Conduct of a personal radiofrequency electromagnetic field measurement study: proposed study protocol.

PubMed

Röösli, Martin; Frei, Patrizia; Bolte, John; Neubauer, Georg; Cardis, Elisabeth; Feychting, Maria; Gajsek, Peter; Heinrich, Sabine; Joseph, Wout; Mann, Simon; Martens, Luc; Mohler, Evelyn; Parslow, Roger C; Poulsen, Aslak Harbo; Radon, Katja; Schüz, Joachim; Thuroczy, György; Viel, Jean-François; Vrijheid, Martine

2010-05-20

The development of new wireless communication technologies that emit radio frequency electromagnetic fields (RF-EMF) is ongoing, but little is known about the RF-EMF exposure distribution in the general population. Previous attempts to measure personal exposure to RF-EMF have used different measurement protocols and analysis methods making comparisons between exposure situations across different study populations very difficult. As a result, observed differences in exposure levels between study populations may not reflect real exposure differences but may be in part, or wholly due to methodological differences. The aim of this paper is to develop a study protocol for future personal RF-EMF exposure studies based on experience drawn from previous research. Using the current knowledge base, we propose procedures for the measurement of personal exposure to RF-EMF, data collection, data management and analysis, and methods for the selection and instruction of study participants. We have identified two basic types of personal RF-EMF measurement studies: population surveys and microenvironmental measurements. In the case of a population survey, the unit of observation is the individual and a randomly selected representative sample of the population is needed to obtain reliable results. For microenvironmental measurements, study participants are selected in order to represent typical behaviours in different microenvironments. These two study types require different methods and procedures. Applying our proposed common core procedures in future personal measurement studies will allow direct comparisons of personal RF-EMF exposures in different populations and study areas.

Computer-Tutors and a Freshman Writer: A Protocol Study.

ERIC Educational Resources Information Center

Strickland, James

Although there are many retrospective accounts from teachers and professional writers concerning the effect of computers on their writing, there are few real-time accounts of students struggling to simultaneously develop as writers and cope with computers. To fill this void in "testimonial data," a study examining talking-aloud protocols from a…

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

PubMed

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

2018-05-15

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

Conduct of a personal radiofrequency electromagnetic field measurement study: proposed study protocol

PubMed Central

2010-01-01

Background The development of new wireless communication technologies that emit radio frequency electromagnetic fields (RF-EMF) is ongoing, but little is known about the RF-EMF exposure distribution in the general population. Previous attempts to measure personal exposure to RF-EMF have used different measurement protocols and analysis methods making comparisons between exposure situations across different study populations very difficult. As a result, observed differences in exposure levels between study populations may not reflect real exposure differences but may be in part, or wholly due to methodological differences. Methods The aim of this paper is to develop a study protocol for future personal RF-EMF exposure studies based on experience drawn from previous research. Using the current knowledge base, we propose procedures for the measurement of personal exposure to RF-EMF, data collection, data management and analysis, and methods for the selection and instruction of study participants. Results We have identified two basic types of personal RF-EMF measurement studies: population surveys and microenvironmental measurements. In the case of a population survey, the unit of observation is the individual and a randomly selected representative sample of the population is needed to obtain reliable results. For microenvironmental measurements, study participants are selected in order to represent typical behaviours in different microenvironments. These two study types require different methods and procedures. Conclusion Applying our proposed common core procedures in future personal measurement studies will allow direct comparisons of personal RF-EMF exposures in different populations and study areas. PMID:20487532

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

PubMed Central

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

2018-01-01

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

Comparative Study on Various Authentication Protocols in Wireless Sensor Networks.

PubMed

Rajeswari, S Raja; Seenivasagam, V

2016-01-01

Wireless sensor networks (WSNs) consist of lightweight devices with low cost, low power, and short-ranged wireless communication. The sensors can communicate with each other to form a network. In WSNs, broadcast transmission is widely used along with the maximum usage of wireless networks and their applications. Hence, it has become crucial to authenticate broadcast messages. Key management is also an active research topic in WSNs. Several key management schemes have been introduced, and their benefits are not recognized in a specific WSN application. Security services are vital for ensuring the integrity, authenticity, and confidentiality of the critical information. Therefore, the authentication mechanisms are required to support these security services and to be resilient to distinct attacks. Various authentication protocols such as key management protocols, lightweight authentication protocols, and broadcast authentication protocols are compared and analyzed for all secure transmission applications. The major goal of this survey is to compare and find out the appropriate protocol for further research. Moreover, the comparisons between various authentication techniques are also illustrated.

Comparative Study on Various Authentication Protocols in Wireless Sensor Networks

PubMed Central

Rajeswari, S. Raja; Seenivasagam, V.

2016-01-01

Wireless sensor networks (WSNs) consist of lightweight devices with low cost, low power, and short-ranged wireless communication. The sensors can communicate with each other to form a network. In WSNs, broadcast transmission is widely used along with the maximum usage of wireless networks and their applications. Hence, it has become crucial to authenticate broadcast messages. Key management is also an active research topic in WSNs. Several key management schemes have been introduced, and their benefits are not recognized in a specific WSN application. Security services are vital for ensuring the integrity, authenticity, and confidentiality of the critical information. Therefore, the authentication mechanisms are required to support these security services and to be resilient to distinct attacks. Various authentication protocols such as key management protocols, lightweight authentication protocols, and broadcast authentication protocols are compared and analyzed for all secure transmission applications. The major goal of this survey is to compare and find out the appropriate protocol for further research. Moreover, the comparisons between various authentication techniques are also illustrated. PMID:26881272

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

PubMed

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

2018-04-24

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

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

PubMed

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

2014-03-01

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

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

PubMed

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

2014-07-16

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

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

PubMed

Kohara, Norihito; Kaneko, Masayuki; Narukawa, Mamoru

2018-01-01

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

A comparative study of two protocols for treadmill walking exercise testing in ambulating subjects with incomplete spinal cord injury.

PubMed

Lundgaard, E; Wouda, M F; Strøm, V

2017-10-01

This is a comparative study of two exercise testing protocols. The objective of this study was to compare maximal oxygen uptake (VO 2 max) and achieved criteria for maximal exercise testing between the Sunnaas Protocol-a newly designed treadmill exercise test protocol-and the Modified Bruce Protocol in persons with incomplete spinal cord injury (SCI). This study was conducted in Sunnaas Rehabilitation Hospital, Norway. Twenty persons (19 men) with incomplete SCI (AIS D) capable of ambulating without assistive devices performed two treadmill walking exercise tests (Sunnaas Protocol and Modified Bruce Protocol) until exhaustion 1-3 days apart. The key differences between the protocols are the smaller increments in speed and shorter duration on each workload in the Sunnaas Protocol. Cardiovascular responses were measured continuously throughout both tests. The subjects exhibited statistically significantly higher VO 2 max when using the Sunnaas Protocol (37.1±9.9 vs 35.4±9.8 ml kg -1  min -1 , P=0.01), with a mean between-test difference of 1.8 ml kg -1  min -1 (95% confidence interval: 0.49-3.16). There was no significant difference in mean maximal heart rate (HR max). Nineteen (95%) subjects achieved at least three of the four criteria for maximal oxygen uptake using the Sunnaas Protocol. Thirteen (65%) subjects achieved at least three of the criteria using a Modified Bruce protocol. The small differences in both VO 2 max and achieved criteria in favor of the Sunnaas Protocol suggest that it could be a useful alternative treadmill exercise test protocol for ambulating persons with incomplete SCI.

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

PubMed Central

2014-01-01

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

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

PubMed Central

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

2016-01-01

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

Hypertension study in anaesthetized rabbits: protocol proposal for AT1 antagonists screening.

PubMed

Politi, Aggeliki P; Zervou, Maria V; Triantafyllidi, Helen; Zoumpoulakis, Panagiotis G; Mavromoustakos, Thomas M; Zoga, Anastasia A; Moutevelis-Minakakis, Panagiota; Kokotos, George; Iliodromitis, Efstathios K; Kremastinos, Dimitris Th

2010-06-01

The aim of this study was to establish an optimized fast and safe protocol for the pharmacological screening of AT(1) antagonists. The pharmaceutical prototype AT(1) antagonist losartan, its active metabolite EXP3174 and the synthetic compound MMK1 were analysed in order to validate the protocol. Ang II was continuously infused while the animals received the drugs in two procedures. In the post-treatment procedure drugs were administered either in a single bolus dose or in a sequential manner. When losartan was administered in a single bolus dose, efficacy was evident until the 7th min (p=0.012) whilst EXP3174 infusion extended the efficiency up to the end of the study (p=0.006). In addition, the sequential injections of losartan prolonged the inhibitory time interval until the end of the study (p=0.045). In the pre-treatment procedure, results suggested a dose-dependent inhibitory effect for both antagonists. The pressor response to Ang II was unchanged after MMK1 administration either in the post- or in the pre-treatment mode. The proposed protocol appears to be safe, simple and fast for the pharmacological screening of AT(1) antagonists and enables the evaluation of new antagonists using lower doses than any other reported in the literature.

[The research protocol III. Study population].

PubMed

Arias-Gómez, Jesús; Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

2016-01-01

The study population is defined as a set of cases, determined, limited, and accessible, that will constitute the subjects for the selection of the sample, and must fulfill several characteristics and distinct criteria. The objectives of this manuscript are focused on specifying each one of the elements required to make the selection of the participants of a research project, during the elaboration of the protocol, including the concepts of study population, sample, selection criteria and sampling methods. After delineating the study population, the researcher must specify the criteria that each participant has to comply. The criteria that include the specific characteristics are denominated selection or eligibility criteria. These criteria are inclusion, exclusion and elimination, and will delineate the eligible population. The sampling methods are divided in two large groups: 1) probabilistic or random sampling and 2) non-probabilistic sampling. The difference lies in the employment of statistical methods to select the subjects. In every research, it is necessary to establish at the beginning the specific number of participants to be included to achieve the objectives of the study. This number is the sample size, and can be calculated or estimated with mathematical formulas and statistic software.

Protocol for rapid sequence intubation in pediatric patients -- a four-year study.

PubMed

Marvez-Valls, Eduardo; Houry, Debra; Ernst, Amy A; Weiss, Steven J; Killeen, James

2002-04-01

To evaluate a protocol for rapid sequence intubation (RSI) for pediatric patients in a Level 1 trauma center. Retrospective review of prospectively gathered Continuing Quality Improvement (CQI) data at an inner city Level 1 trauma center with an emergency medicine residency program. Protocols for RSI were established prior to initiating the study. All pediatric intubations at the center from February 1996 to February 2000 were included. Statistical analysis included descriptive statistics for categorical data and Chi-square for comparisons between groups. Over the 4-year study period there were 83 pediatric intubations ranging in age from 18 months to 17 years; mean age 8.6. All had data collected at the time of intubation. There were 20 (24%) females and 62 (76%) males (p<0.001). Reasons for intubation were related to trauma in 71 (86%) and medical reasons in 12 (14%) (p<0.001). Of the trauma intubations 7 (10%) were for gunshot wounds, 39 (55%) were secondary to MVCs, and the remainder (25; 35%) were from assaults, falls, and closed head injuries. The non-trauma intubations were for smoke inhalation, overdose, seizure, HIV related complications, eclampsia, and near drowning. Intubations were successful with one attempt in 65 (78%) cases. No surgical airways were necessary. Rocuronium was used in 4 cases. Protocol deviations did not lead to complications. This protocol based pediatric rapid sequence intubation method worked well in an EM residency program. More intubations were in males and more were necessary due to trauma in this group.

Comparison of the ultrashort gonadotropin-releasing hormone agonist-antagonist protocol with microdose flare -up protocol in poor responders: a preliminary study

PubMed Central

Berker, Bülent; Duvan, Candan İltemir; Kaya, Cemil; Aytaç, Ruşen; Şatıroğlu, Hakan

2010-01-01

Objective To determine the potential effect of the ultrashort gonadotropin-releasing hormone (GnRH) agonist/GnRH antagonist protocol versus the microdose GnRH agonist protocol in poor responders undergoing intracytoplasmic sperm injection (ICSI). Material and Methods The patients in the Agonist-Antagonist Group (n=41) were administered the ultrashort GnRH-agonist/ antagonist protocol, while the patients in the Microdose Group (n=41) were stimulated according to the microdose flare-up protocol. The mean number of mature oocytes retrieved was the primary outcome measure. Fertilization rate, implantation rate per embryo and clinical pregnancy rates were secondary outcome measures. Results There was no differenc between the mean number of mature oocytes retrieved in the two groups. There were also no statistical differences between the two groups in terms of peak serum E2 level, canceled cycles, endometrial thickness on hCG day, number of 2 pronucleus and number of embryos transferred. However, the total gonadotropin consumption and duration of stimulation were significantly higher with the Agonist-Antagonist Group compared with the Microdose Group. The implantation and clinical pregnancy rates were similar between the two groups. Conclusion Despite the high dose of gonadotropin consumption and longer duration of stimulation with the ultrashort GnRH agonist/ antagonist protocol, it seems that the Agonist-Antagonist Protocol is not inferior to the microdose protocol in poor responders undergoing ICSI. PMID:24591934

Comparison of the ultrashort gonadotropin-releasing hormone agonist-antagonist protocol with microdose flare -up protocol in poor responders: a preliminary study.

PubMed

Berker, Bülent; Duvan, Candan İltemir; Kaya, Cemil; Aytaç, Ruşen; Satıroğlu, Hakan

2010-01-01

To determine the potential effect of the ultrashort gonadotropin-releasing hormone (GnRH) agonist/GnRH antagonist protocol versus the microdose GnRH agonist protocol in poor responders undergoing intracytoplasmic sperm injection (ICSI). The patients in the Agonist-Antagonist Group (n=41) were administered the ultrashort GnRH-agonist/ antagonist protocol, while the patients in the Microdose Group (n=41) were stimulated according to the microdose flare-up protocol. The mean number of mature oocytes retrieved was the primary outcome measure. Fertilization rate, implantation rate per embryo and clinical pregnancy rates were secondary outcome measures. There was no differenc between the mean number of mature oocytes retrieved in the two groups. There were also no statistical differences between the two groups in terms of peak serum E2 level, canceled cycles, endometrial thickness on hCG day, number of 2 pronucleus and number of embryos transferred. However, the total gonadotropin consumption and duration of stimulation were significantly higher with the Agonist-Antagonist Group compared with the Microdose Group. The implantation and clinical pregnancy rates were similar between the two groups. Despite the high dose of gonadotropin consumption and longer duration of stimulation with the ultrashort GnRH agonist/ antagonist protocol, it seems that the Agonist-Antagonist Protocol is not inferior to the microdose protocol in poor responders undergoing ICSI.

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

PubMed

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

2014-12-01

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

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

PubMed

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

2013-05-01

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

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

PubMed

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

2013-02-01

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

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

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

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

2010-12-15

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

Effectiveness of oxaliplatin desensitization protocols.

PubMed

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

2013-03-01

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

Stimulation of the ovaries in women with breast cancer undergoing fertility preservation: Alternative versus standard stimulation protocols; the study protocol of the STIM-trial.

PubMed

Dahhan, T; Balkenende, E M E; Beerendonk, C C M; Fleischer, K; Stoop, D; Bos, A M E; Lambalk, C B; Schats, R; van Golde, R J T; Schipper, I; Louwé, L A; Cantineau, A E P; Smeenk, J M J; de Bruin, J P; Reddy, N; Kopeika, Y; van der Veen, F; van Wely, M; Linn, S C; Goddijn, M

2017-10-01

Chemotherapy for breast cancer may have a negative impact on reproductive function due to gonadotoxicity. Fertility preservation via banking of oocytes or embryos after ovarian stimulation with FSH can increase the likelihood of a future live birth. It has been hypothesized that elevated serum estrogen levels during ovarian stimulation may induce breast tumour growth. This has led to the use of alternative stimulation protocols with addition of tamoxifen or letrozole. The effectiveness of these stimulation protocols in terms of oocyte yield is unknown. Randomized open-label trial comparing ovarian stimulation plus tamoxifen and ovarian stimulation plus letrozole with standard ovarian stimulation in the course of fertility preservation. The study population consists of women with breast cancer who opt for banking of oocytes or embryos, aged 18-43years at randomisation. Primary outcome is the number of oocytes retrieved at follicle aspiration. Secondary outcomes are number of mature oocytes retrieved, number of oocytes or embryos banked and peak E2 levels during ovarian stimulation. Concerning the lack of evidence on which stimulation protocol should be used in women with breast cancer and the growing demand for fertility preservation, there is an urgent need to undertake this study. By performing this study, we will be able to closely monitor the effects of various stimulation protocols in women with breast cancer and pave the way for long term follow up on the safety of this procedure in terms of breast cancer prognosis. NTR4108. Copyright © 2017 Elsevier Inc. All rights reserved.

Prenatal diagnosis and prevention of toxoplasmosis in pregnant women in Northern Vietnam: study protocol.

PubMed

Smit, G Suzanne A; Vu, Thi Lam Binh; Do, Trung Dung; Speybroeck, Niko; Devleesschauwer, Brecht; Padalko, Elizaveta; Roets, Ellen; Dorny, Pierre

2017-05-25

In Vietnam, no systematic prenatal toxoplasmosis screening is in place, and only few studies have assessed the prevalence and importance of this zoonotic parasite infection. In addition, no studies have been conducted to assess the risk factors associated with toxoplasmosis. This study protocol was developed to determine the seroprevalence of toxoplasmosis in pregnant women in Hanoi and Thai Binh, Northern Vietnam, and to evaluate the association with risk factors and congenital toxoplasmosis. The protocol was developed in a way that it could potentially evolve into a countrywide prenatal diagnosis and prevention program, with the main focus on primary prevention. The collaborating gynaecologists will invite eligible pregnant women attending antenatal care for the first time to participate in the study. At first consult, information about toxoplasmosis and its prevention will be provided. All participants will be asked to fill in a questionnaire, which is designed to analyse socio-demographic and biologically plausible risk factors associated with toxoplasmosis, and blood samples will be collected to determine the seroprevalence of toxoplasmosis in pregnant women. In case there is suspicion of a primary infection during pregnancy, the concerned women will be followed-up by the gynaecologists according to a predefined protocol. Every participant will be informed on her serological status, risk factors and prevention measures and is offered appropriate medical information and medical follow-up if required. The hypothesis is that congenital toxoplasmosis is an important but currently under-diagnosed public health problem in Vietnam. This study can strengthen sustainable control of toxoplasmosis in Vietnam, provide a protocol for prenatal diagnosis, boost overall awareness, improve the knowledge about toxoplasmosis prevention and can be essential for evidence-based health policy.

Does adopting a prenatal substance use protocol reduce racial disparities in CPS reporting related to maternal drug use? A California case study.

PubMed

Roberts, S C M; Zahnd, E; Sufrin, C; Armstrong, M A

2015-02-01

This study examined whether adopting a standardized prenatal substance use protocol (protocol) in a hospital labor and delivery unit reduced racial disparities in reporting to child protective services (CPS) related to maternal drug use during pregnancy. This study used an interrupted time series design with a non-equivalent control. One hospital adopted a protocol and another hospital group serving a similar geographic population did not change protocols. Data on CPS reporting disparities from these hospitals over 3.5 years were analyzed using segmented regression. In the hospital that adopted the protocol, almost five times more black than white newborns were reported during the study period. Adopting the protocol was not associated with reduced disparities. Adopting a protocol cannot be assumed to reduce CPS reporting disparities. Efforts to encourage hospitals to adopt protocols as a strategy to reduce disparities may be misguided. Other strategies to reduce disparities are needed.

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

PubMed

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

2015-09-01

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

A land classification protocol for pollinator ecology research: An urbanization case study.

PubMed

Samuelson, Ash E; Leadbeater, Ellouise

2018-06-01

Land-use change is one of the most important drivers of widespread declines in pollinator populations. Comprehensive quantitative methods for land classification are critical to understanding these effects, but co-option of existing human-focussed land classifications is often inappropriate for pollinator research. Here, we present a flexible GIS-based land classification protocol for pollinator research using a bottom-up approach driven by reference to pollinator ecology, with urbanization as a case study. Our multistep method involves manually generating land cover maps at multiple biologically relevant radii surrounding study sites using GIS, with a focus on identifying land cover types that have a specific relevance to pollinators. This is followed by a three-step refinement process using statistical tools: (i) definition of land-use categories, (ii) principal components analysis on the categories, and (iii) cluster analysis to generate a categorical land-use variable for use in subsequent analysis. Model selection is then used to determine the appropriate spatial scale for analysis. We demonstrate an application of our protocol using a case study of 38 sites across a gradient of urbanization in South-East England. In our case study, the land classification generated a categorical land-use variable at each of four radii based on the clustering of sites with different degrees of urbanization, open land, and flower-rich habitat. Studies of land-use effects on pollinators have historically employed a wide array of land classification techniques from descriptive and qualitative to complex and quantitative. We suggest that land-use studies in pollinator ecology should broadly adopt GIS-based multistep land classification techniques to enable robust analysis and aid comparative research. Our protocol offers a customizable approach that combines specific relevance to pollinator research with the potential for application to a wide range of ecological questions

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

PubMed

Alanazi, Adwan; Elleithy, Khaled

2015-09-02

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

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

PubMed Central

Alanazi, Adwan; Elleithy, Khaled

2015-01-01

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

Quarantine and protocol

NASA Technical Reports Server (NTRS)

1981-01-01

The purpose of the Orbiting Quarantine Facility is to provide maximum protection of the terrestrial biosphere by ensuring that the returned Martian samples are safe to bring to Earth. The protocol designed to detect the presence of biologically active agents in the Martian soil is described. The protocol determines one of two things about the sample: (1) that it is free from nonterrestrial life forms and can be sent to a terrestrial containment facility where extensive chemical, biochemical, geological, and physical investigations can be conducted; or (2) that it exhibits "biological effects" of the type that dictate second order testing. The quarantine protocol is designed to be conducted on a small portion of the returned sample, leaving the bulk of the sample undisturbed for study on Earth.

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

PubMed

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

2017-10-12

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

Study protocol for the Cities Changing Diabetes programme: a global mixed-methods approach.

PubMed

Napier, A David; Nolan, John J; Bagger, Malene; Hesseldal, Louise; Volkmann, Anna-Maria

2017-11-08

Urban living has been shown to affect health in various ways. As the world is becoming more urbanised and almost two-thirds of people with diabetes now live in cities, research into the relationship between urban living, health and diabetes is key to improving the lives of many. The majority of people with diabetes have type 2 diabetes, a subset linked to overweight and obesity, decreased physical activity and unhealthy diets. Diabetes has significant consequences for those living with the condition as well as their families, relationships and wider society. Although care and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through the Cities Changing Diabetes (CCD) partnership programme. A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan implementation of findings. Local academic teams execute the study following the global study protocol presented here. A quantitative Rule of Halves analysis obtains measures of the magnitude of the diabetes burden, the diagnosis rates in each city and the outcomes of care. A qualitative Diabetes Vulnerability Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. The protocol steers the collection of primary and secondary data across the study sites. Research ethics board approval has been sought and obtained in each site. Findings from each of the local studies as well as the result from combined multisite (global) analyses will be reported in a series of core scientific journal papers. © Article author

Treatment influencing down-staging in EORTC Melanoma Group sentinel node histological protocol compared with complete step-sectioning: a national multicentre study.

PubMed

Riber-Hansen, Rikke; Hastrup, Nina; Clemmensen, Ole; Behrendt, Nille; Klausen, Siri; Ramsing, Mette; Spaun, Eva; Hamilton-Dutoit, Stephen Jacques; Steiniche, Torben

2012-02-01

Metastasis size in melanoma sentinel lymph nodes (SLNs) is an emerging prognostic factor. Two European melanoma treatment trials include SLN metastasis diameters as inclusion criteria. Whilst diameter estimates are sensitive to the number of sections examined, the level of this bias is largely unknown. We performed a prospective multicentre study to compare the European Organisation for Research and Treatment of Cancer (EORTC) recommended protocol with a protocol of complete step-sectioning. One hundred and thirty-three consecutive SLNs from seven SLN centres were analysed by five central sections 50μm apart (EORTC Protocol) followed by complete 250μm step-sectioning. Overall, 29 patients (21.8%) were SLN-positive. The EORTC Protocol missed eight of these metastases (28%), one metastasis measuring less than 0.1mm in diameter, seven measuring between 0.1 and 1mm. Complete step-sectioning at 250μm intervals (Extensive Protocol) missed one metastasis (3%) that measured less than 0.1mm. Thirteen treatment courses (34%) performed if inclusion was based on the Combined Protocol would not be performed if assessed by the EORTC Protocol. Thus, 10 patients would be without completion lymph node dissection (EORTC MINITUB study), whilst three patients would not be eligible for anti-CTLA4 trial (EORTC protocol 18071). The corresponding number with the Extensive Protocol would be three; one patient for the MINITUB registration study and two patients for the anti-CTLA4 study. Examining SLNs by close central sectioning alone (EORTC Protocol) misses a substantial number of metastases and underestimates the maximum metastasis diameter, leading to important changes in patient eligibility for various treatment protocols. Copyright © 2011 Elsevier Ltd. All rights reserved.

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

PubMed

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

2016-06-27

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

Prayer Healing: A Case Study Research Protocol.

PubMed

Kruijthoff, Dirk J; van der Kooi, Cornelis; Glas, Gerrit; Abma, Tineke A

2017-01-01

Context • Prayer healing is a common practice in many religious communities around the world. Even in the highly secularized Dutch society, cases of prayer healing are occasionally reported in the media, often generating public attention. There is an ongoing debate regarding whether such miraculous cures do actually occur and how to interpret them. Objective • The aim of the article was to present a research protocol for the investigation of reported cases of remarkable and/or unexplained healing after prayer. Design • The research team developed a method to perform a retrospective, case-based study of prayer healing. Reported prayer healings can be investigated systematically in accordance with a step-by-step methodology. The focus is on understanding the healing by studying it from multiple perspectives, using both medical judgment and patients' narratives collected by qualitative methods Setting • The study occurred at Vrije Universiteit (VU) and VU Medical Center (Amsterdam, Netherlands) as well as the general medical practice of the first author. Participants • Potential participants could be any individuals in the Netherlands or neighboring countries who claim to have been healed through prayer. The reports of healing came from multiple sources, including the research team's medical practices and their direct vicinities, newspaper articles, prayer healers, and medical colleagues. Outcome Measures • Medical data were obtained before and after prayer. Subsequently, a member of a research team and of a medical assessment committee made a standardized judgment that evaluated whether a cure was clinically remarkable or scientifically unexplained. The participants' experiences and insider perspectives were studied, using in-depth interviews in accordance with a qualitative research methodology, to gain insight into the perceptions and explanations of the cures that were offered by participants and by the members of the medical assessment committee. The

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.

LAN (Local Area Network) Interoperability Study of Protocols Needed for Distributed Command and Control

DTIC Science & Technology

1985-03-01

model referred to by the study group . IMCKIiN cuINICATION 31215FOR SDATA TWSU•l Sa *BSTtEO POOTO• AA14FTICT’WI PEM1 ITS ...operating systems, compared the DOD and ISO networking protocol architecture models , the protocols for LAN’s developed by the IEEE and ANSI, reviewed and...be initiated, so as to provide the Air Force a roadmap to guide its * "technology develop •ents. 4,’ �/LAN 3-4 .°. SECTION 4.0

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

PubMed

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

2011-12-01

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

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

PubMed

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

2017-01-01

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

Novel methods to estimate antiretroviral adherence: protocol for a longitudinal study.

PubMed

Saberi, Parya; Ming, Kristin; Legnitto, Dominique; Neilands, Torsten B; Gandhi, Monica; Johnson, Mallory O

2018-01-01

There is currently no gold standard for assessing antiretroviral (ARV) adherence, so researchers often resort to the most feasible and cost-effective methods possible (eg, self-report), which may be biased or inaccurate. The goal of our study was to evaluate the feasibility and acceptability of innovative and remote methods to estimate ARV adherence, which can potentially be conducted with less time and financial resources in a wide range of clinic and research settings. Here, we describe the research protocol for studying these novel methods and some lessons learned. The 6-month pilot study aimed to examine the feasibility and acceptability of a remotely conducted study to evaluate the correlation between: 1) text-messaged photographs of pharmacy refill dates for refill-based adherence; 2) text-messaged photographs of pills for pill count-based adherence; and 3) home-collected hair sample measures of ARV concentration for pharmacologic-based adherence. Participants were sent monthly automated text messages to collect refill dates and pill counts that were taken and sent via mobile telephone photographs, and hair collection kits every 2 months by mail. At the study end, feasibility was calculated by specific metrics, such as the receipt of hair samples and responses to text messages. Participants completed a quantitative survey and qualitative exit interviews to examine the acceptability of these adherence evaluation methods. The relationship between the 3 novel metrics of adherence and self-reported adherence will be assessed. Investigators conducting adherence research are often limited to using either self-reported adherence, which is subjective, biased, and often overestimated, or other more complex methods. Here, we describe the protocol for evaluating the feasibility and acceptability of 3 novel and remote methods of estimating adherence, with the aim of evaluating the relationships between them. Additionally, we note the lessons learned from the protocol

Novel methods to estimate antiretroviral adherence: protocol for a longitudinal study

PubMed Central

Saberi, Parya; Ming, Kristin; Legnitto, Dominique; Neilands, Torsten B; Gandhi, Monica; Johnson, Mallory O

2018-01-01

Background There is currently no gold standard for assessing antiretroviral (ARV) adherence, so researchers often resort to the most feasible and cost-effective methods possible (eg, self-report), which may be biased or inaccurate. The goal of our study was to evaluate the feasibility and acceptability of innovative and remote methods to estimate ARV adherence, which can potentially be conducted with less time and financial resources in a wide range of clinic and research settings. Here, we describe the research protocol for studying these novel methods and some lessons learned. Methods The 6-month pilot study aimed to examine the feasibility and acceptability of a remotely conducted study to evaluate the correlation between: 1) text-messaged photographs of pharmacy refill dates for refill-based adherence; 2) text-messaged photographs of pills for pill count-based adherence; and 3) home-collected hair sample measures of ARV concentration for pharmacologic-based adherence. Participants were sent monthly automated text messages to collect refill dates and pill counts that were taken and sent via mobile telephone photographs, and hair collection kits every 2 months by mail. At the study end, feasibility was calculated by specific metrics, such as the receipt of hair samples and responses to text messages. Participants completed a quantitative survey and qualitative exit interviews to examine the acceptability of these adherence evaluation methods. The relationship between the 3 novel metrics of adherence and self-reported adherence will be assessed. Discussion Investigators conducting adherence research are often limited to using either self-reported adherence, which is subjective, biased, and often overestimated, or other more complex methods. Here, we describe the protocol for evaluating the feasibility and acceptability of 3 novel and remote methods of estimating adherence, with the aim of evaluating the relationships between them. Additionally, we note the lessons

EVA Human Health and Performance Benchmarking Study Overview and Development of a Microgravity Protocol

NASA Technical Reports Server (NTRS)

Norcross, Jason; Jarvis, Sarah; Bekdash, Omar; Cupples, Scott; Abercromby, Andrew

2017-01-01

The primary objective of this study is to develop a protocol to reliably characterize human health and performance metrics for individuals working inside various EVA suits under realistic spaceflight conditions. Expected results and methodologies developed during this study will provide the baseline benchmarking data and protocols with which future EVA suits and suit configurations (e.g., varied pressure, mass, center of gravity [CG]) and different test subject populations (e.g., deconditioned crewmembers) may be reliably assessed and compared. Results may also be used, in conjunction with subsequent testing, to inform fitness-for-duty standards, as well as design requirements and operations concepts for future EVA suits and other exploration systems.

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

PubMed Central

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

2016-01-01

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

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

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

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

2015-01-30

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

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

ERIC Educational Resources Information Center

Tikunoff, William J.; And Others

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

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

PubMed

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

2014-01-01

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

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

PubMed

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

2015-10-01

Clinical protocols may decrease unnecessary variation in care and improve compliance with desirable therapies. We evaluated whether highly protocolized ICUs have superior patient outcomes compared with less highly protocolized ICUs. Observational study in which participating ICUs completed a general assessment and enrolled new patients 1 day each week. A total of 6,179 critically ill patients. Fifty-nine ICUs in the United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study. None. The primary exposure was the number of ICU protocols; the primary outcome was hospital mortality. A total of 5,809 participants were followed prospectively, and 5,454 patients in 57 ICUs had complete outcome data. The median number of protocols per ICU was 19 (interquartile range, 15-21.5). In single-variable analyses, there were no differences in ICU and hospital mortality, length of stay, use of mechanical ventilation, vasopressors, or continuous sedation among individuals in ICUs with a high versus low number of protocols. The lack of association was confirmed in adjusted multivariable analysis (p = 0.70). Protocol compliance with two ventilator management protocols was moderate and did not differ between ICUs with high versus low numbers of protocols for lung protective ventilation in acute respiratory distress syndrome (47% vs 52%; p = 0.28) and for spontaneous breathing trials (55% vs 51%; p = 0.27). Clinical protocols are highly prevalent in U.S. ICUs. The presence of a greater number of protocols was not associated with protocol compliance or patient mortality.

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

ERIC Educational Resources Information Center

Tikunoff, William J.; And Others

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

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

PubMed Central

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

2018-01-01

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

Physical Therapy Protocols for Arthroscopic Bankart Repair.

PubMed

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

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

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

PubMed

Decullier, Evelyne; Lhéritier, Véronique; Chapuis, François

2005-10-17

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

CT protocol management: simplifying the process by using a master protocol concept.

PubMed

Szczykutowicz, Timothy P; Bour, Robert K; Rubert, Nicholas; Wendt, Gary; Pozniak, Myron; Ranallo, Frank N

2015-07-08

This article explains a method for creating CT protocols for a wide range of patient body sizes and clinical indications, using detailed tube current information from a small set of commonly used protocols. Analytical expressions were created relating CT technical acquisition parameters which can be used to create new CT protocols on a given scanner or customize protocols from one scanner to another. Plots of mA as a function of patient size for specific anatomical regions were generated and used to identify the tube output needs for patients as a function of size for a single master protocol. Tube output data were obtained from the DICOM header of clinical images from our PACS and patient size was measured from CT localizer radiographs under IRB approval. This master protocol was then used to create 11 additional master protocols. The 12 master protocols were further combined to create 39 single and multiphase clinical protocols. Radiologist acceptance rate of exams scanned using the clinical protocols was monitored for 12,857 patients to analyze the effectiveness of the presented protocol management methods using a two-tailed Fisher's exact test. A single routine adult abdominal protocol was used as the master protocol to create 11 additional master abdominal protocols of varying dose and beam energy. Situations in which the maximum tube current would have been exceeded are presented, and the trade-offs between increasing the effective tube output via 1) decreasing pitch, 2) increasing the scan time, or 3) increasing the kV are discussed. Out of 12 master protocols customized across three different scanners, only one had a statistically significant acceptance rate that differed from the scanner it was customized from. The difference, however, was only 1% and was judged to be negligible. All other master protocols differed in acceptance rate insignificantly between scanners. The methodology described in this paper allows a small set of master protocols to be

CT protocol management: simplifying the process by using a master protocol concept

PubMed Central

Bour, Robert K.; Rubert, Nicholas; Wendt, Gary; Pozniak, Myron; Ranallo, Frank N.

