WorldWideScience

Sample records for protocol initial pilot

  1. RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID−TIA): study protocol for a pilot randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist – that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? Methods/Design This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final

  2. RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID-TIA): study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Edwards, Duncan; Fletcher, Kate; Deller, Rachel; McManus, Richard; Lasserson, Daniel; Giles, Matthew; Sims, Don; Norrie, John; McGuire, Graham; Cohn, Simon; Whittle, Fiona; Hobbs, Vikki; Weir, Christopher; Mant, Jonathan

    2013-07-02

    People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist--that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the

  3. Security analysis of session initiation protocol

    OpenAIRE

    Dobson, Lucas E.

    2010-01-01

    Approved for public release; distribution is unlimited The goal of this thesis is to investigate the security of the Session Initiation Protocol (SIP). This was accomplished by researching previously discovered protocol and implementation vulnerabilities, evaluating the current state of security tools and using those tools to discover new vulnerabilities in SIP software. The CVSS v2 system was used to score protocol and implementation vulnerabilities to give them a meaning that was us...

  4. 75 FR 77935 - Patriot Express Pilot Loan Initiative

    Science.gov (United States)

    2010-12-14

    ... SMALL BUSINESS ADMINISTRATION Patriot Express Pilot Loan Initiative AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of extension of the Patriot Express Pilot Loan Initiative. SUMMARY: This notice extends the Patriot Express Pilot Loan Initiative in its current form through December 31, 2013...

  5. Biometrics based authentication scheme for session initiation protocol

    OpenAIRE

    Xie, Qi; Tang, Zhixiong

    2016-01-01

    Many two-factor challenge-response based session initiation protocol (SIP) has been proposed, but most of them are vulnerable to smart card stolen attacks and password guessing attacks. In this paper, we propose a novel three-factor SIP authentication scheme using biometrics, password and smart card, and utilize the pi calculus-based formal verification tool ProVerif to prove that the proposed protocol achieves security and authentication. Furthermore, our protocol is highly efficient when co...

  6. Biometrics based authentication scheme for session initiation protocol.

    Science.gov (United States)

    Xie, Qi; Tang, Zhixiong

    2016-01-01

    Many two-factor challenge-response based session initiation protocol (SIP) has been proposed, but most of them are vulnerable to smart card stolen attacks and password guessing attacks. In this paper, we propose a novel three-factor SIP authentication scheme using biometrics, password and smart card, and utilize the pi calculus-based formal verification tool ProVerif to prove that the proposed protocol achieves security and authentication. Furthermore, our protocol is highly efficient when compared to other related protocols.

  7. Closed Conference Signalling Using the Session Initiation Protocol.

    Science.gov (United States)

    Miladinovic, Igor; Stadler, Johannes

    2003-01-01

    Introduces an extension of the Session Initiation Protocol (SIP) for closed multiparty conferences; the extension expands SIP for discovery of participant identities in a conference, and ensures that each participant is notified before a new participant joins. Verifies this extension by applying it to two SIP conference models. Concludes with an…

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    Zahid Mehmood

    Full Text Available 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.

  10. Application Protocol, Initial Graphics Exchange Specification (IGES), Layered Electrical Product

    Energy Technology Data Exchange (ETDEWEB)

    O`Connell, L.J. [ed.

    1994-12-01

    An application protocol is an information systems engineering view of a specific product The view represents an agreement on the generic activities needed to design and fabricate the product the agreement on the information needed to support those activities, and the specific constructs of a product data standard for use in transferring some or all of the information required. This application protocol describes the data for electrical and electronic products in terms of a product description standard called the Initial Graphics Exchange Specification (IGES). More specifically, the Layered Electrical Product IGES Application Protocol (AP) specifies the mechanisms for defining and exchanging computer-models and their associated data for those products which have been designed in two dimensional geometry so as to be produced as a series of layers in IGES format The AP defines the appropriateness of the data items for describing the geometry of the various parts of a product (shape and location), the connectivity, and the processing and material characteristics. Excluded is the behavioral requirements which the product was intended to satisfy, except as those requirements have been recorded as design rules or product testing requirements.

  11. A protocol for the retina surgeon's safe initial intravitreal injections.

    Science.gov (United States)

    Frenkel, Ronald E P; Haji, Shamim A; La, Melvin; Frenkel, Max P C; Reyes, Angela

    2010-11-10

    To determine the safety of a surgeon's initial consecutive intravitreal injections using a specific protocol and to review the complications that may be attributed to the injection procedure. A retrospective chart review. Fifty-nine patients (30 females, 29 males) received intravitreal injections of pegaptanib, bevacizumab, or ranibizumab as part of their treatment for neovascular age-related macular degeneration. The average patient age was 80 years. Twenty-two patients were diagnosed with or suspected of having glaucoma. Each patient received an average of 5.8 injections. The charts of 59 patients who received a total of 345 intravitreal injections (104 pegaptanib, 74 bevacizumab, 167 ranibizumab) were reviewed. All injections were performed in an office-based setting. Povidone-iodine, topical antibiotics, and eye speculum were used as part of the pre injection procedure. Vision and intraocular pressure were evaluated immediately following each injection. Incidence of post injection complications, including but not limited to endophthalmitis, retinal detachment, traumatic cataract, and vitreous hemorrhage. There were no cases of endophthalmitis, toxic reactions, traumatic cataracts, retinal detachment, or vitreous hemorrhage. There was one case each of lid swelling, transient floaters, retinal pigment epithelial tear, corneal edema, and corneal abrasion. There were five cases of transient no light perception following pegaptanib injections. The incidence of serious complications was very low for the intravitreal injections given. A surgeon's initial intravitreal injections may be performed with a very high degree of safety using this protocol.

  12. Privacy-Enhancing Security Protocol in LTE Initial Attack

    Directory of Open Access Journals (Sweden)

    Uijin Jang

    2014-12-01

    Full Text Available Long-Term Evolution (LTE is a fourth-generation mobile communication technology implemented throughout the world. It is the communication means of smartphones that send and receive all of the private date of individuals. M2M, IOT, etc., are the base technologies of mobile communication that will be used in the future cyber world. However, identification parameters, such as International Mobile Subscriber Identity (IMSI, Radio Network Temporary Identities (RNTI, etc., in the initial attach section for accessing the LTE network are presented with the vulnerability of being exposed as clear text. Such vulnerability does not end in a mere identification parameter, but can lead to a secondary attack using the identification parameter, such as replication of the smartphone, illegal use of the mobile communication network, etc. This paper proposes a security protocol to safely transmit identification parameters in different cases of the initial attach. The proposed security protocol solves the exposed vulnerability by encrypting the parameters in transmission. Using an OPNET simulator, it is shown that the average rate of delay and processing ratio are efficient in comparison to the existing process.

  13. e-SCP-ECG+ Protocol: An Expansion on SCP-ECG Protocol for Health Telemonitoring—Pilot Implementation

    Directory of Open Access Journals (Sweden)

    George J. Mandellos

    2010-01-01

    Full Text Available Standard Communication Protocol for Computer-assisted Electrocardiography (SCP-ECG provides standardized communication among different ECG devices and medical information systems. This paper extends the use of this protocol in order to be included in health monitoring systems. It introduces new sections into SCP-ECG structure for transferring data for positioning, allergies, and five additional biosignals: noninvasive blood pressure (NiBP, body temperature (Temp, Carbon dioxide (CO2, blood oxygen saturation (SPO2, and pulse rate. It also introduces new tags in existing sections for transferring comprehensive demographic data. The proposed enhanced version is referred to as e-SCP-ECG+ protocol. This paper also considers the pilot implementation of the new protocol as a software component in a Health Telemonitoring System.

  14. A pilot experience launching a national dose protocol for vascular and interventional radiology

    International Nuclear Information System (INIS)

    Vano, E.; Segarra, A.; Fernandez, J. M.; Ordiales, J. M.; Simon, R.; Gallego, J. J.; Del Cerro, J.; Casasola, E.; Verdu, J. F.; Ballester, T.; Sotil, J.; Aspiazu, A.; Garcia, M. A.; Moreno, F.; Carreras, F.; Canis, M.; Soler, M. M.; Palmero, J.; Ciudad, J.; Diaz, F.; Hernandez, J.; Gonzalez, M.; Rosales, P.

    2008-01-01

    The design of a national dose protocol for interventional radiology has been one of the tasks during the European SENTINEL Coordination Action. The present paper describes the pilot experience carried out in cooperation with the Spanish Society on Vascular and Interventional Radiology (SERVEI). A prospective sample of procedures was initially agreed. A common quality control of the X-ray systems was carried out, including calibration of the air kerma area product (KAP) meters. Occupational doses of the radiologists involved in the survey were also included in the survey. A total of 10 Spanish hospitals with interventional X-ray units were involved. Six hundred and sixty-four patient dose data were collected from 397 diagnostic and 267 therapeutic procedures. Occupational doses were evaluated in a sample of 635 values. The obtained KAP median/mean values (Gy.cm 2 ) for the gathered procedures were: biliary drainage (30.6/68.9), fistulography (4.5/9.8), lower limb arteriography (52.2/60.7), hepatic chemoembolisation (175.8/218.3), iliac stent (45.9/73.2) and renal arteriography (39.1/59.8). Occupational doses (mean monthly values, in mSv) were 1.9 (over apron); 0.3 (under apron) and 4.5 (on hands). With this National experience, a protocol was agreed among the SENTINEL partners to conduct future similar surveys in other European countries. (authors)

  15. 38 CFR 3.161 - Expedited Claims Adjudication Initiative-Pilot Program.

    Science.gov (United States)

    2010-07-01

    ... Adjudication Initiative-Pilot Program. 3.161 Section 3.161 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... Claims § 3.161 Expedited Claims Adjudication Initiative—Pilot Program. Rules pertaining to the Expedited Claims Adjudication Initiative Pilot Program are set forth in part 20, subpart P, of this chapter...

  16. Robust and Efficient Authentication Scheme for Session Initiation Protocol

    Directory of Open Access Journals (Sweden)

    Yanrong Lu

    2015-01-01

    Full Text Available The session initiation protocol (SIP is a powerful application-layer protocol which is used as a signaling one for establishing, modifying, and terminating sessions among participants. Authentication is becoming an increasingly crucial issue when a user asks to access SIP services. Hitherto, many authentication schemes have been proposed to enhance the security of SIP. In 2014, Arshad and Nikooghadam proposed an enhanced authentication and key agreement scheme for SIP and claimed that their scheme could withstand various attacks. However, in this paper, we show that Arshad and Nikooghadam’s authentication scheme is still susceptible to key-compromise impersonation and trace attacks and does not provide proper mutual authentication. To conquer the flaws, we propose a secure and efficient ECC-based authentication scheme for SIP. Through the informal and formal security analyses, we demonstrate that our scheme is resilient to possible known attacks including the attacks found in Arshad et al.’s scheme. In addition, the performance analysis shows that our scheme has similar or better efficiency in comparison with other existing ECC-based authentication schemes for SIP.

  17. Peer-to-peer session initiation protocol in highly volatile environments

    NARCIS (Netherlands)

    Oredope, A.; Liotta, A.; Roper, I.; Morphett, J.

    2008-01-01

    The session initiation protocol (SIP) is an IETF standardised protocol for multimedia signalling and communication over the internet. SIP has been used in many deployments in client-server architecture. However, this configuration potentially possesses various scalability and redundancy limitations

  18. A Pilot Study on the effects of Music Therapy on Frontotemporal Dementia - developing a research protocol

    DEFF Research Database (Denmark)

    Ridder, Hanne Mette Ochsner; Wigram, Tony; Ottesen, Anne Marie

    2009-01-01

    , and pharmacological treatment of the psychiatric symptoms is difficult, requiring specialist proficiency in the field. Pilot study: As there is not yet sufficient research that examines the effects of non-pharmacologic treatment with this group there is a need to develop valid and reliable research protocols....... As an example of a non-pharmacologic treatment procedure music therapy was investigated. With the focus to develop a research protocol for a future larger population study a pilot study was carried out. In two case studies a combination of data collection methods were examined with the overall goal to document...... changes in intersubjectivity. In this pilot testing there was a specific interest in selecting a relevant and manageable dementia specific instrument for measuring quality of life and relating it with other instruments. Following three instruments were tested: the Altzheimers Disease-Related Quality...

  19. Biological quarantine on international waters: an initiative for onboard protocols

    Science.gov (United States)

    Takano, Yoshinori; Yano, Hajime; Funase, Ryu; Sekine, Yasuhito; Takai, Ken

    2012-07-01

    The research vessel Chikyu is expanding new frontiers in science, technology, and international collaboration through deep-sea expedition. The Chikyu (length: 210 m, gross tonnage: 56752 tons) has advanced and comprehensive scientific research facilities. One of the scientific purposes of the vessel is to investigate into unexplored biosphere (i.e., undescribed extremophiles) on the Earth. Therefore, "the onboard laboratory" provides us systematic microbiological protocols with a physical containment situation. In parallel, the onboard equipments provide sufficient space for fifty scientists and technical support staff. The helicopter deck also supports various logistics through transporting by a large scale helicopter (See, http://www.jamstec.go.jp/chikyu/eng/). Since the establishment of Panel on Planetary Protection (PPP) in Committee on Space Research (COSPAR), we have an international consensus about the development and promulgation of planetary protection knowledge, policy, and plans to prevent the harmful effects of biological contamination on the Earth (e.g., Rummel, 2002). However, the matter to select a candidate location of initial quarantine at BSL4 level is often problematic. To answer the key issue, we suggest that international waters can be a meaningful option with several advantages to conduct initial onboard-biological quarantine investigation. Hence, the research vessel Chikyu is promising for further PPP requirements (e.g., Enceladus sample return project: Tsou et al., 2012). Rummel, J., Seeking an international consensus in planetary protection: COSPAR's planetary protection panel. Advances in Space Research, 30, 1573-1575 (2002). Tsou, P. et al. LIFE: Life Investigation For Enceladus - A Sample Return Mission Concept in Search for Evidence of Life. Astrobiology, in press.

  20. Comparison of different initiation protocols in the resistant hepatocyte model

    International Nuclear Information System (INIS)

    Espandiari, Parvaneh; Robertson, Larry W.; Srinivasan, Cidambi; Glauert, Howard P.

