic oncology referral centers between 2010 and 2013, then applied to PATHFx, which generated a probability of survival at three and 12-months for each patient. We assessed accuracy using the area under the receiver-operating characteristic curve (AUC), clinical utility using Decision Curve Analysis (DCA), and compared the Italian patient data to the training set (United States) and first external validation set (Scandinavia). The Italian dataset contained 287 records with at least 12 months follow-up information. The AUCs for the three-month and 12-month estimates was 0.80 and 0.77, respectively. There were missing data, including the surgeon's estimate of survival that was missing in the majority of records. Physiologically, Italian patients were similar to patients in the training and first validation sets. However notable differences were observed in the proportion of those surviving three and 12-months, suggesting differences in referral patterns and perhaps indications for surgery. PATHFx was successfully validated in an Italian dataset containing missing data. This study demonstrates its broad applicability to European patients, even in centers with differing treatment philosophies from those previously studied.

Working towards accreditation by the International Standards Organization 15189 Standard: how to validate an in-house developed method an example of lead determination in whole blood by electrothermal atomic absorption spectrometry.

PubMed

Garcia Hejl, Carine; Ramirez, Jose Manuel; Vest, Philippe; Chianea, Denis; Renard, Christophe

2014-09-01

Laboratories working towards accreditation by the International Standards Organization (ISO) 15189 standard are required to demonstrate the validity of their analytical methods. The different guidelines set by various accreditation organizations make it difficult to provide objective evidence that an in-house method is fit for the intended purpose. Besides, the required performance characteristics tests and acceptance criteria are not always detailed. The laboratory must choose the most suitable validation protocol and set the acceptance criteria. Therefore, we propose a validation protocol to evaluate the performance of an in-house method. As an example, we validated the process for the detection and quantification of lead in whole blood by electrothermal absorption spectrometry. The fundamental parameters tested were, selectivity, calibration model, precision, accuracy (and uncertainty of measurement), contamination, stability of the sample, reference interval, and analytical interference. We have developed a protocol that has been applied successfully to quantify lead in whole blood by electrothermal atomic absorption spectrometry (ETAAS). In particular, our method is selective, linear, accurate, and precise, making it suitable for use in routine diagnostics.

VAC protocol for treatment of dogs with stage III hemangiosarcoma.

PubMed

Alvarez, Francisco J; Hosoya, Kenji; Lara-Garcia, Ana; Kisseberth, William; Couto, Guillermo

2013-01-01

Hemangiosarcomas (HSAs) are aggressive tumors with a high rate of metastasis. Clinical stage has been considered a negative prognostic factor for survival. The study authors hypothesized that the median survival time (MST) of dogs with metastatic (stage III) HSA treated with a vincristine, doxorubicin, and cyclophosphamide (VAC) chemotherapy protocol would not be different than those with stage I/II HSA. Sixty-seven dogs with HSA in different anatomic locations were evaluated retrospectively. All dogs received the VAC protocol as an adjuvant to surgery (n = 50), neoadjuvant (n = 3), or as the sole treatment modality (n = 14). There was no significant difference (P = 0.97) between the MST of dogs with stage III and stage I/II HSA. For dogs presenting with splenic HSA alone, there was no significant difference between the MST of dogs with stage III and stage I/II disease (P = 0.12). The overall response rate (complete response [CR] and partial response [PR]) was 86%). No unacceptable toxicities were observed. Dogs with stage III HSA treated with the VAC protocol have a similar prognosis to dogs with stage I/II HSA. Dogs with HSA and evidence of metastases at the time of diagnosis should not be denied treatment.

Multitask protocols to evaluate activities of daily living performance in people with COPD: a systematic review.

PubMed

Paes, Thaís; Machado, Felipe Vilaça Cavallari; Cavalheri, Vinícius; Pitta, Fabio; Hernandes, Nidia Aparecida

2017-07-01

People with chronic obstructive pulmonary disease (COPD) present symptoms such as dyspnea and fatigue, which hinder their performance in activities of daily living (ADL). A few multitask protocols have been developed to assess ADL performance in this population, although measurement properties of such protocols were not yet systematically reviewed. Areas covered: Studies were included if an assessment of the ability to perform ADL was conducted in people with COPD using a (objective) performance-based protocol. The search was conducted in the following databases: Pubmed, EMBASE, Cochrane Library, PEDro, CINAHL and LILACS. Furthermore, hand searches were conducted. Expert commentary: Up to this moment, only three protocols had measurement properties described: the Glittre ADL Test, the Monitored Functional Task Evaluation and the Londrina ADL Protocol were shown to be valid and reliable whereas only the Glittre ADL Test was shown to be responsive to change after pulmonary rehabilitation. These protocols can be used in laboratory settings and clinical practice to evaluate ADL performance in people with COPD, although there is need for more in-depth information on their validity, reliability and especially responsiveness due to the growing interest in the accurate assessment of ADL performance in this population.

Differential high pressure survival in stationary-phase Escherichia coli MG1655

NASA Astrophysics Data System (ADS)

Griffin, Patrick L.; Kish, Adrienne; Steele, Andrew; Hemley, Russell J.

2011-06-01

Hydrostatic pressure exerts a profound influence on nearly all facets of cellular structure and function with exposures to sufficiently high pressure leading to microbial inactivation. We report the first observation of a persistent, pressure-resistant subpopulation within stationary-phase samples of Escherichia coli MG1655, a mesophilic bacterium adapted to surface pressure. This high pressure-resistant subpopulation exhibits pressure survival ranging from 0.6 to 2.0 orders of magnitude greater survival than high pressure treatments at pressures of 225-400 MPa. We also examine some aspects of pressure treatment protocol that may influence the measurements of high pressure survival.

Simultaneous validation of the Grandway MD2301 digital automatic blood pressure monitor by the British Hypertension Society and the Association for the Advancement of Medical Instrumentation/the International Organization for Standardization protocols.

PubMed

Huang, Jinhua; Wang, Yun; Liu, Zhaoying; Wang, Yuling

2017-02-01

The aim of this study was to determine the accuracy of the Grandway MD2301 digital automatic blood pressure monitor by the British Hypertension Society (BHS) and the Association for the Advancement of Medical Instrumentation (AAMI)/the International Organization for Standardization (ISO) protocols. A total of 85 participants were included for evaluation based on the requirements of the BHS and the AAMI/ISO protocols. The validation procedure and data analysis followed the protocols precisely. The device achieved A/A grading for the BHS protocol and maintained A/A grading throughout the low, medium and high blood pressure ranges. The device also fulfilled the requirement of the AAMI/ISO protocol with device-observer differences of -0.9±5.6 and 0.8±5.2 mmHg for systolic and diastolic blood pressure, respectively, for criterion 1, and -0.9±4.7 and 0.8±4.2 mmHg, respectively, for criterion 2. The Grandway MD2301 digital automatic blood pressure monitor achieved A/A grade of the BHS protocol and passed the requirements of the AAMI/ISO protocol in adults.

Electronic data collection for the analysis of surgical maneuvers on patients submitted to rhinoplasty

PubMed Central

Berger, Cezar; Freitas, Renato; Malafaia, Osvaldo; Pinto, José Simão de Paula; Mocellin, Marcos; Macedo, Evaldo; Fagundes, Marina Serrato Coelho

2012-01-01

Summary Introduction: In the health field, computerization has become increasingly necessary in professional practice, since it facilitates data recovery and assists in the development of research with greater scientific rigor. Objective: the present work aimed to develop, apply, and validate specific electronic protocols for patients referred for rhinoplasty. Methods: The prospective research had 3 stages: (1) preparation of theoretical data bases; (2) creation of a master protocol using Integrated System of Electronic Protocol (SINPE©); and (3) elaboration, application, and validation of a specific protocol for the nose and sinuses regarding rhinoplasty. Results: After the preparation of the master protocol, which dealt with the entire field of otorhinolaryngology, we idealized a specific protocol containing all matters related to the patient. In particular, the aesthetic and functional nasal complaints referred for surgical treatment (i.e., rhinoplasty) were organized into 6 main hierarchical categories: anamnesis, physical examination, complementary exams, diagnosis, treatment, and outcome. This protocol utilized these categories and their sub-items: finality; access; surgical maneuvers on the nasal dorsum, tip, and base; clinical evolution after 3, 6, and 12 months; revisional surgery; and quantitative and qualitative evaluations. Conclusion: The developed electronic-specific protocol is feasible and important for information registration from patients referred to rhinoplasty. PMID:25991979

Prediction of Conditional Probability of Survival After Surgery for Gastric Cancer: A Study Based on Eastern and Western Large Data Sets.

PubMed

Zhong, Qing; Chen, Qi-Yue; Li, Ping; Xie, Jian-Wei; Wang, Jia-Bin; Lin, Jian-Xian; Lu, Jun; Cao, Long-Long; Lin, Mi; Tu, Ru-Hong; Zheng, Chao-Hui; Huang, Chang-Ming

2018-04-20

The dynamic prognosis of patients who have undergone curative surgery for gastric cancer has yet to be reported. Our objective was to devise an accurate tool for predicting the conditional probability of survival for these patients. We analyzed 11,551 gastric cancer patients from the Surveillance, Epidemiology, and End Results database. Two-thirds of the patients were selected randomly for the development set and one-third for the validation set. Two nomograms were constructed to predict the conditional probability of overall survival and the conditional probability of disease-specific survival, using conditional survival methods. We then applied these nomograms to the 4,001 patients in the database from Fujian Medical University Union Hospital, Fuzhou, China, one of the most active Chinese institutes. The 5-year conditional probability of overall survival of the patients was 41.6% immediately after resection and increased to 52.8%, 68.2%, and 80.4% at 1, 2, and 3 years after gastrectomy. The 5-year conditional probability of disease-specific survival "increased" from 48.9% at the time of gastrectomy to 59.8%, 74.7%, and 85.5% for patients surviving 1, 2, and 3 years, respectively. Sex; race; age; depth of tumor invasion; lymph node metastasis; and tumor size, site, and grade were associated with overall survival and disease-specific survival (P <.05). Within the Surveillance, Epidemiology, and End Results validation set, the accuracy of the conditional probability of overall survival nomogram was 0.77, 0.81, 0.82, and 0.82 at 1, 3, 5, and 10 years after gastrectomy, respectively. Within the other validation set from the Fujian Medical University Union Hospital (n = 4,001), the accuracy of the conditional probability of overall survival nomogram was 0.76, 0.79, 0.77, and 0.77 at 1, 3, 5, and 10 years, respectively. The accuracy of the conditional probability of disease-specific survival model was also favorable. The calibration curve demonstrated good agreement between the predicted and observed survival rates. Based on the large Eastern and Western data sets, we developed and validated the first conditional nomogram for prediction of conditional probability of survival for patients with gastric cancer to allow consideration of the duration of survivorship. Copyright © 2018 Elsevier Inc. All rights reserved.

Clinical Applicability and Cutoff Values for an Unstructured Neuropsychological Assessment Protocol for Older Adults with Low Formal Education

PubMed Central

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

Background and Objectives 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. Methods and Results 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. Conclusion 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. PMID:24066031

Combining accuracy assessment of land-cover maps with environmental monitoring programs

USGS Publications Warehouse

Stehman, S.V.; Czaplewski, R.L.; Nusser, S.M.; Yang, L.; Zhu, Z.

2000-01-01

A scientifically valid accuracy assessment of a large-area, land-cover map is expensive. Environmental monitoring programs offer a potential source of data to partially defray the cost of accuracy assessment while still maintaining the statistical validity. In this article, three general strategies for combining accuracy assessment and environmental monitoring protocols are described. These strategies range from a fully integrated accuracy assessment and environmental monitoring protocol, to one in which the protocols operate nearly independently. For all three strategies, features critical to using monitoring data for accuracy assessment include compatibility of the land-cover classification schemes, precisely co-registered sample data, and spatial and temporal compatibility of the map and reference data. Two monitoring programs, the National Resources Inventory (NRI) and the Forest Inventory and Monitoring (FIM), are used to illustrate important features for implementing a combined protocol.

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

PubMed

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

2015-01-02

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

A common rejection module (CRM) for acute rejection across multiple organs identifies novel therapeutics for organ transplantation

PubMed Central

Khatri, Purvesh; Roedder, Silke; Kimura, Naoyuki; De Vusser, Katrien; Morgan, Alexander A.; Gong, Yongquan; Fischbein, Michael P.; Robbins, Robert C.; Naesens, Maarten

2013-01-01

Using meta-analysis of eight independent transplant datasets (236 graft biopsy samples) from four organs, we identified a common rejection module (CRM) consisting of 11 genes that were significantly overexpressed in acute rejection (AR) across all transplanted organs. The CRM genes could diagnose AR with high specificity and sensitivity in three additional independent cohorts (794 samples). In another two independent cohorts (151 renal transplant biopsies), the CRM genes correlated with the extent of graft injury and predicted future injury to a graft using protocol biopsies. Inferred drug mechanisms from the literature suggested that two FDA-approved drugs (atorvastatin and dasatinib), approved for nontransplant indications, could regulate specific CRM genes and reduce the number of graft-infiltrating cells during AR. We treated mice with HLA-mismatched mouse cardiac transplant with atorvastatin and dasatinib and showed reduction of the CRM genes, significant reduction of graft-infiltrating cells, and extended graft survival. We further validated the beneficial effect of atorvastatin on graft survival by retrospective analysis of electronic medical records of a single-center cohort of 2,515 renal transplant patients followed for up to 22 yr. In conclusion, we identified a CRM in transplantation that provides new opportunities for diagnosis, drug repositioning, and rational drug design. PMID:24127489

A common rejection module (CRM) for acute rejection across multiple organs identifies novel therapeutics for organ transplantation.

PubMed

Khatri, Purvesh; Roedder, Silke; Kimura, Naoyuki; De Vusser, Katrien; Morgan, Alexander A; Gong, Yongquan; Fischbein, Michael P; Robbins, Robert C; Naesens, Maarten; Butte, Atul J; Sarwal, Minnie M

2013-10-21

Using meta-analysis of eight independent transplant datasets (236 graft biopsy samples) from four organs, we identified a common rejection module (CRM) consisting of 11 genes that were significantly overexpressed in acute rejection (AR) across all transplanted organs. The CRM genes could diagnose AR with high specificity and sensitivity in three additional independent cohorts (794 samples). In another two independent cohorts (151 renal transplant biopsies), the CRM genes correlated with the extent of graft injury and predicted future injury to a graft using protocol biopsies. Inferred drug mechanisms from the literature suggested that two FDA-approved drugs (atorvastatin and dasatinib), approved for nontransplant indications, could regulate specific CRM genes and reduce the number of graft-infiltrating cells during AR. We treated mice with HLA-mismatched mouse cardiac transplant with atorvastatin and dasatinib and showed reduction of the CRM genes, significant reduction of graft-infiltrating cells, and extended graft survival. We further validated the beneficial effect of atorvastatin on graft survival by retrospective analysis of electronic medical records of a single-center cohort of 2,515 renal transplant patients followed for up to 22 yr. In conclusion, we identified a CRM in transplantation that provides new opportunities for diagnosis, drug repositioning, and rational drug design.

International Program to Monitor Cat Flea Populations for Susceptibility to Imidacloprid.

PubMed

Rust, M K; Blagburn, B L; Denholm, I; Dryden, M W; Payne, P; Hinkle, N C; Kopp, S; Williamson, M

2018-06-20

An international team of scientists and veterinarians was assembled in 1999 to develop a monitoring program to determine the susceptibility of cat fleas, Ctenocephalides felis felis (Bouché) (Siphonaptera: Pulicidae), to imidacloprid. Cat flea eggs were collected, shipped to laboratories, and tested for their susceptibility to imidacloprid. Over 3,000 C. felis populations were collected from 2002 to 2017 from 10 different countries. Of these, 66.3% were collected from cats and 33.7% from dogs. C. f. felis populations (n = 2,200) were bioassayed by exposing cat flea eggs and the emerging larvae to a Diagnostic Dose (DD) of 3 ppm imidacloprid in larval rearing medium. Flea eggs hatched and developed in the untreated controls in 1,837 of the isolates (83.5%) bioassayed. Flea isolates (n = 61) that had ≥5% survival at the DD of 3 ppm were retested with a second DD of 3 ppm. None of them had ≥5% survival to the second dose of 3 ppm. Of the 1,837 valid C. felis isolates tested, there has been no evidence of a decreased susceptibility to imidacloprid over the past 17 yr. The methods outlined in this article should provide an acceptable protocol for testing many of the new active ingredients that have been registered for cat flea control.

PTEN Loss as Determined by Clinical-grade Immunohistochemistry Assay Is Associated with Worse Recurrence-free Survival in Prostate Cancer.

PubMed

Lotan, Tamara L; Wei, Wei; Morais, Carlos L; Hawley, Sarah T; Fazli, Ladan; Hurtado-Coll, Antonio; Troyer, Dean; McKenney, Jesse K; Simko, Jeffrey; Carroll, Peter R; Gleave, Martin; Lance, Raymond; Lin, Daniel W; Nelson, Peter S; Thompson, Ian M; True, Lawrence D; Feng, Ziding; Brooks, James D

2016-06-01

PTEN is the most commonly deleted tumor suppressor gene in primary prostate cancer (PCa) and its loss is associated with poor clinical outcomes and ERG gene rearrangement. We tested whether PTEN loss is associated with shorter recurrence-free survival (RFS) in surgically treated PCa patients with known ERG status. A genetically validated, automated PTEN immunohistochemistry (IHC) protocol was used for 1275 primary prostate tumors from the Canary Foundation retrospective PCa tissue microarray cohort to assess homogeneous (in all tumor tissue sampled) or heterogeneous (in a subset of tumor tissue sampled) PTEN loss. ERG status as determined by a genetically validated IHC assay was available for a subset of 938 tumors. Associations between PTEN and ERG status were assessed using Fisher's exact test. Kaplan-Meier and multivariate weighted Cox proportional models for RFS were constructed. When compared to intact PTEN, homogeneous (hazard ratio [HR] 1.66, p = 0.001) but not heterogeneous (HR 1.24, p = 0.14) PTEN loss was significantly associated with shorter RFS in multivariate models. Among ERG-positive tumors, homogeneous (HR 3.07, p < 0.0001) but not heterogeneous (HR 1.46, p = 0.10) PTEN loss was significantly associated with shorter RFS. Among ERG-negative tumors, PTEN did not reach significance for inclusion in the final multivariate models. The interaction term for PTEN and ERG status with respect to RFS did not reach statistical significance ( p = 0.11) for the current sample size. These data suggest that PTEN is a useful prognostic biomarker and that there is no statistically significant interaction between PTEN and ERG status for RFS. We found that loss of the PTEN tumor suppressor gene in prostate tumors as assessed by tissue staining is correlated with shorter time to prostate cancer recurrence after radical prostatectomy.

Childhood Hodgkin International Prognostic Score (CHIPS) Predicts event-free survival in Hodgkin Lymphoma: A Report from the Children’s Oncology Group

PubMed Central

Schwartz, Cindy L.; Chen, Lu; McCarten, Kathleen; Wolden, Suzanne; Constine, Louis S.; Hutchison, Robert E.; de Alarcon, Pedro A.; Keller, Frank G.; Kelly, Kara M.; Trippet, Tanya A.; Voss, Stephan D.; Friedman, Debra L.

2017-01-01

Background Early response to initial chemotherapy in Hodgkin lymphoma (HL) measured by computed tomography (CT) and/or positron emission tomography (PET) after two to three cycles of chemotherapy may inform therapeutic decisions. Risk stratification at diagnosis could, however, allow earlier and potentially more efficacious treatment modifications. Patients and Methods We developed a predictive model for event-free survival (EFS) in pediatric/adolescent HL using clinical data known at diagnosis from 1103 intermediate-risk HL patients treated on Children’s Oncology Group protocol AHOD0031 with doxorubicin, bleomycin, vincristine, etoposide, prednisone, cyclophosphamide (ABVE-PC) chemotherapy and radiation. Independent predictors of EFS were identified and used to develop and validate a prognostic score (Childhood Hodgkin International Prognostic Score [CHIPS]). A training cohort was randomly selected to include approximately half of the overall cohort, with the remainder forming the validation cohort. Results Stage 4 disease, large mediastinal mass, albumin (<3.5), and fever were independent predictors of EFS that were each assigned one point in the CHIPS. Four-year EFS was 93.1% for patients with CHIPS = 0, 88.5% for patients with CHIPS = 1, 77.6% for patients with CHIPS = 2, and 69.2% for patients with CHIPS = 3. Conclusions CHIPS was highly predictive of EFS, identifying a subset (with CHIPS 2 or 3) that comprises 27% of intermediate-risk patients who have a 4-year EFS of <80% and who may benefit from early therapeutic augmentation. Furthermore, CHIPS identified higher risk patients who were not identified by early PET or CT response. CHIPS is a robust and inexpensive approach to predicting risk in patients with intermediate-risk HL that may improve ability to tailor therapy to risk factors known at diagnosis. PMID:27786406

Childhood Hodgkin International Prognostic Score (CHIPS) Predicts event-free survival in Hodgkin Lymphoma: A Report from the Children's Oncology Group.

PubMed

Schwartz, Cindy L; Chen, Lu; McCarten, Kathleen; Wolden, Suzanne; Constine, Louis S; Hutchison, Robert E; de Alarcon, Pedro A; Keller, Frank G; Kelly, Kara M; Trippet, Tanya A; Voss, Stephan D; Friedman, Debra L

2017-04-01

Early response to initial chemotherapy in Hodgkin lymphoma (HL) measured by computed tomography (CT) and/or positron emission tomography (PET) after two to three cycles of chemotherapy may inform therapeutic decisions. Risk stratification at diagnosis could, however, allow earlier and potentially more efficacious treatment modifications. We developed a predictive model for event-free survival (EFS) in pediatric/adolescent HL using clinical data known at diagnosis from 1103 intermediate-risk HL patients treated on Children's Oncology Group protocol AHOD0031 with doxorubicin, bleomycin, vincristine, etoposide, prednisone, cyclophosphamide (ABVE-PC) chemotherapy and radiation. Independent predictors of EFS were identified and used to develop and validate a prognostic score (Childhood Hodgkin International Prognostic Score [CHIPS]). A training cohort was randomly selected to include approximately half of the overall cohort, with the remainder forming the validation cohort. Stage 4 disease, large mediastinal mass, albumin (<3.5), and fever were independent predictors of EFS that were each assigned one point in the CHIPS.  Four-year EFS was 93.1% for patients with CHIPS = 0, 88.5% for patients with CHIPS = 1, 77.6% for patients with CHIPS = 2, and 69.2% for patients with CHIPS = 3. CHIPS was highly predictive of EFS, identifying a subset (with CHIPS 2 or 3) that comprises 27% of intermediate-risk patients who have a 4-year EFS of <80% and who may benefit from early therapeutic augmentation.  Furthermore, CHIPS identified higher risk patients who were not identified by early PET or CT response. CHIPS is a robust and inexpensive approach to predicting risk in patients with intermediate-risk HL that may improve ability to tailor therapy to risk factors known at diagnosis. © 2016 Wiley Periodicals, Inc.

Utility of Survival Motor Neuron ELISA for Spinal Muscular Atrophy Clinical and Preclinical Analyses

PubMed Central

Kobayashi, Dione T.; Olson, Rory J.; Sly, Laurel; Swanson, Chad J.; Chung, Brett; Naryshkin, Nikolai; Narasimhan, Jana; Bhattacharyya, Anuradha; Mullenix, Michael; Chen, Karen S.

2011-01-01

Objectives Genetic defects leading to the reduction of the survival motor neuron protein (SMN) are a causal factor for Spinal Muscular Atrophy (SMA). While there are a number of therapies under evaluation as potential treatments for SMA, there is a critical lack of a biomarker method for assessing efficacy of therapeutic interventions, particularly those targeting upregulation of SMN protein levels. Towards this end we have engaged in developing an immunoassay capable of accurately measuring SMN protein levels in blood, specifically in peripheral blood mononuclear cells (PBMCs), as a tool for validating SMN protein as a biomarker in SMA. Methods A sandwich enzyme-linked immunosorbent assay (ELISA) was developed and validated for measuring SMN protein in human PBMCs and other cell lysates. Protocols for detection and extraction of SMN from transgenic SMA mouse tissues were also developed. Results The assay sensitivity for human SMN is 50 pg/mL. Initial analysis reveals that PBMCs yield enough SMN to analyze from blood volumes of less than 1 mL, and SMA Type I patients' PBMCs show ∼90% reduction of SMN protein compared to normal adults. The ELISA can reliably quantify SMN protein in human and mouse PBMCs and muscle, as well as brain, and spinal cord from a mouse model of severe SMA. Conclusions This SMN ELISA assay enables the reliable, quantitative and rapid measurement of SMN in healthy human and SMA patient PBMCs, muscle and fibroblasts. SMN was also detected in several tissues in a mouse model of SMA, as well as in wildtype mouse tissues. This SMN ELISA has general translational applicability to both preclinical and clinical research efforts. PMID:21904622

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

PubMed Central

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

2016-01-01

Introduction There is an increasing number of new oncology drugs being studied, approved and put into clinical practice based on improvement in progression-free survival, when no overall survival benefits exist. In oncology, the association between progression-free survival and health-related quality of life is currently unknown, despite its importance for patients with cancer, and the unverified assumption that longer progression-free survival indicates improved health-related quality of life. Thus far, only 1 study has investigated this association, providing insufficient evidence and inconclusive results. The objective of this study protocol is to provide increased transparency in supporting a systematic summary of the evidence bearing on this association in oncology. Methods and analysis Using the OVID platform in MEDLINE, Embase and Cochrane databases, we will conduct a systematic review of randomised controlled human trials addressing oncology issues published starting in 2000. A team of reviewers will, in pairs, independently screen and abstract data using standardised, pilot-tested forms. We will employ numerical integration to calculate mean incremental area under the curve between treatment groups in studies for health-related quality of life, along with total related error estimates, and a 95% CI around incremental area. To describe the progression-free survival to health-related quality of life association, we will construct a scatterplot for incremental health-related quality of life versus incremental progression-free survival. To estimate the association, we will use a weighted simple regression approach, comparing mean incremental health-related quality of life with either median incremental progression-free survival time or the progression-free survival HR, in the absence of overall survival benefit. Discussion Identifying direction and magnitude of association between progression-free survival and health-related quality of life is critically important in interpreting results of oncology trials. Systematic evidence produced from our study will contribute to improvement of patient care and practice of evidence-based medicine in oncology. PMID:27591026

Spontaneous Swallow Frequency Compared with Clinical Screening in the Identification of Dysphagia in Acute Stroke

PubMed Central

Crary, Michael A.; Carnaby, Giselle D.; Sia, Isaac

2017-01-01

Background The aim of this study was to compare spontaneous swallow frequency analysis (SFA) with clinical screening protocols for identification of dysphagia in acute stroke. Methods In all, 62 patients with acute stroke were evaluated for spontaneous swallow frequency rates using a validated acoustic analysis technique. Independent of SFA, these same patients received a routine nurse-administered clinical dysphagia screening as part of standard stroke care. Both screening tools were compared against a validated clinical assessment of dysphagia for acute stroke. In addition, psychometric properties of SFA were compared against published, validated clinical screening protocols. Results Spontaneous SFA differentiates patients with versus without dysphagia after acute stroke. Using a previously identified cut point based on swallows per minute, spontaneous SFA demonstrated superior ability to identify dysphagia cases compared with a nurse-administered clinical screening tool. In addition, spontaneous SFA demonstrated equal or superior psychometric properties to 4 validated, published clinical dysphagia screening tools. Conclusions Spontaneous SFA has high potential to identify dysphagia in acute stroke with psychometric properties equal or superior to clinical screening protocols. PMID:25088166

Spontaneous swallow frequency compared with clinical screening in the identification of dysphagia in acute stroke.

PubMed

Crary, Michael A; Carnaby, Giselle D; Sia, Isaac

2014-09-01

The aim of this study was to compare spontaneous swallow frequency analysis (SFA) with clinical screening protocols for identification of dysphagia in acute stroke. In all, 62 patients with acute stroke were evaluated for spontaneous swallow frequency rates using a validated acoustic analysis technique. Independent of SFA, these same patients received a routine nurse-administered clinical dysphagia screening as part of standard stroke care. Both screening tools were compared against a validated clinical assessment of dysphagia for acute stroke. In addition, psychometric properties of SFA were compared against published, validated clinical screening protocols. Spontaneous SFA differentiates patients with versus without dysphagia after acute stroke. Using a previously identified cut point based on swallows per minute, spontaneous SFA demonstrated superior ability to identify dysphagia cases compared with a nurse-administered clinical screening tool. In addition, spontaneous SFA demonstrated equal or superior psychometric properties to 4 validated, published clinical dysphagia screening tools. Spontaneous SFA has high potential to identify dysphagia in acute stroke with psychometric properties equal or superior to clinical screening protocols. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Triage and optimization: A new paradigm in the treatment of massive pulmonary embolism.

PubMed

Pasrija, Chetan; Shah, Aakash; George, Praveen; Kronfli, Anthony; Raithel, Maxwell; Boulos, Francesca; Ghoreishi, Mehrdad; Bittle, Gregory J; Mazzeffi, Michael A; Rubinson, Lewis; Gammie, James S; Griffith, Bartley P; Kon, Zachary N

2018-04-07

Massive pulmonary embolism (PE) remains a highly fatal condition. Although venoarterial extracorporeal membrane oxygenation (VA-ECMO) and surgical pulmonary embolectomy in the management of massive PE have been reported previously, the outcomes remain less than ideal. We hypothesized that the institution of a protocolized approach of triage and optimization using VA-ECMO would result in improved outcomes compared with historical surgical management. All patients with a massive PE referred to the cardiac surgery service between 2010 and 2017 were retrospectively reviewed. Patients were stratified by treatment strategy: historical control versus the protocolized approach. In the historical control group, the primary intervention was surgical pulmonary embolectomy. In the protocol approach group, patients were treated based on an algorithmic approach using VA-ECMO. The primary outcome was 1-year survival. A total of 56 patients (control, n = 27; protocol, n = 29) were identified. All 27 patients in the historical control group underwent surgical pulmonary embolectomy, whereas 2 of 29 patients in the protocol approach group were deemed appropriate for direct surgical pulmonary embolectomy. The remaining 27 patients were placed on VA-ECMO. In the protocol approach group, 15 of 29 patients were treated with anticoagulation alone and 14 patients ultimately required surgical pulmonary embolectomy. One-year survival was significantly lower in the historical control group compared with the protocol approach group (73% vs 96%; P = .02), with no deaths occurring after surgical pulmonary embolectomy in the protocol approach group. A protocolized strategy involving the aggressive institution of VA-ECMO appears to be an effective method to triage and optimize patients with massive PE to recovery or intervention. Implementation of this strategy rather than an aggressive surgical approach may reduce the mortality associated with massive PE. Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Adjuvant and induction chemotherapy in non-small cell lung cancer.

PubMed

Pirker, R; Malayeri, R; Huber, H

1999-01-01

About 25%-30% of patients with non-small cell lung cancer can be resected with curative intent. However, systemic relapses occur in up to 70% of these patients. Thus, postoperative adjuvant chemotherapy was evaluated in several randomised trials but the results of these trials were inconclusive with a survival benefit only in some trials. Shortcomings of these trials included low number of patients, poor patient compliance and inadequate chemotherapy protocols. A recent meta-analysis suggested an absolute survival benefit of 5% at five years for postoperative cisplatin-based chemotherapy as compared to surgery alone. Thus adjuvant chemotherapy with both improved chemotherapy protocols and improved anti-emetics is currently re-evaluated in several randomised trials on large patient populations.

Impact of Inoculation Protocols, Salinity, and pH on the Degradation of Polycyclic Aromatic Hydrocarbons (PAHs) and Survival of PAH-Degrading Bacteria Introduced into Soil

PubMed Central

Kästner, Matthias; Breuer-Jammali, Maren; Mahro, Bernd

1998-01-01

Degradation of polycyclic aromatic hydrocarbons (PAHs) and survival of bacteria in soil was investigated by applying different inoculation protocols. The soil was inoculated with Sphingomonas paucimobilis BA 2 and strain BP 9, which are able to degrade anthracene and pyrene, respectively. CFU of soil bacteria and of the introduced bacteria were monitored in native and sterilized soil at different pHs. Introduction with mineral medium inhibited PAH degradation by the autochthonous microflora and by the strains tested. After introduction with water (without increase of the pore water salinity), no inhibition of the autochthonous microflora was observed and both strains exhibited PAH degradation. PMID:9435090

Comparison of doxorubicin-cyclophosphamide with doxorubicin-dacarbazine for the adjuvant treatment of canine hemangiosarcoma.

PubMed

Finotello, R; Stefanello, D; Zini, E; Marconato, L

2017-03-01

Canine hemangiosarcoma (HSA) is a neoplasm of vascular endothelial origin that has an aggressive biological behaviour, with less than 10% of dogs alive at 12-months postdiagnosis. Treatment of choice consists of surgery followed by adjuvant doxorubicin-based chemotherapy. We prospectively compared adjuvant doxorubicin and dacarbazine (ADTIC) to a traditional doxorubicin and cyclophosphamide (AC) treatment, aiming at determining safety and assessing whether this regimen prolongs survival and time to metastasis (TTM). Twenty-seven dogs were enrolled; following staging work-up, 18 were treated with AC and 9 with ADTIC. Median TTM and survival time were longer for dogs treated with ADTIC compared with those receiving AC (>550 versus 112 days, P = 0.021 and >550 versus 142 days, P = 0.011, respectively). Both protocols were well tolerated, without need for dose reduction or increased interval between treatments. A protocol consisting of combined doxorubicin and dacarbazine is safe in dogs with HSA and prolongs TTM and survival time. © 2015 John Wiley & Sons Ltd.

Survival outcomes following aggressive treatment of oligometastatic breast cancer: a systematic review protocol.

PubMed

Coombe, Robyn; Lisy, Karolina; Campbell, Jared; Perry, Gajen; Prasannan, Subhita

2017-08-01

The objective of this systematic review is to assess the effectiveness of aggressive treatment of oligometastatic breast cancer (OMBC) on survival outcomes by conducting a meta-analysis of current available evidence.More specifically, the objectives are to identify the effectiveness of intensified multidisciplinary treatment with aggressive locoregional therapies on survival time, five-year survival rates and disease free survival. The population is adult women (18 years and over) with OMBC defined as single or few (five or less) metastases limited to a single organ and the comparative group is conventional palliative treatment aimed at disease control. Secondary objectives to be assessed will be adverse outcomes associated with intensified treatment regimes.

An optimized 13C-urea breath test for the diagnosis of H pylori infection

PubMed Central

Campuzano-Maya, Germán

2007-01-01

AIM: To validate an optimized 13C-urea breath test (13C-UBT) protocol for the diagnosis of H pylori infection that is cost-efficient and maintains excellent diagnostic accuracy. METHODS: 70 healthy volunteers were tested with two simplified 13C-UBT protocols, with test meal (Protocol 2) and without test meal (Protocol 1). Breath samples were collected at 10, 20 and 30 min after ingestion of 50 mg 13C-urea dissolved in 10 mL of water, taken as a single swallow, followed by 200 mL of water (pH 6.0) and a circular motion around the waistline to homogenize the urea solution. Performance of both protocols was analyzed at various cut-off values. Results were validated against the European protocol. RESULTS: According to the reference protocol, 65.7% individuals were positive for H pylori infection and 34.3% were negative. There were no significant differences in the ability of both protocols to correctly identify positive and negative H pylori individuals. However, only Protocol 1 with no test meal achieved accuracy, sensitivity, specificity, positive and negative predictive values of 100%. The highest values achieved by Protocol 2 were 98.57%, 97.83%, 100%, 100% and 100%, respectively. CONCLUSION: A 10 min, 50 mg 13C-UBT with no test meal using a cut-off value of 2-2.5 is a highly accurate test for the diagnosis of H pylori infection at a reduced cost. PMID:17907288

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

Treesearch

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...

PNNI Performance Validation Test Report

NASA Technical Reports Server (NTRS)

Dimond, Robert P.

1999-01-01

Two Private Network-Network Interface (PNNI) neighboring peers were monitored with a protocol analyzer to understand and document how PNNI works with regards to initialization and recovery processes. With the processes documented, pertinent events were found and measured to determine the protocols behavior in several environments, which consisted of congestion and/or delay. Subsequent testing of the protocol in these environments was conducted to determine the protocol's suitability for use in satellite-terrestrial network architectures.

Unresectable Hepatocellular Carcinoma: MR Imaging after Intraarterial Therapy. Part I. Identification and Validation of Volumetric Functional Response Criteria

PubMed Central

Bonekamp, Susanne; Li, Zhen; Geschwind, Jean-François H.; Halappa, Vivek Gowdra; Corona-Villalobos, Celia Pamela; Reyes, Diane; Pawlik, Timothy M.; Bonekamp, David; Eng, John

2013-01-01

Purpose: To identify and validate the optimal thresholds for volumetric functional MR imaging response criteria to predict overall survival after intraarterial treatment (IAT) in patients with unresectable hepatocellular carcinoma (HCC). Materials and Methods: Institutional review board approval and waiver of informed consent were obtained. A total of 143 patients who had undergone MR imaging before and 3–4 weeks after the first cycle of IAT were included. MR imaging analysis of one representative HCC index lesion was performed with proprietary software after initial treatment. Subjects were randomly divided into training (n = 114 [79.7%]) and validation (n = 29 [20.3%]) data sets. Uni- and multivariate Cox models were used to determine the best cutoffs, as well as survival differences, between response groups in the validation data set. Results: Optimal cutoffs in the training data set were 23% increase in apparent diffusion coefficient (ADC) and 65% decrease in volumetric enhancement in the portal venous phase (VE). Subsequently, 25% increase in ADC and 65% decrease in VE were used to stratify patients in the validation data set. Comparison of ADC responders (n = 12 [58.6%]) with nonresponders (n = 17 [34.5%]) showed significant differences in survival (25th percentile survival, 11.2 vs 4.9 months, respectively; P = .008), as did VE responders (n = 9 [31.0%]) compared with nonresponders (n = 20 [69.0%]; 25th percentile survival, 11.5 vs 5.1 months, respectively; P = .01). Stratification of patients with a combination of the criteria resulted in significant differences in survival between patients with lesions that fulfilled both criteria (n = 6 [20.7%]; too few cases to determine 25th percentile), one criterion (n = 9 [31.0%]; 25th percentile survival, 6.0 months), and neither criterion (n = 14 [48.3%]; 25th percentile survival, 5.1 months; P = .01). The association between the two criteria and overall survival remained significant in a multivariate analysis that included age, sex, Barcelona Clinic for Liver Cancer stage, and number of follow-up treatments. Conclusion: After IAT for unresectable HCC, patients can be stratified into significantly different survival categories based on responder versus nonresponder status according to MR imaging ADC and VE cutoffs. © RSNA, 2013 PMID:23616631

Validation of the Omron M3 Intellisense (HEM-7051-E) upper arm blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010 in a stage 3-5 chronic kidney disease population.

PubMed

Akpolat, Tekin; Erdem, Emre; Aydogdu, Türkan

2012-01-01

Encouragement of home blood pressure (BP) monitoring has a great potential to improve hypertension control rates. The purpose of this study was to test validation of the Omron M3 Intellisense (HEM-7051-E) upper arm BP measuring monitor for self-measurement according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) in stage 3-5 chronic kidney disease (CKD) patients. 66 patients having CKD stage 3-5 were included in the study. Nine consecutive measurements were made according to the ESH-IP2 protocol. The Omron M3 Intellisense device fulfills the validation criteria of the ESH-IP2 for stage 3-5 CKD patients. Although arterial stiffness can affect accurate BP measurement, there are limited data regarding the use of automated oscillometric devices in CKD. To our knowledge, this is the first study investigating validation of an oscillometric device in stage 3-5 predialysis CKD patients. This study validates the Omron M3 Intellisense upper arm device for stage 3-5 CKD patients. New validation studies investigating other oscillometric sphygmomanometers for CKD patients and involvement of nephrologists in these studies have great potential to increase patient care in CKD. Copyright © 2011 S. Karger AG, Basel.

Validity of an Exercise Test Based on Habitual Gait Speed in Mobility-Limited Older Adults

PubMed Central

Li, Xin; Forman, Daniel E.; Kiely, Dan K.; LaRose, Sharon; Hirschberg, Ronald; Frontera, Walter R.; Bean, Jonathan F.

2013-01-01

Objective To evaluate whether a customized exercise tolerance testing (ETT) protocol based on an individual’s habitual gait speed (HGS) on level ground would be a valid mode of exercise testing older adults. Although ETT provides a useful means to risk-stratify adults, age-related declines in gait speed paradoxically limit the utility of standard ETT protocols for evaluating older adults. A customized ETT protocol may be a useful alternative to these standard methods, and this study hypothesized that this alternative approach would be valid. Design We performed a cross-sectional analysis of baseline data from a randomized controlled trial of older adults with observed mobility problems. Screening was performed using a treadmill-based ETT protocol customized for each individual’s HGS. We determined the content validity by assessing the results of the ETTs, and we evaluated the construct validity of treadmill time in relation to the Physical Activity Scale for the Elderly (PASE) and the Late Life Function and Disability Instrument (LLFDI). Setting Outpatient rehabilitation center. Participants Community-dwelling, mobility-limited older adults (N = 141). Interventions Not applicable. Main Outcome Measures Cardiac instability, ETT duration, peak heart rate, peak systolic blood pressure, PASE, and LLFDI. Results Acute cardiac instability was identified in 4 of the participants who underwent ETT. The remaining participants (n = 137, 68% female; mean age, 75.3y) were included in the subsequent analyses. Mean exercise duration was 9.39 minutes, with no significant differences in durations being observed after evaluating among tertiles by HGS status. Mean peak heart rate and mean peak systolic blood pressure were 126.6 beats/ min and 175.0mmHg, respectively. Within separate multivariate models, ETT duration in each of the 3 gait speed groups was significantly associated (P<.05) with PASE and LLFDI. Conclusions Mobility-limited older adults can complete this customized ETT protocol, allowing for the identification of acute cardiac instability and the achievement of optimal exercise parameters. PMID:22289248

Development and validation of a prognostic nomogram for terminally ill cancer patients.