2015-01-01

This article explains a method for creating CT protocols for a wide range of patient body sizes and clinical indications, using detailed tube current information from a small set of commonly used protocols. Analytical expressions were created relating CT technical acquisition parameters which can be used to create new CT protocols on a given scanner or customize protocols from one scanner to another. Plots of mA as a function of patient size for specific anatomical regions were generated and used to identify the tube output needs for patients as a function of size for a single master protocol. Tube output data were obtained from the DICOM header of clinical images from our PACS and patient size was measured from CT localizer radiographs under IRB approval. This master protocol was then used to create 11 additional master protocols. The 12 master protocols were further combined to create 39 single and multiphase clinical protocols. Radiologist acceptance rate of exams scanned using the clinical protocols was monitored for 12,857 patients to analyze the effectiveness of the presented protocol management methods using a two‐tailed Fisher's exact test. A single routine adult abdominal protocol was used as the master protocol to create 11 additional master abdominal protocols of varying dose and beam energy. Situations in which the maximum tube current would have been exceeded are presented, and the trade‐offs between increasing the effective tube output via 1) decreasing pitch, 2) increasing the scan time, or 3) increasing the kV are discussed. Out of 12 master protocols customized across three different scanners, only one had a statistically significant acceptance rate that differed from the scanner it was customized from. The difference, however, was only 1% and was judged to be negligible. All other master protocols differed in acceptance rate insignificantly between scanners. The methodology described in this paper allows a small set of master protocols to be

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2017-01-01

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

Systematic Review Protocol to Assess the Effectiveness of Usability Questionnaires in mHealth App Studies.

PubMed

Zhou, Leming; Bao, Jie; Parmanto, Bambang

2017-08-01

Usability questionnaires have a wide use in mobile health (mHealth) app usability studies. However, no systematic review has been conducted for assessing the effectiveness of these questionnaires. This paper describes a protocol for conducting a systematic review of published questionnaire-based mHealth app usability studies. In this systematic review, we will select recently published (2008-2017) articles from peer-reviewed journals and conferences that describe mHealth app usability studies and implement at least one usability questionnaire. The search strategy will include terms such as "mobile app" and "usability." Multiple databases such as PubMed, CINAHL, IEEE Xplore, ACM Digital Library, and INSPEC will be searched. There will be 2 independent reviewers in charge of screening titles and abstracts as well as determining those articles that should be included for a full-text review. The third reviewer will act as a mediator between the other 2 reviewers. Moreover, a data extraction form will be created and used during the full article data analysis. Notably, the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines will be followed in reporting this protocol. A preliminary search produced 1271 articles, 40 of which are duplicate records. The inclusion-exclusion criteria are being strictly followed in performing the ongoing study selection. Usability questionnaires are an important tool in mHealth app usability studies. This review will summarize the usability questionnaires used in published research articles while assessing the efficacy of these questionnaires in determining the usability of mHealth apps. ©Leming Zhou, Jie Bao, Bambang Parmanto. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.08.2017.

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

NASA Astrophysics Data System (ADS)

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

2013-12-01

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

Radiation Dose Index of Renal Colic Protocol CT Studies in the United States

PubMed Central

Lukasiewicz, Adam; Bhargavan-Chatfield, Mythreyi; Coombs, Laura; Ghita, Monica; Weinreb, Jeffrey; Gunabushanam, Gowthaman; Moore, Christopher L.

2016-01-01

Purpose To determine radiation dose indexes for computed tomography (CT) performed with renal colic protocols in the United States, including frequency of reduced-dose technique usage and any institutional-level factors associated with high or low dose indexes. Materials and Methods The Dose Imaging Registry (DIR) collects deidentified CT data, including examination type and dose indexes, for CT performed at participating institutions; thus, the DIR portion of the study was exempt from institutional review board approval and was HIPAA compliant. CT dose indexes were examined at the institutional level for CT performed with a renal colic protocol at institutions that contributed at least 10 studies to the registry as of January 2013. Additionally, patients undergoing CT for renal colic at a single institution (with institutional review board approval and informed consent from prospective subjects and waiver of consent from retrospective subjects) were studied to examine individual renal colic CT dose index patterns and explore relationships between patient habitus, demographics, and dose indexes. Descriptive statistics were used to analyze dose indexes, and linear regression and Spearman correlations were used to examine relationships between dose indexes and institutional factors. Results There were 49 903 renal colic protocol CT examinations conducted at 93 institutions between May 2011 and January 2013. Mean age ± standard deviation was 49 years ± 18, and 53.9% of patients were female. Institutions contributed a median of 268 (interquartile range, 77–699) CT studies. Overall mean institutional dose-length product (DLP) was 746 mGy · cm (effective dose, 11.2 mSv), with a range of 307–1497 mGy · cm (effective dose, 4.6–22.5 mSv) for mean DLPs. Only 2% of studies were conducted with a DLP of 200 mGy · cm or lower (a “reduced dose”) (effective dose, 3 mSv), and only 10% of institutions kept DLP at 400 mGy · cm (effective dose, 6 mSv) or less in at

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

PubMed Central

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

2014-01-01

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

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

PubMed

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

2012-11-01

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

Development of an HPV Educational Protocol for Adolescents

PubMed Central

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

2007-01-01

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

A kind of universal quantum secret sharing protocol

NASA Astrophysics Data System (ADS)

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

2017-01-01

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

A kind of universal quantum secret sharing protocol.

PubMed

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

2017-01-12

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

A kind of universal quantum secret sharing protocol

PubMed Central

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

2017-01-01

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

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

PubMed Central

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

2015-01-01

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

Why standard brain-computer interface (BCI) training protocols should be changed: an experimental study

NASA Astrophysics Data System (ADS)

Jeunet, Camille; Jahanpour, Emilie; Lotte, Fabien

2016-06-01

Objective. While promising, electroencephaloraphy based brain-computer interfaces (BCIs) are barely used due to their lack of reliability: 15% to 30% of users are unable to control a BCI. Standard training protocols may be partly responsible as they do not satisfy recommendations from psychology. Our main objective was to determine in practice to what extent standard training protocols impact users’ motor imagery based BCI (MI-BCI) control performance. Approach. We performed two experiments. The first consisted in evaluating the efficiency of a standard BCI training protocol for the acquisition of non-BCI related skills in a BCI-free context, which enabled us to rule out the possible impact of BCIs on the training outcome. Thus, participants (N = 54) were asked to perform simple motor tasks. The second experiment was aimed at measuring the correlations between motor tasks and MI-BCI performance. The ten best and ten worst performers of the first study were recruited for an MI-BCI experiment during which they had to learn to perform two MI tasks. We also assessed users’ spatial ability and pre-training μ rhythm amplitude, as both have been related to MI-BCI performance in the literature. Main results. Around 17% of the participants were unable to learn to perform the motor tasks, which is close to the BCI illiteracy rate. This suggests that standard training protocols are suboptimal for skill teaching. No correlation was found between motor tasks and MI-BCI performance. However, spatial ability played an important role in MI-BCI performance. In addition, once the spatial ability covariable had been controlled for, using an ANCOVA, it appeared that participants who faced difficulty during the first experiment improved during the second while the others did not. Significance. These studies suggest that (1) standard MI-BCI training protocols are suboptimal for skill teaching, (2) spatial ability is confirmed as impacting on MI-BCI performance, and (3) when faced

Why standard brain-computer interface (BCI) training protocols should be changed: an experimental study.

PubMed

Jeunet, Camille; Jahanpour, Emilie; Lotte, Fabien

2016-06-01

While promising, electroencephaloraphy based brain-computer interfaces (BCIs) are barely used due to their lack of reliability: 15% to 30% of users are unable to control a BCI. Standard training protocols may be partly responsible as they do not satisfy recommendations from psychology. Our main objective was to determine in practice to what extent standard training protocols impact users' motor imagery based BCI (MI-BCI) control performance. We performed two experiments. The first consisted in evaluating the efficiency of a standard BCI training protocol for the acquisition of non-BCI related skills in a BCI-free context, which enabled us to rule out the possible impact of BCIs on the training outcome. Thus, participants (N = 54) were asked to perform simple motor tasks. The second experiment was aimed at measuring the correlations between motor tasks and MI-BCI performance. The ten best and ten worst performers of the first study were recruited for an MI-BCI experiment during which they had to learn to perform two MI tasks. We also assessed users' spatial ability and pre-training μ rhythm amplitude, as both have been related to MI-BCI performance in the literature. Around 17% of the participants were unable to learn to perform the motor tasks, which is close to the BCI illiteracy rate. This suggests that standard training protocols are suboptimal for skill teaching. No correlation was found between motor tasks and MI-BCI performance. However, spatial ability played an important role in MI-BCI performance. In addition, once the spatial ability covariable had been controlled for, using an ANCOVA, it appeared that participants who faced difficulty during the first experiment improved during the second while the others did not. These studies suggest that (1) standard MI-BCI training protocols are suboptimal for skill teaching, (2) spatial ability is confirmed as impacting on MI-BCI performance, and (3) when faced with difficult pre-training, subjects seemed to

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

PubMed

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

2008-06-23

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

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

PubMed

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

2013-09-13

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

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

PubMed

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

2017-04-01

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

Security of the arbitrated quantum signature protocols revisited

NASA Astrophysics Data System (ADS)

Kejia, Zhang; Dan, Li; Qi, Su

2014-01-01

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

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

PubMed

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

2011-01-01

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

The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS): a study protocol for a prospective longitudinal study.

PubMed

Fagher, Kristina; Jacobsson, Jenny; Timpka, Toomas; Dahlström, Örjan; Lexell, Jan

2016-01-01

Paralympic sport provides sporting opportunities for athletes with a disability, with the Paralympic Games as the main event. Participation in sport is, however, associated with a significant risk for sustaining injuries and illnesses. Our knowledge of sports-related injuries and illnesses in Paralympic sport is very limited and there are no large-scale epidemiological cohort studies. The purpose here is to present a protocol for a prospective longitudinal study: The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS). An argument-based method for investigation of design problems was used to structure the study protocol. The primary requirement of the protocol is to allow prospective studies over time and include exposure to both training and competition. To reflect the complexity of Paralympic sport with athletes' pre-existing impairments, use of assistive equipment, pain and other and medical issues, it is required that the data collection system is specifically adapted to Paralympic sport. To allow the collection of data, at the same time as there is limited access to coaches and medical personnel, it is advantageous that data can be collected online directly from the athletes. Based on this a self-report athlete monitoring system will be developed, where the athletes can enter data weekly via their mobile phones or lap-tops. Data will be collected from around 100 Swedish Paralympic athletes for approximately 1 year, which will allow us to i) prospectively estimate the annual incidence of sports-related injuries and illnesses and ii) explore risk factors and mechanisms for sustaining sports-related injuries and illnesses based on athlete exposure and training loads. For effective implementation of injury and illness prevention measures, comprehensive epidemiological knowledge is required. This study will be the first prospective longitudinal self-report study of sports-related injuries and illnesses in Paralympic sport over a longer period

Short Review on Quantum Key Distribution Protocols.

PubMed

Giampouris, Dimitris

2017-01-01

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

Quantum-key-distribution protocol with pseudorandom bases

NASA Astrophysics Data System (ADS)

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

2018-01-01

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

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

PubMed

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

2015-03-08

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

Effectiveness of a transdiagnostic internet-based protocol for the treatment of emotional disorders versus treatment as usual in specialized care: study protocol for a randomized controlled trial.

PubMed

González-Robles, Alberto; García-Palacios, Azucena; Baños, Rosa; Riera, Antonio; Llorca, Ginés; Traver, Francisco; Haro, Gonzalo; Palop, Vicente; Lera, Guillem; Romeu, José Enrique; Botella, Cristina

2015-10-31

Emotional disorders (depression and anxiety disorders) are highly prevalent mental health problems. Although evidence showing the effectiveness of disorder-specific treatments exists, high comorbidity rates among emotional disorders limit the utility of these protocols. This has led some researchers to focus their interest on transdiagnostic interventions, a treatment perspective that might be more widely effective across these disorders. Also, the current way of delivering treatments makes it difficult provide assistance to all of the population in need. The use of the Internet in the delivery of evidence-based treatments may help to disseminate treatments among the population. In this study, we aim to test the effectiveness of EmotionRegulation, a new transdiagnostic Internet-based protocol for unipolar mood disorders, five anxiety disorders (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder and anxiety disorder not otherwise specified), and obsessive-compulsive disorder in comparison to treatment as usual as provided in Spanish public specialized mental health care. We will also study its potential impact on basic temperament dimensions (neuroticism/behavioral inhibition and extraversion/behavioral activation). Expectations and opinions of patients about this protocol will also be studied. The study is a randomized controlled trial. 200 participants recruited in specialized care will be allocated to one of two treatment conditions: a) EmotionRegulation or b) treatment as usual. Primary outcome measures will be the BAI and the BDI-II. Secondary outcomes will include a specific measure of the principal disorder, and measures of neuroticism/behavioral inhibition and extraversion/behavioral activation. Patients will be assessed at baseline, post-treatment, and 3- and 12-month follow-ups. Intention to treat and per protocol analyses will be performed. Although the effectiveness of face-to-face transdiagnostic protocols has been

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

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

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

2006-07-01

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

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…

The Robinson Protocol: a treadmill anaerobic performance test.

PubMed

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

2004-08-01

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

Secondary cancers among children with acute lymphoblastic leukaemia treated by the Tokyo Children's Cancer Study Group protocols: a retrospective cohort study.

PubMed

Ishida, Yasushi; Maeda, Miho; Urayama, Kevin Y; Kiyotani, Chikako; Aoki, Yuki; Kato, Yoko; Goto, Shoko; Sakaguchi, Sachi; Sugita, Kenichi; Tokuyama, Mika; Nakadate, Naoya; Ishii, Eizaburo; Tsuchida, Masahiro; Ohara, Akira

2014-01-01

With improvement in survival, it is important to evaluate the impact of treatment on secondary cancers in acute lymphoblastic leukaemia (ALL) survivors. A retrospective cohort study comprising 2918 children diagnosed with ALL and enrolled on Tokyo Children's Cancer Study Group (TCCSG) protocols between 1984 and 2005 was conducted to evaluate the incidence of secondary cancers and associated factors including treatment protocol, cranial irradiation and other characteristics of the primary ALL. Thirty-seven patients developed secondary cancers, including acute myeloid leukaemia (n = 11), myelodysplastic syndrome (n = 5), non-Hodgkin lymphoma (n = 2), brain tumours (n = 13) and other solid carcinomas (n = 6) within a median follow-up duration of 9·5 years. The cumulative incidence of any secondary cancers was 1·0% (95% confidence interval (CI), 0·7-1·4%) at 10 years and 2·4% (95% CI, 1·5-3·7%) at 20 years, respectively. Standardized incidence rate ratio of secondary cancers was 9·3 (95% CI, 6·5-12·8). Multivariate analyses showed an increased risk of secondary cancers associated with the recent treatment protocol and cranial irradiation. There was no evidence of a reduction in secondary cancer incidence despite marked decreases in cranial irradiation use in the recent protocols. © 2013 John Wiley & Sons Ltd.

Entanglement distillation protocols and number theory

NASA Astrophysics Data System (ADS)

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

2005-09-01

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

Salivary Cortisol Protocol Adherence and Reliability by Sociodemographic Features: the Multi-Ethnic Study of Atherosclerosis

PubMed Central

Golden, Sherita Hill; Sánchez, Brisa N.; DeSantis, Amy S.; Wu, Meihua; Castro, Cecilia; Seeman, Teresa E.; Tadros, Sameh; Shrager, Sandi; Diez Roux, Ana V.

2014-01-01

Collection of salivary cortisol has become increasingly popular in large population-based studies. However, the impact of protocol compliance on day-to-day reliabilities of measures, and the extent to which reliabilities differ systematically according to socio-demographic characteristics, has not been well characterized in large-scale population-based studies to date. Using data on 935 men and women from the Multi-ethnic Study of Atherosclerosis, we investigated whether sampling protocol compliance differs systematically according to socio-demographic factors and whether compliance was associated with cortisol estimates, as well as whether associations of cortisol with both compliance and socio-demographic characteristics were robust to adjustments for one another. We further assessed the day-to-day reliability for cortisol features and the extent to which reliabilities vary according to socio-demographic factors and sampling protocol compliance. Overall, we found higher compliance among persons with higher levels of income and education. Lower compliance was significantly associated with a less pronounced cortisol awakening response (CAR) but was not associated with any other cortisol features, and adjustment for compliance did not affect associations of socio-demographic characteristics with cortisol. Reliability was higher for area under the curve (AUC) and wake up values than for other features, but generally did not vary according to socio-demographic characteristics, with few exceptions. Our findings regarding intra-class correlation coefficients (ICCs) support prior research indicating that multiple day collection is preferable to single day collection, particularly for CAR and slopes, more so than wakeup and AUC. There were few differences in reliability by socio-demographic characteristics. Thus, it is unlikely that group-specific sampling protocols are warranted. PMID:24703168

Recommended Protocol for Round Robin Studies in Additive Manufacturing

PubMed Central

Moylan, Shawn; Brown, Christopher U.; Slotwinski, John

2016-01-01

One way to improve confidence and encourage proliferation of additive manufacturing (AM) technologies and parts is by generating more high quality data describing the performance of AM processes and parts. Many in the AM community see round robin studies as a way to generate large data sets while distributing the cost among the participants, thereby reducing the cost to individual users. The National Institute of Standards and Technology (NIST) has conducted and participated in several of these AM round robin studies. While the results of these studies are interesting and informative, many of the lessons learned in conducting these studies concern the logistics and methods of the study and unique issues presented by AM. Existing standards for conducting interlaboratory studies of measurement methods, along with NIST’s experience, form the basis for recommended protocols for conducting AM round robin studies. The role of round robin studies in AM qualification, some of the limitations of round robin studies, and the potential benefit of less formal collaborative experiments where multiple factors, AM machine being only one, are varied simultaneously are also discussed. PMID:27274602

Recommended Protocol for Round Robin Studies in Additive Manufacturing.

PubMed

Moylan, Shawn; Brown, Christopher U; Slotwinski, John

2016-03-01

One way to improve confidence and encourage proliferation of additive manufacturing (AM) technologies and parts is by generating more high quality data describing the performance of AM processes and parts. Many in the AM community see round robin studies as a way to generate large data sets while distributing the cost among the participants, thereby reducing the cost to individual users. The National Institute of Standards and Technology (NIST) has conducted and participated in several of these AM round robin studies. While the results of these studies are interesting and informative, many of the lessons learned in conducting these studies concern the logistics and methods of the study and unique issues presented by AM. Existing standards for conducting interlaboratory studies of measurement methods, along with NIST's experience, form the basis for recommended protocols for conducting AM round robin studies. The role of round robin studies in AM qualification, some of the limitations of round robin studies, and the potential benefit of less formal collaborative experiments where multiple factors, AM machine being only one, are varied simultaneously are also discussed.

Game-theoretic perspective of Ping-Pong protocol

NASA Astrophysics Data System (ADS)

Kaur, Hargeet; Kumar, Atul

2018-01-01

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

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

PubMed Central

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

2008-01-01

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

An Outcomes Study on the Effects of the Singapore General Hospital Burns Protocol.

PubMed

Liang, Weihao; Kok, Yee Onn; Tan, Bien Keem; Chong, Si Jack

2018-01-01

The Singapore General Hospital Burns Protocol was implemented in May 2014 to standardize treatment for all burns patients, incorporate new techniques and materials, and streamline the processes and workflow of burns management. This study aims to analyze the effects of the Burns Protocol 2 years after its implementation. Using a REDCap electronic database, all burns patients admitted from May 2013 to April 2016 were included in the study. The historical preimplementation control group composed of patients admitted from May 2013 to April 2014 (n = 96). The postimplementation prospective study cohort consisted of patients admitted from May 2014 to April 2016 (n = 243). Details of the patients collected included age, sex, comorbidities, total body surface area (TBSA) burns, time until surgery, number of surgeries, number of positive tissue and blood cultures, and length of hospital stay. There was no statistically significant difference in the demographics of both groups. The study group had a statistically significant shorter time to surgery compared with the control group (20.8 vs 38.1, P < 0.0001). The study group also averaged fewer surgeries performed (1.96 vs 2.29, P = 0.285), which, after accounting for the extent of burns, was statistically significant (number of surgeries/TBSA, 0.324 vs 0.506; P = 0.0499). The study group also had significantly shorter length of stay (12.5 vs 16.8, P = 0.0273), a shorter length of stay/TBSA burns (0.874 vs 1.342, P = 0.0101), and fewer positive tissue cultures (0.6 vs 1.3, P = 0.0003). The study group also trended toward fewer positive blood culture results (0.09 vs 0.35, P = 0.0593), although the difference was just shy of statistical significance. The new Singapore General Hospital Burns Protocol had revolutionized Singapore burns care by introducing a streamlined, multidisciplinary burns management, resulting in improved patient outcomes, lowered health care costs, and improved system resource use.

Continuous sweep versus discrete step protocols for studying effects of wearable robot assistance magnitude.

PubMed

Malcolm, Philippe; Rossi, Denise Martineli; Siviy, Christopher; Lee, Sangjun; Quinlivan, Brendan Thomas; Grimmer, Martin; Walsh, Conor J

2017-07-12

Different groups developed wearable robots for walking assistance, but there is still a need for methods to quickly tune actuation parameters for each robot and population or sometimes even for individual users. Protocols where parameters are held constant for multiple minutes have traditionally been used for evaluating responses to parameter changes such as metabolic rate or walking symmetry. However, these discrete protocols are time-consuming. Recently, protocols have been proposed where a parameter is changed in a continuous way. The aim of the present study was to compare effects of continuously varying assistance magnitude with a soft exosuit against discrete step conditions. Seven participants walked on a treadmill wearing a soft exosuit that assists plantarflexion and hip flexion. In Continuous-up, peak exosuit ankle moment linearly increased from approximately 0 to 38% of biological moment over 10 min. Continuous-down was the opposite. In Discrete, participants underwent five periods of 5 min with steady peak moment levels distributed over the same range as Continuous-up and Continuous-down. We calculated metabolic rate for the entire Continuous-up and Continuous-down conditions and the last 2 min of each Discrete force level. We compared kinematics, kinetics and metabolic rate between conditions by curve fitting versus peak moment. Reduction in metabolic rate compared to Powered-off was smaller in Continuous-up than in Continuous-down at most peak moment levels, due to physiological dynamics causing metabolic measurements in Continuous-up and Continuous-down to lag behind the values expected during steady-state testing. When evaluating the average slope of metabolic reduction over the entire peak moment range there was no significant difference between Continuous-down and Discrete. Attempting to correct the lag in metabolics by taking the average of Continuous-up and Continuous-down removed all significant differences versus Discrete. For kinematic and

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

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

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

2015-02-01

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

Establishment and optimization of NMR-based cell metabonomics study protocols for neonatal Sprague-Dawley rat cardiomyocytes.

PubMed

Zhang, Ming; Sun, Bo; Zhang, Qi; Gao, Rong; Liu, Qiao; Dong, Fangting; Fang, Haiqin; Peng, Shuangqing; Li, Famei; Yan, Xianzhong

2017-01-15

A quenching, harvesting, and extraction protocol was optimized for cardiomyocytes NMR metabonomics analysis in this study. Trypsin treatment and direct scraping cells in acetonitrile were compared for sample harvesting. The results showed trypsin treatment cause normalized concentration increasing of phosphocholine and metabolites leakage, since the trypsin-induced membrane broken and long term harvesting procedures. Then the intracellular metabolite extraction efficiency of methanol and acetonitrile were compared. As a result, washing twice with phosphate buffer, direct scraping cells and extracting with acetonitrile were chosen to prepare cardiomyocytes extracts samples for metabonomics studies. This optimized protocol is rapid, effective, and exhibits greater metabolite retention. Copyright © 2016 Elsevier Inc. All rights reserved.

Alternative parallel ring protocols

NASA Technical Reports Server (NTRS)

Mukkamala, R.; Foudriat, E. C.; Maly, Kurt J.; Kale, V.

1990-01-01

Communication protocols are know to influence the utilization and performance of communication network. The effect of two token ring protocols on a gigabit network with multiple ring structure is investigated. In the first protocol, a mode sends at most one message on receiving a token. In the second protocol, a mode sends all the waiting messages when a token is received. The behavior of these protocols is shown to be highly dependent on the number of rings as well as the load in the network.

THE MASTER PROTOCOL CONCEPT

PubMed Central

Allegra, Carmen J.

2015-01-01

During the past decade, biomedical technologies have undergone an explosive evolution---from the publication of the first complete human genome in 2003, after more than a decade of effort and at a cost of hundreds of millions of dollars---to the present time, where a complete genomic sequence can be available in less than a day and at a small fraction of the cost of the original sequence. The widespread availability of next generation genomic sequencing has opened the door to the development of precision oncology. The need to test multiple new targeted agents both alone and in combination with other targeted therapies, as well as classic cytotoxic agents, demand the development of novel therapeutic platforms (particularly Master Protocols) capable of efficiently and effectively testing multiple targeted agents or targeted therapeutic strategies in relatively small patient subpopulations. Here, we describe the Master Protocol concept, with a focus on the expected gains and complexities of the use of this design. An overview of Master Protocols currently active or in development is provided along with a more extensive discussion of the Lung Master Protocol (Lung-MAP study). PMID:26433553

Communications protocol

NASA Technical Reports Server (NTRS)

Zhou, Xiaoming (Inventor); Baras, John S. (Inventor)

2010-01-01

The present invention relates to an improved communications protocol which increases the efficiency of transmission in return channels on a multi-channel slotted Alohas system by incorporating advanced error correction algorithms, selective retransmission protocols and the use of reserved channels to satisfy the retransmission requests.

Reliable broadcast protocols

NASA Technical Reports Server (NTRS)

Joseph, T. A.; Birman, Kenneth P.

1989-01-01

A number of broadcast protocols that are reliable subject to a variety of ordering and delivery guarantees are considered. Developing applications that are distributed over a number of sites and/or must tolerate the failures of some of them becomes a considerably simpler task when such protocols are available for communication. Without such protocols the kinds of distributed applications that can reasonably be built will have a very limited scope. As the trend towards distribution and decentralization continues, it will not be surprising if reliable broadcast protocols have the same role in distributed operating systems of the future that message passing mechanisms have in the operating systems of today. On the other hand, the problems of engineering such a system remain large. For example, deciding which protocol is the most appropriate to use in a certain situation or how to balance the latency-communication-storage costs is not an easy question.

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

PubMed

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

2015-03-01

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

Guidelines and sample protocol for sampling forest gaps.

Treesearch

J.R. Runkle

1992-01-01

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

Translating evidence-based protocol of wound drain management for total joint arthroplasty into practice: A quasi-experimental study.

PubMed

Tsang, Lap Fung; Cheng, Hang Cheong; Ho, Hon Shuen; Hsu, Yung Chak; Chow, Chiu Man; Law, Heung Wah; Fong, Lup Chau; Leung, Lok Ming; Kong, Ivy Ching Yan; Chan, Chi Wai; Sham, Alice So Yuen

2016-05-01

Although various drains have long been used in total joint replacement, evidence suggests inconsistent practice exists in the use of drainage systems including intermittently applying suction or free of drainage suction, and variations in the optimal timing for wound drain removal. A comprehensive systematic review of available evidence up to 2013 was conducted in a previous study and a protocol was adapted for clinical application according to the summary of the retrieved information (Tsang, 2015). To determine if the protocol could reduce blood loss and blood transfusion after operation and to develop a record form so as to enhance communication of drainage record amongst surgeons and nurses. A quasi-experimental time-series design was undertaken. In the conventional group, surgeons ordered free drainage if the drain output was more than 300 ml. The time of removal of the drain was based on their professional judgement. In the protocol group the method of drainage was dependant of the drainage output as was the timing of the removal of the drain. A standardized record form was developed to guide operating room and orthopaedic ward nurses to manage the drainage system. The drain was removed significantly earlier in the protocol group. Blood loss rate at the first hour of post-operation was extremely low in the protocol group due to clamping effect. Blood loss in volume during the first three hours in the protocol group was significantly lower than that in the conventional group. Only in 11.1% and 4% of cases was it necessary to clamp at the three and four hour post-operative hours. No clamping was required at the two and eight hour postoperative period. There was no significant difference in blood loss during the removal of the drain and during blood transfusion, which was required for patients upon removal of the drain in the two groups. This is the first clinical study to develop an evidence-based protocol to manage wound drain effectively in Hong Kong. Total

Automating Security Protocol Analysis

DTIC Science & Technology

2004-03-01

language that allows easy representation of pattern interaction. Using CSP, Lowe tests whether a protocol achieves authentication. In the case of...only to correctly code whatever protocol they intend to evaluate. The tool, OCaml 3.04 [1], translates the protocol into Horn clauses and then...model protocol transactions. One example of automated modeling software is Maude [19]. Maude was the intended language for this research, but Java

Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol

PubMed Central

Agot, Kawango

2017-01-01

Background Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. Objective The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. Methods The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. Results The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3

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

USGS Publications Warehouse

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

2009-01-01

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

DDN (Defense Data Network) Protocol Handbook. Volume 1. DoD Military Standard Protocols

DTIC Science & Technology

1985-12-01

official Military Standard communication protocols in use on the DDN are included, as are several ARPANET (Advanced Research Projects Agency Network... research protocols which are currently in use, and some protocols currently undergoing review. Tutorial information and auxiliary documents are also...compatible with DoD needs, by researchers wishing to improve the protocols, and by impleroentors of local area networks (LANs) wishing their

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

PubMed Central

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

2018-01-01

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

Systematic Review Protocol to Assess the Effectiveness of Usability Questionnaires in mHealth App Studies

PubMed Central

Bao, Jie; Parmanto, Bambang

2017-01-01

Background Usability questionnaires have a wide use in mobile health (mHealth) app usability studies. However, no systematic review has been conducted for assessing the effectiveness of these questionnaires. Objective This paper describes a protocol for conducting a systematic review of published questionnaire-based mHealth app usability studies. Methods In this systematic review, we will select recently published (2008-2017) articles from peer-reviewed journals and conferences that describe mHealth app usability studies and implement at least one usability questionnaire. The search strategy will include terms such as “mobile app” and “usability.” Multiple databases such as PubMed, CINAHL, IEEE Xplore, ACM Digital Library, and INSPEC will be searched. There will be 2 independent reviewers in charge of screening titles and abstracts as well as determining those articles that should be included for a full-text review. The third reviewer will act as a mediator between the other 2 reviewers. Moreover, a data extraction form will be created and used during the full article data analysis. Notably, the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines will be followed in reporting this protocol. Results A preliminary search produced 1271 articles, 40 of which are duplicate records. The inclusion-exclusion criteria are being strictly followed in performing the ongoing study selection. Conclusions Usability questionnaires are an important tool in mHealth app usability studies. This review will summarize the usability questionnaires used in published research articles while assessing the efficacy of these questionnaires in determining the usability of mHealth apps. PMID:28765101

Using salivary cortisol to measure the effects of a Wilbarger protocol-based procedure on sympathetic arousal: a pilot study.

PubMed

Kimball, Judith G; Lynch, Keara M; Stewart, Kelli C; Williams, Nicole E; Thomas, Meghan A; Atwood, Kam D

2007-01-01

This study investigated changes in salivary cortisol, the stress hormone, after administration of a procedure based on the Wilbarger protocol to children diagnosed with sensory defensiveness (SD), a type of sensory modulation dysfunction. Using a single-subject design across participants, we studied 4 boys with SD ages 3 to 5 years. Each participant completed four sessions consisting of the collection of a saliva sample, administration of a procedure based on the Wilbarger protocol, 15 min of quiet neutral activities to allow time for any changes in cortisol level to manifest in the saliva, and the second collection of saliva. Saliva samples were analyzed using enzyme-linked immunosorbent assay (ELISA). Salivary cortisol levels in all participants changed after each of four applications of a procedure based on the Wilbarger protocol. The cortisol levels of 2 children whose levels were relatively higher on pretest decreased at each posttest. The levels of 1 child whose cortisol was higher on pretest three times decreased those three times and increased the one time the pretest cortisol was lower. The levels of 1 child who had the lowest cortisol levels of any of the children increased each time. Therefore, in all participants, cortisol moved in the direction of modulation. In these 4 boys, a procedure based on the Wilbarger protocol modulated cortisol levels toward a middle range. This pilot study indicates that there is an association between sympathetic nervous system response and the Wilbarger protocol-based procedure, as indicated by salivary cortisol levels.

Protocol for a Delay-Tolerant Data-Communication Network

NASA Technical Reports Server (NTRS)

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

2004-01-01

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

IoT real time data acquisition using MQTT protocol

NASA Astrophysics Data System (ADS)

Atmoko, R. A.; Riantini, R.; Hasin, M. K.

2017-05-01

The Internet of Things (IoT) provides ease to monitor and to gain sensor data through the Internet [1]. The need of high quality data is increasing to the extent that data monitoring and acquisition system in real time is required, such as smart city or telediagnostic in medical areas [2]. Therefore, an appropriate communication protocol is required to resolve these problems. Lately, researchers have developed a lot of communication protocols for IoT, of which each has advantages and disadvantages. This study proposes the utilization of MQTT as a communication protocol, which is one of data communication protocols for IoT. This study used temperature and humidity sensors because the physical parameters are often needed as parameters of environment condition [3]. Data acquisition was done in real-time and stored in MySQL database. This study is also completed by interface web-based and mobile for online monitoring. This result of this study is the enhancement of data quality and reliability using MQTT protocol.

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

PubMed

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

2014-01-01

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

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

PubMed Central

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

2008-01-01

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

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

PubMed Central

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

2017-01-01

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

Gender-Specific Combination HIV Prevention for Youth in High-Burden Settings: The MP3 Youth Observational Pilot Study Protocol.

PubMed

Buttolph, Jasmine; Inwani, Irene; Agot, Kawango; Cleland, Charles M; Cherutich, Peter; Kiarie, James N; Osoti, Alfred; Celum, Connie L; Baeten, Jared M; Nduati, Ruth; Kinuthia, John; Hallett, Timothy B; Alsallaq, Ramzi; Kurth, Ann E

2017-03-08

Nearly three decades into the epidemic, sub-Saharan Africa (SSA) remains the region most heavily affected by human immunodeficiency virus (HIV), with nearly 70% of the 34 million people living with HIV globally residing in the region. In SSA, female and male youth (15 to 24 years) are at a disproportionately high risk of HIV infection compared to adults. As such, there is a need to target HIV prevention strategies to youth and to tailor them to a gender-specific context. This protocol describes the process for the multi-staged approach in the design of the MP3 Youth pilot study, a gender-specific, combination, HIV prevention intervention for youth in Kenya. The objective of this multi-method protocol is to outline a rigorous and replicable methodology for a gender-specific combination HIV prevention pilot study for youth in high-burden settings, illustrating the triangulated methods undertaken to ensure that age, sex, and context are integral in the design of the intervention. The mixed-methods, cross-sectional, longitudinal cohort pilot study protocol was developed by first conducting a systematic review of the literature, which shaped focus group discussions around prevention package and delivery options, and that also informed age- and sex- stratified mathematical modeling. The review, qualitative data, and mathematical modeling created a triangulated evidence base of interventions to be included in the pilot study protocol. To design the pilot study protocol, we convened an expert panel to select HIV prevention interventions effective for youth in SSA, which will be offered in a mobile health setting. The goal of the pilot study implementation and evaluation is to apply lessons learned to more effective HIV prevention evidence and programming. The combination HIV prevention package in this protocol includes (1) offering HIV testing and counseling for all youth; (2) voluntary medical circumcision and condoms for males; (3) pre-exposure prophylaxis (Pr

Efficient decentralized consensus protocols

NASA Technical Reports Server (NTRS)

Lakshman, T. V.; Agrawala, A. K.