    2005-01-01

    Several models in rat liver have been developed to study multistage carcinogenesis, including the Solt-Farber resistant hepatocyte model. In this model, initiation consists of either a necrogenic dose of a hepatocarcinogen or a non-necrogenic dose in conjunction with partial hepatectomy (PH). As an alternative to PH, we investigated two different procedures: fasting for 96 h followed by refeeding, or the use of one-day-old neonates. Male Fisher 344 rats were injected p.o. with diethylnitrosamine (DEN) (0, 20, or 100 mg/kg) 24 h after refeeding or PH (controls received DEN alone with no proliferative stimulus). For the neonatal group, male and female Fisher 344 rats were treated with DEN (0 or 20 mg/kg, i.p.) at one day of age. All initiated animals were treated at the same age (11 weeks) with the following selection agents: three daily doses of 2-acetylaminofluorene (AAF) (30 mg/kg), followed by a single dose of carbon tetrachloride (2 ml/kg), followed by three additional daily treatments of AAF (30 mg/kg). Rats were euthanized 2 weeks after the last AAF injection. The PH, neonatal male, and neonatal female groups receiving DEN developed more γ-glutamyl transpeptidase (GGT)-positive foci per cubic centimeter and foci per liver as compared to untreated rats receiving the same proliferative stimulus, whereas the fasting/refeeding group and the group receiving no proliferative stimulus did not. All DEN-treated groups receiving one of the proliferative stimuli had more foci per cubic centimeter than the DEN-treated group receiving no proliferative stimulus. The volume fractions of GGT-positive foci in the PH/DEN and neonatal male/DEN groups were higher than those of both the DEN-treated group receiving no proliferative stimulus and the groups receiving the same proliferative stimulus without DEN. In neonatal females-receiving DEN, the volume fraction was not different from either neonatal females not receiving DEN or DEN-treated rats receiving no proliferative

  1. Emotional assistance in thalassaemia: pilot implementation of a standard protocol

    Directory of Open Access Journals (Sweden)

    M.T. Veit

    2011-12-01

    Full Text Available This study aims to describe the creation process of standard procedures to make possible multicentre studies related to emotional aspects of thalassaemic patients, their families and caregivers; and the pilot phase of the routine implementation. The objectives defined to perform this goal are: i develop routines to assess and manage/treat emotional issues; ii adjust the ABRASTA - Brazilian Association of Thalassaemia computer system to the input of collected data and its compilation; iii conduct a pilot implementation of the routines; iv discuss the whole process and propose next steps. Forty patients were assisted following the above mentioned routines of psychological evaluation, follow-up assistance and management of specific emotional issues. Conclusions are that the routines are adequate to enable multicenter research to compare findings and develop specific interventions to Thalassaemia patients, their families and caregivers; information gathered through them is an important means of supporting medical doctors and other members of the professional team, both in the therapeutic planning and in the communication process with patients and families; finally, considering the nature of the information, psychologists and psychiatrists are the most indicated professionals to perform the assessment and the interventions related to emotional issues, due to their professional background, training and specific skills that allow a free and candid communication with the patients and their families. 本研究旨在描述标准程序的创造过程,来进行关于地中海贫血患者、其家属和照顾者情感方面可能的多中心研究;以及例程实施的试点阶段。 为实现此目的而定下的目标有: 1)制定例程评估和管理/处理情感问题;2)调整巴西地中海贫血病协会(ABRASTA)计算机系统, 输入收集到的数据并对其进行编辑;3)对例程进行试点实施;4)讨论整个过

  2. Treatment results of the Tokai-POSG 8610HR pilot protocol for children with high-risk acute lymphoblastic leukemia

    Energy Technology Data Exchange (ETDEWEB)

    Hongo, Teruaki; Inoue, Noriko [Hamamatsu Medical Univ., Shizuoka (Japan); Horibe, Keizo [and others

    1997-10-01

    We reported the treatment results of Tokai-POSG 8610HR pilot protocol for children with high-risk acute lymphoblastic leukemia (ALL). From Oct. 1986 to Jan. 1991, 43 eligible children were enrolled, who had one or more following high-risk factors: age{>=}10 years old, initial white blood cell count (WBC) of 50,000/{mu}l or more, and extramedullary leukemia. All patients received induction therapy consisting of vincristine, dexamethasone, cyclophosphamide and daunorubicin, followed by central nervous system prophylaxis by 24 Gy cranial irradiation, consolidation therapy and cyclic maintenance by multidrugs for 3 years after diagnosis. Complete remission was achieved in 39 patients. The 5-year event-free survival (EFS) rate was 72.6{+-}7.1%. The only factor of an adverse association with EFS was a initial WBC of 10,000/{mu}l or more (p=0.002) in the 24 patients who were 10 years old or over. The factors related to a negative survival were male gender (p=0.031) and an initial WBC of 10,000/{mu}l or more (p=0.0012) in 43 patients. The major toxicities of the therapy were pancreatitis and allergic reaction due to{sub L}-ASP administration, and growth hormone deficiency due to cranial irradiation. Tokai 8610HR pilot protocol was a promising regimen, but further intensive chemotherapy was needed for improvement or the prognosis of the older patients with high initial WBC greater than 10,000/{mu}l. (author)

  3. Treatment results of the Tokai-POSG 8610HR pilot protocol for children with high-risk acute lymphoblastic leukemia

    International Nuclear Information System (INIS)

    Hongo, Teruaki; Inoue, Noriko; Horibe, Keizo

    1997-01-01

    We reported the treatment results of Tokai-POSG 8610HR pilot protocol for children with high-risk acute lymphoblastic leukemia (ALL). From Oct. 1986 to Jan. 1991, 43 eligible children were enrolled, who had one or more following high-risk factors: age≥10 years old, initial white blood cell count (WBC) of 50,000/μl or more, and extramedullary leukemia. All patients received induction therapy consisting of vincristine, dexamethasone, cyclophosphamide and daunorubicin, followed by central nervous system prophylaxis by 24 Gy cranial irradiation, consolidation therapy and cyclic maintenance by multidrugs for 3 years after diagnosis. Complete remission was achieved in 39 patients. The 5-year event-free survival (EFS) rate was 72.6±7.1%. The only factor of an adverse association with EFS was a initial WBC of 10,000/μl or more (p=0.002) in the 24 patients who were 10 years old or over. The factors related to a negative survival were male gender (p=0.031) and an initial WBC of 10,000/μl or more (p=0.0012) in 43 patients. The major toxicities of the therapy were pancreatitis and allergic reaction due to L -ASP administration, and growth hormone deficiency due to cranial irradiation. Tokai 8610HR pilot protocol was a promising regimen, but further intensive chemotherapy was needed for improvement or the prognosis of the older patients with high initial WBC greater than 10,000/μl. (author)

  4. Multi-Dimensional Assessment of Professional Competence during Initial Pilot Training

    Science.gov (United States)

    Larson, Douglas Andrew

    2017-01-01

    A twenty-year forecast predicting significant increases in global air transportation portends a need to increase the capacity and effectiveness of initial pilot training. In addition to quantitative concerns related to the supply of new pilots, industry leaders have expressed dissatisfaction with the qualitative output of current aviation training…

  5. Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: protocol for a feasibility randomized pilot trial.

    Science.gov (United States)

    Johnstone, Jennie; Meade, Maureen; Marshall, John; Heyland, Daren K; Surette, Michael G; Bowdish, Dawn Me; Lauzier, Francois; Thebane, Lehana; Cook, Deborah J

    2015-01-01

    Probiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate. Patients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 10 10 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded. The primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and

  6. Maine Tidal Power Initiative: Environmental Impact Protocols For Tidal Power

    Energy Technology Data Exchange (ETDEWEB)

    Peterson, Michael Leroy [Univ. of Maine, Orono, ME; Zydlewski, Gayle Barbin [Univ. of Maine, Orono, ME; Xue, Huijie [Univ. of Maine, Orono, ME; Johnson, Teresa R. [Univ. of Maine, Orono, ME

    2014-02-02

    The Maine Tidal Power Initiative (MTPI), an interdisciplinary group of engineers, biologists, oceanographers, and social scientists, has been conducting research to evaluate tidal energy resources and better understand the potential effects and impacts of marine hydro-kinetic (MHK) development on the environment and local community. Project efforts include: 1) resource assessment, 2) development of initial device design parameters using scale model tests, 3) baseline environmental studies and monitoring, and 4) human and community responses. This work included in-situ measurement of the environmental and social response to the pre-commercial Turbine Generator Unit (TGU®) developed by Ocean Renewable Power Company (ORPC) as well as considering the path forward for smaller community scale projects.

  7. Decentralized session initiation protocol solution in ad hoc networks

    Science.gov (United States)

    Han, Lu; Jin, Zhigang; Shu, Yantai; Dong, Linfang

    2006-10-01

    With the fast development of ad hoc networks, SIP has attracted more and more attention in multimedia service. This paper proposes a new architecture to provide SIP service for ad hoc users, although there is no centralized SIP server deployed. In this solution, we provide the SIP service by the introduction of two nodes: Designated SIP Server (DS) and its Backup Server (BDS). The nodes of ad hoc network designate DS and BDS when they join the session nodes set and when some pre-defined events occur. A new sip message type called REGISTRAR is presented so nodes can send others REGISTRAR message to declare they want to be DS. According to the IP information taken in the message, an algorithm works like the election of DR and BDR in OSPF protocol is used to vote DS and BDS SIP servers. Naturally, the DS will be replaced by BDS when the DS is down for predicable or unpredictable reasons. To facilitate this, the DS should register to the BDS and transfer a backup of the SIP users' database. Considering the possibility DS or BDS may abruptly go down, a special policy is given. When there is no DS and BDS, a new election procedure is triggered just like the startup phase. The paper also describes how SIP works normally in the decentralized model as well as the evaluation of its performance. All sessions based on SIP in ad hoc such as DS voting have been tested in the real experiments within a 500m*500m square area where about 30 random nodes are placed.

  8. Scoping review protocol: education initiatives for medical psychiatry collaborative care.

    Science.gov (United States)

    Shen, Nelson; Sockalingam, Sanjeev; Abi Jaoude, Alexxa; Bailey, Sharon M; Bernier, Thérèse; Freeland, Alison; Hawa, Aceel; Hollenberg, Elisa; Woldemichael, Bethel; Wiljer, David

    2017-09-03

    The collaborative care model is an approach providing care to those with mental health and addictions disorders in the primary care setting. There is a robust evidence base demonstrating its clinical and cost-effectiveness in comparison with usual care; however, the transitioning to this new paradigm of care has been difficult. While there are efforts to train and prepare healthcare professionals, not much is known about the current state of collaborative care training programmes. The objective of this scoping review is to understand how widespread these collaborative care education initiatives are, how they are implemented and their impacts. The scoping review methodology uses the established review methodology by Arksey and O'Malley. The search strategy was developed by a medical librarian and will be applied in eight different databases spanning multiple disciplines. A two-stage screening process consisting of a title and abstract scan and a full-text review will be used to determine the eligibility of articles. To be included, articles must report on an existing collaborative care education initiative for healthcare providers. All articles will be independently assessed for eligibility by pairs of reviewers, and all eligible articles will be abstracted and charted in duplicate using a standardised form. The extracted data will undergo a 'narrative review' or a descriptive analysis of the contextual or process-oriented data and simple quantitative analysis using descriptive statistics. Research ethics approval is not required for this scoping review. The results of this scoping review will inform the development of a collaborative care training initiative emerging from the Medical Psychiatry Alliance, a four-institution philanthropic partnership in Ontario, Canada. The results will also be presented at relevant national and international conferences and published in a peer-reviewed journal. © Article author(s) (or their employer(s) unless otherwise stated in

  9. Detecting and Preventing Beacon Replay Attacks in Receiver-Initiated MAC Protocols for Energy Efficient WSNs

    DEFF Research Database (Denmark)

    Di Mauro, Alessio; Fafoutis, Xenofon; Mödersheim, Sebastian Alexander

    2013-01-01

    In receiver-initiated MAC protocols for Wireless Sensor Networks (WSNs), communication is initiated by the receiver of the data through beacons containing the receiver's identity. In this paper, we consider the case of a network intruder that captures and replays such beacons towards legitimate...

  10. Improving Communication With Surrogate Decision-Makers: A Pilot Initiative.

    Science.gov (United States)

    Meltzer, Ellen C; Shi, Zhenzhen; Suppes, Alexandra; Hersh, Jennifer E; Orlander, Jay D; Calhoun, Aaron W; Tung, Judy; Logio, Lia; Manna, Ruth; Bialer, Philip A; Acres, Cathleen A; Fins, Joseph J

    2017-08-01

    Difficult conversations in medical care often occur between physicians and patients' surrogates, individuals entrusted with medical decisions for patients who lack the capacity to make them. Poor communication between patients' surrogates and physicians may exacerbate anxiety and guilt for surrogates, and may contribute to physician stress and burnout. This pilot study assesses the effectiveness of an experiential learning workshop that was conducted in a clinical setting, and aimed at improving resident physician communication skills with a focus on surrogate decision-making. From April through June 2016, we assessed internal medicine residents' baseline communication skills through an objective structured clinical examination (OSCE) with actors representing standardized surrogates. After an intensive, 6-hour communication skills workshop, residents were reassessed via an OSCE on the same day. A faculty facilitator and the surrogate evaluated participants' communication skills via the expanded Gap Kalamazoo Consensus Statement Assessment Form. Wilcoxon signed rank tests (α of .05) compared mean pre- and postworkshop scores. Of 44 residents, 33 (75%) participated. Participants' average preworkshop OSCE scores ( M  = 3.3, SD = 0.9) were significantly lower than postworkshop scores ( M  = 4.3; SD = 0.8; Z  = 4.193; P  decision-making benefit from focused interventions. Our pilot assessment of a workshop showed promise, and additionally demonstrated the feasibility of bringing OSCEs and simulated encounters into a busy clinical practice.

  11. On TCP-based Session Initiation Protocol (SIP) Server Overload Control

    OpenAIRE

    Shen, Charles; Schulzrinne, Henning

    2010-01-01

    The Session Initiation Protocol (SIP) server overload management has attracted interest since SIP is being widely deployed in the Next Generation Networks (NGN) as a core signaling protocol. Yet all existing SIP overload control work is focused on SIP-over-UDP, despite the fact that TCP is increasingly seen as the more viable choice of SIP transport. This paper answers the following questions: is the existing TCP flow control capable of handling the SIP overload problem? If not, why and how c...

  12. Design of Bus Protocol Intelligent Initiation System Based On RS485

    Directory of Open Access Journals (Sweden)

    Li Liming

    2017-01-01

    Full Text Available In order to design an effective and reliable RS485 bus protocol based on RS485 bus, this paper introduces the structure and transmission mode of the command frame and the response frame, and also introduce four control measures and the communication in order to process quality of this system. The communication protocol is open, tolerant, reliable and fast, and can realize ignition more reliable and accurate in the intelligent initiation system.