PubMed

Feliu, Jaime; Jiménez-Gordo, Ana María; Madero, Rosario; Rodríguez-Aizcorbe, José Ramón; Espinosa, Enrique; Castro, Javier; Acedo, Jesús Domingo; Martínez, Beatriz; Alonso-Babarro, Alberto; Molina, Raquel; Cámara, Juan Carlos; García-Paredes, María Luisa; González-Barón, Manuel

2011-11-02

Determining life expectancy in terminally ill cancer patients is a difficult task. We aimed to develop and validate a nomogram to predict the length of survival in patients with terminal disease. From February 1, 2003, to December 31, 2005, 406 consecutive terminally ill patients were entered into the study. We analyzed 38 features prognostic of life expectancy among terminally ill patients by multivariable Cox regression and identified the most accurate and parsimonious model by backward variable elimination according to the Akaike information criterion. Five clinical and laboratory variables were built into a nomogram to estimate the probability of patient survival at 15, 30, and 60 days. We validated and calibrated the nomogram with an external validation cohort of 474 patients who were treated from June 1, 2006, through December 31, 2007. The median overall survival was 29.1 days for the training set and 18.3 days for the validation set. Eastern Cooperative Oncology Group performance status, lactate dehydrogenase levels, lymphocyte levels, albumin levels, and time from initial diagnosis to diagnosis of terminal disease were retained in the multivariable Cox proportional hazards model as independent prognostic factors of survival and formed the basis of the nomogram. The nomogram had high predictive performance, with a bootstrapped corrected concordance index of 0.70, and it showed good calibration. External independent validation revealed 68% predictive accuracy. We developed a highly accurate tool that uses basic clinical and analytical information to predict the probability of survival at 15, 30, and 60 days in terminally ill cancer patients. This tool can help physicians making decisions on clinical care at the end of life.

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

PubMed

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 administrative healthcare databases of these conditions. CRD42015029216. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Simplified dispatch-assisted CPR instructions outperform standard protocol.

PubMed

Dias, J A; Brown, T B; Saini, D; Shah, R C; Cofield, S S; Waterbor, J W; Funkhouser, E; Terndrup, T E

2007-01-01

Dispatch-assisted chest compressions only CPR (CC-CPR) has gained widespread acceptance, and recent research suggests that increasing the proportion of compression time during CPR may increase survival from out-of-hospital cardiac arrest. We created a simplified CC-CPR protocol to reduce time to start chest compressions and to increase the proportion of time spent delivering chest compressions. This simplified protocol was compared to a published protocol, Medical Priority Dispatch System (MPDS) Version 11.2, recommended by the National Academies of Emergency Dispatch. Subjects were randomized to the MPDS v11.2 protocol or a simplified protocol. Data was recorded from a Laerdal Resusci Anne Skillreporter manikin. A simulated emergency medical dispatcher, contacted by cell phone, delivered standardized instructions for both protocols. Outcomes included chest compression rate, depth, hand position, full release, overall proportion of compressions without error, time to start of CPR and total hands-off chest time. Proportions were analyzed by Wilcoxon's Rank Sum tests and time variables with Welch ANOVA and Wilcoxon's Rank Sum test. All tests used a two-sided alpha-level of 0.05. One hundred and seventeen subjects were randomized prospectively, 58 to the standard protocol and 59 to the simplified protocol. The average age of subjects in both groups was 25 years old. For both groups, the compression rate was equivalent (104 simplified versus 94 MPDS, p = 0.13), as was the proportion with total release (1.0 simplified versus 1.0 MPDS, p = 0.09). The proportion to the correct depth was greater in the simplified protocol (0.31 versus 0.03, p < 0.01), as was the proportion of compressions done without error (0.05 versus 0.0, p = 0.16). Time to start of chest compressions and total hands-off chest time were better in the simplified protocol (start time 60.9s versus 78.6s, p < 0.0001; hands-off chest time 69 s versus 95 s, p < 0.0001). The proportion with correct hand position, however, was worse in the simplified protocol (0.35 versus 0.84, p < 0.01). The simplified protocol was as good as, or better than the MPDS v11.2 protocol in every aspect studied except hand position, and the simplified protocol resulted in significant time savings. The protocol may need modification to ensure correct hand position. Time savings and improved quality of CPR achieved by the new set of instructions could be important in strengthening critical links in the cardiac chain of survival.

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

PubMed

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.

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

PubMed

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.

Endpoints and surrogate endpoints in colorectal cancer: a review of recent developments.

PubMed

Piedbois, Pascal; Buyse, Marc

2008-07-01

The purpose of this review is to discuss recently published work on endpoints for early and advanced colorectal cancer, as well as the statistical approaches used to validate surrogate endpoints. Most attempts to validate surrogate endpoints have estimated the correlation between the surrogate and the true endpoint, and between the treatment effects on these endpoints. The correlation approach has made it possible to validate disease-free survival and progression-free survival as acceptable surrogates for overall survival in early and advanced disease, respectively. The search for surrogate endpoints will intensify over the coming years. In parallel, efforts to either standardize or extend the endpoints or both will improve the reliability and relevance of clinical trial results.

Acute Myeloid Leukemia in Adolescents and Young Adults Treated in Pediatric and Adult Departments in the Nordic Countries.

PubMed

Wennström, Lovisa; Edslev, Pernille Wendtland; Abrahamsson, Jonas; Nørgaard, Jan Maxwell; Fløisand, Yngvar; Forestier, Erik; Gustafsson, Göran; Heldrup, Jesper; Hovi, Liisa; Jahnukainen, Kirsi; Jonsson, Olafur Gisli; Lausen, Birgitte; Palle, Josefine; Zeller, Bernward; Holmberg, Erik; Juliusson, Gunnar; Stockelberg, Dick; Hasle, Henrik

2016-01-01

Studies on adolescents and young adults with acute lymphoblastic leukemia suggest better results when using pediatric protocols for adult patients, while corresponding data for acute myeloid leukemia (AML) are limited. We investigated disease characteristics and outcome for de novo AML patients 10-30 years old treated in pediatric or adult departments. We included 166 patients 10-18 years of age with AML treated according to the pediatric NOPHO-protocols (1993-2009) compared with 253 patients aged 15-30 years treated in hematology departments (1996-2009) in the Nordic countries. The incidence of AML was 4.9/million/year for the age group 10-14 years, 6.5 for 15-18 years, and 6.9 for 19-30 years. Acute promyelocytic leukemia (APL) was more frequent in adults and in females of all ages. Pediatric patients with APL had similar overall survival as pediatric patients without APL. Overall survival at 5 years was 60% (52-68%) for pediatric patients compared to 65% (58-70%) for adult patients. Cytogenetics and presenting white blood cell count were the only independent prognostic factors for overall survival. Age was not an independent prognostic factor. No difference was found in outcome for AML patients age 10-30 years treated according to pediatric as compared to adult protocols. © 2015 Wiley Periodicals, Inc.

Developing an evidence-based practice protocol: implications for midwifery practice.

PubMed

Carr, K C

2000-01-01

Evidence-based practice is defined and its importance to midwifery practice is presented. Guidelines are provided for the development of an evidence-based practice protocol. These include: identifying the clinical question, obtaining the evidence, evaluating the validity and importance of the evidence, synthesizing the evidence and applying it to the development of a protocol or clinical algorithm, and, finally, developing an evaluation plan or measurement strategy to see if the new protocol is effective.

Advanced orbiting systems test-bedding and protocol verification

NASA Technical Reports Server (NTRS)

Noles, James; De Gree, Melvin

1989-01-01

The Consultative Committee for Space Data Systems (CCSDS) has begun the development of a set of protocol recommendations for Advanced Orbiting Systems (SOS). The AOS validation program and formal definition of AOS protocols are reviewed, and the configuration control of the AOS formal specifications is summarized. Independent implementations of the AOS protocols by NASA and ESA are discussed, and cross-support/interoperability tests which will allow the space agencies of various countries to share AOS communication facilities are addressed.

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

PubMed

van den Heuvel-Eibrink, Marry M; Hol, Janna A; Pritchard-Jones, Kathy; van Tinteren, Harm; Furtwängler, Rhoikos; Verschuur, Arnauld C; Vujanic, Gordan M; Leuschner, Ivo; Brok, Jesper; Rübe, Christian; Smets, Anne M; Janssens, Geert O; Godzinski, Jan; Ramírez-Villar, Gema L; de Camargo, Beatriz; Segers, Heidi; Collini, Paola; Gessler, Manfred; Bergeron, Christophe; Spreafico, Filippo; Graf, Norbert

2017-12-01

The Renal Tumour Study Group of the International Society of Paediatric Oncology (SIOP-RTSG) has developed a new protocol for the diagnosis and treatment of childhood renal tumours, the UMBRELLA SIOP-RTSG 2016 (the UMBRELLA protocol), to continue international collaboration in the treatment of childhood renal tumours. This protocol will support integrated biomarker and imaging research, focussing on assessing the independent prognostic value of genomic changes within the tumour and the volume of the blastemal component that survives preoperative chemotherapy. Treatment guidelines for Wilms tumours in the UMBRELLA protocol include recommendations for localized, metastatic, and bilateral disease, for all age groups, and for relapsed disease. These recommendations have been established by a multidisciplinary panel of leading experts on renal tumours within the SIOP-RTSG. The UMBRELLA protocol should promote international collaboration and research and serve as the SIOP-RTSG best available treatment standard.

[Long-term destiny of adolescents and young adults with de novo acute lymphoblastic leukemia treated with a pediatric protocol type].

PubMed

López-Hernández, Manuel Antonio; Alvarado-Ibarra, Martha; Álvarez-Veral, José Luis; Ortiz-Zepeda, Maricela; Guajardo-Leal, Martha Lilia; Cota-Range, Xochitl

The prognosis, in the long term, of adolescents and young adults with acute de novo lymphoblastic leukemia, treated with a pediatric type protocol. To analyze the efficacy and tolerability of a chemotherapy regimen of pediatric type on patients 15-35 years old with de novo acute lymphoblastic leukemia, Ph(-). A retrospective study of patients received from 2001 to 2013, without initial infiltration of the central nervous system. They received the regimen called LALÍN. Terminal goals: frequency of initial remission, probability of survival free of leukemia and event-free survival for five years. We included 101 patients; there were 29 relapses and 19 deaths. There was initial remission in 97% of the cases; survival free of leukemia of 0.58 and event-free survival 0.44. No difference in patients aged 16-21 years vs. 22-35 (p > 0.55). Negative prognostic factors: abnormal karyotypes, except hyperdiploids (p = 0.001); > 5% of blasts, on 14 day induction (p = 0. 0001); delay in the punctuality of the courses of the chemotherapy regimen (p = 0.0001). A pediatric type regimen is applicable to patients aged from 16 to 35 years with acute lymphoblastic leukemia, without greater toxicity and a best survival free of leukemia. The count of > 5% of blasts and the delay in the execution of the stages of the chemotherapy regimen are the stronger negative prognostic factors.

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.

PubMed

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 < .0001 for both arms combined). This association remained true on a multivariate analysis that allowed for lymph node status (hazard ratio, 0.41; 95% confidence interval, 0.27-0.63; P < .0001). In the current sample, 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.

Fluorescence Microscopy Methods for Determining the Viability of Bacteria in Association with Mammalian Cells

PubMed Central

Johnson, M. Brittany; Criss, Alison K.

2013-01-01

Central to the field of bacterial pathogenesis is the ability to define if and how microbes survive after exposure to eukaryotic cells. Current protocols to address these questions include colony count assays, gentamicin protection assays, and electron microscopy. Colony count and gentamicin protection assays only assess the viability of the entire bacterial population and are unable to determine individual bacterial viability. Electron microscopy can be used to determine the viability of individual bacteria and provide information regarding their localization in host cells. However, bacteria often display a range of electron densities, making assessment of viability difficult. This article outlines protocols for the use of fluorescent dyes that reveal the viability of individual bacteria inside and associated with host cells. These assays were developed originally to assess survival of Neisseria gonorrhoeae in primary human neutrophils, but should be applicable to any bacterium-host cell interaction. These protocols combine membrane-permeable fluorescent dyes (SYTO9 and 4',6-diamidino-2-phenylindole [DAPI]), which stain all bacteria, with membrane-impermeable fluorescent dyes (propidium iodide and SYTOX Green), which are only accessible to nonviable bacteria. Prior to eukaryotic cell permeabilization, an antibody or fluorescent reagent is added to identify extracellular bacteria. Thus these assays discriminate the viability of bacteria adherent to and inside eukaryotic cells. A protocol is also provided for using the viability dyes in combination with fluorescent antibodies to eukaryotic cell markers, in order to determine the subcellular localization of individual bacteria. The bacterial viability dyes discussed in this article are a sensitive complement and/or alternative to traditional microbiology techniques to evaluate the viability of individual bacteria and provide information regarding where bacteria survive in host cells. PMID:24056524

[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].

PubMed

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 < 10(-3)). The average 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.

Interaction of Bio-Aerosols with Shock/Blast Waves: Dispersion, Activation, and Destruction of Airborne Biological Threats

DTIC Science & Technology

2011-05-01

laboratory protocol was used to investigate the post-shock-heating survival of three strains of endospores ( Bacillus atrophaeus, Bacillus subtilis ...investigate the post-shock-heating survival of three strains of endospores ( Bacillus atrophaeus, Bacillus subtilis and Bacillus thuringiensis, Al Hakam...investigated: Bacillus subtilis , Bacillus atrophaeus and Bacillus thuringiensis (Al Hakam). The exposporium on these three strains are radically different

Positron Emission Tomography-Guided Therapy of Aggressive Non-Hodgkin Lymphomas (PETAL): A Multicenter, Randomized Phase III Trial.

PubMed

Dührsen, Ulrich; Müller, Stefan; Hertenstein, Bernd; Thomssen, Henrike; Kotzerke, Jörg; Mesters, Rolf; Berdel, Wolfgang E; Franzius, Christiane; Kroschinsky, Frank; Weckesser, Matthias; Kofahl-Krause, Dorothea; Bengel, Frank M; Dürig, Jan; Matschke, Johannes; Schmitz, Christine; Pöppel, Thorsten; Ose, Claudia; Brinkmann, Marcus; La Rosée, Paul; Freesmeyer, Martin; Hertel, Andreas; Höffkes, Heinz-Gert; Behringer, Dirk; Prange-Krex, Gabriele; Wilop, Stefan; Krohn, Thomas; Holzinger, Jens; Griesshammer, Martin; Giagounidis, Aristoteles; Raghavachar, Aruna; Maschmeyer, Georg; Brink, Ingo; Bernhard, Helga; Haberkorn, Uwe; Gaska, Tobias; Kurch, Lars; van Assema, Daniëlle M E; Klapper, Wolfram; Hoelzer, Dieter; Geworski, Lilli; Jöckel, Karl-Heinz; Scherag, André; Bockisch, Andreas; Rekowski, Jan; Hüttmann, Andreas

2018-05-11

Purpose Interim positron emission tomography (PET) using the tracer, [ 18 F]fluorodeoxyglucose, may predict outcomes in patients with aggressive non-Hodgkin lymphomas. We assessed whether PET can guide therapy in patients who are treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Patients and Methods Newly diagnosed patients received two cycles of CHOP-plus rituximab (R-CHOP) in CD20-positive lymphomas-followed by a PET scan that was evaluated using the ΔSUV max method. PET-positive patients were randomly assigned to receive six additional cycles of R-CHOP or six blocks of an intensive Burkitt's lymphoma protocol. PET-negative patients with CD20-positive lymphomas were randomly assigned or allocated to receive four additional cycles of R-CHOP or the same treatment with two additional doses rituximab. The primary end point was event-free survival time as assessed by log-rank test. Results Interim PET was positive in 108 (12.5%) and negative in 754 (87.5%) of 862 patients treated, with statistically significant differences in event-free survival and overall survival. Among PET-positive patients, 52 were randomly assigned to R-CHOP and 56 to the Burkitt protocol, with 2-year event-free survival rates of 42.0% (95% CI, 28.2% to 55.2%) and 31.6% (95% CI, 19.3% to 44.6%), respectively (hazard ratio, 1.501 [95% CI, 0.896 to 2.514]; P = .1229). The Burkitt protocol produced significantly more toxicity. Of 754 PET-negative patients, 255 underwent random assignment (129 to R-CHOP and 126 to R-CHOP with additional rituximab). Event-free survival rates were 76.4% (95% CI, 68.0% to 82.8%) and 73.5% (95% CI, 64.8% to 80.4%), respectively (hazard ratio, 1.048 [95% CI, 0.684 to 1.606]; P = .8305). Outcome prediction by PET was independent of the International Prognostic Index. Results in diffuse large B-cell lymphoma were similar to those in the total group. Conclusion Interim PET predicted survival in patients with aggressive lymphomas treated with R-CHOP. PET-based treatment intensification did not improve outcome.

Evaluation of the University of Florida lomustine, vincristine, procarbazine, and prednisone chemotherapy protocol for the treatment of relapsed lymphoma in dogs: 33 cases (2003-2009).

PubMed

Fahey, Christine E; Milner, Rowan J; Barabas, Karri; Lurie, David; Kow, Kelvin; Parfitt, Shannon; Lyles, Sarah; Clemente, Monica

2011-07-15

To evaluate the toxicity and efficacy of a modification of a previously evaluated combination of lomustine, vincristine, procarbazine, and prednisone (LOPP) as a rescue protocol for refractory lymphoma in dogs. Retrospective case series. Animals-33 dogs with a cytologic or histologic diagnosis of lymphoma that developed resistance to their induction chemotherapy protocol. Lomustine was administered on day 0 of the protocol. Vincristine was administered on day 0 and again 1 time on day 14. Procarbazine and prednisone were administered on days 0 through 13 of the protocol. This cycle was repeated every 28 days. Median time from initiation to discontinuation of the University of Florida LOPP protocol was 84 days (range, 10 to 308 days). Overall median survival time was 290 days (range, 51 to 762 days). Overall response rate with this protocol was 61% (20/33), with 36% (12) having a complete response and 24% (8) having a partial response. Toxicosis rates were lower than for the previously published LOPP protocol. The University of Florida LOPP protocol may be an acceptable alternative to the mechlorethamine, vincristine, procarbazine, and prednisone protocol as a rescue protocol for dogs with lymphoma.

Prevention of Osmotic Injury to Human Umbilical Vein Endothelial Cells for Biopreservation: A First Step Toward Biobanking of Endothelial Cells for Vascular Tissue Engineering.

PubMed

Niu, Dan; Zhao, Gang; Liu, Xiaoli; Zhou, Ping; Cao, Yunxia

2016-03-01

High-survival-rate cryopreservation of endothelial cells plays a critical role in vascular tissue engineering, while optimization of osmotic injuries is the first step toward successful cryopreservation. We designed a low-cost, easy-to-use, microfluidics-based microperfusion chamber to investigate the osmotic responses of human umbilical vein endothelial cells (HUVECs) at different temperatures, and then optimized the protocols for using cryoprotective agents (CPAs) to minimize osmotic injuries and improve processes before freezing and after thawing. The fundamental cryobiological parameters were measured using the microperfusion chamber, and then, the optimized protocols using these parameters were confirmed by survival evaluation and cell proliferation experiments. It was revealed for the first time that HUVECs have an unusually small permeability coefficient for Me2SO. Even at the concentrations well established for slow freezing of cells (1.5 M), one-step removal of CPAs for HUVECs might result in inevitable osmotic injuries, indicating that multiple-step removal is essential. Further experiments revealed that multistep removal of 1.5 M Me2SO at 25°C was the best protocol investigated, in good agreement with theory. These results should prove invaluable for optimization of cryopreservation protocols of HUVECs.

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

PubMed

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.

Multidisciplinary effort in treating children with hepatoblastoma in China.

PubMed

Yuan, Xiao-Jun; Wang, Huan-Min; Jiang, Hui; Tang, Meng-Jie; Li, Zhang-Lin; Zou, Xiang; Fang, Yong-Jun; Pan, Ci; Tou, Jin-Fa; Zhang, Ke-Ren; Liu, Xiang; Li, Wei-Song; Li, Yang; Lu, Jun; Wu, Ye-Ming

2016-05-28

The purpose of this study is to report the first nationwide protocol (Wuhan Protocol) developed by Chinese Children's Cancer Group and the results of multidisciplinary effort in treating hepatoblastoma. In this study, we reported the final analysis, which includes 153 hepatoblastoma patients in 13 hospitals from January 2006 to December 2013. The 6-year overall survival and event-free survival rates were 83.3 ± 3.1% and 71.0 ± 3.7%, respectively, in this cohort. The univariate analysis revealed that female (P = 0.027), under 5 years of age (P = 0.039), complete surgical resection (P = 0.000), no metastases (P = 0.000), and delayed surgery following neoadjuvant chemotherapy (P = 0.000) had better prognosis. In multivariate analysis, male, 5 years of age or above, stage PRETEXT III or IV, and incomplete surgical resection were among the some adverse factors contributing to poor prognosis. The preliminary results from this study showed that patients who underwent treatment following Wuhan Protocol had similar OS and EFS rates compared to those in developed countries. However, the protocol remains to be further optimized in standardizing surgical resection (including liver transplantation), refining risk stratification and risk-based chemotherapy. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Development and Validation of a qRT-PCR Classifier for Lung Cancer Prognosis

PubMed Central

Chen, Guoan; Kim, Sinae; Taylor, Jeremy MG; Wang, Zhuwen; Lee, Oliver; Ramnath, Nithya; Reddy, Rishindra M; Lin, Jules; Chang, Andrew C; Orringer, Mark B; Beer, David G

2011-01-01

Purpose This prospective study aimed to develop a robust and clinically-applicable method to identify high-risk early stage lung cancer patients and then to validate this method for use in future translational studies. Patients and Methods Three published Affymetrix microarray data sets representing 680 primary tumors were used in the survival-related gene selection procedure using clustering, Cox model and random survival forest (RSF) analysis. A final set of 91 genes was selected and tested as a predictor of survival using a qRT-PCR-based assay utilizing an independent cohort of 101 lung adenocarcinomas. Results The RSF model built from 91 genes in the training set predicted patient survival in an independent cohort of 101 lung adenocarcinomas, with a prediction error rate of 26.6%. The mortality risk index (MRI) was significantly related to survival (Cox model p < 0.00001) and separated all patients into low, medium, and high-risk groups (HR = 1.00, 2.82, 4.42). The MRI was also related to survival in stage 1 patients (Cox model p = 0.001), separating patients into low, medium, and high-risk groups (HR = 1.00, 3.29, 3.77). Conclusions The development and validation of this robust qRT-PCR platform allows prediction of patient survival with early stage lung cancer. Utilization will now allow investigators to evaluate it prospectively by incorporation into new clinical trials with the goal of personalized treatment of lung cancer patients and improving patient survival. PMID:21792073

Protein profiles associated with survival in lung adenocarcinoma

PubMed Central

Chen, Guoan; Gharib, Tarek G; Wang, Hong; Huang, Chiang-Ching; Kuick, Rork; Thomas, Dafydd G.; Shedden, Kerby A.; Misek, David E.; Taylor, Jeremy M. G.; Giordano, Thomas J.; Kardia, Sharon L. R.; Iannettoni, Mark D.; Yee, John; Hogg, Philip J.; Orringer, Mark B.; Hanash, Samir M.; Beer, David G.

2003-01-01

Morphologic assessment of lung tumors is informative but insufficient to adequately predict patient outcome. We previously identified transcriptional profiles that predict patient survival, and here we identify proteins associated with patient survival in lung adenocarcinoma. A total of 682 individual protein spots were quantified in 90 lung adenocarcinomas by using quantitative two-dimensional polyacrylamide gel electrophoresis analysis. A leave-one-out cross-validation procedure using the top 20 survival-associated proteins identified by Cox modeling indicated that protein profiles as a whole can predict survival in stage I tumor patients (P = 0.01). Thirty-three of 46 survival-associated proteins were identified by using mass spectrometry. Expression of 12 candidate proteins was confirmed as tumor-derived with immunohistochemical analysis and tissue microarrays. Oligonucleotide microarray results from both the same tumors and from an independent study showed mRNAs associated with survival for 11 of 27 encoded genes. Combined analysis of protein and mRNA data revealed 11 components of the glycolysis pathway as associated with poor survival. Among these candidates, phosphoglycerate kinase 1 was associated with survival in the protein study, in both mRNA studies and in an independent validation set of 117 adenocarcinomas and squamous lung tumors using tissue microarrays. Elevated levels of phosphoglycerate kinase 1 in the serum were also significantly correlated with poor outcome in a validation set of 107 patients with lung adenocarcinomas using ELISA analysis. These studies identify new prognostic biomarkers and indicate that protein expression profiles can predict the outcome of patients with early-stage lung cancer. PMID:14573703

A Novel HURRAH Protocol Reveals High Numbers of Monomorphic MHC Class II Loci and Two Asymmetric Multi-Locus Haplotypes in the Père David's Deer

PubMed Central

Wan, Qiu-Hong; Zhang, Pei; Ni, Xiao-Wei; Wu, Hai-Long; Chen, Yi-Yan; Kuang, Ye-Ye; Ge, Yun-Fa; Fang, Sheng-Guo

2011-01-01

The Père David's deer is a highly inbred, but recovered, species, making it interesting to consider their adaptive molecular evolution from an immunological perspective. Prior to this study, genomic sequencing was the only method for isolating all functional MHC genes within a certain species. Here, we report a novel protocol for isolating MHC class II loci from a species, and its use to investigate the adaptive evolution of this endangered deer at the level of multi-locus haplotypes. This protocol was designated “HURRAH” based on its various steps and used to estimate the total number of MHC class II loci. We confirmed the validity of this novel protocol in the giant panda and then used it to examine the Père David's deer. Our results revealed that the Père David's deer possesses nine MHC class II loci and therefore has more functional MHC class II loci than the eight genome-sequenced mammals for which full MHC data are currently available. This could potentially account at least in part for the strong survival ability of this species in the face of severe bottlenecking. The results from the HURRAH protocol also revealed that: (1) All of the identified MHC class II loci were monomorphic at their antigen-binding regions, although DRA was dimorphic at its cytoplasmic tail; and (2) these genes constituted two asymmetric functional MHC class II multi-locus haplotypes: DRA1*01 ∼ DRB1 ∼ DRB3 ∼ DQA1 ∼ DQB2 (H1) and DRA1*02 ∼ DRB2 ∼ DRB4 ∼ DQA2 ∼ DQB1 (H2). The latter finding indicates that the current members of the deer species have lost the powerful ancestral MHC class II haplotypes of nine or more loci, and have instead fixed two relatively weak haplotypes containing five genes. As a result, the Père David's deer are currently at risk for increased susceptibility to infectious pathogens. PMID:21267075

A protocol for validating Land Surface Temperature from Sentinel-3

NASA Astrophysics Data System (ADS)

Ghent, D.

2015-12-01

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. The Sentinel-3 Cal-Val Plan for evaluating the level-2 SL_2_LST product builds on an established validation protocol for satellite-based LST. This set of guidelines provides a standardized framework for structuring LST validation activities, and is rapidly gaining international recognition. 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 SLSTR which is designed around biome-based coefficients, thus emphasizing the importance of non-traditional forms of validation such as radiance-based techniques. Here we present examples of the application of the protocol to data produced within the ESA DUE GlobTemperature Project. The lessons learnt here are helping to fine-tune the methodology in preparation for Sentinel-3 commissioning.

Low dietary boron reduces parasite (nematoda) survival and alters cytokine profiles but the infection modifies liver minerals in mice.

PubMed

Bourgeois, Annie-Claude; Scott, Marilyn E; Sabally, Kebba; Koski, Kristine G

2007-09-01

Although boron (B) is an essential trace mineral, any interactions that it may have with gastrointestinal (GI) nematode infections are unknown. This study explored whether low dietary B would: 1) alter survival or reproduction of Heligmosomoides bakeri (Nematoda); 2) modify the resulting cytokine response to this parasitic infection; or 3) influence liver mineral concentrations in the infected host. Balb/c mice were fed either a low-B (0.2 microg B/g), marginal (2.0 microg B/g), or control (12.0 microg B/g) diet. Diets commenced 3 wk before a primary infection and were fed for 4 wk (primary infection protocol) and 8-9 wk (challenge infection protocol). Mice were killed 6 d post-primary infection (d6ppi), or dewormed then reinfected (challenge infection protocol) and killed 14 or 21 d post-challenge infection (d14pci or d21pci, respectively). Low and marginal dietary B intakes impaired survival of the parasite, reduced intestinal inflammation, and modulated a broad range of cytokines and chemokines despite similar liver B concentrations in diet groups. Compared with control mice, cytokine production was lower following low and marginal B intakes at d6ppi but was elevated at d21pci. Serum alkaline phosphatase was higher at d6ppi than at d14pci and d21pci. Compared with d14pci, liver zinc, iron, and B concentrations were reduced at d21pci when worm numbers were also lower, whereas concentrations of sodium, potassium, molybdenum, chromium, and sulfur were higher. This study shows that parasite survival and cytokine and inflammatory responses are modified by dietary B intake but indicates that a GI nematode infection alters liver mineral concentrations.

CD200/BTLA deletions in pediatric precursor B-cell acute lymphoblastic leukemia treated according to the EORTC-CLG 58951 protocol

PubMed Central

Ghazavi, Farzaneh; Clappier, Emmanuelle; Lammens, Tim; Suciu, Stefan; Caye, Aurélie; Zegrari, Samira; Bakkus, Marleen; Grardel, Nathalie; Benoit, Yves; Bertrand, Yves; Minckes, Odile; Costa, Vitor; Ferster, Alina; Mazingue, Françoise; Plat, Geneviève; Plouvier, Emmanuel; Poirée, Marilyne; Uyttebroeck, Anne; van der Werff-ten Bosch, Jutte; Yakouben, Karima; Helsmoortel, Hetty; Meul, Magali; Van Roy, Nadine; Philippé, Jan; Speleman, Frank; Cavé, Hélène; Van Vlierberghe, Pieter; De Moerloose, Barbara

2015-01-01

DNA copy number analysis has been instrumental for the identification of genetic alterations in B-cell precursor acute lymphoblastic leukemia. Notably, some of these genetic defects have been associated with poor treatment outcome and might be relevant for future risk stratification. In this study, we characterized recurrent deletions of CD200 and BTLA genes, mediated by recombination-activating genes, and used breakpoint-specific polymerase chain reaction assay to screen a cohort of 1154 cases of B-cell precursor acute lymphoblastic leukemia uniformly treated according to the EORTC-CLG 58951 protocol. CD200/BTLA deletions were identified in 56 of the patients (4.8%) and were associated with an inferior 8-year event free survival in this treatment protocol [70.2% ± 1.2% for patients with deletions versus 83.5% ± 6.4% for non-deleted cases (hazard ratio 2.02; 95% confidence interval 1.23–3.32; P=0.005)]. Genetically, CD200/BTLA deletions were strongly associated with ETV6-RUNX1-positive leukemias (P<0.0001), but were also identified in patients who did not have any genetic abnormality that is currently used for risk stratification. Within the latter population of patients, the presence of CD200/BTLA deletions was associated with inferior event-free survival and overall survival. Moreover, the multivariate Cox model indicated that these deletions had independent prognostic impact on event-free survival when adjusting for conventional risk criteria. All together, these findings further underscore the rationale for copy number profiling as an important tool for risk stratification in human B-cell precursor acute lymphoblastic leukemia. This trial was registered at www.ClinicalTrials.gov as #NCT00003728. PMID:26137961

CD200/BTLA deletions in pediatric precursor B-cell acute lymphoblastic leukemia treated according to the EORTC-CLG 58951 protocol.

PubMed

Ghazavi, Farzaneh; Clappier, Emmanuelle; Lammens, Tim; Suciu, Stefan; Caye, Aurélie; Zegrari, Samira; Bakkus, Marleen; Grardel, Nathalie; Benoit, Yves; Bertrand, Yves; Minckes, Odile; Costa, Vitor; Ferster, Alina; Mazingue, Françoise; Plat, Geneviève; Plouvier, Emmanuel; Poirée, Marilyne; Uyttebroeck, Anne; van der Werff-Ten Bosch, Jutte; Yakouben, Karima; Helsmoortel, Hetty; Meul, Magali; Van Roy, Nadine; Philippé, Jan; Speleman, Frank; Cavé, Hélène; Van Vlierberghe, Pieter; De Moerloose, Barbara

2015-10-01

DNA copy number analysis has been instrumental for the identification of genetic alterations in B-cell precursor acute lymphoblastic leukemia. Notably, some of these genetic defects have been associated with poor treatment outcome and might be relevant for future risk stratification. In this study, we characterized recurrent deletions of CD200 and BTLA genes, mediated by recombination-activating genes, and used breakpoint-specific polymerase chain reaction assay to screen a cohort of 1154 cases of B-cell precursor acute lymphoblastic leukemia uniformly treated according to the EORTC-CLG 58951 protocol. CD200/BTLA deletions were identified in 56 of the patients (4.8%) and were associated with an inferior 8-year event free survival in this treatment protocol [70.2% ± 1.2% for patients with deletions versus 83.5% ± 6.4% for non-deleted cases (hazard ratio 2.02; 95% confidence interval 1.23-3.32; P=0.005)]. Genetically, CD200/BTLA deletions were strongly associated with ETV6-RUNX1-positive leukemias (P<0.0001), but were also identified in patients who did not have any genetic abnormality that is currently used for risk stratification. Within the latter population of patients, the presence of CD200/BTLA deletions was associated with inferior event-free survival and overall survival. Moreover, the multivariate Cox model indicated that these deletions had independent prognostic impact on event-free survival when adjusting for conventional risk criteria. All together, these findings further underscore the rationale for copy number profiling as an important tool for risk stratification in human B-cell precursor acute lymphoblastic leukemia. This trial was registered at www.ClinicalTrials.gov as #NCT00003728. Copyright© Ferrata Storti Foundation.

Optimizing Immunosuppressive Regimens Among Living-Donor Renal Transplant Recipients.

PubMed

Bakr, Mohamed Adel; Nagib, Ayman Maher; Gheith, Osama Ashry; Hamdy, Ahmed Farouk; Refaie, Ayman Fathi; Donia, Ahmed Farouk; Neamatalla, Ahmed Hassan; Eldahshan, Khaled Farouk; Denewar, Ahmed Abdelfattah; Abbas, Mohamed Hamed; Mostafa, Amany Ismail; Ghoneim, Mohamed Ahmed

2017-02-01

We review different immunosuppressant protocols used for living-donor kidney transplant recipients at our center. Many prospective randomized studies from our center have been reported between March 1976 and 2016, with more than 2700 renal transplant procedures conducted. The first study was a prospective randomized trial of azathioprine versus cyclosporine. The second study compared triple therapy (prednisolone + azathioprine + cyclosporine) versus conventional therapy (prednisolone + azathioprine). The third study was a cost-saving study, in which 100 patients received ketoconazole along with the triple regimen. Another trial demonstrated the advantages of a microemulsion form of cyclosporine. A subsequent trial compared calcineurin inhibitor minimization versus avoidance protocols. Rescue therapies were carried out to intensify immunosuppressive regimens after repeated rejection. In addition, steroid-free regimens were evaluated during both short- and long-term treatment. A recent trial reported a step-forward avoidance protocol with a calcineurin inhibitor and a steroid-free regimen, whereas another current study is the TRANSFORM one. The rationale behind antibody therapy was tho roughly evaluated among living-donor renal trans plant recipients with different agents, including basiliximab, daclizumab, antithymocyte globulin, and alemtuzumab. Earlier studies have demonstrated the efficacy of conventional regimens without induction therapy, especially in longer follow-up. The standard triple therapy has emerged with intensified immunosuppressive and lowered dose of each drug, especially cyclosporine. In minimization studies, no significant differences were encountered regarding patient and graft survival, even in the long-term. Steroid avoidance was safe and effective. Calcineurin inhibitors and steroid-free regimens have shown comparable patient and graft survival. Induction therapy has lowered the incidence and severity of acute rejection. A better 5-year graft survival and less posttransplant complications have been achieved with steroid avoidance after induction with basiliximab. Induction therapy did not affect graft and patient survival rates despite lowered incidence and severity of acute rejections.

Meta-analysis of gene expression profiles associated with histological classification and survival in 829 ovarian cancer samples.

PubMed

Fekete, Tibor; Rásó, Erzsébet; Pete, Imre; Tegze, Bálint; Liko, István; Munkácsy, Gyöngyi; Sipos, Norbert; Rigó, János; Györffy, Balázs

2012-07-01

Transcriptomic analysis of global gene expression in ovarian carcinoma can identify dysregulated genes capable to serve as molecular markers for histology subtypes and survival. The aim of our study was to validate previous candidate signatures in an independent setting and to identify single genes capable to serve as biomarkers for ovarian cancer progression. As several datasets are available in the GEO today, we were able to perform a true meta-analysis. First, 829 samples (11 datasets) were downloaded, and the predictive power of 16 previously published gene sets was assessed. Of these, eight were capable to discriminate histology subtypes, and none was capable to predict survival. To overcome the differences in previous studies, we used the 829 samples to identify new predictors. Then, we collected 64 ovarian cancer samples (median relapse-free survival 24.5 months) and performed TaqMan Real Time Polimerase Chain Reaction (RT-PCR) analysis for the best 40 genes associated with histology subtypes and survival. Over 90% of subtype-associated genes were confirmed. Overall survival was effectively predicted by hormone receptors (PGR and ESR2) and by TSPAN8. Relapse-free survival was predicted by MAPT and SNCG. In summary, we successfully validated several gene sets in a meta-analysis in large datasets of ovarian samples. Additionally, several individual genes identified were validated in a clinical cohort. Copyright © 2011 UICC.

Association Between a Germline OCA2 Polymorphism at Chromosome 15q13.1 and Estrogen Receptor–Negative Breast Cancer Survival

PubMed Central

Tyrer, Jonathan; Fasching, Peter A.; Beckmann, Matthias W.; Ekici, Arif B.; Schulz-Wendtland, Rüdiger; Bojesen, Stig E.; Nordestgaard, Børge G.; Flyger, Henrik; Milne, Roger L.; Arias, José Ignacio; Menéndez, Primitiva; Benítez, Javier; Chang-Claude, Jenny; Hein, Rebecca; Wang-Gohrke, Shan; Nevanlinna, Heli; Heikkinen, Tuomas; Aittomäki, Kristiina; Blomqvist, Carl; Margolin, Sara; Mannermaa, Arto; Kosma, Veli-Matti; Kataja, Vesa; Beesley, Jonathan; Chen, Xiaoqing; Chenevix-Trench, Georgia; Couch, Fergus J.; Olson, Janet E.; Fredericksen, Zachary S.; Wang, Xianshu; Giles, Graham G.; Severi, Gianluca; Baglietto, Laura; Southey, Melissa C.; Devilee, Peter; Tollenaar, Rob A. E. M.; Seynaeve, Caroline; García-Closas, Montserrat; Lissowska, Jolanta; Sherman, Mark E.; Bolton, Kelly L.; Hall, Per; Czene, Kamila; Cox, Angela; Brock, Ian W.; Elliott, Graeme C.; Reed, Malcolm W. R.; Greenberg, David; Anton-Culver, Hoda; Ziogas, Argyrios; Humphreys, Manjeet; Easton, Douglas F.; Caporaso, Neil E.; Pharoah, Paul D. P.

2010-01-01

Background Traditional prognostic factors for survival and treatment response of patients with breast cancer do not fully account for observed survival variation. We used available genotype data from a previously conducted two-stage, breast cancer susceptibility genome-wide association study (ie, Studies of Epidemiology and Risk factors in Cancer Heredity [SEARCH]) to investigate associations between variation in germline DNA and overall survival. Methods We evaluated possible associations between overall survival after a breast cancer diagnosis and 10 621 germline single-nucleotide polymorphisms (SNPs) from up to 3761 patients with invasive breast cancer (including 647 deaths and 26 978 person-years at risk) that were genotyped previously in the SEARCH study with high-density oligonucleotide microarrays (ie, hypothesis-generating set). Associations with all-cause mortality were assessed for each SNP by use of Cox regression analysis, generating a per rare allele hazard ratio (HR). To validate putative associations, we used patient genotype information that had been obtained with 5′ nuclease assay or mass spectrometry and overall survival information for up to 14 096 patients with invasive breast cancer (including 2303 deaths and 70 019 person-years at risk) from 15 international case–control studies (ie, validation set). Fixed-effects meta-analysis was used to generate an overall effect estimate in the validation dataset and in combined SEARCH and validation datasets. All statistical tests were two-sided. Results In the hypothesis-generating dataset, SNP rs4778137 (C>G) of the OCA2 gene at 15q13.1 was statistically significantly associated with overall survival among patients with estrogen receptor–negative tumors, with the rare G allele being associated with increased overall survival (HR of death per rare allele carried = 0.56, 95% confidence interval [CI] = 0.41 to 0.75, P = 9.2 × 10−5). This association was also observed in the validation dataset (HR of death per rare allele carried = 0.88, 95% CI = 0.78 to 0.99, P = .03) and in the combined dataset (HR of death per rare allele carried = 0.82, 95% CI = 0.73 to 0.92, P = 5 × 10−4). Conclusion The rare G allele of the OCA2 polymorphism, rs4778137, may be associated with improved overall survival among patients with estrogen receptor–negative breast cancer. PMID:20308648

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

PubMed

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.

Trends in parameterization, economics and host behaviour in influenza pandemic modelling: a review and reporting protocol

PubMed Central

2013-01-01

Background The volume of influenza pandemic modelling studies has increased dramatically in the last decade. Many models incorporate now sophisticated parameterization and validation techniques, economic analyses and the behaviour of individuals. Methods We reviewed trends in these aspects in models for influenza pandemic preparedness that aimed to generate policy insights for epidemic management and were published from 2000 to September 2011, i.e. before and after the 2009 pandemic. Results We find that many influenza pandemics models rely on parameters from previous modelling studies, models are rarely validated using observed data and are seldom applied to low-income countries. Mechanisms for international data sharing would be necessary to facilitate a wider adoption of model validation. The variety of modelling decisions makes it difficult to compare and evaluate models systematically. Conclusions We propose a model Characteristics, Construction, Parameterization and Validation aspects protocol (CCPV protocol) to contribute to the systematisation of the reporting of models with an emphasis on the incorporation of economic aspects and host behaviour. Model reporting, as already exists in many other fields of modelling, would increase confidence in model results, and transparency in their assessment and comparison. PMID:23651557

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.