1986-01-01

Decentralized consensus protocols are characterized by successive rounds of message interchanges. Protocols which achieve a consensus in one round of message interchange require O(N-squared) messages, where N is the number of participants. In this paper, a communication scheme, based on finite projective planes, which requires only O(N sq rt N) messages for each round is presented. Using this communication scheme, decentralized consensus protocols which achieve a consensus within two rounds of message interchange are developed. The protocols are symmetric, and the communication scheme does not impose any hierarchical structure. The scheme is illustrated using blocking and nonblocking commit protocols, decentralized extrema finding, and computation of the sum function.

Effect of different analyte diffusion/adsorption protocols on SERS signals

NASA Astrophysics Data System (ADS)

Li, Ruoping; Petschek, Rolfe G.; Han, Junhe; Huang, Mingju

2018-07-01

The effect of different analyte diffusion/adsorption protocols was studied which is often overlooked in surface-enhanced Raman scattering (SERS) technique. Three protocols: highly concentrated dilution (HCD) protocol, half-half dilution (HHD) protocol and layered adsorption (LA) protocol were studied and the SERS substrates were monolayer films of 80 nm Ag nanoparticles (NPs) which were modified by polyvinylpyrrolidone. The diffusion/adsorption mechanisms were modelled using the diffusion equation and the electromagnetic field distribution of two adjacent Ag NPs was simulated by the finite-different time-domain method. All experimental data and theoretical analysis suggest that different diffusion/adsorption behaviour of analytes will cause different SERS signal enhancements. HHD protocol could produce the most uniform and reproducible samples, and the corresponding signal intensity of the analyte is the strongest. This study will help to understand and promote the use of SERS technique in quantitative analysis.

Satellite Communications Using Commercial Protocols

NASA Technical Reports Server (NTRS)

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

2000-01-01

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

COGNITIVE-HD study: protocol of an observational study of neurocognitive functioning and association with clinical outcomes in adults with end-stage kidney disease treated with haemodialysis.

PubMed

Palmer, Suetonia C; Ruospo, Marinella; Barulli, Maria Rosaria; Iurillo, Annalisa; Saglimbene, Valeria; Natale, Patrizia; Gargano, Letizia; Murgo, Angelo M; Loy, Clement; van Zwieten, Anita; Wong, Germaine; Tortelli, Rosanna; Craig, Jonathan C; Johnson, David W; Tonelli, Marcello; Hegbrant, Jörgen; Wollheim, Charlotta; Logroscino, Giancarlo; Strippoli, G F M

2015-12-09

The prevalence of cognitive impairment may be increased in adults with end-stage kidney disease compared with the general population. However, the specific patterns of cognitive impairment and association of cognitive dysfunction with activities of daily living and clinical outcomes (including withdrawal from treatment) among haemodialysis patients remain incompletely understood. The COGNITIVE impairment in adults with end-stage kidney disease treated with HemoDialysis (COGNITIVE-HD) study aims to characterise the age-adjusted and education-adjusted patterns of cognitive impairment (using comprehensive testing for executive function, perceptual-motor function, language, learning and memory, and complex attention) in patients on haemodialysis and association with clinical outcomes. A prospective, longitudinal, cohort study of 750 adults with end-stage kidney disease treated with long-term haemodialysis has been recruited within haemodialysis centres in Italy (July 2013 to April 2014). Testing for neurocognitive function was carried out by a trained psychologist at baseline to assess cognitive functioning. The primary study factor is cognitive impairment and secondary study factors will be specific domains of cognitive function. The primary outcome will be total mortality. Secondary outcomes will be cause-specific mortality, major cardiovascular events, fatal and non-fatal myocardial infarction and stroke, institutionalisation, and withdrawal from treatment at 12 months. This protocol was approved before study conduct by the following responsible ethics committees: Catania (approval reference 186/BE; 26/09/2013), Agrigento (protocol numbers 61-62; 28/6/2013), USL Roma C (CE 39217; 24/6/2013), USL Roma F (protocol number 0041708; 23/7/2013), USL Latina (protocol number 20090/A001/2011; 12/7/2013), Trapani (protocol number 3413; 16/7/2013) and Brindisi (protocol number 40259; 6/6/2013). All participants have provided written and informed consent and can withdraw from

Reproductive studies with the anti-inflammatory agent, piroxicam: modification of classical protocols.

PubMed

Perraud, J; Stadler, J; Kessedjian, M J; Monro, A M

1984-02-14

Reproductive toxicology studies were conducted in rabbits and rats given piroxicam, a non-steroidal anti-inflammatory agent (NSAI), orally at 2, 5 and 10 mg/kg/day. In teratology studies there was neither drug-related embryotoxicity nor teratogenicity. As piroxicam, like other NSAI, affects parturition in rats and leads to a progressive toxicity in lactating females, standard protocols were modified: dams of the female fertility study were treated from 2 weeks prior to mating until day 6 of gestation and females of the post-natal toxicity study were treated from parturition until day 12 of lactation. No other adverse effects on reproduction, fertility and postnatal development were observed.

Benchmarking pediatric cranial CT protocols using a dose tracking software system: a multicenter study.

PubMed

De Bondt, Timo; Mulkens, Tom; Zanca, Federica; Pyfferoen, Lotte; Casselman, Jan W; Parizel, Paul M

2017-02-01

To benchmark regional standard practice for paediatric cranial CT-procedures in terms of radiation dose and acquisition parameters. Paediatric cranial CT-data were retrospectively collected during a 1-year period, in 3 different hospitals of the same country. A dose tracking system was used to automatically gather information. Dose (CTDI and DLP), scan length, amount of retakes and demographic data were stratified by age and clinical indication; appropriate use of child-specific protocols was assessed. In total, 296 paediatric cranial CT-procedures were collected. Although the median dose of each hospital was below national and international diagnostic reference level (DRL) for all age categories, statistically significant (p-value < 0.001) dose differences among hospitals were observed. The hospital with lowest dose levels showed smallest dose variability and used age-stratified protocols for standardizing paediatric head exams. Erroneous selection of adult protocols for children still occurred, mostly in the oldest age-group. Even though all hospitals complied with national and international DRLs, dose tracking and benchmarking showed that further dose optimization and standardization is possible by using age-stratified protocols for paediatric cranial CT. Moreover, having a dose tracking system revealed that adult protocols are still applied for paediatric CT, a practice that must be avoided. • Significant differences were observed in the delivered dose between age-groups and hospitals. • Using age-adapted scanning protocols gives a nearly linear dose increase. • Sharing dose-data can be a trigger for hospitals to reduce dose levels.

Application of a motivation-behavioral skills protocol in gingival lichen planus: a short-term study.

PubMed

López-Jornet, Pia; Camacho-Alonso, Fabio

2010-10-01

The main objective of the present study was to assess the efficacy of a motivation–behavioral skills protocol for plaque control in patients with gingival lichen planus. A pre- and post-test descriptive clinical study was made of 40 consecutive white patients with gingival lichen planus: five males (12.5%) and 35 females (87.5%); mean age: 57 years. A motivation–behavioral skills protocol for oral hygiene was applied, with the determination of gingival scores (gingival index, plaque extension, and Community Periodontal Index of Treatment Needs [CPITN]) and patient evaluation after 4 and 8 weeks. The clinical parameters in relation to the different forms of gingival lichen planus showed statistically significant improvements for gingival index, plaque extension, and CPITN (P <0.001) as determined 4 and 8 weeks after starting the program. The application of an active prevention program in patients with gingival lichen planus is important because it offers benefits for periodontal health. However, more long-term studies are needed to confirm the results obtained.

A Family of Quantum Protocols

NASA Astrophysics Data System (ADS)

Devetak, Igor; Harrow, Aram W.; Winter, Andreas

2004-12-01

We introduce three new quantum protocols involving noisy quantum channels and entangled states, and relate them operationally and conceptually with four well-known old protocols. Two of the new protocols (the mother and father) can generate the other five “child” protocols by direct application of teleportation and superdense coding, and can be derived in turn by making the old protocols “coherent.” This gives very simple proofs for two famous old protocols (the hashing inequality and quantum channel capacity) and provides the basis for optimal trade-off curves in several quantum information processing tasks.

Protocol to Exploit Waiting Resources for UASNs.

PubMed

Hung, Li-Ling; Luo, Yung-Jeng

2016-03-08

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

Breaking Megrelishvili protocol using matrix diagonalization

NASA Astrophysics Data System (ADS)

Arzaki, Muhammad; Triantoro Murdiansyah, Danang; Adi Prabowo, Satrio

2018-03-01

In this article we conduct a theoretical security analysis of Megrelishvili protocol—a linear algebra-based key agreement between two participants. We study the computational complexity of Megrelishvili vector-matrix problem (MVMP) as a mathematical problem that strongly relates to the security of Megrelishvili protocol. In particular, we investigate the asymptotic upper bounds for the running time and memory requirement of the MVMP that involves diagonalizable public matrix. Specifically, we devise a diagonalization method for solving the MVMP that is asymptotically faster than all of the previously existing algorithms. We also found an important counterintuitive result: the utilization of primitive matrix in Megrelishvili protocol makes the protocol more vulnerable to attacks.

Optimizing protocols for risk prediction in asymptomatic carotid stenosis using embolic signal detection: the Asymptomatic Carotid Emboli Study.

PubMed

King, Alice; Shipley, Martin; Markus, Hugh

2011-10-01

Improved methods are required to identify patients with asymptomatic carotid stenosis at high risk for stroke. The Asymptomatic Carotid Emboli Study recently showed embolic signals (ES) detected by transcranial Doppler on 2 recordings that lasted 1-hour independently predict 2-year stroke risk. ES detection is time-consuming, and whether similar predictive information could be obtained from simpler recording protocols is unknown. In a predefined secondary analysis of Asymptomatic Carotid Emboli Study, we looked at the temporal variation of ES. We determined the predictive yield associated with different recording protocols and with the use of a higher threshold to indicate increased risk (≥2 ES). To compare the different recording protocols, sensitivity and specificity analyses were performed using analysis of receiver-operator characteristic curves. Of 477 patients, 467 had baseline recordings adequate for analysis; 77 of these had ES on 1 or both of the 2 recordings. ES status on the 2 recordings was significantly associated (P<0.0001), but there was poor agreement between ES positivity on the 2 recordings (κ=0.266). For the primary outcome of ipsilateral stroke or transient ischemic attack, the use of 2 baseline recordings lasting 1 hour had greater predictive accuracy than either the first baseline recording alone (P=0.0005), a single 30-minute (P<0.0001) recording, or 2 recordings lasting 30 minutes (P<0.0001). For the outcome of ipsilateral stroke alone, two recordings lasting 1 hour had greater predictive accuracy when compared to all other recording protocols (all P<0.0001). Our analysis demonstrates the relative predictive yield of different recording protocols that can be used in application of the technique in clinical practice. Two baseline recordings lasting 1 hour as used in Asymptomatic Carotid Emboli Study gave the best risk prediction.

Health care access for rural youth on equal terms? A mixed methods study protocol in northern Sweden.

PubMed

Goicolea, Isabel; Carson, Dean; San Sebastian, Miguel; Christianson, Monica; Wiklund, Maria; Hurtig, Anna-Karin

2018-01-11

The purpose of this paper is to propose a protocol for researching the impact of rural youth health service strategies on health care access. There has been no published comprehensive assessment of the effectiveness of youth health strategies in rural areas, and there is no clearly articulated model of how such assessments might be conducted. The protocol described here aims to gather information to; i) Assess rural youth access to health care according to their needs, ii) Identify and understand the strategies developed in rural areas to promote youth access to health care, and iii) Propose actions for further improvement. The protocol is described with particular reference to research being undertaken in the four northernmost counties of Sweden, which contain a widely dispersed and diverse youth population. The protocol proposes qualitative and quantitative methodologies sequentially in four phases. First, to map youth access to health care according to their health care needs, including assessing horizontal equity (equal use of health care for equivalent health needs,) and vertical equity (people with greater health needs should receive more health care than those with lesser needs). Second, a multiple case study design investigates strategies developed across the region (youth clinics, internet applications, public health programs) to improve youth access to health care. Third, qualitative comparative analysis of the 24 rural municipalities in the region identifies the best combination of conditions leading to high youth access to health care. Fourth, a concept mapping study involving rural stakeholders, care providers and youth provides recommended actions to improve rural youth access to health care. The implementation of this research protocol will contribute to 1) generating knowledge that could contribute to strengthening rural youth access to health care, as well as to 2) advancing the application of mixed methods to explore access to health care.

A robust ECC based mutual authentication protocol with anonymity for session initiation protocol.

PubMed

Mehmood, Zahid; Chen, Gongliang; Li, Jianhua; Li, Linsen; Alzahrani, Bander

2017-01-01

Over the past few years, Session Initiation Protocol (SIP) is found as a substantial application-layer protocol for the multimedia services. It is extensively used for managing, altering, terminating and distributing the multimedia sessions. Authentication plays a pivotal role in SIP environment. Currently, Lu et al. presented an authentication protocol for SIP and profess that newly proposed protocol is protected against all the familiar attacks. However, the detailed analysis describes that the Lu et al.'s protocol is exposed against server masquerading attack and user's masquerading attack. Moreover, it also fails to protect the user's identity as well as it possesses incorrect login and authentication phase. In order to establish a suitable and efficient protocol, having ability to overcome all these discrepancies, a robust ECC-based novel mutual authentication mechanism with anonymity for SIP is presented in this manuscript. The improved protocol contains an explicit parameter for user to cope the issues of security and correctness and is found to be more secure and relatively effective to protect the user's privacy, user's masquerading and server masquerading as it is verified through the comprehensive formal and informal security analysis.

A protocol for isolating insect mitochondrial genomes: a case study of NUMT in Melipona flavolineata (Hymenoptera: Apidae).

PubMed

Françoso, Elaine; Gomes, Fernando; Arias, Maria Cristina

2016-07-01

Nuclear mitochondrial DNA insertions (NUMTs) are mitochondrial DNA sequences that have been transferred into the nucleus and are recognized by the presence of indels and stop codons. Although NUMTs have been identified in a diverse range of species, their discovery was frequently accidental. Here, our initial goal was to develop and standardize a simple method for isolating NUMTs from the nuclear genome of a single bee. Subsequently, we tested our new protocol by determining whether the indels and stop codons of the cytochrome c oxidase subunit I (COI) sequence of Melipona flavolineata are of nuclear origin. The new protocol successfully demonstrated the presence of a COI NUMT. In addition to NUMT investigations, the protocol described here will also be very useful for studying mitochondrial mutations related to diseases and for sequencing complete mitochondrial genomes with high read coverage by Next-Generation technology.

Eliciting improved quantitative judgements using the IDEA protocol: A case study in natural resource management.

PubMed

Hemming, Victoria; Walshe, Terry V; Hanea, Anca M; Fidler, Fiona; Burgman, Mark A

2018-01-01

Natural resource management uses expert judgement to estimate facts that inform important decisions. Unfortunately, expert judgement is often derived by informal and largely untested protocols, despite evidence that the quality of judgements can be improved with structured approaches. We attribute the lack of uptake of structured protocols to the dearth of illustrative examples that demonstrate how they can be applied within pressing time and resource constraints, while also improving judgements. In this paper, we demonstrate how the IDEA protocol for structured expert elicitation may be deployed to overcome operational challenges while improving the quality of judgements. The protocol was applied to the estimation of 14 future abiotic and biotic events on the Great Barrier Reef, Australia. Seventy-six participants with varying levels of expertise related to the Great Barrier Reef were recruited and allocated randomly to eight groups. Each participant provided their judgements using the four-step question format of the IDEA protocol ('Investigate', 'Discuss', 'Estimate', 'Aggregate') through remote elicitation. When the events were realised, the participant judgements were scored in terms of accuracy, calibration and informativeness. The results demonstrate that the IDEA protocol provides a practical, cost-effective, and repeatable approach to the elicitation of quantitative estimates and uncertainty via remote elicitation. We emphasise that i) the aggregation of diverse individual judgements into pooled group judgments almost always outperformed individuals, and ii) use of a modified Delphi approach helped to remove linguistic ambiguity, and further improved individual and group judgements. Importantly, the protocol encourages review, critical appraisal and replication, each of which is required if judgements are to be used in place of data in a scientific context. The results add to the growing body of literature that demonstrates the merit of using structured

Minimizing variance in Care of Pediatric Blunt Solid Organ Injury through Utilization of a hemodynamic-driven protocol: a multi-institution study.

PubMed

Cunningham, Aaron J; Lofberg, Katrine M; Krishnaswami, Sanjay; Butler, Marilyn W; Azarow, Kenneth S; Hamilton, Nicholas A; Fialkowski, Elizabeth A; Bilyeu, Pamela; Ohm, Erika; Burns, Erin C; Hendrickson, Margo; Krishnan, Preetha; Gingalewski, Cynthia; Jafri, Mubeen A

2017-12-01

An expedited recovery protocol for management of pediatric blunt solid organ injury (spleen, liver, and kidney) was instituted across two Level 1 Trauma Centers, managed by nine pediatric surgeons within three hospital systems. Data were collected for 18months on consecutive patients after protocol implementation. Patient demographics (including grade of injury), surgeon compliance, National Surgical Quality Improvement Program (NSQIP) complications, direct hospital cost, length of stay, time in the ICU, phlebotomy, and re-admission were compared to an 18-month control period immediately preceding study initiation. A total of 106 patients were treated (control=55, protocol=51). Demographics were similar among groups, and compliance was 78%. Hospital stay (4.6 vs. 3.5days, p=0.04), ICU stay (1.9 vs. 1.0days, p=0.02), and total phlebotomy (7.7 vs. 5.3 draws, p=0.007) were significantly less in the protocol group. A decrease in direct hospital costs was also observed ($11,965 vs. $8795, p=0.09). Complication rates (1.8% vs. 3.9%, p=0.86, no deaths) were similar. An expedited, hemodynamic-driven, pediatric solid organ injury protocol is achievable across hospital systems and surgeons. Through implementation we maintained quality while impacting length of stay, ICU utilization, phlebotomy, and cost. Future protocols should work to further limit resource utilization. Retrospective cohort study. Level II. Copyright © 2017 Elsevier Inc. All rights reserved.

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

PubMed

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

2017-06-24

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

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

PubMed

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

2010-03-01

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

Sampling and measurement protocols for long-term silvicultural studies on the Penobscot Experimental Forest

Treesearch

Justin D. Waskiewicz; Laura S. Kenefic; Nicole S. Rogers; Joshua J. Puhlick; John C. Brissette; Richard J. Dionne

2015-01-01

The U.S. Forest Service, Northern Research Station has been conducting research on the silviculture of northern conifers on the Penobscot Experimental Forest (PEF) in Maine since 1950. Formal study plans provide guidance and specifications for the experimental treatments, but documentation is also needed to ensure consistency in data collection and sampling protocols....

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.

The Interface of Clinical Decision-Making With Study Protocols for Knowledge Translation From a Walking Recovery Trial.

PubMed

Hershberg, Julie A; Rose, Dorian K; Tilson, Julie K; Brutsch, Bettina; Correa, Anita; Gallichio, Joann; McLeod, Molly; Moore, Craig; Wu, Sam; Duncan, Pamela W; Behrman, Andrea L

2017-01-01

Despite efforts to translate knowledge into clinical practice, barriers often arise in adapting the strict protocols of a randomized, controlled trial (RCT) to the individual patient. The Locomotor Experience Applied Post-Stroke (LEAPS) RCT demonstrated equal effectiveness of 2 intervention protocols for walking recovery poststroke; both protocols were more effective than usual care physical therapy. The purpose of this article was to provide knowledge-translation tools to facilitate implementation of the LEAPS RCT protocols into clinical practice. Participants from 2 of the trial's intervention arms: (1) early Locomotor Training Program (LTP) and (2) Home Exercise Program (HEP) were chosen for case presentation. The two cases illustrate how the protocols are used in synergy with individual patient presentations and clinical expertise. Decision algorithms and guidelines for progression represent the interface between implementation of an RCT standardized intervention protocol and clinical decision-making. In each case, the participant presents with a distinct clinical challenge that the therapist addresses by integrating the participant's unique presentation with the therapist's expertise while maintaining fidelity to the LEAPS protocol. Both participants progressed through an increasingly challenging intervention despite their own unique presentation. Decision algorithms and exercise progression for the LTP and HEP protocols facilitate translation of the RCT protocol to the real world of clinical practice. The two case examples to facilitate translation of the LEAPS RCT into clinical practice by enhancing understanding of the protocols, their progression, and their application to individual participants.Video Abstract available for more insights from the authors (see Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A147).

Comparison of Ovulation Induction Protocols After Endometrioma Resection

PubMed Central

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

2014-01-01

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

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

PubMed Central

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

2012-01-01

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

A Simple XML Producer-Consumer Protocol

NASA Technical Reports Server (NTRS)

Smith, Warren; Gunter, Dan; Quesnel, Darcy

2000-01-01

This document describes a simple XML-based protocol that can be used for producers of events to communicate with consumers of events. The protocol described here is not meant to be the most efficient protocol, the most logical protocol, or the best protocol in any way. This protocol was defined quickly and it's intent is to give us a reasonable protocol that we can implement relatively easily and then use to gain experience in distributed event services. This experience will help us evaluate proposals for event representations, XML-based encoding of information, and communication protocols. The next section of this document describes how we represent events in this protocol and then defines the two events that we choose to use for our initial experiments. These definitions are made by example so that they are informal and easy to understand. The following section then proceeds to define the producer-consumer protocol we have agreed upon for our initial experiments.

“Counterfactual” quantum protocols

NASA Astrophysics Data System (ADS)

Vaidman, L.

2016-05-01

The counterfactuality of recently proposed protocols is analyzed. A definition of “counterfactuality” is offered and it is argued that an interaction-free measurement (IFM) of the presence of an opaque object can be named “counterfactual”, while proposed “counterfactual” measurements of the absence of such objects are not counterfactual. The quantum key distribution protocols which rely only on measurements of the presence of the object are counterfactual, but quantum direct communication protocols are not. Therefore, the name “counterfactual” is not appropriate for recent “counterfactual” protocols which transfer quantum states by quantum direct communication.

Pharmacy-enforced outpatient drug treatment protocols: a case study of Medi-Cal restrictions for cefaclor.

PubMed

McCombs, J S; Nichol, M B

1993-02-01

To evaluate whether a pharmacy-enforced treatment protocol successfully limited the use of a high-cost medication to high-risk patients. A case study cost-effectiveness analysis was conducted to evaluate a treatment protocol for cefaclor. Episodes of care were defined, healthcare expenditures for all services were aggregated, and demographic data were retrieved from a five percent random sample of California Medicaid (Medi-Cal) recipients. Data were available for episodes occurring before cefaclor was made available under Medi-Cal. Medi-Cal added cefaclor to its formulary, limiting its use to patients over 50 years of age with lower respiratory tract infections (LRTIs). The unit of analysis was an episode of outpatient antibiotic treatment. Confirmed LRTI episodes and unconfirmed LRTI cefaclor episodes were analyzed, including multiple episodes of treatment for individual patients. A total of 7855 non-cefaclor LRTI episodes and 2556 cefaclor episodes were analyzed. The primary outcome measures were healthcare expenditures three months after the initiation of antibiotic therapy, differentiated by type of service. Physicians directed cefaclor toward higher-risk patients over age 50 years, even in unconfirmed LRTI episodes. Cefaclor use was estimated to reduce posttreatment costs by $388 per patient (p < 0.001), primarily because of reduced hospital expenditures of $366 (p < 0.001). Pharmacy-enforced outpatient drug treatment protocols may be a viable alternative to restrictive formularies and prior authorization. In the case of cefaclor, the Medi-Cal treatment protocol appeared to allow high-risk patients better access to a high-cost medication while reducing total posttreatment costs.

Two-party quantum key agreement protocols under collective noise channel

NASA Astrophysics Data System (ADS)

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

2018-06-01

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

[Multidisciplinary protocol for computed tomography imaging and angiographic embolization of splenic injury due to trauma: assessment of pre-protocol and post-protocol outcomes].

PubMed

Koo, M; Sabaté, A; Magalló, P; García, M A; Domínguez, J; de Lama, M E; López, S

2011-11-01

To assess conservative treatment of splenic injury due to trauma, following a protocol for computed tomography (CT) and angiographic embolization. To quantify the predictive value of CT for detecting bleeding and need for embolization. The care protocol developed by the multidisciplinary team consisted of angiography with embolization of lesions revealed by contrast extravasation under CT as well as embolization of grade III-V injuries observed, or grade I-II injuries causing hemodynamic instability and/or need for blood transfusion. We collected data on demographic variables, injury severity score (ISS), angiographic findings, and injuries revealed by CT. Pre-protocol and post-protocol outcomes were compared. The sensitivity and specificity of CT findings were calculated for all patients who required angiographic embolization. Forty-four and 30 angiographies were performed in the pre- and post-protocol periods, respectively. The mean (SD) ISSs in the two periods were 25 (11) and 26 (12), respectively. A total of 24 (54%) embolizations were performed in the pre-protocol period and 28 (98%) after implementation of the protocol. Two and 7 embolizations involved the spleen in the 2 periods, respectively; abdominal laparotomies numbered 32 and 25, respectively, and 10 (31%) vs 4 (16%) splenectomies were performed. The specificity and sensitivity values for contrast extravasation found on CT and followed by embolization were 77.7% and 79.5%. The implementation of this multidisciplinary protocol using CT imaging and angiographic embolization led to a decrease in the number of splenectomies. The protocol allows us to take a more conservative treatment approach.

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.

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

PubMed

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

2018-04-19

Out-of-hospital cardiac arrest is one of the leading causes of death in industrialised countries. Survival depends on prompt identification of cardiac arrest and on the quality and timing of cardiopulmonary resuscitation (CPR) and defibrillation. For laypeople, there has been a growing interest on hands-only CPR, meaning continuous chest compression without interruption to perform ventilations. It has been demonstrated that intentional interruptions in hands-only CPR can increase its quality. The aim of this randomised trial is to compare three CPR protocols performed with different intentional interruptions with hands-only CPR. This is a prospective randomised trial performed in eight training centres. Laypeople who passed a basic life support course will be randomised to one of the four CPR protocols in an 8 min simulated cardiac arrest scenario on a manikin: (1) 30 compressions and 2 s pause; (2) 50 compressions and 5 s pause; (3) 100 compressions and 10 s pause; (4) hands-only. The calculated sample size is 552 people. The primary outcome is the percentage of chest compression performed with correct depth evaluated by a computerised feedback system (Laerdal QCPR). ETHICS AND DISSEMINATION: . Due to the nature of the study, we obtained a waiver from the Ethics Committee (IRCCS Policlinico San Matteo, Pavia, Italy). All participants will sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journal. The data collected will also be made available in a public data repository. NCT02632500. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Study of accent-based music speech protocol development for improving voice problems in stroke patients with mixed dysarthria.

PubMed

Kim, Soo Ji; Jo, Uiri

2013-01-01

Based on the anatomical and functional commonality between singing and speech, various types of musical elements have been employed in music therapy research for speech rehabilitation. This study was to develop an accent-based music speech protocol to address voice problems of stroke patients with mixed dysarthria. Subjects were 6 stroke patients with mixed dysarthria and they received individual music therapy sessions. Each session was conducted for 30 minutes and 12 sessions including pre- and post-test were administered for each patient. For examining the protocol efficacy, the measures of maximum phonation time (MPT), fundamental frequency (F0), average intensity (dB), jitter, shimmer, noise to harmonics ratio (NHR), and diadochokinesis (DDK) were compared between pre and post-test and analyzed with a paired sample t-test. The results showed that the measures of MPT, F0, dB, and sequential motion rates (SMR) were significantly increased after administering the protocol. Also, there were statistically significant differences in the measures of shimmer, and alternating motion rates (AMR) of the syllable /K$\\inve$/ between pre- and post-test. The results indicated that the accent-based music speech protocol may improve speech motor coordination including respiration, phonation, articulation, resonance, and prosody of patients with dysarthria. This suggests the possibility of utilizing the music speech protocol to maximize immediate treatment effects in the course of a long-term treatment for patients with dysarthria.

Internet Protocol Transition Workbook

DTIC Science & Technology

1982-03-01

U N C-* INTERNET PROTOCOL TRANSITION WORKBOOK March 1982 Network Information Canter SRI International Menlo Park, CA 94025 t tv l...Feinler Network Information Center SRI International Menlo Park. California 94025 (415) 859-3695 FEINLEROSRI-NIC (Online mail) [Page ii] I.7 Internet ...31 Postel. J., " Internet Control Message Protocol - DARPA Internet Program Protocol Specification." RFC 792, USC/ Information Sciences Institute

Energy-Aware RFID Anti-Collision Protocol.

PubMed

Arjona, Laura; Simon, Hugo Landaluce; Ruiz, Asier Perallos

2018-06-11

The growing interest in mobile devices is transforming wireless identification technologies. Mobile and battery-powered Radio Frequency Identification (RFID) readers, such as hand readers and smart phones, are are becoming increasingly attractive. These RFID readers require energy-efficient anti-collision protocols to minimize the tag collisions and to expand the reader's battery life. Furthermore, there is an increasing interest in RFID sensor networks with a growing number of RFID sensor tags. Thus, RFID application developers must be mindful of tag anti-collision protocols. Energy-efficient protocols involve a low reader energy consumption per tag. This work presents a thorough study of the reader energy consumption per tag and analyzes the main factor that affects this metric: the frame size update strategy. Using the conclusion of this analysis, the anti-collision protocol Energy-Aware Slotted Aloha (EASA) is presented to decrease the energy consumption per tag. The frame size update strategy of EASA is configured to minimize the energy consumption per tag. As a result, EASA presents an energy-aware frame. The performance of the proposed protocol is evaluated and compared with several state of the art Aloha-based anti-collision protocols based on the current RFID standard. Simulation results show that EASA, with an average of 15 mJ consumed per tag identified, achieves a 6% average improvement in the energy consumption per tag in relation to the strategies of the comparison.

Changes in deciduous and permanent dentinal tubules diameter after several conditioning protocols: In vitro study.

PubMed

de Los Angeles Moyaho-Bernal, María; Contreras-Bulnes, Rosalía; Rodríguez-Vilchis, Laura Emma; Rubio-Rosas, Efraín

2018-05-08

Innovators conditioning protocols are emerged in permanent dentin, however for deciduous dentin the information is limited; the aim of this study was to evaluate in vitro diameter of deciduous and permanent dentinal tubules after several conditioning protocols. Eighty dentin samples were distributed in sixteen groups (n = 5 p/g) and dentin surface was conditioned as follow: G1D/G1P acid etching; G2D/G2P, self-etch adhesive; G3D/G3P, G4D/G4P, Er: YAG laser irradiation at 200 mJ-25.5 J/cm 2 and 300 mJ-38.2 J/cm 2 , at 10 Hz under water spray respectively; G5D/G5P, G6D/G6P, G7D/G7P, and G8D/G8P were irradiated under the same energy densities followed phosphoric acid or self-etch adhesive conditioning. The sample dentin of deciduous and permanent teeth was analyzed with scanning electron microscopy and tubule diameter was evaluated by Image Tools Scandium program. Data were subjected to one-way analysis ANOVA to compare among groups with a level of significance at p ≤ .05. For deciduous dentin, diameters were from 1.52 ± 0.32 µm in G3D to 3.88 ± 0.37 µm in G1D; narrowest and widest diameter, respectively (p < .000). While permanent dentin tubules exhibited diameters from 1.16 ± 0.16/1.19 ± 0.12 µm in G7P/G8P to 2.76 ± 0.28 µm in G6P; narrowest and widest diameter, respectively (p < .000). All dentin conditioning protocols produced more open dentin tubules (diameter size) in deciduous dentin than permanent, specific conditioning protocols are required for each tissue (deciduous or permanent dentin), since same protocol produced stronger effects on primary dentin, which is important for dental clinical success in children and adolescents. © 2018 Wiley Periodicals, Inc.

Evaluation of a Modified Pamidronate Protocol for the Treatment of Osteogenesis Imperfecta.

PubMed

Palomo, Telma; Andrade, Maria C; Peters, Barbara S E; Reis, Fernanda A; Carvalhaes, João Tomás A; Glorieux, Francis H; Rauch, Frank; Lazaretti-Castro, Marise

2016-01-01

Intravenous pamidronate is widely used to treat children with osteogenesis imperfecta (OI). In a well-studied protocol ('standard protocol'), pamidronate is given at a daily dose of 1 mg per kg body weight over 4 h on 3 successive days; infusion cycles are repeated every 4 months. Here, we evaluated renal safety of a simpler protocol for intravenous pamidronate infusions (2 mg per kg body weight given in a single infusion over 2 h, repeated every 4 months; 'modified protocol'). Results of 18 patients with OI types I, III, or IV treated with the modified protocol for 12 months were compared to 18 historic controls, treated with standard protocol. In the modified protocol, mild transient post-infusion increases in serum creatinine were found during each infusion but after 12 months serum creatinine remained similar from baseline [0.40 mg/dl (SD: 0.13)] to the end of the study [0.41 mg/dl (SD: 0.11)] (P = 0.79). The two protocols led to similar changes in serum creatinine during the first pamidronate infusion [modified protocol: +2% (SD: 21%); standard protocol: -3% (SD: 8%); P = 0.32]. Areal lumbar spine bone mineral density Z-scores increased from -2.7 (SD: 1.5) to -1.8 (SD: 1.4) with the modified protocol, and from -4.1 (SD: 1.4) to -3.1 (SD: 1.1) with standard protocol (P = 0.68 for group differences in bone density Z-score changes). The modified pamidronate protocol is safe and may have similar effects on bone density as the standard pamidronate protocol. More studies are needed with longer follow-up to prove anti-fracture efficacy.

Treatment algorithms and protocolized care.