  13. Microdose flare protocol with interrupted follicle stimulating hormone and added androgen for poor responders--an observational pilot study.

    Science.gov (United States)

    Mitri, Frederic; Behan, Lucy Ann; Murphy, Courtney A; Hershko-Klement, Anat; Casper, Robert F; Bentov, Yaakov

    2016-01-01

    To investigate whether temporarily withholding FSH and adding androgen could improve follicular response during a microdose flare protocol in women with slow follicular growth or asynchronous follicular development. Observational pilot study. University-affiliated private fertility center. Twenty-six women aged 34-47 years with poor response to stimulation or a previous cancelled IVF cycle and with slow or asynchronous follicular growth during a microdose flare cycle. For 13 women, after initiation of ovarian stimulation using the microdose flare protocol, gonadotropin administration was interrupted and transdermal testosterone gel was added for several days (4.4 ± 1.2 d) starting after cycle day 7 (mean cycle day 10 ± 2.6). FSH, E2, follicular growth, and total number of mature oocytes retrieved were determined for all of the patients. Cycle cancellation rate as well as pregnancy rate following embryo transfer were also documented when applicable. FSH levels declined (25.2 ± 6.5 to 6.8 ± 3.2 IU/L), E2 levels increased (896 ± 687 to 2,163 ± 1,667 pmol/L), and follicular growth improved significantly during gonadotropin interruption and were tracked for 2 days during this time frame. The average number of oocytes retrieved was 5.3 ± 2.6, and the ratio of mature to total oocytes was 4:5. Four of the 13 women in the interruption group conceived following frozen embryo transfer, whereas none in the control group did. The androgen-interrupted FSH protocol may improve follicular response to gonadotropins in cycles that might otherwise be cancelled. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2018-01-01

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

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

    Science.gov (United States)

    2018-01-01

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

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

    Science.gov (United States)

    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 Ca, Fe, K, Mg, Na, S, Ti, Ag, As, Ba, Be, Bi, Cd, Ce, Co, Cr, Cs, Cu, Ga, In, La, Li, Mn, Mo, Nb, Ni, P, Pb, Rb, Sb, Sc, Sn, Sr, Te, Th, Tl, U, V, W, Y, and Zn by inductively coupled plasma-mass spectrometry and inductively coupled plasma-atomic emission spectrometry following a near-total digestion in a mixture of HCl, HNO3, HClO4, and HF. Separate methods were used for Hg, Se, total C, and carbonate-C on this same size fraction. Only Ag, In, and Te had a large percentage of concentrations below the detection limit. Quality control (QC) of the analyses was monitored at three levels: the laboratory performing the analysis, the USGS QC officer, and the principal investigator for the study. This level of review resulted in an average of one QC sample for every 20 field samples, which proved to be minimally adequate for such a large-scale survey. Additional QC samples should be added to monitor within-batch quality to the extent that no more than 10 samples are analyzed between a QC sample. Only Cr (77%), Y (82%), and Sb (80%) fell outside the acceptable limits of accuracy (% recovery between 85 and 115%) because of likely residence in mineral phases resistant to the acid digestion. A separate sample of 0-5-cm material was collected at each site for determination of organic compounds. A subset of 73 of these samples was analyzed for a suite of

  17. Rush allergen specific immunotherapy protocol in feline atopic dermatitis: a pilot study of four cats.

    Science.gov (United States)

    Trimmer, Ann M; Griffin, Craig E; Boord, Mona J; Rosenkrantz, Wayne S

    2005-10-01

    Rush immunotherapy has been shown to be as safe as conventional immunotherapy in canine atopic patients. Rush immunotherapy has not been reported in the feline atopic patient. The purpose of this pilot study was to determine a safe protocol for rush immunotherapy in feline atopic patients. Four atopic cats diagnosed by history, physical examination and exclusion of appropriate differential diagnoses were included in the study. Allergens were identified via liquid phase immunoenzymatic testing (VARL: Veterinary Allergy Reference Labs, Pasadena, CA). Cats were premedicated with 1.5 mg triamcinolone orally 24 and 2 h prior to first injection and 10 mg hydroxyzine PO 24, 12 and 2 h prior to first injection. An intravenous catheter was placed prior to first injection. Allergen extracts (Greer Laboratories, Lenoir, North Carolina) were all administered subcutaneously at increasing protein nitrogen units (pnu) every 30 minutes for 5 h to maintenance dose of 15,000 pnus ml-1. Vital signs were assessed every 15 minutes. Two cats developed mild pruritus and the subsequent injection was delayed 30 minutes. No changes in either cat's vital signs were noted, nor was there any further pruritus. All four cats successfully completed rush immunotherapy. Two cats developed a dermal swelling on the dorsal neck one week later. In these four cats, this protocol appeared to be a safe regimen to reach maintenance therapy. A larger sample of feline patients is needed to determine the incidence of adverse reactions and to follow the success of ASIT based upon this method of induction.

  18. A Receiver-Initiated Collision-Avoidance Protocol for Multi-Channel Networks

    Science.gov (United States)

    2001-01-01

    00-00-2001 to 00-00-2001 4. TITLE AND SUBTITLE A Receiver-Initiated Collision-Avoidance Protocol for Multi-Channel Netowrks 5a. CONTRACT NUMBER...images. 14. ABSTRACT 15. SUBJECT TERMS 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF PAGES 10 19a. NAME OF RESPONSIBLE

  19. General Atomic reprocessing pilot plant: description and results of initial testing

    International Nuclear Information System (INIS)

    1977-12-01

    In June 1976 General Atomic completed the construction of a reprocessing head-end cold pilot plant. In the year since then, each system within the head end has been used for experiments which have qualified the designs. This report describes the equipment in the plant and summarizes the results of the initial phase of reprocessing testing

  20. Quality improvement initiative: Preventative Surgical Site Infection Protocol in Vascular Surgery.

    Science.gov (United States)

    Parizh, David; Ascher, Enrico; Raza Rizvi, Syed Ali; Hingorani, Anil; Amaturo, Michael; Johnson, Eric

    2018-02-01

    Objective A quality improvement initiative was employed to decrease single institution surgical site infection rate in open lower extremity revascularization procedures. In an attempt to lower patient morbidity, we developed and implemented the Preventative Surgical Site Infection Protocol in Vascular Surgery. Surgical site infections lead to prolonged hospital stays, adjunctive procedure, and additive costs. We employed targeted interventions to address the common risk factors that predispose patients to post-operative complications. Methods Retrospective review was performed between 2012 and 2016 for all surgical site infections after revascularization procedures of the lower extremity. A quality improvement protocol was initiated in January 2015. Primary outcome was the assessment of surgical site infection rate reduction in the pre-protocol vs. post-protocol era. Secondary outcomes evaluated patient demographics, closure method, perioperative antibiotic coverage, and management outcomes. Results Implementation of the protocol decreased the surgical site infection rate from 6.4% to 1.6% p = 0.0137). Patient demographics and comorbidities were assessed and failed to demonstrate a statistically significant difference among the infection and no-infection groups. Wound closure with monocryl suture vs. staple proved to be associated with decreased surgical site infection rate ( p site infections in the vascular surgery population are effective and necessary. Our data suggest that there may be benefit in the incorporation of MRSA and Gram-negative coverage as part of the Surgical Care Improvement Project perioperative guidelines.

  1. Safety of a DVT chemoprophylaxis protocol following traumatic brain injury: a single center quality improvement initiative.

    Science.gov (United States)

    Nickele, Christopher M; Kamps, Timothy K; Medow, Joshua E

    2013-04-01

    Venous thromboembolism (VTE) is a complication that affects approximately 30 % of moderate and severe traumatic brain injury (TBI) patients when pharmacologic prophylaxis is not used. Following TBI, specifically in the case of contusions, the safety and efficacy of pharmacologic thromboembolism prophylaxis (PTP) has been studied only in small sample sizes. In this study, we attempt to assess the safety and efficacy of a PTP protocol for TBI patients, as a quality improvement (QI) initiative, in the neuroscience intensive care unit (NSICU). Between January 1st and December 31st, 2009, consecutive patients discharged from the University of Wisconsin NSICU after >a 48 h minimum stay were evaluated as part of a QI project. A protocol for the initiation of PTP was designed and implemented for NSICU patients. The protocol did not vary based on type of intracranial injury. The rate of VTE was reported as was heparin-induced thrombocytopenia and PTP-related expansion of intracranial hemorrhage (IH) requiring reoperation. The number of patients receiving PTP and the timing of therapy were tracked. Patients were excluded for persistent coagulopathy, other organ system bleeding (such as the gastrointestinal tract), or pregnancy. Faculty could opt out of the protocol without reason. Using the same criteria, patients discharged during the preceding 6 months, from July 1st to December 31st, 2008, were evaluated as controls as the PTP protocol was not in effect during this time. During the control period, there were 48 head trauma admissions who met the inclusion criteria. In 22 patients (45.8 %), PTP was initiated at an average of 4.9 ± 5.4 days after admission. During the protocol period, there were 87 head trauma admissions taken from 1,143 total NSICU stays who met criteria. In 63 patients (72.4 %), the care team in the NSICU successfully initiated PTP, at an average of 3.4 ± 2.8 days after admission. All 87 trauma patients were analyzed, and the rate of clinically

  2. The pilot European Alzheimer's Disease Neuroimaging Initiative of the European Alzheimer's Disease Consortium

    DEFF Research Database (Denmark)

    Frisoni, G.B.; Henneman, W.J.; Weiner, M.W.

    2008-01-01

    BACKGROUND: In North America, the Alzheimer's Disease Neuroimaging Initiative (ADNI) has established a platform to track the brain changes of Alzheimer's disease. A pilot study has been carried out in Europe to test the feasibility of the adoption of the ADNI platform (pilot E-ADNI). METHODS: Seven...... academic sites of the European Alzheimer's Disease Consortium (EADC) enrolled 19 patients with mild cognitive impairment (MCI), 22 with AD, and 18 older healthy persons by using the ADNI clinical and neuropsychological battery. ADNI compliant magnetic resonance imaging (MRI) scans, cerebrospinal fluid...

  3. Framework and indicator testing protocol for developing and piloting quality indicators for the UK quality and outcomes framework

    Directory of Open Access Journals (Sweden)

    Burke Martyn

    2011-08-01

    Full Text Available Abstract Background Quality measures should be subjected to a testing protocol before being used in practice using key attributes such as acceptability, feasibility and reliability, as well as identifying issues derived from actual implementation and unintended consequences. We describe the methodologies and results of an indicator testing protocol (ITP using data from proposed quality indicators for the United Kingdom Quality and Outcomes Framework (QOF. Methods The indicator testing protocol involved a multi-step and methodological process: 1 The RAND/UCLA Appropriateness Method, to test clarity and necessity, 2 data extraction from patients' medical records, to test technical feasibility and reliability, 3 diaries, to test workload, 4 cost-effectiveness modelling, and 5 semi-structured interviews, to test acceptability, implementation issues and unintended consequences. Testing was conducted in a sample of representative family practices in England. These methods were combined into an overall recommendation for each tested indicator. Results Using an indicator testing protocol as part of piloting was seen as a valuable way of testing potential indicators in 'real world' settings. Pilot 1 (October 2009-March 2010 involved thirteen indicators across six clinical domains and twelve indicators passed the indicator testing protocol. However, the indicator testing protocol identified a number of implementation issues and unintended consequences that can be rectified or removed prior to national roll out. A palliative care indicator is used as an exemplar of the value of piloting using a multiple attribute indicator testing protocol - while technically feasible and reliable, it was unacceptable to practice staff and raised concerns about potentially causing actual patient harm. Conclusions This indicator testing protocol is one example of a protocol that may be useful in assessing potential quality indicators when adapted to specific country health

  4. A Mechanically Proved and an Incremental Development of the Session Initiation Protocol INVITE Transaction

    Directory of Open Access Journals (Sweden)

    Rajaa Filali

    2014-01-01

    Full Text Available The Session Initiation Protocol (SIP is an application layer signaling protocol used to create, manage, and terminate sessions in an IP based network. SIP is considered as a transactional protocol. There are two main SIP transactions, the INVITE transaction and the non-INVITE transaction. The SIP INVITE transaction specification is described in an informal way in Request for Comments (RFC 3261 and modified in RFC 6026. In this paper we focus on the INVITE transaction of SIP, over reliable and unreliable transport mediums, which is used to initiate a session. In order to ensure the correctness of SIP, the INVITE transaction is modeled and verified using event-B method and its Rodin platform. The Event-B refinement concept allows an incremental development by defining the studied system at different levels of abstraction, and Rodin discharges almost all proof obligations at each level. This interaction between modeling and proving reduces the complexity and helps in assuring that the INVITE transaction SIP specification is correct, unambiguous, and easy to understand.

  5. Development and Pilot Implementation of a Search Protocol to Improve Patient Safety on a Psychiatric Inpatient Unit.

    Science.gov (United States)

    Abela-Dimech, Frances; Johnston, Kim; Strudwick, Gillian

    A mental health organization in Ontario, Canada, noted an increase in unsafe items entering locked inpatient units. The purpose of this project was to develop and implement a search protocol to improve patient, staff, and visitor safety by preventing unsafe items from entering a locked inpatient unit. Under the guidance of a clinical nurse specialist, an interprofessional team used the Failure Mode and Effects Analysis framework to identify what items were considered unsafe, how these unsafe items were entering the unit, and what strategies could be used to prevent these items from entering the unit. A standardized search protocol was identified as a strategy to prevent items from entering the unit. The standardized search protocol was developed and piloted on 1 unit. To support the search protocol, an interprofessional team created a poster using a mnemonic aid to educate patients, staff, and visitors about which items could not be brought onto the unit. Educational sessions on the search protocol were provided for staff. The difference between the number of incidents before and after the implementation of the search protocol was statistically significant. Safety on an inpatient unit was increased as incidents of unsafe items entering the unit decreased.

  6. Individual Learning Account Pilot Initiative: A Learning Tool for the 21st Century. Report to the OPM Director.

    Science.gov (United States)

    President's Task Force on Federal Training Technology, Washington, DC.