PubMed

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.

Development and evaluation of an instrument to measure health-related quality of life in Cuban breast cancer patients receiving radiotherapy.

PubMed

Lugo, Josefina; Nápoles, Misleidy; Pérez, Inés; Ordaz, Niurka; Luzardo, Mario; Fernández, Leticia

2014-01-01

INTRODUCTION Although modern technology has extended the survival of breast cancer patients, treatment's adverse effects impact their health-related quality of life. Currently, no instrument exists capable of identifying the range of problems affecting breast cancer patients receiving radiotherapy in Cuba's socioeconomic and cultural context. OBJECTIVES Construct and validate an instrument to measure the effects of breast cancer and radiotherapy on health-related quality of life in Cuban patients. METHODS The study was conducted at the Oncology and Radiobiology Institute, Havana, Cuba, from January 2010 through December 2011. Inclusion criteria were: adult female, histological diagnosis of breast cancer, treated with ambulatory radiotherapy, and written informed consent; patients unable to communicate orally or in writing, or who had neurologic or psychiatric conditions were excluded. Development phase: focus groups guided by a list of questions were carried out with 50 women. The patients reported 61 problems affecting their health-related quality-of-life. A nominal group (six oncologists and two nurses) identified the same problems. A syntactic analysis of the information was performed to create items for study and measurement scales. Content validity was determined by a nominal group of seven experts using professional judgment. Another 20 patients were selected to evaluate face validity. Validation phase: the instrument was applied to 230 patients at three different points: before radiotherapy, at the end of radiotherapy and four weeks after radiotherapy was concluded. Reliability, construct validity, discriminant validity, predictive validity, interpretability and response burden were evaluated. RESULTS The final instrument developed had 33 items distributed in 4 domains: physical functioning, psychological functioning, social and family relationships, and physical and emotional adverse effects of disease and treatment. There were two discrete items: perceived general health and perceived health-related quality of life. Content validity and face validity were assessed as acceptable, by experts and patients respectively. Homogeneity, construct validity, and discriminant validity were satisfactory. The best results were obtained with test-retest reliability, predictive validity, and interpretability; the low rate of unanswered questions indicated that the instrument did not produce excessive patient response burden. CONCLUSION The new instrument fulfilled the requirements for measuring impact of breast cancer and of radiotherapy on health-related quality of life in these Cuban patients, validating its usefulness for inclusion in clinical trial protocols.

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

PubMed

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.

The EpiOcular Eye Irritation Test (EIT) for hazard identification and labelling of eye irritating chemicals: protocol optimisation for solid materials and the results after extended shipment.

PubMed

Kaluzhny, Yulia; Kandárová, Helena; Handa, Yuki; DeLuca, Jane; Truong, Thoa; Hunter, Amy; Kearney, Paul; d'Argembeau-Thornton, Laurence; Klausner, Mitchell

2015-05-01

The 7th Amendment to the EU Cosmetics Directive and the EU REACH Regulation have reinforced the need for in vitro ocular test methods. Validated in vitro ocular toxicity tests that can predict the human response to chemicals, cosmetics and other consumer products are required for the safety assessment of materials that intentionally, or inadvertently, come into contact with the eye. The EpiOcular Eye Irritation Test (EIT), which uses the normal human cell-based EpiOcular™ tissue model, was developed to address this need. The EpiOcular-EIT is able to discriminate, with high sensitivity and accuracy, between ocular irritant/corrosive materials and those that require no labelling. Although the original EpiOcular-EIT protocol was successfully pre-validated in an international, multicentre study sponsored by COLIPA (the predecessor to Cosmetics Europe), data from two larger studies (the EURL ECVAM-COLIPA validation study and an independent in-house validation at BASF SE) resulted in a sensitivity for the protocol for solids that was below the acceptance criteria set by the Validation Management Group (VMG) for eye irritation, and indicated the need for improvement of the assay's sensitivity for solids. By increasing the exposure time for solid materials from 90 minutes to 6 hours, the optimised EpiOcular-EIT protocol achieved 100% sensitivity, 68.4% specificity and 84.6% accuracy, thereby meeting all the acceptance criteria set by the VMG. In addition, to satisfy the needs of Japan and the Pacific region, the EpiOcular-EIT method was evaluated for its performance after extended shipment and storage of the tissues (4-5 days), and it was confirmed that the assay performs with similar levels of sensitivity, specificity and reproducibility in these circumstances. 2015 FRAME.

Can the combination of laparoscopy and enhanced recovery improve long-term survival after elective colorectal cancer surgery?

PubMed

Curtis, N J; Taylor, M; Fraser, L; Salib, E; Noble, E; Hipkiss, R; Allison, A S; Dalton, R; Ockrim, J B; Francis, Nader K

2018-02-01

Enhanced recovery after surgery (ERAS) programmes and laparoscopic techniques both provide short-term benefits to patients undergoing colorectal cancer surgery. ERAS protocol compliance may improve long-term survival in those undergoing open colorectal resection but as laparoscopic data has not been reported. Therefore, we aimed to investigate the impact of the combination of laparoscopy and ERAS management on 5-year overall survival. A dedicated prospectively populated colorectal cancer surgery database was reviewed. Patient inclusion criteria were biopsy-proven colorectal adenocarcinoma, undergoing elective surgery undertaken with curative intent. All patients were managed within an established ERAS programme and routinely followed up for 5 years. Overall survival was measured using the log-rank Kaplan-Meier method at 5 years. Eight hundred fifty-four patients met the inclusion criteria. Four hundred eighty-one (56%) cases were laparoscopic with 98 patients (20%) requiring conversion. There were no differences in patient or tumour demographics between the surgical groups. Median ERAS protocol compliance was 93% (range 53-100%). Five-year overall survival was superior in laparoscopic cases compared with that of converted and open surgery (78 vs 68 vs 70%, respectively, p < 0.007). An open approach (HR 1.55, 95%CI 1.16-2.06, p = 0.002) and delayed hospital discharge (> 7 days, HR 1.5, 95%CI 1.13-1.9, p = 0.003) were the only modifiable risk factors associated with poor survival. The use of a laparoscopic approach with enhanced recovery after surgery management appears to have long-term survival benefits following colorectal cancer resection.

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

PubMed

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.

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

PubMed

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

2017-12-15

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

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

PubMed

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.

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).

PubMed

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 (

[T-cell pediatric acute lymphoblastic leukemia: analysis of survival and prognostic factors in 4 consecutive protocols of the Spanish cooperative study group SHOP].

PubMed

Rives, Susana; Estella, Jesús; Camós, Mireia; García-Miguel, Purificación; Verdeguer, Amparo; Couselo, José Miguel; Tasso, María; Molina, Javier; Gómez, Pedro; Fernández-Delgado, Rafael; Navajas, Aurora; Badell, Isabel

2012-07-07

Acute lymphoblastic leukemia (ALL) is the most frequent cancer in childhood, with cure rates of 80-85%. In T-cell ALL (15% of ALL), prognostic factors are ill defined. We aimed to describe the event-free survival (EFS) and analyze clinical prognostic factors in a series of pediatric T-ALL of 4 consecutive clinical trials. Children with T-ALL aged 1-18 years treated in 37 institutions in Spain were enrolled in 4 consecutive trials from February-1989 to November-2009. A total of 218 T-ALL patients out of 1,652 pediatric ALL were evaluable during the study period (SHOP/ALL-89: 35, ALL-94: 63, ALL-99: 62, ALL-2005: 58). There were 164 boys (75%). Median age (years) was 7.8 range (1.3-18.6). Median leukocytes (10(9)/L) was 78.2, range 0.8-930. Fifteen (6.8%) children had central nervous system (CNS) involvement at diagnosis. Regarding response to induction treatment, 150 (75%) patients had less than 5% blasts on day-14 bone marrow and 199 achieved complete remission at the end of induction. Overall survival (OS) at 60 months for SHOP/ALL-89, ALL-94, ALL-99 was 48 (8), 49 (6), 70 (6) %, respectively, and at 48 months for SHOP/ALL-2005 (ongoing protocol) was 74 (8) %. Median follow-up (months) was 206, 152, 74 and 17 respectively. Analysis of prognostic factors revealed no statistical differences regarding sex or age. Leukocyte count over 200×10(9)/l (P=.024), CNS infiltration at diagnosis (P<.006) and treatment response had prognostic significance (end-induction complete remission) (P=.0000), day 14-bone marrow (P=.005). Results for the SHOP/ALL-89 and ALL-94 protocols were inferior to other contemporary protocols but there has been an improvement in survival in the 2 last trials. In line with other T-ALL series, response to treatment had the strongest prognostic impact. Copyright © 2011 Elsevier España, S.L. All rights reserved.

SurvExpress: an online biomarker validation tool and database for cancer gene expression data using survival analysis.

PubMed

Aguirre-Gamboa, Raul; Gomez-Rueda, Hugo; Martínez-Ledesma, Emmanuel; Martínez-Torteya, Antonio; Chacolla-Huaringa, Rafael; Rodriguez-Barrientos, Alberto; Tamez-Peña, José G; Treviño, Victor

2013-01-01

Validation of multi-gene biomarkers for clinical outcomes is one of the most important issues for cancer prognosis. An important source of information for virtual validation is the high number of available cancer datasets. Nevertheless, assessing the prognostic performance of a gene expression signature along datasets is a difficult task for Biologists and Physicians and also time-consuming for Statisticians and Bioinformaticians. Therefore, to facilitate performance comparisons and validations of survival biomarkers for cancer outcomes, we developed SurvExpress, a cancer-wide gene expression database with clinical outcomes and a web-based tool that provides survival analysis and risk assessment of cancer datasets. The main input of SurvExpress is only the biomarker gene list. We generated a cancer database collecting more than 20,000 samples and 130 datasets with censored clinical information covering tumors over 20 tissues. We implemented a web interface to perform biomarker validation and comparisons in this database, where a multivariate survival analysis can be accomplished in about one minute. We show the utility and simplicity of SurvExpress in two biomarker applications for breast and lung cancer. Compared to other tools, SurvExpress is the largest, most versatile, and quickest free tool available. SurvExpress web can be accessed in http://bioinformatica.mty.itesm.mx/SurvExpress (a tutorial is included). The website was implemented in JSP, JavaScript, MySQL, and R.

SurvExpress: An Online Biomarker Validation Tool and Database for Cancer Gene Expression Data Using Survival Analysis

PubMed Central

Aguirre-Gamboa, Raul; Gomez-Rueda, Hugo; Martínez-Ledesma, Emmanuel; Martínez-Torteya, Antonio; Chacolla-Huaringa, Rafael; Rodriguez-Barrientos, Alberto; Tamez-Peña, José G.; Treviño, Victor

2013-01-01

Validation of multi-gene biomarkers for clinical outcomes is one of the most important issues for cancer prognosis. An important source of information for virtual validation is the high number of available cancer datasets. Nevertheless, assessing the prognostic performance of a gene expression signature along datasets is a difficult task for Biologists and Physicians and also time-consuming for Statisticians and Bioinformaticians. Therefore, to facilitate performance comparisons and validations of survival biomarkers for cancer outcomes, we developed SurvExpress, a cancer-wide gene expression database with clinical outcomes and a web-based tool that provides survival analysis and risk assessment of cancer datasets. The main input of SurvExpress is only the biomarker gene list. We generated a cancer database collecting more than 20,000 samples and 130 datasets with censored clinical information covering tumors over 20 tissues. We implemented a web interface to perform biomarker validation and comparisons in this database, where a multivariate survival analysis can be accomplished in about one minute. We show the utility and simplicity of SurvExpress in two biomarker applications for breast and lung cancer. Compared to other tools, SurvExpress is the largest, most versatile, and quickest free tool available. SurvExpress web can be accessed in http://bioinformatica.mty.itesm.mx/SurvExpress (a tutorial is included). The website was implemented in JSP, JavaScript, MySQL, and R. PMID:24066126

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.

PubMed

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 < 0.001 for both; C-statistic = 0.815 for ASCERT and 0.781 for PROM). Prolonged ventilation, stroke, and hospital length of stay were also predictive of long-term death. The ASCERT survival probability calculator was externally 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.

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

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

Dandekar, Prasad; Harmer, Clive; Barbachano, Yolanda

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. Localmore » 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.« less

Mitigative Effects of a Combination of Multiple Pharmaceutical Drugs on the Survival of Mice Exposed to Lethal Ionizing Radiation.

PubMed

Hirouchi, Tokuhisa; Ito, Koichi; Nakano, Manabu; Monzen, Satoru; Yoshino, Hironori; Chiba, Mitsuru; Hazawa, Masaharu; Nakano, Akira; Ishikawa, Junya; Yamaguchi, Masaru; Tanaka, Kimio; Kashiwakura, Ikuo

2015-01-01

It is important to establish an easy-to-use therapeutic protocol for the emergency medical care of patients involved in radiation accidents to reduce the radiation-related casualties. The present study aimed to establish an optimum therapeutic protocol using currently approved pharmaceutical drugs to increase the survival of victims exposed to lethal radiation. Different combinations of four drugs-recombinant human erythropoietin (EPO), granulocyte-colony stimulating factor (G-CSF), c-mpl receptor agonist romiplostim (RP) and nandrolone decanoate (ND)-were administered to mice within 2 h after exposure to a lethal 7 Gy dose of γ-irradiation. On day 30 after irradiation, the condition of the mice was analyzed using various hematological parameters, such as the number of peripheral blood cells, bone marrow cells, hematopoietic progenitor cells and the expression of cell surface antigens. Approximately 10% of the untreated irradiated control mice survived for 21 days, but all of the control mice died by day 30. The combined administration of G-CSF, EPO and RP for five days immediately after irradiation led to a complete survival of the irradiated mice until day 30. However, the treatment with G-CSF, EPO and RP with ND led to only 75% survival at day 30. The hematological analyses showed that the numbers of almost all of hematopoietic cells in the surviving mice treated with effective medications recovered to the levels of non-irradiated mice. The present findings show that the combination of G-CSF, EPO and RP may be a useful countermeasure for victims exposed to accidental lethal irradiation.

Long-term outcome of concurrent chemoradiotherapy with elective nodal irradiation for inoperable esophageal cancer.

PubMed

Jing, Zhao; Chen, Tian; Zhang, Xuebang; Wu, Shixiu

2017-09-01

Elective nodal irradiation (ENI) might improve overall survival in patients with inoperable esophageal cancer. We conducted a retrospective analysis to assess the long-term survival and toxicity of esophageal cancer patients treated with ENI versus conventional-field irradiation (CFI). All data in the present study were based on our institutional experience from 2000 to 2005 of patients with inoperable esophageal cancer treated with ENI or CFI plus two concurrent cycles of paclitaxel/cisplatin. Based on the inclusion and exclusion criteria, 89 patients were included in the analysis. Of these patients, 51 were treated with ENI, whereas 38 were treated with CFI. For the per-protocol population, the patients in the ENI group significantly improved in terms of their 10-year disease-specific overall survival (43.1% vs 10.5%, P = 0.019), 10-year disease-free survival (36.7% vs 10.2%, P = 0.040) and 10-year local recurrence-free survival (47.2% vs 17.2%, P = 0.018) compared with the CFI group. Aside from radiation esophagitis, the incidence of grade 3 or greater acute toxicities did not differ between the two groups. Multivariate analysis showed that radiation field, tumor length and clinical stage were independent prognostic factors associated with OS. Concurrent chemoradiotherapy with ENI improves both disease-specific overall survival and loco-regional control in patients with inoperable esophageal cancer receiving per-protocol treatment. The regimen has a manageable tolerability profile. © 2017 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

Remote Patron Validation: Posting a Proxy Server at the Digital Doorway.

ERIC Educational Resources Information Center

Webster, Peter

2002-01-01

Discussion of remote access to library services focuses on proxy servers as a method for remote access, based on experiences at Saint Mary's University (Halifax). Topics include Internet protocol user validation; browser-directed proxies; server software proxies; vendor alternatives for validating remote users; and Internet security issues. (LRW)

75 FR 60843 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-01

... Effectiveness of a Proposed Rule Change Relating to FINRA Trade Reporting Notice on Price Validation and Price... (``Notice'') that explains the price validation protocol of the FINRA trade reporting facilities and sets... trades by comparing the submitted price against price validation parameters established by FINRA...

Validity of breast, lung and colorectal cancer diagnoses in administrative databases: a systematic review protocol.

PubMed

Abraha, Iosief; Giovannini, Gianni; Serraino, Diego; Fusco, Mario; Montedori, Alessandro

2016-03-18

Breast, lung and colorectal cancers constitute the most common cancers worldwide and their epidemiology, related health outcomes and quality indicators can be studied using administrative healthcare databases. To constitute a reliable source for research, administrative healthcare databases need to be validated. The aim of this protocol is to perform the first systematic review of studies reporting the validation of International Classification of Diseases 9th and 10th revision codes to identify breast, lung and colorectal cancer diagnoses in administrative healthcare databases. This review protocol has been developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) 2015 statement. We will search the following databases: MEDLINE, EMBASE, Web of Science and the Cochrane Library, using appropriate search strategies. We will include validation studies that used administrative data to identify breast, lung and colorectal cancer diagnoses or studies that evaluated the validity of breast, lung and colorectal cancer codes in administrative data. The following inclusion criteria will be used: (1) the presence of a reference standard case definition for the disease of interest; (2) the presence of at least one test measure (eg, sensitivity, positive predictive values, etc) and (3) the use of data source from an administrative database. Pairs of reviewers will independently abstract data using standardised forms and will assess quality using a checklist based on the Standards for Reporting of Diagnostic accuracy (STARD) criteria. Ethics approval is not required. We will submit results of this study to a peer-reviewed journal for publication. The results will serve as a guide to identify appropriate case definitions and algorithms of breast, lung and colorectal cancers for researchers involved in validating administrative healthcare databases as well as for outcome research on these conditions that used administrative healthcare databases. CRD42015026881. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Comparative Resuscitation Measures for Drug Toxicities Utilizing Lipid Emulsions

DTIC Science & Technology

2015-01-13

experimental, mixed research design Methods: For each drug studied, seven swine were assigned to eight ACLS or BLS protocol resuscitation groups ...studied drug overdose. For example, with bupivacaine, seventy- one percent of the epinephrine/lipid group survived compared to 19% of all the groups ...surviving. The Epinephrine only group yielded three survivors and the Lipid emulsion only group yielded one survivor. No swine in the CPR only or

Efficacy of combination chemotherapy for treatment of gastrointestinal lymphoma in dogs.

PubMed

Rassnick, K M; Moore, A S; Collister, K E; Northrup, N C; Kristal, O; Chretin, J D; Bailey, D B

2009-01-01

Chemotherapy for multicentric canine lymphoma has favorable results. The gastrointestinal (GI) tract is the most common extranodal site of canine lymphoma, but there have been no prospective studies to determine outcome when dogs with GI lymphoma are treated with chemotherapy. Treatment with a multiagent chemotherapy protocol is associated with a poor outcome in dogs with GI lymphoma. Eighteen dogs with histologically confirmed GI lymphoma. Prospective clinical trial in which dogs with GI lymphoma were treated with a 20-week combination chemotherapy protocol consisting of induction and consolidation phases. Thirteen dogs had primary GI lymphoma and 5 had multicentric lymphoma with GI involvement. The majority of the lymphomas (63%) were of T-cell origin. Overall remission rate was 56%; 9 dogs achieved a complete remission for a median of 86 days (range, 22-420 days) and 1 dog achieved a partial remission for 26 days. Overall median survival time was 77 days (range, 6-700 days). Dogs that failed to achieve a remission (10 versus 117 days; P= .002) or had diarrhea at initial presentation (70 versus 700 days; P < .001) had shorter survival times. The response and survival of dogs with GI lymphoma treated with multiagent chemotherapy is poor but long-term survival is possible.

Orbital implant placement using a computer-aided design and manufacturing (CAD/CAM) stereolithographic surgical template protocol.

PubMed

Goh, B T; Teoh, K H

2015-05-01

Surgical implant placement in the orbital region for the support of a prosthesis is challenging due to the thin orbital rim and proximity to vital structures. This article reports the use of a computer-aided design and manufacturing (CAD/CAM) stereolithographic surgical template protocol for orbital implant placement in four patients, who were followed-up for about 7 years. A total of 11 orbital implants were inserted, eight of these in irradiated bone. No intraoperative complications were noted in any of the patients and the implants were all inserted in the planned positions. The survival rate of implants placed in irradiated bone that received hyperbaric oxygen therapy was 62.5% (5/8). One implant failed in a burns injury patient at 74 months after functional loading. The overall survival of implants in the orbital region and the cumulative survival at 7 years was 63.6%. With regard to skin reactions around the abutments, 85% were grade 0, 13% were grade 1, and 2% were grade 2 according to the Holgers classification. The mean survival time of the first prosthesis was 49 months. High patient satisfaction was achieved with the implant-retained orbital prostheses. Copyright © 2014 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Comparison of cyclophosphamide-thalidomide-dexamethasone to bortezomib-cyclophosphamide-dexamethasone as induction therapy for multiple myeloma patients in Brazil.

PubMed

Vigolo, Suelen; Zuckermann, Joice; Bittencourt, Rosane Isabel; Silla, Lúcia; Pilger, Diogo André

2017-09-01

Chemotherapy followed by autologous hematopoietic stem cell transplantation (HSCT) remains the standard treatment for multiple myeloma (MM). Thalidomide or bortezomib may be combined with cyclophosphamide and dexamethasone, in what are known as the CTD and VCD protocols, respectively. The objective of this study was to evaluate the clinical characteristics and response rates obtained with CTD and VCD, observing whether the inclusion of bortezomib to treat MM patients in Brazil increases therapeutic efficiency. Forty-three MM patients treated with induction protocols CTD and VCD between January 2010 and March 2015 were included. The parameters analyzed were staging, frequency of comorbidities prior to treatment, response rates obtained at each induction cycle, progression-free survival, and overall survival of patients. Very good partial response and complete response obtained with the VCD protocol were superior, compared with the CTD treatment. The presence of comorbidities was similar in the two groups, except kidney failure, which prevailed in the VCD group. Also, 78.3% and 48.3% of patients treated with the VCD and CTD protocols underwent autologous HSCT, respectively. In patients given the VCD protocol, 45.5% had complete response before autologous HSCT. Among those given CTD, this number was only 7.1% (p=0.023). Disease progression after autologous HSCT did not differ between the two groups. VCD afforded better responses than the CTD protocol, and improved patient condition before autologous HSCT. However, more studies are necessary including more patients and addressing various clinical conditions, besides the analysis of cost-effectiveness of these treatments. Copyright © 2017 King Faisal Specialist Hospital & Research Centre. Published by Elsevier B.V. All rights reserved.

Comparative recovery of uninjured and heat-injured Listeria monocytogenes cells from bovine milk.

PubMed Central

Crawford, R G; Beliveau, C M; Peeler, J T; Donnelly, C W; Bunning, V K

1989-01-01

The standard selective enrichment protocols of the Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) were compared with an experimental nonselective broth enrichment (NSB) protocol and variations of the standard cold-enrichment (CE) protocol for the recovery of heat-injured Listeria monocytogenes. Bacterial cells (10(7)/ml) were suspended in sterile milk and heated at 71.7 degrees C in a slug-flow heat exchanger for holding times ranging from 1 to 30 s. Surviving cells were determined (50% endpoint) by the given protocols, and the following D values were obtained: NSB, D = 2.0 +/- 0.5 s; FDA, D = 1.4 +/- 0.3 s; USDA, D = 0.6 +/- 0.2 s; CE, D less than or equal to 1.2 s. The respective direct-plating media used in these enrichments were also analyzed for recovery, and the following D values were calculated from the enumeration of surviving cells; NSB, D = 2.7 +/- 0.8 s; FDA, D = 1.3 +/- 0.4 s; USDA, D = 0.7 +/- 0.2 s. The low levels of heat-injured L. monocytogenes cells which were detected at inactivation endpoints on the optimal nonselective media (25 degrees C for 7 days) failed to recover and multiply during experimental CEs (4 degrees C for 28 days). Initial inactivation experiments in which raw whole milk was used as the heating menstruum gave much lower recoveries with all protocols. The detectable limits for uninjured cells that were suspended in raw milk were similar (0.35 to 3.2 cells per ml) for the standard CE, FDA, and USDA protocols.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:2504109

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.

PubMed

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 (

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

PubMed

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

2016-09-02

There is an increasing number of new oncology drugs being studied, approved and put into clinical practice based on improvement in progression-free survival, when no overall survival benefits exist. In oncology, the association between progression-free survival and health-related quality of life is currently unknown, despite its importance for patients with cancer, and the unverified assumption that longer progression-free survival indicates improved health-related quality of life. Thus far, only 1 study has investigated this association, providing insufficient evidence and inconclusive results. The objective of this study protocol is to provide increased transparency in supporting a systematic summary of the evidence bearing on this association in oncology. Using the OVID platform in MEDLINE, Embase and Cochrane databases, we will conduct a systematic review of randomised controlled human trials addressing oncology issues published starting in 2000. A team of reviewers will, in pairs, independently screen and abstract data using standardised, pilot-tested forms. We will employ numerical integration to calculate mean incremental area under the curve between treatment groups in studies for health-related quality of life, along with total related error estimates, and a 95% CI around incremental area. To describe the progression-free survival to health-related quality of life association, we will construct a scatterplot for incremental health-related quality of life versus incremental progression-free survival. To estimate the association, we will use a weighted simple regression approach, comparing mean incremental health-related quality of life with either median incremental progression-free survival time or the progression-free survival HR, in the absence of overall survival benefit. Identifying direction and magnitude of association between progression-free survival and health-related quality of life is critically important in interpreting results of oncology trials. Systematic evidence produced from our study will contribute to improvement of patient care and practice of evidence-based medicine in oncology. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Primary Tumor and MEF Cell Isolation to Study Lung Metastasis.

PubMed

Dong, Shengli; Maziveyi, Mazvita; Alahari, Suresh K

2015-05-20

In breast tumorigenesis, the metastatic stage of the disease poses the greatest threat to the affected individual. Normal breast cells with altered genotypes now possess the ability to invade and survive in other tissues. In this protocol, mouse mammary tumors are removed and primary cells are prepared from tumors. The cells isolated from this procedure are then available for gene profiling experiments. For successful metastasis, these cells must be able to intravasate, survive in circulation, extravasate to distant organs, and survive in that new organ system. The lungs are the typical target of breast cancer metastasis. A set of genes have been discovered that mediates the selectivity of metastasis to the lung. Here we describe a method of studying lung metastasis from a genetically engineered mouse model.. Furthermore, another protocol for analyzing mouse embryonic fibroblasts (MEFs) from the mouse embryo is included. MEF cells from the same animal type provide a clue of non-cancer cell gene expression. Together, these techniques are useful in studying mouse mammary tumorigenesis, its associated signaling mechanisms and pathways of the abnormalities in embryos.

Generation and maturation of bone marrow-derived DCs under serum-free conditions.

PubMed

Kim, Sung Jung; Diamond, Betty

2007-06-30

Standard protocols for the generation of murine dendritic cells (DCs) employ medium supplemented with heat-inactivated fetal calf serum (FCS). Recently, several attempts have been made to avoid serum exposure during DC culture. The impetus for these efforts has been a desire to generate DCs for clinical use, as preclinical data have demonstrated their efficacy in immune activation and in immune suppression both in vitro and in vivo. However, these protocols have resulted in contradictory outcomes with respect to DC survival in culture and activation status. In this report, we compared several serum-free culture conditions with respect to survival, differentiation, activation, and cytokine profile of murine DC progenitors. DC progenitors can survive only in some serum-free conditions. Surprisingly, DCs grown in serum-free medium display a higher expression of activation markers upon stimulation. They produce increased IL-12 and decreased IL-6 following stimulation. Furthermore, DCs derived under serum-free conditions may express unusual surface markers, B220 and Ly6C/G, implying an increased differentiation to plasmacytoid DCs (pDCs).

Tackling reliability and construct validity: the systematic development of a qualitative protocol for skill and incident analysis.

PubMed

Savage, Trevor Nicholas; McIntosh, Andrew Stuart

2017-03-01

It is important to understand factors contributing to and directly causing sports injuries to improve the effectiveness and safety of sports skills. The characteristics of injury events must be evaluated and described meaningfully and reliably. However, many complex skills cannot be effectively investigated quantitatively because of ethical, technological and validity considerations. Increasingly, qualitative methods are being used to investigate human movement for research purposes, but there are concerns about reliability and measurement bias of such methods. Using the tackle in Rugby union as an example, we outline a systematic approach for developing a skill analysis protocol with a focus on improving objectivity, validity and reliability. Characteristics for analysis were selected using qualitative analysis and biomechanical theoretical models and epidemiological and coaching literature. An expert panel comprising subject matter experts provided feedback and the inter-rater reliability of the protocol was assessed using ten trained raters. The inter-rater reliability results were reviewed by the expert panel and the protocol was revised and assessed in a second inter-rater reliability study. Mean agreement in the second study improved and was comparable (52-90% agreement and ICC between 0.6 and 0.9) with other studies that have reported inter-rater reliability of qualitative analysis of human movement.

Optimization and validation of sample preparation for metagenomic sequencing of viruses in clinical samples.

PubMed

Lewandowska, Dagmara W; Zagordi, Osvaldo; Geissberger, Fabienne-Desirée; Kufner, Verena; Schmutz, Stefan; Böni, Jürg; Metzner, Karin J; Trkola, Alexandra; Huber, Michael

2017-08-08

Sequence-specific PCR is the most common approach for virus identification in diagnostic laboratories. However, as specific PCR only detects pre-defined targets, novel virus strains or viruses not included in routine test panels will be missed. Recently, advances in high-throughput sequencing allow for virus-sequence-independent identification of entire virus populations in clinical samples, yet standardized protocols are needed to allow broad application in clinical diagnostics. Here, we describe a comprehensive sample preparation protocol for high-throughput metagenomic virus sequencing using random amplification of total nucleic acids from clinical samples. In order to optimize metagenomic sequencing for application in virus diagnostics, we tested different enrichment and amplification procedures on plasma samples spiked with RNA and DNA viruses. A protocol including filtration, nuclease digestion, and random amplification of RNA and DNA in separate reactions provided the best results, allowing reliable recovery of viral genomes and a good correlation of the relative number of sequencing reads with the virus input. We further validated our method by sequencing a multiplexed viral pathogen reagent containing a range of human viruses from different virus families. Our method proved successful in detecting the majority of the included viruses with high read numbers and compared well to other protocols in the field validated against the same reference reagent. Our sequencing protocol does work not only with plasma but also with other clinical samples such as urine and throat swabs. The workflow for virus metagenomic sequencing that we established proved successful in detecting a variety of viruses in different clinical samples. Our protocol supplements existing virus-specific detection strategies providing opportunities to identify atypical and novel viruses commonly not accounted for in routine diagnostic panels.

Multiprofissional electronic protocol in ophtalmology with enfasis in strabismus.

PubMed

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 "Protocolo Eletrônico" da Oftalmologia ao Sistema Integrado de Protocolos Eletrônicos (SINPE(c)). este é um estudo descritivo e a metodologia aplicada em seu desenvolvimento está didaticamente dividida em três fases: 1) criação da base teórica de dados clínicos de oftalmologia com ênfase em estrabismo; 2) informatização da base teórica dos dados utilizando o SINPE(c); e 3) interpretação das informações com demonstração dos resultados. A informatização da base de dados foi realizada pela utilização da concessão de uso do SINPE(c). Foram incluídos neste protocolo 50 pacientes com estrabismo para validação do protocolo. o protocolo eletrônico desenvolvido permitiu armazenar informações relacionadas à anamnese, exame físico, exames complementares, diagnóstico e tratamento de pacientes com doenças oftalmológicas, com ênfase em estrabismo. Foram incluídos neste trabalho 2141 itens no protocolo mestre e foram criados 20 protocolos específicos de estrabismo, cada um com suas particularidades. Os 50 pacientes que foram incluídos nos protocolos específicos demonstraram a eficácia do método empregado. foi criada uma base eletrônica de dados em oftalmologia com ênfase em estrabismo através da coleta padronizada de informações. Esta base de dados foi informatizada sob a forma de software onde os futuros usuários poderão utilizar o protocolo eletrônico multiprofissional de doenças oftalmológicas com ênfase em estrabismo para a coleta de seus dados.

RF Systems in Space. Volume I. Space Antennas Frequency (SARF) Simulation.

DTIC Science & Technology

1983-04-01

lens SBR designs were investigated. The survivability of an SBR system was analyzed. The design of ground based SBR validation experiments for large...aperture SBR concepts were investigated. SBR designs were investigated for ground target detection. N1’IS GRAMI DTIC TAB E Unannounced E Justificat... designs :~~.~...: .-..:. ->.. - . *.* . ..- . . .. . -. . ..- . .4. To analyze the survivability of space radar 5. To design ground-based validation

A framework for the definition of standardized protocols for measuring upper-extremity kinematics.

PubMed

Kontaxis, A; Cutti, A G; Johnson, G R; Veeger, H E J

2009-03-01

Increasing interest in upper extremity biomechanics has led to closer investigations of both segment movements and detailed joint motion. Unfortunately, conceptual and practical differences in the motion analysis protocols used up to date reduce compatibility for post data and cross validation analysis and so weaken the body of knowledge. This difficulty highlights a need for standardised protocols, each addressing a set of questions of comparable content. The aim of this work is therefore to open a discussion and propose a flexible framework to support: (1) the definition of standardised protocols, (2) a standardised description of these protocols, and (3) the formulation of general recommendations. Proposal of a framework for the definition of standardized protocols. The framework is composed by two nested flowcharts. The first defines what a motion analysis protocol is by pointing out its role in a motion analysis study. The second flowchart describes the steps to build a protocol, which requires decisions on the joints or segments to be investigated and the description of their mechanical equivalent model, the definition of the anatomical or functional coordinate frames, the choice of marker or sensor configuration and the validity of their use, the definition of the activities to be measured and the refinements that can be applied to the final measurements. Finally, general recommendations are proposed for each of the steps based on the current literature, and open issues are highlighted for future investigation and standardisation. Standardisation of motion analysis protocols is urgent. The proposed framework can guide this process through the rationalisation of the approach.

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

PubMed

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.

Development of UV Testing Protocol and Recommendations

EPA Science Inventory

The goal of this effort is to develop and present new protocols for UV validation testing and analysis that leverage advances and may help to improve implementation and operation at PWSs. This document also provides for updated clarifications to the UVDGM based on evolving practi...

CHOP chemotherapy for the treatment of canine multicentric T-cell lymphoma.

PubMed

Rebhun, R B; Kent, M S; Borrofka, S A E B; Frazier, S; Skorupski, K; Rodriguez, C O

2011-03-01

Dogs with multicentric T-cell lymphoma are commonly treated with CHOP chemotherapy protocols that include cyclophosphamide, doxorubicin, vincristine and prednisone. The purpose of this study was to evaluate the use of CHOP chemotherapy for dogs with multicentric T-cell lymphoma. Identification of prognostic factors in this specific subset of dogs was of secondary interest. Twenty-three out of 24 dogs responded to CHOP chemotherapy and these dogs remained on the protocol for a median of 146 days. No variable was associated with progression free survival (PFS) including stage, substage, hypercalcemia or radiographic evidence of a cranial mediastinal mass. The median overall survival time (OST) for all dogs was 235 days. Dogs that were thrombocytopenic at presentation experienced a significantly longer OST (323 versus 212 days, P=0.01). © 2010 Blackwell Publishing Ltd.

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

NASA Technical Reports Server (NTRS)

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

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

NASA Technical Reports Server (NTRS)

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

Results of a multicenter prospective clinical study in Japan for evaluating efficacy and safety of desensitization protocol based on rituximab in ABO-incompatible kidney transplantation.

PubMed

Takahashi, Kota; Saito, Kazuhide; Takahara, Shiro; Fuchinoue, Shohei; Yagisawa, Takashi; Aikawa, Atsushi; Watarai, Yoshihiko; Yoshimura, Norio; Tanabe, Kazunari; Morozumi, Kunio; Shimazu, Motohide

2017-08-01

Deceased organ donations are rare in Japan, with most kidney transplants performed from a limited number of living donors. Researchers have thus developed highly successful ABO-incompatible transplantation procedures, emphasizing preoperative desensitization and postoperative immunosuppression. A recent open-label, single-arm, multicenter clinical study prospectively examined the efficacy and safety of rituximab/mycophenolate mofetil desensitization in ABO-incompatible kidney transplantation without splenectomy. Mycophenolate mofetil and low dose steroid were started 28 days pretransplant, followed by two doses of rituximab 375 mg/m 2 at day -14 and day -1, and postoperative immunosuppression with tacrolimus or ciclosporin and basiliximab. The primary endpoint was the non-occurrence rate of acute antibody-mediated rejection. Patient survival and graft survival were monitored for 1 year posttransplant. Eighteen patients received rituximab and underwent ABO-incompatible kidney transplantation. CD19-positive peripheral B cell count decreased rapidly after the first rituximab infusion and recovered gradually after week 36. The desensitization protocol was tolerable, and most rituximab-related infusion reactions were mild. No anti-A/B antibody-mediated rejection occurred with this series. One patient developed anti-HLA antibody-mediated rejection (Banff 07 type II) on day 2, which was successfully managed. Patient and graft survival were both 100 % after 1 year. Our desensitization protocol was confirmed to be clinically effective and with acceptable toxicities for ABO-I-KTx (University Hospital Medical Information Network Registration Number: UMIN000006635).

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

PubMed

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

2017-11-21

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

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

PubMed

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

2016-09-02

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

Field monitoring of plant-growth-promoting rhizobacteria by colony immunoblotting.

PubMed

Krishnen, Ganisan; Kecskés, Mihály L; Rose, Michael T; Geelan-Small, Peter; Amprayn, Khanok-on; Pereg, Lily; Kennedy, Ivan R

2011-11-01

Inoculant plant-growth-promoting bacteria are emerging as an important component of sustainable agriculture. There is a need to develop inexpensive methods for enumerating these organisms after their application in the field, to better understand their survival and impacts on yields. Immunoblotting is one potential method to measure viable cells, but the high cost of the conventionally used nylon membranes makes this method prohibitive. In this study, less expensive alternative materials such as filter papers, glossy photo papers, and transparencies for the purpose of colony immunoblotting were evaluated and the best substance was chosen for further studies. Whatman filter paper No. 541 combined with a 0.01 mol·L(-1) H(2)SO(4) rinsing step gave similar results to nylon membranes but <20% of the overall cost of the original colony immunoblotting assay. The application of the modified immunoblot method was tested on nonsterile clay soil samples that were spiked with high numbers (>10(7) CFU·g(-1)) of the plant-growth-promoting bacteria Pseudomonas fluorescens , Azospirillum brasilense , or Rhizobium leguminosarum . The modified protocol allowed the identification and recovery of over 50% of the inoculated cells of all three strains, amidst a background of the native soil microflora. Subsequently, the survival of P. fluorescens was successfully monitored for several months after application to field-grown rice at Jerilderie, New South Wales, Australia, thus validating the procedure.

Cryopreservation of veliger larvae of trumpet shell, Charonia sauliae: an essential preparation to artificial propagation

NASA Astrophysics Data System (ADS)

Kang, Kyoung Ho; Zhang, Zhifeng; Bao, Zhenmin; Shao, Mingyu

2009-09-01

Trumpet shell, Charonia sauliae, is an endangered and valuable species, but its artificial propagation protocol has not been successfully established. To estimate the possibility of cryopreservation for larvae of C. sauliae, which is a potential preparation for its artificial reproduction and further research, in this study a protocol for the cryopreservation of veliger larvae of trumpet shell was optimized. Through a two-step cryopreservation procedure, four kinds of cryoprotectants (ethylene glycol, 1, 2-propanediol, dimethyl sulfoxide and glycerol) were employed at three concentrations (1.0, 1.5 and 2.0 molL-1) respectively and survival rates of larvae were determined after a storage of 1h. The larvae frozen with these four cryoprotectants after 1 h storage were cultured, and then survival rates were determined at 24, 72 and 120 h after thawing. Dimethyl sulfoxide at a concentration of 1.5 molL-1 showed the best protective effect in all experiments ( p<0.05). And survival rates of larvae frozen with dimethyl sulfoxide were determined after 1, 7 and 15 d of storage. The survival rates of larvae frozen with 1.5 molL-1 dimethyl sulfoxide after 1 h, 1 d, 7 d and 15 d of storage were 80.77% ±7.51%, 80.34% ±11.28%, 83.10% ±9.14% and 77.23% ±6.22% respectively. No significant differences in survival rates of larvae frozen with dimethyl sulfoxide were observed after various storage periods ( p>0.05).

A semi-automatic method for left ventricle volume estimate: an in vivo validation study

NASA Technical Reports Server (NTRS)

Corsi, C.; Lamberti, C.; Sarti, A.; Saracino, G.; Shiota, T.; Thomas, J. D.

2001-01-01

This study aims to the validation of the left ventricular (LV) volume estimates obtained by processing volumetric data utilizing a segmentation model based on level set technique. The validation has been performed by comparing real-time volumetric echo data (RT3DE) and magnetic resonance (MRI) data. A validation protocol has been defined. The validation protocol was applied to twenty-four estimates (range 61-467 ml) obtained from normal and pathologic subjects, which underwent both RT3DE and MRI. A statistical analysis was performed on each estimate and on clinical parameters as stroke volume (SV) and ejection fraction (EF). Assuming MRI estimates (x) as a reference, an excellent correlation was found with volume measured by utilizing the segmentation procedure (y) (y=0.89x + 13.78, r=0.98). The mean error on SV was 8 ml and the mean error on EF was 2%. This study demonstrated that the segmentation technique is reliably applicable on human hearts in clinical practice.