PubMed

Morris, Alan H

2003-06-01

Excess information in complex ICU environments exceeds human decision-making limits and likely contributes to unnecessary variation in clinical care, increasing the likelihood of clinical errors. I reviewed recent critical care clinical trials searching for information about the impact of protocol use on clinically pertinent outcomes. Several recently published clinical trials illustrate the importance of distinguishing efficacy and effectiveness trials. One of these trials illustrates the danger of conducting effectiveness trials before the efficacy of an intervention is established. The trials also illustrate the importance of distinguishing guidelines and inadequately explicit protocols from adequately explicit protocols. Only adequately explicit protocols contain enough detail to lead different clinicians to the same decision when faced with the same clinical scenario. Differences between guidelines and protocols are important. Guidelines lack detail and provide general guidance that requires clinicians to fill in many gaps. Computerized or paper-based protocols are detailed and, when used for complex clinical ICU problems, can generate patient-specific, evidence-based therapy instructions that can be carried out by different clinicians with almost no interclinician variability. Individualization of patient therapy can be preserved by these protocols when they are driven by individual patient data. Explicit decision-support tools (eg, guidelines and protocols) have favorable effects on clinician and patient outcomes and can reduce the variation in clinical practice. Guidelines and protocols that aid ICU decision makers should be more widely distributed.

Effects of a dynamic balance training protocol on podalic support in older women. Pilot Study.

PubMed

Battaglia, Giuseppe; Bellafiore, Marianna; Bianco, Antonino; Paoli, Antonio; Palma, Antonio

2010-01-01

The foot provides the only direct contact with supporting surfaces and therefore plays an important role in all postural tasks. Changes in the musculoskeletal and neurological characteristics of the foot with advancing age can alter plantar loading patterns and postural balance. Several studies have reported that exercise training improves postural performance in elderly individuals. The aim of our study was to investigate the effectiveness of a dynamic balance training protocol performed for 5 weeks on the support surface, percentage distribution of load in both feet, and body balance performance in healthy elderly women. Ten subjects (68.67±5.50 yrs old; 28.17±3.35 BMI) were evaluated with a monopodalic performance test and baropodometric analyses before and after the training period. We found a significant improvement in balance unipedal performance times on left and right foot by 20.18% and 26.23% respectively (p<0.05). The support surface of the right foot significantly increased in response to the training protocol and, in particular, in both forefoot and rearfoot regions (p<0.05). In addition, before the training period, load distribution on the left foot was greater than on the right one; equal load redistribution was measured on both feet in response to exercise (p>0.05). The increased support surface and equal redistribution of body weight on both feet obtained in response to our training protocol may be postural adaptations sufficient to improve static balance in elderly women.

Comment on "flexible protocol for quantum private query based on B92 protocol"

NASA Astrophysics Data System (ADS)

Chang, Yan; Zhang, Shi-Bin; Zhu, Jing-Min

2017-03-01

In a recent paper (Quantum Inf Process 13:805-813, 2014), a flexible quantum private query (QPQ) protocol based on B92 protocol is presented. Here we point out that the B92-based QPQ protocol is insecure in database security when the channel has loss, that is, the user (Alice) will know more records in Bob's database compared with she has bought.

Hydrogen peroxide bleaching induces changes in the physical properties of dental restorative materials: Effects of study protocols.

PubMed

Yu, Hao; Zhang, Chang-Yuan; Wang, Yi-Ning; Cheng, Hui

2018-03-01

The purpose of this study was to evaluate the influence of study protocols on the effects of bleaching on the surface roughness, substance loss, flexural strength (FS), flexural modulus (FM), Weibull parameters, and color of 7 restorative materials. The test materials included 4 composite resins, 1 glass-ionomer cement, 1 dental ceramic, and 1 polyacid-modified composite. The specimens were randomly divided into 4 groups (n = 20) according to different study protocols: a bleaching group at 25°C (group 25B), a bleaching group at 37°C (group 37B), a control group at 25°C (group 25C), and a control group at 37°C (group 37C). The specimens in the bleaching group were treated with 40% hydrogen peroxide for 80 min at the respective environmental temperatures. The surface roughness, substance loss, FS, FM, and color of the specimens were measured before and after treatment. FS data were also subjected to Weibull analysis, which was used to estimate of the Weibull modulus (m) and the characteristic strength (σ 0 ). Surface roughness increased and significant color changes were observed for all tested specimens after bleaching treatment, except for the ceramic. After bleaching at 37°C, the polyacid-modified composite showed significantly reduced FS, FM, m, and σ 0 values in comparison to the control specimens stored at 37°C in whole saliva. Significant differences were also found between the 37B and 25B polyacid-modified composite groups in terms of surface roughness, FS, m, σ 0 , and color changes. Varying effects of bleaching on the physical properties of dental restorative materials were observed, and the influences of the study protocols on bleaching effects were found to be material-dependent. The influence of study protocols on the effects of bleaching on the surface roughness, flexural properties, and color of dental restorative materials are material-dependent and should be considered when evaluating the effects of bleaching on dental restorative

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

PubMed Central

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

2015-01-01

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

Abdominal stab wound protocol: prospective study documents applicability for widespread use.

PubMed

Rosemurgy, A S; Albrink, M H; Olson, S M; Sherman, H; Albertini, J; Kramer, R; Camps, M; Reiss, A

1995-02-01

Traditionally, stab wounds violating the abdominal wall fascia led to exploratory celiotomy that was often nontherapeutic. In an attempt to limit the number of nontherapeutic celiotomies (NTC), we devised a protocol to prospectively study stab wounds violating the anterior abdominal wall fascia. Through protocol, abdominal stab wounds were explored in stable adults. If the anterior fascia was violated, paracentesis and, if necessary, peritoneal lavage was undertaken in the absence of previous abdominal surgery. If evisceration was noted, it was reduced and the patient lavaged. Fascial penetration was noted in 72 patients. 46 patients underwent celiotomy: because of shock/peritonitis in 8 (2 NTC), fascial penetration with a history of previous celiotomy in 7 (5 NTC), positive paracentesis in 20 (5 NTC), or positive lavage in 10 (4 NTC). One patient underwent late celiotomy without ill-effect after a negative lavage because she subsequently developed fever and localized peritonitis (ice pick injury to cecum). Eleven patients had evisceration; nine underwent celiotomy. Patients with abdominal stab wounds can be selectively managed safely. More than one-third with fascial penetration, some with evisceration, avoided exploration. Only one patient underwent delayed celiotomy and did so without detriment. Nontherapeutic celiotomy rates were highest in patients with previous abdominal surgery who, thereby, could not undergo paracentesis/lavage; excluding these patients, the nontherapeutic celiotomy rate was 17% (11/65) for those with fascial penetration.

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2017-01-01

Pediatric sepsis has a high mortality rate in limited resource settings. Sepsis protocols have been shown to be a cost-effective strategy to improve morbidity and mortality in a variety of populations and settings. At Dhaka Hospital in Bangladesh, mortality from pediatric sepsis in high-risk children previously approached 60%, which prompted the implementation of an evidenced-based protocol in 2010. The clinical effectiveness of this protocol had not been measured. We hypothesized that implementation of a pediatric sepsis protocol improved clinical outcomes, including reducing mortality and length of hospital stay. This was a retrospective cohort study of children 1-59 months old with a diagnosis of sepsis, severe sepsis or septic shock admitted to Dhaka Hospital from 10/25/2009-10/25/2011. The primary outcome was inpatient mortality pre- and post-protocol implementation. Secondary outcomes included fluid overload, heart failure, respiratory insufficiency, length of hospital stay, and protocol compliance, as measured by antibiotic and fluid bolus administration within 60 minutes of hospital presentation. 404 patients were identified by a key-word search of the electronic medical record; 328 patients with a primary diagnosis of sepsis, severe sepsis, or septic shock were included (143 pre- and185 post-protocol) in the analysis. Pre- and post-protocol mortality were similar and not statistically significant (32.17% vs. 34.59%, p = 0.72). The adjusted odds ratio (AOR) for post-protocol mortality was 1.55 (95% CI, 0.88-2.71). The odds for developing fluid overload were significantly higher post-protocol (AOR 3.45, 95% CI, 2.04-5.85), as were the odds of developing heart failure (AOR 4.52, 95% CI, 1.43-14.29) and having a longer median length of stay (AOR 1.81, 95% CI 1.10-2.96). There was no statistically significant difference in respiratory insufficiency (pre- 65.7% vs. post- 70.3%, p = 0.4) or antibiotic administration between the cohorts (pre- 16.08% vs. post- 12

Problematic protocols: An overview of medical research protocols not approved by the LUMC medical ethics review committee.

PubMed

Tersmette, Derek Gideon; Engberts, Dirk Peter

2017-01-01

The Committee for Medical Ethics (CME) of Leiden University Medical Center (LUMC) was established as the first medical ethics reviewing committee (MREC) in the Netherlands. In the period 2000-2010 the CME received 2,162 protocols for review. Some of these protocols were never approved. Until now, there has existed neither an overview of these failed protocols nor an overview of the reasons for their failure. This report draws on data from the digital database, the physical archives, and the minutes of the meetings of the CME. Additional information has been obtained from the Central Committee on Research involving Human Subjects (CCRH) and survey-based research. Protocols were itemized based on characteristic features and their reviewing procedures were analyzed. In total, 1,952 out of 2,162 research protocols submitted during 2000-2010 (90.3%) were approved by the CME; 210 of 2,162 protocols (9.7%) were not approved. Of these 210 protocols, 177 failed due to reasons not related to CME reviewing. In 15 cases CME reviewing led to protocol failure, while another 10 protocols were rejected outright. Eight of the 210 submitted protocols without approval had been conducted prior to submission. In the aforementioned period, little protocol failure occurred. For the most part, protocol failure was caused by problems that are not CME related. This type of failure has several identifiable factors, none of which have anything to do with the ethical reviewing procedure by the CME. A mere 1.2% of protocols failed due to ethical review. Unacceptable burden and risks to the subject and an inadequate methodology are the most common reasons for this CME-related protocol failure.

Microcomputer Nurse-Practitioner Protocols

PubMed Central

Way, Anthony B.; Rowley, Blair A.; White, Melanie A.

1982-01-01

We have developed a set of protocols on a microcomputer to assist in the management of a geographically isolated nurse practitioner. If a mid-level practitioner is supervised by a physician, some system is needed to ensure that approved care is being provided. The currently available paper-based protocols do not adequately serve all the needs for training, auditing, and record keeping. Conversely, adequate systems based on large computers are not feasible for small clinics. We have therefore developed a microcomputer-based system of protocols for a small rural nurse-practitioner's clinic. Our programs are designed for direct use by the practitioners while the patient is in the clinic. The user is given immediate feedback about any errors. The supervisor is later provided with a summary of the protocol uses and errors, and a copy of any erroneous records. The system appears to be easy to use by the nurse practitioner. The protocols are quickly learned and auditing is facilitated.

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

PubMed

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

2006-07-01

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

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

PubMed Central

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

2006-01-01

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

Detailed analysis of routing protocols with different network limitations

NASA Astrophysics Data System (ADS)

Masood, Mohsin; Abuhelala, Mohamed; Glesk, Ivan

2016-12-01

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

Protocols — EDRN Public Portal

Cancer.gov

EDRN investigators protocols. The following is a list of the EDRN protocols that have been captured and curated. Additional information will be added as it is available. Contact information is provided as part of the detail for each protocol.

Protocol matters: which methylome are you actually studying?

PubMed Central

Robinson, Mark D; Statham, Aaron L; Speed, Terence P; Clark, Susan J

2011-01-01

The field of epigenetics is now capitalizing on the vast number of emerging technologies, largely based on second-generation sequencing, which interrogate DNA methylation status and histone modifications genome-wide. However, getting an exhaustive and unbiased view of a methylome at a reasonable cost is proving to be a significant challenge. In this article, we take a closer look at the impact of the DNA sequence and bias effects introduced to datasets by genome-wide DNA methylation technologies and where possible, explore the bioinformatics tools that deconvolve them. There remains much to be learned about the performance of genome-wide technologies, the data we mine from these assays and how it reflects the actual biology. While there are several methods to interrogate the DNA methylation status genome-wide, our opinion is that no single technique suitably covers the minimum criteria of high coverage and, high resolution at a reasonable cost. In fact, the fraction of the methylome that is studied currently depends entirely on the inherent biases of the protocol employed. There is promise for this to change, as the third generation of sequencing technologies is expected to again ‘revolutionize’ the way that we study genomes and epigenomes. PMID:21566704

SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2015-12-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

PubMed Central

Chan, An-Wen; Tetzlaff, Jennifer M.; Altman, Douglas G.; Laupacis, Andreas; Gøtzsche, Peter C.; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A.; Doré, Caroline J.; Parulekar, Wendy R.; Summerskill, William S.M.; Groves, Trish; Schulz, Kenneth F.; Sox, Harold C.; Rockhold, Frank W.; Rennie, Drummond; Moher, David

2016-01-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders. PMID:23295957

SPIRIT 2013 statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Doré, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2013-02-05

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

Efficiency of different protocols for enamel clean-up after bracket debonding: an in vitro study

PubMed Central

Sigilião, Lara Carvalho Freitas; Marquezan, Mariana; Elias, Carlos Nelson; Ruellas, Antônio Carlos; Sant'Anna, Eduardo Franzotti

2015-01-01

Objective: This study aimed to assess the efficiency of six protocols for cleaning-up tooth enamel after bracket debonding. Methods: A total of 60 premolars were divided into six groups, according to the tools used for clean-up: 12-blade bur at low speed (G12L), 12-blade bur at high speed (G12H), 30-blade bur at low speed (G30L), DU10CO ORTHO polisher (GDU), Renew System (GR) and Diagloss polisher (GD). Mean roughness (Ra) and mean roughness depth (Rz) of enamel surface were analyzed with a profilometer. Paired t-test was used to assess Ra and Rz before and after enamel clean-up. ANOVA/Tukey tests were used for intergroup comparison. The duration of removal procedures was recorded. The association between time and variation in enamel roughness (∆Ra, ∆Rz) were evaluated by Pearson's correlation test. Enamel topography was assessed by scanning electron microscopy (SEM). Results: In Groups G12L and G12H, original enamel roughness did not change significantly. In Groups G30L, GDU, GR and GD, a smoother surface (p < 0.05) was found after clean-up. In Groups G30L and GD, the protocols used were more time-consuming than those used in the other groups. Negative and moderate correlation was observed between time and (∆Ra, ∆Rz); Ra and (∆Ra, ∆Rz); Rz (r = - 0.445, r = - 0.475, p < 0.01). Conclusion: All enamel clean-up protocols were efficient because they did not result in increased surface roughness. The longer the time spent performing the protocol, the lower the surface roughness. PMID:26560825

The Geneva Protocol of 1925: Past and Present.

ERIC Educational Resources Information Center

Harbison, John L.

1982-01-01

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

Using semantics for representing experimental protocols.

PubMed

Giraldo, Olga; García, Alexander; López, Federico; Corcho, Oscar

2017-11-13

An experimental protocol is a sequence of tasks and operations executed to perform experimental research in biological and biomedical areas, e.g. biology, genetics, immunology, neurosciences, virology. Protocols often include references to equipment, reagents, descriptions of critical steps, troubleshooting and tips, as well as any other information that researchers deem important for facilitating the reusability of the protocol. Although experimental protocols are central to reproducibility, the descriptions are often cursory. There is the need for a unified framework with respect to the syntactic structure and the semantics for representing experimental protocols. In this paper we present "SMART Protocols ontology", an ontology for representing experimental protocols. Our ontology represents the protocol as a workflow with domain specific knowledge embedded within a document. We also present the S ample I nstrument R eagent O bjective (SIRO) model, which represents the minimal common information shared across experimental protocols. SIRO was conceived in the same realm as the Patient Intervention Comparison Outcome (PICO) model that supports search, retrieval and classification purposes in evidence based medicine. We evaluate our approach against a set of competency questions modeled as SPARQL queries and processed against a set of published and unpublished protocols modeled with the SP Ontology and the SIRO model. Our approach makes it possible to answer queries such as Which protocols use tumor tissue as a sample. Improving reporting structures for experimental protocols requires collective efforts from authors, peer reviewers, editors and funding bodies. The SP Ontology is a contribution towards this goal. We build upon previous experiences and bringing together the view of researchers managing protocols in their laboratory work. Website: https://smartprotocols.github.io/ .

Study and Simulation of Enhancements for TCP (Transmission Control Protocol) Performance Over Noisy, High-Latency Links

NASA Technical Reports Server (NTRS)

Shepard, Timothy J.; Partridge, Craig; Coulter, Robert

1997-01-01

The designers of the TCP/IP protocol suite explicitly included support of satellites in their design goals. The goal of the Internet Project was to design a protocol which could be layered over different networking technologies to allow them to be concatenated into an internet. The results of this project included two protocols, IP and TCP. IP is the protocol used by all elements in the network and it defines the standard packet format for IP datagrams. TCP is the end-to-end transport protocol commonly used between end systems on the Internet to derive a reliable bi-directional byte-pipe service from the underlying unreliable IP datagram service. Satellite links are explicitly mentioned in Vint Cerf's 2-page article which appeared in 1980 in CCR [2] to introduce the specifications for IP and TCP. In the past fifteen years, TCP has been demonstrated to work over many differing networking technologies, including over paths including satellites links. So if satellite links were in the minds of the designers from the beginning, what is the problem? The problem is that the performance of TCP has in some cases been disappointing. A goal of the authors of the original specification of TCP was to specify only enough behavior to ensure interoperability. The specification left a number of important decisions, in particular how much data is to be sent when, to the implementor. This was deliberately' done. By leaving performance-related decisions to the implementor, this would allow the protocol TCP to be tuned and adapted to different networks and situations in the future without the need to revise the specification of the protocol, or break interoperability. Interoperability would continue while future implementations would be allowed flexibility to adapt to needs which could not be anticipated at the time of the original protocol design.

Assessing the Efficacy of an App-Based Method of Family Planning: The Dot Study Protocol.

PubMed

Simmons, Rebecca G; Shattuck, Dominick C; Jennings, Victoria H

2017-01-18

assess pregnancy status over time. This paper outlines the protocol for this efficacy trial, following the Standard Protocol Items: Recommendations for Intervention Trials checklist, to provide an overview of the rationale, methodology, and analysis plan. Participants will be asked to provide daily sexual history data and periodically answer surveys administered through a call center or directly on their phone. Funding for the study was provided in 2013 under the United States Agency for International Development Fertility Awareness for Community Transformation project. Recruitment for the study will begin in January of 2017. The study is expected to last approximately 18 months, depending on recruitment. Findings on the study's primary outcomes are expected to be finalized by September 2018. Reproducibility and transparency, important aspects of all research, are particularly critical in developing new approaches to research design. This protocol outlines the first study to prospectively test both the efficacy (correct use) and effectiveness (actual use) of a pregnancy prevention app. This protocol and the processes it describes reflect the dynamic integration of mobile technologies, a call center, and Health Insurance Portability and Accountability Act-compliant study procedures. Future fertility app studies can build on our approaches to develop methodologies that can contribute to the evidence base around app-based methods of contraception. ClinicalTrials.gov NCT02833922; https://clinicaltrials.gov/ct2/show/NCT02833922 (Archived be WebCite at http://www.webcitation.org/6nDkr0e76). ©Rebecca G Simmons, Dominick C Shattuck, Victoria H Jennings. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.01.2017.

Continuous Subcutaneous Insulin Infusion in Children: A Pilot Study Validating a Protocol to Avoid Hypoglycemia at Initiation.

PubMed

Manousaki, Despoina; Deladoëy, Johnny; Geoffroy, Louis; Olivier, Patricia

2017-01-01

The occurrence of hypoglycemia and hyperglycemia during the first days after transition to continuous subcutaneous insulin infusion (CSII) in patients with type 1 diabetes has not been systematically studied in children. The aim of this prospective study was to demonstrate that the protocol applied in our diabetes clinic is safe at CSII initiation in children. We assessed 22 pediatric patients with type 1 diabetes, using continuous glucose monitoring (CGM) before and after CSII initiation (±3 days). After CSII initiation, there was no difference in the rates of hypoglycemic events expressed as relative rates (RRs) per person-reading (RR = 0.85, p  = 0.52, 95% CI 0.52-1.39), as well as in the number of prolonged hypoglycemic events (>1 h) per day (RR = 1.12, p  = 0.56, 95% CI 0.75-1.68). We observed only a trend toward prolonged episodes of hyperglycemia after pump initiation (RR = 1.52, p  = 0.06, 95% CI 0.97-2.35). Our study is the first to assess, through CGM and in a prospective way, the impact of a CSII initiation protocol on glycemic values. Our protocol provides a safe model to avoid hypoglycemia at CSII initiation in children. www.ClinicalTrials.gov, identifier NCT01840358.

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

PubMed

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

2017-03-01

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

Bidirectional Teleportation Protocol in Quantum Wireless Multi-hop Network

NASA Astrophysics Data System (ADS)

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

2018-06-01

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

Bidirectional Teleportation Protocol in Quantum Wireless Multi-hop Network

NASA Astrophysics Data System (ADS)

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

2018-02-01

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

Analysis of limiting information characteristics of quantum-cryptography protocols

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

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

2005-01-31

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

FTP Extensions for Variable Protocol Specification

NASA Technical Reports Server (NTRS)

Allman, Mark; Ostermann, Shawn

2000-01-01

The specification for the File Transfer Protocol (FTP) assumes that the underlying network protocols use a 32-bit network address and a 16-bit transport address (specifically IP version 4 and TCP). With the deployment of version 6 of the Internet Protocol, network addresses will no longer be 32-bits. This paper species extensions to FTP that will allow the protocol to work over a variety of network and transport protocols.

Mars Sample Handling Protocol Workshop Series: Workshop 4

NASA Technical Reports Server (NTRS)

Race Margaret S. (Editor); DeVincenzi, Donald L. (Editor); Rummel, John D. (Editor); Acevedo, Sara E. (Editor)

2001-01-01

In preparation for missions to Mars that will involve the return of samples to Earth, it will be necessary to prepare for the receiving, handling, testing, distributing, and archiving of martian materials here on Earth. Previous groups and committees have studied selected aspects of sample return activities, but specific detailed protocols for the handling and testing of returned samples must still be developed. To further refine the requirements for sample hazard testing and to develop the criteria for subsequent release of sample materials from quarantine, the NASA Planetary Protection Officer convened a series of workshops in 2000-2001. The overall objective of the Workshop Series was to produce a Draft Protocol by which returned martian sample materials can be assessed for biological hazards and examined for evidence of life (extant or extinct) while safeguarding the purity of the samples from possible terrestrial contamination. This report also provides a record of the proceedings of Workshop 4, the final Workshop of the Series, which was held in Arlington, Virginia, June 5-7, 2001. During Workshop 4, the sub-groups were provided with a draft of the protocol compiled in May 2001 from the work done at prior Workshops in the Series. Then eight sub-groups were formed to discuss the following assigned topics: Review and Assess the Draft Protocol for Physical/Chemical Testing Review and Assess the Draft Protocol for Life Detection Testing Review and Assess the Draft Protocol for Biohazard Testing Environmental and Health/Monitoring and Safety Issues Requirements of the Draft Protocol for Facilities and Equipment Contingency Planning for Different Outcomes of the Draft Protocol Personnel Management Considerations in Implementation of the Draft Protocol Draft Protocol Implementation Process and Update Concepts This report provides the first complete presentation of the Draft Protocol for Mars Sample Handling to meet planetary protection needs. This Draft Protocol

Analysis of human microcirculation in weightlessness: Study protocol and pre-study experiments.

PubMed

Bimpong-Buta, Nana-Yaw; Jirak, Peter; Wernly, Bernhard; Lichtenauer, Michael; Masyuk, Maryna; Muessig, Johanna Maria; Braun, Kristina; Kaya, Sema; Kelm, Malte; Jung, Christian

2018-04-14

In weightlessness, alterations in organ systems have been reported. The microcirculation consists of a network of blood vessels with diameters of a few μm. It is considered the largest part of the circulatory system of the human body and essential for exchange of gas, nutrients and waste products. An investigation of the microcirculation in weightlessness seems warranted but has not yet been performed. In this paper, we outline a study in which we will investigate the possible interrelations between weightlessness and microcirculation. We will induce weightlessness in the course of parabolic flight maneuvers, which will be conducted during a parabolic flight campaign. In this study protocol also an evaluation of a possible influence of parabolic flight premedication on microcirculation will be described. The microcirculation will be investigated by sublingual intravital measurements applying sidestream darkfield microscopy. Parameters of macrocirculation such as heart rate, blood pressure and blood oxygenation will also be investigated. In our pre-study experiments, neither dimenhydrinate nor scopolamine altered microcirculation. As the application of motion sickness therapy did not alter microcirculation, it will be applied during the parabolic flight maneuvers of the campaign. Our results might deepen the understanding of microcirculation on space missions and on earth.

Understanding protocol performance: impact of test performance.

PubMed

Turner, Robert G

2013-01-01

This is the second of two articles that examine the factors that determine protocol performance. The objective of these articles is to provide a general understanding of protocol performance that can be used to estimate performance, establish limits on performance, decide if a protocol is justified, and ultimately select a protocol. The first article was concerned with protocol criterion and test correlation. It demonstrated the advantages and disadvantages of different criterion when all tests had the same performance. It also examined the impact of increasing test correlation on protocol performance and the characteristics of the different criteria. To examine the impact on protocol performance when individual tests in a protocol have different performance. This is evaluated for different criteria and test correlations. The results of the two articles are combined and summarized. A mathematical model is used to calculate protocol performance for different protocol criteria and test correlations when there are small to large variations in the performance of individual tests in the protocol. The performance of the individual tests that make up a protocol has a significant impact on the performance of the protocol. As expected, the better the performance of the individual tests, the better the performance of the protocol. Many of the characteristics of the different criteria are relatively independent of the variation in the performance of the individual tests. However, increasing test variation degrades some criteria advantages and causes a new disadvantage to appear. This negative impact increases as test variation increases and as more tests are added to the protocol. Best protocol performance is obtained when individual tests are uncorrelated and have the same performance. In general, the greater the variation in the performance of tests in the protocol, the more detrimental this variation is to protocol performance. Since this negative impact is increased as

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

PubMed

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

2018-05-21

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

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

PubMed

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

2015-01-01

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

Application of the Putting Women First protocol in a study on violence against immigrant women in Spain.

PubMed

Torrubiano-Domínguez, Jordi; Vives-Cases, Carmen

2013-01-01

In this paper, we describe our experience of using the Putting Women First protocol in the design and implementation of a cross-sectional study on violence against women (VAW) among 1607 immigrant women from Morocco, Ecuador and Romania living in Spain in 2011. The Putting Women First protocol is an ethical guideline for VAW research, which includes recommendations to ensure the safety of the women involved in studies on this subject. The response rate in this study was 59.3%. The prevalence of VAW cases last year was 11.7%, of which 15.6% corresponded to Ecuadorian women, 10.9% to Moroccan women and 8.6% to Romanian women. We consider that the most important goal for future research is the use of VAW scales validated in different languages, which would help to overcome the language barriers encountered in this study. Copyright © 2012 SESPAS. Published by Elsevier Espana. All rights reserved.

Behavioral Interventions to Prevent or Delay Dementia: Protocol for a Randomized Comparative Effectiveness Study.

PubMed

Smith, Glenn; Chandler, Melanie; Locke, Dona Ec; Fields, Julie; Phatak, Vaishali; Crook, Julia; Hanna, Sherrie; Lunde, Angela; Morris, Miranda; Graff-Radford, Michelle; Hughes, Christine A; Lepore, Susan; Cuc, Andrea; Caselli, Maria; Hurst, Duane; Wethe, Jennifer; Francone, Andrea; Eilertsen, Jeanne; Lucas, Pauline; Hoffman Snyder, Charlene; Kuang, LeeAnn; Becker, Marigrace; Dean, Pamela; Diehl, Nancy; Lofquist, Marvin; Vanderhook, Shirley; Myles, Diana; Cochran, Denise

2017-11-27

Currently, people at risk for dementia and their caregivers are confronted with confusing choices about what behavioral interventions are most effective. The objective of this study is to determine which empirically supported behavioral interventions most impact the outcomes highly valued by patients with mild cognitive impairment and their partners. This protocol describes a comparative effectiveness trial targeting 300 participants with mild cognitive impairment and their study partners. The trial is being conducted at the Mayo Clinic campuses in Arizona, Florida, Minnesota, and the University of Washington in Seattle. The study examines the contribution of five behavioral interventions (yoga, memory compensation training, computerized cognitive training, support groups, and wellness education) on primary outcomes of participant and partner quality of life and self-efficacy. In this unique 10-day multicomponent intervention, groups of couples were randomized to have one of the five interventions withheld while receiving the other four. Although the longitudinal follow-up is still under way, enrollment results are available and reported. In total, 272 couples have been enrolled in the trial and follow-up visits continue. Outcomes will be assessed at the end-of-intervention and 6-, 12-, and 18-month follow-ups. We anticipate reporting on our primary and secondary outcomes across time points in the next 2 years. This paper describes the protocol for a randomized comparative effectiveness study of behavioral interventions to prevent or delay dementia. We describe of the rationale, design, power analysis, and analysis plan. Also because enrollment is complete and we are in follow-up phases of the study, we have included enrollment data from the trial.  ClinicalTrials.gov NCT02265757; http://clinicaltrials.gov/ctsshow/ NCT02265757 (Archived by WebCite at http://www.webcitation.org/6ueRfwSYv). ©Glenn Smith, Melanie Chandler, Dona EC Locke, Julie Fields, Vaishali

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

PubMed

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

2018-04-01

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

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

NASA Technical Reports Server (NTRS)

Kamat, Sanjay; Zhao, Wei

1992-01-01

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

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

PubMed

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

2015-03-08

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

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

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.

21 CFR 312.30 - Protocol amendments.

Code of Federal Regulations, 2011 CFR

2011-04-01

.... (b) Changes in a protocol. (1) A sponsor shall submit a protocol amendment describing any change in a Phase 1 protocol that significantly affects the safety of subjects or any change in a Phase 2 or 3... forth the provisions under which new protocols may be submitted and changes in previously submitted...

21 CFR 312.30 - Protocol amendments.

Code of Federal Regulations, 2010 CFR

2010-04-01

.... (b) Changes in a protocol. (1) A sponsor shall submit a protocol amendment describing any change in a Phase 1 protocol that significantly affects the safety of subjects or any change in a Phase 2 or 3... forth the provisions under which new protocols may be submitted and changes in previously submitted...

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

PubMed

Jadidi, Masoud; Båth, Magnus; Nyrén, Sven

2018-04-09

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

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

PubMed

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

2014-04-01

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

Study protocol for the recruitment of female sex workers and their non-commercial partners into couple-based HIV research.

PubMed

Syvertsen, Jennifer L; Robertson, Angela M; Abramovitz, Daniela; Rangel, M Gudelia; Martinez, Gustavo; Patterson, Thomas L; Ulibarri, Monica D; Vera, Alicia; El-Bassel, Nabila; Strathdee, Steffanie A

2012-02-20

Researchers are increasingly recognizing the importance of addressing sexual and drug-related HIV risk within the context of intimate relationships rather than solely focusing on individual behaviors. Practical and effective methods are needed to recruit, screen, and enroll the high risk and hard-to-reach couples who would most benefit from HIV interventions, such as drug-using female sex workers (FSWs) and their intimate, non-commercial partners. This paper outlines a bi-national, multidisciplinary effort to develop and implement a study protocol for research on the social context and epidemiology of HIV, sexually transmitted infections (STI), and high risk behaviors among FSWs and their non-commercial male partners in Tijuana and Ciudad Juarez, Mexico. We provide an overview of our study and specifically focus on the sampling, recruitment, screening, and successful enrollment of high risk couples into a public health study in this context. We used targeted and snowball sampling to recruit couples through the female partner first and administered a primary screener to check her initial eligibility. Willing and eligible females then invited their primary male partners for couple-based screening using a couple verification screening (CVS) instrument adapted from previous studies. The CVS rechecked eligibility and separately asked each partner the same questions about their relationship to "test" if the couple was legitimate. We adapted the original protocol to consider issues of gender and power within the local cultural and socioeconomic context and expanded the question pool to create multiple versions of the CVS that were randomly administered to potential couples to determine eligibility and facilitate study enrollment. The protocol successfully enrolled 214 high risk couples into a multi-site public health study. This work suggests the importance of collaborating to construct a study protocol, understanding the local population and context, and drawing on

Protocol dependence of mechanical properties in granular systems.

PubMed

Inagaki, S; Otsuki, M; Sasa, S

2011-11-01

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

Protocol-based care: the standardisation of decision-making?

PubMed

Rycroft-Malone, Jo; Fontenla, Marina; Seers, Kate; Bick, Debra

2009-05-01

To explore how protocol-based care affects clinical decision-making. In the context of evidence-based practice, protocol-based care is a mechanism for facilitating the standardisation of care and streamlining decision-making through rationalising the information with which to make judgements and ultimately decisions. However, whether protocol-based care does, in the reality of practice, standardise decision-making is unknown. This paper reports on a study that explored the impact of protocol-based care on nurses' decision-making. Theoretically informed by realistic evaluation and the promoting action on research implementation in health services framework, a case study design using ethnographic methods was used. Two sites were purposively sampled; a diabetic and endocrine unit and a cardiac medical unit. Within each site, data collection included observation, postobservation semi-structured interviews with staff and patients, field notes, feedback sessions and document review. Data were inductively and thematically analysed. Decisions made by nurses in both sites were varied according to many different and interacting factors. While several standardised care approaches were available for use, in reality, a variety of information sources informed decision-making. The primary approach to knowledge exchange and acquisition was person-to-person; decision-making was a social activity. Rarely were standardised care approaches obviously referred to; nurses described following a mental flowchart, not necessarily linked to a particular guideline or protocol. When standardised care approaches were used, it was reported that they were used flexibly and particularised. While the logic of protocol-based care is algorithmic, in the reality of clinical practice, other sources of information supported nurses' decision-making process. This has significant implications for the political goal of standardisation. The successful implementation and judicious use of tools such as

Protocol to monitor trade agreement food-related aspects: the Fiji case study.

PubMed

Ravuvu, Amerita; Friel, Sharon; Thow, Anne Marie; Snowdon, Wendy; Wate, Jillian

2017-04-26

Despite the growing rates of obesity and diet-related non-communicable diseases, globally, public health attention has only relatively recently turned to the links between trade agreements and the nutritional risks associated with it. Specific trade agreements appear to have played an influential role in the volume and types of foods entering different countries, yet there is currently no systematic and objective monitoring of trade agreements for their impacts on food environments. Recently, INFORMAS was set up to monitor and benchmark food environments, government policies and private sector actions within countries and globally. One of its projects/modules focuses on trade policy and in particular the food-related aspects of trade agreements. This paper describes the INFORMAS trade protocol, an approach to collecting food-related information about four domains of trade: trade in goods; trade in services and foreign direct investment; domestic supports, and policy space. Specifically, the protocol is tested in Fiji. The development and testing of this protocol in Fiji represents the first effort to set out a framework and process for objectively monitoring trade agreements and their impacts on national food supply and the wider food environment. It has shown that entry into WTO trade agreements contributed to the nutrition transition in Fiji through the increased availability of imported foods with varying nutritional quality. We observed an increase in imports of both healthy and less healthy foods. The application of the monitoring protocol also highlights challenges for data collection associated with each trade domain that should be considered for future data collection and analysis in other low and middle income countries. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Eavesdropping on the improved three-party quantum secret sharing protocol

NASA Astrophysics Data System (ADS)

Gao, Gan

2011-02-01

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

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

PubMed

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

2015-02-01

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

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

NASA Astrophysics Data System (ADS)

Gu, Jun; Hwang, Tzonelih

2017-10-01

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

The effects of physical therapy with neuromuscular electrical stimulation in patients with septic shock: Study protocol for a randomized cross-over design.