    The U.S. Office of Personnel Management (OPM) evaluated the feasibility of individual learning accounts (ILAs) as an approach to workforce development. Thirteen federal agencies volunteered to participate in the initiative. Together, they conducted a total of 17 pilot tests. Some pilot tests included all employees in the agency. Others targeted…

  7. A Two-Layered Mobility Architecture Using Fast Mobile IPv6 and Session Initiation Protocol

    Directory of Open Access Journals (Sweden)

    Nursimloo DeeyaS

    2008-01-01

    Full Text Available Abstract This paper proposes an integrated mobility scheme that combines the procedures of fast handover for Mobile IPv6 (FMIPv6 and session initiation protocol (SIP mobility for realtime communications. This integrated approach is based on the context of the applications utilized. Furthermore, to reduce system redundancies and signaling loads, several functionalities of FMIPv6 and SIP have been integrated to optimize the integrated mobility scheme. The proposed scheme aims at reducing the handover latency and packet loss for an ongoing realtime traffic. Using ns-2 simulation, we analyze the performance of the proposed integrated scheme and compare it with the existing protocols for a VoIP and for a video stream traffic. This mobility architecture achieves lower handover delay and less packet loss than using either FMIPv6 or SIP and hence presents a powerful handover mobility scheme for next generation IP-based wireless systems.

  8. A Two-Layered Mobility Architecture Using Fast Mobile IPv6 and Session Initiation Protocol

    Directory of Open Access Journals (Sweden)

    Deeya S. Nursimloo

    2007-12-01

    Full Text Available This paper proposes an integrated mobility scheme that combines the procedures of fast handover for Mobile IPv6 (FMIPv6 and session initiation protocol (SIP mobility for realtime communications. This integrated approach is based on the context of the applications utilized. Furthermore, to reduce system redundancies and signaling loads, several functionalities of FMIPv6 and SIP have been integrated to optimize the integrated mobility scheme. The proposed scheme aims at reducing the handover latency and packet loss for an ongoing realtime traffic. Using ns-2 simulation, we analyze the performance of the proposed integrated scheme and compare it with the existing protocols for a VoIP and for a video stream traffic. This mobility architecture achieves lower handover delay and less packet loss than using either FMIPv6 or SIP and hence presents a powerful handover mobility scheme for next generation IP-based wireless systems.

  9. Initial Characterization of Optical Communications with Disruption-Tolerant Network Protocols

    Science.gov (United States)

    Schoolcraft, Joshua; Wilson, Keith

    2011-01-01

    Disruption-tolerant networks (DTNs) are groups of network assets connected with a suite of communication protocol technologies designed to mitigate the effects of link delay and disruption. Application of DTN protocols to diverse groups of network resources in multiple sub-networks results in an overlay network-of-networks with autonomous data routing capability. In space environments where delay or disruption is expected, performance of this type of architecture (such as an interplanetary internet) can increase with the inclusion of new communications mediums and techniques. Space-based optical communication links are therefore an excellent building block of space DTN architectures. When compared to traditional radio frequency (RF) communications, optical systems can provide extremely power-efficient and high bandwidth links bridging sub-networks. Because optical links are more susceptible to link disruption and experience the same light-speed delays as RF, optical-enabled DTN architectures can lessen potential drawbacks and maintain the benefits of autonomous optical communications over deep space distances. These environment-driven expectations - link delay and interruption, along with asymmetric data rates - are the purpose of the proof-of-concept experiment outlined herein. In recognizing the potential of these two technologies, we report an initial experiment and characterization of the performance of a DTN-enabled space optical link. The experiment design employs a point-to-point free-space optical link configured to have asymmetric bandwidth. This link connects two networked systems running a DTN protocol implementation designed and written at JPL for use on spacecraft, and further configured for higher bandwidth performance. Comparing baseline data transmission metrics with and without periodic optical link interruptions, the experiment confirmed the DTN protocols' ability to handle real-world unexpected link outages while maintaining capability of

  10. Recall of intensive care unit stay in patients managed with a sedation protocol or a sedation protocol with daily sedative interruption: a pilot study.

    Science.gov (United States)

    Ethier, Cheryl; Burry, Lisa; Martinez-Motta, Carlos; Tirgari, Sam; Jiang, Depeng; McDonald, Ellen; Granton, John; Cook, Deborah; Mehta, Sangeeta

    2011-04-01

    Analgesics and sedatives are integral for the relief of pain and anxiety in critically ill patients. However, these agents may contribute to amnesia for intensive care unit (ICU) events; which has been associated with development of posttraumatic stress disorder. Drug administration strategies that minimize sedative use have been associated with less amnesia. The objective of this pilot study was to evaluate recall of ICU stay in patients managed with 2 sedation strategies: a sedation protocol or a combination of sedation protocol and daily sedative/analgesic interruption. A questionnaire was administered on day 3 following ICU discharge to evaluate patients' recollections of pain, anxiety, fear, and sleep, as well as memories for specific ICU procedures. Participants were ICU survivors who had been enrolled in SLEAP - a randomized pilot trial comparing two sedation strategies, at 3 university-affiliated medical/surgical ICUs. Twenty-one patients who regained orientation within 72 hours of ICU discharge completed the questionnaire. More than 50% of patients recalled experiencing pain, anxiety, and fear to a moderate or extreme extent; and 57% reported inadequate sleep while in the ICU. Of the 21 patients, 48%, 33%, and 29% had no memories of endotracheal tube suctioning, being on a "breathing machine," and being bathed, respectively. A notable percentage of patients discharged from the ICU report moderate to extreme pain, anxiety, and fear, and inability to sleep during their ICU stay; and 29% to 48% have no recall of specific ICU events. Copyright © 2011 Elsevier Inc. All rights reserved.

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

    OpenAIRE

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

    2016-01-01

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

  12. Uma aplicação de voz sobre IP baseada no Session Initiation Protocol

    OpenAIRE

    Maia da Silva Junior, Jucimar

    2006-01-01

    Neste trabalho é implementada uma aplicação de Voz Sobre IP utilizando o Session Initiation Protocol (SIP) como protocolo de sinalização. Para alcançar este objetivo, são analisadas algumas tecnologias importantes, como os protocolos da Internet Engineering Task Force (IETF) para Telefonia IP, codificadores de voz, e a utilização da aplicação para verificação de atrasos, jitter e perda de pacotes. A aplicação foi desenvolvida em Java e pode facilmente ser modificada para adequa...

  13. Evaluation of quality improvement initiative in pediatric oncology: implementation of aggressive hydration protocol.

    Science.gov (United States)

    Fratino, Lisa M; Daniel, Denise A; Cohen, Kenneth J; Chen, Allen R

    2009-01-01

    Our goal was to improve the efficiency of chemotherapy administration for pediatric oncology patients. We identified prechemotherapy hydration as the process that most often delayed chemotherapy administration. An aggressive hydration protocol, supported by fluid order sets, was developed for patients receiving planned chemotherapy. The mean interval from admission to achieving adequate hydration status was reduced significantly from 4.9 to 1.4 hours with a minor reduction in the time to initiate chemotherapy from 9.6 to 8.6 hours. Chemotherapy availability became the new rate-limiting process.

  14. Layered Electrical Product Application Protocol (AP). Draft: Initial Graphics Exchange Specification (IGES)

    Energy Technology Data Exchange (ETDEWEB)

    1994-09-01

    An application protocol is an information systems engineering view of a specific product. The view represents an agreement on the generic activities needed to design and fabricate the product, the agreement on the information needed to support those activities, and the specific constructs of a product data standard for use in transfering some or all of the information required. This applications protocol describes the data for electrical and electronic products in terms of a product description standard called the Initial Graphics Exchange Specification (IGES). More specifically, the Layered Electrical Product IGES Application Protocol (AP) specifies the mechanisms for defining and exchanging computer-models and their associated data for those products which have been designed in two dimensional geometry so as to be produced as a series of layers in IGES format. The AP defines the appropriateness of the data items for describing the geometry of the various parts of a product (shape and location), the connectivity, and the processing and material characteristics. Excluded is the behavioral requirements which the product was intended to satisfy, except as those requirements have been recorded as design rules or product testing requirements.

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

    Science.gov (United States)

    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.

  16. Altruistic Backoff: Collision Avoidance for Receiver-Initiated MAC Protocols for Wireless Sensor Networks

    DEFF Research Database (Denmark)

    Fafoutis, Xenofon; Orfanidis, Charalampos; Dragoni, Nicola

    2014-01-01

    In receiver-initiated medium access control (MAC) protocols for wireless sensor networks, communication is initiated by the receiver node which transmits beacons indicating its availability to receive data. In the case of multiple senders having traffic for a given receiver, such beacons form...... points where collisions are likely to happen. In this paper, we present altruistic backoff (AB), a novel collision avoidance mechanism that aims to avoid collisions before the transmission of a beacon. As a result of an early backoff, senders spend less time in idle listening waiting for a beacon, thus...... saving significant amounts of energy. We present an implementation of AB for Texas Instruments' eZ430-rf2500 sensor nodes and we evaluate its performance with simulations and experiments....

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

    LENUS (Irish Health Repository)

    Olaitan, Oyedolamu K

    2010-02-01

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

  18. Initial Development and Pilot Study Design of Interactive Lecture Demonstrations for ASTRO 101

    Science.gov (United States)

    Schwortz, Andria C.; French, D. A; Gutierrez, Joseph V; Sanchez, Richard L; Slater, Timothy F.; Tatge, Coty

    2014-06-01

    Interactive lecture demonstrations (ILDs) have repeatedly shown to be effective tools for improving student achievement in the context of learning physics. As a first step toward systematic development of interactive lecture demonstrations in ASTRO 101, the introductory astronomy survey course, a systematic review of education research, describing educational computer simulations (ECSs) reveals that initial development requires a targeted study of how ASTRO 101 students respond to ECSs in the non-science majoring undergraduate lecture setting. In this project we have adopted the process by which ILDs were designed, pilot-tested, and successfully implemented in the context of physics teaching (Sokoloff & Thornton, 1997; Sokoloff & Thornton, 2004). We have designed the initial pilot-test set of ASTRO 101 ILD instructional materials relying heavily on ECSs. Both an instructor’s manual and a preliminary classroom-ready student workbook have been developed, and we are implementing a pilot study to explore their effectiveness in communicating scientific content, and the extent to which they might enhance students’ knowledge of and perception about astronomy and science in general. The study design uses a pre-/post-test quasi-experimental study design measuring students’ normalized gain scores, calculated as per Hake (1998) and Prather (2009), using a slightly modified version of S. Slater’s (2011) Test Of Astronomy STandards TOAST combined with other instruments. The results of this initial study will guide the iterative development of ASTRO 101 ILDs that are intended to both be effective at enhancing student achievement and easy for instructors to successfully implement.

  19. The Agricultural Model Intercomparison and Improvement Project (AgMIP): Protocols and Pilot Studies

    Science.gov (United States)

    Rosenzweig, C.; Jones, J. W.; Hatfield, J. L.; Ruane, A. C.; Boote, K. J.; Thorburn, P.; Antle, J. M.; Nelson, G. C.; Porter, C.; Janssen, S.; hide

    2012-01-01

    The Agricultural Model Intercomparison and Improvement Project (AgMIP) is a major international effort linking the climate, crop, and economic modeling communities with cutting-edge information technology to produce improved crop and economic models and the next generation of climate impact projections for the agricultural sector. The goals of AgMIP are to improve substantially the characterization of world food security due to climate change and to enhance adaptation capacity in both developing and developed countries. Analyses of the agricultural impacts of climate variability and change require a transdisciplinary effort to consistently link state-of-the-art climate scenarios to crop and economic models. Crop model outputs are aggregated as inputs to regional and global economic models to determine regional vulnerabilities, changes in comparative advantage, price effects, and potential adaptation strategies in the agricultural sector. Climate, Crop Modeling, Economics, and Information Technology Team Protocols are presented to guide coordinated climate, crop modeling, economics, and information technology research activities around the world, along with AgMIP Cross-Cutting Themes that address uncertainty, aggregation and scaling, and the development of Representative Agricultural Pathways (RAPs) to enable testing of climate change adaptations in the context of other regional and global trends. The organization of research activities by geographic region and specific crops is described, along with project milestones. Pilot results demonstrate AgMIP's role in assessing climate impacts with explicit representation of uncertainties in climate scenarios and simulations using crop and economic models. An intercomparison of wheat model simulations near Obregón, Mexico reveals inter-model differences in yield sensitivity to [CO2] with model uncertainty holding approximately steady as concentrations rise, while uncertainty related to choice of crop model increases with

  20. A pilot audit of a protocol for ambulatory investigation of predicted low-risk patients with possible pulmonary embolism.

    Science.gov (United States)

    McDonald, A H; Murphy, R

    2011-09-01

    Patients with possible pulmonary embolism (PE) commonly present to acute medical services. Research has led to the identification of low-risk patients suitable for ambulatory management. We report on a protocol designed to select low-risk patients for ambulatory investigation if confirmatory imaging is not available that day. The protocol was piloted in the Emergency Department and Medical Assessment Area at the Royal Infirmary of Edinburgh. We retrospectively analysed electronic patient records in an open observational audit of all patients managed in the ambulatory arm over five months of use. We analysed 45 patients' records. Of these, 91.1% required imaging to confirm or refute PE, 62.2% received a computed tomography pulmonary angiogram (CTPA). In 25% of patients, PE was confirmed with musculoskeletal pain (22.7%), and respiratory tract infection (15.9%) the next most prevalent diagnoses. Alternative diagnoses was provided by CTPA in 32% of cases. We identified no adverse events or readmissions but individualised follow-up was not attempted. The data from this audit suggests this protocol can be applied to select and manage low-risk patients suitable for ambulatory investigation of possible PE. A larger prospective comparative study would be required to accurately define the safety and effectiveness of this protocol.

  1. Transitioning Adolescents and Young Adults With HIV Infection to Adult Care: Pilot Testing the "Movin' Out" Transitioning Protocol.