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

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

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 applyingmore » 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.« less

Comparing the biocidal properties of non-thermal plasma sources by reference protocol

NASA Astrophysics Data System (ADS)

Khun, Josef; Jirešová, Jana; Kujalová, Lucie; Hozák, Pavel; Scholtz, Vladimír

2017-10-01

The previously proposed reference protocol enabling easy comparison of biocidal properties of different non-thermal plasma sources has been followed and discussed. For inactivation tests the reference protocol has used spores of Gram positive bacterium Bacillus subtilis (ATCC 6633) deposited on a polycarbonate membrane as reference sample. In this work, biocidal properties of a negative glow corona, positive streamer corona, positive transient spark and cometary discharges are being compared in both open air and closed apparatus. Despite the total number of bacteria surviving 1 h exposure has decreased by up to 7 orders in closed apparatus, in open one, only weak inhibition bactericidal effect has been observed.

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

PubMed

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.

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

PubMed

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

2017-01-01

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

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

Treesearch

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...

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

PubMed

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

2013-12-01

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

Infused autograft lymphocyte-to-monocyte ratio and survival in T-cell lymphoma post-autologous peripheral blood hematopoietic stem cell transplantation.

PubMed

Porrata, Luis F; Inwards, David J; Ansell, Stephen M; Micallef, Ivana N; Johnston, Patrick B; Hogan, William J; Markovic, Svetomir N

2015-07-03

The infused autograft lymphocyte-to-monocyte ratio (A-LMR) is a prognostic factor for survival in B-cell lymphomas post-autologous peripheral hematopoietic stem cell transplantation (APHSCT). Thus, we set out to investigate if the A-LMR is also a prognostic factor for survival post-APHSCT in T-cell lymphomas. From 1998 to 2014, 109 T-cell lymphoma patients that underwent APHSCT were studied. Receiver operating characteristic (ROC) and area under the curve (AUC) were used to identify the optimal cut-off value of A-LMR for survival analysis and k-fold cross-validation model to validate the A-LMR cut-off value. Univariate and multivariate Cox proportional hazard models were used to assess the prognostic discriminator power of A-LMR. ROC and AUC identified an A-LMR ≥ 1 as the best cut-off value and was validated by k-fold cross-validation. Multivariate analysis showed A-LMR to be an independent prognostic factor for overall survival (OS) and progression-free survival (PFS). Patients with an A-LMR ≥ 1.0 experienced a superior OS and PFS versus patients with an A-LMR < 1.0 [median OS was not reached vs 17.9 months, 5-year OS rates of 87% (95% confidence interval (CI), 75-94%) vs 26% (95% CI, 13-42%), p < 0.0001; median PFS was not reached vs 11.9 months, 5-year PFS rates of 72% (95% CI, 58-83%) vs 16% (95% CI, 6-32%), p < 0.0001]. A-LMR is also a prognostic factor for clinical outcomes in patients with T-cell lymphomas undergoing APHSCT.

STANDARDIZATION AND VALIDATION OF METHODS FOR ENUMERATION OF FECAL COLIFORM AND SALMONELLA IN BIOSOLIDS

EPA Science Inventory

Current federal regulations required monitoring for fecal coliforms or Salmonella in biosolids destined for land application. Methods used for analysis of fecal coliforms and Salmonella were reviewed and a standard protocol was developed. The protocols were then...

STANDARDIZATION AND VALIDATION OF METHODS FOR ENUMERATION OF FECAL COLIFORM AND SALMONELLA IN BIOSOLIDS

EPA Science Inventory

Current federal regulations require monitoring for fecal coliforms or Salmonella in biosolids destined for land application. Methods used for analysis of fecal coliforms and Salmonella were reviewed and a standard protocol was developed. The protocols were then evaluated by testi...

Clinical decision rules for termination of resuscitation in out-of-hospital cardiac arrest.

PubMed

Sherbino, Jonathan; Keim, Samuel M; Davis, Daniel P

2010-01-01

Out-of-hospital cardiac arrest (OHCA) has a low probability of survival to hospital discharge. Four clinical decision rules (CDRs) have been validated to identify patients with no probability of survival. Three of these rules focus on exclusive prehospital basic life support care for OHCA, and two of these rules focus on prehospital advanced life support care for OHCA. Can a CDR for the termination of resuscitation identify a patient with no probability of survival in the setting of OHCA? Six validation studies were selected from a PubMed search. A structured review of each of the studies is presented. In OHCA receiving basic life support care, the BLS-TOR (basic life support termination of resuscitation) rule has a positive predictive value for death of 99.5% (95% confidence interval 98.9-99.8%), and decreases the transportation of all patients by 62.6%. This rule has been appropriately validated for widespread use. In OHCA receiving advanced life support care, no current rule has been appropriately validated for widespread use. The BLS-TOR rule is a simple rule that identifies patients who will not survive OHCA. Further research is required to identify similarly robust CDRs for patients receiving advanced life support care in the setting of OHCA. Copyright 2010 Elsevier Inc. All rights reserved.

General A Scheme to Share Information via Employing Discrete Algorithm to Quantum States

NASA Astrophysics Data System (ADS)

Kang, Guo-Dong; Fang, Mao-Fa

2011-02-01

We propose a protocol for information sharing between two legitimate parties (Bob and Alice) via public-key cryptography. In particular, we specialize the protocol by employing discrete algorithm under mod that maps integers to quantum states via photon rotations. Based on this algorithm, we find that the protocol is secure under various classes of attacks. Specially, owe to the algorithm, the security of the classical privacy contained in the quantum public-key and the corresponding ciphertext is guaranteed. And the protocol is robust against the impersonation attack and the active wiretapping attack by designing particular checking processing, thus the protocol is valid.

A Phase III Clinical Trial of the Epidermal Growth Factor Vaccine CIMAvax-EGF as Switch Maintenance Therapy in Advanced Non-Small Cell Lung Cancer Patients.

PubMed

Rodriguez, Pedro C; Popa, Xitllaly; Martínez, Odeth; Mendoza, Silvia; Santiesteban, Eduardo; Crespo, Tatiana; Amador, Rosa M; Fleytas, Ricardo; Acosta, Soraida C; Otero, Yanine; Romero, Gala N; de la Torre, Ana; Cala, Mireysi; Arzuaga, Lina; Vello, Loisel; Reyes, Delmairis; Futiel, Niurka; Sabates, Teresa; Catala, Mauricio; Flores, Yoanna I; Garcia, Beatriz; Viada, Carmen; Lorenzo-Luaces, Patricia; Marrero, Maria A; Alonso, Liuba; Parra, Jenelin; Aguilera, Nadia; Pomares, Yaisel; Sierra, Patricia; Rodríguez, Gryssell; Mazorra, Zaima; Lage, Agustin; Crombet, Tania; Neninger, Elia

2016-08-01

EGFR is a well-validated target for patients with non-small cell lung cancer (NSCLC). CIMAvax-EGF is a therapeutic cancer vaccine composed of human recombinant EGF conjugated to a carrier protein and Montanide ISA51 as adjuvant. The vaccine is intended to induce antibodies against self EGFs that block EGF-EGFR interaction. To evaluate overall survival, safety, immunogenicity, and EGF concentration in serum after CIMAvax-EGF, a randomized phase III trial was done in patients with advanced NSCLC. Four to 6 weeks after first-line chemotherapy, 405 patients with stage IIIB/IV NSCLC were randomly assigned to a vaccine group, which received CIMAvax-EGF or a control group, treated with best supportive care. Long-term vaccination was very safe. Most frequent adverse reactions were grade 1 or 2 injection-site pain, fever, vomiting, and headache. Vaccination induced anti-EGF antibodies and decreased serum EGF concentration. In the safety population, median survival time (MST) was 10.83 months in the vaccine arm versus 8.86 months in the control arm. These differences were not significant according the standard log rank (HR, 0.82; P = 0.100), but according a weighted log rank (P = 0.04) that was applied once the nonproportionality of the HR was verified. Survival benefit was significant (HR, 0.77; P = 0.036) in the per-protocol setting (patients receiving at least four vaccine doses): MST was 12.43 months for the vaccine arm versus 9.43 months for the control arm. MST was higher (14.66 months) for vaccinated patients with high EGF concentration at baseline. Switch maintenance with CIMAvax-EGF was well tolerated and significantly increased MST of patients that completed induction vaccination. Baseline EGF concentration predicted survival benefit. Clin Cancer Res; 22(15); 3782-90. ©2016 AACR. ©2016 American Association for Cancer Research.

A novel cuffless device for self-measurement of blood pressure: concept, performance and clinical validation.

PubMed

Boubouchairopoulou, N; Kollias, A; Chiu, B; Chen, B; Lagou, S; Anestis, P; Stergiou, G S

2017-07-01

A pocket-size cuffless electronic device for self-measurement of blood pressure (BP) has been developed (Freescan, Maisense Inc., Zhubei, Taiwan). The device estimates BP within 10 s using three embedded electrodes and one force sensor that is applied over the radial pulse to evaluate the pulse wave. Before use, basic anthropometric characteristics are recorded on the device, and individualized initial calibration is required based on a standard BP measurement performed using an upper-arm BP monitor. The device performance in providing valid BP readings was evaluated in 313 normotensive and hypertensive adults in three study phases during which the device sensor was upgraded. A formal validation study of a prototype device against mercury sphygmomanometer was performed according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 2013 protocol. The test device succeeded in obtaining a valid BP measurement (three successful readings within up to five attempts) in 55-72% of the participants, which reached 87% with device sensor upgrade. For the validation study, 125 adults were recruited and 85 met the protocol requirements for inclusion. The mean device-observers BP difference was 3.2±6.7 (s.d.) mm Hg for systolic and 2.6±4.6 mm Hg for diastolic BP (criterion 1). The estimated s.d. (inter-subject variability) were 5.83 and 4.17 mm Hg respectively (criterion 2). These data suggest that this prototype cuffless BP monitor provides valid self-measurements in the vast majority of adults, and satisfies the BP measurement accuracy criteria of the ANSI/AAMI/ISO 2013 validation protocol.

Reliability and Validity of Objective Measures of Physical Activity in Youth With Cerebral Palsy Who Are Ambulatory.

PubMed

O'Neil, Margaret E; Fragala-Pinkham, Maria; Lennon, Nancy; George, Ameeka; Forman, Jeffrey; Trost, Stewart G

2016-01-01

Physical therapy for youth with cerebral palsy (CP) who are ambulatory includes interventions to increase functional mobility and participation in physical activity (PA). Thus, reliable and valid measures are needed to document PA in youth with CP. The purpose of this study was to evaluate the inter-instrument reliability and concurrent validity of 3 accelerometer-based motion sensors with indirect calorimetry as the criterion for measuring PA intensity in youth with CP. Fifty-seven youth with CP (mean age=12.5 years, SD=3.3; 51% female; 49.1% with spastic hemiplegia) participated. Inclusion criteria were: aged 6 to 20 years, ambulatory, Gross Motor Function Classification System (GMFCS) levels I through III, able to follow directions, and able to complete the full PA protocol. Protocol activities included standardized activity trials with increasing PA intensity (resting, writing, household chores, active video games, and walking at 3 self-selected speeds), as measured by weight-relative oxygen uptake (in mL/kg/min). During each trial, participants wore bilateral accelerometers on the upper arms, waist/hip, and ankle and a portable indirect calorimeter. Intraclass coefficient correlations (ICCs) were calculated to evaluate inter-instrument reliability (left-to-right accelerometer placement). Spearman correlations were used to examine concurrent validity between accelerometer output (activity and step counts) and indirect calorimetry. Friedman analyses of variance with post hoc pair-wise analyses were conducted to examine the validity of accelerometers to discriminate PA intensity across activity trials. All accelerometers exhibited excellent inter-instrument reliability (ICC=.94-.99) and good concurrent validity (rho=.70-.85). All accelerometers discriminated PA intensity across most activity trials. This PA protocol consisted of controlled activity trials. Accelerometers provide valid and reliable measures of PA intensity among youth with CP. © 2016 American Physical Therapy Association.

Virtual Global Transplant Laboratory Standard Operating Procedures for Blood Collection, PBMC Isolation, and Storage.

PubMed

Higdon, Lauren E; Lee, Karim; Tang, Qizhi; Maltzman, Jonathan S

2016-09-01

Research on human immune responses frequently involves the use of peripheral blood mononuclear cells (PBMC) immediately, or at significantly delayed timepoints, after collection. This requires PBMC isolation from whole blood and cryopreservation for some applications. It is important to standardize protocols for blood collection, PBMC isolation, cryopreservation, and thawing that maximize survival and functionality of PBMC at the time of analysis. This resource includes detailed protocols describing blood collection tubes, isolation of PBMC using a density gradient, cryopreservation of PBMC, and thawing of cells as well as preparation for functional assays. For each protocol, we include important considerations, such as timing, storage temperatures, and freezing rate. In addition, we provide alternatives so that researchers can make informed decisions in determining the optimal protocol for their application.

Reinstatement of contextual conditioned anxiety in virtual reality and the effects of transcutaneous vagus nerve stimulation in humans.

PubMed

Genheimer, Hannah; Andreatta, Marta; Asan, Esther; Pauli, Paul

2017-12-20

Since exposure therapy for anxiety disorders incorporates extinction of contextual anxiety, relapses may be due to reinstatement processes. Animal research demonstrated more stable extinction memory and less anxiety relapse due to vagus nerve stimulation (VNS). We report a valid human three-day context conditioning, extinction and return of anxiety protocol, which we used to examine effects of transcutaneous VNS (tVNS). Seventy-five healthy participants received electric stimuli (unconditioned stimuli, US) during acquisition (Day1) when guided through one virtual office (anxiety context, CTX+) but never in another (safety context, CTX-). During extinction (Day2), participants received tVNS, sham, or no stimulation and revisited both contexts without US delivery. On Day3, participants received three USs for reinstatement followed by a test phase. Successful acquisition, i.e. startle potentiation, lower valence, higher arousal, anxiety and contingency ratings in CTX+ versus CTX-, the disappearance of these effects during extinction, and successful reinstatement indicate validity of this paradigm. Interestingly, we found generalized reinstatement in startle responses and differential reinstatement in valence ratings. Altogether, our protocol serves as valid conditioning paradigm. Reinstatement effects indicate different anxiety networks underlying physiological versus verbal responses. However, tVNS did neither affect extinction nor reinstatement, which asks for validation and improvement of the stimulation protocol.

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

PubMed

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 (P<.001). Learning 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 distributed learning is the future of sharing data in health care. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

An Updated Protocol to Detect Invalid Entries in an Online Survey of Men Who Have Sex with Men (MSM): How Do Valid and Invalid Submissions Compare?

PubMed Central

Konstan, Joseph; Iantaffi, Alex; Wilkerson, J. Michael; Galos, Dylan; Simon Rosser, B. R.

2017-01-01

Researchers use protocols to screen for suspicious survey submissions in online studies. We evaluated how well a de-duplication and cross-validation process detected invalid entries. Data were from the Sexually Explicit Media Study, an Internet-based HIV prevention survey of men who have sex with men. Using our protocol, 146 (11.6 %) of 1254 entries were identified as invalid. Most indicated changes to the screening questionnaire to gain entry (n = 109, 74.7 %), matched other submissions’ payment profiles (n = 56, 41.8 %), or featured an IP address that was recorded previously (n = 43, 29.5 %). We found few demographic or behavioral differences between valid and invalid samples, however. Invalid submissions had lower odds of reporting HIV testing in the past year (OR 0.63), and higher odds of requesting no payment compared to check payments (OR 2.75). Thus, rates of HIV testing would have been underestimated if invalid submissions had not been removed, and payment may not be the only incentive for invalid participation. PMID:25805443

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.

PubMed

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.

The prediction of progression-free and overall survival in women with an advanced stage of epithelial ovarian carcinoma.

PubMed

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 <1 cm (P = 0.004) predicted PFS with a optimism corrected c-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 <1 cm (P = 0.028) with a optimism corrected c-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.

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

PubMed Central

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

Respiration Traits as Novel Markers for Plant Robustness Under the Threat of Climate Change: A Protocol for Validation.

PubMed

Arnholdt-Schmitt, Birgit

2017-01-01

Respiration traits allow calculating temperature-dependent carbon use efficiency and prediction of growth rates. This protocol aims (1) to enable validation of respiration traits as non-DNA biomarkers for breeding on robust plants in support of sustainable and healthy plant production; (2) to provide an efficient, novel way to identify and predict functionality of DNA-based markers (genes, polymorphisms, edited genes, transgenes, genomes, and hologenomes), and (3) to directly help farmers select robust material appropriate for a specified region. The protocol is based on applying isothermal calorespirometry and consists of four steps: plant tissue preparation, calorespirometry measurements, data processing, and final validation through massive field-based data.The methodology can serve selection and improvement for a wide range of crops. Several of them are currently being tested in the author's lab. Among them are important cereals, such as wheat, barley, and rye, and diverse vegetables. However, it is critical that the protocol for measuring respiration traits be well adjusted to the plant species by considering deep knowledge on the specific physiology and functional cell biology behind the final target trait for production. Here, Daucus carota L. is chosen as an advanced example to demonstrate critical species-specific steps for protocol development. Carrot is an important global vegetable that is grown worldwide and in all climate regions (moderate, subtropical, and tropical). Recently, this species is also used in my lab as a model for studies on alternative oxidase (AOX) gene diversity and evolutionary dynamics in interaction with endophytes.

Presence, fate and effects of the intense sweetener sucralose in the aquatic environment.

PubMed

Tollefsen, Knut Erik; Nizzetto, Luca; Huggett, Duane B

2012-11-01

Sucralose (1,6-dichloro-1,6-dideoxy-b-D-fructo-furanosyl 4-chloro-4-deoxy-a-D-galactopyranoside), sold under the trade name Splenda, has been detected in municipal effluents and surface waters in the United States and Europe. The environmental presence of sucralose has led to interest in the possibility of toxic effects in non-target species. This review presents an environmental risk assessment of sucralose based on available data concerning its presence, fate and effects in the environment. Sucralose, which is made by selective chlorination of sucrose, is a highly stable compound, which undergoes negligible metabolism in mammals, including humans, and displays a low biodegradation potential in the environment. This intense sweetener is highly soluble in water, displays a low bioaccumulation potential and a low sorption potential to soil and organic matter, and thus is predominantly present in the water column. The predicted environmental concentration (PEC) for sucralose, based on measured data in surface waters, was determined to be 10 μg/L. Aquatic toxicity studies using standardized, validated protocols used in regulatory decision making indicate that sucralose does not alter survival, growth and reproduction of aquatic organisms (such as plants, algae, crustaceans and fish) at concentrations >9000 times higher than those detected in the environment. Some studies, using non-standardized protocols, have reported behavioral and other non-traditional responses in aquatic organisms, but the relevance of these findings for assessing adverse effects on individuals and populations will require further investigation. In terms of traditional risk assessment, the proposed predicted no effect concentration for aquatic organisms (PNEC) was determined to be 0.93 mg/L, based on the lowest no effect concentration (NOEC) from a validated chronic study with mysid shrimp and an application factor of 100. The resultant PEC/PNEC quotient was determined to be well below 1 (PEC/PNEC=0.08), thus indicating a limited risk to the environment using traditional ecological risk assessment approaches. Copyright © 2012 Elsevier B.V. All rights reserved.

An investigation of a hypothermic to ischemic ratio in patients following out-of-hospital cardiac arrest presenting with a shockable rhythm.

PubMed

Sawyer, Kelly N; Kurz, Michael C; Elswick, R K

2014-06-01

Targeted temperature management (TTM) improves outcome after out-of-hospital cardiac arrest (OHCA). We hypothesized that there may be a significant relationship between the dose of hypothermia, the time to return of spontaneous circulation (ROSC), and survival to discharge. Retrospective pilot investigation on 99 consecutive OHCA patients with initial shockable rhythm, surviving to admission, and undergoing TTM between 2008 and 2011. Dose of hypothermia was defined as the sum of the induction interval (time to target temperature [from ROSC to 33°C]); the controlled hypothermia interval (from reaching 33°C until rewarming); and the rewarming interval (from 33°C to 37°C). Time to ROSC was measured from pulselessness or 911 call time to ROSC. The ratio between the two was termed the hypothermic to ischemic ratio. Purposeful variable selection for logistic regression modeling was used to assess the influence of the hypothermic/ischemic ratio on survival. Odds ratios (OR) were used to examine the effects of predictor variables on survival. Of 99 patients, eight were excluded for deviation from protocol, death during protocol, or missing data. From the univariate models, survivors were more likely to be younger, have a shorter time to ROSC, and have a larger hypothermic/ischemic ratio. Survivors also had a nonsignificant trend toward a longer time to target temperature. In multivariable modeling, the hypothermic/ischemic ratio was the most significant predictor for survival (OR 2.161 [95% confidence interval 1.371, 3.404]). In this pilot study, the hypothermic to ischemic ratio was significantly associated with survival to discharge for patients with an initial shockable rhythm. Further investigation of the relationship between the dose of hypothermia and time to ROSC for postresuscitation TTM is needed.

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

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

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 survivalmore » 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.« less

Evaluation of Hydroxyatrazine in the Endocrine Disruptor Screening and Testing Program’s Male and Female Pubertal Protocols.

EPA Science Inventory

Evaluation of Hydroxyatrazine in the Endocrine Disruptor Screening and Testing Program’s Male and Female Pubertal Protocols. ABSTRACT Two critical components of the validation of any in vivo screening assay are to demonstrate sensitivity (ability to detect weak endocrine ...

Validation of Microbial Source Tracking Markers and Detection Protocols: Considerations for Effective Interpretation

EPA Science Inventory

The goal of this chapter is to provide an overview of MST marker characteristics, to describe performance criteria of detection protocols used and to offer guidelines for the effective interpretation of the results. Since the trend in the research community has shifted towards (q...

Connecting Levels of Representation: Emergent versus Submergent Perspective

ERIC Educational Resources Information Center

Rappoport, Lana T.; Ashkenazi, Guy

2008-01-01

Chemical phenomena can be described using three representation modes: macro, submicro, and symbolic. The way students use and connect these modes when solving conceptual problems was studied, using a think-aloud interview protocol. The protocol was validated through interviews with six faculty members, and then applied to four graduate and six…

Handwriting assessment of Franco-Quebec primary school-age students

PubMed

Couture, Mélanie; Morin, Marie-France; Coallier, Mélissa; Lavigne, Audrey; Archambault, Patricia; Bolduc, Émilie; Chartier, Émilie; Liard, Karolane; Jasmin, Emmanuelle

2016-12-01

Reasons for referring school-age children to occupational therapy mainly relate to handwriting problems. However, there are no validated tools or reference values for assessing handwriting in francophone children in Canada. This study aimed to adapt and validate the writing tasks described in an English Canadian handwriting assessment protocol and to develop reference values for handwriting speed for francophone children. Three writing tasks from the Handwriting Assessment Protocol-2nd Edition (near-point and far-point copying and dictation) were adapted for Québec French children and administered to 141 Grade 1 ( n = 73) and Grade 2 ( n = 68) students. Reference values for handwriting speed were obtained for near point and far point copying tasks. This adapted protocol and these reference values for speed will improve occupational therapy handwriting assessments for the target population.

Frequency and Type of Prosthetic Complications Associated with Interim, Immediately Loaded Full-Arch Prostheses: A 2-Year Retrospective Chart Review.

PubMed

Drago, Carl

2016-08-01

The purpose of this report was to retrospectively evaluate implant and immediate full-arch prosthesis survival rates over a 24-month period; patients were consecutively treated with immediate occlusal loading. Dental arch, gender, and implant orientation (vertical vs. tilted) were also noted. All Brånemark System implants (Nobel Active) and interim, all-acrylic resin prostheses placed in patients following an All-on-Four™ protocol, in a single private practice were assessed by retrospective patient chart review. The amount of space provided surgically for implant restorative components and prostheses was determined from measurements of the vertical heights of the interim prostheses in the right/left anterior and posterior segments. These measurements were made in the laboratory. Interim prosthetic repairs (type, frequency, length of time from insertion) were analyzed by type, arch, gender, and implant orientation. Implant survival and insertion torque values were also measured. Inclusion criteria consisted of all Brånemark System implants placed with the All-on-Four protocol from September 1, 2011, until August 31, 2013. Specific dietary instructions were given for the first 7 days immediately postoperatively and for the weeks prior to insertion of the definitive prostheses. One hundred twenty-nine patients, comprising 191 arches (766 implants) from September 1, 2011, until August 31, 2013, were included in the study. One patient experienced implant failure yielding an overall implant survival rate (SR) of 99.5% (762 of 766). Four hundred twenty-six of 430 maxillary implants and 336 of 336 mandibular implants survived for SRs of 99.1% and 100%, respectively. Regarding implant orientation, 415 of 417 tilted implants (SR 99.5%) and 343 of 345 (CSR 95.6%) vertical implants were noted to be clinically stable. Interim, all-acrylic resin prostheses were in place for a mean of 199.2 days; mandibular prostheses were in place for an average of 195.4 days; maxillary prostheses were in place for an average of 202.0 days. Thirty four of the 191 interim prostheses (17.8%) warranted at least one repair during the treatment period. The average overall implant insertion torque value was 60.74 Ncm; mandibular torque values averaged 63.08 Ncm; maxillary torque values averaged 59.00 Ncm. The results from this study suggest that dental arch, gender, and implant orientation for implants placed and immediately restored with interim, all-acrylic resin, full-arch prostheses per the All-on-Four protocol did not have significant statistical or clinical effects on prosthetic complications of the interim prostheses or implant survival. Only one of the 129 patients experienced implant failures, indicating that the All-on-Four treatment protocol used in this study is a viable alternative to other protocols for rehabilitating edentulous patients. © 2015 by the American College of Prosthodontists.

Highly Efficient Training, Refinement, and Validation of a Knowledge-based Planning Quality-Control System for Radiation Therapy Clinical Trials

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

Li, Nan; Carmona, Ruben; Sirak, Igor

Purpose: To demonstrate an efficient method for training and validation of a knowledge-based planning (KBP) system as a radiation therapy clinical trial plan quality-control system. Methods and Materials: We analyzed 86 patients with stage IB through IVA cervical cancer treated with intensity modulated radiation therapy at 2 institutions according to the standards of the INTERTECC (International Evaluation of Radiotherapy Technology Effectiveness in Cervical Cancer, National Clinical Trials Network identifier: 01554397) protocol. The protocol used a planning target volume and 2 primary organs at risk: pelvic bone marrow (PBM) and bowel. Secondary organs at risk were rectum and bladder. Initial unfiltered dose-volumemore » histogram (DVH) estimation models were trained using all 86 plans. Refined training sets were created by removing sub-optimal plans from the unfiltered sample, and DVH estimation models… and DVH estimation models were constructed by identifying 30 of 86 plans emphasizing PBM sparing (comparing protocol-specified dosimetric cutpoints V{sub 10} (percentage volume of PBM receiving at least 10 Gy dose) and V{sub 20} (percentage volume of PBM receiving at least 20 Gy dose) with unfiltered predictions) and another 30 of 86 plans emphasizing bowel sparing (comparing V{sub 40} (absolute volume of bowel receiving at least 40 Gy dose) and V{sub 45} (absolute volume of bowel receiving at least 45 Gy dose), 9 in common with the PBM set). To obtain deliverable KBP plans, refined models must inform patient-specific optimization objectives and/or priorities (an auto-planning “routine”). Four candidate routines emphasizing different tradeoffs were composed, and a script was developed to automatically re-plan multiple patients with each routine. After selection of the routine that best met protocol objectives in the 51-patient training sample (KBP{sub FINAL}), protocol-specific DVH metrics and normal tissue complication probability were compared for original versus KBP{sub FINAL} plans across the 35-patient validation set. Paired t tests were used to test differences between planning sets. Results: KBP{sub FINAL} plans outperformed manual planning across the validation set in all protocol-specific DVH cutpoints. The mean normal tissue complication probability for gastrointestinal toxicity was lower for KBP{sub FINAL} versus validation-set plans (48.7% vs 53.8%, P<.001). Similarly, the estimated mean white blood cell count nadir was higher (2.77 vs 2.49 k/mL, P<.001) with KBP{sub FINAL} plans, indicating lowered probability of hematologic toxicity. Conclusions: This work demonstrates that a KBP system can be efficiently trained and refined for use in radiation therapy clinical trials with minimal effort. This patient-specific plan quality control resulted in improvements on protocol-specific dosimetric endpoints.« less

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

PubMed

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.

Rectal lymphoma in 11 dogs: a retrospective study.

PubMed

Van den Steen, N; Berlato, D; Polton, G; Dobson, J; Stewart, J; Maglennon, G; Hayes, A M; Murphy, S

2012-10-01

To retrospectively evaluate the clinical behaviour and immunophenotype of lymphoma of the rectum in dogs. Eleven dogs diagnosed with lymphoma of the rectum on histopathology were retrospectively reviewed. Immunohistochemistry with CD3 and CD79a antibodies was performed at diagnosis or retrospectively. Treatment protocol varied with six dogs undergoing surgery and adjuvant chemotherapy, two received chemotherapy after only incisional biopsy, one had surgical resection only, one was treated symptomatically and one dog was not treated. Chemotherapy treatment consisted of either a -low-dose COP (cyclophosphamide - prednisolone - vincristine) protocol (four dogs) or a six-week CHOP-based (cyclophosphamide - vincristine - -prednisolone - anthracycline) protocol (four dogs). Dogs that received chemotherapy lived significantly longer than dogs that did not receive chemotherapy (2352 versus 70 days). Median survival time was not reached, and there was an overall mean survival time of 1697 days. Immunohistochemistry was performed in 10 of 11 samples, and was consistent with B-cell -lymphoma in all cases. Canine lymphoma of the rectum is associated with a favourable prognosis. Immunohistochemical evaluation of these lesions was consistent with B-cell lymphoma in all cases in which it was examined. © 2012 British Small Animal Veterinary Association.

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

PubMed

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.

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

PubMed

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.

The validity of the ActiPed for physical activity monitoring.

PubMed

Brown, D K; Grimwade, D; Martinez-Bussion, D; Taylor, M J D; Gladwell, V F

2013-05-01

The ActiPed (FitLinxx) is a uniaxial accelerometer, which objectively measures physical activity, uploads the data wirelessly to a website, allowing participants and researchers to view activity levels remotely. The aim was to validate ActiPed's step count, distance travelled and activity time against direct observation. Further, to compare against pedometer (YAMAX), accelerometer (ActiGraph) and manufacturer's guidelines. 22 participants, aged 28±7 years, undertook 4 protocols, including walking on different surfaces and incremental running protocol (from 2 mph to 8 mph). Bland-Altman plots allowed comparison of direct observation against ActiPed estimates. For step count, the ActiPed showed a low % bias in all protocols: walking on a treadmill (-1.30%), incremental treadmill protocol (-1.98%), walking over grass (-1.67%), and walking over concrete (-0.93%). When differentiating between walking and running step count the ActiPed showed a % bias of 4.10% and -6.30%, respectively. The ActiPed showed >95% accuracy for distance and duration estimations overall, although underestimated distance (p<0.01) for walking over grass and concrete. Overall, the ActiPed showed acceptable levels of accuracy comparable to previous validated pedometers and accelerometers. The accuracy combined with the simple and informative remote gathering of data, suggests that the ActiPed could be a useful tool in objective physical activity monitoring. © Georg Thieme Verlag KG Stuttgart · New York.

Interview protocols and ergonomics checklist for analysing overexertion back accidents among nursing personnel.

PubMed

Engkvist, I L; Hagberg, M; Wigaeus-Hjelm, E; Menckel, E; Ekenvall, L

1995-06-01

No documented strategy, including preventive strategies, for systematic investigation of overexertion back accidents among nursing personnel has yet been published. One aim of the present study was to develop standardized instruments for the systematic investigation of back accidents among nursing personnel in order to develop preventive strategies. Another aim was to produce a screening tool that could easily be used for identifying potential overexertion back accident hazards. Two structured interview protocols were developed, one for the injured person and one for the supervisor. An ergonomics checklist was designed for the most important spaces according to accident statistics: patient's room, corridor, toilet, and also one for 'other space', eg X-ray and treatment rooms. The instruments were developed by frequent discussions and adjustments in a task force of researchers and occupational health personnel. The protocols were tested in two steps before a final version was established. The construct validity and interobserver reliability of the checklist were tested by ten ergonomists, who checked a patient's room, a toilet and a corridor with some known hazards. The constructed validity agreement was 90% in 19 of 26 items in the checklist. The interobserver reliability had the same figures as the validity for all items in the checklist. The interview protocols and checklist appear to be suitable for systematic investigation of overexertion back accidents.

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.

PubMed

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.

Can we Replace Arterial Blood Gas Analysis by Pulse Oximetry in Neonates with Respiratory Distress Syndrome, who are Treated According to INSURE Protocol?

PubMed Central

Niknafs, Pedram; Norouzi, Elahe; Bahman Bijari, Bahareh; Baneshi, Mohammad Reza

2015-01-01

Neonates with respiratory distress syndrome (RDS), who are treated according to INSURE protocol; require arterial blood gas (ABG) analysis to decide on appropriate management. We conducted this study to investigate the validity of pulse oximetry instead of frequent ABG analysis in the evaluation of these patients. From a total of 193 blood samples obtained from 30 neonates <1500 grams with RDS, 7.2% were found to have one or more of the followings: acidosis, hypercapnia, or hypoxemia. We found that pulse oximetry in the detection of hyperoxemia had a good validity to appropriately manage patients without blood gas analysis. However, the validity of pulse oximetry was not good enough to detect acidosis, hypercapnia, and hypoxemia. PMID:25999627

Search Strategy to Identify Dental Survival Analysis Articles Indexed in MEDLINE.

PubMed

Layton, Danielle M; Clarke, Michael

2016-01-01

Articles reporting survival outcomes (time-to-event outcomes) in patients over time are challenging to identify in the literature. Research shows the words authors use to describe their dental survival analyses vary, and that allocation of medical subject headings by MEDLINE indexers is inconsistent. Together, this undermines accurate article identification. The present study aims to develop and validate a search strategy to identify dental survival analyses indexed in MEDLINE (Ovid). A gold standard cohort of articles was identified to derive the search terms, and an independent gold standard cohort of articles was identified to test and validate the proposed search strategies. The first cohort included all 6,955 articles published in the 50 dental journals with the highest impact factors in 2008, of which 95 articles were dental survival articles. The second cohort included all 6,514 articles published in the 50 dental journals with the highest impact factors for 2012, of which 148 were dental survival articles. Each cohort was identified by a systematic hand search. Performance parameters of sensitivity, precision, and number needed to read (NNR) for the search strategies were calculated. Sensitive, precise, and optimized search strategies were developed and validated. The performances of the search strategy maximizing sensitivity were 92% sensitivity, 14% precision, and 7.11 NNR; the performances of the strategy maximizing precision were 93% precision, 10% sensitivity, and 1.07 NNR; and the performances of the strategy optimizing the balance between sensitivity and precision were 83% sensitivity, 24% precision, and 4.13 NNR. The methods used to identify search terms were objective, not subjective. The search strategies were validated in an independent group of articles that included different journals and different publication years. Across the three search strategies, dental survival articles can be identified with sensitivity up to 92%, precision up to 93%, and NNR of less than two articles to identify relevant records. This research has highlighted the impact that variation in reporting and indexing has on article identification and has improved researchers' ability to identify dental survival articles.

Decision curve analysis and external validation of the postoperative Karakiewicz nomogram for renal cell carcinoma based on a large single-center study cohort.

PubMed

Zastrow, Stefan; Brookman-May, Sabine; Cong, Thi Anh Phuong; Jurk, Stanislaw; von Bar, Immanuel; Novotny, Vladimir; Wirth, Manfred

2015-03-01

To predict outcome of patients with renal cell carcinoma (RCC) who undergo surgical therapy, risk models and nomograms are valuable tools. External validation on independent datasets is crucial for evaluating accuracy and generalizability of these models. The objective of the present study was to externally validate the postoperative nomogram developed by Karakiewicz et al. for prediction of cancer-specific survival. A total of 1,480 consecutive patients with a median follow-up of 82 months (IQR 46-128) were included into this analysis with 268 RCC-specific deaths. Nomogram-estimated survival probabilities were compared with survival probabilities of the actual cohort, and concordance indices were calculated. Calibration plots and decision curve analyses were used for evaluating calibration and clinical net benefit of the nomogram. Concordance between predictions of the nomogram and survival rates of the cohort was 0.911 after 12, 0.909 after 24 months and 0.896 after 60 months. Comparison of predicted probabilities and actual survival estimates with calibration plots showed an overestimation of tumor-specific survival based on nomogram predictions of high-risk patients, although calibration plots showed a reasonable calibration for probability ranges of interest. Decision curve analysis showed a positive net benefit of nomogram predictions for our patient cohort. The postoperative Karakiewicz nomogram provides a good concordance in this external cohort and is reasonably calibrated. It may overestimate tumor-specific survival in high-risk patients, which should be kept in mind when counseling patients. A positive net benefit of nomogram predictions was proven.

Outcome for children and young people with Early T-cell precursor acute lymphoblastic leukaemia treated on a contemporary protocol, UKALL 2003.

PubMed

Patrick, Katharine; Wade, Rachel; Goulden, Nick; Mitchell, Chris; Moorman, Anthony V; Rowntree, Clare; Jenkinson, Sarah; Hough, Rachael; Vora, Ajay

2014-08-01

We investigated the outcome for children and young people with Early T-precursor acute lymphoblastic leukaemia (ETP-ALL), a recently described poor prognosis sub-group of T-ALL, treated on a contemporary protocol, UKALL 2003. After a median follow-up of 4 years and 10 months, the ETP sub-group, representing 16% of T-ALL patients, had non-significantly inferior 5-year event-free survival (76·7% vs. 84·6%, P = 0·2) and overall survival (82·4% vs. 90·9%, P = 0·1), and a higher relapse rate (18·6% vs. 9·6%, P = 0·1) compared to typical T-ALL. ETP-ALL has an intermediate risk outcome, which does not warrant experimental treatment or first remission allogeneic transplant for the group universally. © 2014 John Wiley & Sons Ltd.

Apricot (Prunus armeniaca L.).

PubMed

Petri, César; Alburquerque, Nuria; Burgos, Lorenzo

2015-01-01

A protocol for Agrobacterium-mediated stable transformation of whole leaf explants of the apricot (Prunus armeniaca) cultivars 'Helena' and 'Canino' is described. Regenerated buds were selected using a two-step selection strategy with paromomycin sulfate and transferred to bud multiplication medium 1 week after they were detected for optimal survival. After buds were transferred to bud multiplication medium, antibiotic was changed to kanamycin and concentration increased gradually at each transfer to fresh medium in order to eliminate possible escapes and chimeras. Transformation efficiency, based on PCR analysis of individual putative transformed shoots from independent lines, was 5.6%. Green and healthy buds, surviving high kanamycin concentration, were transferred to shoot multiplication medium where they elongated in shoots and proliferated. Elongated transgenic shoots were rooted in a medium containing 70 μM kanamycin. Rooted plants were acclimatized following standard procedures. This constitutes the only transformation protocol described for apricot clonal tissues and one of the few of Prunus.

Esthetic Outcomes of Immediately Loaded Locking Taper Implants in the Anterior Maxilla: A Case Series Study.

PubMed

Lombardo, Giorgio; Corrocher, Giovanni; Pighi, Jacopo; Mascellaro, Anna; Marincola, Mauro; Nocini, Per Francesco

2016-06-01

The purpose of this study was to evaluate the esthetic outcome of single-tooth locking taper connection implants placed in the anterior maxilla following a postextractive nonfunctional loading protocol. This preliminary clinical study involving 16 patients evaluated the results of 21 implants placed in areas with high esthetic value. For each implant the pink esthetic score, white esthetic score, cumulative survival rate, and health status of peri-implant tissues were evaluated. The cumulative survival rate was 100% 2 years after prosthetic loading, and the mean total pink esthetic score/white esthetic score was 16.9 ± 1.14 on a maximum value of 20. There was excellent plaque control in all patients, and inflammation indices were within the norm. Within the limits of this study, this immediate nonfunctional loading protocol seems to be a successful procedure esthetically and for the maintenance of peri-implant soft tissues.

High-Throughput, Survivable Protocols for CDMA Packet-Radio Networks (SRNTN-74)

DTIC Science & Technology

1990-03-01

published in a paper by Jubin and Tornow [2], however the reader must be aware that the current SURAP algorithms deviate slightly from this reference...threading policy outlined by Jubin and Tornow is equivalent to a link- level window size of one, meaning a policy of not transmitting a new packet to a... Tornow . The DARPA packet-radio network protocols. Proceedings of the IEEE, 75(1):21-32, January 1987. [31 N. Gower and J. Jubin. Congestion control using

STANDARDIZATION AND VALIDATION OF MICROBIOLOGICAL METHODS FOR EXAMINATION OF BIOSOLIDS

EPA Science Inventory

The objective of this presentation is to discuss pathogens of concern in biosolids, the analytical techniques used to evaluate microorganisms in biosolids, and to discuss standardization and validation of analytical protocols for microbes within a complex matrix. Implications of ...

MICROORGANISMS IN BIOSOLIDS: ANALYTICAL METHODS DEVELOPMENT, STANDARDIZATION, AND VALIDATION

EPA Science Inventory

The objective of this presentation is to discuss pathogens of concern in biosolids, the analytical techniques used to evaluate microorganisms in biosolids, and to discuss standardization and validation of analytical protocols for microbes within such a complex matrix. Implicatio...

In-Hospital Quality-of-Care Measures for Pediatric Sepsis Syndrome.