PubMed

Lago, Alessandra Fabiane; de Oliveira, Anamaria Siriani; de Souza, Hugo Celso Dutra; da Silva, João Santana; Basile-Filho, Anibal; Gastaldi, Ada Clarice

2018-02-01

Septic shock is a potentially fatal organ dysfunction caused by an imbalance of the host response to infection. The changes in microcirculation during sepsis can be explained by the alterations in the endothelial barrier function. Endothelial progenitor cells (EPCs) are a potential recovery index of endothelial function and it an increase in response to neuromuscular electrical stimulation (NMES) was demonstrated. Therefore, the objective of this study is to investigate the effects of NMES in patients with septic shock. It is a study protocol for a randomized cross-over design in an intensive care unit of a tertiary University hospital. Thirty-one patients aged 18 to 65 years. The study will be divided in 2 phases: the phase one will be held in the first 72 hours of septic shock and the phase two after 3 days of first assessment. Patients will be randomly selected to the intervention protocol (decubitus position with the limbs raised and NMES) and control protocol (decubitus position with the limbs raised without NMES). After this procedure, the patients will be allocated in group 1 (intervention and control protocol) or group 2 (control and intervention protocol) with a wash-out period of 4 to 6 hours between them. The main outcome is mobilization of EPCs. The secondary outcome is metabolic and hemodynamic data. A linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.

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

PubMed

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

2016-06-01

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

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

PubMed Central

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

2016-01-01

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

An Evaluation of Protocol Enhancing Proxies and File Transport Protocols for Satellite Communication

NASA Technical Reports Server (NTRS)

Finch, Patrick Eugene; Sullivan, Donald; Ivancic, William D.

2012-01-01

NASA is utilizing Global Hawk aircraft in high-altitude, long-duration Earth science missions. Communications with the onboard research equipment and sensors (the science payload) is via Ku-Band radio utilizing satellites in geostationary orbits. All payload communications use standard Internet Protocols and routing, and much of the data to be transferred is comprised of very large files. The science community is interested in fully utilizing these communication links to retrieve data as quickly and reliably as possible. A test bed was developed at NASA Ames to evaluate modern transport protocols as well as Protocol Enhancing Proxies (PEPs) to determine what tools best fit the needs of the science community. This paper describes the test bed used, the protocols, the PEPs that were evaluated, the particular tests performed and the results and conclusions.

Short and long-term effectiveness of couple counselling: a study protocol

PubMed Central

2012-01-01

Background Healthy couple relationships are fundamental to a healthy society, whereas relationship breakdown and discord are linked to a wide range of negative health and wellbeing outcomes. Two types of relationship services (couple counselling and relationship education) have demonstrated efficacy in many controlled studies but evidence of the effectiveness of community-based relationship services has lagged behind. This study protocol describes an effectiveness evaluation of the two types of community-based relationship services. The aims of the Evaluation of Couple Counselling study are to: map the profiles of clients seeking agency-based couple counselling and relationship enhancement programs in terms of socio-demographic, relationship, health, and health service use indicators; to determine 3 and 12-month outcomes for relationship satisfaction, commitment, and depression; and determine relative contributions of client and therapy factors to outcomes. Methods/Design A quasi-experimental pre-post-post evaluation design is used to assess outcomes for couples presenting for the two types of community-based relationship services. The longitudinal design involves a pre-treatment survey and two follow-up surveys at 3- and 12-months post-intervention. The study is set in eight Relationships Australia Victoria centres, across metropolitan, outer suburbs, and regional/rural sites. Relationships Australia, a non-government organisation, is the largest provider of couple counselling and relationship services in Australia. The key outcomes are couple satisfaction, relationship commitment, and depression measured by the CESD-10. Multi-level modelling will be used to account for the dyadic nature of couple data. Discussion The study protocol describes the first large scale investigation of the effectiveness of two types of relationship services to be conducted in Australia. Its significance lies in providing more detailed profiles of couples who seek relationship services

Protocols for Automated Protist Analysis

DTIC Science & Technology

2011-12-01

Report No: CG-D-14-13 Protocols for Automated Protist Analysis December 2011 Distribution Statement A: Approved for public...release; distribution is unlimited. Protocols for Automated Protist Analysis ii UNCLAS//Public | CG-926 RDC | B. Nelson, et al. | Public...Director United States Coast Guard Research & Development Center 1 Chelsea Street New London, CT 06320 Protocols for Automated Protist Analysis

Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis.

PubMed

Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

2016-08-01

Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of seven papers

From policy to practice: implementing frontline community health services for substance dependence--study protocol.

PubMed

Gill, Kathryn J; Campbell, Emily; Gauthier, Gail; Xenocostas, Spyridoula; Charney, Dara; Macaulay, Ann C

2014-08-20

Substance abuse is a worldwide public health concern. Extensive scientific research has shown that screening and brief interventions for substance use disorders administered in primary care provide substantial benefit at relatively low cost. Frontline health clinicians are well placed to detect and treat patients with substance use disorders. Despite effectiveness shown in research, there are many factors that impact the implementation of these practices in real-world clinical practice. Recently, the Ministry of Health and Social Services in Quebec, Canada, issued two policy documents aimed at introducing screening and early intervention for substance abuse into frontline healthcare clinics in Quebec. The current research protocol was developed in order to study the process of implementation of evidence-based addiction treatment practices at three primary care clinics in Montreal (Phase 1). In addition, the research protocol was designed to examine the efficacy of overall policy implementation, including barriers and facilitators to addictions program development throughout Quebec (Phase 2). Phase 1 will provide an in-depth case study of knowledge translation and implementation. The study protocol will utilize an integrated knowledge translation strategy to build collaborative mechanisms for knowledge exchange between researchers, addiction specialists, and frontline practitioners (guided by the principles of participatory-action research), and directly examine the process of knowledge uptake and barriers to transfer using both qualitative and quantitative methodologies. Evaluation will involve multiple measures, time points and domains; program uptake and effectiveness will be determined by changes in healthcare service delivery, sustainability and outcomes. In Phase 2, qualitative methods will be utilized to examine the contextual facilitators and barriers that frontline organizations face in implementing services for substance dependence. Phase 2 will provide

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

PubMed

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

2014-07-01

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

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.

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.

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

PubMed

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

2013-05-07

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

Comparison of microdose flare-up and antagonist multiple-dose protocols for poor-responder patients: a randomized study.

PubMed

Demirol, Aygul; Gurgan, Timur

2009-08-01

To compare the efficacy of the microdose flare-up and multiple-dose antagonist protocols for poor-responder patients in intracytoplasmic sperm injection-ET cycles. A randomized, prospective study. Center for assisted reproductive technology in Turkey. Ninety patients with poor ovarian response in a minimum of two previous IVF cycles. All women were prospectively randomized into two groups by computer-assisted randomization. The patients in group 1 were stimulated according to the microdose flare-up protocol (n = 45), while the patients in group 2 were stimulated according to antagonist multiple-dose protocol (n = 45). The mean number of mature oocytes retrieved was the primary outcome measure, and fertilization rate, implantation rate per embryo, and clinical pregnancy rates were secondary outcome measures. The mean age of the women, the mean duration of infertility, basal FSH level, and the number of previous IVF cycles were similar in both groups. The total gonadotropin dose used was significantly higher in group 2, while the number of oocytes retrieved was significantly greater in group 1. Although the fertilization and clinical pregnancy rates were nonsignificantly higher in group 1 compared with group 2, the implantation rate was significantly higher in the microdose flare-up group than in the multiple-dose antagonist group (22% vs. 11%). The microdose flare-up protocol seems to have a better outcome in poor-responder patients, with a significantly higher mean number of mature oocytes retrieved and higher implantation rate.

GENERIC VERIFICATION PROTOCOL: DISTRIBUTED GENERATION AND COMBINED HEAT AND POWER FIELD TESTING PROTOCOL

EPA Science Inventory

This report is a generic verification protocol by which EPA’s Environmental Technology Verification program tests newly developed equipment for distributed generation of electric power, usually micro-turbine generators and internal combustion engine generators. The protocol will ...

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

ERIC Educational Resources Information Center

University of South Florida, Tampa.

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

The covert channel over HTTP protocol

NASA Astrophysics Data System (ADS)

Graniszewski, Waldemar; Krupski, Jacek; Szczypiorski, Krzysztof

2016-09-01

The paper presents a new steganographic method - the covert channel is created over HTTP protocol header, i.e. trailer field. HTTP protocol is one of the most frequently used in the Internet. The popularity of the Web servers and network traffic from, and to them, is one of the requirements for undetectable message exchange. To study this kind of the information hiding technique an application in Javascript language based on the Node.js framework was written. The results of the experiment that was performed to send a message in the covert channel are also presented.

Using generalizability theory to develop clinical assessment protocols.

PubMed

Preuss, Richard A

2013-04-01

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

Objective and automated protocols for the evaluation of biomedical search engines using No Title Evaluation protocols.

PubMed

Campagne, Fabien

2008-02-29

The evaluation of information retrieval techniques has traditionally relied on human judges to determine which documents are relevant to a query and which are not. This protocol is used in the Text Retrieval Evaluation Conference (TREC), organized annually for the past 15 years, to support the unbiased evaluation of novel information retrieval approaches. The TREC Genomics Track has recently been introduced to measure the performance of information retrieval for biomedical applications. We describe two protocols for evaluating biomedical information retrieval techniques without human relevance judgments. We call these protocols No Title Evaluation (NT Evaluation). The first protocol measures performance for focused searches, where only one relevant document exists for each query. The second protocol measures performance for queries expected to have potentially many relevant documents per query (high-recall searches). Both protocols take advantage of the clear separation of titles and abstracts found in Medline. We compare the performance obtained with these evaluation protocols to results obtained by reusing the relevance judgments produced in the 2004 and 2005 TREC Genomics Track and observe significant correlations between performance rankings generated by our approach and TREC. Spearman's correlation coefficients in the range of 0.79-0.92 are observed comparing bpref measured with NT Evaluation or with TREC evaluations. For comparison, coefficients in the range 0.86-0.94 can be observed when evaluating the same set of methods with data from two independent TREC Genomics Track evaluations. We discuss the advantages of NT Evaluation over the TRels and the data fusion evaluation protocols introduced recently. Our results suggest that the NT Evaluation protocols described here could be used to optimize some search engine parameters before human evaluation. Further research is needed to determine if NT Evaluation or variants of these protocols can fully substitute

Internet-Protocol-Based Satellite Bus Architecture Designed

NASA Technical Reports Server (NTRS)

Slywczak, Richard A.

2004-01-01

NASA is designing future complex satellite missions ranging from single satellites and constellations to space networks and sensor webs. These missions require more interoperability, autonomy, and coordination than previous missions; in addition, a desire exists to have scientists retrieve data directly from the satellite rather than a central distribution source. To meet these goals, NASA has been studying the possibility of extending the Transmission Control Protocol/Internet Protocol (TCP/IP) suite for spacebased applications.

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

DTIC Science & Technology

2007-06-01

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

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.

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

PubMed Central

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

2015-01-01

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

Evaluation of a single‐scan protocol for radiochromic film dosimetry

PubMed Central

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

2015-01-01

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

Optimization of the protocols for the use of contrast agents in PET/CT studies.

PubMed

Pelegrí Martínez, L; Kohan, A A; Vercher Conejero, J L

The introduction of PET/CT scanners in clinical practice in 1998 has improved care for oncologic patients throughout the clinical pathway, from the initial diagnosis of disease through the evaluation of the response to treatment to screening for possible recurrence. The CT component of a PET/CT study is used to correct the attenuation of PET studies; CT also provides anatomic information about the distribution of the radiotracer. CT is especially useful in situations where PET alone can lead to false positives and false negatives, and CT thereby improves the diagnostic performance of PET. The use of intravenous or oral contrast agents and optimal CT protocols have improved the detection and characterization of lesions. However, there are circumstances in which the systematic use of contrast agents is not justified. The standard acquisition in PET/CT scanners is the whole body protocol, but this can lead to artifacts due to the position of patients and respiratory movements between the CT and PET acquisitions. This article discusses these aspects from a constructive perspective with the aim of maximizing the diagnostic potential of PET/CT and providing better care for patients. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

Evaluating Protocol Lifecycle Time Intervals in HIV/AIDS Clinical Trials

PubMed Central

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

2014-01-01

Background Identifying efficacious interventions for the prevention and treatment of human diseases depends on the efficient development and implementation of controlled clinical trials. Essential to reducing the time and burden of completing the clinical trial lifecycle is determining which aspects take the longest, delay other stages, and may lead to better resource utilization without diminishing scientific quality, safety, or the protection of human subjects. Purpose In this study we modeled time-to-event data to explore relationships between clinical trial protocol development and implementation times, as well as identify potential correlates of prolonged development and implementation. Methods We obtained time interval and participant accrual data from 111 interventional clinical trials initiated between 2006 and 2011 by NIH’s HIV/AIDS Clinical Trials Networks. We determined the time (in days) required to complete defined phases of clinical trial protocol development and implementation. Kaplan-Meier estimates were used to assess the rates at which protocols reached specified terminal events, stratified by study purpose (therapeutic, prevention) and phase group (pilot/phase I, phase II, and phase III/ IV). We also examined several potential correlates to prolonged development and implementation intervals. Results Even though phase grouping did not determine development or implementation times of either therapeutic or prevention studies, overall we observed wide variation in protocol development times. Moreover, we detected a trend toward phase III/IV therapeutic protocols exhibiting longer developmental (median 2 ½ years) and implementation times (>3years). We also found that protocols exceeding the median number of days for completing the development interval had significantly longer implementation. Limitations The use of a relatively small set of protocols may have limited our ability to detect differences across phase groupings. Some timing effects

Protocol Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and

Quantum Tomography Protocols with Positivity are Compressed Sensing Protocols (Open Access)

DTIC Science & Technology

2015-12-08

ARTICLE OPEN Quantum tomography protocols with positivity are compressed sensing protocols Amir Kalev1, Robert L Kosut2 and Ivan H Deutsch1...Characterising complex quantum systems is a vital task in quantum information science. Quantum tomography, the standard tool used for this purpose, uses a well...designed measurement record to reconstruct quantum states and processes. It is, however, notoriously inefficient. Recently, the classical signal

Brazilian Samba Protocol for Individuals With Parkinson's Disease: A Clinical Non-Randomized Study.

PubMed

Tillmann, Ana Cristina; Andrade, Alexandro; Swarowsky, Alessandra; Guimarães, Adriana Coutinho De Azevedo

2017-07-04

In the 10 most populated countries in the world, Parkinson's disease (PD) affects more than 5 million individuals. Despite optimal treatment options already developed for the disease, concomitant involvement of other areas of health care plays an important role in complementing the treatment. From this perspective, dancing can be viewed as a non-drug alternative that can reduce falls by improving some motor skills, such as mobility, balance, gait, and posture, and can also improve the overall quality of life. Brazilian samba promotes improvement in motor and non-motor symptoms in individuals with PD, providing a new treatment option for this population. The main objective of this quasi-experimental study is to provide a 12-week samba protocol (2x/week) for individuals with PD and to compare its effects with the group without intervention. The hypothesis is that the Brazilian samba protocol will promote improvement in primary (motor) and secondary (non-motor) outcomes in individuals with PD. The sample will be selected at random from individuals diagnosed with PD in the city of Florianopolis (SC, Brazil). Sample size calculation was performed with the G*Power 3.1.9.2 software, with 0.447 effect size, at 5% significance level, power of 0.9, and test and sample loss of 20%. This yielded 60 individuals divided between the intervention and control groups. The questionnaires will be filled out before and after the dance intervention. The data collection for the control group will be held simultaneously to the intervention group. The classes will last for 1 hour, twice a week in the evening for 12 weeks, and all classes will be divided into warm-up, main part, and relaxation. Two-way analysis of variance with repeated measures and Sidak post-hoc comparison test will be used for a comparative analysis of the final results of the control group with the experimental group and of the within-group changes between pre- and postintervention period. We expect to complete follow

Application of two segmentation protocols during the processing of virtual images in rapid prototyping: ex vivo study with human dry mandibles.

PubMed

Ferraz, Eduardo Gomes; Andrade, Lucio Costa Safira; dos Santos, Aline Rode; Torregrossa, Vinicius Rabelo; Rubira-Bullen, Izabel Regina Fischer; Sarmento, Viviane Almeida

2013-12-01

The aim of this study was to evaluate the accuracy of virtual three-dimensional (3D) reconstructions of human dry mandibles, produced from two segmentation protocols ("outline only" and "all-boundary lines"). Twenty virtual three-dimensional (3D) images were built from computed tomography exam (CT) of 10 dry mandibles, in which linear measurements between anatomical landmarks were obtained and compared to an error probability of 5 %. The results showed no statistically significant difference among the dry mandibles and the virtual 3D reconstructions produced from segmentation protocols tested (p = 0,24). During the designing of a virtual 3D reconstruction, both "outline only" and "all-boundary lines" segmentation protocols can be used. Virtual processing of CT images is the most complex stage during the manufacture of the biomodel. Establishing a better protocol during this phase allows the construction of a biomodel with characteristics that are closer to the original anatomical structures. This is essential to ensure a correct preoperative planning and a suitable treatment.

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

PubMed

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

2017-06-15

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

[Computerized clinical protocol for occlusion].

PubMed

Salsench, J; Ferrer, J; Nogueras, J

1988-11-01

In making a protocol it is necessary that all members of the team who are going to collect information have the same unity of criterion about the different variables that compose it. The drawing up of this document is as much or more necessary than the protocol itself. In this work we all data collected in the protocol and we give the explanations of each concept.

Accuracy of prehospital triage protocols in selecting severely injured patients: A systematic review.

PubMed

van Rein, Eveline A J; Houwert, R Marijn; Gunning, Amy C; Lichtveld, Rob A; Leenen, Luke P H; van Heijl, Mark

2017-08-01

Prehospital trauma triage ensures proper transport of patients at risk of severe injury to hospitals with an appropriate corresponding level of trauma care. Incorrect triage results in undertriage and overtriage. The American College of Surgeons Committee on Trauma recommends an undertriage rate below 5% and an overtriage rate below 50% for prehospital trauma triage protocols. To find the most accurate prehospital trauma triage protocol, a clear overview of all currently available protocols and corresponding outcomes is necessary. The aim of this systematic review was to evaluate the current literature on all available prehospital trauma triage protocols and determine accuracy of protocol-based triage quality in terms of sensitivity and specificity. A search of Pubmed, Embase, and Cochrane Library databases was performed to identify all studies describing prehospital trauma triage protocols before November 2016. The search terms included "trauma," "trauma center," or "trauma system" combined with "triage," "undertriage," or "overtriage." All studies describing protocol-based triage quality were reviewed. To assess the quality of these type of studies, a new critical appraisal tool was developed. In this review, 21 articles were included with numbers of patients ranging from 130 to over 1 million. Significant predictors for severe injury were: vital signs, suspicion of certain anatomic injuries, mechanism of injury, and age. Sensitivity ranged from 10% to 100%; specificity from 9% to 100%. Nearly all protocols had a low sensitivity, thereby failing to identify severely injured patients. Additionally, the critical appraisal showed poor quality of the majority of included studies. This systematic review shows that nearly all protocols are incapable of identifying severely injured patients. Future studies of high methodological quality should be performed to improve prehospital trauma triage protocols. Systematic review, level III.

Families of quantum fingerprinting protocols

NASA Astrophysics Data System (ADS)

Lovitz, Benjamin; Lütkenhaus, Norbert

2018-03-01

We introduce several families of quantum fingerprinting protocols to evaluate the equality function on two n -bit strings in the simultaneous message passing model. The original quantum fingerprinting protocol uses a tensor product of a small number of O (logn ) -qubit high-dimensional signals [H. Buhrman et al., Phys. Rev. Lett. 87, 167902 (2001), 10.1103/PhysRevLett.87.167902], whereas a recently proposed optical protocol uses a tensor product of O (n ) single-qubit signals, while maintaining the O (logn ) information leakage of the original protocol [J. M. Arazola and N. Lütkenhaus, Phys. Rev. A 89, 062305 (2014), 10.1103/PhysRevA.89.062305]. We find a family of protocols which interpolate between the original and optical protocols while maintaining the O (logn ) information leakage, thus demonstrating a tradeoff between the number of signals sent and the dimension of each signal. There has been interest in experimental realization of the recently proposed optical protocol using coherent states [F. Xu et al., Nat. Commun. 6, 8735 (2015), 10.1038/ncomms9735; J.-Y. Guan et al., Phys. Rev. Lett. 116, 240502 (2016), 10.1103/PhysRevLett.116.240502], but as the required number of laser pulses grows linearly with the input size n , eventual challenges for the long-time stability of experimental setups arise. We find a coherent state protocol which reduces the number of signals by a factor 1/2 while also reducing the information leakage. Our reduction makes use of a simple modulation scheme in optical phase space, and we find that more complex modulation schemes are not advantageous. Using a similar technique, we improve a recently proposed coherent state protocol for evaluating the Euclidean distance between two real unit vectors [N. Kumar et al., Phys. Rev. A 95, 032337 (2017), 10.1103/PhysRevA.95.032337] by reducing the number of signals by a factor 1/2 and also reducing the information leakage.

Maternal antecedents of adiposity and studying the transgenerational role of hyperglycemia and insulin (MAASTHI): a prospective cohort study : Protocol of birth cohort at Bangalore, India.

PubMed

Babu, Giridhara R; Murthy, Gvs; Deepa, R; Yamuna; Prafulla; Kumar, H Kiran; Karthik, Maithili; Deshpande, Keerti; Benjamin Neelon, Sara E; Prabhakaran, D; Kurpad, Anura; Kinra, Sanjay

2016-10-14

India is experiencing an epidemic of obesity-hyperglycaemia, which coincides with child bearing age for women. The epidemic can be sustained and augmented through transgenerational transmission of adiposity and glucose intolerance in women. This presents an opportunity for exploring a clear strategy for the control of this epidemic in India. We conducted a study between November 2013 and May 2015 to inform the design of a large pregnancy cohort study. Based on the findings of this pilot, we developed the protocol for the proposed birth cohort of 5000 women, the recruitment for which will start in April 2016. The protocol of the study documents the processes which aim at advancing the available knowledge, linking several steps in the evolution of obesity led hyperglycemia. Maternal Antecedents of Adiposity and Studying the Transgenerational role of Hyperglycemia and Insulin (MAASTHI) is a cohort study in the public health facilities in Bangalore, India. The objective of MAASTHI is to prospectively assess the effects of glucose levels in pregnancy on the risk of adverse infant outcomes, especially in predicting the possible risk markers of later chronic diseases. The primary objective of the proposed study is to investigate the effect of glucose levels in pregnancy on skinfold thickness (adiposity) in infancy as a marker of future obesity and diabetes in offspring. The secondary objective is to assess the association between psychosocial environment of mothers and adverse neonatal outcomes including adiposity. The study aims to recruit 5000 pregnant women and follow them and their offspring for a period of 4 years. The institutional review board at The Indian Institute of Public Health (IIPH)-H, Bangalore, Public Health Foundation of India has approved the protocol. All participants are required to provide written informed consent. The findings from this study may help to address important questions on screening and management of high blood sugar in pregnancy. It

Developing family planning nurse practitioner protocols.

PubMed

Hawkins, J W; Roberto, D

1984-01-01

This article focuses on the process of development of protocols for family planning nurse practitioners. A rationale for the use of protocols, a definition of the types and examples, and the pros and cons of practice with protocols are presented. A how-to description for the development process follows, including methods and a suggested tool for critique and evaluation. The aim of the article is to assist nurse practitioners in developing protocols for their practice.

Protocol Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and

A case-crossover study of transient risk factors influence on occupational injuries: a study protocol based on a review of previous studies.

PubMed

Oesterlund, Anna H; Lander, Flemming; Lauritsen, Jens

2016-10-01

The occupational injury incident rate remains relatively high in the European Union. The case-crossover study gives a unique opportunity to study transient risk factors that normally would be very difficult to approach. Studies like this have been carried out in both America and Asia, but so far no relevant research has been conducted in Europe. Case-crossover studies of occupational injuries were collected from PubMed and Embase and read through. Previous experiences concerning method, exposure and outcome, time-related measurements and construction of the questionnaire were taken into account in the preparation of a pilot study. Consequently, experiences from the pilot study were used to design the study protocol. Approximately 2000 patients with an occupational injury will be recruited from the emergency departments in Herning and Odense, Denmark. A standardised questionnaire will be used to collect basic demographic data and information on eight transient risk factors. Based on previous studies and knowledge on occupational injuries the transient risk factors we chose to examine were: time pressure, performing a task with a different method/using unaccustomed technique, change in working surroundings, using a phone, disagreement, feeling ill, being distracted and using malfunctioning machinery/tools or work material. Exposure time 'just before the injury' will be compared with two control periods, 'previous day at the same time of the injury' (pair match) and the previous work week (usual frequency). This study protocol describes a unique opportunity to calculate the effect of transient risk factors on occupational injuries in a European setting. 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/

National Sample Assessment Protocols

ERIC Educational Resources Information Center

Ministerial Council on Education, Employment, Training and Youth Affairs (NJ1), 2012

2012-01-01

These protocols represent a working guide for planning and implementing national sample assessments in connection with the national Key Performance Measures (KPMs). The protocols are intended for agencies involved in planning or conducting national sample assessments and personnel responsible for administering associated tenders or contracts,…

Cryotherapy for acute ankle sprains: a randomised controlled study of two different icing protocols.

PubMed

Bleakley, C M; McDonough, S M; MacAuley, D C; Bjordal, J

2006-08-01

The use of cryotherapy in the management of acute soft tissue injury is largely based on anecdotal evidence. Preliminary evidence suggests that intermittent cryotherapy applications are most effective at reducing tissue temperature to optimal therapeutic levels. However, its efficacy in treating injured human subjects is not yet known. To compare the efficacy of an intermittent cryotherapy treatment protocol with a standard cryotherapy treatment protocol in the management of acute ankle sprains. Sportsmen (n = 44) and members of the general public (n = 45) with mild/moderate acute ankle sprains. Subjects were randomly allocated, under strictly controlled double blind conditions, to one of two treatment groups: standard ice application (n = 46) or intermittent ice application (n = 43). The mode of cryotherapy was standardised across groups and consisted of melting iced water (0 degrees C) in a standardised pack. Function, pain, and swelling were recorded at baseline and one, two, three, four, and six weeks after injury. Subjects treated with the intermittent protocol had significantly (p<0.05) less ankle pain on activity than those using a standard 20 minute protocol; however, one week after ankle injury, there were no significant differences between groups in terms of function, swelling, or pain at rest. Intermittent applications may enhance the therapeutic effect of ice in pain relief after acute soft tissue injury.

Danish method study on cervical screening in women offered HPV vaccination as girls (Trial23): a study protocol.

PubMed

Thamsborg, Lise Holst; Andersen, Berit; Larsen, Lise Grupe; Christensen, Jette; Johansen, Tonje; Hariri, Jalil; Christiansen, Sanne; Rygaard, Carsten; Lynge, Elsebeth

2018-05-26

The first birth cohorts of women offered human papillomavirus (HPV) vaccination as girls are now entering cervical screening. However, there is no international consensus on how to screen HPV vaccinated women. These women are better protected against cervical cancer and could therefore be offered less intensive screening. Primary HPV testing is more sensitive than cytology, allowing for a longer screening interval. The aim of Trial23 is to investigate if primary HPV testing with cytology triage of HPV positive samples is a reasonable screening scheme for women offered HPV vaccination as girls. Trial23 is a method study embedded in the existing cervical screening programme in four out of five Danish regions. Without affecting the screening programme, women born in 1994 are randomised to present screening with liquid-based cytology every third year (present programme arm) or present screening plus an HPV test (HPV arm). The study started 1 February 2017 and will run over three screening rounds corresponding to 7-8 years. The primary endpoint is cervical intraepithelial neoplasia grade 3 or above. The trial is undertaken as a non-inferiority study including intention-to-treat and per-protocol analyses. The potential effect of primary HPV screening with a 6-year interval will be calculated from the observed data. The study protocol has been submitted to the ethical committee and deemed a method study. All women are screened according to routine guidelines. The study will contribute new evidence on the future screening of HPV vaccinated birth cohorts of women. All results will be published in open-access journal. NCT03049553; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

PubMed

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

2014-08-01

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

Quantum protocols within Spekkens' toy model

NASA Astrophysics Data System (ADS)

Disilvestro, Leonardo; Markham, Damian

2017-05-01

Quantum mechanics is known to provide significant improvements in information processing tasks when compared to classical models. These advantages range from computational speedups to security improvements. A key question is where these advantages come from. The toy model developed by Spekkens [R. W. Spekkens, Phys. Rev. A 75, 032110 (2007), 10.1103/PhysRevA.75.032110] mimics many of the features of quantum mechanics, such as entanglement and no cloning, regarded as being important in this regard, despite being a local hidden variable theory. In this work, we study several protocols within Spekkens' toy model where we see it can also mimic the advantages and limitations shown in the quantum case. We first provide explicit proofs for the impossibility of toy bit commitment and the existence of a toy error correction protocol and consequent k -threshold secret sharing. Then, defining a toy computational model based on the quantum one-way computer, we prove the existence of blind and verified protocols. Importantly, these two last quantum protocols are known to achieve a better-than-classical security. Our results suggest that such quantum improvements need not arise from any Bell-type nonlocality or contextuality, but rather as a consequence of steering correlations.

Phase Transition in Protocols Minimizing Work Fluctuations

NASA Astrophysics Data System (ADS)

Solon, Alexandre P.; Horowitz, Jordan M.

2018-05-01

For two canonical examples of driven mesoscopic systems—a harmonically trapped Brownian particle and a quantum dot—we numerically determine the finite-time protocols that optimize the compromise between the standard deviation and the mean of the dissipated work. In the case of the oscillator, we observe a collection of protocols that smoothly trade off between average work and its fluctuations. However, for the quantum dot, we find that as we shift the weight of our optimization objective from average work to work standard deviation, there is an analog of a first-order phase transition in protocol space: two distinct protocols exchange global optimality with mixed protocols akin to phase coexistence. As a result, the two types of protocols possess qualitatively different properties and remain distinct even in the infinite duration limit: optimal-work-fluctuation protocols never coalesce with the minimal-work protocols, which therefore never become quasistatic.

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

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

Tseng, H; Fan, J; Kupinski, M

2015-06-15

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

40 CFR 161.70 - Acceptable protocols.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Development (OECD) Protocols. Tests conducted in accordance with the requirements and recommendations of the... data generated by the study will satisfy the requirements of this part. (c) Procedures for requesting...

Study protocol for the recruitment of female sex workers and their non-commercial partners into couple-based HIV research

PubMed Central

2012-01-01

Background Researchers are increasingly recognizing the importance of addressing sexual and drug-related HIV risk within the context of intimate relationships rather than solely focusing on individual behaviors. Practical and effective methods are needed to recruit, screen, and enroll the high risk and hard-to-reach couples who would most benefit from HIV interventions, such as drug-using female sex workers (FSWs) and their intimate, non-commercial partners. This paper outlines a bi-national, multidisciplinary effort to develop and implement a study protocol for research on the social context and epidemiology of HIV, sexually transmitted infections (STI), and high risk behaviors among FSWs and their non-commercial male partners in Tijuana and Ciudad Juarez, Mexico. We provide an overview of our study and specifically focus on the sampling, recruitment, screening, and successful enrollment of high risk couples into a public health study in this context. Methods/Design We used targeted and snowball sampling to recruit couples through the female partner first and administered a primary screener to check her initial eligibility. Willing and eligible females then invited their primary male partners for couple-based screening using a couple verification screening (CVS) instrument adapted from previous studies. The CVS rechecked eligibility and separately asked each partner the same questions about their relationship to "test" if the couple was legitimate. We adapted the original protocol to consider issues of gender and power within the local cultural and socioeconomic context and expanded the question pool to create multiple versions of the CVS that were randomly administered to potential couples to determine eligibility and facilitate study enrollment. Discussion The protocol successfully enrolled 214 high risk couples into a multi-site public health study. This work suggests the importance of collaborating to construct a study protocol, understanding the local

A Security Analysis of the 802.11s Wireless Mesh Network Routing Protocol and Its Secure Routing Protocols

PubMed Central

Tan, Whye Kit; Lee, Sang-Gon; Lam, Jun Huy; Yoo, Seong-Moo

2013-01-01

Wireless mesh networks (WMNs) can act as a scalable backbone by connecting separate sensor networks and even by connecting WMNs to a wired network. The Hybrid Wireless Mesh Protocol (HWMP) is the default routing protocol for the 802.11s WMN. The routing protocol is one of the most important parts of the network, and it requires protection, especially in the wireless environment. The existing security protocols, such as the Broadcast Integrity Protocol (BIP), Counter with cipher block chaining message authentication code protocol (CCMP), Secure Hybrid Wireless Mesh Protocol (SHWMP), Identity Based Cryptography HWMP (IBC-HWMP), Elliptic Curve Digital Signature Algorithm HWMP (ECDSA-HWMP), and Watchdog-HWMP aim to protect the HWMP frames. In this paper, we have analyzed the vulnerabilities of the HWMP and developed security requirements to protect these identified vulnerabilities. We applied the security requirements to analyze the existing secure schemes for HWMP. The results of our analysis indicate that none of these protocols is able to satisfy all of the security requirements. We also present a quantitative complexity comparison among the protocols and an example of a security scheme for HWMP to demonstrate how the result of our research can be utilized. Our research results thus provide a tool for designing secure schemes for the HWMP. PMID:24002231

A security analysis of the 802.11s wireless mesh network routing protocol and its secure routing protocols.

PubMed

Tan, Whye Kit; Lee, Sang-Gon; Lam, Jun Huy; Yoo, Seong-Moo

2013-09-02

Wireless mesh networks (WMNs) can act as a scalable backbone by connecting separate sensor networks and even by connecting WMNs to a wired network. The Hybrid Wireless Mesh Protocol (HWMP) is the default routing protocol for the 802.11s WMN. The routing protocol is one of the most important parts of the network, and it requires protection, especially in the wireless environment. The existing security protocols, such as the Broadcast Integrity Protocol (BIP), Counter with cipher block chaining message authentication code protocol (CCMP), Secure Hybrid Wireless Mesh Protocol (SHWMP), Identity Based Cryptography HWMP (IBC-HWMP), Elliptic Curve Digital Signature Algorithm HWMP (ECDSA-HWMP), and Watchdog-HWMP aim to protect the HWMP frames. In this paper, we have analyzed the vulnerabilities of the HWMP and developed security requirements to protect these identified vulnerabilities. We applied the security requirements to analyze the existing secure schemes for HWMP. The results of our analysis indicate that none of these protocols is able to satisfy all of the security requirements. We also present a quantitative complexity comparison among the protocols and an example of a security scheme for HWMP to demonstrate how the result of our research can be utilized. Our research results thus provide a tool for designing secure schemes for the HWMP.