    Science.gov (United States)

    Maturo, Donna; Powell, Alexis; Major-Wilson, Hannah; Sanchez, Kenia; De Santis, Joseph P; Friedman, Lawrence B

    2015-01-01

    Advances in care and treatment of adolescents/young adults with HIV infection have made survival into adulthood possible, requiring transition to adult care. Researchers have documented that the transition process is challenging for adolescents/young adults. To ensure successful transition, a formal transition protocol is needed. Despite existing research, little quantitative evaluation of the transition process has been conducted. The purpose of the study was to pilot test the "Movin' Out" Transitioning Protocol, a formalized protocol developed to assist transition to adult care. A retrospective medical/nursing record review was conducted with 38 clients enrolled in the "Movin' Out" Transitioning Protocol at a university-based adolescent medicine clinic providing care to adolescents/young adults with HIV infection. Almost half of the participants were able to successfully transition to adult care. Reasons for failure to transition included relocation, attrition, lost to follow-up, and transfer to another adult service. Failure to transition to adult care was not related to adherence issues, X(2) (1, N=38)=2.49, p=.288; substance use, X(2) (1, N=38)=1.71, p=.474; mental health issues, X(2) (1, N=38)=2.23, p=.322; or pregnancy/childrearing, X(2) (1, N=38)=0.00, p=.627). Despite the small sample size, the "Movin' Out" Transitioning Protocol appears to be useful in guiding the transition process of adolescents/young adults with HIV infection to adult care. More research is needed with a larger sample to fully evaluate the "Movin' Out" Transitioning Protocol. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. FY 2008 Next Generation Safeguards Initiative International Safeguards Education and Training Pilot Progerams Summary Report

    Energy Technology Data Exchange (ETDEWEB)

    Dreicer, M; Anzelon, G; Essner, J; Dougan, A; Doyle, J; Boyer, B; Hypes, P; Sokova, E; Wehling, F

    2008-10-17

    Key component of the Next Generation Safeguards Initiative (NGSI) launched by the National Nuclear Security Administration is the development of human capital to meet present and future challenges to the safeguards regime. An effective university-level education in safeguards and related disciplines is an essential element in a layered strategy to rebuild the safeguards human resource capacity. Two pilot programs at university level, involving 44 students, were initiated and implemented in spring-summer 2008 and linked to hands-on internships at LANL or LLNL. During the internships, students worked on specific safeguards-related projects with a designated Laboratory Mentor to provide broader exposure to nuclear materials management and information analytical techniques. The Safeguards and Nuclear Material Management pilot program was a collaboration between the Texas A&M University (TAMU), Los Alamos National Laboratory (LANL) and Lawrence Livermore National Laboratory (LLNL). It included a 16-lecture course held during a summer internship program. The instructors for the course were from LANL together with TAMU faculty and LLNL experts. The LANL-based course was shared with the students spending their internship at LLNL via video conference. A week-long table-top (or hands-on) exercise on was also conducted at LANL. The student population was a mix of 28 students from a 12 universities participating in a variety of summer internship programs held at LANL and LLNL. A large portion of the students were TAMU students participating in the NGSI pilot. The International Nuclear Safeguards Policy and Information Analysis pilot program was implemented at the Monterey Institute for International Studies (MIIS) in cooperation with LLNL. It included a two-week intensive course consisting of 20 lectures and two exercises. MIIS, LLNL, and speakers from other U.S. national laboratories (LANL, BNL) delivered lectures for the audience of 16 students. The majority of students were

  3. FY 2008 Next Generation Safeguards Initiative International Safeguards Education and Training Pilot Programs Summary Report

    International Nuclear Information System (INIS)

    Dreicer, M.; Anzelon, G.; Essner, J.; Dougan, A.; Doyle, J.; Boyer, B.; Hypes, P.; Sokova, E.; Wehling, F.

    2008-01-01

    Key component of the Next Generation Safeguards Initiative (NGSI) launched by the National Nuclear Security Administration is the development of human capital to meet present and future challenges to the safeguards regime. An effective university-level education in safeguards and related disciplines is an essential element in a layered strategy to rebuild the safeguards human resource capacity. Two pilot programs at university level, involving 44 students, were initiated and implemented in spring-summer 2008 and linked to hands-on internships at LANL or LLNL. During the internships, students worked on specific safeguards-related projects with a designated Laboratory Mentor to provide broader exposure to nuclear materials management and information analytical techniques. The Safeguards and Nuclear Material Management pilot program was a collaboration between the Texas A and M University (TAMU), Los Alamos National Laboratory (LANL) and Lawrence Livermore National Laboratory (LLNL). It included a 16-lecture course held during a summer internship program. The instructors for the course were from LANL together with TAMU faculty and LLNL experts. The LANL-based course was shared with the students spending their internship at LLNL via video conference. A week-long table-top (or hands-on) exercise on was also conducted at LANL. The student population was a mix of 28 students from a 12 universities participating in a variety of summer internship programs held at LANL and LLNL. A large portion of the students were TAMU students participating in the NGSI pilot. The International Nuclear Safeguards Policy and Information Analysis pilot program was implemented at the Monterey Institute for International Studies (MIIS) in cooperation with LLNL. It included a two-week intensive course consisting of 20 lectures and two exercises. MIIS, LLNL, and speakers from other U.S. national laboratories (LANL, BNL) delivered lectures for the audience of 16 students. The majority of students

  4. Parenting for Autism, Language, And Communication Evaluation Study (PALACES): protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Williams, Margiad Elen; Hastings, Richard; Charles, Joanna Mary; Evans, Sue; Hutchings, Judy

    2017-02-16

    Children with autistic spectrum disorder (ASD) often have associated behavioural difficulties that can present a challenge for parents and parenting. There are several effective social learning theory-based parenting programmes for dealing with behavioural difficulties, including the Incredible Years (IY) parent programmes. However, these programmes typically do not specifically target parents of children with ASD. Recently, a new addition to the IY suite of programmes known as the IY Autistic Spectrum and Language Delays (IY-ASLD) parent programme was developed. The main aims of the present study are to examine the feasibility of delivering this programme within child health services and to provide initial evidence for effectiveness and economic costs. The Parenting for Autism, Language, And Communication Evaluation Study (PALACES) trial is a pragmatic, multicentre, pilot randomised controlled trial comparing the IY-ASLD programme with a wait-list control condition. 72 parents of children with ASD (aged 3-8 years) will be randomly allocated to either the intervention or control condition. Data will be collected prior to randomisation and 6 months postrandomisation for all families. Families in the intervention condition only will also be followed up at 12 and 18 months postrandomisation. This study will provide initial evidence of effectiveness for the newly developed IY-ASLD parenting programme. It will also add to the limited economic evidence for an intervention targeting parents of children with ASD and provide longer term data, an important component for evaluations of parenting programmes. Approval for the study was granted by the Research Ethics Committee at the School of Psychology, Bangor University (reference number: 2016-15768) and the North Wales Research Ethics Committee, UK (reference number: 16/WA/0224). The findings will be disseminated through research conferences and peer-reviewed journals. ISRCTN57070414; Pre-results. Published by the BMJ

  5. Feasibility and effectiveness of the baby friendly community initiative in rural Kenya: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kimani-Murage, Elizabeth W; Kimiywe, Judith; Kabue, Mark; Wekesah, Frederick; Matiri, Evelyn; Muhia, Nelson; Wanjohi, Milka; Muriuki, Peterrock; Samburu, Betty; Kanyuira, James N; Young, Sera L; Griffiths, Paula L; Madise, Nyovani J; McGarvey, Stephen T

    2015-09-28

    Interventions promoting optimal infant and young child nutrition could prevent a fifth of under-5 deaths in countries with high mortality. Poor infant and young child feeding practices are widely documented in Kenya, with potential detrimental effects on child growth, health and survival. Effective strategies to improve these practices are needed. This study aims to pilot implementation of the Baby Friendly Community Initiative (BFCI), a global initiative aimed at promoting optimal infant and young child feeding practices, to determine its feasibility and effectiveness with regards to infant feeding practices, nutrition and health outcomes in a rural setting in Kenya. The study, employing a cluster-randomized trial design, will be conducted in rural Kenya. A total of 12 clusters, constituting community units within the government's Community Health Strategy, will be randomized, with half allocated to the intervention and the other half to the control arm. A total of 812 pregnant women and their respective children will be recruited into the study. The mother-child pairs will be followed up until the child is 6 months old. Recruitment will last approximately 1 year from January 2015, and the study will run for 3 years, from 2014 to 2016. The intervention will involve regular counseling and support of mothers by trained community health workers and health professionals on maternal, infant and young child nutrition. Regular assessment of knowledge, attitudes and practices on maternal, infant and young child nutrition will be done, coupled with assessment of nutritional status of the mother-child pairs and morbidity for the children. Statistical methods will include analysis of covariance, multinomial logistic regression and multilevel modeling. The study is funded by the NIH and USAID through the Program for Enhanced Research (PEER) Health. Findings from the study outlined in this protocol will inform potential feasibility and effectiveness of a community

  6. A protocol for the retina surgeon’s safe initial intravitreal injections

    Directory of Open Access Journals (Sweden)

    Ronald EP Frenkel

    2010-11-01

    Full Text Available Ronald EP Frenkel1,2, Shamim A Haji1,2, Melvin La1, Max PC Frenkel1, Angela Reyes11Eye Research Foundation, Stuart, FL, USA; 2East Florida Eye Institute, Stuart, FL, USAPurpose: To determine the safety of a surgeon’s initial consecutive intravitreal injections using a specific protocol and to review the complications that may be attributed to the injection procedure.Design: A retrospective chart review.Participants: Fifty-nine patients (30 females, 29 males received intravitreal injections of pegaptanib, bevacizumab, or ranibizumab as part of their treatment for neovascular age-related macular degeneration. The average patient age was 80 years. Twenty-two patients were diagnosed with or suspected of having glaucoma. Each patient received an average of 5.8 injections.Methods: The charts of 59 patients who received a total of 345 intravitreal injections (104 pegaptanib, 74 bevacizumab, 167 ranibizumab were reviewed. All injections were performed in an office-based setting. Povidone–iodine, topical antibiotics, and eye speculum were used as part of the pre injection procedure. Vision and intraocular pressure were evaluated immediately following each injection.Main outcome measures: Incidence of post injection complications, including but not limited to endophthalmitis, retinal detachment, traumatic cataract, and vitreous hemorrhage.Results: There were no cases of endophthalmitis, toxic reactions, traumatic cataracts, retinal detachment, or vitreous hemorrhage. There was one case each of lid swelling, transient floaters, retinal pigment epithelial tear, corneal edema, and corneal abrasion. There were five cases of transient no light perception following pegaptanib injections.Conclusion: The incidence of serious complications was very low for the intravitreal injections given. A surgeon’s initial intravitreal injections may be performed with a very high degree of safety using this protocol.Keywords: intravitreal injection, post injection

  7. Hemodialysis Infection Prevention Protocols Ontario—Shower Technique (HIPPO-ST: A Pilot Randomized Trial

    Directory of Open Access Journals (Sweden)

    S. Daisy Kosa

    2017-03-01

    Discussion: This HIPPO-ST pilot study demonstrated the feasibility of the larger HIPPO-ST study, especially given the high levels of education success with the HIPPO-ST arm and the low levels of contamination in the control arm.

  8. Contraception Initiation in the Emergency Department: A Pilot Study on Providers' Knowledge, Attitudes, and Practices.

    Science.gov (United States)

    Liles, Iyanna; Haddad, Lisa B; Lathrop, Eva; Hankin, Abigail

    2016-05-01

    Almost half of all pregnancies in the United States are unintended; these pregnancies are associated with adverse outcomes. Many reproductive-age females seek care in the emergency department (ED), are at risk of pregnancy, and are amenable to contraceptive services in this setting. Through a pilot study, we sought to assess ED providers' current practices; attitudes; and knowledge of emergency contraception (EC) and nonemergency contraception (non-EC), as well as barriers with respect to contraception initiation. ED physicians and associate providers in Georgia were e-mailed a link to an anonymous Internet questionnaire using state professional databases and contacts. The questionnaire included Likert scales with multiple-choice questions to assess study objectives. Descriptive statistics were generated as well as univariate analyses using χ(2) and Fisher exact tests. A total of 1232 providers were e-mailed, with 119 questionnaires completed. Participants were predominantly physicians (80%), men (59%), and individuals younger than 45 years (59%). Common practices were referrals (96%), EC prescriptions (77%), and non-EC prescriptions (40%). Common barriers were perceived as low likelihood for follow-up (63%), risk of complications (58%), and adverse effects (51%). More than 70% of participants correctly identified the highly effective contraceptive methods, 3% identified the correct maximum EC initiation time, and 42% correctly recognized pregnancy as a higher risk than hormonal contraception use for pulmonary embolism. Most ED providers in this pilot study referred patients for contraception; however, there was no universal contraceptive counseling and management. Many ED providers in this study had an incorrect understanding of the efficacy, risks, and eligibility associated with contraceptive methods. This lack of understanding may affect patient access and be a barrier to patient care.

  9. Modelling and Initial Validation of the DYMO Routing Protocol for Mobile Ad-Hoc Networks

    DEFF Research Database (Denmark)

    Espensen, Kristian Asbjørn Leth; Kjeldsen, Mads Keblov; Kristensen, Lars Michael

    2008-01-01

    A mobile ad-hoc network (MANET) is an infrastructureless network established by a set of mobile devices using wireless communication. The Dynamic MANET On-demand (DYMO) protocol is a routing protocol for multi-hop communication in MANETs currently under development by the Internet Engineering Task...... Force (IETF). This paper presents a Coloured Petri Net (CPN) model of the mandatory parts of the DYMO protocol, and shows how scenario-based state space exploration has been used to validate key properties of the protocol. Our CPN modelling and verification work has spanned two revisions of the DYMO...... protocol specification and have had direct impact on the most recent version of the protocol specification....

  10. Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in elderly care units: study protocol.

    Science.gov (United States)

    Drahota, Amy; Gal, Diane; Windsor, Julie; Dixon, Simon; Udell, Julie; Ward, Derek; Soilemezi, Dia; Dean, Taraneh; Severs, Martin

    2011-12-01

    Falls are an issue disproportionately affecting older people who are at increased risk of falls and injury. This protocol describes a pilot study investigating shock-absorbing flooring for fall-related injuries in wards for older people. To inform future research by evaluating fall-related injuries on the intervention and existing flooring, assessing the sustainability of the flooring in ward environments, estimating the cost-effectiveness of the floor and assessing how the floor affects patients and other users. This study uses mixed methods a pilot cluster randomised controlled trial, observation via mechanical testing and interviews. Eight participating wards (clusters) are randomised using a computer-generated list. No blinding is incorporated into the study. Each site has a baseline period of approximately 6 months. Then, four sites receive the intervention floor, while four continue using standard floors. Sites are then followed up for approximately 1 year. Any person admitted to a bed in the 'study area' of a participating ward can be entered into the trial. Orientated patients, visitors and any hospital staff who use the floor in a study area are eligible for inclusion in an interview. An 8.3 mm thick vinyl floor covering with polyvinyl chloride foam backing (Tarkett Omnisports EXCEL). The primary outcome is fall-related injuries. Severity of injuries, falls, cost-effectiveness, user views and mechanical performance (shock absorbency and slip resistance) are also being assessed.