PubMed

Odetola, Folafoluwa O; Freed, Gary; Shevrin, Caroline; Madden, Brian; McCormick, Julie; Dombkowski, Kevin

2017-07-24

Sepsis syndrome, comprising sepsis, severe sepsis, and septic shock, is a leading cause of child mortality and morbidity, for which the delivery of time-sensitive care leads to improved survival. We aimed to describe the development and testing of quality measures for in-hospital care of pediatric sepsis syndrome. Seven measures of quality of care for children hospitalized with sepsis syndrome were developed by using an iterative process including literature review, development of concepts and candidate measures, and selection of measures for feasibility and importance by 2 panels of experts. The measures were tested for reliability and validity among children 0 to 18 years of age hospitalized with sepsis syndrome from January 1, 2012, to June 30, 2013. Of 27 hospitals, 59% had no protocol for the identification and treatment of pediatric sepsis syndrome. Blood culture was performed in only 70% of patients with pediatric sepsis syndrome. Antibiotics were administered within 1 hour of diagnosis in 70% of patients with pediatric severe sepsis or septic shock, and timely fluid resuscitation was performed in 50% of patients with severe sepsis or septic shock. Documentation of heart rate during fluid resuscitation of children with severe sepsis or septic shock was observed in 18% of cases. Two measures could not be rigorously tested for validity and reliability given the rarity of septic shock and were deemed infeasible. This multisite study to develop and validate measures of the quality of hospital care of children with sepsis syndrome highlights the existence of important gaps in delivery of care. Copyright © 2017 by the American Academy of Pediatrics.

The impact of glucocorticosteroids administered for systemic diseases on the osseointegration and survival of dental implants placed without bone grafting-A retrospective study in 31 patients.

PubMed

Petsinis, Vassilis; Kamperos, Georgios; Alexandridi, Foteini; Alexandridis, Konstantinos

2017-08-01

To evaluate the impact of glucocorticosteroids, administered for the treatment of systemic diseases, on the osseointegration and survival of dental implants placed without bone grafting. A retrospective study was conducted in search of patients treated with dental implants while receiving glucocorticosteroid therapy for various systemic diseases. In these cases, a conventional two-stage surgical protocol was used, without bone regeneration procedures. The osseointegration was clinically and radiographically tested at the uncovering of the implants. The follow-up after loading was set at a minimum of 3 years. A total of 31 patients were included in the study. Of the 105 dental implants placed, 104 were osseointegrated (99%). No bone absorption was radiographically noted at the uncovering of the osseointegrated implants. All of the osseointegrated implants were successfully loaded for the prosthetic restoration. The mean follow-up period after loading was 71 months, with an implant survival rate of 99%. Glucocorticosteroid intake for systemic diseases does not have a significant impact on the osseointegration and the 3-year survival of dental implants placed with a conventional two-stage surgical protocol and without bone grafting. Therefore, it should not be considered a contraindication for dental implant placement. Copyright © 2017 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Quality assessment of lymph node sampling in rhabdomyosarcoma: A surveillance, epidemiology, and end results (SEER) program study.

PubMed

Lobeck, Inna; Dupree, Phylicia; Karns, Rebekah; Rodeberg, David; von Allmen, Daniel; Dasgupta, Roshni

2017-04-01

Lymph node sampling is integral in the management of extremity and paratesticular rhabdomyosarcoma (RMS). The aim of this study was to determine overall surgical compliance with treatment protocols and impact of nodal sampling outcomes in these tumors. A query of the surveillance, epidemiology, and end results program (SEER) database was performed from 2003 to 2008 for patients <19years of age with RMS. Data obtained included demographics, five-year survival and rate of nodal sampling. Analysis was performed utilizing chi-squared, Kaplan-Meier and hazard ratio modeling. Of 537 patients with extremity RMS, nodal sampling was performed in 25.7% (n=138). This lack of nodal sampling had a negative outcome on survival (p=0.004). Sixty five patients with paratesticular RMS aged greater than 10 were identified and also displayed low rates of lymph node sampling (47.7%, n=31). For paratesticular patients, a similar increase in survival was seen in patients who underwent nodal evaluation (p=0.024). Lymph node sampling is the standard of care in RMS. However, surgical compliance with treatment protocols is poor. Nodal evaluation correlated significantly with overall survival. These findings suggest a need for improved education among surgeons and oncologists regarding the need lymph node assessment in pediatric oncology patients. Evidence rating/classification: Prognosis study, Level III. Copyright © 2017 Elsevier Inc. All rights reserved.

Three-Year Outcome of Fixed Partial Rehabilitations Supported by Implants Inserted with Flap or Flapless Surgical Techniques.

PubMed

Maló, Paulo; de Araújo Nobre, Miguel; Lopes, Armando

2016-07-01

The aim of this prospective clinical study was to evaluate the 3-year outcome of fixed partial prostheses supported by implants with immediate provisionalization without occlusal contacts inserted in predominantly soft bone with flap and flapless protocols. Forty-one patients partially rehabilitated with 72 NobelSpeedy implants (51 maxillary; 21 mandibular) were consecutively included and treated with a flapless surgical protocol (n = 20 patients; 32 implants) and flapped surgical protocol (n = 21 patients; 40 implants). Primary outcome measure was implant survival; secondary outcome measures were marginal bone resorption (comparing the bone levels at 1 and 3 years with baseline) and the incidence of biological, mechanical, and esthetic complications. Survival was computed through life tables; descriptive statistics were applied to the remaining variables of interest. Eight patients with eight implants dropped out of the study. One implant failed in one patient (flapless group) giving an overall cumulative survival rate (CSR) of 98.6%. No failures were noted with the flapped protocol (CSR 100%), while for the implants placed with the flapless surgical technique, a 96.9% CSR was registered. The overall average marginal bone resorption at 3 years was 1.37 mm (SD = 0.94 mm), with 1.14 mm (SD = 0.49 mm) and 1.60 mm (SD = 1.22 mm) for the flap and flapless groups, respectively. Mechanical complications occurred in nine patients (n = 5 patients in the flapless group; n = 4 patients in the flap group). Implant infection was registered in three implants and three patients (flapless group), who exhibited inadequate oral hygiene levels. Partial edentulism rehabilitation through immediate provisionalization fixed prosthesis supported by dental implants inserted through flap or flapless surgical techniques in areas of predominantly soft bone was viable at 3 years of follow-up. The limitations and risks of the "free-hand" method in flapless surgery should be considered when planning implant-supported fixed prosthetic reconstructions. © 2015 by the American College of Prosthodontists.

Maintained benefits and improved survival of dynamic cardiomyoplasty by activity-rest stimulation: 5-year results of the Italian trial on "demand" dynamic cardiomyoplasty.

PubMed

Rigatelli, Gianluca; Barbiero, Mario; Rigatelli, Giorgio; Riccardi, Roberto; Cobelli, Franco; Cotogni, Angelo; Bandello, Attilio; Carraro, Ugo

2003-01-01

Latissimus dorsi (LD) muscular degeneration caused by continuous electrical stimulation has been the main cause of the poor results of dynamic cardiomyoplasty (DCMP) and its exclusion from the recent international guidelines on heart failure. To avoid full transformation of the LD and to improve results, a new stimulation protocol was developed; fewer impulses per day are delivered, providing the LD wrap with daily periods of rest ("demand" stimulation), based on a heart rate cut-off. The aim of this work is to report the results at 5 years of follow-up of the Italian Trial of Demand Dynamic Cardiomyoplasty and to discuss their impact on the destiny of this type of cardiac assistance. Twelve patients with dilated myocardiopathy (M/F=11/1, mean age 58.2+/-5.8 years, sinus rhythm/atrial fibrillation=11/1) were submitted during the period 1993-1996 to DCMP and at different intervals to demand protocol. Clinical, echocardiographic, mechanographic and cardiac invasive assessments were scheduled before initiating the demand protocol and during the follow-up at 0, 6 and every 12 months. The mean duration of follow-up was 40.2+/-13.8 months (range 18-64). There were no perioperative deaths. The demand stimulation protocol showed a decrease in 5 years in New York Health Association (NYHA) class (3.17+/-0.38-1.67+/-0.77, P=0.0001), an improvement of left ventricular ejection fraction (22.6+/-4.38-32.0+/-7.0, P<0.001), a 5-year actuarial survival of 83.3% (one patient was switched to heart transplantation programme due to clinical worsening and another one died of massive pulmonary embolism). Demand DCMP maintains over time LD muscular properties, enhances clinical benefits and improves survival of DCMP, thus reopening the debate whether this type of treatment should be considered in patients with end-stage heart failure.

R package PRIMsrc: Bump Hunting by Patient Rule Induction Method for Survival, Regression and Classification

PubMed Central

Dazard, Jean-Eudes; Choe, Michael; LeBlanc, Michael; Rao, J. Sunil

2015-01-01

PRIMsrc is a novel implementation of a non-parametric bump hunting procedure, based on the Patient Rule Induction Method (PRIM), offering a unified treatment of outcome variables, including censored time-to-event (Survival), continuous (Regression) and discrete (Classification) responses. To fit the model, it uses a recursive peeling procedure with specific peeling criteria and stopping rules depending on the response. To validate the model, it provides an objective function based on prediction-error or other specific statistic, as well as two alternative cross-validation techniques, adapted to the task of decision-rule making and estimation in the three types of settings. PRIMsrc comes as an open source R package, including at this point: (i) a main function for fitting a Survival Bump Hunting model with various options allowing cross-validated model selection to control model size (#covariates) and model complexity (#peeling steps) and generation of cross-validated end-point estimates; (ii) parallel computing; (iii) various S3-generic and specific plotting functions for data visualization, diagnostic, prediction, summary and display of results. It is available on CRAN and GitHub. PMID:26798326

Demonstrating Nonhexavelent Chrome Steel Conversion Coatings on Stryker High Hard Armor Steel Hatches

DTIC Science & Technology

2014-01-01

29 Draft Joint Test Protocol – Validation of Pretreatments for Steel Armor 68 4.4.7 Rising Step Load (Stress Corrosion Cracking) 4.4.7.1...Cost Assessment 27 9. Schedule of Activities 29 10. Management and Staffing 29 11. References 30 Appendix A. Joint Test Protocol 33 Appendix B...in accordance with the tests delineated in the joint test protocol (JTP) provided in appendix A. The functional performance objectives are

The Effect of the Dynamic Skills Protocol RTI Model on Reading Achievement in an Elementary School and the Predictive Validity of Phonics Screening Measures Implemented in the Model

ERIC Educational Resources Information Center

Laben, Joyce

2012-01-01

With the implementation of RTI, educators are attempting to find models that are the best fit for their schools. The problem solving and standard protocol models are the two most common. This study of 65 students examines a new model, the dynamic skills protocol implemented in an elementary school starting in their fourth quarter of kindergarten…

GalT-KO pig lungs are highly susceptible to acute vascular rejection in baboons, which may be mitigated by transgenic expression of hCD47 on porcine blood vessels.

PubMed

Watanabe, Hironosuke; Sahara, Hisashi; Nomura, Shunichiro; Tanabe, Tatsu; Ekanayake-Alper, Dilrukshi K; Boyd, Lennan K; Louras, Nathan J; Asfour, Arsenoi; Danton, Makenzie A; Ho, Siu-Hong; Arn, Scott J; Hawley, Robert J; Shimizu, Akira; Nagayasu, Takeshi; Ayares, David; Lorber, Marc I; Sykes, Megan; Sachs, David H; Yamada, Kazuhiko

2018-03-12

Despite recent progress in survival times of xenografts in non-human primates, there are no reports of survival beyond 5 days of histologically well-aerated porcine lung grafts in baboons. Here, we report our initial results of pig-to-baboon xeno-lung transplantation (XLTx). Eleven baboons received genetically modified porcine left lungs from either GalT-KO alone (n = 3), GalT-KO/humanCD47(hCD47)/hCD55 (n = 3), GalT-KO/hD47/hCD46 (n = 4), or GalT-KO/hCD39/hCD46/hCD55/TBM/EPCR (n = 1) swine. The first 2 XLTx procedures were performed under a non-survival protocol that allowed a 72-hour follow-up of the recipients with general anesthesia, while the remaining 9 underwent a survival protocol with the intention of weaning from ventilation. Lung graft survivals in the 2 non-survival animals were 48 and >72 hours, while survivals in the other 9 were 25 and 28 hours, at 5, 5, 6, 7, >7, 9, and 10 days. One baboon with graft survival >7 days, whose entire lung graft remained well aerated, was euthanized on POD 7 due to malfunction of femoral catheters. hCD47 expression of donor lungs was detected in both alveoli and vessels only in the 3 grafts surviving >7, 9, and 10 days. All other grafts lacked hCD47 expression in endothelial cells and were completely rejected with diffuse hemorrhagic changes and antibody/complement deposition detected in association with early graft loss. To our knowledge, this is the first evidence of histologically viable porcine lung grafts beyond 7 days in baboons. Our results indicate that GalT-KO pig lungs are highly susceptible to acute humoral rejection and that this may be mitigated by transgenic expression of hCD47. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Validation of chronic obstructive pulmonary disease (COPD) diagnoses in healthcare databases: a systematic review protocol.

PubMed

Rimland, Joseph M; Abraha, Iosief; Luchetta, Maria Laura; Cozzolino, Francesco; Orso, Massimiliano; Cherubini, Antonio; Dell'Aquila, Giuseppina; Chiatti, Carlos; Ambrosio, Giuseppe; Montedori, Alessandro

2016-06-01

Healthcare databases are useful sources to investigate the epidemiology of chronic obstructive pulmonary disease (COPD), to assess longitudinal outcomes in patients with COPD, and to develop disease management strategies. However, in order to constitute a reliable source for research, healthcare databases need to be validated. The aim of this protocol is to perform the first systematic review of studies reporting the validation of codes related to COPD diagnoses in healthcare databases. MEDLINE, EMBASE, Web of Science and the Cochrane Library databases will be searched using appropriate search strategies. Studies that evaluated the validity of COPD codes (such as the International Classification of Diseases 9th Revision and 10th Revision system; the Real codes system or the International Classification of Primary Care) in healthcare databases will be included. Inclusion criteria will be: (1) the presence of a reference standard case definition for COPD; (2) the presence of at least one test measure (eg, sensitivity, positive predictive values, etc); and (3) the use of a healthcare database (including administrative claims databases, electronic healthcare databases or COPD registries) as a data source. Pairs of reviewers will independently abstract data using standardised forms and will assess quality using a checklist based on 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-Analyses Protocol (PRISMA-P) 2015 statement. Ethics approval is not required. Results of this study will be submitted to a peer-reviewed journal for publication. The results from this systematic review will be used for outcome research on COPD and will serve as a guide to identify appropriate case definitions of COPD, and reference standards, for researchers involved in validating healthcare databases. CRD42015029204. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

A Weak Value Based QKD Protocol Robust Against Detector Attacks

NASA Astrophysics Data System (ADS)

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.

Does the decision in a validation process of a surrogate endpoint change with level of significance of treatment effect? A proposal on validation of surrogate endpoints.

PubMed

Sertdemir, Y; Burgut, R

2009-01-01

In recent years the use of surrogate end points (S) has become an interesting issue. In clinical trials, it is important to get treatment outcomes as early as possible. For this reason there is a need for surrogate endpoints (S) which are measured earlier than the true endpoint (T). However, before a surrogate endpoint can be used it must be validated. For a candidate surrogate endpoint, for example time to recurrence, the validation result may change dramatically between clinical trials. The aim of this study is to show how the validation criterion (R(2)(trial)) proposed by Buyse et al. are influenced by the magnitude of treatment effect with an application using real data. The criterion R(2)(trial) proposed by Buyse et al. (2000) is applied to the four data sets from colon cancer clinical trials (C-01, C-02, C-03 and C-04). Each clinical trial is analyzed separately for treatment effect on survival (true endpoint) and recurrence free survival (surrogate endpoint) and this analysis is done also for each center in each trial. Results are used for standard validation analysis. The centers were grouped by the Wald statistic in 3 equal groups. Validation criteria R(2)(trial) were 0.641 95% CI (0.432-0.782), 0.223 95% CI (0.008-0.503), 0.761 95% CI (0.550-0.872) and 0.560 95% CI (0.404-0.687) for C-01, C-02, C-03 and C-04 respectively. The R(2)(trial) criteria changed by the Wald statistics observed for the centers used in the validation process. Higher the Wald statistic groups are higher the R(2)(trial) values observed. The recurrence free survival is not a good surrogate for overall survival in clinical trials with non significant treatment effects and moderate for significant treatment effects. This shows that the level of significance of treatment effect should be taken into account in validation process of surrogate endpoints.

Research- and Practice-Based Nutrition Education and Cooking Workshops in Pediatric Oncology: Protocol for Implementation and Development of Curriculum.

PubMed

Chaput, Cynthia; Beaulieu-Gagnon, Sabrina; Bélanger, Véronique; Drouin, Simon; Bertout, Laurence; Lafrance, Lucie; Olivier, Cinthia; Robitaille, Marthe; Laverdière, Caroline; Sinnett, Daniel; Marquis, Marie; Marcil, Valérie

2018-01-09

Progresses in childhood cancer treatment, diagnosis, and management have resulted in childhood cancer survival rates of over 80%. However, this therapeutic success comes with a heavy price: two-thirds of childhood cancer survivors will be affected by further complications, including cardiovascular and metabolic diseases. Adequate nutrition during cancer treatment is essential to ensure the child's optimal development, improve tolerance to treatments, and can contribute to lower the risk of developing cardiometabolic diseases. Side effects of cancer treatments can negatively impact children's nutritional intake and eating behaviors. Involving the families of childhood cancer patients in educational workshops could be a promising avenue to promote healthy eating during and after cancer treatment. The objectives of this study were to develop, validate, and implement a family-based nutrition education and cooking workshop curriculum in a pediatric oncology setting that addresses the nutritional issues encountered during treatments while promoting the adoption of healthy eating habits for the prevention of long-term cardiometabolic effects. The workshops were developed and validated following an 8-step iterative process, including a review of the literature and consultations with a steering committee. An evaluation tool was also developed. A nonrandomized study protocol was elaborated to implement the workshops and measure their impact. The themes of the 6 research- and practice-based lessons are as follows: meal fortification during cancer treatment, changes in taste during cancer therapy and their impact on children, adapting diet to eating-related side effects of treatments, nutritional support during cancer treatment, Mediterranean diet and health, and planning quick and economic meals. The validation process included consultations with the institution's clinical nutrition professionals. Self-administered post questionnaires were developed according to the content of each workshop to measure short-term outcomes, namely, participants' perception of knowledge acquisition, behavioral intention, and satisfaction. Medium-term outcomes that will be evaluated are participants' anthropometric profile, quality of the diet, and circulating biomarkers of metabolic health. The project was funded in 2016 and enrollment will be completed in 2021. Data analysis is currently under way and the first results are expected to be submitted for publication in 2019. This research- and practice-based nutrition education and cooking demonstration curriculum could be a valuable complement to a multidisciplinary lifestyle intervention for the prevention of long-term cardiometabolic complications in childhood cancer. ©Cynthia Chaput, Sabrina Beaulieu-Gagnon, Véronique Bélanger, Simon Drouin, Laurence Bertout, Lucie Lafrance, Cinthia Olivier, Marthe Robitaille, Caroline Laverdière, Daniel Sinnett, Marie Marquis, Valérie Marcil. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.01.2018.

Correlation of tumor p53 and PCNA with response and survival of glioblastoma in patients treated with an ECOG protocol of pre-irradiation chemotherapy.

PubMed

Grunnet, M L; O'Neill, A; Gilbert, M; Hellman, R

2000-01-01

The ability to predict treatment responsiveness and survival of patients with glioblastoma multiforme, the most malignant and most common primary brain tumor, would be a valuable asset. Tumor and proliferation markers such as p53 and PCNA have been immunohistochemically defined and have been useful in other tumors in determining prognosis. Therefore, the authors studied the correlation of responsiveness to treatment, time to progression and survival with p53 and PCNA labeling indices in a pre-irradiation chemotherapy study of the glioblastoma multiforme. Immunohistopathology for labeling indices for p53 and PCNA using formalin-fixed, paraffin-embedded tissue from the glioblastomas of 23 patients entered into a phase II ECOG trial of pre-irradiation chemotherapy were defined using the streptavidin-peroxidase technique with AEC chromogen. The labeling indices were correlated with response to treatment time to progression and overall survival. Most patients received three cycles of BCNU for three days over three months and cisplatin monthly for three days over three months prior to external beam irradiation. There were no significant differences in treatment response, time to progression or overall survival in glioblastoma, patients with positive p53 labeling index (> 5%) versus a negative p53 labeling index (< or = 5%) or positive PCNA labeling (> 10%) versus a negative labeling index (< or = 10%) or any combination of P53 and PCNA labeling indices. Using this protocol of pre-irradiation chemotherapy, p53 and PCNA labeling indices in the glioblastoma multiforme did not predict treatment benefit.

Long-Term Survival of Dental Implants with Different Prosthetic Loading Times in Healthy Patients: A 5-Year Retrospective Clinical Study.

PubMed

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.

Effectiveness of bevacizumab and cetuximab in metastatic colorectal cancer across selected public hospitals in Queensland.

PubMed

Chapman, Suzannah J; McKavanagh, Daniel; Burge, Matthew E; McPherson, Ian; Walpole, Euan; Hollingworth, Samantha A

2017-10-01

Metastatic colorectal cancer has a large burden of disease in Australia. Medical therapy is fundamental to extending survival and improving quality of life. The benefits of two costly medicines, bevacizumab and cetuximab, used in Australia remain unclear. The aim of this study was to retrospectively examine the use of these two medicines in metastatic colorectal cancer across five public hospitals in south east Queensland and to compare clinical outcomes to those of published clinical trials. We extracted data from the chemotherapy prescribing database for patients planned for bevacizumab or cetuximab therapy between 2009 and 2013. Median overall survival was estimated using Kaplan-Meier methods. There were 490 bevacizumab-containing protocols planned and 292 patients received at least one dose of bevacizumab. Median overall survival was 17.2 months (95% confidence interval [CI], 15.4-19.3). Of 208 planned cetuximab-containing protocols, 134 patients received at least one dose of cetuximab. Median overall survival was 9.1 months (95% CI, 7.6-12.0). Thirty-day mortality rates from date of first dose were 0.7% for bevacizumab and 7.5% for cetuximab. Overall survival of patients receiving bevacizumab and cetuximab was consistent with clinical trials, providing some assurance that benefits seen in trials are observed in usual practice. This study provides a methodology of using routinely collected health data for clinical monitoring and research. Because of the high cost of these medicines and the lack of toxicity data in this study, further analysis in the postmarketing setting should be explored. © 2016 John Wiley & Sons Australia, Ltd.

Real-Time System Verification by Kappa-Induction

NASA Technical Reports Server (NTRS)

Pike, Lee S.

2005-01-01

We report the first formal verification of a reintegration protocol for a safety-critical, fault-tolerant, real-time distributed embedded system. A reintegration protocol increases system survivability by allowing a node that has suffered a fault to regain state consistent with the operational nodes. The protocol is verified in the Symbolic Analysis Laboratory (SAL), where bounded model checking and decision procedures are used to verify infinite-state systems by k-induction. The protocol and its environment are modeled as synchronizing timeout automata. Because k-induction is exponential with respect to k, we optimize the formal model to reduce the size of k. Also, the reintegrator's event-triggered behavior is conservatively modeled as time-triggered behavior to further reduce the size of k and to make it invariant to the number of nodes modeled. A corollary is that a clique avoidance property is satisfied.

Nomograms for predicting graft function and survival in living donor kidney transplantation based on the UNOS Registry.

PubMed

Tiong, H Y; Goldfarb, D A; Kattan, M W; Alster, J M; Thuita, L; Yu, C; Wee, A; Poggio, E D

2009-03-01

We developed nomograms that predict transplant renal function at 1 year (Modification of Diet in Renal Disease equation [estimated glomerular filtration rate]) and 5-year graft survival after living donor kidney transplantation. Data for living donor renal transplants were obtained from the United Network for Organ Sharing registry for 2000 to 2003. Nomograms were designed using linear or Cox regression models to predict 1-year estimated glomerular filtration rate and 5-year graft survival based on pretransplant information including demographic factors, immunosuppressive therapy, immunological factors and organ procurement technique. A third nomogram was constructed to predict 5-year graft survival using additional information available by 6 months after transplantation. These data included delayed graft function, any treated rejection episodes and the 6-month estimated glomerular filtration rate. The nomograms were internally validated using 10-fold cross-validation. The renal function nomogram had an r-square value of 0.13. It worked best when predicting estimated glomerular filtration rate values between 50 and 70 ml per minute per 1.73 m(2). The 5-year graft survival nomograms had a concordance index of 0.71 for the pretransplant nomogram and 0.78 for the 6-month posttransplant nomogram. Calibration was adequate for all nomograms. Nomograms based on data from the United Network for Organ Sharing registry have been validated to predict the 1-year estimated glomerular filtration rate and 5-year graft survival. These nomograms may facilitate individualized patient care in living donor kidney transplantation.

Prognostic value of purinergic P2X7 receptor expression in patients with hepatocellular carcinoma after curative resection.

PubMed

Liu, Haiou; Liu, Weisi; Liu, Zheng; Liu, Yidong; Zhang, Weijuan; Xu, Le; Xu, Jiejie

2015-07-01

The family of type 2 purinergic (P2) receptors, especially P2X7, is responsible for the direct tumor-killing functions of extracellular adenosine triphosphate (ATP), but the precise role of P2X7 in the progression of hepatocellular carcinoma (HCC) remains elusive. This study aims to evaluate prognostic value of P2X7 expression in HCC patients after surgical resection. Expression of P2X7 was assessed by immunohistochemistry in tissue microarrays containing paired tumor and peritumoral liver tissues from 273 patients with HCC who had undergone hepatectomy between 2006 and 2007. Prognostic value of P2X7 expression and clinical outcomes were evaluated. Peritumoral P2X7 expression was significantly higher than intratumoral P2X7 expression. No significant prognostic difference was observed for overall survival for intratumoral P2X7 density, whereas peritumoral P2X7 density indicates unfavorable overall survival in training set and BCLC stage 0-A subset. Besides, peritumoral P2X7 density, which correlated with tumor size, venous invasion, and BCLC stage, was identified as an independent poor prognosticator for overall survival and recurrence-free survival. The association was further validated in validation set. Peritumoral P2X7 is a potential unfavorable prognosticator for overall survival and recurrence free survival in HCC patients after surgical resection. Further external validation and functional analysis should be pursued to evaluate its potential prognostic value and therapeutic significance for HCC patients.

Early goal-directed therapy (EGDT) for severe sepsis/septic shock: which components of treatment are more difficult to implement in a community-based emergency department?

PubMed

O'Neill, Rory; Morales, Javier; Jule, Michael

2012-05-01

Early goal-directed therapy (EGDT) has been shown to reduce mortality in patients with severe sepsis/septic shock, however, implementation of this protocol in the emergency department (ED) is sometimes difficult. We evaluated our sepsis protocol to determine which EGDT elements were more difficult to implement in our community-based ED. This was a non-concurrent cohort study of adult patients entered into a sepsis protocol at a single community hospital from July 2008 to March 2009. Charts were reviewed for the following process measures: a predefined crystalloid bolus, antibiotic administration, central venous catheter insertion, central venous pressure measurement, arterial line insertion, vasopressor utilization, central venous oxygen saturation measurement, and use of a standardized order set. We also compared the individual component adherence with survival to hospital discharge. A total of 98 patients presented over a 9-month period. Measures with the highest adherence were vasopressor administration (79%; 95% confidence interval [CI] 69-89%) and antibiotic use (78%; 95% CI 68-85%). Measures with the lowest adherence included arterial line placement (42%; 95% CI 32-52%), central venous pressure measurement (27%; 95% CI 18-36%), and central venous oxygen saturation measurement (15%; 95% CI 7-23%). Fifty-seven patients survived to hospital discharge (Mortality: 33%). The only element of EDGT to demonstrate a statistical significance in patients surviving to hospital discharge was the crystalloid bolus (79% vs. 46%) (respiratory rate [RR] = 1.76, 95% CI 1.11-2.58). In our community hospital, arterial line placement, central venous pressure measurement, and central venous oxygen saturation measurement were the most difficult elements of EGDT to implement. Patients who survived to hospital discharge were more likely to receive the crystalloid bolus. Copyright © 2012 Elsevier Inc. All rights reserved.

Metastatic medulloblastoma in adults: outcome of patients treated according to the HIT2000 protocol.

PubMed

von Bueren, André O; Friedrich, Carsten; von Hoff, Katja; Kwiecien, Robert; Müller, Klaus; Pietsch, Torsten; Warmuth-Metz, Monika; Hau, Peter; Benesch, Martin; Kuehl, Joachim; Kortmann, Rolf D; Rutkowski, Stefan

2015-11-01

Due to the rarity of metastatic medulloblastoma in adults, knowledge about the efficacy and toxicity of intensified chemotherapy and radiotherapy is limited. Adults with disseminated medulloblastoma registered in the HIT2000 trial as observational patients and treated according to one of two different treatment regimens were analysed. The sandwich strategy MET-HIT2000AB4 consists of postoperative chemotherapy, hyperfractionated craniospinal radiotherapy, and maintenance chemotherapy; while the HIT'91 maintenance strategy consists of postoperative craniospinal radiotherapy, and maintenance chemotherapy. Twenty-three patients (median age: 30.7years), diagnosed from November 2001 to July 2009, and treated in 18 institutions in Germany and Austria, were eligible. The median follow-up of surviving patients was 3.99years. The 4-year event-free survival (EFS) and overall survival (OS)±standard error (SE) were 52%±12% and 91%±6%, respectively. The survival was similar in both treatment groups (HIT'91 maintenance strategy, n=9; MET-HIT2000AB4 sandwich strategy, n=14). Patients with large cell/anaplastic medulloblastoma relapsed and died (n=2; 4-year EFS/OS: 0%) and OS differed compared to patients with classic (n=11; 4-year EFS/OS: 71%/91%) and desmoplastic medulloblastoma (n=10; 4-year EFS/OS: 48%/100%), respectively (p=0.161 for EFS and p=0.033 for OS). Treatment-induced toxicities consisted mainly of neurotoxicity (50% of patients, ⩾ °II), followed by haematotoxicity and nephrotoxicity/ototoxicity. The professional outcome appeared to be negatively affected in the majority of evaluable patients (9/10). Treatment of adults with metastatic medulloblastoma according to the intensified paediatric HIT2000 protocol was feasible with acceptable toxicities. EFS rates achieved by both chemotherapeutic protocols were favourable and appear to be inferior to those obtained in older children/adolescents with metastatic disease. Copyright © 2015 Elsevier Ltd. All rights reserved.

A Randomized 2x2 Factorial Clinical Trial of Renal Transplantation: Steroid-Free Maintenance Immunosuppression with Calcineurin Inhibitor Withdrawal after Six Months Associates with Improved Renal Function and Reduced Chronic Histopathology.

PubMed

Stevens, R Brian; Foster, Kirk W; Miles, Clifford D; Kalil, Andre C; Florescu, Diana F; Sandoz, John P; Rigley, Theodore H; Malik, Tamer; Wrenshall, Lucile E

2015-01-01

The two most significant impediments to renal allograft survival are rejection and the direct nephrotoxicity of the immunosuppressant drugs required to prevent it. Calcineurin inhibitors (CNI), a mainstay of most immunosuppression regimens, are particularly nephrotoxic. Until less toxic antirejection agents become available, the only option is to optimize our use of those at hand. To determine whether intensive rabbit anti-thymocyte globulin (rATG) induction followed by CNI withdrawal would individually or combined improve graft function and reduce graft chronic histopathology-surrogates for graft and, therefore, patient survival. As previously reported, a single large rATG dose over 24 hours was well-tolerated and associated with better renal function, fewer infections, and improved patient survival. Here we report testing whether complete CNI discontinuation would improve renal function and decrease graft pathology. Between April 20, 2004 and 4-14-2009 we conducted a prospective, randomized, non-blinded renal transplantation trial of two rATG dosing protocols (single dose, 6 mg/kg vs. divided doses, 1.5 mg/kg every other day x 4; target enrollment = 180). Subsequent maintenance immunosuppression consisted of tacrolimus, a CNI, and sirolimus, a mammalian target of rapamycin inhibitor. We report here the outcome of converting patients after six months either to minimized tacrolimus/sirolimus or mycophenolate mofetil/sirolimus. Primary endpoints were graft function and chronic histopathology from protocol kidney biopsies at 12 and 24 months. CNI withdrawal (on-treatment analysis) associated with better graft function (p <0.001) and lower chronic histopathology composite scores in protocol biopsies at 12 (p = 0.003) and 24 (p = 0.013) months, without affecting patient (p = 0.81) or graft (p = 0.93) survival, or rejection rate (p = 0.17). CNI (tacrolimus) withdrawal at six months may provide a strategy for decreased nephrotoxicity and improved long-term function in steroid-free low immunological risk renal transplant patients. ClinicalTrials.gov NCT00556933.

Validity and usefulness of the Line Drill test for adolescent basketball players: a Bayesian multilevel analysis.

PubMed

Carvalho, Humberto M; Gonçalves, Carlos E; Grosgeorge, Bernard; Paes, Roberto R

2017-01-01

The study examined the validity of the Line Drill test (LD) in male adolescent basketball players (10-15 years). Sensitiveness of the LD to changes in performance across a training and competition season (4 months) was also considered. Age, maturation, body size and LD were measured (n = 57). Sensitiveness of the LD was examined pre- and post-competitive season in a sub-sample (n = 44). The time at each of the four shuttle sprints of the LD (i.e. four stages) was modelled with Bayesian multilevel models. We observed very large correlation of performance at stage 4 (full LD protocol) with stage 3, but lower correlations with the early LD stages. Players' performance by somatic maturity differed substantially only when considering full LD protocol performance. Substantial improvements in all stages of the protocol were observed across the 4-month competitive season. The LD protocol should be shortened by the last full court shuttle sprint, remaining sensitive to training exposure, and independent of maturity status and body size.

PTEN Loss as Determined by Clinical-grade Immunohistochemistry Assay Is Associated with Worse Recurrence-free Survival in Prostate Cancer

PubMed Central

Lotan, Tamara L.; Wei, Wei; Morais, Carlos L.; Hawley, Sarah T.; Fazli, Ladan; Hurtado-Coll, Antonio; Troyer, Dean; McKenney, Jesse K.; Simko, Jeffrey; Carroll, Peter R.; Gleave, Martin; Lance, Raymond; Lin, Daniel W.; Nelson, Peter S.; Thompson, Ian M.; True, Lawrence D.; Feng, Ziding; Brooks, James D.

2015-01-01

Background PTEN is the most commonly deleted tumor suppressor gene in primary prostate cancer (PCa) and its loss is associated with poor clinical outcomes and ERG gene rearrangement. Objective We tested whether PTEN loss is associated with shorter recurrence-free survival (RFS) in surgically treated PCa patients with known ERG status. Design, setting, and participants A genetically validated, automated PTEN immunohistochemistry (IHC) protocol was used for 1275 primary prostate tumors from the Canary Foundation retrospective PCa tissue microarray cohort to assess homogeneous (in all tumor tissue sampled) or heterogeneous (in a subset of tumor tissue sampled) PTEN loss. ERG status as determined by a genetically validated IHC assay was available for a subset of 938 tumors. Outcome measurements and statistical analysis Associations between PTEN and ERG status were assessed using Fisher’s exact test. Kaplan-Meier and multivariate weighted Cox proportional models for RFS were constructed. Results and limitations When compared to intact PTEN, homogeneous (hazard ratio [HR] 1.66, p = 0.001) but not heterogeneous (HR 1.24, p = 0.14) PTEN loss was significantly associated with shorter RFS in multivariate models. Among ERG-positive tumors, homogeneous (HR 3.07, p < 0.0001) but not heterogeneous (HR 1.46, p = 0.10) PTEN loss was significantly associated with shorter RFS. Among ERG-negative tumors, PTEN did not reach significance for inclusion in the final multivariate models. The interaction term for PTEN and ERG status with respect to RFS did not reach statistical significance (p = 0.11) for the current sample size. Conclusions These data suggest that PTEN is a useful prognostic biomarker and that there is no statistically significant interaction between PTEN and ERG status for RFS. Patient summary We found that loss of the PTEN tumor suppressor gene in prostate tumors as assessed by tissue staining is correlated with shorter time to prostate cancer recurrence after radical prostatectomy. PMID:27617307

Algorithm for predicting death among older adults in the home care setting: study protocol for the Risk Evaluation for Support: Predictions for Elder-life in the Community Tool (RESPECT)

PubMed Central

Manuel, Douglas G; Taljaard, Monica; Chalifoux, Mathieu; Bennett, Carol; Costa, Andrew P; Bronskill, Susan; Kobewka, Daniel; Tanuseputro, Peter

2016-01-01

Introduction Older adults living in the community often have multiple, chronic conditions and functional impairments. A challenge for healthcare providers working in the community is the lack of a predictive tool that can be applied to the broad spectrum of mortality risks observed and may be used to inform care planning. Objective To predict survival time for older adults in the home care setting. The final mortality risk algorithm will be implemented as a web-based calculator that can be used by older adults needing care and by their caregivers. Design Open cohort study using the Resident Assessment Instrument for Home Care (RAI-HC) data in Ontario, Canada, from 1 January 2007 to 31 December 2013. Participants The derivation cohort will consist of ∼437 000 older adults who had an RAI-HC assessment between 1 January 2007 and 31 December 2012. A split sample validation cohort will include ∼122 000 older adults with an RAI-HC assessment between 1 January and 31 December 2013. Main outcome measures Predicted survival from the time of an RAI-HC assessment. All deaths (n≈245 000) will be ascertained through linkage to a population-based registry that is maintained by the Ministry of Health in Ontario. Statistical analysis Proportional hazards regression will be estimated after assessment of assumptions. Predictors will include sociodemographic factors, social support, health conditions, functional status, cognition, symptoms of decline and prior healthcare use. Model performance will be evaluated for 6-month and 12-month predicted risks, including measures of calibration (eg, calibration plots) and discrimination (eg, c-statistics). The final algorithm will use combined development and validation data. Ethics and dissemination Research ethics approval has been granted by the Sunnybrook Health Sciences Centre Review Board. Findings will be disseminated through presentations at conferences and in peer-reviewed journals. Trial registration number NCT02779309, Pre-results. PMID:27909039

Severe Sepsis and Septic Shock Cases Meeting Guidelines Among Patients in a University Hospital Setting.

PubMed

Charrier, J A; Steen, C L; Borrero, E

2017-01-01

A diagnosis of severe sepsis or septic shock has been shown to significantly increase mortality rate independent of other factors. Research has revealed all cause hospital case fatality rates have declined yet the percentage of severe sepsis cases continues to increase and age-adjusted mortality rates from severe sepsis and septic shock has significantly increased during the same time period. Patients with severe sepsis demonstrate ongoing mortality rate increases for up to 2 years following hospitalization when compared to aged matched controls of nonseptic patients. International guidelines with mortality benefit for the management of severe sepsis and septic shock have been illustrated in the latest surviving sepsis campaign. The objective of this study was to increase the percentage of patients admitted to the hospital with a diagnosis of severe sepsis or septic shock who met guidelines based on surviving sepsis campaign. A retrospective chart review was conducted for patients admitted to UHC from January 2016 to present to identify cases with a diagnosis of severe sepsis or septic shock, and whether they met guidelines set forth by surviving sepsis campaign both before and after an intervention program which included interviews with providers failing to meet protocol, educational sessions on guidelines to meet protocol, resident led quality improvement workshops to address barriers to meeting protocol, and development of an EMR power plan to assist providers on meeting protocol. 139 cases with a diagnosis, or meeting criteria for, severe sepsis or septic shock were identified during the period of 1/1/2016-9/30/2016 with an average of 43 percent of total cases which met guidelines. Trend analysis revealed increased compliance following resident lead intervention program with 31 percent and 49 percent before and after intervention, respectively. ICU data is currently being analyzed for meeting guidelines and have not been included in current data. The most common reason for failing guidelines was failure to obtain or repeat lactic acid on time (46 percent ); and failure to give timely antibiotics (22 percent );. The percentage of patients admitted to the hospital with a diagnosis of severe sepsis or septic shock at UHC meeting guidelines set forth by surviving sepsis campaign has improved following resident lead intervention program. Intervention strategies to further improve compliance with guidelines with a goal >60 percent are currently being analyzed.

Use of Flowchart for Automation of Clinical Protocols in mHealth.

PubMed

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

2017-01-01

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

Predicting implementation from organizational readiness for change: a study protocol

PubMed Central

2011-01-01

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 different aspects of job satisfaction: satisfaction with leadership, which should be highly correlated with readiness, versus satisfaction with salary, which should be less correlated with readiness. Content validity will be assessed using an expert panel and modified Delphi technique. Discussion We propose a comprehensive protocol for validating a survey instrument for assessing organizational readiness to change that specifically addresses key threats of bias related to halo effect, method bias and questions of construct validity that often go unexplored in research using measures of organizational constructs. PMID:21777479

High-Sensitivity C-Reactive Protein Complements Plasma Epstein-Barr Virus Deoxyribonucleic Acid Prognostication in Nasopharyngeal Carcinoma: A Large-Scale Retrospective and Prospective Cohort Study

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

Tang, Lin-Quan; Department of Nasopharyngeal Carcinoma, Sun Yat-sen University, Guangzhou; Li, Chao-Feng

Purpose: To evaluate the effects of combining the assessment of circulating high-sensitivity C-reactive protein (hs-CRP) with that of Epstein-Barr virus DNA (EBV DNA) in the pretherapy prognostication of nasopharyngeal carcinoma (NPC). Patients and Methods: Three independent cohorts of NPC patients (training set of n=3113, internal validation set of n=1556, and prospective validation set of n=1668) were studied. Determinants of disease-free survival, distant metastasis–free survival, and overall survival were assessed by multivariate analysis. Hazard ratios and survival probabilities of the patient groups, segregated by clinical stage (T1-2N0-1M0, T3-4N0-1M0, T1-2N2-3M0, and T3-4N2-3M0) and EBV DNA load (low or high) alone, and alsomore » according to hs-CRP level (low or high), were compared. Results: Elevated hs-CRP and EBV DNA levels were significantly correlated with poor disease-free survival, distant metastasis–free survival, and overall survival in both the training and validation sets. Associations were similar and remained significant after excluding patients with cardiovascular disease, diabetes, and chronic hepatitis B. Patients with advanced-stage disease were segregated by high EBV DNA levels and high hs-CRP level into a poorest-risk group, and participants with either high EBV DNA but low hs-CRP level or high hs-CRP but low EBV DNA values had poorer survival compared with the bottom values for both biomarkers. These findings demonstrate a significant improvement in the prognostic ability of conventional advanced NPC staging. Conclusion: Baseline plasma EBV DNA and serum hs-CRP levels were significantly correlated with survival in NPC patients. The combined interpretation of EBV DNA with hs-CRP levels led to refinement of the risks for the patient subsets, with improved risk discrimination in patients with advanced-stage disease.« less

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

PubMed

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.