In-memory interconnect protocol configuration registers

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

Cheng, Kevin Y.; Roberts, David A.

Systems, apparatuses, and methods for moving the interconnect protocol configuration registers into the main memory space of a node. The region of memory used for storing the interconnect protocol configuration registers may also be made cacheable to reduce the latency of accesses to the interconnect protocol configuration registers. Interconnect protocol configuration registers which are used during a startup routine may be prefetched into the host's cache to make the startup routine more efficient. The interconnect protocol configuration registers for various interconnect protocols may include one or more of device capability tables, memory-side statistics (e.g., to support two-level memory data mappingmore » decisions), advanced memory and interconnect features such as repair resources and routing tables, prefetching hints, error correcting code (ECC) bits, lists of device capabilities, set and store base address, capability, device ID, status, configuration, capabilities, and other settings.« less

Development of Uniform Protocol for Alopecia Areata Clinical Trials.

PubMed

Solomon, James A

2015-11-01

Developing a successful treatment for alopecia areata (AA), clearly has not been at the forefront of the agenda for new drug/device development among the pharmaceutical and medical device industry. The National Alopecia Areata Foundation (NAAF), a patient advocacy group, initiated a plan to facilitate and drive clinical research toward finding safe and efficacious treatments for AA. As such, Alopecia Areata Uniform Protocols for clinical trials to test new treatments for AA were developed. The design of the uniform protocol is to accomplish the development of a plug-and-play template as well as to provide a framework wherein data from studies utilizing the uniform protocol can be compared through consistency of inclusions/exclusions, safety, and outcome assessment measures. A core uniform protocol for use by pharmaceutical companies in testing proof of concept for investigational products to treat AA. The core protocol includes standardized title, informed consent, inclusion/exclusion criteria, disease outcome assessments, and safety assessments. The statistical methodology to assess successful outcomes will also be standardized. The protocol as well as the informed consent form has been approved in concept by Liberty IRB and is ready to present to pharmaceutical companies.

The Network Protocol Analysis Technique in Snort

NASA Astrophysics Data System (ADS)

Wu, Qing-Xiu

Network protocol analysis is a network sniffer to capture data for further analysis and understanding of the technical means necessary packets. Network sniffing is intercepted by packet assembly binary format of the original message content. In order to obtain the information contained. Required based on TCP / IP protocol stack protocol specification. Again to restore the data packets at protocol format and content in each protocol layer. Actual data transferred, as well as the application tier.

The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

PubMed

Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

2015-07-01

The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

Spacelab system analysis: The modified free access protocol: An access protocol for communication systems with periodic and Poisson traffic

NASA Technical Reports Server (NTRS)

Ingels, Frank; Owens, John; Daniel, Steven

1989-01-01

The protocol definition and terminal hardware for the modified free access protocol, a communications protocol similar to Ethernet, are developed. A MFA protocol simulator and a CSMA/CD math model are also developed. The protocol is tailored to communication systems where the total traffic may be divided into scheduled traffic and Poisson traffic. The scheduled traffic should occur on a periodic basis but may occur after a given event such as a request for data from a large number of stations. The Poisson traffic will include alarms and other random traffic. The purpose of the protocol is to guarantee that scheduled packets will be delivered without collision. This is required in many control and data collection systems. The protocol uses standard Ethernet hardware and software requiring minimum modifications to an existing system. The modification to the protocol only affects the Ethernet transmission privileges and does not effect the Ethernet receiver.

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

PubMed Central

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

2014-01-01

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

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees

PubMed Central

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-01-01

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. PMID:26811365

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

NASA Astrophysics Data System (ADS)

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

2017-01-01

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

Protocol Coordinator | Center for Cancer Research

Cancer.gov

diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. KEY ROLES/RESPONSIBILITIES The Protocol Coordinator II: Provides comprehensive clinical and administrative support to the Brain Tumor Trial Collaborative, Neuro-Oncology Branch, NCI, National Institutes of Health Serves as a liaison with Principal Investigators (PIs), the associated study teams and a variety of offices associated with protocol development and approvals Orchestrates meetings with investigators and other key medical staff to identify required support Coordinates the writing and regulatory review processes that occur in tandem, facilitates the bi-directional dialogue and feedback between various teams, and assists investigators and medical writers on the production/revision of clinical research protocols Assists research staff in coordinating/navigating requirements for special circumstances and facilitates access to necessary services Facilitates initiation of intramural research by providing assistance in obtaining required approvals Coordinates with investigators and medical writers to ensure Institutional Review Board (IRB) and Food and Drug Administration (FDA) stipulations are appropriately addressed in a timely manner Provides consultation and assistance for all aspects of the protocol lifecycle including initial Investigational New Drug (IND) submission, IRB submission, continuing review applications, protocol amendments, annual reports, and protocol inactivation with IRB and FDA Tracks a portfolio of protocols through each lifecycle step; processes and tracks appropriate approvals (e.g., IRB, Data and Safety Monitoring Board, Radiation Safety, Office of Protocol Services, etc.) Provides

Judges' Agreement and Disagreement Patterns When Encoding Verbal Protocols.

ERIC Educational Resources Information Center

Schael, Jocelyne; Dionne, Jean-Paul

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

In silico toxicology protocols.

PubMed

Myatt, Glenn J; Ahlberg, Ernst; Akahori, Yumi; Allen, David; Amberg, Alexander; Anger, Lennart T; Aptula, Aynur; Auerbach, Scott; Beilke, Lisa; Bellion, Phillip; Benigni, Romualdo; Bercu, Joel; Booth, Ewan D; Bower, Dave; Brigo, Alessandro; Burden, Natalie; Cammerer, Zoryana; Cronin, Mark T D; Cross, Kevin P; Custer, Laura; Dettwiler, Magdalena; Dobo, Krista; Ford, Kevin A; Fortin, Marie C; Gad-McDonald, Samantha E; Gellatly, Nichola; Gervais, Véronique; Glover, Kyle P; Glowienke, Susanne; Van Gompel, Jacky; Gutsell, Steve; Hardy, Barry; Harvey, James S; Hillegass, Jedd; Honma, Masamitsu; Hsieh, Jui-Hua; Hsu, Chia-Wen; Hughes, Kathy; Johnson, Candice; Jolly, Robert; Jones, David; Kemper, Ray; Kenyon, Michelle O; Kim, Marlene T; Kruhlak, Naomi L; Kulkarni, Sunil A; Kümmerer, Klaus; Leavitt, Penny; Majer, Bernhard; Masten, Scott; Miller, Scott; Moser, Janet; Mumtaz, Moiz; Muster, Wolfgang; Neilson, Louise; Oprea, Tudor I; Patlewicz, Grace; Paulino, Alexandre; Lo Piparo, Elena; Powley, Mark; Quigley, Donald P; Reddy, M Vijayaraj; Richarz, Andrea-Nicole; Ruiz, Patricia; Schilter, Benoit; Serafimova, Rositsa; Simpson, Wendy; Stavitskaya, Lidiya; Stidl, Reinhard; Suarez-Rodriguez, Diana; Szabo, David T; Teasdale, Andrew; Trejo-Martin, Alejandra; Valentin, Jean-Pierre; Vuorinen, Anna; Wall, Brian A; Watts, Pete; White, Angela T; Wichard, Joerg; Witt, Kristine L; Woolley, Adam; Woolley, David; Zwickl, Craig; Hasselgren, Catrin

2018-07-01

The present publication surveys several applications of in silico (i.e., computational) toxicology approaches across different industries and institutions. It highlights the need to develop standardized protocols when conducting toxicity-related predictions. This contribution articulates the information needed for protocols to support in silico predictions for major toxicological endpoints of concern (e.g., genetic toxicity, carcinogenicity, acute toxicity, reproductive toxicity, developmental toxicity) across several industries and regulatory bodies. Such novel in silico toxicology (IST) protocols, when fully developed and implemented, will ensure in silico toxicological assessments are performed and evaluated in a consistent, reproducible, and well-documented manner across industries and regulatory bodies to support wider uptake and acceptance of the approaches. The development of IST protocols is an initiative developed through a collaboration among an international consortium to reflect the state-of-the-art in in silico toxicology for hazard identification and characterization. A general outline for describing the development of such protocols is included and it is based on in silico predictions and/or available experimental data for a defined series of relevant toxicological effects or mechanisms. The publication presents a novel approach for determining the reliability of in silico predictions alongside experimental data. In addition, we discuss how to determine the level of confidence in the assessment based on the relevance and reliability of the information. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Electroacupuncture versus sham electroacupuncture for urinary retention in poststroke patients: study protocol for a multicenter, randomized controlled trial.

PubMed

Shin, Seungwon; Lee, Jiwon; Yoo, Junghee; Lim, Sung Min; Lee, Euiju

2016-04-12

This study protocol evaluates the effectiveness of adjuvant electroacupuncture (EA) for urinary retention in poststroke patients undergoing conventional treatments, in comparison with that of a sham control. A multicenter, blinded, randomized controlled trial will be conducted in three hospitals in the Republic of Korea. We are recruiting 54 stroke survivors (aged >19 years), who were diagnosed with urinary retention based on the results of two consecutive post-void residual (PVR) tests, and dividing them randomly into two arms: the EA and Park-sham control groups. They will receive ten sessions of EA or sham treatment for 2 weeks. The participants will be blinded with non-penetrating needles and fake sounds of EA stimulators. The daily PVR ratio will be primarily measured at baseline and at the end of the study to statistically test the effectiveness of EA for poststroke urinary retention. Then, the Korean version of the Qualiveen Questionnaire, the Korean version of the International Prostate Symptom Score, and the blinding index will be assessed. After each EA session or sham EA, adverse events will be reported to evaluate the safety of EA. Results will be analyzed by using the independent t-test or Mann-Whitney U test, based on both intention-to-treat and per-protocol principles. The findings will provide clinical evidence for the effectiveness of EA treatment to improve urinary retention in stroke survivors. This study protocol was registered in ClinicalTrials.gov (NCT02472288) on 10 June 2015.

Protocol deviations before and after IV tPA in community hospitals

PubMed Central

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

2015-01-01

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

The Decremental Protocol as an Alternative Protocol to Measure Maximal Oxygen Consumption in Athletes.

PubMed

Taylor, Katrina; Seegmiller, Jeffrey; Vella, Chantal A

2016-11-01

To determine whether a decremental protocol could elicit a higher maximal oxygen consumption (VO 2 max) than an incremental protocol in trained participants. A secondary aim was to examine whether cardiac-output (Q) and stroke-volume (SV) responses differed between decremental and incremental protocols in this sample. Nineteen runners/triathletes were randomized to either the decremental or incremental group. All participants completed an initial incremental VO 2 max test on a treadmill, followed by a verification phase. The incremental group completed 2 further incremental tests. The decremental group completed a second VO 2 max test using the decremental protocol, based on their verification phase. The decremental group then completed a final incremental test. During each test, VO 2 , ventilation, and heart rate were measured, and cardiac variables were estimated with thoracic bioimpedance. Repeated-measures analysis of variance was conducted with an alpha level set at .05. There were no significant main effects for group (P = .37) or interaction (P = .10) over time (P = .45). VO 2 max was similar between the incremental (57.29 ± 8.94 mL · kg -1 · min -1 ) and decremental (60.82 ± 8.49 mL · kg -1 · min -1 ) groups over time. Furthermore, Q and SV were similar between the incremental (Q 22.72 ± 5.85 L/min, SV 119.64 ± 33.02 mL/beat) and decremental groups (Q 20.36 ± 4.59 L/min, SV 109.03 ± 24.27 mL/beat) across all 3 trials. The findings suggest that the decremental protocol does not elicit higher VO 2 max than an incremental protocol but may be used as an alternative protocol to measure VO 2 max in runners and triathletes.

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

PubMed

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

2012-10-04

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

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

PubMed

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

2016-09-01

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

The Physiological Bases of Hidden Noise-Induced Hearing Loss: Protocol for a Functional Neuroimaging Study.

PubMed

Dewey, Rebecca Susan; Hall, Deborah A; Guest, Hannah; Prendergast, Garreth; Plack, Christopher J; Francis, Susan T

2018-03-09

Rodent studies indicate that noise exposure can cause permanent damage to synapses between inner hair cells and high-threshold auditory nerve fibers, without permanently altering threshold sensitivity. These demonstrations of what is commonly known as hidden hearing loss have been confirmed in several rodent species, but the implications for human hearing are unclear. Our Medical Research Council-funded program aims to address this unanswered question, by investigating functional consequences of the damage to the human peripheral and central auditory nervous system that results from cumulative lifetime noise exposure. Behavioral and neuroimaging techniques are being used in a series of parallel studies aimed at detecting hidden hearing loss in humans. The planned neuroimaging study aims to (1) identify central auditory biomarkers associated with hidden hearing loss; (2) investigate whether there are any additive contributions from tinnitus or diminished sound tolerance, which are often comorbid with hearing problems; and (3) explore the relation between subcortical functional magnetic resonance imaging (fMRI) measures and the auditory brainstem response (ABR). Individuals aged 25 to 40 years with pure tone hearing thresholds ≤20 dB hearing level over the range 500 Hz to 8 kHz and no contraindications for MRI or signs of ear disease will be recruited into the study. Lifetime noise exposure will be estimated using an in-depth structured interview. Auditory responses throughout the central auditory system will be recorded using ABR and fMRI. Analyses will focus predominantly on correlations between lifetime noise exposure and auditory response characteristics. This paper reports the study protocol. The funding was awarded in July 2013. Enrollment for the study described in this protocol commenced in February 2017 and was completed in December 2017. Results are expected in 2018. This challenging and comprehensive study will have the potential to impact diagnostic

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

PubMed

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

2014-10-15

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

Group schema therapy for eating disorders: study protocol.

PubMed

Calvert, Fiona; Smith, Evelyn; Brockman, Rob; Simpson, Susan

2018-01-01

The treatment of eating disorders is a difficult endeavor, with only a relatively small proportion of clients responding to and completing standard cognitive behavioural therapy (CBT). Given the prevalence of co-morbidity and complex personality traits in this population, Schema Therapy has been identified as a potentially viable treatment option. A case series of Group Schema Therapy for Eating Disorders (ST-E-g) yielded positive findings and the study protocol outlined in this article aims to extend upon these preliminary findings to evaluate group Schema Therapy for eating disorders in a larger sample ( n  = 40). Participants undergo a two-hour assessment where they complete a number of standard questionnaires and their diagnostic status is ascertained using the Eating Disorder Examination. Participants then commence treatment, which consists of 25 weekly group sessions lasting for 1.5 h and four individual sessions. Each group consists of five to eight participants and is facilitated by two therapists, at least one of who is a registered psychologist trained on schema therapy. The primary outcome in this study is eating disorder symptom severity. Secondary outcomes include: cognitive schemas, self-objectification, general quality of life, self-compassion, schema mode presentations, and Personality Disorder features. Participants complete psychological measures and questionnaires at pre, post, six-month and 1-year follow-up. This study will expand upon preliminary research into the efficacy of group Schema Therapy for individuals with eating disorders. If group Schema Therapy is shown to reduce eating disorder symptoms, it will hold considerable promise as an intervention option for a group of disorders that is typically difficult to treat. ACTRN12615001323516. Registered: 2/12/2015 (retrospectively registered, still recruiting).

The Wiley Protocol: an analysis of ethical issues.

PubMed

Rosenthal, M Sara

2008-01-01

: This review explores the ethical issues surrounding an unregulated protocol that is advertised to women through consumer books, the popular press, and the Internet, known as the Wiley Protocol. : A content analysis of relevant documents was conducted, followed by telephone interviews with investigators and former participants to verify facts. : The Wiley Protocol is an example of unregulated research involving potentially unsafe doses of bioidentical hormones applied to an unselected population of women. This protocol fails to use research ethics guidelines such as informed consent, investigator expertise, sound methodology, standardized data collection, and data safety monitoring. : Clinical ethics breaches include lack of full disclosure of risks, coercive influences, as well as misinformation about the study goals and safety. Breaches of professional ethics include conflicts of interest with respect to financial incentives, patient accrual, and inadequate standards of awareness and proficiency among participating investigators. It appears evident that the failure to regulate nutriceuticals and products of compounding pharmacy has provided the opportunity for these ethical violations.

[Study protocol of a prevention of recurrent suicidal behaviour program based on case management (PSyMAC)].

PubMed

Sáiz, Pilar A; Rodríguez-Revuelta, Julia; González-Blanco, Leticia; Burón, Patricia; Al-Halabí, Susana; Garrido, Marlen; García-Alvarez, Leticia; García-Portilla, Paz; Bobes, Julio

2014-01-01

Prevention of suicidal behaviour is a public health priority in the European Union. A previous suicide attempt is the best risk predictor for future attempts, as well as completed suicides. The primary aim of this article is to describe a controlled study protocol designed for prevention of recurrent suicidal behaviour that proposes case management, and includes a psychoeducation program, as compared with the standard intervention (PSyMAC). Patients admitted from January 2011 to June 2013 to the emergency room of the Hospital Universitario Central de Asturias were evaluated using a protocol including sociodemographic, psychiatric, and psychosocial assessment. Patients were randomly assigned to either a group receiving continuous case management including participation in a psychoeducation program (experimental group), or a control group receiving standard care. The primary objective is to examine whether or not the period of time until recurrent suicidal behaviour in the experimental group is significantly different from that of the control group. PSyMAC proposes low cost and easily adaptable interventions to the usual clinical setting that can help to compensate the shortcoming of specific action protocols and suicidal behaviour prevention programs in our country. The evaluation of PSyMAC results will determine their real effectivity as a case-magament program to reduce suicidal risk. Copyright © 2013 SEP y SEPB. Published by Elsevier España. All rights reserved.

Birth cohort study on the effects of desert dust exposure on children's health: protocol of an adjunct study of the Japan Environment & Children's Study.

PubMed

Kanatani, Kumiko T; Adachi, Yuichi; Sugimoto, Nobuo; Noma, Hisashi; Onishi, Kazunari; Hamazaki, Kei; Takahashi, Yoshimitsu; Ito, Isao; Egawa, Miho; Sato, Keiko; Go, Tohshin; Kurozawa, Youichi; Inadera, Hidekuni; Konishi, Ikuo; Nakayama, Takeo

2014-06-23

Desert dust is estimated to constitute about 35% of aerosol in the troposphere. Desertification, climatic variability and global warming all can contribute to increased dust formation. This study aims to examine possible health effects of desert dust exposure on pregnant women and their children. The purpose of this report was to present the study protocol. This 4-year birth cohort study began in 2011 as an adjunct study of the Japan Environment & Children's Study (JECS) involving three regions: Kyoto, Toyama and Tottori. The JECS participants of the three regions above who also agreed to participate in this adjunct study were enrolled prior to delivery. Light Detecting and Ranging (LIDAR) with a polarisation analyser, which can distinguish mineral dust particles from other particles, is used for exposure measurements. Outcomes are allergic symptoms for mothers and development of asthma and other allergic or respiratory diseases for their children. Data are acquired in a timely manner by connecting local LIDAR equipment to an online questionnaire system. Participants answer the online questionnaire using mobile phones or personal computers. The study protocol was approved by the ethics committees of Kyoto University, University of Toyama and Tottori University. All participants provided written informed consent. The results of this study will be published in peer-reviewed journals and disseminated to the scientific community and general public. UMIN000010826. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Instructor Handbook for the Protocol Modules on Classroom Management. Utah Protocol Materials Project.

ERIC Educational Resources Information Center

Langer, Philip; Borg, Walter R.

This handbook is designed to acquaint the teacher educator with the training materials in classroom management prepared by the Utah State University Protocol Training Project. It deals with the protocol materials generally and with each module specifically, and includes the following sections: (a) an introduction to and rationale for protocol…

Cryotherapy for acute ankle sprains: a randomised controlled study of two different icing protocols

PubMed Central

Bleakley, C M; McDonough, S M; MacAuley, D C

2006-01-01

Background The use of cryotherapy in the management of acute soft tissue injury is largely based on anecdotal evidence. Preliminary evidence suggests that intermittent cryotherapy applications are most effective at reducing tissue temperature to optimal therapeutic levels. However, its efficacy in treating injured human subjects is not yet known. Objective : To compare the efficacy of an intermittent cryotherapy treatment protocol with a standard cryotherapy treatment protocol in the management of acute ankle sprains. Subjects Sportsmen (n  =  44) and members of the general public (n  =  45) with mild/moderate acute ankle sprains. Methods Subjects were randomly allocated, under strictly controlled double blind conditions, to one of two treatment groups: standard ice application (n  =  46) or intermittent ice application (n  =  43). The mode of cryotherapy was standardised across groups and consisted of melting iced water (0°C) in a standardised pack. Function, pain, and swelling were recorded at baseline and one, two, three, four, and six weeks after injury. Results Subjects treated with the intermittent protocol had significantly (p<0.05) less ankle pain on activity than those using a standard 20 minute protocol; however, one week after ankle injury, there were no significant differences between groups in terms of function, swelling, or pain at rest. Conclusion Intermittent applications may enhance the therapeutic effect of ice in pain relief after acute soft tissue injury. PMID:16611722

Using the intervention mapping protocol to reduce European preschoolers' sedentary behavior, an application to the ToyBox-Study.

PubMed

De Decker, Ellen; De Craemer, Marieke; De Bourdeaudhuij, Ilse; Verbestel, Vera; Duvinage, Kristin; Iotova, Violeta; Grammatikaki, Evangelia; Wildgruber, Andreas; Mouratidou, Theodora; Manios, Yannis; Cardon, Greet

2014-02-19

High levels of sedentary behavior are often measured in preschoolers, but only a few interventions have been developed to counteract this. Furthermore, detailed descriptions of interventions in preschoolers targeting different forms of sedentary behavior could not be located in the literature. The aim of the present paper was to describe the different steps of the Intervention Mapping Protocol used towards the development of an intervention component of the ToyBox-study focusing on decreasing preschoolers' sedentary behavior. The ToyBox-study focuses on the prevention of overweight in 4- to 6-year-old children by implementing a multi-component kindergarten-based intervention with family involvement in six different European countries. Applying the Intervention Mapping Protocol, six different steps were systematically completed for the structured planning and development of the intervention. A literature search and results from focus groups with parents/caregivers and kindergarten teachers were used as a guide during the development of the intervention and the intervention materials. The application of the different steps in the Intervention Mapping Protocol resulted in the creation of matrices of change objectives, followed by the selection of practical applications for five different intervention tools that could be used at the individual level of the preschool child, at the interpersonal level (i.e., parents/caregivers) and at the organizational level (i.e., kindergarten teachers). No cultural differences regarding preschoolers' sedentary behavior were identified between the participating countries during the focus groups, so cultural and local adaptations of the intervention materials were not necessary to improve the adoption and implementation of the intervention. A systematic and evidence-based approach was used for the development of this kindergarten-based family-involved intervention targeting preschoolers, with the inclusion of parental involvement. The

Using the intervention mapping protocol to reduce European preschoolers’ sedentary behavior, an application to the ToyBox-Study

PubMed Central

2014-01-01

Background High levels of sedentary behavior are often measured in preschoolers, but only a few interventions have been developed to counteract this. Furthermore, detailed descriptions of interventions in preschoolers targeting different forms of sedentary behavior could not be located in the literature. The aim of the present paper was to describe the different steps of the Intervention Mapping Protocol used towards the development of an intervention component of the ToyBox-study focusing on decreasing preschoolers’ sedentary behavior. The ToyBox-study focuses on the prevention of overweight in 4- to 6-year-old children by implementing a multi-component kindergarten-based intervention with family involvement in six different European countries. Methods Applying the Intervention Mapping Protocol, six different steps were systematically completed for the structured planning and development of the intervention. A literature search and results from focus groups with parents/caregivers and kindergarten teachers were used as a guide during the development of the intervention and the intervention materials. Results The application of the different steps in the Intervention Mapping Protocol resulted in the creation of matrices of change objectives, followed by the selection of practical applications for five different intervention tools that could be used at the individual level of the preschool child, at the interpersonal level (i.e., parents/caregivers) and at the organizational level (i.e., kindergarten teachers). No cultural differences regarding preschoolers’ sedentary behavior were identified between the participating countries during the focus groups, so cultural and local adaptations of the intervention materials were not necessary to improve the adoption and implementation of the intervention. Conclusions A systematic and evidence-based approach was used for the development of this kindergarten-based family-involved intervention targeting preschoolers, with

Birth cohort study on the effects of desert dust exposure on children's health: protocol of an adjunct study of the Japan Environment & Children’s Study

PubMed Central

Kanatani, Kumiko T; Adachi, Yuichi; Sugimoto, Nobuo; Noma, Hisashi; Onishi, Kazunari; Hamazaki, Kei; Takahashi, Yoshimitsu; Ito, Isao; Egawa, Miho; Sato, Keiko; Go, Tohshin; Kurozawa, Youichi; Inadera, Hidekuni; Konishi, Ikuo; Nakayama, Takeo

2014-01-01

Introduction Desert dust is estimated to constitute about 35% of aerosol in the troposphere. Desertification, climatic variability and global warming all can contribute to increased dust formation. This study aims to examine possible health effects of desert dust exposure on pregnant women and their children. The purpose of this report was to present the study protocol. Methods and analysis This 4-year birth cohort study began in 2011 as an adjunct study of the Japan Environment & Children’s Study (JECS) involving three regions: Kyoto, Toyama and Tottori. The JECS participants of the three regions above who also agreed to participate in this adjunct study were enrolled prior to delivery. Light Detecting and Ranging (LIDAR) with a polarisation analyser, which can distinguish mineral dust particles from other particles, is used for exposure measurements. Outcomes are allergic symptoms for mothers and development of asthma and other allergic or respiratory diseases for their children. Data are acquired in a timely manner by connecting local LIDAR equipment to an online questionnaire system. Participants answer the online questionnaire using mobile phones or personal computers. Ethics and dissemination The study protocol was approved by the ethics committees of Kyoto University, University of Toyama and Tottori University. All participants provided written informed consent. The results of this study will be published in peer-reviewed journals and disseminated to the scientific community and general public. Trial Registration number UMIN000010826. PMID:24958210

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.

21 CFR 1301.18 - Research protocols.

Code of Federal Regulations, 2014 CFR

2014-04-01

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

21 CFR 1301.18 - Research protocols.

Code of Federal Regulations, 2011 CFR

2011-04-01

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

21 CFR 1301.18 - Research protocols.

Code of Federal Regulations, 2010 CFR

2010-04-01

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

21 CFR 1301.18 - Research protocols.

Code of Federal Regulations, 2013 CFR

2013-04-01

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

21 CFR 1301.18 - Research protocols.

Code of Federal Regulations, 2012 CFR

2012-04-01

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

Evaluation of Interoperability Protocols in Repositories of Electronic Theses and Dissertations

ERIC Educational Resources Information Center

Hakimjavadi, Hesamedin; Masrek, Mohamad Noorman

2013-01-01

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

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

PubMed

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

2015-07-01

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

The effectiveness of Korean medicine treatment in male patients with infertility: a study protocol for a prospective observational pilot study.

PubMed

Kim, Kwan-Ii; Jo, Junyoung

2018-01-01

Male factor subfertility has increasingly been considered the cause of infertility in couples. Many men with male infertility have sperm problems such as oligozoospermia, asthenozoospermia, or teratozoospermia. Because abnormal semen parameters are idiopathic to some extent, no standard therapy has been established to date. Herbal medicine has been reported to have beneficial properties in the treatment of subfertility, especially in improving semen quality both in vivo and in human studies. Therefore, we intend to investigate the effectiveness and safety of treatment using Korean medicine (KM) for infertile male patients with poor semen quality.This will be a single-center, prospective, case-only observational pilot study. About 20 male patients with infertility who visit Conmaul Hospital of Korean Medicine will be recruited. We will follow the standard treatment protocol, which has shown good results in the treatment of male infertility. The protocol is composed mainly of a 10-week herbal decoction treatment; acupuncture and/or pharmacopuncture are added when needed. Semen samples, quality of life, and the scrotal temperatures of infertile men will be observed before and after the 10-week treatment with KM.The study has received ethical approval from the Public Institutional Review Board (approval number: P01-201708-21-008). The findings will be disseminated to appropriate audiences via peer-reviewed publication and conference presentations. Korean Clinical Trial Registry (CRIS), Republic of Korea: KCT0002611.

Clomiphene Stair-Step Protocol for Women With Polycystic Ovary Syndrome.

PubMed

Jones, Tiffanny; Ho, Jacqueline R; Gualtieri, Marc; Bruno-Gaston, Janet; Chung, Karine; Paulson, Richard J; Bendikson, Kristin A

2018-01-01

To compare time to ovulation, ovulation rates, and side effect profile of traditional and the stair-step protocol for ovulation induction using clomiphene citrate in women with polycystic ovary syndrome (PCOS). We performed a retrospective study of women seeking care for infertility with a diagnosis of PCOS at a university-based infertility clinic from July 2012 to July 2014. We included patients who were resistant to the initial starting dose of 50 mg clomiphene. The primary outcome was time to ovulation. Secondary outcomes included ovulation rates, clinical pregnancy rates, and mild and moderate-to-severe side effects based on dose. For the traditional protocol, higher doses of clomiphene were used each subsequent month if no ovulation occurred. For the stair-step protocol, higher doses of clomiphene were given 7 days after the last dose if no dominant follicles were seen on ultrasonography. Our study had 80% power to detect a 20% difference in ovulation. One hundred nine patients were included in the analysis with 66 (60.6%) in the traditional and 43 (39.4%) in the stair-step protocol. Age and body mass index were similar between groups. The time to ovulation was decreased in the stair-step protocol group compared with the traditional protocol group (23.1±0.9 days vs 47.5±6.3 days). Ovulation rates were increased in the stair-step group compared with the traditional group at 150 mg (16 [37%] vs 8 [12%], P=.004) and at 200 mg (9 [21%] vs 3 [5%], P=.01). Pregnancy rates were similar between groups once ovulation was achieved (12 [18.1%] vs 7 [16.3%], P=.08). The stair-step protocol had an increased incidence of mild side effects (vasomotor flushes, headaches, gastrointestinal disturbance, mastalgia, changes in mood; 18 [41%] vs 8 [12%]), but there was no difference in the incidence of severe side effects (headaches, visual disturbances). For women with PCOS, the stair-step clomiphene protocol is associated with decreased time to ovulation and increased ovulation

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

Study protocol: Mother and Infant Nutritional Assessment (MINA) cohort study in Qatar and Lebanon.

PubMed

Naja, Farah; Nasreddine, Lara; Al Thani, Al Anoud; Yunis, Khaled; Clinton, Michael; Nassar, Anwar; Farhat Jarrar, Sara; Moghames, Patricia; Ghazeeri, Ghina; Rahman, Sajjad; Al-Chetachi, Walaa; Sadoun, Eman; Lubbad, Nibal; Bashwar, Zelaikha; Bawadi, Hiba; Hwalla, Nahla

2016-05-04

The Middle East and North Africa region harbors significant proportions of stunting and wasting coupled with surging rates of non-communicable diseases (NCDs). Recent evidence identified nutrition during the first 1000 days of life as a common denominator not only for optimal growth but also for curbing the risk of NCDs later in life. The main objective of this manuscript is to describe the protocol of the first cohort in the region to investigate the association of nutrition imbalances early in life with birth outcomes, growth patterns, as well as early determinants of non-communicable diseases. More specifically the cohort aims to 1) examine the effects of maternal and early child nutrition and lifestyle characteristics on birth outcomes and growth patterns and 2) develop evidence-based nutrition and lifestyle guidelines for pregnant women and young children. A multidisciplinary team of researchers was established from governmental and private academic and health sectors in Lebanon and Qatar to launch the Mother and Infant Nutritional Assessment 3-year cohort study. Pregnant women (n = 250 from Beirut, n = 250 from Doha) in their first trimester are recruited from healthcare centers in Beirut, Lebanon and Doha, Qatar. Participants are interviewed three times during pregnancy (once every trimester) and seven times at and after delivery (when the child is 4, 6, 9, 12, 18, and 24 months old). Delivery and birth data is obtained from hospital records. Data collection includes maternal socio-demographic and lifestyle characteristics, dietary intake, anthropometric measurements, and household food security data. For biochemical assessment of various indicators of nutritional status, a blood sample is obtained from women during their first trimester. Breastfeeding and complementary feeding practices, dietary intake, as well as anthropometric measurements of children are also examined. The Delphi technique will be used for the development of the nutrition and lifestyle

A MBD-seq protocol for large-scale methylome-wide studies with (very) low amounts of DNA.

PubMed

Aberg, Karolina A; Chan, Robin F; Shabalin, Andrey A; Zhao, Min; Turecki, Gustavo; Staunstrup, Nicklas Heine; Starnawska, Anna; Mors, Ole; Xie, Lin Y; van den Oord, Edwin Jcg

2017-09-01

We recently showed that, after optimization, our methyl-CpG binding domain sequencing (MBD-seq) application approximates the methylome-wide coverage obtained with whole-genome bisulfite sequencing (WGB-seq), but at a cost that enables adequately powered large-scale association studies. A prior drawback of MBD-seq is the relatively large amount of genomic DNA (ideally >1 µg) required to obtain high-quality data. Biomaterials are typically expensive to collect, provide a finite amount of DNA, and may simply not yield sufficient starting material. The ability to use low amounts of DNA will increase the breadth and number of studies that can be conducted. Therefore, we further optimized the enrichment step. With this low starting material protocol, MBD-seq performed equally well, or better, than the protocol requiring ample starting material (>1 µg). Using only 15 ng of DNA as input, there is minimal loss in data quality, achieving 93% of the coverage of WGB-seq (with standard amounts of input DNA) at similar false/positive rates. Furthermore, across a large number of genomic features, the MBD-seq methylation profiles closely tracked those observed for WGB-seq with even slightly larger effect sizes. This suggests that MBD-seq provides similar information about the methylome and classifies methylation status somewhat more accurately. Performance decreases with <15 ng DNA as starting material but, even with as little as 5 ng, MBD-seq still achieves 90% of the coverage of WGB-seq with comparable genome-wide methylation profiles. Thus, the proposed protocol is an attractive option for adequately powered and cost-effective methylome-wide investigations using (very) low amounts of DNA.

The UNC/UMN Baby Connectome Project (BCP): An overview of the study design and protocol development.