  11. American College of Surgeons NSQIP: quality in-training initiative pilot study.

    Science.gov (United States)

    Sellers, Morgan M; Reinke, Caroline E; Kreider, Susan; Meise, Chelsey; Nelis, Kara; Volpe, Anita; Anzlovar, Nancy; Ko, Clifford; Kelz, Rachel R

    2013-11-01

    Clinical outcomes data are playing an increasingly important role in medical decision-making, reimbursement, and provider evaluation, but there are no documented programs that provide outcomes data to surgical residents as part of a structured curriculum. Our objectives were to develop a national collaborative of training programs to unify the efforts between quality and education personnel and demonstrate the feasibility of generating customized reports of patient outcomes for use in surgical education. The pool of potential hospitals was evaluated by comparing ACS NSQIP participants with the roster of clinical sites for general surgery residency programs maintained by FREIDA Online. A program and user guide was developed to generate custom reports based on institutional data, and a voluntary pilot was conducted, consisting of initial development, implementation, and feedback stages. Programs that successfully completed installation and report generation were queried for feedback on time and resources used. Of 245 general surgery residency programs, 47% had a NSQIP-affiliated sponsor institution, and an additional 31% had at least 1 NSQIP-affiliated participant institution. Sixty general surgery residency programs have expressed interest in collaboration. Seventeen pilot sites completed training and installation, and were able to independently generate custom reports. The response rate for the post-report survey was 50%. Participants reported that training and installation typically required one 2-hour phone call, and that total time devoted to the project was less than 8 hours. Collaboration between educators and quality improvement personnel from a diverse group of organizations to integrate outcomes data into surgical education is feasible. Obtaining resident and team reports from ACS NSQIP can be done with minimal effort. Future efforts will be aimed at developing a national data-centered curriculum for general surgery programs. Copyright © 2013 American

  12. A nurse-initiated pain protocol in the ED improves pain treatment in patients with acute musculoskeletal pain

    NARCIS (Netherlands)

    Pierik, J.G.; Berben, S.A.A.; IJzerman, M.J.; Gaakeer, M.I.; Eenennaam, F.L. van; Vugt, A.B. van; Doggen, C.J.

    2016-01-01

    While acute musculoskeletal pain is a frequent complaint, its management is often neglected. An implementation of a nurse-initiated pain protocol based on the algorithm of a Dutch pain management guideline in the emergency department might improve this. A pre-post intervention study was performed as

  13. A nurse-initiated pain protocol in the ED improves pain treatment in patients with acute musculoskeletal pain

    NARCIS (Netherlands)

    Pierik, Jorien; Berben, Sivera A.; IJzerman, Maarten Joost; Gaakeer, Menno I.; Eenennaam, Fred L.; van Vugt, Arie B.; Doggen, Catharina Jacoba Maria

    2016-01-01

    While acute musculoskeletal pain is a frequent complaint, its management is often neglected. An implementation of a nurse-initiated pain protocol based on the algorithm of a Dutch pain management guideline in the emergency department might improve this. A pre–post intervention study was performed as

  14. Using the "Knowledge Quartet" to Quantify Mathematical Knowledge in Teaching: The Development of a Protocol for Initial Teacher Education

    Science.gov (United States)

    Weston, Tracy L.

    2013-01-01

    This study examined trainee teachers' mathematical knowledge in teaching (MKiT) over their final year in a US Initial Teacher Education (ITE) programme. This paper reports on an exploratory methodological approach taken to use the "Knowledge Quartet" to quantify MKiT through the development of a new protocol to code trainees' teaching of…

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

    Science.gov (United States)

    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.

  16. A Pilot Study Involving the Effect of Two Different Complex Training Protocols on Lower Body Power

    OpenAIRE

    Smith Chad E.; Lyons Brian; Hannon James C.

    2014-01-01

    Purpose. Complex training (CT) involves the coupling of two exercises ostensibly to enhance the effect of the second exercise. Typically, the first exercise is a strength exercise and the second exercise is a power exercise involving similar muscles. In most cases, CT is designed to enhance power. The purpose of this study was twofold. First, this study was designed to determine if lower body power could be enhanced using complex training protocols. Second, this study investigated whether the...

  17. Pilot study: Assessing the effect of continual position monitoring technology on compliance with patient turning protocols

    OpenAIRE

    Schutt, Suann Cirigliano; Tarver, Christine; Pezzani, Michelle

    2017-01-01

    Abstract Aim The study aim was to evaluate if continual patient position monitoring, taking into account self‐turns and clinician‐assisted turns, would increase the percentage of time a patient's position changed at least every 2 hr. Background While patient turning has clinical benefits, current models to help staff remember to turn patients, such as “turn clocks” and timers, have not resulted in high compliance with turning protocols. In addition, reminders are based on arbitrary 2‐hr windo...

  18. A Rehabilitation Protocol for Empowering Spatial Orientation in MCI. A Pilot Study.

    Science.gov (United States)

    Gadler, Erminia; Grassi, Alessandra; Riva, Giuseppe

    2009-01-01

    Spatial navigation is among the first cognitive functions to be impaired in Alzheimer's disease [1] and deficit in this domain is detectable earlier in patients with Mild Cognitive Impairment [2]. Since efficacy of cognitive training in persons with MCI was successfully assessed [3], we developed a multitasking training protocol using virtual environments for stimulating attention, perception and visuo-spatial cognition in order to empower spatial orientation in MCI. Two healthy elders were exposed to the training over a period of four weeks and both showed improved performances in attention and orientation after the end of the intervention.

  19. Surgery versus Active Monitoring in Intermittent Exotropia (SamExo: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Buck Deborah

    2012-10-01

    Full Text Available Abstract Background Childhood intermittent exotropia [X(T] is a type of strabismus (squint in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision. Treatment options for X(T include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T are limited, and there is no randomised controlled trial (RCT evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia pilot study has been designed to test the feasibility of such a trial in the UK. Methods Design: an external pilot patient randomised controlled trial. Setting: four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust. Participants: children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T. Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit. Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T. Interventions: initial clinical assessment; randomisation (eye muscle surgery or active monitoring; 3-, 6- and 9-month (primary outcome clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire; qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial. Outcomes: recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or

  20. General Atomic HTGR fuel reprocessing pilot plant: results of initial sequential equipment operation

    International Nuclear Information System (INIS)

    1978-09-01

    In September 1977, the processing of 20 large high-temperature gas-cooled reactor (LHTGR) fuel elements was completed sequentially through the head-end cold pilot plant equipment. This report gives a brief description of the equipment and summarizes the results of the sequential operation of the pilot plant. 32 figures, 15 tables

  1. Pilot study: Assessing the effect of continual position monitoring technology on compliance with patient turning protocols.

    Science.gov (United States)

    Schutt, Suann Cirigliano; Tarver, Christine; Pezzani, Michelle

    2018-01-01

    The study aim was to evaluate if continual patient position monitoring, taking into account self-turns and clinician-assisted turns, would increase the percentage of time a patient's position changed at least every 2 hr. While patient turning has clinical benefits, current models to help staff remember to turn patients, such as "turn clocks" and timers, have not resulted in high compliance with turning protocols. In addition, reminders are based on arbitrary 2-hr windows (such as turning on "even" hours) rather than on individual patient activity, including self-turns. This is a first inpatient, non-randomized, pre-/postintervention study. Data collection occurred from May 2013-February 2014 on a 39-bed medical unit in a community hospital. Baseline patient turning data were recorded by a sensor; however, the patient data were not displayed at the nurses' station to establish compliance with the hospital's turning protocol. Postintervention, patient position information was wirelessly displayed on nurses' station computer monitors in real time. A Student t test was used to compare baseline to postintervention "mean time in compliance." Data from 138 patients ( N  =   7,854 hr of monitoring) were collected. The baseline phase yielded 4,322 hr of position monitoring data and the postintervention phase yielded 3,532 hr of data. Statistically significant improvement was demonstrated in the percentage of time a patient's position changed at least every 2 hr from baseline to postintervention.

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

    Science.gov (United States)

    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 (p0.05). 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.

  3. FY2017 Pilot Project Plan for the Nuclear Energy Knowledge and Validation Center Initiative

    Energy Technology Data Exchange (ETDEWEB)

    Ren, Weiju [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

    2016-10-30

    To prepare for technical development of computational code validation under the Nuclear Energy Knowledge and Validation Center (NEKVAC) initiative, several meetings were held by a group of experts of the Idaho National Laboratory (INL) and the Oak Ridge National Laboratory (ORNL) to develop requirements of, and formulate a structure for, a transient fuel database through leveraging existing resources. It was concluded in discussions of these meetings that a pilot project is needed to address the most fundamental issues that can generate immediate stimulus to near-future validation developments as well as long-lasting benefits to NEKVAC operation. The present project is proposed based on the consensus of these discussions. Analysis of common scenarios in code validation indicates that the incapability of acquiring satisfactory validation data is often a showstopper that must first be tackled before any confident validation developments can be carried out. Validation data are usually found scattered in different places most likely with interrelationships among the data not well documented, incomplete with information for some parameters missing, nonexistent, or unrealistic to experimentally generate. Furthermore, with very different technical backgrounds, the modeler, the experimentalist, and the knowledgebase developer that must be involved in validation data development often cannot communicate effectively without a data package template that is representative of the data structure for the information domain of interest to the desired code validation. This pilot project is proposed to use the legendary TREAT Experiments Database to provide core elements for creating an ideal validation data package. Data gaps and missing data interrelationships will be identified from these core elements. All the identified missing elements will then be filled in with experimental data if available from other existing sources or with dummy data if nonexistent. The resulting hybrid

  4. Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice

    Directory of Open Access Journals (Sweden)

    Tulledge-Scheitel Sidna M

    2009-12-01

    Full Text Available Abstract Background Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1 preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE for postmenopausal women at risk for osteoporotic fractures; and (2 assess the feasibility and validity (i.e., absence of contamination of patient-level randomization (vs. cluster randomization in pilot trials of decision aid efficacy. Methods/Design This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of STEOPOROSIS CHOICE on five outcomes: (a patient knowledge regarding osteoporosis risk factors and treatment; (b quality of the decision-making process for both the patient and clinician; (c patient and clinician acceptability and satisfaction with the decision aid; (d rate of bisphosphonate use and adherence, and (e trial processes (e.g., ability to recruit participants, collect patient outcomes. To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination. Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months. Discussion This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach -- decision aids -- to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform

  5. Electroacupuncture for treating insomnia in patients with cancer: a study protocol for a randomised pilot clinical trial.

    Science.gov (United States)

    Kim, Mikyung; Kim, Jung-Eun; Lee, Hye-Yoon; Kim, Ae-Ran; Park, Hyo-Ju; Kwon, O-Jin; Kim, Bo-Kyung; Cho, Jung Hyo; Kim, Joo-Hee

    2017-08-11

    Although insomnia is one of the most prevalent and disturbing symptoms among patients with cancer, it has not been properly managed. Electroacupuncture (EA) has received attention as a promising intervention for insomnia, and a few previous studies have reported that this intervention may be beneficial for treating insomnia in patients with cancer. The aim of this pilot study is to explore the feasibility and preliminary effectiveness of EA on the sleep disturbance of patients with cancer with insomnia using a subjective method, patient-reported questionnaires and an objective tool, actigraphy, to measure the quality of sleep. This is a study protocol for a randomised, three-arm, multicentre, pilot clinical trial. A total of 45 patients with cancer who have continuous insomnia related to cancer treatment or cancer itself will be randomly allocated to an EA group, sham EA group or usual care group in equal proportions. The EA group will receive 10 sessions of EA treatment over 4 weeks. The sham EA group will receive sham EA at non-acupoints using non-penetrating Streitberger acupuncture needles with mock EA. The usual care group will not receive EA treatment. All participants will be provided a brochure on the management of sleep disorders regardless of their group assignment. The primary outcome measure is the mean change in the insomnia severity index from the baseline to week 5. Information related to sleep quality will also be obtained through the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Participants will complete the trial by visiting the research centre at week 9 for follow-up assessment. This study protocol was approved by the institutional review boards of each research centre. Written informed consent will be obtained from all participants. The result of this study will be published in peer-reviewed journals or presented at academic conferences. KCT0002162; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated

  6. Pilot Study: Colostomy and Urine Collection Protocol for Investigating Potential Inciting Causes of Hen Diuresis Syndrome.

    Science.gov (United States)

    Jones, Kelli; Turner, Bradley; Brandão, João; Hubbard, Sue Ann; Magee, Danny; Baughman, Brittany; Wills, Robert; Tully, Thomas

    2015-06-01

    Hen diuresis syndrome has emerged over the past 5 yr as a significant cause of mortality in the U.S. broiler breeder industry. The condition affects hens in production and is characterized by transient muscle weakness in the vent region, transient diuresis, and often urate deposits on the skin below the vent. Affected hens are often seen straining to lay an egg, which suggests oviduct contraction is also impaired. Related hen mortality, often reaching 1% or more a week, is believed to be primarily the result of male aggression of the vent region (Turner et al., "Investigating Causes of Excessive Urate Production in Broiler Breeder Hens Associated with Peritonitis and Cannibalism Mortality," Oral Presentation at The American Association of Avian Pathologists Annual Meeting, p. 139, 2010). The exact association between the cause of mortality and this syndrome is unknown, but it may be the consequence of transient partial to full oviduct prolapse, which predisposes or stimulates cannibalism and aggression. Based on unpublished work done prior to this study (Turner et al., ibid.), the evidence suggests the underlying problem is metabolic. We feel that urine collection and analysis is an essential component to understanding this condition. This study serves as a pilot study for future investigations that attempt to identify the nature and cause of the metabolic disturbance through paired urine and serum collection and analysis. For the purpose of this study, a small sample of 10 affected and 10 unaffected birds was used for sample collection. In order to collect pure urine, the birds were surgically colostomized. Colostomy did prove to be a useful means of collecting urine free of feces, and for the purposes of our study it yielded adequate urine samples for analysis. There were statistically relevant urine values observed. Affected birds had a higher presence of blood in the urine, a lower uric acid excretion rate (mg/hr), higher concentration (mEq/L) of urine Na+, and

  7. Cognitive rehabiliation for Parkinson's disease demantia: a study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Hindle, John V; Watermeyer, Tamlyn J; Roberts, Julie; Martyr, Anthony; Lloyd-Williams, Huw; Brand, Andrew; Gutting, Petra; Hoare, Zoe; Edwards, Rhiannon Tudor; Clare, Linda

    2016-03-22

    There is growing interest in developing non-pharmacological treatments to address the cognitive deficits apparent in Parkinson's disease dementia and dementia with Lewy bodies. Cognitive rehabilitation is a goal-oriented behavioural intervention which focuses on improving everyday functioning through management of cognitive difficulties; it has been shown to be effective in Alzheimer's disease. To date, no studies have assessed its potential efficacy for addressing the impact of cognitive impairment in people with Parkinson's disease or dementia with Lewy bodies. Participants (n = 45) will be recruited from movement disorders, care for the elderly and memory clinics. Inclusion criteria include: a diagnosis of Parkinson's disease, Parkinson's disease dementia or dementia with Lewy bodies according to consensus criteria and an Addenbrooke's Cognitive Examination - III score of ≤ 82. Exclusion criteria include: a diagnosis of any other significant neurological condition; major psychiatric disorder, including depression, which is not related to the patient's Parkinson's disease and unstable medication use for their physical or cognitive symptoms. A single-blind pilot randomised controlled trial, with concurrent economic evaluation, will compare the relative efficacy of cognitive rehabilitation with that of two control conditions. Following a goal-setting interview, the participants will be randomised to one of the three study arms: cognitive rehabilitation (eight weekly sessions), relaxation therapy (eight weekly sessions) or treatment as usual. Randomisation and treatment group allocation will be carried out by a clinical trials unit using a dynamic adaptive sequential randomisation algorithm. The primary outcomes are patients' perceived goal attainment at a 2-months post-intervention assessment and a 6-months follow-up. Secondary outcomes include patients' objective cognitive performance (on tests of memory and executive function) and satisfaction with goal

  8. Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial.