DESCQA: Synthetic Sky Catalog Validation Framework

NASA Astrophysics Data System (ADS)

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.

Comparison of two instruments for assessing risk of postoperative nausea and vomiting.

PubMed

Kapoor, Rachna; Hola, Eric T; Adamson, Robert T; Mathis, A Scott

2008-03-01

Two instruments for assessing patients' risk of postoperative nausea and vomiting (PONV) were compared. The existing protocol (protocol 1) assessed PONV risk using 16 weighted risk factors and was used for both adults and pediatric patients. The new protocol (protocol 2) included a form for adults and a pediatric-specific form. The form for adults utilized the simplified risk score, calculated using a validated, nonweighted, 4-point scale, and categorized patients' risk of PONV as low, moderate, or high. The form for pediatric patients used a 7-point, non-weighted scale and categorized patients' risk of PONV as moderate or high. A list was generated of all patients who had surgery during August 2005, for whom protocol 1 was used, and during April 2006, for whom protocol 2 was used. Fifty patients from each time period were randomly selected for data analysis. Data collected included the percentage of the form completed, the development of PONV, the number of PONV risk factors, patient demographics, and the appropriateness of prophylaxis. The mean +/- S.D. number of PONV risk factors was significantly lower in the group treated according to protocol 2 ( p = 0.001), but fewer patients in this group were categorized as low or moderate risk and more patients were identified as high risk (p < 0.001). More patients assessed by protocol 2 received fewer interventions than recommended (p < 0.001); however, the frequency of PONV did not significantly differ between groups. Implementation of a validated and simplified PONV risk-assessment tool appeared to improve form completion rates and appropriate risk assessment; however, the rates of PONV remained similar and fewer patients received appropriate prophylaxis compared with patients assessed by the existing risk-assessment tool.

Intravenous versus intramuscular cobinamide compared to intravenous saline (control) in the treatment of acute, survivable, mitochondrial toxins in swine (Sus Scrofa): a pilot study

DTIC Science & Technology

2018-04-10

Type of Research: Animal Research 3. Title: Intravenous versus intramuscular cobinamide compared to intravenous saline ( control ) in the treatment...the hyperkalemia under control and in our upcoming protocol we feel we will finally be able to induce apnea with the toxin and calcium channel...intramuscular cobinamide compared to intravenous saline ( control ) in the treatment of acute, survivable, mitochondrial toxins in swine (Sus Scrofa): a pilot

Research in DRM architecture based on watermarking and PKI

NASA Astrophysics Data System (ADS)

Liu, Ligang; Chen, Xiaosu; Xiao, Dao-ju; Yi, Miao

2005-02-01

Analyze the virtue and disadvantage of the present digital copyright protecting system, design a kind of security protocol model of digital copyright protection, which equilibrium consider the digital media"s use validity, integrality, security of transmission, and trade equity, make a detailed formalize description to the protocol model, analyze the relationship of the entities involved in the digital work copyright protection. The analysis of the security and capability of the protocol model shows that the model is good at security and practicability.

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

PubMed

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 <1 %) and test-retest reliability. A total of 26 images were needed to stabilize the system. Participants in the pilot studies indicated that they felt comfortable throughout the assessment. The use of only one image can offer measurements that underestimate or overestimate the 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 clinical use, since it managed to reduce several measurement errors, amongst which parallax distortion.

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

PubMed

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.

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.

PubMed

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.

[Can the degree of renal artery stenosis be automatically quantified?].

PubMed

Cherrak, I; Jaulent, M C; Azizi, M; Plouin, P F; Degoulet, P; Chatellier, G

2000-08-01

The objective of the reported study is to validate a computer system, QUASAR, dedicated to the quantification of renal artery stenoses. This system estimates automatically the reference diameter and calculates the minimum diameter to compute a degree of stenosis. A hundred and eighty images of atheromatous stenoses between 10% and 80% were collected from two French independent protocols. For the 49 images of the EMMA protocol, the results from QUASAR were compared with the visual estimation of an initial investigator and with the results from a reference method based on a panel of fixe experienced experts. For the 131 images of the ASTARTE protocol, the results from QUASAR were compared with those from a semi-automatic quantification system and with those from a system based on densitometric analysis. The present work validates QUASAR in a population of narrow atheromatous stenoses (> 50%). In the context of the EMMA protocol, QUASAR is not significantly different from the mean of the fixe experts. It is unbiased and more precise than the estimation of a single investigator. In the context of the ASTARTE protocol, there is no significant difference between the three methods for the stenoses higher than 50%, however, globally, QUASAR surestimates significantly (up to 10%) the degree of stenosis.

Treatment of feline intermediate- to high-grade lymphoma with a modified university of Wisconsin-Madison protocol: 119 cases (2004-2012).

PubMed

Collette, S A; Allstadt, S D; Chon, E M; Vernau, W; Smith, A N; Garrett, L D; Choy, K; Rebhun, R B; Rodriguez, C O; Skorupski, K A

2016-08-01

CHOP-based (cyclophosphamide, doxorubicin, vinca alkaloid, prednisolone) chemotherapy protocols are often recommended for treatment of feline lymphoma. While maintenance-free CHOP-based protocols have been published and readily used in dogs, there is limited literature regarding similar maintenance-free protocols in cats. The purpose of this study was to describe the outcome of cats with intermediate- to high-grade lymphoma that were prescribed a modified 25-week University of Wisconsin-Madison (UW-25) chemotherapy protocol. A secondary objective was examination of potential prognostic factors. One hundred and nineteen cats from five institutions treated with a UW-25-based protocol were included. The Kaplan-Meier median progression-free interval (PFI) and survival time (MST) were 56 and 97 (range 2-2019) days, respectively. Cats assessed as having a complete response (CR) to therapy had significantly longer PFI and MST than those with partial or no response (PFI 205 versus 54 versus 21 days, respectively, P < 0.0001 and MST 318 versus 85 versus 27 days, respectively, P < 0.0001). © 2015 John Wiley & Sons Ltd.

Validation of an Instrument and Testing Protocol for Measuring the Combinatorial Analysis Schema.

ERIC Educational Resources Information Center

Staver, John R.; Harty, Harold

1979-01-01

Designs a testing situation to examine the presence of combinatorial analysis, to establish construct validity in the use of an instrument, Combinatorial Analysis Behavior Observation Scheme (CABOS), and to investigate the presence of the schema in young adolescents. (Author/GA)

Joint Test Protocol for Validation of Alternatives to Aliphatic Isocyanate Polyurethanes

NASA Technical Reports Server (NTRS)

Lewis, Pattie

2005-01-01

The primary objective of this effort is to demonstrate and validate alternatives to aliphatic isocyanate polyurethanes. Successful completion of this project will result in one or more isocyanate-free coatings qualified for use at AFSPC and NASA installations participating in this project.

Time to publication for publicly funded clinical trials in Australia: an observational study.

PubMed

Strand, Linn Beate; Clarke, Philip; Graves, Nicholas; Barnett, Adrian G

2017-03-22

To examine the length of time between receiving funding and publishing the protocol and main paper for randomised controlled trials. An observational study using survival analysis. Publicly funded health and medical research in Australia. Randomised controlled trials funded by the National Health and Medical Research Council of Australia between 2008 and 2010. Time from funding to the protocol paper and main results paper. Multiple variable survival models examining whether study characteristics predicted publication times. We found 77 studies with a total funding of $A59 million. The median time to publication of the protocol paper was 6.4 years after funding (95% CI 4.1 to 8.1). The proportion with a published protocol paper 8 years after funding was 0.61 (95% CI 0.48 to 0.74). The median time to publication of the main results paper was 7.1 years after funding (95% CI 6.3 to 7.6). The proportion with a published main results paper 8 years after funding was 0.72 (95% CI 0.56 to 0.87). The HRs for how study characteristics might influence timing were generally close to one with narrow CIs, the notable exception was that a longer study length lengthened the time to the main paper (HR=0.62 per extra study year, 95% CI 0.43 to 0.89). Despite the widespread registration of clinical trials, there remain serious concerns of trial results not being published or being published with a long delay. We have found that these same concerns apply to protocol papers, which should be publishable soon after funding. Funding agencies could set a target of publishing the protocol paper within 18 months of funding. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

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

PubMed

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.

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

PubMed

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

2018-06-08

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

Optimization and validation of a fast amplification protocol for AmpFlSTR® Profiler Plus® for rapid forensic human identification.

PubMed

Laurin, Nancy; Frégeau, Chantal

2012-01-01

The goal of this work was to optimize and validate a fast amplification protocol for the multiplex amplification of the STR loci included in AmpFlSTR(®) Profiler Plus(®) to expedite human DNA identification. By modifying the cycling conditions and by combining the use of a DNA polymerase optimized for high speed PCR (SpeedSTAR™ HS) and a more efficient thermal cycler instrument (Bio-RAD C1000™), we were able to reduce the amplification process from 4h to 26 min. No modification to the commercial AmpFlSTR(®) Profiler Plus(®) primer mix was required. When compared to the current Royal Canadian Mounted Police (RCMP) amplification protocol, no differences with regards to specificity, sensitivity, heterozygote peak height ratios and overall profile balance were noted. Moreover, complete concordance was obtained with profiles previously generated with the standard amplification protocol and minor alleles in mixture samples were reliably typed. An increase in n-4 stutter ratios (2.2% on average for all loci) was observed for profiles amplified with the fast protocol compared to the current procedure. Our results document the robustness of this rapid amplification protocol for STR profiling using the AmpFlSTR(®) Profiler Plus(®) primer set and demonstrate that comparable data can be obtained in substantially less time. This new approach could provide an alternative option to current multiplex STR typing amplification protocols in order to increase throughput or expedite time-sensitive cases. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Rapid learning in practice: A lung cancer survival decision support system in routine patient care data

PubMed Central

Dekker, Andre; Vinod, Shalini; Holloway, Lois; Oberije, Cary; George, Armia; Goozee, Gary; Delaney, Geoff P.; Lambin, Philippe; Thwaites, David

2016-01-01

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. PMID:25241994

Dual Kidney Allocation Score: A Novel Algorithm Utilizing Expanded Donor Criteria for the Allocation of Dual Kidneys in Adults.

PubMed

Johnson, Adam P; Price, Thea P; Lieby, Benjamin; Doria, Cataldo

2016-09-08

BACKGROUND Dual kidney transplantation (DKT) of expanded-criteria donors is a cost-intensive procedure that aims to increase the pool of available deceased organ donors and has demonstrated equivalent outcomes to expanded-criteria single kidney transplantation (eSKT). The objective of this study was to develop an allocation score based on predicted graft survival from historical dual and single kidney donors. MATERIAL AND METHODS We analyzed United Network for Organ Sharing (UNOS) data for 1547 DKT and 26 381 eSKT performed between January 1994 and September 2013. We utilized multivariable Cox regression to identify variables independently associated with graft survival in dual and single kidney transplantations. We then derived a weighted multivariable product score from calculated hazard ratios to model the benefit of transplantation as dual kidneys. RESULTS Of 36 donor variables known at the time of listing, 13 were significantly associated with graft survival. The derived dual allocation score demonstrated good internal validity with strong correlation to improved survival in dual kidney transplants. Donors with scores less than 2.1 transplanted as dual kidneys had a worsened median survival of 594 days (24%, p-value 0.031) and donors with scores greater than 3.9 had improved median survival of 1107 days (71%, p-value 0.002). There were 17 733 eSKT (67%) and 1051 DKT (67%) with scores in between these values and no differences in survival (p-values 0.676 and 0.185). CONCLUSIONS We have derived a dual kidney allocation score (DKAS) with good internal validity. Future prospective studies will be required to demonstrate external validity, but this score may help to standardize organ allocation for dual kidney transplantation.

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.

PubMed

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 useful tool for evaluating risk for chronic excessive drinking as defined by AUDIT scores. It strongly predicted the highest level of risk, although it was inadequate for assessing lower levels of risk.

Psychometric Analysis of the Heart Failure Somatic Perception Scale as a Measure of Patient Symptom Perception.

PubMed

Jurgens, Corrine Y; Lee, Christopher S; Riegel, Barbara

Symptoms are known to predict survival among patients with heart failure (HF), but discrepancies exist between patients' and health providers' perceptions of HF symptom burden. The purpose of this study is to quantify the internal consistency, validity, and prognostic value of patient perception of a broad range of HF symptoms using an HF-specific physical symptom measure, the 18-item HF Somatic Perception Scale v. 3. Factor analysis of the HF Somatic Perception Scale was conducted in a convenience sample of 378 patients with chronic HF. Convergent validity was examined using the Physical Limitation subscale of the Kansas City Cardiomyopathy Questionnaire. Divergent validity was examined using the Self-care of HF Index self-care management score. One-year survival based on HF Somatic Perception Scale scores was quantified using Cox regression controlling for Seattle HF Model scores to account for clinical status, therapeutics, and lab values. The sample was 63% male, 85% white, 67% functionally compromised (New York Heart Association class III-IV) with a mean (SD) age of 63 (12.8) years. Internal consistency of the HF Somatic Perception Scale was α = .90. Convergent (r = -0.54, P < .0001) and divergent (r = 0.18, P > .05) validities were supported. Controlling for Seattle HF scores, HF Somatic Perception Scale was a significant predictor of 1-year survival, with those most symptomatic having worse survival (hazard ratio, 1.012; 95% confidence interval, 1.001-1.024; P = .038). Perception of HF symptom burden as measured by the HF Somatic Perception Scale is a significant predictor of survival, contributing additional prognostic value over and above objective Seattle HF Risk Model scores. This analysis suggests that assessment of a broad range of HF symptoms, or those related to dyspnea or early and subtle symptoms, may be useful in evaluating therapeutic outcomes and predicting event-free survival.

Technical Analysis of SSP-21 Protocol

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

Bromberger, S.

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 usemore » other advanced technologies to provide a subset of security services.« less

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

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

Mein, S; Rankine, L; Department of Radiation Oncology, Washington University School of Medicine

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) bymore » 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 optical-CT within a week of treatment. The protocol requires small corrections for temporal and spatially-dependent behaviors observed between irradiation and readout.« less

The Relationships between Coaching and Instruction in the Primary Grades: Evidence from High-Poverty Schools

ERIC Educational Resources Information Center

Walpole, Sharon; McKenna, Michael C.; Uribe-Zarain, Ximena; Lamitina, David

2010-01-01

In this study of 116 high-poverty schools, we explored teaching and coaching in grades K-3. We developed and validated observation protocols for both coaching and teaching. Exploratory and confirmatory factor analyses were computed to identify and confirm factors that explained the protocol data. Three coaching factors were identified in both…

Detecting Random, Partially Random, and Nonrandom Minnesota Multiphasic Personality Inventory-2 Protocols

ERIC Educational Resources Information Center

Pinsoneault, Terry B.

2007-01-01

The ability of the Minnesota Multiphasic Personality Inventory-2 (MMPI-2; J. N. Butcher et al., 2001) validity scales to detect random, partially random, and nonrandom MMPI-2 protocols was investigated. Investigations included the Variable Response Inconsistency scale (VRIN), F, several potentially useful new F and VRIN subscales, and F-sub(b) - F…

Test/QA plan for the validation of the verification protocol for high speed pesticide spray drift reduction technologies for row and field crops

EPA Science Inventory

This test/QA plan for evaluation the generic test protocol for high speed wind tunnel, representing aerial application, pesticide spray drift reduction technologies (DRT) for row and field crops is in conformance with EPA Requirements for Quality Assurance Project Plans (EPA QA/R...

Test/QA plan for the validation of the verification protocol for low speed pesticide spray drift reduction technologies for row and field crops

EPA Science Inventory

This test/QA plan for evaluation the generic test protocol for high speed wind tunnel, representing aerial application, pesticide spray drift reduction technologies (DRT) for row and field crops is in conformance with EPA Requirements for Quality Assurance Project Plans (EPA QA/R...

Validity of a Protocol for Adult Self-Report of Dyslexia and Related Difficulties

ERIC Educational Resources Information Center

Snowling, Margaret; Dawes, Piers; Nash, Hannah; Hulme, Charles

2012-01-01

Background: There is an increased prevalence of reading and related difficulties in children of dyslexic parents. In order to understand the causes of these difficulties, it is important to quantify the risk factors passed from parents to their offspring. Method: 417 adults completed a protocol comprising a 15-item questionnaire rating reading and…

Three-Gene Immunohistochemical Panel Adds to Clinical Staging Algorithms to Predict Prognosis for Patients With Esophageal Adenocarcinoma

PubMed Central

Ong, Chin-Ann J.; Shapiro, Joel; Nason, Katie S.; Davison, Jon M.; Liu, Xinxue; Ross-Innes, Caryn; O'Donovan, Maria; Dinjens, Winand N.M.; Biermann, Katharina; Shannon, Nicholas; Worster, Susannah; Schulz, Laura K.E.; Luketich, James D.; Wijnhoven, Bas P.L.; Hardwick, Richard H.; Fitzgerald, Rebecca C.

2013-01-01

Purpose Esophageal adenocarcinoma (EAC) is a highly aggressive disease with poor long-term survival. Despite growing knowledge of its biology, no molecular biomarkers are currently used in routine clinical practice to determine prognosis or aid clinical decision making. Hence, this study set out to identify and validate a small, clinically applicable immunohistochemistry (IHC) panel for prognostication in patients with EAC. Patients and Methods We recently identified eight molecular prognostic biomarkers using two different genomic platforms. IHC scores of these biomarkers from a UK multicenter cohort (N = 374) were used in univariate Cox regression analysis to determine the smallest biomarker panel with the greatest prognostic power with potential therapeutic relevance. This new panel was validated in two independent cohorts of patients with EAC who had undergone curative esophagectomy from the United States and Europe (N = 666). Results Three of the eight previously identified prognostic molecular biomarkers (epidermal growth factor receptor [EGFR], tripartite motif-containing 44 [TRIM44], and sirtuin 2 [SIRT2]) had the strongest correlation with long-term survival in patients with EAC. Applying these three biomarkers as an IHC panel to the validation cohort segregated patients into two different prognostic groups (P < .01). Adjusting for known survival covariates, including clinical staging criteria, the IHC panel remained an independent predictor, with incremental adverse overall survival (OS) for each positive biomarker (hazard ratio, 1.20; 95% CI, 1.03 to 1.40 per biomarker; P = .02). Conclusion We identified and validated a clinically applicable IHC biomarker panel, consisting of EGFR, TRIM44, and SIRT2, that is independently associated with OS and provides additional prognostic information to current survival predictors such as stage. PMID:23509313

[Efficacy of interventions with video games consoles in stroke patients: a systematic review].

PubMed

Ortiz-Huerta, J H; Perez-de-Heredia-Torres, M; Guijo-Blanco, V; Santamaria-Vazquez, M

2018-01-16

In recent years video games and games consoles have been developed that are potentially useful in rehabilitation, which has led to studies conducted to evaluate the degree of efficacy of these treatments for people following a stroke. To analyse the literature available related to the effectiveness of applying video games consoles in the functional recovery of the upper extremities in subjects who have survived a stroke. A review of the literature was conducted in the CINHAL, Medline, PEDro, PsycArticles, PsycInfo, Science Direct, Scopus and Web of Science databases, using the query terms 'video game', 'stroke', 'hemiplegia', 'upper extremity' and 'hemiparesis'. After applying the eligibility criteria (clinical trials published between 2007 and 2017, whose participants were adults who had suffered a stroke with involvement of the upper extremity and who used video games), the scientific quality of the selected studies was rated by means of the PEDro scale. Eleven valid clinical trials were obtained for the systematic review. The studies that were selected, all of which were quantitative, presented different data and the inferential results indicated different levels of significance between control and experimental groups (82%) or between the different types of treatment (18%). The use of video games consoles is a useful complement for the conventional rehabilitation of the upper extremities of persons who have survived a stroke, since it increases rehabilitation time and enhances the recovery of motor functioning. Nevertheless, homogeneous intervention protocols need to be implemented in order to standardise the intervention.

Reliability and Validity of the Standing Heel-Rise Test

ERIC Educational Resources Information Center

Yocum, Allison; McCoy, Sarah Westcott; Bjornson, Kristie F.; Mullens, Pamela; Burton, Gay Naganuma

2010-01-01

A standardized protocol for a pediatric heel-rise test was developed and reliability and validity are reported. Fifty-seven children developing typically (CDT) and 34 children with plantar flexion weakness performed three tests: unilateral heel rise, vertical jump, and force measurement using handheld dynamometry. Intraclass correlation…

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

PubMed

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.

Effectiveness of multi-drug regimen chemotherapy treatment in osteosarcoma patients: a network meta-analysis of randomized controlled trials.

PubMed

Wang, Xiaojie; Zheng, Hong; Shou, Tao; Tang, Chunming; Miao, Kun; Wang, Ping

2017-03-29

Osteosarcoma is the most common malignant bone tumour. Due to the high metastasis rate and drug resistance of this disease, multi-drug regimens are necessary to control tumour cells at various stages of the cell cycle, eliminate local or distant micrometastases, and reduce the emergence of drug-resistant cells. Many adjuvant chemotherapy protocols have shown different efficacies and controversial results. Therefore, we classified the types of drugs used for adjuvant chemotherapy and evaluated the differences between single- and multi-drug chemotherapy regimens using network meta-analysis. We searched electronic databases, including PubMed (MEDLINE), EmBase, and the Cochrane Library, through November 2016 using the keywords "osteosarcoma", "osteogenic sarcoma", "chemotherapy", and "random*" without language restrictions. The major outcome in the present analysis was progression-free survival (PFS), and the secondary outcome was overall survival (OS). We used a random effect network meta-analysis for mixed multiple treatment comparisons. We included 23 articles assessing a total of 5742 patients in the present systematic review. The analysis of PFS indicated that the T12 protocol (including adriamycin, bleomycin, cyclophosphamide, dactinomycin, methotrexate, cisplatin) plays a more critical role in osteosarcoma treatment (surface under the cumulative ranking (SUCRA) probability 76.9%), with a better effect on prolonging the PFS of patients when combined with ifosfamide (94.1%) or vincristine (81.9%). For the analysis of OS, we separated the regimens to two groups, reflecting the disconnection. The T12 protocol plus vincristine (94.7%) or the removal of cisplatinum (89.4%) is most likely the best regimen. We concluded that multi-drug regimens have a better effect on prolonging the PFS and OS of osteosarcoma patients, and the T12 protocol has a better effect on prolonging the PFS of osteosarcoma patients, particularly in combination with ifosfamide or vincristine. The OS analysis showed that the T12 protocol plus vincristine or the T12 protocol with the removal of cisplatinum might be a better regimen for improving the OS of patients. However, well-designed randomized controlled trials of chemotherapeutic protocols are still necessary.

Validation of Land Surface Temperature from Sentinel-3

NASA Astrophysics Data System (ADS)

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-based coefficients, thus emphasizing the importance of non-traditional forms of validation such as radiance-based techniques. Here we present examples of the ongoing routine application of the protocol to operational Sentinel-3 LST data.

Optimal vitrification protocol for mouse ovarian tissue cryopreservation: effect of cryoprotective agents and in vitro culture on vitrified-warmed ovarian tissue survival.

PubMed

Youm, Hye Won; Lee, Jung Ryeol; Lee, Jaewang; Jee, Byung Chul; Suh, Chang Suk; Kim, Seok Hyun

2014-04-01

What is the optimal vitrification protocol according to the cryoprotective agent (CPA) for ovarian tissue (OT) cryopreservation? The two-step protocol with 7.5% ethylene glycol (EG) and 7.5% dimethyl sulfoxide (DMSO) for 10 min then 20% EG, 20% DMSO and 0.5 M sucrose for 5 min showed the best results in mouse OT vitrification. Establishing the optimal cryopreservation protocol is one of the most important steps to improve OT survival. However, only a few studies have compared vitrification protocols with different CPAs and investigated the effect of in vitro culture (IVC) on vitrified-warmed OT survival. Some recent papers proposed that a combination of CPAs has less toxicity than one type of CPA. However, the efficacy of different types and concentrations of CPA are not yet well documented. A total of 644 ovaries were collected from 4-week-old BDF1 mice, of which 571 ovaries were randomly assigned to 8 groups and vitrified using different protocols according to CPA composition and the remaining 73 ovaries were used as controls. After warming, each of the eight groups of ovaries was further randomly divided into four subgroups and in vitro cultured for 0, 0.5, 2 and 4 h, respectively. Ovaries of the best two groups among the eight groups were autotransplanted after IVC. The CPA solutions for the eight groups were composed of EDS, ES, ED, EPS, EF, EFS, E and EP, respectively (E, EG; D, DMSO; P, propanediol; S, sucrose; F, Ficoll). The IVC medium was composed of α-minimal essential medium, 10% fetal bovine serum and 10 mIU/ml follicle-stimulating hormone (FSH). Autotransplantation of vitrified-warmed OTs after IVC (0 to 4 h) using the EDS or ES protocol was performed, and the grafts were recovered after 3 weeks. Ovarian follicles were assessed for morphology, apoptosis, proliferation and FSH level. The percentages of the morphologically intact (G1) and apoptotic follicles in each group at 0, 0.5, 2 and 4 h of IVC were compared. For G1 follicles at 0 and 4 h of IVC, the EDS group showed the best results at 63.8 and 46.6%, respectively, whereas the EP group showed the worst results at 42.2 and 12.8%, respectively. The apoptotic follicle ratio was lowest in the EDS group at 0 h (8.1%) and 0.5 h (12.7%) of IVC. All of the eight groups showed significant decreases in G1 follicles and increases in apoptotic follicles as IVC duration progressed. After autotransplantation, the EDS 0 h group showed a significantly higher G1 percentage (84.9%) than did the other groups (42.4-58.8%), while only the ES 4 h group showed a significant decrease in the number of proliferative cells (80.6%, 87.6-92.9%). However, no significant differences in apoptotic rates and FSH levels were observed between the groups after autotransplantation. The limitation of this study was the absence of in vitro fertilization using oocytes obtained from OT grafts, which should be performed to confirm the outcomes of ovarian cryopreservation and transplantation. We compared eight vitrification protocols according to CPA composition and found the EDS protocol to be the optimal method among them. The data presented herein will help improve OT cryopreservation protocols for humans or other animals.

Reducing recurrence in child protective services: impact of a targeted safety protocol.

PubMed

Fluke, J; Edwards, M; Bussey, M; Wells, S; Johnson, W

2001-08-01

Statewide implementation of a child safety assessment protocol by the Illinois Department of Children and Family Services (DCFS) in 1995 is assessed to determine its impact on near-term recurrence of child maltreatment. Literature on the use of risk and safety assessment as a decision-making tool supports the DCFS's approach. The literature on the use of recurrence as a summative measure for evaluation is described. Survival analysis is used with an administrative data set of 400,000 children reported to DCFS between October 1994 and November 1997. An ex-post facto design tests the hypothesis that the use of the protocol cannot be ruled out as an explanation for the observed decline in recurrence following implementation. Several alternative hypotheses are tested: change in use of protective custody, other concurrent changes in state policy, and the concurrent experience of other states. The impact of the protocol to reduce recurrence was not ruled out.

Validation of a Nylon-Flocked-Swab Protocol for Efficient Recovery of Bacterial Spores from Smooth and Rough Surfaces▿

PubMed Central

Probst, Alexander; Facius, Rainer; Wirth, Reinhard; Moissl-Eichinger, Christine

2010-01-01

In order to meet planetary-protection requirements, culturable bacterial spore loads are measured representatively for the total microbial contamination of spacecraft. However, the National Aeronautics and Space Administration's (NASA's) cotton swab protocols for spore load determination have not changed for decades. To determine whether a more efficient alternative was available, a novel swab was evaluated for recovery of different Bacillus atrophaeus spore concentrations on stainless steel and other surfaces. Two protocols for the nylon-flocked swab (NFS) were validated and compared to the present NASA standard protocol. The results indicate that the novel swab protocols recover 3- to 4-fold more (45.4% and 49.0% recovery efficiency) B. atrophaeus spores than the NASA standard method (13.2%). Moreover, the nylon-flocked-swab protocols were superior in recovery efficiency for spores of seven different Bacillus species, including Bacillus anthracis Sterne (recovery efficiency, 20%). The recovery efficiencies for B. atrophaeus spores from different surfaces showed a variation from 5.9 to 62.0%, depending on the roughness of the surface analyzed. Direct inoculation of the swab resulted in a recovery rate of about 80%, consistent with the results of scanning electron micrographs that allowed detailed comparisons of the two swab types. The results of this investigation will significantly contribute to the cleanliness control of future life detection missions and will provide significant improvement in detection of B. anthracis contamination for law enforcement and security efforts. PMID:20543054

External validation of type 2 diabetes computer simulation models: definitions, approaches, implications and room for improvement-a protocol for a systematic review.

PubMed

Ogurtsova, Katherine; Heise, Thomas L; Linnenkamp, Ute; Dintsios, Charalabos-Markos; Lhachimi, Stefan K; Icks, Andrea

2017-12-29

Type 2 diabetes mellitus (T2DM), a highly prevalent chronic disease, puts a large burden on individual health and health care systems. Computer simulation models, used to evaluate the clinical and economic effectiveness of various interventions to handle T2DM, have become a well-established tool in diabetes research. Despite the broad consensus about the general importance of validation, especially external validation, as a crucial instrument of assessing and controlling for the quality of these models, there are no systematic reviews comparing such validation of diabetes models. As a result, the main objectives of this systematic review are to identify and appraise the different approaches used for the external validation of existing models covering the development and progression of T2DM. We will perform adapted searches by applying respective search strategies to identify suitable studies from 14 electronic databases. Retrieved study records will be included or excluded based on predefined eligibility criteria as defined in this protocol. Among others, a publication filter will exclude studies published before 1995. We will run abstract and full text screenings and then extract data from all selected studies by filling in a predefined data extraction spreadsheet. We will undertake a descriptive, narrative synthesis of findings to address the study objectives. We will pay special attention to aspects of quality of these models in regard to the external validation based upon ISPOR and ADA recommendations as well as Mount Hood Challenge reports. All critical stages within the screening, data extraction and synthesis processes will be conducted by at least two authors. This protocol adheres to PRISMA and PRISMA-P standards. The proposed systematic review will provide a broad overview of the current practice in the external validation of models with respect to T2DM incidence and progression in humans built on simulation techniques. PROSPERO CRD42017069983 .

Understanding the antiangiogenic effect of metronomic chemotherapy through a simple mathematical model

NASA Astrophysics Data System (ADS)

Rodrigues, Diego S.; Mancera, Paulo F. A.; Pinho, Suani T. R.

2016-12-01

Despite the current and increasingly successful fight against cancer, there are some important questions concerning the efficiency of its treatment - in particular, the design of oncology chemotherapy protocols. Seeking efficiency, schedules based on more frequent, low-doses of drugs, known as metronomic chemotherapy, have been proposed as an alternative to the classical standard protocol of chemotherapy administration. The in silico approach may be very useful for providing a comparative analysis of these two kinds of protocols. In so doing, we found that metronomic schedules are more effective in eliminating tumour cells mainly due to their chemotherapeutic action on endothelial cells and that more frequent, low drug doses also entail outcomes in which the survival time of patient is increased.

Optimization of a vitrification protocol for hatched blastocysts from the dromedary camel (Camelus dromedarius).

PubMed

Herrid, M; Billah, M; Malo, C; Skidmore, J A

2016-03-01

The objective of this study was to modify and optimize a vitrification protocol (open pulled straw) that was originally designed for human oocytes and embryos, to make it suitable for the cryopreservation of camel hatched blastocysts. The original open pulled straw protocol was a complex process with 15-minute exposure of oocytes/embryos in 7.5% ethylene glycol (EG) and 7.5% dimethyl sulfoxide (Me2SO) for equilibration, and cooling in 16% EG + 16% Me2SO + 1 M sucrose. Recognizing a need to better control the cryoprotectant (CPA) concentrations, while avoiding toxicity to the embryos, the effects on the survival rate and developmental potential of camel embryos in vitro were investigated using two different methods of loading the CPAs into the embryos (stepwise and semicontinuous increase in concentration), two different loading temperature/time (room temperature ∼24 °C/15 min and body 37 °C/3 min), and the replacement of Me2SO with EG alone or in combination with glycerol (Gly). A total of 145 in vivo-derived embryos were subjected to these processes, and after warming their morphological quality and integrity, and re-expansion was assessed after 0, 2, 24, 48, 72, and 96 hours of culture. Exposure of embryos in a stepwise method was more beneficial to the survival of embryos than was the semicontinuous process, and loading of CPAs at 37 °C with a short exposure time (3 minutes) resulted in an outcome comparable to the original processing at room temperature with a longer exposure time (15 minutes). The replacement of the Me2SO + EG mixture with EG only or a combination of EG + Gly in the vitrification medium significantly improved the outcome of all these evaluation criteria (P < 0.05). The modified protocol of loading EG at 37 °C for 3 minutes has increased the embryo survival of the original protocol from 67% to 91% and the developmental rate from 57% to 83% at 5-day culture. These results were comparable to or better than those reported in human or other species, indicating that this optimized method is well suited to any commercial embryo transfer program in the dromedary camel. Copyright © 2016 Elsevier Inc. All rights reserved.

Development and Validation of a Scoring System to Predict Outcomes of Patients With Primary Biliary Cirrhosis Receiving Ursodeoxycholic Acid Therapy.

PubMed

Lammers, Willem J; Hirschfield, Gideon M; Corpechot, Christophe; Nevens, Frederik; Lindor, Keith D; Janssen, Harry L A; Floreani, Annarosa; Ponsioen, Cyriel Y; Mayo, Marlyn J; Invernizzi, Pietro; Battezzati, Pier M; Parés, Albert; Burroughs, Andrew K; Mason, Andrew L; Kowdley, Kris V; Kumagi, Teru; Harms, Maren H; Trivedi, Palak J; Poupon, Raoul; Cheung, Angela; Lleo, Ana; Caballeria, Llorenç; Hansen, Bettina E; van Buuren, Henk R

2015-12-01

Approaches to risk stratification for patients with primary biliary cirrhosis (PBC) are limited, single-center based, and often dichotomous. We aimed to develop and validate a better model for determining prognoses of patients with PBC. We performed an international, multicenter meta-analysis of 4119 patients with PBC treated with ursodeoxycholic acid at liver centers in 8 European and North American countries. Patients were randomly assigned to derivation (n = 2488 [60%]) and validation cohorts (n = 1631 [40%]). A risk score (GLOBE score) to predict transplantation-free survival was developed and validated with univariate and multivariable Cox regression analyses using clinical and biochemical variables obtained after 1 year of ursodeoxycholic acid therapy. Risk score outcomes were compared with the survival of age-, sex-, and calendar time-matched members of the general population. The prognostic ability of the GLOBE score was evaluated alongside those of the Barcelona, Paris-1, Rotterdam, Toronto, and Paris-2 criteria. Age (hazard ratio = 1.05; 95% confidence interval [CI]: 1.04-1.06; P < .0001); levels of bilirubin (hazard ratio = 2.56; 95% CI: 2.22-2.95; P < .0001), albumin (hazard ratio = 0.10; 95% CI: 0.05-0.24; P < .0001), and alkaline phosphatase (hazard ratio = 1.40; 95% CI: 1.18-1.67; P = .0002); and platelet count (hazard ratio/10 units decrease = 0.97; 95% CI: 0.96-0.99; P < .0001) were all independently associated with death or liver transplantation (C-statistic derivation, 0.81; 95% CI: 0.79-0.83, and validation cohort, 0.82; 95% CI: 0.79-0.84). Patients with risk scores >0.30 had significantly shorter times of transplant-free survival than matched healthy individuals (P < .0001). The GLOBE score identified patients who would survive for 5 years and 10 years (responders) with positive predictive values of 98% and 88%, respectively. Up to 22% and 21% of events and nonevents, respectively, 10 years after initiation of treatment were correctly reclassified in comparison with earlier proposed criteria. In subgroups of patients aged <45, 45-52, 52-58, 58-66, and ≥66 years, age-specific GLOBE-score thresholds beyond which survival significantly deviated from matched healthy individuals were -0.52, 0.01, 0.60, 1.01 and 1.69, respectively. Transplant-free survival could still be accurately calculated by the GLOBE score with laboratory values collected at 2-5 years after treatment. We developed and validated scoring system (the GLOBE score) to predict transplant-free survival of ursodeoxycholic acid-treated patients with PBC. This score might be used to select strategies for treatment and care. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

Protocol for the validation of microbiological control of cellular products according to German regulators recommendations--Boon and Bane for the manufacturer.

PubMed

Störmer, M; Radojska, S; Hos, N J; Gathof, B S

2015-04-01

In order to generate standardized conditions for the microbiological control of HPCs, the PEI recommended defined steps for validation that will lead to extensive validation as shown in this study, where a possible validation principle for the microbiological control of allogeneic SCPs is presented. Although it could be demonstrated that automated culture improves microbial safety of cellular products, the requirement for extensive validation studies needs to be considered. © 2014 International Society of Blood Transfusion.

Optimizing Survival of Patients With Marginally Operable Stage IIIA Non-Small-Cell Lung Cancer Receiving Chemoradiotherapy With or Without Surgery.

PubMed

Yang, Kai-Lin; Chang, Yih-Chen; Ko, Hui-Ling; Chi, Mau-Shin; Wang, Hsin-Ell; Hsu, Pei-Sung; Lin, Chen-Chun; Yeh, Diana Yu-Wung; Kao, Shang-Jyh; Jiang, Jiunn-Song; Chi, Kwan-Hwa

2016-11-01

For marginally operable stage IIIA non-small-cell lung cancer (NSCLC), surgery might not be done as planned after neoadjuvant concurrent chemoradiotherapy (CCRT) for reasons (unresectable or medically inoperable conditions, or patient refusal). This study aims to investigate the outcomes of a phased CCRT protocol established to maximize the operability of marginally operable stage IIIA NSCLC and to care for reassessed inoperable patients, in comparison with continuous-course definitive CCRT. Forty-seven patients with marginally operable stage IIIA NSCLC receiving CCRT were included. Twenty-eight patients were treated with our phased CCRT protocol, including neoadjuvant CCRT followed by surgery (group A, n = 16) or, for reassessed inoperable patients, maintenance chemotherapy and split-course CCRT boost (group B, n = 12). The other 19 were treated with continuous-course definitive CCRT (group C). Overall survival (OS) and progression-free survival (PFS) were analyzed. Among all, median OS and PFS were 35.6 and 12.8 months, respectively (median follow-up, 22.3 months). The median OS of group A (not reached) was better than that of group B (34.4 months) and group C (15.2 months) (P = .009). On multivariate analysis, performance status 0 to 1 (hazard ratio [HR], 0.026; P < .001), adenocarcinoma (HR, 0.156; P = .003), and group A (HR, 0.199; P = .033) were independent prognostic factors. The OS of group B (HR, 0.450; 95% confidence interval, 0.118-1.717; P = .243) was not statistically different from that of group C. For marginally operable stage IIIA NSCLC, our phased CCRT strategy may optimize survival by maximizing operability and maintain an acceptable survival for reassessed inoperable patients by split-course CCRT boost following maintenance chemotherapy. Copyright © 2016 Elsevier Inc. All rights reserved.

Effect of timing and duration of a single chest compression pause on short-term survival following prolonged ventricular fibrillation.

PubMed

Walcott, Gregory P; Melnick, Sharon B; Walker, Robert G; Banville, Isabelle; Chapman, Fred W; Killingsworth, Cheryl R; Ideker, Raymond E

2009-04-01

Pauses during chest compressions are thought to have a detrimental effect on resuscitation outcome. The Guidelines 2005 have recently eliminated the post-defibrillation pause. Previous animal studies have shown that multiple pauses of increasing duration decrease resuscitation success. We investigated the effect of varying the characteristics of a single pause near defibrillation on resuscitation outcome. Part A: 48 swine were anesthetized, fibrillated for 7min and randomized. Chest compressions were initiated for 90s followed by defibrillation and then resumption of chest compressions. Four groups were studied-G2000: 40s pause beginning 20s before, and ending 20s after defibrillation, A1: a 20s pause just before defibrillation, A2: a 20s pause ending 30s prior to defibrillation, and group A3: a 10s pause ending 30s prior to defibrillation. Part B: 12 swine (Group B) were studied with a protocol identical to Part A but with no pause in chest compressions. Primary endpoint was survival to 4h. The survival rate was significantly higher for groups A1, A2, A3, and B (5/12, 7/12, 5/12, and 5/12 survived) than for the G2000 group (0/12, p<0.05). Survival did not differ significantly among groups A1, A2, A3, and B. These results suggest that the Guidelines 2005 recommendation to omit the post-shock pulse check and immediately resume chest compressions may be an important resuscitation protocol change. However, these results also suggest that clinical maneuvers further altering a single pre-shock chest compression pause provide no additional benefit.

Effect of timing and duration of a single chest compression pause on short-term survival following prolonged ventricular fibrillation☆

PubMed Central

Walcott, Gregory P.; Melnick, Sharon B.; Walker, Robert G.; Banville, Isabelle; Chapman, Fred W.; Killingsworth, Cheryl R.; Ideker, Raymond E.