PubMed

Howell, Brittany R; Styner, Martin A; Gao, Wei; Yap, Pew-Thian; Wang, Li; Baluyot, Kristine; Yacoub, Essa; Chen, Geng; Potts, Taylor; Salzwedel, Andrew; Li, Gang; Gilmore, John H; Piven, Joseph; Smith, J Keith; Shen, Dinggang; Ugurbil, Kamil; Zhu, Hongtu; Lin, Weili; Elison, Jed T

2018-03-22

The human brain undergoes extensive and dynamic growth during the first years of life. The UNC/UMN Baby Connectome Project (BCP), one of the Lifespan Connectome Projects funded by NIH, is an ongoing study jointly conducted by investigators at the University of North Carolina at Chapel Hill and the University of Minnesota. The primary objective of the BCP is to characterize brain and behavioral development in typically developing infants across the first 5 years of life. The ultimate goals are to chart emerging patterns of structural and functional connectivity during this period, map brain-behavior associations, and establish a foundation from which to further explore trajectories of health and disease. To accomplish these goals, we are combining state of the art MRI acquisition and analysis techniques, including high-resolution structural MRI (T1-and T2-weighted images), diffusion imaging (dMRI), and resting state functional connectivity MRI (rfMRI). While the overall design of the BCP largely is built on the protocol developed by the Lifespan Human Connectome Project (HCP), given the unique age range of the BCP cohort, additional optimization of imaging parameters and consideration of an age appropriate battery of behavioral assessments were needed. Here we provide the overall study protocol, including approaches for subject recruitment, strategies for imaging typically developing children 0-5 years of age without sedation, imaging protocol and optimization, a description of the battery of behavioral assessments, and QA/QC procedures. Combining HCP inspired neuroimaging data with well-established behavioral assessments during this time period will yield an invaluable resource for the scientific community. Copyright © 2018 Elsevier Inc. All rights reserved.

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

Prosthesis Prescription Protocol of the Arm (PPP-Arm): The implementation of a national prosthesis prescription protocol.

PubMed

Wijdenes, Paula; Brouwers, Michael; van der Sluis, Corry K

2018-02-01

In order to create more uniformity in the prescription of upper limb prostheses by Dutch rehabilitation teams, the development and implementation of a Prosthesis Prescription Protocol of the upper limb (PPP-Arm) was initiated. The aim was to create a national digital protocol to structure, underpin, and evaluate the prescription of upper limb prostheses for clients with acquired or congenital arm defects. Prosthesis Prescription Protocol of the Arm (PPP-Arm) was developed on the basis of the International Classification of Functioning and consisted of several layers. All stakeholders (rehabilitation teams, orthopedic workshops, patients, and insurance companies) were involved in development and implementation. A national project coordinator and knowledge brokers in each team were essential for the project. PPP-Arm was successfully developed and implemented in nine Dutch rehabilitation teams. The protocol improved team collaboration, structure, and completeness of prosthesis prescriptions and treatment uniformity and might be interesting for other countries as well. Clinical relevance A national protocol to prescribe upper limb prostheses can be helpful to create uniformity in treatment of patients with upper limb defects. Such a protocol improves quality of care for all patients in the country.

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

PubMed

Li, Rebecca H; Wacholtz, Mary C; Barnes, Mark; Boggs, Liam; Callery-D'Amico, Susan; Davis, Amy; Digilova, Alla; Forster, David; Heffernan, Kate; Luthin, Maeve; Lynch, Holly Fernandez; McNair, Lindsay; Miller, Jennifer E; Murphy, Jacquelyn; Van Campen, Luann; Wilenzick, Mark; Wolf, Delia; Woolston, Cris; Aldinger, Carmen; Bierer, Barbara E

2016-04-01

A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. 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/

Automatic image hanging protocol for chest radiographs in PACS.

PubMed

Luo, Hui; Hao, Wei; Foos, David H; Cornelius, Craig W

2006-04-01

Chest radiography is one of the most widely used techniques in diagnostic imaging. It comprises at least one-third of all diagnostic radiographic procedures in hospitals. However, in the picture archive and communication system, images are often stored with the projection and orientation unknown or mislabeled, which causes inefficiency for radiologists' interpretation. To address this problem, an automatic hanging protocol for chest radiographs is presented. The method targets the most effective region in a chest radiograph, and extracts a set of size-, rotation-, and translation-invariant features from it. Then, a well-trained classifier is used to recognize the projection. The orientation of the radiograph is later identified by locating the neck, heart, and abdomen positions in the radiographs. Initial experiments are performed on the radiographs collected from daily routine chest exams in hospitals and show promising results. Using the presented protocol, 98.2% of all cases could be hung correctly on projection view (without protocol, 62%), and 96.1% had correct orientation (without protocol, 75%). A workflow study on the protocol also demonstrates a significant improvement in efficiency for image display.

Clinical Simulation: A Protocol for Evaluation of Mobile Technology.

PubMed

Mather, Carey; Jensen, Sanne; Cummings, Elizabeth

2017-01-01

For mobile technology to be accepted at point of care in healthcare environments there is a need to demonstrate benefits whilst ameliorating the risks and challenges. To provide a standardised approach to evaluation of mobile technology a simulation protocol was developed to provide guidance for its use in healthcare environments. Simulated conditions provide the opportunity to assess intended and unintended consequences and identify potential workarounds when using technology. The protocol can also be used to demonstrate the importance of the development of digital professionalism by end-users prior to students entering the clinical practice setting. The mobile technology protocol was adapted from a health information systems protocol developed and used at the ITX Lab, Denmark for use in other simulation laboratories. Use case scenarios were developed to enable evaluation of mobile technology for mobile learning of nurses, nurse supervisors, students and patients. The scenarios can be used in a range of simulated environments including hospital bedside, outpatient clinic or community settings. A case study exemplar of a nurse and patient is included to demonstrate how the mobile technology protocol can be applied.

Nonblocking and orphan free message logging protocols

NASA Technical Reports Server (NTRS)

Alvisi, Lorenzo; Hoppe, Bruce; Marzullo, Keith

1992-01-01

Currently existing message logging protocols demonstrate a classic pessimistic vs. optimistic tradeoff. We show that the optimistic-pessimistic tradeoff is not inherent to the problem of message logging. We construct a message-logging protocol that has the positive features of both optimistic and pessimistic protocol: our protocol prevents orphans and allows simple failure recovery; however, it requires no blocking in failure-free runs. Furthermore, this protocol does not introduce any additional message overhead as compared to one implemented for a system in which messages may be lost but processes do not crash.

Nonblocking and orphan free message logging protocols

NASA Astrophysics Data System (ADS)

Alvisi, Lorenzo; Hoppe, Bruce; Marzullo, Keith

1992-12-01

Currently existing message logging protocols demonstrate a classic pessimistic vs. optimistic tradeoff. We show that the optimistic-pessimistic tradeoff is not inherent to the problem of message logging. We construct a message-logging protocol that has the positive features of both optimistic and pessimistic protocol: our protocol prevents orphans and allows simple failure recovery; however, it requires no blocking in failure-free runs. Furthermore, this protocol does not introduce any additional message overhead as compared to one implemented for a system in which messages may be lost but processes do not crash.

Input of Psychosocial Information During Multidisciplinary Team Meetings at Medical Oncology Departments: Protocol for an Observational Study.

PubMed

Horlait, Melissa; Van Belle, Simon; Leys, Mark

2018-02-26

Multidisciplinary team meetings (MDTMs) have become standard practice in oncology and gained the status of the key decision-making forum for cancer patient management. The current literature provides evidence that MDTMs are achieving their intended objectives but there are also indications to question the positive impact of MDTMs in oncology settings. For cancer management to be patient-centered, it is crucial that medical information as well as psychosocial aspects-such as the patients' living situation, possible family problems, patients' mental state, and patients' perceptions and values or preferences towards treatment or care-are considered and discussed during MDTMs. Previous studies demonstrate that failure to account for patients' psychosocial information has a negative impact on the implementation of the treatment recommendations formulated during MDTMs. Few empirical studies have demonstrated the predominant role of physicians during MDTMs, leading to the phenomenon that medical information is shared almost exclusively at the expense of psychosocial information. However, more in-depth insight on the underlying reasons why MDTMs fail to take into account psychosocial information of cancer patients is needed. This paper presents a research protocol for a cross-sectional observational study that will focus on exploring the barriers to considering psychosocial information during MDTMs at medical oncology departments. This protocol encompasses a cross-sectional comparative case study of MDTMs at medical oncology departments in Flanders, Belgium. MDTMs from various oncology subspecialties at inpatient medical oncology departments in multiple hospitals (academic as well as general hospitals) are compared. The observations focus on the "multidisciplinary oncology consultation" (MOC), a formally regulated and financed type of MDTM in Belgian oncology since 2003. Data are collected through nonparticipant observations of MOC-meetings. Observational data are

Protocol Support for a New Satellite-Based Airspace Communication Network

NASA Technical Reports Server (NTRS)

Shang, Yadong; Hadjitheodosiou, Michael; Baras, John

2004-01-01

We recommend suitable transport protocols for an aeronautical network supporting Internet and data services via satellite. We study the characteristics of an aeronautical satellite hybrid network and focus on the problems that cause dramatically degraded performance of the Transport Protocol. We discuss various extensions to standard TCP that alleviate some of these performance problems. Through simulation, we identify those TCP implementations that can be expected to perform well. Based on the observation that it is difficult for an end-to-end solution to solve these problems effectively, we propose a new TCP-splitting protocol, termed Aeronautical Transport Control Protocol (AeroTCP). The main idea of this protocol is to use a fixed window for flow control and one duplicated acknowledgement (ACK) for fast recovery. Our simulation results show that AeroTCP can maintain higher utilization for the satellite link than end-to-end TCP, especially in high BER environment.

Protocol compliance and time management in blunt trauma resuscitation.

PubMed

Spanjersberg, W R; Bergs, E A; Mushkudiani, N; Klimek, M; Schipper, I B

2009-01-01

To study advanced trauma life support (ATLS) protocol adherence prospectively in trauma resuscitation and to analyse time management of daily multidisciplinary trauma resuscitation at a level 1 trauma centre, for both moderately and severely injured patients. All victims of severe blunt trauma were consecutively included. Patients with a revised trauma score (RTS) of 12 were resuscitated by a "minor trauma" team and patients with an RTS of less than 12 were resuscitated by a "severe trauma" team. Digital video recordings were used to analyse protocol compliance and time management during initial assessment. From 1 May to 1 September 2003, 193 resuscitations were included. The "minor trauma" team assessed 119 patients, with a mean injury severity score (ISS) of 7 (range 1-45). Overall protocol compliance was 42%, ranging from 0% for thoracic percussion to 93% for thoracic auscultation. The median resuscitation time was 45.9 minutes (range 39.7-55.9). The "severe team" assessed 74 patients, with a mean ISS of 22 (range 1-59). Overall protocol compliance was 53%, ranging from 4% for thoracic percussion to 95% for thoracic auscultation. Resuscitation took 34.8 minutes median (range 21.6-44.1). Results showed the current trauma resuscitation to be ATLS-like, with sometimes very low protocol compliance rates. Timing of secondary survey and radiology and thus time efficiency remains a challenge in all trauma patients. To assess the effect of trauma resuscitation protocols on outcome, protocol adherence needs to be improved.

The Quantum Steganography Protocol via Quantum Noisy Channels

NASA Astrophysics Data System (ADS)

Wei, Zhan-Hong; Chen, Xiu-Bo; Niu, Xin-Xin; Yang, Yi-Xian

2015-08-01

As a promising branch of quantum information hiding, Quantum steganography aims to transmit secret messages covertly in public quantum channels. But due to environment noise and decoherence, quantum states easily decay and change. Therefore, it is very meaningful to make a quantum information hiding protocol apply to quantum noisy channels. In this paper, we make the further research on a quantum steganography protocol for quantum noisy channels. The paper proved that the protocol can apply to transmit secret message covertly in quantum noisy channels, and explicity showed quantum steganography protocol. In the protocol, without publishing the cover data, legal receivers can extract the secret message with a certain probability, which make the protocol have a good secrecy. Moreover, our protocol owns the independent security, and can be used in general quantum communications. The communication, which happen in our protocol, do not need entangled states, so our protocol can be used without the limitation of entanglement resource. More importantly, the protocol apply to quantum noisy channels, and can be used widely in the future quantum communication.

Evaluation of Protocol Uniformity Concerning Laparoscopic Cholecystectomy in The Netherlands

PubMed Central

Goossens, Richard H. M.; van Eijk, Daan J.; Lange, Johan F.

2008-01-01

Background Iatrogenic bile duct injury remains a current complication of laparoscopic cholecystectomy. One uniform and standardized protocol, based on the “critical view of safety” concept of Strasberg, should reduce the incidence of this complication. Furthermore, owing to the rapid development of minimally invasive surgery, technicians are becoming more frequently involved. To improve communication between the operating team and technicians, standardized actions should also be defined. The aim of this study was to compare existing protocols for laparoscopic cholecystectomy from various Dutch hospitals. Methods Fifteen Dutch hospitals were contacted for evaluation of their protocols for laparoscopic cholecystectomy. All evaluated protocols were divided into six steps and were compared accordingly. Results In total, 13 hospitals responded—5 academic hospitals, 5 teaching hospitals, 3 community hospitals—of which 10 protocols were usable for comparison. Concerning the trocar positions, only minor differences were found. The concept of “critical view of safety” was represented in just one protocol. Furthermore, the order of clipping and cutting the cystic artery and duct differed. Descriptions of instruments and apparatus were also inconsistent. Conclusions Present protocols differ too much to define a universal procedure among surgeons in The Netherlands. The authors propose one (inter)national standardized protocol, including standardized actions. This uniform standardized protocol has to be officially released and recommended by national scientific associations (e.g., the Dutch Society of Surgery) or international societies (e.g., European Association for Endoscopic Surgery and Society of American Gastrointestinal and Endoscopic Surgeons). The aim is to improve patient safety and professional communication, which are necessary for new developments. PMID:18224485

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

PubMed

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

1999-11-15

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

Fluid resuscitation for major burn patients with the TMMU protocol.

PubMed

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

2009-12-01

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

Evaluation of the reproducibility of a protocol for the pharmacokinetic study of breast tumors by dynamic magnetic resonance imaging.

PubMed

Etxano, J; García-Lallana Valbuena, A; Antón Ibáñez, I; Elizalde, A; Pina, L; García-Foncillas, J; Boni, V

2015-01-01

To evaluate the reproducibility of a protocol for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for the pharmacokinetic study of breast tumors. We carried out this prospective study from October 2009 through December 2009. We studied 12 patients with stage ii-iii invasive breast cancer without prior treatment. Our center's research ethics committee approved the study. The 12 patients underwent on two consecutive days DCE-MRI with a high temporal resolution protocol (21 acquisitions/minute). The data obtained in an ROI traced around the largest diameter of the tumor (ROI 1) and in another ROI traced around the area of the lesion's highest K(trans) intensity (ROI 2) were analyzed separately. We used parametric and nonparametric statistical tests to study the reproducibility and concordance of the principal pharmacokinetic variables (K(trans), Kep, Ve and AUC90). The correlations were very high (r>.80; P<.01) for all the variables for ROI 1 and high (r=.70-.80; P<.01) for all the variables for ROI 2, with the exception of Ve both in ROI 1 (r=.44; P=.07) and in ROI 2 (r=.13; P=.235). There were no statistically significant differences between the two studies in the values obtained for K(trans), Kep and AUC90 (P>.05 for each), but there was a statistically significant difference between the two studies in the values obtained for Ve in ROI 2 (P=.008). The high temporal resolution protocol for DCE-MRI used at out center is very reproducible for the principal pharmacokinetic constants of breast. Copyright © 2012 SERAM. Published by Elsevier España, S.L.U. All rights reserved.

A Simple XML Producer-Consumer Protocol

NASA Technical Reports Server (NTRS)

Smith, Warren; Gunter, Dan; Quesnel, Darcy; Biegel, Bryan (Technical Monitor)

2001-01-01

There are many different projects from government, academia, and industry that provide services for delivering events in distributed environments. The problem with these event services is that they are not general enough to support all uses and they speak different protocols so that they cannot interoperate. We require such interoperability when we, for example, wish to analyze the performance of an application in a distributed environment. Such an analysis might require performance information from the application, computer systems, networks, and scientific instruments. In this work we propose and evaluate a standard XML-based protocol for the transmission of events in distributed systems. One recent trend in government and academic research is the development and deployment of computational grids. Computational grids are large-scale distributed systems that typically consist of high-performance compute, storage, and networking resources. Examples of such computational grids are the DOE Science Grid, the NASA Information Power Grid (IPG), and the NSF Partnerships for Advanced Computing Infrastructure (PACIs). The major effort to deploy these grids is in the area of developing the software services to allow users to execute applications on these large and diverse sets of resources. These services include security, execution of remote applications, managing remote data, access to information about resources and services, and so on. There are several toolkits for providing these services such as Globus, Legion, and Condor. As part of these efforts to develop computational grids, the Global Grid Forum is working to standardize the protocols and APIs used by various grid services. This standardization will allow interoperability between the client and server software of the toolkits that are providing the grid services. The goal of the Performance Working Group of the Grid Forum is to standardize protocols and representations related to the storage and distribution of

Pilot study of a robotic protocol to treat shoulder subluxation in patients with chronic stroke

PubMed Central

2013-01-01

Background Shoulder subluxation is a frequent complication of motor impairment after stroke, leading to soft tissue damage, stretching of the joint capsule, rotator cuff injury, and in some cases pain, thus limiting use of the affected extremity beyond weakness. In this pilot study, we determined whether robotic treatment of chronic shoulder subluxation can lead to functional improvement and whether any improvement was robust. Methods 18 patients with chronic stroke (3.9 ± 2.9 years from acute stroke), completed 6 weeks of robotic training using the linear shoulder robot. Training was performed 3 times per week on alternate days. Each session consisted of 3 sets of 320 repetitions of the affected arm, and the robotic protocol alternated between training vertical arm movements, shoulder flexion and extension, in an anti-gravity plane, and training horizontal arm movements, scapular protraction and retraction, in a gravity eliminated plane. Results Training with the linear robot improved shoulder stability, motor power, and resulted in improved functional outcomes that were robust 3 months after training. Conclusion In this uncontrolled pilot study, the robotic protocol effectively treated shoulder subluxation in chronic stroke patients. Treatment of subluxation can lead to improved functional use of the affected arm, likely by increasing motor power in the trained muscles. PMID:23914834

Pilot study of a robotic protocol to treat shoulder subluxation in patients with chronic stroke.

PubMed

Dohle, Carolin I; Rykman, Avrielle; Chang, Johanna; Volpe, Bruce T

2013-08-05

Shoulder subluxation is a frequent complication of motor impairment after stroke, leading to soft tissue damage, stretching of the joint capsule, rotator cuff injury, and in some cases pain, thus limiting use of the affected extremity beyond weakness. In this pilot study, we determined whether robotic treatment of chronic shoulder subluxation can lead to functional improvement and whether any improvement was robust. 18 patients with chronic stroke (3.9 ± 2.9 years from acute stroke), completed 6 weeks of robotic training using the linear shoulder robot. Training was performed 3 times per week on alternate days. Each session consisted of 3 sets of 320 repetitions of the affected arm, and the robotic protocol alternated between training vertical arm movements, shoulder flexion and extension, in an anti-gravity plane, and training horizontal arm movements, scapular protraction and retraction, in a gravity eliminated plane. Training with the linear robot improved shoulder stability, motor power, and resulted in improved functional outcomes that were robust 3 months after training. In this uncontrolled pilot study, the robotic protocol effectively treated shoulder subluxation in chronic stroke patients. Treatment of subluxation can lead to improved functional use of the affected arm, likely by increasing motor power in the trained muscles.

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

PubMed

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

2014-02-01

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

Three-step semiquantum secure direct communication protocol

NASA Astrophysics Data System (ADS)

Zou, XiangFu; Qiu, DaoWen

2014-09-01

Quantum secure direct communication is the direct communication of secret messages without need for establishing a shared secret key first. In the existing schemes, quantum secure direct communication is possible only when both parties are quantum. In this paper, we construct a three-step semiquantum secure direct communication (SQSDC) protocol based on single photon sources in which the sender Alice is classical. In a semiquantum protocol, a person is termed classical if he (she) can measure, prepare and send quantum states only with the fixed orthogonal quantum basis {|0>, |1>}. The security of the proposed SQSDC protocol is guaranteed by the complete robustness of semiquantum key distribution protocols and the unconditional security of classical one-time pad encryption. Therefore, the proposed SQSDC protocol is also completely robust. Complete robustness indicates that nonzero information acquired by an eavesdropper Eve on the secret message implies the nonzero probability that the legitimate participants can find errors on the bits tested by this protocol. In the proposed protocol, we suggest a method to check Eves disturbing in the doves returning phase such that Alice does not need to announce publicly any position or their coded bits value after the photons transmission is completed. Moreover, the proposed SQSDC protocol can be implemented with the existing techniques. Compared with many quantum secure direct communication protocols, the proposed SQSDC protocol has two merits: firstly the sender only needs classical capabilities; secondly to check Eves disturbing after the transmission of quantum states, no additional classical information is needed.

EXACT2: the semantics of biomedical protocols

PubMed Central

2014-01-01

Background The reliability and reproducibility of experimental procedures is a cornerstone of scientific practice. There is a pressing technological need for the better representation of biomedical protocols to enable other agents (human or machine) to better reproduce results. A framework that ensures that all information required for the replication of experimental protocols is essential to achieve reproducibility. Methods We have developed the ontology EXACT2 (EXperimental ACTions) that is designed to capture the full semantics of biomedical protocols required for their reproducibility. To construct EXACT2 we manually inspected hundreds of published and commercial biomedical protocols from several areas of biomedicine. After establishing a clear pattern for extracting the required information we utilized text-mining tools to translate the protocols into a machine amenable format. We have verified the utility of EXACT2 through the successful processing of previously 'unseen' (not used for the construction of EXACT2) protocols. Results The paper reports on a fundamentally new version EXACT2 that supports the semantically-defined representation of biomedical protocols. The ability of EXACT2 to capture the semantics of biomedical procedures was verified through a text mining use case. In this EXACT2 is used as a reference model for text mining tools to identify terms pertinent to experimental actions, and their properties, in biomedical protocols expressed in natural language. An EXACT2-based framework for the translation of biomedical protocols to a machine amenable format is proposed. Conclusions The EXACT2 ontology is sufficient to record, in a machine processable form, the essential information about biomedical protocols. EXACT2 defines explicit semantics of experimental actions, and can be used by various computer applications. It can serve as a reference model for for the translation of biomedical protocols in natural language into a semantically

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

PubMed

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

2017-01-01

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

Dysphonia risk screening protocol

PubMed Central

Nemr, Katia; Simões-Zenari, Marcia; da Trindade Duarte, João Marcos; Lobrigate, Karen Elena; Bagatini, Flavia Alves

2016-01-01

OBJECTIVE: To propose and test the applicability of a dysphonia risk screening protocol with score calculation in individuals with and without dysphonia. METHOD: This descriptive cross-sectional study included 365 individuals (41 children, 142 adult women, 91 adult men and 91 seniors) divided into a dysphonic group and a non-dysphonic group. The protocol consisted of 18 questions and a score was calculated using a 10-cm visual analog scale. The measured value on the visual analog scale was added to the overall score, along with other partial scores. Speech samples allowed for analysis/assessment of the overall degree of vocal deviation and initial definition of the respective groups and after six months, the separation of the groups was confirmed using an acoustic analysis. RESULTS: The mean total scores were different between the groups in all samples. Values ranged between 37.0 and 57.85 in the dysphonic group and between 12.95 and 19.28 in the non-dysphonic group, with overall means of 46.09 and 15.55, respectively. High sensitivity and specificity were demonstrated when discriminating between the groups with the following cut-off points: 22.50 (children), 29.25 (adult women), 22.75 (adult men), and 27.10 (seniors). CONCLUSION: The protocol demonstrated high sensitivity and specificity in differentiating groups of individuals with and without dysphonia in different sample groups and is thus an effective instrument for use in voice clinics. PMID:27074171

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

PubMed

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

2012-05-01

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

CSMA/RN: A universal protocol for gigabit networks

NASA Technical Reports Server (NTRS)

Foudriat, E. C.; Maly, Kurt J.; Overstreet, C. Michael; Khanna, S.; Paterra, Frank

1990-01-01

Networks must provide intelligent access for nodes to share the communications resources. In the range of 100 Mbps to 1 Gbps, the demand access class of protocols were studied extensively. Many use some form of slot or reservation system and many the concept of attempt and defer to determine the presence or absence of incoming information. The random access class of protocols like shared channel systems (Ethernet), also use the concept of attempt and defer in the form of carrier sensing to alleviate the damaging effects of collisions. In CSMA/CD, the sensing of interference is on a global basis. All systems discussed above have one aspect in common, they examine activity on the network either locally or globally and react in an attempt and whatever mechanism. Of the attempt + mechanisms discussed, one is obviously missing; that is attempt and truncate. Attempt and truncate was studied in a ring configuration called the Carrier Sensed Multiple Access Ring Network (CSMA/RN). The system features of CSMA/RN are described including a discussion of the node operations for inserting and removing messages and for handling integrated traffic. The performance and operational features based on analytical and simulation studies which indicate that CSMA/RN is a useful and adaptable protocol over a wide range of network conditions are discussed. Finally, the research and development activities necessary to demonstrate and realize the potential of CSMA/RN as a universal, gigabit network protocol is outlined.

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

PubMed

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

2018-05-31

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

A literature review: polypharmacy protocol for primary care.

PubMed

Skinner, Mary

2015-01-01

The purpose of this literature review is to critically evaluate published protocols on polypharmacy in adults ages 65 and older that are currently used in primary care settings that may potentially lead to fewer adverse drug events. A review of OVID, CINAHL, EBSCO, Cochrane Library, Medline, and PubMed databases was completed using the following key words: protocol, guideline, geriatrics, elderly, older adult, polypharmacy, and primary care. Inclusion criteria were: articles in medical, nursing, and pharmacology journals with an intervention, protocol, or guideline addressing polypharmacy that lead to fewer adverse drug events. Qualitative and quantitative studies were included. Exclusion criteria were: publications prior to the year 1992. A gap exists in the literature. No standardized protocol for addressing polypharmacy in the primary care setting was found. Mnemonics, algorithms, clinical practice guidelines, and clinical strategies for addressing polypharmacy in a variety of health care settings were found throughout the literature. Several screening instruments for use in primary care to assess potentially inappropriate prescription of medications in the elderly, such as the Beers Criteria and the STOPP screening tool, were identified. However, these screening instruments were not included in a standardized protocol to manage polypharmacy in primary care. Polypharmacy in the elderly is a critical problem that may result in adverse drug events such as falls, hospitalizations, and increased expenditures for both the patient and the health care system. No standardized protocols to address polypharmacy specific to the primary care setting were identified in this review of the literature. Given the growing population of elderly in this country and the high number of medications they consume, it is critical to focus on the utilization of a standardized protocol to address the potential harm of polypharmacy in the primary care setting and evaluate its effects on

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

PubMed

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

2004-02-06

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

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.

MR efficiency using automated MRI-desktop eProtocol

NASA Astrophysics Data System (ADS)

Gao, Fei; Xu, Yanzhe; Panda, Anshuman; Zhang, Min; Hanson, James; Su, Congzhe; Wu, Teresa; Pavlicek, William; James, Judy R.

2017-03-01

MRI protocols are instruction sheets that radiology technologists use in routine clinical practice for guidance (e.g., slice position, acquisition parameters etc.). In Mayo Clinic Arizona (MCA), there are over 900 MR protocols (ranging across neuro, body, cardiac, breast etc.) which makes maintaining and updating the protocol instructions a labor intensive effort. The task is even more challenging given different vendors (Siemens, GE etc.). This is a universal problem faced by all the hospitals and/or medical research institutions. To increase the efficiency of the MR practice, we designed and implemented a web-based platform (eProtocol) to automate the management of MRI protocols. It is built upon a database that automatically extracts protocol information from DICOM compliant images and provides a user-friendly interface to the technologists to create, edit and update the protocols. Advanced operations such as protocol migrations from scanner to scanner and capability to upload Multimedia content were also implemented. To the best of our knowledge, eProtocol is the first MR protocol automated management tool used clinically. It is expected that this platform will significantly improve the radiology operations efficiency including better image quality and exam consistency, fewer repeat examinations and less acquisition errors. These protocols instructions will be readily available to the technologists during scans. In addition, this web-based platform can be extended to other imaging modalities such as CT, Mammography, and Interventional Radiology and different vendors for imaging protocol management.

SPP: A data base processor data communications protocol

NASA Technical Reports Server (NTRS)

Fishwick, P. A.

1983-01-01

The design and implementation of a data communications protocol for the Intel Data Base Processor (DBP) is defined. The protocol is termed SPP (Service Port Protocol) since it enables data transfer between the host computer and the DBP service port. The protocol implementation is extensible in that it is explicitly layered and the protocol functionality is hierarchically organized. Extensive trace and performance capabilities have been supplied with the protocol software to permit optional efficient monitoring of the data transfer between the host and the Intel data base processor. Machine independence was considered to be an important attribute during the design and implementation of SPP. The protocol source is fully commented and is included in Appendix A of this report.

Behavioral Interventions to Prevent or Delay Dementia: Protocol for a Randomized Comparative Effectiveness Study

PubMed Central

Chandler, Melanie; Locke, Dona EC; Fields, Julie; Phatak, Vaishali; Crook, Julia; Hanna, Sherrie; Lunde, Angela; Morris, Miranda; Graff-Radford, Michelle; Hughes, Christine A; Lepore, Susan; Cuc, Andrea; Caselli, Maria; Hurst, Duane; Wethe, Jennifer; Francone, Andrea; Eilertsen, Jeanne; Lucas, Pauline; Hoffman Snyder, Charlene; Kuang, LeeAnn; Becker, Marigrace; Dean, Pamela; Diehl, Nancy; Lofquist, Marvin; Vanderhook, Shirley; Myles, Diana; Cochran, Denise

2017-01-01

Background Currently, people at risk for dementia and their caregivers are confronted with confusing choices about what behavioral interventions are most effective. Objective The objective of this study is to determine which empirically supported behavioral interventions most impact the outcomes highly valued by patients with mild cognitive impairment and their partners. Methods This protocol describes a comparative effectiveness trial targeting 300 participants with mild cognitive impairment and their study partners. The trial is being conducted at the Mayo Clinic campuses in Arizona, Florida, Minnesota, and the University of Washington in Seattle. The study examines the contribution of five behavioral interventions (yoga, memory compensation training, computerized cognitive training, support groups, and wellness education) on primary outcomes of participant and partner quality of life and self-efficacy. In this unique 10-day multicomponent intervention, groups of couples were randomized to have one of the five interventions withheld while receiving the other four. Although the longitudinal follow-up is still under way, enrollment results are available and reported. Results In total, 272 couples have been enrolled in the trial and follow-up visits continue. Outcomes will be assessed at the end-of-intervention and 6-, 12-, and 18-month follow-ups. We anticipate reporting on our primary and secondary outcomes across time points in the next 2 years. Conclusions This paper describes the protocol for a randomized comparative effectiveness study of behavioral interventions to prevent or delay dementia. We describe of the rationale, design, power analysis, and analysis plan. Also because enrollment is complete and we are in follow-up phases of the study, we have included enrollment data from the trial. Trial Registration  ClinicalTrials.gov NCT02265757; http://clinicaltrials.gov/ctsshow/ NCT02265757 (Archived by WebCite at http://www.webcitation.org/6ueRfwSYv) PMID

Advanced dementia pain management protocols.

PubMed

Montoro-Lorite, Mercedes; Canalias-Reverter, Montserrat

Pain management in advanced dementia is complex because of neurological deficits present in these patients, and nurses are directly responsible for providing interventions for the evaluation, management and relief of pain for people suffering from this health problem. In order to facilitate and help decision-makers, pain experts recommend the use of standardized protocols to guide pain management, but in Spain, comprehensive pain management protocols have not yet been developed for advanced dementia. This article reflects the need for an integrated management of pain in advanced dementia. From the review and analysis of the most current and relevant studies in the literature, we performed an approximation of the scales for the determination of pain in these patients, with the observational scale PAINAD being the most recommended for the hospital setting. In addition, we provide an overview for comprehensive management of pain in advanced dementia through the conceptual framework «a hierarchy of pain assessment techniques by McCaffery and Pasero» for the development and implementation of standardized protocols, including a four-phase cyclical process (evaluation, planning/performance, revaluation and recording), which can facilitate the correct management of pain in these patients. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

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

PubMed

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

2011-03-01

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

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

PubMed Central

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

2007-01-01

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

BLUE-protocol and FALLS-protocol: two applications of lung ultrasound in the critically ill.

PubMed

Lichtenstein, Daniel A

2015-06-01

This review article describes two protocols adapted from lung ultrasound: the bedside lung ultrasound in emergency (BLUE)-protocol for the immediate diagnosis of acute respiratory failure and the fluid administration limited by lung sonography (FALLS)-protocol for the management of acute circulatory failure. These applications require the mastery of 10 signs indicating normal lung surface (bat sign, lung sliding, A-lines), pleural effusions (quad and sinusoid sign), lung consolidations (fractal and tissue-like sign), interstitial syndrome (lung rockets), and pneumothorax (stratosphere sign and the lung point). These signs have been assessed in adults, with diagnostic accuracies ranging from 90% to 100%, allowing consideration of ultrasound as a reasonable bedside gold standard. In the BLUE-protocol, profiles have been designed for the main diseases (pneumonia, congestive heart failure, COPD, asthma, pulmonary embolism, pneumothorax), with an accuracy > 90%. In the FALLS-protocol, the change from A-lines to lung rockets appears at a threshold of 18 mm Hg of pulmonary artery occlusion pressure, providing a direct biomarker of clinical volemia. The FALLS-protocol sequentially rules out obstructive, then cardiogenic, then hypovolemic shock for expediting the diagnosis of distributive (usually septic) shock. These applications can be done using simple grayscale machines and one microconvex probe suitable for the whole body. Lung ultrasound is a multifaceted tool also useful for decreasing radiation doses (of interest in neonates where the lung signatures are similar to those in adults), from ARDS to trauma management, and from ICUs to points of care. If done in suitable centers, training is the least of the limitations for making use of this kind of visual medicine.

40 CFR 792.120 - Protocol.

Code of Federal Regulations, 2010 CFR

2010-07-01

... the test system. (8) A description of the experimental design, including methods for the control of... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Protocol. 792.120 Section 792.120... at which the study is being conducted. (4) The proposed experimental start and termination dates. (5...

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

PubMed Central

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

2017-01-01

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

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

NASA Technical Reports Server (NTRS)

Ivancic, William D.

2006-01-01

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

Nationwide cross-sectional survey of schistosomiasis and soil-transmitted helminthiasis in Sudan: study protocol.