    Science.gov (United States)

    Hunger, Christina; Hilzinger, Rebecca; Koch, Theresa; Mander, Johannes; Sander, Anja; Bents, Hinrich; Schweitzer, Jochen

    2016-03-31

    Social anxiety disorders are among the most prevalent anxiety disorders in the general population. The efficacy of cognitive behavioral therapy (CBT) for social anxiety disorders is well demonstrated. However, only three studies point to the efficacy of systemic therapy (ST) in anxiety disorders, and only two of them especially focus on social anxiety disorders. These ST studies either do not use a good comparator but minimal supportive therapy, they do not use a multi-person ST but a combined therapy, or they do not especially focus on social anxiety disorders but mood and anxiety disorders in general. Though ST was approved as evidence based in Germany for a variety of disorders in 2008, evidence did not include anxiety disorders. This is the first pilot study that will investigate multi-person ST, integrating a broad range of systemic methods, specifically for social anxiety disorders and that will compare ST to the "gold standard" CBT. This article describes the rationale and protocol of a prospective, open, interventive, balanced, bi-centric, pilot randomized controlled trial (RCT). A total of 32 patients with a primary SCID diagnosis of social anxiety disorder will be randomized to either CBT or ST. Both treatments will be manualized. The primary outcome will include social anxiety symptoms at the end of therapy. Therapy will be restricted to no more than 26 hours (primary endpoint). Secondary outcomes will include psychological, social systems and interpersonal functioning, symptom adjustment, and caregiver burden, in addition to change measures, therapist variables and treatment adherence. At the secondary endpoints, 9 and 12 months after the beginning of therapy, we will again assess all outcomes. The study is expected to pilot test a RCT which will be the first to directly compare CBT and multi-person ST, integrating a broad range of systemic methods, for social anxiety disorders, and it will provide empirical evidence for the calculation of the number of

  9. Immediate effect of three different electroacupuncture protocols on fasting blood glucose in obese patients: a pilot study.

    Science.gov (United States)

    Belivani, Maria; Lundeberg, Thomas; Cummings, Mike; Dimitroula, Charikleia; Belivani, Nicole; Vasilakos, Dimitris; Hatzitolios, Apostolos

    2015-04-01

    Obesity is an increasing global health problem, and current methods of management are limited. Preliminary research data suggest that acupuncture may have an influence on metabolic parameters related to obesity. To determine the electroacupuncture (EA) protocol to be used in a future clinical trial examining the effect of acupuncture on metabolic parameters related to obesity and to examine whether a single EA treatment can change fasting blood glucose in obese subjects. 16 obese women aged 30-52 years with body mass index >30 kg/m(2) were assigned consecutively into three groups and their fasting blood glucose was measured before and after administering a single session, lasting 30 min, of one of three EA treatment protocols. The Dorsal group received EA to dorsal segmental acupuncture points BL18-23 bilaterally (corresponding to the segmental levels innervating the pancreas); the Ear group received EA to ear points in the cavum conchae; and the Limb group received EA to points in the arms and legs (LI10-LI11, ST36-Zongping). After a single session of EA there was a statistically significant decrease in fasting blood glucose in the Dorsal and Limb groups, but there was no change and even a trend towards an increase in the glucose level in the Ear group. The findings of this small pilot study suggest that EA to either dorsal segmental points corresponding to the pancreas or to muscle points in all four limbs may exert a beneficial effect on glucose metabolism in obese women. 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.

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

    Science.gov (United States)

    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

  11. [An integrative and transdiagnostic relaxation protocol for anxious patients. Results of a pilot study].

    Science.gov (United States)

    Servant, D; Germe, A; Autuori, M; De Almeida, F; Hay, M; Douilliez, C; Vaiva, G

    2014-12-01

    The literature data show that relaxation practice is effective in reducing anxiety symptoms. Different techniques such as progressive muscular relaxation, autogenic training, applied relaxation and meditation have been evaluated independently for anxiety disorders. The question is to know whether the combination of various techniques may be of interest in the transdiagnostic treatment of anxiety disorders. The present study assessed the short-term efficacy of a 10-week integrative and transdiagnostic relaxation program for anxiety disorders in outpatients of an anxiety disorders unit. The diagnoses were made according to the Mini-International Neuropsychiatric Interview (MINI; Sheehan et al., 1998) and completed with an assessment of anxiety and depressive symptoms using: the State Trait Anxiety Inventory (STAI-Y, -S and -T), the Penn State Worry Questionnaire (PSWQ) and the Beck Depression Inventory (BDI-II). Four techniques were integrated into the structured 10-week protocol: breathing control, muscular relaxation, meditation and mental visualization. Twenty-eight patients (12 men and 16 women), mean age (S.D.)=38.82 years (11.57), were included in the study. All the included patients fulfilled the DSM-IV criteria for a current diagnosis of Generalized Anxiety Disorder (n=13) or Panic Disorder (n=15) with or without agoraphobia. At the end of the 10 sessions, we found a significant reduction in mean scores (S.D.) on the STAI-T from 53.179 (6.037) to 49.821 (8.028) (P<0.02), the BDI-II 20.964 (13.167) to 15.429 (11.341) (d=0.6543) and the QIPS 55.071 (10.677) to 49.679 (11.7) (d=0.5938). The observed reduction in the STAI-S (d=0.2776) was not significant. The results of this open study showed that this program significantly decreases the level of trait anxiety, depression and worry. The integrative and transdiagnostic relaxation program could represent an accessible and effective treatment to reduce anxious and depressive symptoms in various anxiety disorders

  12. Receiver-initiated medium access control protocols for wireless sensor networks

    DEFF Research Database (Denmark)

    Fafoutis, Xenofon; Di Mauro, Alessio; Vithanage, Madava D.

    2015-01-01

    One of the fundamental building blocks of a Wireless Sensor Network (WSN) is the Medium Access Control (MAC) protocol, that part of the system governing when and how two independent neighboring nodes activate their respective transceivers to directly interact. Historically, data exchange has always...

  13. Evaluation of the COPING parent online universal programme: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Owen, Dawn Adele; Griffith, Nia; Hutchings, Judy

    2017-04-26

    Bangor University, Brigantia Building, College Road, Bangor, LL57 2AS, UK INTRODUCTION: The COPING parent online universal programme is a web-based parenting intervention for parents of children aged 3-8 years with an interest in positive parenting. The programme focuses on strengthening parent-child relationships and encouraging positive child behaviour. This trial will evaluate whether the intervention is effective in increasing the use of positive parenting strategies outlined in the programme using parent report and blind observation measures. This is a pilot randomised controlled trial with intervention and wait-list control conditions. The intervention is a 10-week online parenting programme to promote positive parent-child relations by teaching core social learning theory principles that encourage positive child behaviour, primarily through the use of praise and rewards. Health visitors and school nurses will circulate a recruitment poster to parents of children aged 3-8 years on their current caseloads. Recruitment posters will also be distributed via local primary schools and nurseries. Parents recruited to the trial will be randomised on a 2:1 ratio to intervention or wait-list control conditions (stratified according to child gender and age). The primary outcome measure is positive parenting as measured by a behavioural observation of parent-child interactions using the Dyadic Parent-Child Interaction Coding System. Secondary outcomes include parent report of child behaviour, and self-reported parental sense of competence, parenting behaviour and parental mental health. Data will be collected at baseline and 3 months later (postintervention) for all participants and 6 months postbaseline for the intervention group only. Analysis of covariance will be the main statistical method used. The trial has received ethical approval from the NHS Betsi Cadwaladr University Health Board Ethics Committee (REC) and the School of Psychology, Bangor University REC (15

  14. A novel medical protocol to treat uterotubal spasm during Essure hysteroscopic sterilization: a pilot study

    Directory of Open Access Journals (Sweden)

    Chapa HO

    2012-06-01

    Full Text Available Hector O Chapa,1 Gonzalo Venegas21Women's Specialty Center, Dallas, TX, USA; 2Clinical Faculty, Department ObGyn Methodist Medical Center, Dallas, TX, USAObjective: To evaluate sublingual hyoscyamine (0.125 mg as a uterotubal spasm reliever to increase successful bilateral, first-attempt Essure microinsert placement.Study design: Prospective cohort study as pilot clinical investigation of study medicine.Setting: An inner-city Dallas, TX obstetrics and gynecology office practice.Materials and methods: The study period was January 1, 2008 to July 1, 2010. Patients requesting sterilization were offered Essure under local anesthesia (office setting. Those declining were referred for operative laparoscopy. Patients accepting office sterilization were offered study participation. Study patients noted to have intraoperative uni/bilateral uterotubal spasms preventing cannulation were given one sublingual hyoscyamine (0.125 mg tablet. Primary endpoint: spasm alleviation and successful tubal cannulation (bilaterally. Secondary endpoint: percentage of bilateral tubal occlusions documented by follow up hysterosalpingogram (12 weeks, and adverse events possibly related to medication.Results: Within the study period, 316 patients underwent office sterilization (local anesthesia; 21 had unilateral tubal spasm preventing cannulation (6%. Spasm was relieved in 17/21 (80% after hyoscyamine, allowing for microinsert placement. The mean time from attempted cannulation to medication was 9 minutes (8.3–10.5 minutes, and the mean time for spasm resolution was 53 seconds (49–72 seconds. At follow-up confirmation testing, all 17 who were hyoscynamine responders were found to have bilateral tubal occlusion as well as proper microinsert location. The 4/21 hyoscyamine nonresponders underwent a second unilateral attempt 48–72 hours later. Fifty percent (n = 2 had successful placement, leaving two for alternative care. Rapid pulse was reported by 1/21 (4.7% 5 minutes

  15. A Pilot Study Involving the Effect of Two Different Complex Training Protocols on Lower Body Power

    Directory of Open Access Journals (Sweden)

    Smith Chad E.

    2014-09-01

    Full Text Available Purpose. Complex training (CT involves the coupling of two exercises ostensibly to enhance the effect of the second exercise. Typically, the first exercise is a strength exercise and the second exercise is a power exercise involving similar muscles. In most cases, CT is designed to enhance power. The purpose of this study was twofold. First, this study was designed to determine if lower body power could be enhanced using complex training protocols. Second, this study investigated whether the inclusion of a power exercise instead of a strength exercise as the first exercise in CT would produce differences in lower body power. Methods. Thirty-six recreationally-trained men and women aged 20 to 29 years attending a college physical education course were randomly assigned to one of three groups: squat and countermovement squat jumps (SSJ, kettlebell swings and countermovement squat jumps (KSJ, and a control (CON. Training involving CT lasted 6 weeks. All participants were pre- and posttested for vertical jump performance in order to assess lower body power. Results. Vertical jump scores improved for all groups (p < 0.01. The results also indicated that there were no statistically significant differences between group scores across time (p = 0.215. The statistical power for this analysis was low (0.312, most likely due to the small sample size. However, the results did reveal a trend suggesting that the training improvements were greater for both the SSJ and KSJ groups compared with the CON (by 171% and 107%, respectively although significance was not reached. Conclusions. Due to the observed trend, a replication of this study with a greater number of participants over a longer period of time is warranted.

  16. Providing Home-Based HIV Testing and Counseling for Transgender Youth (Project Moxie): Protocol for a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Stephenson, Rob; Metheny, Nicholas; Sharma, Akshay; Sullivan, Stephen; Riley, Erin

    2017-11-28

    Transgender and gender nonconforming people experience some of the highest human immunodeficiency virus (HIV) rates in the United States, and experience many structural and behavioral barriers that may limit their engagement in HIV testing, prevention, and care. Evidence suggests that transgender and gender nonconforming youth (TY) are especially vulnerable to acquiring HIV, yet there is little research on TY and few services are targeted towards HIV testing, prevention, and care for this population. Telehealth presents an opportunity to mitigate some structural barriers that TY experience in accessing HIV testing, allowing TY to engage in HIV testing and counseling in a safe and nonjudgmental space of their choosing. Project Moxie is an HIV prevention intervention that pairs the use of HIV self-testing with remote video-based counseling and support from a trained, gender-affirming counselor. This study aims to offer a more positive HIV testing and counseling experience, with the goal of improving HIV testing frequency. Project Moxie involves a pilot randomized controlled trial (RCT) of 200 TY aged 15-24 years, who are randomized on a 1:1 basis to control or intervention arms. The aim is to examine whether the addition of counseling provided via telehealth, coupled with home-based HIV testing, can create gains in routine HIV testing among TY over a six-month follow-up period. This study implements a prospective pilot RCT of 200 TY recruited online. Participants in the control arm will receive one HIV self-testing kit and will be asked to report their results via the study's website. Participants in the experimental arm will receive one HIV self-testing kit and will test with a remotely-located counselor during a prescheduled video-counseling session. Participants are assessed at baseline, and at three and six months posttesting. Project Moxie was launched in June 2017 and recruitment is ongoing. As of August 21, 2017, the study had enrolled 130 eligible

  17. PARENTS 2 study protocol: pilot of Parents' Active Role and ENgagement in the review of Their Stillbirth/perinatal death.