2014-01-01

Background Pauses during chest compressions are thought to have a detrimental effect on resuscitation outcome. The Guidelines 2005 have recently eliminated the post-defibrillation pause. Previous animal studies have shown that multiple pauses of increasing duration decrease resuscitation success. We investigated the effect of varying the characteristics of a single pause near defibrillation on resuscitation outcome. Methods Part A: 48 swine were anesthetized, fibrillated for 7 min and randomized. Chest compressions were initiated for 90 s followed by defibrillation and then resumption of chest compressions. Four groups were studied—G2000: 40 s pause beginning 20 s before, and ending 20 s after defibrillation, A1: a 20 s pause just before defibrillation, A2: a 20 s pause ending 30 s prior to defibrillation, and group A3: a 10 s pause ending 30 s prior to defibrillation. Part B: 12 swine (Group B) were studied with a protocol identical to Part A but with no pause in chest compressions. Primary endpoint was survival to 4 h. Results The survival rate was significantly higher for groups A1, A2, A3, and B (5/12, 7/12, 5/12, and 5/12 survived) than for the G2000 group (0/12, p < 0.05). Survival did not differ significantly among groups A1, A2, A3, and B. Conclusions These results suggest that the Guidelines 2005 recommendation to omit the post-shock pulse check and immediately resume chest compressions may be an important resuscitation protocol change. However, these results also suggest that clinical maneuvers further altering a single pre-shock chest compression pause provide no additional benefit. PMID:19185411

Prospective Validation of Objective Prognostic Score for Advanced Cancer Inpatients in South Korea: A Multicenter Study.

PubMed

Yoon, Seok Joon; Suh, Sang-Yeon; Lee, Yong Joo; Park, Jeanno; Hwang, Sunwook; Lee, Sanghee Shiny; Ahn, Hong Yup; Koh, Su-Jin; Park, Keon Uk

2017-01-01

Objective Prognostic Score (OPS) was developed as an easy and simple prognosticating tool in South Korea. It has been validated retrospectively in a single center in South Korea. We aimed to validate the OPS prospectively for advanced cancer inpatients in South Korea using a multicenter study. This was a prospective cohort study. We enrolled 243 advanced cancer patients admitted in five palliative care units in South Korea from May 2013 till March 2015. Seven members of the Korean Palliative Medicine Research Network who are experts of palliative care led the study. Clinical variables (dyspnea/anorexia/performance status) and laboratory variables (total leukocyte counts/serum total bilirubin/serum creatinine/lactate dehydrogenase) were collected at the enrollment. Survival time was calculated as days from enrollment to death during admission. A total of 217 patients were included in the final analysis (feasibility: 89.3%). Survival time of the higher OPS group (OPS ≥3) and the lower OPS group (OPS <3) was 10.0 (95% confidence interval (CI) 7.72-12.28) days and 32.0 (95% CI 25.44-38.56) days, respectively. There were significant differences between the 2 groups (p < 0.001). Overall accuracy of OPS ≥3 for predicting survival less than three weeks was 71.0%. OPS was successfully validated using a prospective multicenter study in South Korea. It is a useful method to predict three-week survival of Korean inpatients with advanced cancer.

The First European Interdisciplinary Ewing Sarcoma Research Summit

PubMed Central

Kovar, Heinrich; Alonso, Javier; Aman, Pierre; Aryee, Dave N. T.; Ban, Jozef; Burchill, Sue A.; Burdach, Stefan; De Alava, Enrique; Delattre, Olivier; Dirksen, Uta; Fourtouna, Argyro; Fulda, Simone; Helman, Lee J.; Herrero-Martin, David; Hogendoorn, Pancras C. W.; Kontny, Udo; Lawlor, Elizabeth R.; Lessnick, Stephen L.; Llombart-Bosch, Antonio; Metzler, Markus; Moriggl, Richard; Niedan, Stephan; Potratz, Jenny; Redini, Françoise; Richter, Günther H. S.; Riedmann, Lucia T.; Rossig, Claudia; Schäfer, Beat W.; Schwentner, Raphaela; Scotlandi, Katia; Sorensen, Poul H.; Staege, Martin S.; Tirode, Franck; Toretsky, Jeffrey; Ventura, Selena; Eggert, Angelika; Ladenstein, Ruth

2012-01-01

The European Network for Cancer Research in Children and Adolescents (ENCCA) provides an interaction platform for stakeholders in research and care of children with cancer. Among ENCCA objectives is the establishment of biology-based prioritization mechanisms for the selection of innovative targets, drugs, and prognostic markers for validation in clinical trials. Specifically for sarcomas, there is a burning need for novel treatment options, since current chemotherapeutic treatment protocols have met their limits. This is most obvious for metastatic Ewing sarcoma (ES), where long term survival rates are still below 20%. Despite significant progress in our understanding of ES biology, clinical translation of promising laboratory results has not yet taken place due to fragmentation of research and lack of an institutionalized discussion forum. To fill this gap, ENCCA assembled 30 European expert scientists and five North American opinion leaders in December 2011 to exchange thoughts and discuss the state of the art in ES research and latest results from the bench, and to propose biological studies and novel promising therapeutics for the upcoming European EWING2008 and EWING2012 clinical trials. PMID:22662320

The first European interdisciplinary ewing sarcoma research summit.

PubMed

Kovar, Heinrich; Alonso, Javier; Aman, Pierre; Aryee, Dave N T; Ban, Jozef; Burchill, Sue A; Burdach, Stefan; De Alava, Enrique; Delattre, Olivier; Dirksen, Uta; Fourtouna, Argyro; Fulda, Simone; Helman, Lee J; Herrero-Martin, David; Hogendoorn, Pancras C W; Kontny, Udo; Lawlor, Elizabeth R; Lessnick, Stephen L; Llombart-Bosch, Antonio; Metzler, Markus; Moriggl, Richard; Niedan, Stephan; Potratz, Jenny; Redini, Françoise; Richter, Günther H S; Riedmann, Lucia T; Rossig, Claudia; Schäfer, Beat W; Schwentner, Raphaela; Scotlandi, Katia; Sorensen, Poul H; Staege, Martin S; Tirode, Franck; Toretsky, Jeffrey; Ventura, Selena; Eggert, Angelika; Ladenstein, Ruth

2012-01-01

The European Network for Cancer Research in Children and Adolescents (ENCCA) provides an interaction platform for stakeholders in research and care of children with cancer. Among ENCCA objectives is the establishment of biology-based prioritization mechanisms for the selection of innovative targets, drugs, and prognostic markers for validation in clinical trials. Specifically for sarcomas, there is a burning need for novel treatment options, since current chemotherapeutic treatment protocols have met their limits. This is most obvious for metastatic Ewing sarcoma (ES), where long term survival rates are still below 20%. Despite significant progress in our understanding of ES biology, clinical translation of promising laboratory results has not yet taken place due to fragmentation of research and lack of an institutionalized discussion forum. To fill this gap, ENCCA assembled 30 European expert scientists and five North American opinion leaders in December 2011 to exchange thoughts and discuss the state of the art in ES research and latest results from the bench, and to propose biological studies and novel promising therapeutics for the upcoming European EWING2008 and EWING2012 clinical trials.

Prism adaptation for spatial neglect after stroke: translational practice gaps.

PubMed

Barrett, A M; Goedert, Kelly M; Basso, Julia C

2012-10-01

Spatial neglect increases hospital morbidity and costs in around 50% of the 795,000 people per year in the USA who survive stroke, and an urgent need exists to reduce the care burden of this condition. However, effective acute treatment for neglect has been elusive. In this article, we review 48 studies of a treatment of intense neuroscience interest: prism adaptation training. Due to its effects on spatial motor 'aiming', prism adaptation training may act to reduce neglect-related disability. However, research failed, first, to suggest methods to identify the 50-75% of patients who respond to treatment; second, to measure short-term and long-term outcomes in both mechanism-specific and functionally valid ways; third, to confirm treatment utility during the critical first 8 weeks poststroke; and last, to base treatment protocols on systematic dose-response data. Thus, considerable investment in prism adaptation research has not yet touched the fundamentals needed for clinical implementation. We suggest improved standards and better spatial motor models for further research, so as to clarify when, how and for whom prism adaptation should be applied.

Promoting Robust Design of Diode Lasers for Space: A National Initiative

NASA Technical Reports Server (NTRS)

Tratt, David M.; Amzajerdian, Farzin; Kashem, Nasir B.; Shapiro, Andrew A.; Mense, Allan T.

2007-01-01

The Diode-laser Array Working Group (DAWG) is a national-level consumer/provider forum for discussion of engineering and manufacturing issues which influence the reliability and survivability of high-power broad-area laser diode devices in space, with an emphasis on laser diode arrays (LDAs) for optical pumping of solid-state laser media. The goals of the group are to formulate and validate standardized test and qualification protocols, operational control recommendations, and consensus manufacturing and certification standards. The group is using reliability and lifetime data collected by laser diode manufacturers and the user community to develop a set of standardized guidelines for specifying and qualifying laser diodes for long-duration operation in space, the ultimate goal being to promote an informed U.S. Government investment and procurement strategy for assuring the availability and durability of space-qualified LDAs. The group is also working to establish effective implementation of statistical design techniques at the supplier design, development, and manufacturing levels to help reduce product performance variability and improve product reliability for diodes employed in space applications

Prism adaptation for spatial neglect after stroke: translational practice gaps

PubMed Central

Barrett, A. M.; Goedert, Kelly M.; Basso, Julia C.

2012-01-01

Spatial neglect increases hospital morbidity and costs in around 50% of the 795,000 people per year in the USA who survive stroke, and an urgent need exists to reduce the care burden of this condition. However, effective acute treatment for neglect has been elusive. In this article, we review 48 studies of a treatment of intense neuroscience interest: prism adaptation training. Due to its effects on spatial motor ‘aiming’, prism adaptation training may act to reduce neglect-related disability. However, research failed, first, to suggest methods to identify the 50–75% of patients who respond to treatment; second, to measure short-term and long-term outcomes in both mechanism-specific and functionally valid ways; third, to confirm treatment utility during the critical first 8 weeks poststroke; and last, to base treatment protocols on systematic dose–response data. Thus, considerable investment in prism adaptation research has not yet touched the fundamentals needed for clinical implementation. We suggest improved standards and better spatial motor models for further research, so as to clarify when, how and for whom prism adaptation should be applied. PMID:22926312

RICH Economic Games for Networked Relationships and Communities: Development and Preliminary Validation in Yasawa, Fiji

ERIC Educational Resources Information Center

Gervais, Matthew M.

2017-01-01

Experimental economic games reveal significant population variation in human social behavior. However, most protocols involve anonymous recipients, limiting their validity to fleeting interactions. Understanding human relationship dynamics will require methods with the virtues of economic games that also tap recipient identity-conditioned…

Evaluation of the repeatability and reproducibility of a suite of qPCR based microbial source tracking methods

EPA Science Inventory

Many PCR-based methods for microbial source tracking (MST) have been developed and validated within individual research laboratories. Inter-laboratory validation of these methods, however, has been minimal, and the effects of protocol standardization regimes have not been thor...

Validating an Observation Protocol to Measure Special Education Teacher Effectiveness

ERIC Educational Resources Information Center

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…

Improving survival and storage stability of bacteria recalcitrant to freeze-drying: a coordinated study by European culture collections.

PubMed

Peiren, Jindrich; Buyse, Joke; De Vos, Paul; Lang, Elke; Clermont, Dominique; Hamon, Sylviane; Bégaud, Evelyne; Bizet, Chantal; Pascual, Javier; Ruvira, María A; Macián, M Carmen; Arahal, David R

2015-04-01

The objective of this study is to improve the viability after freeze-drying and during storage of delicate or recalcitrant strains safeguarded at biological resource centers. To achieve this objective, a joint experimental strategy was established among the different involved partner collections of the EMbaRC project ( www.embarc.eu ). Five bacterial strains considered as recalcitrant to freeze-drying were subjected to a standardized freeze-drying protocol and to seven agreed protocol variants. Viability of these strains was determined before and after freeze-drying (within 1 week, after 6 and 12 months, and after accelerated storage) for each of the protocols. Furthermore, strains were exchanged between partners to perform experiments with different freeze-dryer-dependent parameters. Of all tested variables, choice of the lyoprotectant had the biggest impact on viability after freeze-drying and during storage. For nearly all tested strains, skim milk as lyoprotectant resulted in lowest viability after freeze-drying and storage. On the other hand, best freeze-drying and storage conditions were strain and device dependent. For Aeromonas salmonicida CECT 894(T), best survival was obtained when horse serum supplemented with trehalose was used as lyoprotectant, while Aliivibrio fischeri LMG 4414(T) should be freeze-dried in skim milk supplemented with marine broth in a 1:1 ratio. Freeze-drying Campylobacter fetus CIP 53.96(T) using skim milk supplemented with trehalose as lyoprotectant resulted in best recovery. Xanthomonas fragariae DSM 3587(T) expressed high viability after freeze-drying and storage for all tested lyoprotectants and could not be considered as recalcitrant. In contrary, Flavobacterium columnare LMG 10406(T) did not survive the freeze-drying process under all tested conditions.

A prospective protocol for nasopharyngeal carcinoma in children and adolescents: the Italian Rare Tumors in Pediatric Age (TREP) project.

PubMed

Casanova, Michela; Bisogno, Gianni; Gandola, Lorenza; Cecchetto, Giovanni; Di Cataldo, Andrea; Basso, Eleonora; Indolfi, Paolo; D'Angelo, Paolo; Favini, Francesca; Collini, Paola; Potepan, Paolo; Ferrari, Andrea

2012-05-15

Nasopharyngeal carcinoma (NPC) is very rare in childhood. It differs from its adult counterpart in the prevalence of the nonkeratinizing, undifferentiated subtype and by an advanced clinical stage at onset and better chances of survival. The risk of long-term treatment-related toxicity also may be a more important issue in younger individuals. A prospective chemoradiotherapy protocol for pediatric NPC was started in Italy in 2000 within the framework of the Rare Tumors in Pediatric Age (TREP) project. Three courses of cisplatin/5-fluorouracil induction chemotherapy were followed by radiotherapy (doses up to 65 grays) with concomitant cisplatin. Forty-six patients (ages 9-17 years) were considered eligible for the study over a 10-year period. The ratio of observed to expected cases based on epidemiological data was approximately 1 for both children and adolescents. All but 1 patient had lymph node involvement, and 5 patients had distant metastases. The rate of response to primary chemotherapy was 90%. The 5-year overall and progression-free survival rates were 80.9% and 79.3%, respectively (median follow-up, 62 months). The only statistically significant prognostic variable was the presence or absence of distant metastases. A 65% incidence of late sequelae was reported. This study demonstrates the feasibility and efficacy of a prospective protocol even for such rare tumors as pediatric NPC. The use of lower radiotherapy doses than those used in adults did not affect locoregional failure rates. Long-term follow-up will be needed to obtain more information on both survival and treatment sequelae. The next objective will be to establish broader, international prospective cooperation schemes. Copyright © 2011 American Cancer Society.

Kidney Transplantation Results in Very Highly Sensitized Patients Included in a Virtual Crossmatch Program: Analysis of Kidney Pairs.

PubMed

Mazuecos, A; Alvarez, A; Nieto, A; Gentil, M A; Cabello, M; Rodriguez-Benot, A; Gracia, C; Gonzalez, F; Castro, P; Alonso, M

2016-11-01

Kidney transplantation in highly-sensitized (HS) patients can improve with organ-exchange strategies based on virtual crossmatch (V-XM). Experience in very-HS patients is limited. In June 2012, Andalusia started a V-XM protocol for very-HS patients (calculated panel reactive antibodies ≥95%). After organ allocation a cytotoxic-XM performed immediately before transplantation had to be negative for surgery to proceed. We analyzed results up until December 2015. Whenever possible we also compared the course of the recipient (non-HS) of the other kidney from the same donor. Of the 57 grafts, 52 kidney transplantations were performed (the pretransplantation cytotoxic-XM was positive in 5; predictive value 91.3%). Five patients (9.6%) experienced acute rejection (4 antibody-mediated rejections [AMRs]; 7.6%). Donor-specific antibodies developed in 10 patients. No patient died. One-year graft survival was 98%. We compared the course of the non-HS recipient of the other kidney, excluding cases with no pair (n = 5), pairs who were children recipients (n = 3), pancreas-kidney recipients (n = 5), or pairs already included in the V-XM protocol (n = 4). Finally, 35 pairs were studied. More HS-patients developed donor-specific antibodies (P = .016). No significant differences were seen in acute rejection, but AMR was more common (P = .057). No deaths occurred in either group, and there were no differences in graft survival or renal function. Although a few patients still developed AMR, our V-XM based protocol with a final pretransplantation cytotoxic-XM achieved very satisfactory results. Although the number of patients was limited, the initial survival of these high-risk recipients was comparable to the controls. Copyright © 2016 Elsevier Inc. All rights reserved.

Survival Analysis in Patients with Pancreatic Ductal Adenocarcinoma Undergoing Chemoradiotherapy Followed by Surgery According to the International Consensus on the 2017 Definition of Borderline Resectable Cancer.

PubMed

Hayasaki, Aoi; Isaji, Shuji; Kishiwada, Masashi; Fujii, Takehiro; Iizawa, Yusuke; Kato, Hiroyuki; Tanemura, Akihiro; Murata, Yasuhiro; Azumi, Yoshinori; Kuriyama, Naohisa; Mizuno, Shugo; Usui, Masanobu; Sakurai, Hiroyuki

2018-03-05

Background : The aim of this study was to validate a new definition of borderline resectable pancreatic ductal adenocarcinoma (PDAC) provided by the 2017 international consensus on the basis of three dimensions of anatomical (A), biological (B), and conditional (C) factors, using the data of the patients who had been registered for our institutional protocol of chemoradiotherapy followed by surgery (CRTS) for localized patients with PDAC. Methods : Among 307 consecutive patients pathologically diagnosed with localized PDAC who were enrolled in our CRTS protocol from February 2005 to December 2016, we selected 285 patients who could be re-evaluated after CRT. These 285 patients were classified according to international consensus A definitions as follows: R (resectable; n = 62), BR-PV (borderline resectable, superior mesenteric vein (SMV)/portal vein (PV) involvement alone; n = 27), BR-A (borderline resectable, arterial involvement; n = 50), LA (locally advanced; n = 146). Disease-specific survival (DSS) was analyzed according to A, B (serum CA 19-9 levels and lymph node metastasis diagnosed by computed tomography findings before CRT), and C factors (performance status (PS)) factors. Results : The rates of resection and R0 resection were similar between R (83.9 and 98.0%) and BR-PV (85.2 and 95.5%), but much lower in BR-A (70.0 and 84.8%) and LA (46.6 and 62.5%). DSS evaluated by median survival time (months) showed a similar trend to surgical outcomes: 33.7 in R, 27.3 in BR-PV, 18.9 in BR-A and 19.3 in LA, respectively. DSS in R patients with CA 19-9 levels > 500 U/mL was significantly poorer than in patients with CA 19-9 levels ≤ 500 U/mL, but there were no differences in DSS among BR-PV, BR-A, and LA patients according to CA 19-9 levels. Regarding lymph node metastasis, there was no significant difference in DSS according to each resectability group. DSS in R patients with PS ≥ 2 was significantly worse than in patients with PS 0-1. Conclusions : The international consensus on the definition of BR-PDAC based on three dimensions of A, B, and C is useful and practicable because prognosis of PDAC patients is influenced by anatomical factors as well as biological and conditional factors, which in turn may help to decide treatment strategy.

Millon Clinical Multiaxial Inventory–III Subtypes of Opioid Dependence: Validity and Matching to Behavioral Therapies

PubMed Central

Ball, Samuel A.; Nich, Charla; Rounsaville, Bruce J.; Eagan, Dorothy; Carroll, Kathleen M.

2013-01-01

The concurrent and predictive validity of 2 different methods of Millon Clinical Multiaxial Inventory–III subtyping (protocol sorting, cluster analysis) was evaluated in 125 recently detoxified opioid-dependent outpatients in a 12-week randomized clinical trial. Participants received naltrexone and relapse prevention group counseling and were assigned to 1 of 3 intervention conditions: (a) no-incentive vouchers, (b) incentive vouchers alone, or (c) incentive vouchers plus relationship counseling. Affective disturbance was the most common Axis I protocol-sorted subtype (66%), antisocial–narcissistic was the most common Axis II subtype (46%), and cluster analysis suggested that a 2-cluster solution (high vs. low psychiatric severity) was optimal. Predictive validity analyses indicated less symptom improvement for the higher problem subtypes, and patient treatment matching analyses indicated that some subtypes had better outcomes in the no-incentive voucher conditions. PMID:15301655

Failure of antiarrhythmic drugs to prevent experimental reperfusion ventricular fibrillation.

PubMed

Naito, M; Michelson, E L; Kmetzo, J J; Kaplinsky, E; Dreifus, L S

1981-01-01

Ninety-nine adult mongrel dogs underwent acute ligation of the proximal left anterior descending coronary artery. Thirty minutes later, the occlusion was released to evaluate the effectiveness of five antiarrhythmic protocols in eliminating reperfusion ventricular fibrillation. The five protocols included: protocol 1 --i.v. lidocaine, preligation and prerelease (n = 19); protocol 2 -- i.v. lidocaine, prereperfusion only (n = 22); protocol 3 -- chronic, oral, daily amiodarone for 2 weeks preligation (n = 19); protocol 4 -- i.v. procainamide, preligation and prereperfusion (n = 21); and protocol 5 -- i.v. verapamil, prereperfusion (n = 18). Each regimen was evaluated with respect to the incidence of reperfusion ventricular fibrillation in dogs that survived to reperfusion, and the results were compared to 77 control dogs that underwent identical coronary artery occlusion and release procedures without drug therapy. The incidence of reperfusion ventricular fibrillation was as follows: protocol 1 -- seven of 15 dogs (47%); protocol 2 -- six of 18 (33%); protocol 3 -- 11 of 16 dogs (69%); protocol 4 -- eight of 17 dogs (47%); and protocol 5 -- 10 of 17 dogs (59%), compared with 36 of 60 (60%) in control dogs. Using chi-square analysis, protocol 2 was beneficial (p < 0.05). The dogs were then stratified into high- and low-risk subgroups based on the arrhythmic events of the antecedent coronary artery ligation periods, and predictive risk indexes for the occurrence of reperfusion ventricular fibrillation were developed. the Mantel-Haenszel method of statistical analysis revealed that none of these protocols resulted in a statistically significant reduction in the incidence of reperfusion ventricular fibrillation. Thus, use of these predictive indexes plus appropriate statistical methods has revealed, unexpectedly, limitations in the efficacy of a spectrum of antiarrhythmic agents in preventing reperfusion ventricular fibrillation.

Effect of Intensity Modulated Radiation Therapy With Concurrent Chemotherapy on Survival for Patients With Cervical Esophageal Carcinoma

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

McDowell, Lachlan J.; Huang, Shao Hui; Xu, Wei

Purpose: We evaluated the effect of consecutive protocols on overall survival (OS) for cervical esophageal carcinoma (CEC). Methods and Materials: All CEC cases that received definitive radiation therapy (RT) with or without chemotherapy from 1997 to 2013 in 3 consecutive protocols were reviewed. Protocol 1 (P1) consisted of 2-dimensional RT of 54 Gy in 20 fractions with 5-fluorouracil plus either mitomycin C or cisplatin. Protocol 2 (P2) consisted of 3-dimensional conformal RT (3DRT) of ≥60 Gy in 30 fractions plus elective nodal irradiation plus cisplatin. Protocol 3 (P3) consisted of intensity modulated RT (IMRT) of ≥60 Gy in 30 fractions plus elective nodalmore » irradiation plus cisplatin. Multivariable analyses were used to assess the effect of the treatment protocol, RT technique, and RT dose on OS, separately. Results: Of 81 cases (P1, 21; P2, 23; and P3, 37), 34 local (P1, 11 [52%]; P2, 12 [52%]; and P3, 11 [30%]), 16 regional (P1, 6 [29%]); P2, 3 [13%]; and P3, 7 [19%]), and 34 distant (P1, 10 [48%]; P2, 9 [39%]; and P3, 15 [41%]) failures were identified. After adjusting for age (P=.49) and chemotherapy (any vs none; hazard ratio [HR] 0.5, 95% confidence interval [CI] 0.3-0.9; P=.023), multivariable analysis showed P3 had improved OS compared with P1 (HR 0.4, 95% CI 0.2-0.8; P=.005), with a trend shown for benefit compared with P2 (HR 0.6, 95% CI 0.3-1.0; P=.061). OS between P1 and P2 did not differ (P=.29). Analyzed as a continuous variable, higher RT doses were associated with a borderline improved OS (HR 0.97, 95% CI 0.95-1.0; P=.075). IMRT showed improved OS compared with non-IMRT (HR 0.57, 95% CI 0.3-0.8; P=.008). Conclusions: The present retrospective consecutive cohort study showed improved OS with our current protocol (P3; high-dose IMRT with concurrent high-dose cisplatin) compared with historical protocols. The outcomes for patients with CEC remain poor, and novel approaches to improve the therapeutic ratio are warranted.« less

Multivariable model development and internal validation for prostate cancer specific survival and overall survival after whole-gland salvage Iodine-125 prostate brachytherapy.

PubMed

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

2016-04-01

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 develop a multivariable, internally validated prognostic model for survival after whole-gland salvage I-125-brachytherapy. Whole-gland salvage I-125-brachytherapy patients treated in the Netherlands from 1993-2010 were included. Eligible patients had a transrectal ultrasound-guided biopsy-confirmed localised recurrence after biochemical failure (clinical judgement, ASTRO or Phoenix-definition). Recurrences were assessed clinically and with CT and/or MRI. Metastases were excluded using CT/MRI and technetium-99m scintigraphy. Multivariable Cox-regression was used to assess the predictive value of clinical characteristics in relation to PCa-specific and overall mortality. PCa-specific mortality was defined as patients dying with distant metastases present. Missing data were handled using multiple imputation (20 imputed sets). Internal validation was performed and the C-statistic calculated. Calibration plots were created to visually assess the goodness-of-fit of the final model. Optimism-corrected survival proportions were calculated. All analyses were performed according to the TRIPOD statement. Median total follow-up was 78months (range 5-139). A total of 62 patients were treated, of which 28 (45%) died from PCa after mean (±SD) 82 (±36) months. Overall, 36 patients (58%) patients died after mean 84 (±40) months. PSA doubling time (PSADT) remained a predictive factor for both types of mortality (PCa-specific and overall): corrected hazard ratio's (HR's) 0.92 (95% CI: 0.86-0.98, p=0.02) and 0.94 (95% CI: 0.90-0.99, p=0.01), respectively (C-statistics 0.71 and 0.69, respectively). Calibration was accurate up to 96month follow-up. Over 80% of patients can survive 8years if PSADT>24months (PCaSS) and >33months (OS). Only approximately 50% survival is achieved with a PSADT of 12months. A PSADT of respectively >24months and >33months can result in >80% probability of PCa- specific and overall survival 8years after whole-gland salvage I-125-brachytherapy. Survival should be weighed against toxicity from a salvage procedure. Larger series and external validation are necessary. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

An Exploratory Factor Analysis of the Sheltered Instruction Observation Protocol as an Evaluation Tool to Measure Teaching Effectiveness

ERIC Educational Resources Information Center

Polat, Nihat; Cepik, Saban

2016-01-01

To narrow the achievement gap between English language learners (ELLs) and their native-speaking peers in K-12 settings in the United States, effective instructional models must be identified. However, identifying valid observation protocols that can measure the effectiveness of specially designed instructional practices is not an easy task. This…

The Aging of lignin rich papers upon exposure to light : its quantification and prediction

Treesearch

James S. Bond; Rajai H. Atalla; Agarwal Umesh P.; Chris G. Hunt

1999-01-01

A program was undertaken at the Forest Products Laboratory in conjunction with the American Society for Testing and Materials (ASTM) to develop guidelines for a credible accelerated photoaging protocol for printing and writing papers. In support of this, indepth studies of photodegredation were undertaken in sufficient detail to establish the validity of the protocol....

Successful vitrification and autografting of baboon (Papio anubis) ovarian tissue.

PubMed

Amorim, Christiani A; Jacobs, Sophie; Devireddy, Ram V; Van Langendonckt, Anne; Vanacker, Julie; Jaeger, Jonathan; Luyckx, Valérie; Donnez, Jacques; Dolmans, Marie-Madeleine

2013-08-01

Can a vitrification protocol using an ethylene glycol/dimethyl sulphoxide-based solution and a cryopin successfully cryopreserve baboon ovarian tissue? Our results show that baboon ovarian tissue can be successfully cryopreserved with our vitrification protocol. Non-human primates have already been used as an animal model to test vitrification protocols for human ovarian tissue cryopreservation. Ovarian biopsies from five adult baboons were vitrified, warmed and autografted for 5 months. After grafting, follicle survival, growth and function and also the quality of stromal tissue were assessed histologically and by immunohistochemistry. The influence of the vitrification procedure on the cooling rate was evaluated by a computer model. After vitrification, warming and long-term grafting, follicles were able to grow and maintain their function, as illustrated by Ki67, anti-Müllerian hormone (AMH) and growth differentiation factor-9 (GDF-9) immunostaining. Corpora lutea were also observed, evidencing successful ovulation in all the animals. Stromal tissue quality did not appear to be negatively affected by our cryopreservation procedure, as demonstrated by vascularization and proportions of fibrotic areas, which were similar to those found in fresh ungrafted ovarian tissue. Despite our promising findings, before applying this technique in a clinical setting, we need to validate it by achieving pregnancies. In addition to encouraging results obtained with our vitrification procedure for non-human ovarian tissue, this study also showed, for the first time, expression of AMH and GDF-9 in ovarian follicles. This study was supported by grants from the Fonds National de la Recherche Scientifique de Belgique (grant Télévie No. 7.4507.10, grant 3.4.590.08 awarded to Marie-Madeleine Dolmans), Fonds Spéciaux de Recherche, Fondation St Luc, Foundation Against Cancer, and Department of Mechanical Engineering at Louisiana State University (support to Ram Devireddy), and donations from Mr Pietro Ferrero, Baron Frère and Viscount Philippe de Spoelberch. None of the authors has any competing interests to declare.

Gradual training of alpacas to the confinement of metabolism pens reduces stress when normal excretion behavior is accommodated.

PubMed

Lund, Kirrin E; Maloney, Shane K; Milton, John T B; Blache, Dominique

2012-01-01

Confinement in metabolism pens may provoke a stress response in alpacas that will reduce the welfare of the animal and jeopardize the validity of scientific results obtained in such pens. In this study, we tested a protocol designed to successfully train alpacas to be held in a specially designed metabolism pen so that the animals' confinement would not jeopardize their welfare. We hypothesized that the alpacas would show fewer behaviors associated with a response to stress as training gradually progressed, and that they would adapt to being in the confinement of the metabolism pen. The training protocol was successful at introducing alpacas to the metabolism pens, and it did reduce the incidence of behavioral responses to stress as the training progressed. The success of the training protocol may be attributed to the progressive nature of the training, the tailoring of the protocol to suit alpacas, and the use of positive reinforcement. This study demonstrated that both animal welfare and the validity of the scientific outcomes could be maximized by the gradual training of experimental animals, thereby minimizing the stress imposed on the animals during experimental procedures.

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.

PubMed

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.

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

PubMed

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.

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

PubMed

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

PubMed Central

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

Health-related quality of life among colorectal cancer patients in Malaysia: a study protocol

PubMed Central

2012-01-01

Background Colorectal cancer is a major public health problem in Malaysia. However, it is also one of the most treatable cancers, resulting in significant numbers of survivors. Therefore, the impact of surviving treatment for colorectal cancer on health related quality of life is important for the patients, clinicians and policy makers, and may differ in different cultures and populations. The aim of this study was to validate the Malaysian versions of the European Organization for Research and Treatment of Cancer quality of life instruments among colorectal cancers patients. Methods/design This is a cross sectional multi centre study. Three hospitals were included, the University of Malaya Medical Centre, the Universiti Kebangsaan Malaysia Medical Centre and Hospital Tuanku Jaafar Seremban. Malaysian citizens and permanent residence were studied and demographic and clinical information obtained from hospital records. The European Organization for Research and Treatment of Cancer Quality of life Core 30, colorectal cancer CR29, and the colorectal cancer liver metastasis LMC 21 were used and an observer assessment of performance obtained with the Karnofsky Performance Scale. Questionnaires were translated into three most commonly spoken languages in Malaysia (Bahasa Malaysia, Chinese and Tamil), then administered, scored and analyzed following the developers’ guidelines. Ethical approval was obtained from the participating centres. Tests of reliability and validity were performed to examine the validity of these instruments. Conclusion The result of pilot testing shows that the use of the Malaysian versions of EORTC QLQ C30, CR29 instruments is feasible in our sample of colorectal cancer patients. Instructions for completion as well as questions were well understood except the questions on the overall quality of life, overall health status and sexual activity. Thus we anticipate obtaining good psychometric properties for the instruments at the end of the study. PMID:22937765

Health-related quality of life among colorectal cancer patients in Malaysia: a study protocol.

PubMed

Magaji, Bello Arkilla; Moy, Foong Ming; Roslani, April Camilla; Sagap, Ismail; Zakaria, Jasiah; Blazeby, Jane M; Law, Chee Wei

2012-09-03

Colorectal cancer is a major public health problem in Malaysia. However, it is also one of the most treatable cancers, resulting in significant numbers of survivors. Therefore, the impact of surviving treatment for colorectal cancer on health related quality of life is important for the patients, clinicians and policy makers, and may differ in different cultures and populations. The aim of this study was to validate the Malaysian versions of the European Organization for Research and Treatment of Cancer quality of life instruments among colorectal cancers patients. This is a cross sectional multi centre study. Three hospitals were included, the University of Malaya Medical Centre, the Universiti Kebangsaan Malaysia Medical Centre and Hospital Tuanku Jaafar Seremban. Malaysian citizens and permanent residence were studied and demographic and clinical information obtained from hospital records. The European Organization for Research and Treatment of Cancer Quality of life Core 30, colorectal cancer CR29, and the colorectal cancer liver metastasis LMC 21 were used and an observer assessment of performance obtained with the Karnofsky Performance Scale. Questionnaires were translated into three most commonly spoken languages in Malaysia (Bahasa Malaysia, Chinese and Tamil), then administered, scored and analyzed following the developers' guidelines. Ethical approval was obtained from the participating centres. Tests of reliability and validity were performed to examine the validity of these instruments. The result of pilot testing shows that the use of the Malaysian versions of EORTC QLQ C30, CR29 instruments is feasible in our sample of colorectal cancer patients. Instructions for completion as well as questions were well understood except the questions on the overall quality of life, overall health status and sexual activity. Thus we anticipate obtaining good psychometric properties for the instruments at the end of the study.

Object-oriented regression for building predictive models with high dimensional omics data from translational studies.

PubMed

Zhao, Lue Ping; Bolouri, Hamid

2016-04-01

Maturing omics technologies enable researchers to generate high dimension omics data (HDOD) routinely in translational clinical studies. In the field of oncology, The Cancer Genome Atlas (TCGA) provided funding support to researchers to generate different types of omics data on a common set of biospecimens with accompanying clinical data and has made the data available for the research community to mine. One important application, and the focus of this manuscript, is to build predictive models for prognostic outcomes based on HDOD. To complement prevailing regression-based approaches, we propose to use an object-oriented regression (OOR) methodology to identify exemplars specified by HDOD patterns and to assess their associations with prognostic outcome. Through computing patient's similarities to these exemplars, the OOR-based predictive model produces a risk estimate using a patient's HDOD. The primary advantages of OOR are twofold: reducing the penalty of high dimensionality and retaining the interpretability to clinical practitioners. To illustrate its utility, we apply OOR to gene expression data from non-small cell lung cancer patients in TCGA and build a predictive model for prognostic survivorship among stage I patients, i.e., we stratify these patients by their prognostic survival risks beyond histological classifications. Identification of these high-risk patients helps oncologists to develop effective treatment protocols and post-treatment disease management plans. Using the TCGA data, the total sample is divided into training and validation data sets. After building up a predictive model in the training set, we compute risk scores from the predictive model, and validate associations of risk scores with prognostic outcome in the validation data (P-value=0.015). Copyright © 2016 Elsevier Inc. All rights reserved.

Object-Oriented Regression for Building Predictive Models with High Dimensional Omics Data from Translational Studies

PubMed Central

Zhao, Lue Ping; Bolouri, Hamid

2016-01-01

Maturing omics technologies enable researchers to generate high dimension omics data (HDOD) routinely in translational clinical studies. In the field of oncology, The Cancer Genome Atlas (TCGA) provided funding support to researchers to generate different types of omics data on a common set of biospecimens with accompanying clinical data and to make the data available for the research community to mine. One important application, and the focus of this manuscript, is to build predictive models for prognostic outcomes based on HDOD. To complement prevailing regression-based approaches, we propose to use an object-oriented regression (OOR) methodology to identify exemplars specified by HDOD patterns and to assess their associations with prognostic outcome. Through computing patient’s similarities to these exemplars, the OOR-based predictive model produces a risk estimate using a patient’s HDOD. The primary advantages of OOR are twofold: reducing the penalty of high dimensionality and retaining the interpretability to clinical practitioners. To illustrate its utility, we apply OOR to gene expression data from non-small cell lung cancer patients in TCGA and build a predictive model for prognostic survivorship among stage I patients, i.e., we stratify these patients by their prognostic survival risks beyond histological classifications. Identification of these high-risk patients helps oncologists to develop effective treatment protocols and post-treatment disease management plans. Using the TCGA data, the total sample is divided into training and validation data sets. After building up a predictive model in the training set, we compute risk scores from the predictive model, and validate associations of risk scores with prognostic outcome in the validation data (p=0.015). PMID:26972839

Six years' experience of tolerance induction in renal transplantation using stem cell therapy.

PubMed

Vanikar, Aruna V; Trivedi, Hargovind L; Thakkar, Umang G

2018-02-01

Tolerance induction (TI) has been attempted with chimerism/clonal deletion. We report results of TI protocol (TIP) using stem cell therapy (SCT) included adipose derived mesenchymal stem cells (AD-MSC) and hematopoietic stem cells (HSC) in 10 living-donor related renal transplantation (LDRT) patients under non-myeloablative conditioning with Bortezomib, Methylprednisone, rabbit-anti-thymoglobulin and Rituximab, without using conventional immunosuppression. Transplantation was performed following acceptable lymphocyte cross-match, flow cross-match, single antigen assay and negative mixed lymphocyte reaction (MLR). Monitoring included serum creatinine (SCr), donor specific antibodies (DSA) and MLR. Protocol biopsies were planned after 100days and yearly in willing patients. Rescue immunosuppression was planned for rejection/DSA/positive MLR. Over mean 6±0.37year follow-up patient survival was 80% and death-censored graft survival was 90%. Mean SCr was 1.44±0.41mg/dL. This is the first clinical report of sustained TI in LDRT for 6years using SCT. Copyright © 2017 Elsevier Inc. All rights reserved.

Partiality, impartiality and the ethics of triage.

PubMed

Okorie, Ndukaku

2018-06-22

In this paper, I discuss the question of partiality and impartiality in the application of triage. Triage is a process in medical research which recommends that patients should be sorted for treatment according to the degree or severity of their injury. In employing the triage protocol, however, the question of partiality arises because socially vulnerable groups will be neglected since there is the likelihood that the social determinants of a patient's health may diminish her chance of survival. As a process that is based on the severity of a patient's injury, triage will be unfair, and hence negatively partial, to socially vulnerable people. Thus, I aim in this paper to show that the triage protocol fails as an impartial evaluative process because its only aim is to maximize survivability. I contend that: (i) triage would lead to the neglect of the social condition of patients or victims, and (ii) it will only serve the utilitarian purpose of maximization of outcomes which may not be justified in some cases. © 2018 John Wiley & Sons Ltd.

Immediate prosthesis over implants retained using abutments with flexible screws: A preliminary study.

PubMed

Peñarrocha-Oltra, David; Serra-Pastor, Blanca; Balaguer-Martí, José-Carlos; Peñarrocha-Diago, Miguel; Agustín-Panadero, Rubén

2017-12-01

Immediate loading protocols for the rehabilitation of edentulous or partially edentulous patients have become very popular, due to the conveniences they afford in comparison with conventional loading techniques. A preliminary study was carried out with 8 patients subjected to dental implant treatment with an immediate loading protocol involving a novel system of abutments with flexible screws. Implant survival was analyzed, together with marginal bone loss and patient and dentist satisfaction. A total of 35 implants were subjected to immediate loading using the abutments with flexible screws. The mean patient and dentist satisfaction score was 9.1 and 8.5, respectively. After 12 months the dental implant survival rate was 95.8%, with a mean marginal bone loss of 0.51 ± 0.12 mm. The novel system of abutments with flexible screws offers a good alternative to conventional immediate loading, since it allows rapid and simple manufacture of a reliable passive fit, fixed interim prosthesis after surgery. Key words: Dental implants, Flexafit®, Immediate loading, Immediate prosthesis.

Design and Evaluation of Complex Moving HIFU Treatment Protocols

NASA Astrophysics Data System (ADS)

Kargl, Steven G.; Andrew, Marilee A.; Kaczkowski, Peter J.; Brayman, Andrew A.; Crum, Lawrence A.

2005-03-01

The use of moving high-intensity focused ultrasound (HIFU) treatment protocols is of interest in achieving efficient formation of large-volume thermal lesions in tissue. Judicious protocol design is critical in order to avoid collateral damage to healthy tissues outside the treatment zone. A KZK-BHTE model, extended to simulate multiple, moving scans in tissue, is used to investigate protocol design considerations. Prediction and experimental observations are presented which 1) validate the model, 2) illustrate how to assess the effects of acoustic nonlinearity, and 3) demonstrate how to assess and control collateral damage such as prefocal lesion formation and lesion formation resulting from thermal conduction without direct HIFU exposure. Experimental data consist of linear and circular scan protocols delivered over a range of exposure regimes in ex vivo bovine liver.

Design, Synthesis, and Validation of an Effective, Reusable Silicon-Based Transfer Agent for Room-Temperature Pd-Catalyzed Cross-Coupling Reactions of Aryl and Heteroaryl Chlorides with Readily Available Aryl Lithium Reagents

PubMed Central

Martinez-Solorio, Dionicio; Melillo, Bruno; Sanchez, Luis; Liang, Yong; Lam, Erwin; Houk, K. N.; Smith, Amos B.