PubMed

Cha, Seungman; Hong, Sung-Tae; Lee, Young-Ha; Lee, Keon Hoon; Cho, Dae Seong; Lee, Jinmoo; Chai, Jong-Yil; Elhag, Mousab Siddig; Khaled, Soheir Gabralla Ahmad; Elnimeiri, Mustafa Khidir Mustafa; Siddig, Nahid Abdelgadeir Ali; Abdelrazig, Hana; Awadelkareem, Sarah; Elshafie, Azza Tag Eldin; Ismail, Hassan Ahmed Hassan Ahmed; Amin, Mutamad

2017-09-12

Schistosomiasis and soil-transmitted helminthiasis (STHs) are target neglected tropical diseases (NTDs) of preventive chemotherapy, but the control and elimination of these diseases have been impeded due to resource constraints. Few reports have described study protocol to draw on when conducting a nationwide survey. We present a detailed methodological description of the integrated mapping of schistosomiasis and STHs on the basis of our experiences, hoping that this protocol can be applied to future surveys in similar settings. In addition to determining the ecological zones requiring mass drug administration interventions, we aim to provide precise estimates of the prevalence of these diseases. A school-based cross-sectional design will be applied for the nationwide survey across Sudan. The survey is designed to cover all districts in every state. We have divided each district into 3 different ecological zones depending on proximity to bodies of water. We will employ a probability-proportional-to-size sampling method for schools and systematic sampling for student selection to provide adequate data regarding the prevalence for schistosomiasis and STHs in Sudan at the state level. A total of 108,660 students will be selected from 1811 schools across Sudan. After the survey is completed, 391 ecological zones will be mapped out. To carry out the survey, 655 staff members were recruited. The feces and urine samples are microscopically examined by the Kato-Katz method and the sediment smears for helminth eggs respectively. For quality control, a minimum of 10% of the slides will be rechecked by the federal supervisors in each state and also 5% of the smears are validated again within one day by independent supervisors. This nationwide mapping is expected to generate important epidemiological information and indicators about schistosomiasis and STHs that will be useful for monitoring and evaluating the control program. The mapping data will also be used for overviewing

From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology

PubMed Central

Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C.; Hobbs, Brian P.; Berry, Donald A.; Pentz, Rebecca D.; Tam, Alda; Hong, Waun K.; Ellis, Lee M.; Abbruzzese, James; Overman, Michael J.

2015-01-01

Purpose The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. Methods We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. Results A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007). Conclusion Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting. PMID:26304898

Development and Field-Testing of a Study Protocol, including a Web-Based Occupant Survey Tool, for Use in Intervention Studies of Indoor Environmental Quality

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

Mendell, Mark; Eliseeva, Ekaterina; Spears, Michael

We developed and pilot-tested an overall protocol for intervention studies to evaluate the effects of indoor environmental changes in office buildings on the health symptoms and comfort of occupants. The protocol includes a web-based survey to assess the occupant's responses, as well as specific features of study design and analysis. The pilot study, carried out on two similar floors in a single building, compared two types of ventilation system filter media. With support from the building's Facilities staff, the implementation of the filter change intervention went well. While the web-based survey tool worked well also, low overall response rates (21-34percentmore » among the three work groups included) limited our ability to evaluate the filter intervention., The total number of questionnaires returned was low even though we extended the study from eight to ten weeks. Because another simultaneous study we conducted elsewhere using the same survey had a high response rate (>70percent), we conclude that the low response here resulted from issues specific to this pilot, including unexpected restrictions by some employing agencies on communication with occupants.« less

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

PubMed

Sousa-Santos, A R; Amaral, T F

2017-10-16

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

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

USGS Publications Warehouse

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

2004-01-01

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

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

PubMed

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

2018-02-01

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

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

Reliable multicast protocol specifications protocol operations

NASA Technical Reports Server (NTRS)

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

1995-01-01

This appendix contains the complete state tables for Reliable Multicast Protocol (RMP) Normal Operation, Multi-RPC Extensions, Membership Change Extensions, and Reformation Extensions. First the event types are presented. Afterwards, each RMP operation state, normal and extended, is presented individually and its events shown. Events in the RMP specification are one of several things: (1) arriving packets, (2) expired alarms, (3) user events, (4) exceptional conditions.

Tracheal decannulation protocol in patients affected by traumatic brain injury.

PubMed

Zanata, Isabel de Lima; Santos, Rosane Sampaio; Hirata, Gisela Carmona

2014-04-01

Introduction The frequency of tracheostomy in patients with traumatic brain injury (TBI) contrasts with the lack of objective criteria for its management. The study arose from the need for a protocol in the decision to remove the tracheal tube. Objective To evaluate the applicability of a protocol for tracheal decannulation. Methods A prospective study with 20 patients, ranging between 21 and 85 years of age (average 33.55), 4 of whom were women (20%) and 16 were men (80%). All patients had been diagnosed by a neurologist as having TBI, and the anatomical region of the lesion was known. Patients were evaluated following criteria for tracheal decannulation through a clinical evaluation protocol developed by the authors. Results Decannulation was performed in 12 (60%) patients. Fourteen (70%) had a score greater than 8 on the Glasgow Coma Scale and only 2 (14%) of these were not able to undergo decannulation. Twelve (60%) patients maintained the breathing pattern with occlusion of the tube and were successfully decannulated. Of the 20 patients evaluated, 11 (55%) showed no signs suggestive of tracheal aspiration, and of these, 9 (82%) began training on occlusion of the cannula. The protocol was relevant to establish the beginning of the decannulation process. The clinical assessment should focus on the patient's condition to achieve early tracheal decannulation. Conclusion This study allowed, with the protocol, to establish six criteria for tracheal decannulation: level of consciousness, respiration, tracheal secretion, phonation, swallowing, and coughing.

Tracheal Decannulation Protocol in Patients Affected by Traumatic Brain Injury

PubMed Central

Zanata, Isabel de Lima; Santos, Rosane Sampaio; Hirata, Gisela Carmona

2014-01-01

Introduction The frequency of tracheostomy in patients with traumatic brain injury (TBI) contrasts with the lack of objective criteria for its management. The study arose from the need for a protocol in the decision to remove the tracheal tube. Objective To evaluate the applicability of a protocol for tracheal decannulation. Methods A prospective study with 20 patients, ranging between 21 and 85 years of age (average 33.55), 4 of whom were women (20%) and 16 were men (80%). All patients had been diagnosed by a neurologist as having TBI, and the anatomical region of the lesion was known. Patients were evaluated following criteria for tracheal decannulation through a clinical evaluation protocol developed by the authors. Results Decannulation was performed in 12 (60%) patients. Fourteen (70%) had a score greater than 8 on the Glasgow Coma Scale and only 2 (14%) of these were not able to undergo decannulation. Twelve (60%) patients maintained the breathing pattern with occlusion of the tube and were successfully decannulated. Of the 20 patients evaluated, 11 (55%) showed no signs suggestive of tracheal aspiration, and of these, 9 (82%) began training on occlusion of the cannula. The protocol was relevant to establish the beginning of the decannulation process. The clinical assessment should focus on the patient's condition to achieve early tracheal decannulation. Conclusion This study allowed, with the protocol, to establish six criteria for tracheal decannulation: level of consciousness, respiration, tracheal secretion, phonation, swallowing, and coughing. PMID:25992074

Giving Voice to Study Volunteers: Comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research

PubMed Central

Roberts, Laura Weiss; Kim, Jane Paik

2014-01-01

Motivation Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable. Methods Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation. Results Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives

Giving voice to study volunteers: comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research.

PubMed

Roberts, Laura Weiss; Kim, Jane Paik

2014-09-01

Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable. Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation. Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives regarding the ethical

Protocol for the prospective validation study: 'Screening programme for pre-eclampsia' (SPREE).

PubMed

Tan, M Y; Koutoulas, L; Wright, D; Nicolaides, K H; Poon, L C Y

2017-08-01

Pre-eclampsia (PE), which affects about 2% of pregnancies, is a major cause of maternal and perinatal morbidity and mortality. Early detection of PE can improve pregnancy outcome by providing timely intervention and closer monitoring. The current guideline from the UK National Institute for Health and Care Excellence (NICE) recommends that, at the booking visit, women identified with one major risk factor or more than one moderate risk factor for PE should be advised to take low-dose aspirin daily from 12 weeks until delivery. However, performance of the current method of screening is poor and identifies only about 35% of PE. Extensive studies in the last decade have established that the best performance for early prediction of PE can be achieved by using a novel Bayes' theorem-based method that combines maternal characteristics and medical history together with measurements of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI), serum placental growth factor (PlGF) and pregnancy-associated plasma protein-A (PAPP-A) at 11-13 weeks' gestation. This forms the 'combined test', which could be simplified to the 'mini combined test' when only maternal factors, MAP and PAPP-A are taken into consideration. We present the protocol (version 3.1, 14 November 2016) for the 'Screening programme for pre-eclampsia' (SPREE) study, a prospective multicenter cohort study that will be carried out in seven National Health Service maternity hospitals in England. Eligible pregnant women attending their routine scan at 11-13 weeks' gestation will be invited to participate in this study. Maternal characteristics and history and measurements of MAP, UtA-PI, serum PAPP-A and PlGF will be recorded according to standardized protocols. The patient-specific risk for PE will be calculated and data on pregnancy outcomes collected. We hypothesize that the first-trimester mini combined test and combined test for PE screening, using the Bayes' theorem-based method, are likely to

Cognitive Protocol Stack Design

DTIC Science & Technology

2015-12-30

SECURITY CLASSIFICATION OF: In the ARO “ Cognitive Protocol Stack Design" project we proposed cognitive networking solutions published in international...areas related to cognitive networking, opening also new lines of research that was not possible to forecast at the beginning of the project. In a...Distribution Unlimited Final Report: Cognitive Protocol Stack Design The views, opinions and/or findings contained in this report are those of the author(s

Detecting Hidden Communications Protocols

DTIC Science & Technology

2013-02-11

Protocols FA9550-09-1-0173 Richard R Brooks Clemson University PO Box 340915 Clemson, SC 29634-0915 Air Force Office of Scientific Research/RSL 875...two botnet detection methods: centralized botnet traffic detection using HMMs and probabilistic context-free grammars (PCFGs) for centralized and...final report for the Detecting Hidden Communications Protocols AFOSR grant with R. R. Brooks form Clemson University as PI. The work funded by the

Colon cleansing protocol in children: research conditions vs. clinical practice.

PubMed

Elitsur, Yoram; Balfaqih, Yaslam; Preston, Deborah

2018-04-01

 Colon preparation rates are the limiting factor for a successful diagnostic colonoscopy in children. Different colon cleansing protocols have been published for use in children. Unfortunately, the applicability of those published research protocols has not been formally evaluated in routine clinical practice. We investigated the success rate of our previously published colon cleansing protocol as utilized in our clinical practice.  This was a retrospective study. In the clinical practice, the colon cleansing protocol included PEG-3350 at a dose of 2 g/kg/day plus Dulcolax (Bisacodyl, Boehringer Ingelheim, TX USA) 5 mg/day for 2 days. Adequate colon preparation was graded between 1 - 5, as previously described, and grade ≥ 4.0 was considered an adequate preparation. Patients were instructed to complete a questionnaire that included PEG-3350 dose, number of stools per day, consistency of each stool, and side effects (vomiting, abdominal pain). Clinical and endoscopic results were compared between the protocol under research conditions and routine practice.  The success rate of the colon preparation in our clinical practice was similar to the results observed under our research protocol (75 % vs. 73.6 %). Moreover, the total number of stools, stool consistency, and the intubation rate of the terminal ileum were also similar. We concluded, that in our experience, the colon cleansing protocol used under research conditions was effective and appropriate for use in routine clinical practice.  We recommend testing each new protocol under the routine conditions of clinical practice to confirm its applicability for general practitioners.

Sources of Variation in a Two-Step Monitoring Protocol for Species Clustered in Conspicuous Points: Dolichotis patagonum as a Case Study.

PubMed

Alonso Roldán, Virginia; Bossio, Luisina; Galván, David E

2015-01-01

In species showing distributions attached to particular features of the landscape or conspicuous signs, counts are commonly made by making focal observations where animals concentrate. However, to obtain density estimates for a given area, independent searching for signs and occupancy rates of suitable sites is needed. In both cases, it is important to estimate detection probability and other possible sources of variation to avoid confounding effects on measurements of abundance variation. Our objective was to assess possible bias and sources of variation in a two-step protocol in which random designs were applied to search for signs while continuously recording video cameras were used to perform abundance counts where animals are concentrated, using mara (Dolichotis patagonum) as a case study. The protocol was successfully applied to maras within the Península Valdés protected area, given that the protocol was logistically suitable, allowed warrens to be found, the associated adults to be counted, and the detection probability to be estimated. Variability was documented in both components of the two-step protocol. These sources of variation should be taken into account when applying this protocol. Warren detectability was approximately 80% with little variation. Factors related to false positive detection were more important than imperfect detection. The detectability for individuals was approximately 90% using the entire day of observations. The shortest sampling period with a similar detection capacity than a day was approximately 10 hours, and during this period, the visiting dynamic did not show trends. For individual mara, the detection capacity of the camera was not significantly different from the observer during fieldwork. The presence of the camera did not affect the visiting behavior of adults to the warren. Application of this protocol will allow monitoring of the near-threatened mara providing a minimum local population size and a baseline for

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

PubMed Central

2012-01-01

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

Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols.

PubMed

Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

2015-09-29

International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan

Space Wire Upper Layer Protocols

NASA Technical Reports Server (NTRS)

Rakow, Glenn; Schnurr, Richard; Gilley, Daniel; Parkes, Steve

2004-01-01

This viewgraph presentation addresses efforts to provide a streamlined approach for developing SpaceWire Upper layer protocols which allows industry to drive standardized communication solutions for real projects. The presentation proposes a simple packet header that will allow flexibility in implementing a diverse range of protocols.

40 CFR 766.14 - Contents of protocols.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Contents of protocols. 766.14 Section 766.14 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT DIBENZO-PARA-DIOXINS/DIBENZOFURANS General Provisions § 766.14 Contents of protocols. Protocols...

Autologous Stem Cells in Achilles Tendinopathy (ASCAT): protocol for a phase IIA, single-centre, proof-of-concept study

PubMed Central

Goldberg, Andrew J; Zaidi, Razi; Brooking, Deirdre; Kim, Louise; Korda, Michelle; Masci, Lorenzo; Green, Ruth; O’Donnell, Paul; Smith, Roger

2018-01-01

Introduction Achilles tendinopathy (AT) is a cause of pain and disability affecting both athletes and sedentary individuals. More than 150 000 people in the UK every year suffer from AT. While there is much preclinical work on the use of stem cells in tendon pathology, there is a scarcity of clinical data looking at the use of mesenchymal stem cells to treat tendon disease and there does not appear to be any studies of the use of autologous cultured mesenchymal stem cells (MSCs) for AT. Our hypothesis is that autologous culture expanded MSCs implanted into an area of mid-portion AT will lead to improved pain-free mechanical function. The current paper presents the protocol for a phase IIa clinical study. Methods and analysis The presented protocol is for a non-commercial, single-arm, open-label, phase IIa proof-of-concept study. The study will recruit 10 participants and will follow them up for 6 months. Included will be patients aged 18–70 years with chronic mid-portion AT who have failed at least 6 months of non-operative management. Participants will have a bone marrow aspirate collected from the posterior iliac crest under either local or general anaesthetic. MSCs will be isolated and expanded from the bone marrow. Four to 6 weeks after the harvest, participants will undergo implantation of the culture expanded MSCs under local anaesthetic and ultrasound guidance. The primary outcome will be safety as defined by the incidence rate of serious adverse reaction. The secondary outcomes will be efficacy as measured by patient-reported outcome measures and radiological outcome using ultrasound techniques. Ethics and dissemination The protocol has been approved by the National Research Ethics Service Committee (London, Harrow; reference 13/LO/1670). Trial findings will be disseminated through peer-reviewed publications and conference presentations. Trial registration number NCT02064062. PMID:29764889

Teaching and Learning Foreign Languages via System of "Voice over Internet Protocol" and Language Interactions Case Study: Skype

ERIC Educational Resources Information Center

Wahid, Wazira Ali Abdul; Ahmed, Eqbal Sulaiman; Wahid, Muntaha Ali Abdul

2015-01-01

This issue expresses a research study based on the online interactions of English teaching specially conversation through utilizing VOIP (Voice over Internet Protocol) and cosmopolitan online theme. Data has been achieved by interviews. Simplifiers indicate how oral tasks require to be planned upon to facilitate engagement models propitious to…

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

Where Words Fail, Music Speaks: A Mixed Method Study of an Evidence-Based Music Protocol.

PubMed

Daniels, Ruby A; Torres, David; Reeser, Cathy

2016-01-01

Despite numerous studies documenting the benefits of music, hospice social workers are often unfamiliar with evidence-based music practices that may improve end of life care. This mixed method study tested an intervention to teach hospice social workers and chaplains (N = 10) an evidence-based music protocol. Participants used the evidence-based practice (EBP) for 30 days, recording 226 journal entries that described observations of 84 patients and their families. There was a significant increase in EBP knowledge (35%). Prompting behavioral and emotional responses, music was described frequently as a catalyst that facilitated deeper dialogue between patients, families, social workers, and chaplains.

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

PubMed Central

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

2016-01-01

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

Development of a Protocol for Epidemiologal Studies of Whole-Body Vibration and Musculoskeletal Disorders of the Lower Back

NASA Astrophysics Data System (ADS)

Magnusson, M. L.; Pope, M. H.; Hulshof, C. T. J.; Bovenzi, M.

1998-08-01

It seems evident from a large number of studies that there is a positive relationship between exposure to whole body vibration (WBV) and the occurrence of low back pain. There are existing standards for evaluating the human exposure to WBV, which are based on other factors than the effect of musculoskeletal disorders. Several national and international standards also exist for evaluating human exposure to WBV. The exposure limit values or health guidance caution zones included in some of these standards are not or only to a limited extent based on systematic epidemiological investigations. It has not yet been possible to establish a clear exposure-response relationship. There are many confounding or contributing factors which influence the hazards to workers caused by exposure to WBV. Reliable methods for the detection and prevention of injury due to vibration exposure at work, alone or in combination with other risk factors, need to be implemented. The aim of this paper was to design a protocol and a questionnaire for conducting collaborative studies of WBV and musculoskeletal back disorders. The protocol will be tested in a pilot study before it will be used in multi-center studies.

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

PubMed Central

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

2017-01-01

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

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

PubMed Central

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

2010-01-01

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

Prospective randomized study of arthroscopic rotator cuff repair using an early versus delayed postoperative physical therapy protocol.

PubMed

Cuff, Derek J; Pupello, Derek R

2012-11-01

This study evaluated patient outcomes and rotator cuff healing after arthroscopic rotator cuff repair using a postoperative physical therapy protocol with early passive motion compared with a delayed protocol that limited early passive motion. The study enrolled 68 patients (average age, 63.2 years) who met inclusion criteria. All patients had a full-thickness crescent-shaped tear of the supraspinatus that was repaired using a transosseous equivalent suture-bridge technique along with subacromial decompression. In the early group, 33 patients were randomized to passive elevation and rotation that began at postoperative day 2. In the delayed group, 35 patients began the same protocol at 6 weeks. Patients were monitored clinically for a minimum of 12 months, and rotator cuff healing was assessed using ultrasound imaging. Both groups had similar improvements in preoperative to postoperative American Shoulder and Elbow Surgeons scores (early group: 43.9 to 91.9, P < .0001; delayed group: 41.0 to 92.8, P < .0001) and Simple Shoulder Test scores (early group: 5.5 to 11.1, P < .0001; delayed group: 5.1 to 11.1, P < .0001). There were no significant differences in patient satisfaction, rotator cuff healing, or range of motion between the early and delayed groups. Patients in the early group and delayed group both demonstrated very similar outcomes and range of motion at 1 year. There was a slightly higher rotator cuff healing rate in the delayed passive range of motion group compared with the early passive range of motion group (91% vs 85%). Copyright © 2012 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

Large-Scale Wearable Sensor Deployment in Parkinson's Patients: The Parkinson@Home Study Protocol.

PubMed

Silva de Lima, Ana Lígia; Hahn, Tim; de Vries, Nienke M; Cohen, Eli; Bataille, Lauren; Little, Max A; Baldus, Heribert; Bloem, Bastiaan R; Faber, Marjan J

2016-08-26

Long-term management of Parkinson's disease does not reach its full potential because we lack knowledge about individual variations in clinical presentation and disease progression. Continuous and longitudinal assessments in real-life (ie, within the patients' own home environment) might fill this knowledge gap. The primary aim of the Parkinson@Home study is to evaluate the feasibility and compliance of using multiple wearable sensors to collect clinically relevant data. Our second aim is to address the usability of these data for answering clinical research questions. Finally, we aim to build a database for future validation of novel algorithms applied to sensor-derived data from Parkinson's patients during daily functioning. The Parkinson@Home study is a two-phase observational study involving 1000 Parkinson's patients and 250 physiotherapists. Disease status is assessed using a short version of the Parkinson's Progression Markers Initiative protocol, performed by certified physiotherapists. Additionally, participants will wear a set of sensors (smartwatch, smartphone, and fall detector), and use these together with a customized smartphone app (Fox Insight), 24/7 for 3 months. The sensors embedded within the smartwatch and fall detector may be used to estimate physical activity, tremor, sleep quality, and falls. Medication intake and fall incidents will be measured via patients' self-reports in the smartphone app. Phase one will address the feasibility of the study protocol. In phase two, mathematicians will distill relevant summary statistics from the raw sensor signals, which will be compared against the clinical outcomes. Recruitment of 300 participants for phase one was concluded in March, 2016, and the follow-up period will end in June, 2016. Phase two will include the remaining participants, and will commence in September, 2016. The Parkinson@Home study is expected to generate new insights into the feasibility of integrating self-collected information from

Model Checking A Self-Stabilizing Synchronization Protocol for Arbitrary Digraphs

NASA Technical Reports Server (NTRS)

Malekpour, Mahyar R.

2012-01-01

This report presents the mechanical verification of a self-stabilizing distributed clock synchronization protocol for arbitrary digraphs in the absence of faults. This protocol does not rely on assumptions about the initial state of the system, other than the presence of at least one node, and no central clock or a centrally generated signal, pulse, or message is used. The system under study is an arbitrary, non-partitioned digraph ranging from fully connected to 1-connected networks of nodes while allowing for differences in the network elements. Nodes are anonymous, i.e., they do not have unique identities. There is no theoretical limit on the maximum number of participating nodes. The only constraint on the behavior of the node is that the interactions with other nodes are restricted to defined links and interfaces. This protocol deterministically converges within a time bound that is a linear function of the self-stabilization period. A bounded model of the protocol is verified using the Symbolic Model Verifier (SMV) for a subset of digraphs. Modeling challenges of the protocol and the system are addressed. The model checking effort is focused on verifying correctness of the bounded model of the protocol as well as confirmation of claims of determinism and linear convergence with respect to the self-stabilization period.

A randomized trial of protocol-based care for early septic shock.

PubMed

Yealy, Donald M; Kellum, John A; Huang, David T; Barnato, Amber E; Weissfeld, Lisa A; Pike, Francis; Terndrup, Thomas; Wang, Henry E; Hou, Peter C; LoVecchio, Frank; Filbin, Michael R; Shapiro, Nathan I; Angus, Derek C

2014-05-01

In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock, mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT), in which intravenous fluids, vasopressors, inotropes, and blood transfusions were adjusted to reach central hemodynamic targets, than among those receiving usual care. We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary. In 31 emergency departments in the United States, we randomly assigned patients with septic shock to one of three groups for 6 hours of resuscitation: protocol-based EGDT; protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions; or usual care. The primary end point was 60-day in-hospital mortality. We tested sequentially whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy. Secondary outcomes included longer-term mortality and the need for organ support. We enrolled 1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based standard therapy, and 456 to usual care. Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids, vasopressors, inotropes, and blood transfusions. By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 81 in the protocol-based standard-therapy group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care, 1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83; relative risk with protocol-based EGDT vs. protocol-based standard therapy, 1.15; 95% CI, 0.88 to 1

Probability Distributions over Cryptographic Protocols

DTIC Science & Technology

2009-06-01

Artificial Immune Algorithm . . . . . . . . . . . . . . . . . . . 9 3 Design Decisions 11 3.1 Common Ground...creation algorithm for unbounded distribution . . . . . . . 24 4.2 Message creation algorithm for unbounded naive distribution . . . . 24 4.3 Protocol...creation algorithm for intended-run distributions . . . . . . 26 4.4 Protocol and message creation algorithm for realistic distribution . . 32 ix THIS

Optimization of stent implantation using a high pressure inflation protocol.

PubMed

Vallurupalli, Srikanth; Bahia, Amit; Ruiz-Rodriguez, Ernesto; Ahmed, Zubair; Hakeem, Abdul; Uretsky, Barry F

2016-01-01

High-pressure inflation is the universal standard for stent deployment but a specific protocol for its use is lacking. We developed a standardized "pressure optimization protocol" (POP) using time to inflation pressure stability as an endpoint for determining the required duration of stent inflation. The primary study purpose was to determine the stent inflation time (IT) in a large patient cohort using the standardized inflation protocol, to correlate various patient and lesion characteristics with IT, and ascertain in an in vitro study the time for pressure accommodation within an inflation system. Six hundred fifteen stent implants in 435 patients were studied. Multivariate analysis was performed to determine predictors of longer ITs. In an in vitro study, various stents and balloons were inflated in air to determine the pressure accommodation time of the inflation system. The mean stent IT was 104 ± 41 sec (range 30-380 sec). Stent length was the only predictor of prolonged stent inflation. The "accommodation time" in vitro of the stent inflation system itself was 33 ± 24 sec. The protocol was safe requiring premature inflation termination in <3% of stent implants. No serious adverse events occurred. Achieving stable inflation pressure requires on average over 100 sec and may require several minutes in individual cases. Stent length increases IT. These results suggest that the widespread practice of rapid inflation/deflation may not be sufficient to fully expand the stent and that the use of a pressure stability protocol will allow for safe, predictable, and more complete stent deployment. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Routing Protocols in Wireless Sensor Networks

PubMed Central

Villalba, Luis Javier García; Orozco, Ana Lucila Sandoval; Cabrera, Alicia Triviño; Abbas, Cláudia Jacy Barenco

2009-01-01

The applications of wireless sensor networks comprise a wide variety of scenarios. In most of them, the network is composed of a significant number of nodes deployed in an extensive area in which not all nodes are directly connected. Then, the data exchange is supported by multihop communications. Routing protocols are in charge of discovering and maintaining the routes in the network. However, the appropriateness of a particular routing protocol mainly depends on the capabilities of the nodes and on the application requirements. This paper presents a review of the main routing protocols proposed for wireless sensor networks. Additionally, the paper includes the efforts carried out by Spanish universities on developing optimization techniques in the area of routing protocols for wireless sensor networks. PMID:22291515

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

Routing protocols in wireless sensor networks.

PubMed

Villalba, Luis Javier García; Orozco, Ana Lucila Sandoval; Cabrera, Alicia Triviño; Abbas, Cláudia Jacy Barenco

2009-01-01

The applications of wireless sensor networks comprise a wide variety of scenarios. In most of them, the network is composed of a significant number of nodes deployed in an extensive area in which not all nodes are directly connected. Then, the data exchange is supported by multihop communications. Routing protocols are in charge of discovering and maintaining the routes in the network. However, the appropriateness of a particular routing protocol mainly depends on the capabilities of the nodes and on the application requirements. This paper presents a review of the main routing protocols proposed for wireless sensor networks. Additionally, the paper includes the efforts carried out by Spanish universities on developing optimization techniques in the area of routing protocols for wireless sensor networks.

Testing warning messages on smokers’ cigarette packages: A standardized protocol

PubMed Central

Brewer, Noel T.; Hall, Marissa G.; Lee, Joseph G. L.; Peebles, Kathryn; Noar, Seth M.; Ribisl, Kurt M.

2015-01-01

Purpose Lab experiments on cigarette warnings typically use a brief one-time exposure that is not paired with the cigarette packs smokers use every day, leaving open the question of how repeated warning exposure over several weeks may affect smokers. This proof of principle study sought to develop a new protocol for testing cigarette warnings that better reflects real-world exposure by presenting them on cigarette smokers’ own packs. Methods We tested a cigarette pack labeling protocol with 76 US smokers ages 18 and older. We applied graphic warnings to the front and back of smokers’ cigarette packs. Results Most smokers reported that at least 75% of the packs of cigarettes they smoked during the study had our warnings. Nearly all said they would participate in the study again. Using cigarette packs with the study warnings increased quit intentions (p<.05). Conclusion Our findings suggest a feasible pack labeling protocol with six steps: (1) schedule appointments at brief intervals; (2) determine typical cigarette consumption; (3) ask smokers to bring a supply of cigarette packs to study appointments; (4) apply labels to smokers’ cigarette packs; (5) provide participation incentives at the end of appointments; and (6) refer smokers to cessation services at end of the study. When used in randomized controlled trials in settings with real-world message exposure over time, this protocol may help identify the true impact of warnings and thus better inform tobacco product labeling policy. PMID:25564282

Mars Communication Protocols

NASA Technical Reports Server (NTRS)

Kazz, G. J.; Greenberg, E.

2000-01-01

Over the next decade, international plans and commitments are underway to develop an infrastructure at Mars to support future exploration of the red planet. The purpose of this infrastructure is to provide reliable global communication and navigation coverage for on-approach, landed, roving, and in-flight assets at Mars. The claim is that this infrastructure will: 1) eliminate the need of these assets to carry Direct to Earth (DTE) communications equipment, 2) significantly increase data return and connectivity, 3) enable small mission exploration of Mars without DTE equipment, 4) provide precision navigation i.e., 10 to 100m position resolution, 5) supply timing reference accurate to 10ms. This paper in particular focuses on two CCSDS recommendations for that infrastructure: CCSDS Proximity-1 Space Link Protocol and CCSDS File Delivery Protocol (CFDP). A key aspect of Mars exploration will be the ability of future missions to interoperate. These protocols establish a framework for interoperability by providing standard communication, navigation, and timing services. In addition, these services include strategies to recover gracefully from communication interruptions and interference while ensuring backward compatibility with previous missions from previous phases of exploration.

Respiratory Therapist Job Perceptions: The Impact of Protocol Use.

PubMed

Metcalf, Ashley Y; Stoller, James K; Habermann, Marco; Fry, Timothy D

2015-11-01

Demand for respiratory care services and staffing levels of respiratory therapists (RTs) is expected to increase over the next several years. Hence, RT job satisfaction will be a critical factor in determining recruitment and retention of RTs. Determinants of RT job satisfaction measures have received little attention in the literature. This study examines the use of respiratory care protocols and associated levels of RT job satisfaction, turnover intentions, and job stress. Four-hundred eighty-one RTs at 44 hospitals responded to an online survey regarding job satisfaction, turnover intentions, and job stress. Random coefficient modeling was used for analysis and to account for the nested structure of the data. Higher levels of RT protocol use were associated with higher levels of job satisfaction, lower rates of turnover intentions, and lower levels of job stress. In addition, RTs with greater experience had higher levels of job satisfaction, and RTs working at teaching hospitals had lower rates of turnover intentions. The study extends prior research by examining how the use of respiratory care protocols favorably affects RTs' perceptions of job satisfaction, turnover intention, and job stress. In a time of increasing demand for respiratory care services, protocols may enhance retention of RTs. Copyright © 2015 by Daedalus Enterprises.

Three-stage treatment protocol for recalcitrant distal femoral nonunion.

PubMed

Ma, Ching-Hou; Chiu, Yen-Chun; Tu, Yuan-Kun; Yen, Cheng-Yo; Wu, Chin-Hsien

2017-04-01

In this study, we proposed a three-stage treatment protocol for recalcitrant distal femoral nonunion and aimed to analyze the clinical results. We retrospective reviewed 12 consecutive patients with recalcitrant distal femoral nonunion undergoing our three-stage treatment protocol from January 2010 to December 2014 in our institute. The three-stage treatment protocol comprised debridement of the nonunion site, lengthening to eliminate leg length discrepancy, deformity correction, stabilization with a locked plate, filling of the defect with cement spacer for inducing membrane formation, and bone reconstruction using a cancellous bone autograft (Masquelet technique) or free vascularized fibular bone graft. The bone union time, wound complication, lower limbs alignment, amount of lengthening, knee range of motion, and functional outcomes were evaluated. Osseous union with angular deformity <5° and leg length discrepancy <1 cm were achieved in all the patients. The average amount of lengthening was 5.88 cm (range 3.5-12 cm). Excellent or good outcomes were obtained in 9 patients. Although the current study involved only a small number of patients and the intervention comprised three stages, we believe that such a protocol may be a valuable alternative for the treatment of recalcitrant distal femoral nonunion.

Exploring the Effect of Video Used to Enhance the Retrospective Verbal Protocol Analysis: A Multiple Case Study

ERIC Educational Resources Information Center

Monroe, Steven D.

2012-01-01

The purpose of this study was to explore how the use of video in the cognitive task analysis (CTA) retrospective verbal protocol analysis (RVPA) during a job analysis affects: (a) the quality of performing the CTA, (b) the time to complete the CTA, and (c) the cost to execute the CTA. Research has shown when using the simultaneous VPA during a CTA…

A Survey on Underwater Acoustic Sensor Network Routing Protocols.

PubMed

Li, Ning; Martínez, José-Fernán; Meneses Chaus, Juan Manuel; Eckert, Martina

2016-03-22

Underwater acoustic sensor networks (UASNs) have become more and more important in ocean exploration applications, such as ocean monitoring, pollution detection, ocean resource management, underwater device maintenance, etc. In underwater acoustic sensor networks, since the routing protocol guarantees reliable and effective data transmission from the source node to the destination node, routing protocol design is an attractive topic for researchers. There are many routing algorithms have been proposed in recent years. To present the current state of development of UASN routing protocols, we review herein the UASN routing protocol designs reported in recent years. In this paper, all the routing protocols have been classified into different groups according to their characteristics and routing algorithms, such as the non-cross-layer design routing protocol, the traditional cross-layer design routing protocol, and the intelligent algorithm based routing protocol. This is also the first paper that introduces intelligent algorithm-based UASN routing protocols. In addition, in this paper, we investigate the development trends of UASN routing protocols, which can provide researchers with clear and direct insights for further research.

A Survey on Underwater Acoustic Sensor Network Routing Protocols

PubMed Central

Li, Ning; Martínez, José-Fernán; Meneses Chaus, Juan Manuel; Eckert, Martina

2016-01-01

Underwater acoustic sensor networks (UASNs) have become more and more important in ocean exploration applications, such as ocean monitoring, pollution detection, ocean resource management, underwater device maintenance, etc. In underwater acoustic sensor networks, since the routing protocol guarantees reliable and effective data transmission from the source node to the destination node, routing protocol design is an attractive topic for researchers. There are many routing algorithms have been proposed in recent years. To present the current state of development of UASN routing protocols, we review herein the UASN routing protocol designs reported in recent years. In this paper, all the routing protocols have been classified into different groups according to their characteristics and routing algorithms, such as the non-cross-layer design routing protocol, the traditional cross-layer design routing protocol, and the intelligent algorithm based routing protocol. This is also the first paper that introduces intelligent algorithm-based UASN routing protocols. In addition, in this paper, we investigate the development trends of UASN routing protocols, which can provide researchers with clear and direct insights for further research. PMID:27011193

Protocols for second-generation business satellites systems

NASA Astrophysics Data System (ADS)

Evans, B. G.; Coakley, F. P.; El Amin, M. H. M.

The paper discusses the nature and mix of traffic in business satellite systems and describes the limitations on the protocol imposed by the differing impairments of speech, video, and data. A simple TDMA system protocol is presented which meets the requirements of mixed-service operation. The efficiency of the protocol together with implications for allocation, scheduling and synchronisation are discussed. Future-generation satellites will probably use on-board processing. Some initial work on protocols that make use of on-board processing and the implications for satellite and earth-station equipment are presented.

Processing Protocol for Soil Samples Potentially ...

EPA Pesticide Factsheets