2016-01-01

A reusable silicon-based transfer agent (1) has been designed, synthesized, and validated for effective room-temperature palladium-catalyzed cross-coupling reactions (CCRs) of aryl and heteroaryl chlorides with readily accessible aryl lithium reagents. The crystalline, bench-stable siloxane transfer agent (1) is easily prepared via a one-step protocol. Importantly, this “green” CCR protocol circumvents prefunctionalization, isolation of organometallic cross-coupling partners, and/or stoichiometric waste aside from LiCl. DFT calculations support a σ-bond metathesis mechanism during transmetalation and lead to insights on the importance of the CF3 groups. PMID:26835838

Continuous variable quantum key distribution: finite-key analysis of composable security against coherent attacks.

PubMed

Furrer, F; Franz, T; Berta, M; Leverrier, A; Scholz, V B; Tomamichel, M; Werner, R F

2012-09-07

We provide a security analysis for continuous variable quantum key distribution protocols based on the transmission of two-mode squeezed vacuum states measured via homodyne detection. We employ a version of the entropic uncertainty relation for smooth entropies to give a lower bound on the number of secret bits which can be extracted from a finite number of runs of the protocol. This bound is valid under general coherent attacks, and gives rise to keys which are composably secure. For comparison, we also give a lower bound valid under the assumption of collective attacks. For both scenarios, we find positive key rates using experimental parameters reachable today.

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

PubMed

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.

The cardiocerebral resuscitation protocol for treatment of out-of-hospital primary cardiac arrest.

PubMed

Ewy, Gordon A

2012-09-15

Out-of-hospital cardiac arrest (OHCA) is a significant public health problem in most westernized industrialized nations. In spite of national and international guidelines for cardiopulmonary resuscitation and emergency cardiac care, the overall survival of patients with OHCA was essentially unchanged for 30 years--from 1978 to 2008 at 7.6%. Perhaps a better indicator of Emergency Medical System (EMS) effectiveness in treating patients with OHCA is to focus on the subgroup that has a reasonable chance of survival, e.g., patients found to be in ventricular fibrillation (VF). But even in this subgroup, the average survival rate was 17.7% in the United States, unchanged between 1980 and 2003, and 21% in Europe, unchanged between 1980 and 2004. Prior to 2003, the survival of patients with OHCA, in VF in Tucson, Arizona was less than 9% in spite of incorporating previous guideline recommendations. An alternative (non-guidelines) approach to the therapy of patients with OHCA and a shockable rhythm, called Cardiocerebral Resuscitation, based on our extensive physiologic laboratory studies, was introduced in Tucson in 2003, in rural Wisconsin in 2004, and in selected EMS areas in the metropolitan Phoenix area in 2005. Survival of patients with OHCA due to VF treated with Cardiocerebral Resuscitation in rural Wisconsin increased to 38% and in 60 EMS systems in Arizona to 39%. In 2004, we began a statewide program to advocate chest compression-only CPR for bystanders of witnessed primary OHCA. Over the next five years, we found that survival of patients with a shockable rhythm was 17.7% in those treated with standard bystander CPR (mouth-to-mouth ventilations plus chest compression) compared to 33.7% for those who received bystander chest-compression-only CPR. This article on Cardiocerebral Resuscitation, by invitation following a presentation at the 2011 Danish Society Emergency Medical Conference, summarizes the results of therapy of patients with primary OHCA treated with Cardiocerebral Resuscitation, with requested emphasis on the EMS protocol.

The Cardiocerebral Resuscitation protocol for treatment of out-of-hospital primary cardiac arrest

PubMed Central

2012-01-01

Out-of-hospital cardiac arrest (OHCA) is a significant public health problem in most westernized industrialized nations. In spite of national and international guidelines for cardiopulmonary resuscitation and emergency cardiac care, the overall survival of patients with OHCA was essentially unchanged for 30 years--from 1978 to 2008 at 7.6%. Perhaps a better indicator of Emergency Medical System (EMS) effectiveness in treating patients with OHCA is to focus on the subgroup that has a reasonable chance of survival, e.g., patients found to be in ventricular fibrillation (VF). But even in this subgroup, the average survival rate was 17.7% in the United States, unchanged between 1980 and 2003, and 21% in Europe, unchanged between 1980 and 2004. Prior to 2003, the survival of patients with OHCA, in VF in Tucson, Arizona was less than 9% in spite of incorporating previous guideline recommendations. An alternative (non-guidelines) approach to the therapy of patients with OHCA and a shockable rhythm, called Cardiocerebral Resuscitation, based on our extensive physiologic laboratory studies, was introduced in Tucson in 2003, in rural Wisconsin in 2004, and in selected EMS areas in the metropolitan Phoenix area in 2005. Survival of patients with OHCA due to VF treated with Cardiocerebral Resuscitation in rural Wisconsin increased to 38% and in 60 EMS systems in Arizona to 39%. In 2004, we began a statewide program to advocate chest compression-only CPR for bystanders of witnessed primary OHCA. Over the next five years, we found that survival of patients with a shockable rhythm was 17.7% in those treated with standard bystander CPR (mouth-to-mouth ventilations plus chest compression) compared to 33.7% for those who received bystander chest-compression-only CPR. This article on Cardiocerebral Resuscitation, by invitation following a presentation at the 2011 Danish Society Emergency Medical Conference, summarizes the results of therapy of patients with primary OHCA treated with Cardiocerebral Resuscitation, with requested emphasis on the EMS protocol. PMID:22980487

A blueprint for a sepsis protocol.

PubMed

Shapiro, Nathan I; Howell, Michael; Talmor, Daniel

2005-04-01

Despite numerous advances in medicine, sepsis remains an unconquered challenge. Although outcomes have improved slightly over decades, the unacceptably high mortality rate of 30%-50% for severe sepsis and septic shock continues. However, after years of unsuccessful clinical trials, several investigations over the last few years have reported survival benefit in the treatment of sepsis. Physicians now have several proven therapies to treat sepsis, but have yet to implement them on a widespread, systematic basis. This led 11 international professional societies spanning multiple specialties and continents to come together to create the Surviving Sepsis Campaign. The product of their work is an international effort organized to improve care of patients with sepsis and includes consensus, evidence-based guidelines for care that improves survival in septic patients, and an action plan for change. Given the clear role of early identification and treatment in stopping the sepsis cascade, therapy must start early in the emergency department (ED) and continue throughout the hospital course. The first of the recommendations by the Surviving Sepsis Campaign is the aggressive resuscitation strategy of early goal-directed therapy (EGDT). EGDT is reported to reduce absolute mortality by a staggering 16%. The use of recombinant activated protein C was demonstrated to confer a 6% absolute survival benefit. Steroid supplementation in adrenal insufficiency produced a 10% benefit. Additionally, early and appropriate use of antibiotics remains a cornerstone of therapy. Although no randomized trial will be performed, the effects are undisputed. Finally, although predominantly intensive care unit therapies, tight glucose control and low-tidal-volume ventilation strategies have also led to improved survival. Armed with these new therapies, the medical community must rise to this call to action. Clinicians must change the approach to this disease, as well as the way the septic patient is viewed. Although complex and challenging, these therapies must be brought to the patient's bedside. We propose and describe the Multiple Urgent Sepsis Therapies (MUST) protocol as a practical way to implement a comprehensive treatment plan using available evidence-based therapies.

Chemoradiotherapy, with adjuvant surgery for local control, confers a durable survival advantage in adenocarcinoma and squamous cell carcinoma of the oesophagus.

PubMed

Bass, G A; Furlong, H; O'Sullivan, K E; Hennessy, T P J; Walsh, T N

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. Long-term results of two simultaneous randomised controlled trials (RCTs) comparing neo-adjuvant chemo-radiotherapy and surgery (MMT) with surgical monotherapy were examined, and the response of adenocarcinoma (AC) and squamous cell carcinoma (SCC) to identical regimens compared. Between 1990 and 1997, two RCTs were undertaken on 211 patients. Patients with AC (n=113) or SCC (n=98) were separately-randomised to identical protocols of MMT or surgical monotherapy. 211 patients were followed to 206 months; 104 patients were randomised to MMT (58 AC and 46 SCC, respectively) and 107 to surgery. MMT provided a significant survival-advantage over surgical monotherapy for AC (P=0.004), SCC (P=0.01). There was a 54% relative risk-reduction in lymph-node metastasis following MMT, compared with surgery (64% versus 29%, P<0.001). MMT produced a pathologic complete response (pCR) in 25% and 31% of AC and SCC, respectively. Survival advantage accrued to MMT, pCR and node-negative patients: AC pCR versus surgical monotherapy (P=0.001); residual disease following MMT versus surgical monotherapy (P=0.008); SCC pCR versus surgical monotherapy (P=0.033). A survival advantage for MMT persisted long-term in AC and was replicated in SCC. MMT produced loco-regional tumour down-staging to extinction in 25-31% of patients, potentially permitting personalised treatment in this cohort that avoids the morbidity and mortality associated with resection. Node-negative patients with residual localised disease following MMT had a survival advantage over node-negative patients following surgery alone, supporting a systemic effect on micro-metastatic disease. Copyright © 2014 Elsevier Ltd. All rights reserved.

The Best of Both Worlds: Building on the COPUS and RTOP Observation Protocols to Easily and Reliably Measure Various Levels of Reformed Instructional Practice

PubMed Central

Lund, Travis J.; Pilarz, Matthew; Velasco, Jonathan B.; Chakraverty, Devasmita; Rosploch, Kaitlyn; Undersander, Molly; Stains, Marilyne

2015-01-01

Researchers, university administrators, and faculty members are increasingly interested in measuring and describing instructional practices provided in science, technology, engineering, and mathematics (STEM) courses at the college level. Specifically, there is keen interest in comparing instructional practices between courses, monitoring changes over time, and mapping observed practices to research-based teaching. While increasingly common observation protocols (Reformed Teaching Observation Protocol [RTOP] and Classroom Observation Protocol in Undergraduate STEM [COPUS]) at the postsecondary level help achieve some of these goals, they also suffer from weaknesses that limit their applicability. In this study, we leverage the strengths of these protocols to provide an easy method that enables the reliable and valid characterization of instructional practices. This method was developed empirically via a cluster analysis using observations of 269 individual class periods, corresponding to 73 different faculty members, 28 different research-intensive institutions, and various STEM disciplines. Ten clusters, called COPUS profiles, emerged from this analysis; they represent the most common types of instructional practices enacted in the classrooms observed for this study. RTOP scores were used to validate the alignment of the 10 COPUS profiles with reformed teaching. Herein, we present a detailed description of the cluster analysis method, the COPUS profiles, and the distribution of the COPUS profiles across various STEM courses at research-intensive universities. PMID:25976654

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

PubMed

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.

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

PubMed

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

2017-03-01

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

The Classroom Observation Protocol for Undergraduate STEM (COPUS): a new instrument to characterize university STEM classroom practices.

PubMed

Smith, Michelle K; Jones, Francis H M; Gilbert, Sarah L; Wieman, Carl E

2013-01-01

Instructors and the teaching practices they employ play a critical role in improving student learning in college science, technology, engineering, and mathematics (STEM) courses. Consequently, there is increasing interest in collecting information on the range and frequency of teaching practices at department-wide and institution-wide scales. To help facilitate this process, we present a new classroom observation protocol known as the Classroom Observation Protocol for Undergraduate STEM or COPUS. This protocol allows STEM faculty, after a short 1.5-hour training period, to reliably characterize how faculty and students are spending their time in the classroom. We present the protocol, discuss how it differs from existing classroom observation protocols, and describe the process by which it was developed and validated. We also discuss how the observation data can be used to guide individual and institutional change.

The Classroom Observation Protocol for Undergraduate STEM (COPUS): A New Instrument to Characterize University STEM Classroom Practices

PubMed Central

Smith, Michelle K.; Jones, Francis H. M.; Gilbert, Sarah L.; Wieman, Carl E.

2013-01-01

Instructors and the teaching practices they employ play a critical role in improving student learning in college science, technology, engineering, and mathematics (STEM) courses. Consequently, there is increasing interest in collecting information on the range and frequency of teaching practices at department-wide and institution-wide scales. To help facilitate this process, we present a new classroom observation protocol known as the Classroom Observation Protocol for Undergraduate STEM or COPUS. This protocol allows STEM faculty, after a short 1.5-hour training period, to reliably characterize how faculty and students are spending their time in the classroom. We present the protocol, discuss how it differs from existing classroom observation protocols, and describe the process by which it was developed and validated. We also discuss how the observation data can be used to guide individual and institutional change. PMID:24297289

Criteria to assess human oocyte quality after cryopreservation.

PubMed

Coticchio, G; Bonu, M A; Bianchi, V; Flamigni, C; Borini, A

2005-10-01

Oocyte cryopreservation certainly represents one of the most attractive developments in the field of assisted reproduction, with the aim of preserving female fertility and circumventing the ethical and legal drawbacks associated with embryo freezing. Despite the achievement of the first pregnancy from frozen oocytes dating back as early as 1987, since then fewer than 150 pregnancies have been reported. Over a long period of time, application of oocyte storage on a large scale has been prevented by various factors, namely poor post-thaw survival. Fertilization rates remained low even after the introduction of intracytoplasmic sperm injection. Modifications of slow-freezing protocols, mainly based on the increase of the concentration of sucrose used as non-penetrating cryoprotectant (CPA) and the replacement of sodium with choline, appear to have decisively improved survival rates to over 80%. Investigations at the cellular level on thawed oocytes are largely lacking. Fertilization rates have also benefited from protocol modifications, reaching values indistinguishable from those normally obtained with fresh material. Vitrification protocols have also been tested, giving rise to improvements whose reproducibility is still uncertain. Data on the dynamics of fertilization and preimplantation development of embryos derived from frozen oocytes are extremely scarce. At the moment, clinical efficiency of oocyte cryopreservation cannot be precisely assessed because of the lack of controlled studies, although it appears to be considerably lower than that achieved with embryo freezing. In summary, encouraging advances have been made in the field of oocyte cryopreservation, but presently no protocol can ensure standards of success and safety comparable to those guaranteed by embryo storage.

The efficacy of periodic +Gz exposure in the prevention of bedrest induced orthostatic intolerance

NASA Technical Reports Server (NTRS)

Ludwig, D. A.; Vernikos, J.; Duvoisin, M. R; Stinn, J. L.

1992-01-01

What is the most efficient dosage of periodic exposure to positive 1G(z) during microgravity to maintain a functional upright position after returning to a positive 1G(z) environment? The answer has implications for the type of countermeasures astronauts will be required to perform during long term space flight. Methods: Nine males were subjected to four different positive 1G exposure protocols plus a control protocol ('zero G(z)') during four days of continuous bedrest. The four positive 1G(z) exposures consisted of periodic standing or walking, each for a total period of two or four hours. Each subject was returned for bedrest on five different occasions over a period of approximately one year to obtain data on each of the nine subjects across all four positive 1G(z) treatments and the control. A 30 min tilt test was used to measure orthostatic response during pre and post bedrest. Results: In terms of survival rate (percentage of subjects who did not faint after 30 sec of tilt), four hours of intermittent standing was the only protocol that maintained a rate comparable to pre bedrest levels (87.5 percent). Although the other three positive 1G(z) protocols performed better than the 'zero G(z) control (22.2 percent), only the four hour standing returned post bedrest survival rates to pre bedrest levels. Conclusions: The results will need to be evaluated with regards to a variety of other physiological systems which are known to decondition during microgravitry.

Reliability of chronic allograft nephropathy diagnosis in sequential protocol biopsies.

PubMed

Serón, Daniel; Moreso, Francesc; Fulladosa, Xavier; Hueso, Miguel; Carrera, Marta; Grinyó, Josep M

2002-02-01

Chronic allograft nephropathy (CAN) progresses rapidly during the first few months and slowly thereafter. Although the presence of CAN in protocol renal biopsies is a predictor of outcome, the reliability of this diagnosis according to Banff criteria has not been characterized. Renal lesions were evaluated according to the Banff criteria in sequential protocol biopsies performed at 4 and 14 months in 310 biopsies obtained from 155 patients. CAN progressed from 40 to 53% (P=0.001) while serum creatinine remained stable (146 +/- 44 vs. 147 +/- 48 micromol/L, P=NS). Graft survival in patients with and without CAN in the first biopsy was 74 versus 91% (P < 0.05), and in the second biopsy 75 versus 94% (P < 0.05). In 54 patients (35%) no CAN was present in both biopsies, 39 (25%) showed progression to CAN, 19 (12%) showed regression of CAN, and 43 (28%) showed CAN in both biopsies. Graft survival was: 100%, 81.6%, 82.6% and 69.4%, respectively (P < 0.01). Assuming that CAN does not regress and sampling error is normally distributed, we estimated that 25% of biopsies cannot be properly classified. The increase in the incidence of CAN between the 4th and 14th month is lower than the proportion of misclassified biopsies. Thus, monitoring the progression of CAN by means of two sequential biopsies at 4 and 14 months is inaccurate. We suggest that progression of scarring be monitored by means of a donor and a protocol biopsy performed during the first year evaluated with a quantitative approach.

Architecture for Survivable Systems Processing (ASSP). Technology benefits for Open System Interconnects

NASA Technical Reports Server (NTRS)

Wood, Richard J.

1992-01-01

The Architecture for Survivable Systems Processing (ASSP) program is a two phase program whose objective is the derivation, specification, development and validation of an open system architecture capable of supporting advanced processing needs of space, ground, and launch vehicle operations. The output of the first phase is a set of hardware and software standards and specifications defining this architecture at three levels. The second phase will validate these standards and develop the technology necessary to achieve strategic hardness, packaging density, throughput requirements, and interoperability/interchangeability.

Performance of the Colson MAM BP 3AA1-2 automatic blood pressure monitor according to the European Society of Hypertension validation protocol.

PubMed

Pereira, Telmo; Maldonado, João

2005-11-01

To evaluate the performance of the Colson MAM BP 3AA1-2 oscillometric automatic blood pressure monitor according to the validation protocol of the European Society of Hypertension, testing its suitability for self-measurement of blood pressure. The performance of the device was assessed in relation to various clinical variables, including age, gender, body mass index, arm circumference and arterial stiffness. 33 subjects (15 men and 18 women), with a mean age of 47 +/- 10 years, were studied according to the procedures laid down in the European Society of Hypertension validation protocol. Sequential same-arm blood pressure measurements were made, alternating between a mercury standard and the automatic device. The differences among the test-control measurements were assessed and divided into categorization zones of 5, 10 and 15 mmHg discrepancy. Aortic pulse wave velocity was assessed in all subjects with a Complior device (Colson, Paris). The Colson MAM BP 3AA1-2 passed all three phases of the protocol for both systolic and diastolic blood pressure. The mean differences between the test and control measurements were -1.0 +/- 5.0 mmHg for systolic blood pressure and -1.1 +/- 4.1 mmHg for diastolic blood pressure. Both standard deviations are well below the 8 mmHg limit proposed by the Association for the Advancement of Medical Instrumentation. The predictive value of various clinical variables for the discrepancies was assessed by a regression model analysis, with no variable being found that independently undermined the performance of the monitor. In another regression analysis, we found a similar relation between test and control blood pressures and aortic pulse wave velocity, a widely recognized and validated index of target organ damage. These data show that the Colson MAM BP 3AA1-2 satisfies the quality requirements proposed by the European Society of Hypertension, demonstrating its suitability for inclusion in integrated programs of clinical surveillance based on self-measurement of blood pressure. The uniformity of its performance over a wide spectrum of clinical characteristics and the relation found with pulse wave velocity further reinforce its clinical validity.

Editing wild points in isolation - Fast agreement for reliable systems (Preliminary version)

NASA Technical Reports Server (NTRS)

Kearns, Phil; Evans, Carol

1989-01-01

Consideration is given to the intuitively appealing notion of discarding sensor values which are strongly suspected of being erroneous in a modified approximate agreement protocol. Approximate agreement with editing imposes a time bound upon the convergence of the protocol - no such bound was possible for the original approximate agreement protocol. This new approach is potentially useful in the construction of asynchronous fault tolerant systems. The main result is that a wild-point replacement technique called t-worst editing can be shown to guarantee convergence of the approximate agreement protocol to a valid agreement value. Results are presented for a four-processor synchronous system in which a single processor may be faulty.

Determinants of health and disability in ageing population: the COURAGE in Europe Project (collaborative research on ageing in Europe).

PubMed

Leonardi, Matilde; Chatterji, Somnath; Koskinen, Seppo; Ayuso-Mateos, Jose Luis; Haro, Josep Maria; Frisoni, Giovanni; Frattura, Lucilla; Martinuzzi, Andrea; Tobiasz-Adamczyk, Beata; Gmurek, Michal; Serrano, Ramon; Finocchiaro, Carla

2014-01-01

COURAGE in Europe was a 3-year project involving 12 partners from four European countries and the World Health Organization. It was inspired by the pressing need to integrate international studies on disability and ageing in light of an innovative perspective based on a validated data-collection protocol. COURAGE in Europe Project collected data on the determinants of health and disability in an ageing population, with specific tools for the evaluation of the role of the built environment and social networks on health, disability, quality of life and well-being. The main survey was conducted by partners in Finland, Poland and Spain where the survey has been administered to a sample of 10,800 persons, which was completed in March 2012. The newly developed and validated COURAGE Protocol for Ageing Studies has proven to be a valid tool for collecting comparable data in ageing population, and the COURAGE in Europe Project has created valid and reliable scientific evidence, demonstrating cross-country comparability, for disability and ageing research and policy development. It is therefore recommended that future studies exploring determinants of health and disability in ageing use the COURAGE-derived methodology. COURAGE in Europe Project collected data on the determinants of health and disability in an ageing population, with specific tools for the evaluation of the role of built environment and social networks on health, disability quality of life and well-being. The COURAGE Protocol for Ageing Studies has proven to be a valid tool for collecting comparable data in the ageing population. The COURAGE in Europe Consortium recommends that future studies exploring determinants of health and disability in ageing use COURAGE-derived methodology. Copyright © 2013 John Wiley & Sons, Ltd.

Performance of a Blood Pressure Smartphone App in Pregnant Women: The iPARR Trial (iPhone App Compared With Standard RR Measurement).

PubMed

Raichle, Christina J; Eckstein, Jens; Lapaire, Olav; Leonardi, Licia; Brasier, Noé; Vischer, Annina S; Burkard, Thilo

2018-06-01

Hypertensive disorders are one of the leading causes of maternal death worldwide. Several smartphone apps claim to measure blood pressure (BP) using photoplethysmographic signals recorded by smartphone cameras. However, no single app has been validated for this use to date. We aimed to validate a new, promising smartphone algorithm. In this subgroup analysis of the iPARR trial (iPhone App Compared With Standard RR Measurement), we tested the Preventicus BP smartphone algorithm on 32 pregnant women. The trial was conducted based on the European Society of Hypertension International Protocol revision 2010 for validation of BP measuring devices in adults. Each individual received 7 sequential BP measurements starting with the reference device (Omron-HBP-1300) and followed by the smartphone measurement, resulting in 96 BP comparisons. Validation requirements of the European Society of Hypertension International Protocol revision 2010 were not fulfilled. Mean (±SD) systolic BP disagreement between the test and reference devices was 5.0 (±14.5) mm Hg. The number of absolute differences between test and reference device within 5, 10, and 15 mm Hg was 31, 53, and 64 of 96, respectively. A Bland-Altman plot showed an overestimation of smartphone-determined systolic BP in comparison with reference systolic BP in low range but an underestimation in medium-range BP. The Preventicus BP smartphone algorithm failed the accuracy criteria for estimating BP in pregnant women and was thus not commercialized. Pregnant women should be discouraged from using BP smartphone apps, unless there are algorithms specifically validated according to common protocols. URL: https://www.clinicaltrials.gov. Unique identifier: NCT02552030. © 2018 American Heart Association, Inc.

A covert authentication and security solution for GMOs.

PubMed

Mueller, Siguna; Jafari, Farhad; Roth, Don

2016-09-21

Proliferation and expansion of security risks necessitates new measures to ensure authenticity and validation of GMOs. Watermarking and other cryptographic methods are available which conceal and recover the original signature, but in the process reveal the authentication information. In many scenarios watermarking and standard cryptographic methods are necessary but not sufficient and new, more advanced, cryptographic protocols are necessary. Herein, we present a new crypto protocol, that is applicable in broader settings, and embeds the authentication string indistinguishably from a random element in the signature space and the string is verified or denied without disclosing the actual signature. Results show that in a nucleotide string of 1000, the algorithm gives a correlation of 0.98 or higher between the distribution of the codon and that of E. coli, making the signature virtually invisible. This algorithm may be used to securely authenticate and validate GMOs without disclosing the actual signature. While this protocol uses watermarking, its novelty is in use of more complex cryptographic techniques based on zero knowledge proofs to encode information.

Time to first compression using Medical Priority Dispatch System compression-first dispatcher-assisted cardiopulmonary resuscitation protocols.

PubMed

Van Vleet, Lee M; Hubble, Michael W

2012-01-01

Without bystander cardiopulmonary resuscitation (CPR), cardiac arrest survival decreases 7%-10% for every minute of delay until defibrillation. Dispatcher-assisted CPR (D-CPR) has been shown to increase the rates of bystander CPR and cardiac arrest survival. Other reports suggest that the most critical component of bystander CPR is chest compressions with minimal interruption. Beginning with version 11.2 of the Medical Priority Dispatch System (MPDS) protocols, instructions for mouth-to-mouth ventilation (MTMV) and pulse check were removed and a compression-first pathway was introduced to facilitate rapid delivery of compressions. Additionally, unconscious choking and third-trimester pregnancy decision-making criteria were added in versions 11.3 and 12.0, respectively. However, the effects of these changes on time to first compression (TTFC) have not been evaluated. We sought to quantify the TTFC of MPDS versions 11.2, 11.3, and 12.0 for all calls identified as cardiac arrest on call intake that did not require MTMV instruction. Audio recordings of all D-CPR events for October 2005 through May 2010 were analyzed for TTFC. Differences in TTFC across versions were compared using the Kruskal-Wallis test. A total of 778 cases received D-CPR. Of these, 259 were excluded because they met criteria for MTMV (pediatric patients, allergic reaction, etc.), were missing data, or were not initially identified as cardiac arrest. Of the remaining 519 calls, the mean TTFC was 240 seconds, with no significant variation across the MPDS versions (p = 0.08). Following the removal of instructions for pulse check and MTMV, as well as other minor changes in the MPDS protocols, we found the overall TTFC to be 240 seconds with little variation across the three versions evaluated. This represents an improvement in TTFC compared with reports of an earlier version of MPDS that included pulse checks and MTMV instructions (315 seconds). However, the MPDS TTFC does not compare favorably with reports of older, non-MPDS protocols that included pulse checks and MTMV. Efforts should continue to focus on improving this key, and modifiable, determinant of cardiac arrest survival.

The OECD program to validate the rat uterotrophic bioassay to screen compounds for in vivo estrogenic responses: phase 1.

PubMed Central

Kanno, J; Onyon, L; Haseman, J; Fenner-Crisp, P; Ashby, J; Owens, W

2001-01-01

The Organisation for Economic Co-operation and Development has completed the first phase of an international validation program for the rodent uterotrophic bioassay. This uterotrophic bioassay is intended to identify the in vivo activity of compounds that are suspected agonists or antagonists of estrogen. This information could, for example, be used to help prioritize positive compounds for further testing. Using draft protocols, we tested and compared two model systems, the immature female rat and the adult ovariectomized rat. Data from 19 participating laboratories using a high-potency reference agonist, ethinyl estradiol (EE), and an antagonist, ZM 189,154, indicate no substantive performance differences between models. All laboratories and all protocols successfully detected increases in uterine weights using EE in phase 1. These significant uterine weight increases were achieved under a variety of experimental conditions (e.g., strain, diet, housing protocol, bedding, vehicle). For each protocol, there was generally good agreement among laboratories with regard to the actual EE doses both in producing the first significant increase in uterine weights and achieving the maximum uterine response. Furthermore, the Hill equation appears to model the dose response satisfactorily and indicates general agreement based on calculated effective dose (ED)(10) and ED(50) within and among laboratories. The feasibility of an antagonist assay was also successfully demonstrated. Therefore, both models appear robust, reproducible, and transferable across laboratories for high-potency estrogen agonists such as EE. For the next phase of the OECD validation program, both models will be tested against a battery of weak, partial estrogen agonists. PMID:11564613

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

PubMed

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

2008-10-01

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

Millon Clinical Multiaxial Inventory-III Subtypes of Opioid Dependence: Validity and Matching to Behavioral Therapies

ERIC Educational Resources Information Center

Ball, Samuel A.; Nich, Charla; Rounsaville, Bruce J.; Eagan, Dorothy; Carroll, Kathleen M.

2004-01-01

The concurrent and predictive validity of 2 different methods of Millon Clinical Multiaxial Inventory-III subtyping (protocol sorting, cluster analysis) was evaluated in 125 recently detoxified opioid-dependent outpatients in a 12-week randomized clinical trial. Participants received naltrexone and relapse prevention group counseling and were…

Establishing Validity of the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)

ERIC Educational Resources Information Center

Zraick, Richard I.; Kempster, Gail B.; Connor, Nadine P.; Thibeault, Susan; Klaben, Bernice K.; Bursac, Zoran; Thrush, Carol R.; Glaze, Leslie E.

2011-01-01

Purpose: The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) was developed to provide a protocol and form for clinicians to use when assessing the voice quality of adults with voice disorders (Kempster, Gerratt, Verdolini Abbott, Barkmeier-Kramer, & Hillman, 2009). This study examined the reliability and the empirical validity of the…

Think Aloud: Using Cognitive Interviewing to Validate the PISA Assessment of Student Self-Efficacy in Mathematics

ERIC Educational Resources Information Center

Pepper, David; Hodgen, Jeremy; Lamesoo, Katri; Kõiv, Pille; Tolboom, Jos

2018-01-01

Cognitive interviewing (CI) provides a method of systematically collecting validity evidence of response processes for questionnaire items. CI involves a range of techniques for prompting individuals to verbalise their responses to items. One such technique is concurrent verbalisation, as developed in Think Aloud Protocol (TAP). This article…

Validating Cognitive Models of Task Performance in Algebra on the SAT®. Research Report No. 2009-3

ERIC Educational Resources Information Center

Gierl, Mark J.; Leighton, Jacqueline P.; Wang, Changjiang; Zhou, Jiawen; Gokiert, Rebecca; Tan, Adele

2009-01-01

The purpose of the study is to present research focused on validating the four algebra cognitive models in Gierl, Wang, et al., using student response data collected with protocol analysis methods to evaluate the knowledge structures and processing skills used by a sample of SAT test takers.

Integrative analysis of micro-RNA, gene expression, and survival of glioblastoma multiforme.

PubMed

Huang, Yen-Tsung; Hsu, Thomas; Kelsey, Karl T; Lin, Chien-Ling

2015-02-01

Glioblastoma multiforme (GBM), the most common type of malignant brain tumor, is highly fatal. Limited understanding of its rapid progression necessitates additional approaches that integrate what is known about the genomics of this cancer. Using a discovery set (n = 348) and a validation set (n = 174) of GBM patients, we performed genome-wide analyses that integrated mRNA and micro-RNA expression data from GBM as well as associated survival information, assessing coordinated variability in each as this reflects their known mechanistic functions. Cox proportional hazards models were used for the survival analyses, and nonparametric permutation tests were performed for the micro-RNAs to investigate the association between the number of associated genes and its prognostication. We also utilized mediation analyses for micro-RNA-gene pairs to identify their mediation effects. Genome-wide analyses revealed a novel pattern: micro-RNAs related to more gene expressions are more likely to be associated with GBM survival (P = 4.8 × 10(-5)). Genome-wide mediation analyses for the 32,660 micro-RNA-gene pairs with strong association (false discovery rate [FDR] < 0.01%) identified 51 validated pairs with significant mediation effect. Of the 51 pairs, miR-223 had 16 mediation genes. These 16 mediation genes of miR-223 were also highly associated with various other micro-RNAs and mediated their prognostic effects as well. We further constructed a gene signature using the 16 genes, which was highly associated with GBM survival in both the discovery and validation sets (P = 9.8 × 10(-6)). This comprehensive study discovered mediation effects of micro-RNA to gene expression and GBM survival and provided a new analytic framework for integrative genomics. © 2014 WILEY PERIODICALS, INC.

Opportunistic Mobility Support for Resource Constrained Sensor Devices in Smart Cities

PubMed Central

Granlund, Daniel; Holmlund, Patrik; Åhlund, Christer

2015-01-01

A multitude of wireless sensor devices and technologies are being developed and deployed in cities all over the world. Sensor applications in city environments may include highly mobile installations that span large areas which necessitates sensor mobility support. This paper presents and validates two mechanisms for supporting sensor mobility between different administrative domains. Firstly, EAP-Swift, an Extensible Authentication Protocol (EAP)-based sensor authentication protocol is proposed that enables light-weight sensor authentication and key generation. Secondly, a mechanism for handoffs between wireless sensor gateways is proposed. We validate both mechanisms in a real-life study that was conducted in a smart city environment with several fixed sensors and moving gateways. We conduct similar experiments in an industry-based anechoic Long Term Evolution (LTE) chamber with an ideal radio environment. Further, we validate our results collected from the smart city environment against the results produced under ideal conditions to establish best and real-life case scenarios. Our results clearly validate that our proposed mechanisms can facilitate efficient sensor authentication and handoffs while sensors are roaming in a smart city environment. PMID:25738767

Opportunistic mobility support for resource constrained sensor devices in smart cities.

PubMed

Granlund, Daniel; Holmlund, Patrik; Åhlund, Christer

2015-03-02

A multitude of wireless sensor devices and technologies are being developed and deployed in cities all over the world. Sensor applications in city environments may include highly mobile installations that span large areas which necessitates sensor mobility support. This paper presents and validates two mechanisms for supporting sensor mobility between different administrative domains. Firstly, EAP-Swift, an Extensible Authentication Protocol (EAP)-based sensor authentication protocol is proposed that enables light-weight sensor authentication and key generation. Secondly, a mechanism for handoffs between wireless sensor gateways is proposed. We validate both mechanisms in a real-life study that was conducted in a smart city environment with several fixed sensors and moving gateways. We conduct similar experiments in an industry-based anechoic Long Term Evolution (LTE) chamber with an ideal radio environment. Further, we validate our results collected from the smart city environment against the results produced under ideal conditions to establish best and real-life case scenarios. Our results clearly validate that our proposed mechanisms can facilitate efficient sensor authentication and handoffs while sensors are roaming in a smart city environment.

Modeling and validating the cost and clinical pathway of colorectal cancer.

PubMed

Joranger, Paal; Nesbakken, Arild; Hoff, Geir; Sorbye, Halfdan; Oshaug, Arne; Aas, Eline

2015-02-01

Cancer is a major cause of morbidity and mortality, and colorectal cancer (CRC) is the third most common cancer in the world. The estimated costs of CRC treatment vary considerably, and if CRC costs in a model are based on empirically estimated total costs of stage I, II, III, or IV treatments, then they lack some flexibility to capture future changes in CRC treatment. The purpose was 1) to describe how to model CRC costs and survival and 2) to validate the model in a transparent and reproducible way. We applied a semi-Markov model with 70 health states and tracked age and time since specific health states (using tunnels and 3-dimensional data matrix). The model parameters are based on an observational study at Oslo University Hospital (2049 CRC patients), the National Patient Register, literature, and expert opinion. The target population was patients diagnosed with CRC. The model followed the patients diagnosed with CRC from the age of 70 until death or 100 years. The study focused on the perspective of health care payers. The model was validated for face validity, internal and external validity, and cross-validity. The validation showed a satisfactory match with other models and empirical estimates for both cost and survival time, without any preceding calibration of the model. The model can be used to 1) address a range of CRC-related themes (general model) like survival and evaluation of the cost of treatment and prevention measures; 2) make predictions from intermediate to final outcomes; 3) estimate changes in resource use and costs due to changing guidelines; and 4) adjust for future changes in treatment and trends over time. The model is adaptable to other populations. © The Author(s) 2014.

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.

PubMed

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.

Scoring Systems to Estimate Intracerebral Control and Survival Rates of Patients Irradiated for Brain Metastases;Brain metastases; Radiation therapy; Local control; Survival; Prognostic scores

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

Rades, Dirk, E-mail: Rades.Dirk@gmx.net; Dziggel, Liesa; Haatanen, Tiina

2011-07-15

Purpose: To create and validate scoring systems for intracerebral control (IC) and overall survival (OS) of patients irradiated for brain metastases. Methods and Materials: In this study, 1,797 patients were randomly assigned to the test (n = 1,198) or the validation group (n = 599). Two scoring systems were developed, one for IC and another for OS. The scores included prognostic factors found significant on multivariate analyses. Age, performance status, extracerebral metastases, interval tumor diagnosis to RT, and number of brain metastases were associated with OS. Tumor type, performance status, interval, and number of brain metastases were associated with IC.more » The score for each factor was determined by dividing the 6-month IC or OS rate (given in percent) by 10. The total score represented the sum of the scores for each factor. The score groups of the test group were compared with the corresponding score groups of the validation group. Results: In the test group, 6-month IC rates were 17% for 14-18 points, 49% for 19-23 points, and 77% for 24-27 points (p < 0.0001). IC rates in the validation group were 19%, 52%, and 77%, respectively (p < 0.0001). In the test group, 6-month OS rates were 9% for 15-19 points, 41% for 20-25 points, and 78% for 26-30 points (p < 0.0001). OS rates in the validation group were 7%, 39%, and 79%, respectively (p < 0.0001). Conclusions: Patients irradiated for brain metastases can be given scores to estimate OS and IC. IC and OS rates of the validation group were similar to the test group demonstrating the validity and reproducibility of both scores.« less

Guidelines for randomized clinical trial protocol content: a systematic review

PubMed Central

2012-01-01

Background All randomized clinical trials (RCTs) require a protocol; however, numerous studies have highlighted protocol deficiencies. Reporting guidelines may improve the content of research reports and, if developed using robust methods, may increase the utility of reports to stakeholders. The objective of this study was to systematically identify and review RCT protocol guidelines, to assess their characteristics and methods of development, and to compare recommendations. Methods We conducted a systematic review of indexed literature (MEDLINE, EMBASE and the Cochrane Methodology Register from inception to September 2010; reference lists; related article features; forward citation searching) and a targeted search of supplementary sources, including a survey of major trial funding agencies in six countries. Records were eligible if they described a content guideline in English or French relevant to RCT protocols. Guidelines were excluded if they specified content for protocols for trials of specific procedures or conditions or were intended to assess trial quality. We extracted guideline characteristics and methods. Content was mapped for a subset of guidelines that described development methods or had institutional endorsement. Results Forty guidelines published in journals, books and institutional reports were included in the review; seven were specific to RCT protocols. Only eight (20%) described development methods which included informal consensus methods, pilot testing and formal validation; no guideline described all of these methods. No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development. The guidelines included a median of 23 concepts per guideline (interquartile range (IQR) = 14 to 34; range = 7 to 109). Among the subset of guidelines (n = 23) for which content was mapped, approximately 380 concepts were explicitly addressed (median concepts per guideline IQR = 31 (24,80); range = 16 to 150); most concepts were addressed in a minority of guidelines. Conclusions Existing guidelines for RCT protocol content varied substantially in their recommendations. Few reports described the methods of guideline development, limiting comparisons of guideline validity. Given the importance of protocols to diverse stakeholders, we believe a systematically developed, evidence-informed guideline for clinical trial protocols is needed. PMID:23006870

Guidelines for randomized clinical trial protocol content: a systematic review.

PubMed

Tetzlaff, Jennifer M; Chan, An-Wen; Kitchen, Jessica; Sampson, Margaret; Tricco, Andrea C; Moher, David

2012-09-24

All randomized clinical trials (RCTs) require a protocol; however, numerous studies have highlighted protocol deficiencies. Reporting guidelines may improve the content of research reports and, if developed using robust methods, may increase the utility of reports to stakeholders. The objective of this study was to systematically identify and review RCT protocol guidelines, to assess their characteristics and methods of development, and to compare recommendations. We conducted a systematic review of indexed literature (MEDLINE, EMBASE and the Cochrane Methodology Register from inception to September 2010; reference lists; related article features; forward citation searching) and a targeted search of supplementary sources, including a survey of major trial funding agencies in six countries. Records were eligible if they described a content guideline in English or French relevant to RCT protocols. Guidelines were excluded if they specified content for protocols for trials of specific procedures or conditions or were intended to assess trial quality. We extracted guideline characteristics and methods. Content was mapped for a subset of guidelines that described development methods or had institutional endorsement. Forty guidelines published in journals, books and institutional reports were included in the review; seven were specific to RCT protocols. Only eight (20%) described development methods which included informal consensus methods, pilot testing and formal validation; no guideline described all of these methods. No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development. The guidelines included a median of 23 concepts per guideline (interquartile range (IQR) = 14 to 34; range = 7 to 109). Among the subset of guidelines (n = 23) for which content was mapped, approximately 380 concepts were explicitly addressed (median concepts per guideline IQR = 31 (24,80); range = 16 to 150); most concepts were addressed in a minority of guidelines. Existing guidelines for RCT protocol content varied substantially in their recommendations. Few reports described the methods of guideline development, limiting comparisons of guideline validity. Given the importance of protocols to diverse stakeholders, we believe a systematically developed, evidence-informed guideline for clinical trial protocols is needed.

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

PubMed

Rahman, M Shafiqur; Ambler, Gareth; Choodari-Oskooei, Babak; Omar, Rumana Z

2017-04-18

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. 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. 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. 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 accuracy curves. In addition, we recommend to investigate the characteristics of the validation data such as the level of censoring and the distribution of the prognostic index derived in the validation setting before choosing the performance measures.

Antioxidants and anti-stress compounds improve the survival of cryopreserved Arabidopsis seedlings

USDA-ARS?s Scientific Manuscript database

Cryopreservation is a safe and cost-effective tool for the long-term storage of plant germplasm. Successful cryopreservation depends on suitable cryoprotection protocol. In Arabidopsis seedlings cryopreservation, the growth ability could be partly restored in 60-h seedlings, whereas 72-h seedlings d...