    Science.gov (United States)

    Bakhbakhi, Danya; Siassakos, Dimitrios; Storey, Claire; Heazell, Alexander; Lynch, Mary; Timlin, Laura; Burden, Christy

    2018-01-10

    The perinatal mortality review meeting that takes place within the hospital following a stillbirth or neonatal death enables clinicians to learn vital lessons to improve care for women and their families for the future. Recent evidence suggests that parents are unaware that a formal review following the death of their baby takes place. Many would welcome the opportunity to feedback into the meeting itself. Parental involvement in the perinatal mortality review meeting has the potential to improve patient satisfaction, drive improvements in patient safety and promote an open culture within healthcare. Yet evidence on the feasibility of involving bereaved parents in the review process is lacking. This paper describes the protocol for the Parents' Active Role and Engangement iN the review of their Stillbirth/perinatal death study (PARENTS 2) , whereby healthcare professionals' and stakeholders' perceptions of parental involvement will be investigated, and parental involvement in the perinatal mortality review will be piloted and evaluated at two hospitals. We will investigate perceptions of parental involvement in the perinatal mortality review process by conducting four focus groups. A three-round modified Delphi technique will be employed to gain a consensus on principles of parental involvement in the perinatal mortality review process. We will use three sequential rounds, including a national consensus meeting workshop with experts in stillbirth, neonatal death and bereavement care, and a two-stage anonymous online questionnaire. We will pilot a new perinatal mortality review process with parental involvement over a 6-month study period. The impact of the new process will be evaluated by assessing parents' experiences of their care and parents' and staff perceptions of their involvement in the process by conducting further focus groups and using a Parent Generated Index questionnaire. This study has ethical approval from the UK Health Research Authority. We will

  18. Pilot scale test of a produced water-treatment system for initial removal of organic compounds

    Energy Technology Data Exchange (ETDEWEB)

    Sullivan, Enid J [Los Alamos National Laboratory; Kwon, Soondong [UT-AUSTIN; Katz, Lynn [UT-AUSTIN; Kinney, Kerry [UT-AUSTIN

    2008-01-01

    A pilot-scale test to remove polar and non-polar organics from produced water was performed at a disposal facility in Farmington NM. We used surfactant-modified zeolite (SMZ) adsorbent beds and a membrane bioreactor (MBR) in combination to reduce the organic carbon content of produced water prior to reverse osmosis (RO). Reduction of total influent organic carbon (TOC) to 5 mg/L or less is desirable for efficient RO system operation. Most water disposed at the facility is from coal-bed gas production, with oil production waters intermixed. Up to 20 gal/d of produced water was cycled through two SMZ adsorbent units to remove volatile organic compounds (BTEX, acetone) and semivolatile organic compounds (e.g., napthalene). Output water from the SMZ units was sent to the MBR for removal of the organic acid component of TOC. Removal of inorganic (Mn and Fe oxide) particulates by the SMZ system was observed. The SMZ columns removed up to 40% of the influent TOC (600 mg/L). BTEX concentrations were reduced from the initial input of 70 mg/L to 5 mg/L by the SMZ and to an average of 2 mg/L after the MBR. Removal rates of acetate (input 120-170 mg/L) and TOC (input up to 45 mg/L) were up to 100% and 92%, respectively. The water pH rose from 8.5 to 8.8 following organic acid removal in the MBR; this relatively high pH was likely responsible for observed scaling of the MBR internal membrane. Additional laboratory studies showed the scaling can be reduced by metered addition of acid to reduce the pH. Significantly, organic removal in the MBR was accomplished with a very low biomass concentration of 1 g/L throughout the field trial. An earlier engineering evaluation shows produced water treatment by the SMZ/MBR/RO system would cost from $0.13 to $0.20 per bbl at up to 40 gpm. Current estimated disposal costs for produced water are $1.75 to $4.91 per bbl when transportation costs are included, with even higher rates in some regions. Our results suggest that treatment by an SMZ

  19. The Smartphone Peer Physical Activity Counseling (SPPAC) Program for Manual Wheelchair Users: Protocol of a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Best, Krista L; Routhier, François; Sweet, Shane N; Arbour-Nicitopoulos, Kelly P; Borisoff, Jaimie F; Noreau, Luc; Martin Ginis, Kathleen A

    2017-04-26

    mixed-model ANCOVA will be conducted, controlling for covariates (primary and secondary objectives). The strength and direction of the relationships between the primary and secondary outcomes will be explored (secondary objective). Descriptive and content analysis will be used to appraise program implementation (tertiary objective). Funding has been obtained from the Craig Neilsen Foundation and the Canadian Disability Participation Project, with additional funds being sought from the Canadian Institute for Health Research and Fonds de Recherche du Québec-Santé. Pilot evaluation of intervention implementation is currently underway, with enrollment anticipated to begin early 2018. There may be substantial benefits for the SPPAC program including limited burden on health care professionals, decreased barriers (eg. accessibility, transportation), development of peer social supports, and potential cost savings related to physical inactivity. Before conducting a large and expensive multisite RCT within a small heterogeneous population of manual wheelchair users, a pilot study affords a prudent step to establishing an adequate study protocol and implementation strategies. ClinicalTrials.gov NCT02826707; https://clinicaltrials.gov/ct2/show/NCT02826707 (Archived by WebCite at http://www.webcitation.org/6pqIc14dU). ©Krista L Best, François Routhier, Shane N Sweet, Kelly P Arbour-Nicitopoulos, Jaimie F Borisoff, Luc Noreau, Kathleen A Martin Ginis. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 26.04.2017.

  20. 14 CFR 135.345 - Pilots: Initial, transition, and upgrade ground training.

    Science.gov (United States)

    2010-01-01

    ... communication procedures; (7) Visual cues before and during descent below DA/DH or MDA; (8) ETOPS, if applicable... necessary to ensure the pilot's competence. (b) For each aircraft type— (1) A general description; (2) Performance characteristics; (3) Engines and propellers; (4) Major components; (5) Major aircraft systems (i.e...

  1. 14 CFR 91.1101 - Pilots: Initial, transition, and upgrade ground training.

    Science.gov (United States)

    2010-01-01

    ...) Normal and emergency communication procedures; (7) Visual cues before and during descent below Decision Altitude or MDA; and (8) Other instructions necessary to ensure the pilot's competence. (b) For each aircraft type— (1) A general description; (2) Performance characteristics; (3) Engines and propellers; (4...

  2. Characterisation of immune responses in healthy foals when a multivalent vaccine protocol was initiated at age 90 or 180 days.

    Science.gov (United States)

    Davis, E G; Bello, N M; Bryan, A J; Hankins, K; Wilkerson, M

    2015-11-01

    Protection from infectious disease requires antigen-specific immunity. In foals, most vaccine protocols are delayed until 6 months to avoid maternal antibody interference. Susceptibility to disease may exist prior to administration of vaccination at age 4-6 months. The aim of this investigation was to characterise immune activation among healthy foals in response to a multivalent vaccine protocol and compare immune responses when foals were vaccinated at age either 90 or 180 days. Randomised block design. Twelve healthy foals with colostral transfer were blocked for age and randomly assigned to vaccination at age 90 days (treatment) or at age 180 days (control). Vaccination protocols included a 3-dose series and booster vaccine administered at age 11 months. Immune response following vaccination at age 90 or 180 days was comparable for several measures of cellular immunity. Antigen specific CD4+ and CD8+ expression of interleukin-4, interferon-γ and granzyme B to eastern equine encephalomyelitis, western equine encephalomyelitis, West Nile virus, tetanus toxoid, equine influenza and equine herpesvirus-1/4 antigens were evident for both groups 30 days after initial vaccine and at age 344 days. Both groups showed a significant increase in antigen-specific immunoglobulin G expression following booster vaccine at age 11 months, thereby indicating memory immune responses. The data presented in this report demonstrate that young foals are capable of immune activation following a 3-dose series with a multivalent vaccine, despite presence of maternal antibodies. Although immune activation does not automatically confer protection, several of the immune indicators measured showed comparable expression in foals vaccinated at 3 months relative to control foals vaccinated at age 6 months. In high-risk situations where immunity may be required earlier than following a conventional vaccine series, our data provide evidence that foals respond to immunisation initiated at 3 months

  3. Two Year Longitudinal Change and Test-Retest-Precision of Knee Cartilage Morphology in a Pilot Study for the Osteoarthritis Initiative

    Science.gov (United States)

    Eckstein, Felix; Kunz, Manuela; Schutzer, Matt; Hudelmaier, Martin; Jackson, Rebecca D.; Yu, Joseph; Eaton, Charles B.; Schneider, Erika

    2009-01-01

    Objective Fast low angle shot (FLASH) and double echo steady state (DESS) MRI sequences were recently cross-calibrated for quantification of cartilage morphology at 3 Tesla. In this pilot study for the Osteoarthritis Initiative we compare their test-retest precision and sensitivity to longitudinal change. Method 9 participants with mild to moderate clinical OA were imaged at baseline, year 1 and year 2. Coronal 1.5mm FLASH and sagittal 0.7mm DESS sequences were acquired; 1.5mm coronal multiplanar reformats (MPR) were obtained from the DESS. Patellar, femoral and tibial cartilage plates were quantified in paired fashion, with blinding to time point. Results In the weight-bearing femorotibial joint, average precision errors across plates were 1.8% for FLASH, 2.6% for DESS, and 3.0% for MPR-DESS. Volume loss at year 1 was not significant; at year 2 the average change across the femorotibial cartilage plates was −1.7% for FLASH, −2.8% for DESS, and −0.3% for MPR-DESS. Volume change in the lateral tibia (−5.5%; p<0.03), and in the medial (−2.9%; p<0.04) and lateral femorotibial compartment (−3.8%; p<0.03) were significant for DESS. Conclusion FLASH, MPR-DESS and DESS all displayed adequate test-retest precision. Although the comparison between protocols is limited by the small number of participants and by the relatively small longitudinal change in cartilage morphology in this pilot study, the data suggest that significant change can be detected with MRI in a small sample of OA subjects over 2 years. PMID:17560813

  4. Optimization of Nonambulant Mass Casualty Decontamination Protocols as Part of an Initial or Specialist Operational Response to Chemical Incidents.

    Science.gov (United States)

    Chilcott, Robert P; Mitchell, Hannah; Matar, Hazem

    2018-05-30

    The UK's Initial Operational Response (IOR) is a new process for improving the survival of multiple casualties following a chemical, biological, radiological or nuclear incident. Whilst the introduction of IOR represents a patient-focused response for ambulant casualties, there is currently no provision for disrobe and dry decontamination of nonambulant casualties. Moreover, the current specialist operational response (SOR) protocol for nonambulant casualty decontamination (also referred to as "clinical decontamination") has not been subject to rigorous evaluation or development. Therefore, the aim of this study was to confirm the effectiveness of putatively optimized dry (IOR) and wet (SOR) protocols for nonambulant decontamination in human volunteers. Dry and wet decontamination protocols were objectively evaluated using human volunteers. Decontamination effectiveness was quantified by liquid chromatography-mass spectrometry analysis of the recovery of a chemical warfare agent simulant (methylsalicylate) from skin and hair of volunteers, with whole-body fluorescence imaging to quantify the skin distribution of residual simulant. Both the dry and wet decontamination processes were rapid (3 and 4 min, respectively) and were effective in removing simulant from the hair and skin of volunteers, with no observable adverse effects related to skin surface spreading of contaminant. Further studies are required to assess the combined effectiveness of dry and wet decontamination under more realistic conditions and to develop appropriate operational procedures that ensure the safety of first responders.

  5. Improving Early Childhood Development among Vulnerable Populations: A Pilot Initiative at a Women, Infants, and Children Clinic

    Directory of Open Access Journals (Sweden)

    Brian A. Ferguson

    2018-01-01

    Full Text Available Objective. Early childhood development (ECD programs have demonstrated drastic improvements in survival, growth, health, and social productivity. An ECD pilot intervention was delivered to vulnerable populations of a Women, Infants, and Children (WIC clinic in Des Moines, Iowa, to assess ECD outcomes and parental receivability in this setting. Study Design. In a randomized, single blinded control initiative, WIC group sessions of mothers (children aged 2 years and younger were selected for pilot ECD intervention (37 participants or control (36. Care for Child Development ECD course material was supplemented to intervention groups. Survey results were assessed with paired samples T-testing and by an ANOVA. Results. Pilot session receivability demonstrated significance in all areas relative to control: enjoyment, p=0.008; learning capacity, p=0.011; and participant sharing, p=0.023. Furthermore, the previously validated ECD intervention demonstrated significantly improved cumulative 1 month behavior outcomes following the intervention: p=0.006. Conclusions. The WIC setting provides an ideal environment for delivering ECD education beyond traditional counseling in nutrition. High receivability indices among parents demonstrate remarkable capacity for improvement and growth. The significance in receivability, as well as 1 month behavior outcomes, represents parents’ overall readiness to enhance the home environment for their child if merely educated how.

  6. The Promises and Challenges of Ecological Momentary Assessment in Schizophrenia: Development of an Initial Experimental Protocol

    Directory of Open Access Journals (Sweden)

    Brandon A. Gaudiano

    2015-07-01

    Full Text Available Severe mental illnesses, including schizophrenia and other psychotic-spectrum disorders, are a major cause of disability worldwide. Although efficacious pharmacological and psychosocial interventions have been developed for treating patients with schizophrenia, relapse rates are high and long-term recovery remains elusive for many individuals. Furthermore, little is still known about the underlying mechanisms of these illnesses. Thus, there is an urgent need to better understand the contextual factors that contribute to psychosis so that they can be better targeted in future interventions. Ecological Momentary Assessment (EMA is a dynamic procedure that permits the measurement of variables in natural settings in real-time through the use of brief assessments delivered via mobile electronic devices (i.e., smartphones. One advantage of EMA is that it is less subject to retrospective memory biases and highly sensitive to fluctuating environmental factors. In the current article, we describe the research-to-date using EMA to better understand fluctuating symptoms and functioning in patients with schizophrenia and other psychotic disorders and potential applications to treatment. In addition, we describe a novel EMA protocol that we have been employing to study the outcomes of patients with schizophrenia following a hospital discharge. We also report the lessons we have learned thus far using EMA methods in this challenging clinical population.

  7. Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol.

    Science.gov (United States)

    Haslbeck, Friederike Barbara; Bucher, Hans-Ulrich; Bassler, Dirk; Hagmann, Cornelia

    2017-01-01

    Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support brain development in preterm infants. Music appears to promote neurobiological processes and neuronal learning in the human brain. Creative music therapy (CMT) is an individualized, interactive therapeutic approach based on the theory and methods of Nordoff and Robbins. CMT may promote brain development in preterm infants via concurrent interaction and meaningful auditory stimulation. We hypothesize that preterm infants who receive creative music therapy during neonatal intensive care admission will have developmental benefits short- and long-term brain function. A prospective, randomized controlled single-center pilot trial involving 60 clinically stable preterm infants under 32 weeks of gestational age is conducted in preparation for a multi-center trial. Thirty infants each are randomized to either standard neonatal intensive care or standard care with CMT. Music therapy intervention is approximately 20 min in duration three times per week. A trained music therapist sings for the infants in lullaby style, individually entrained and adjusted to the infant's rhythm and affect. Primary objectives of this study are feasibility of protocol implementation and investigating the potential mechanism of efficacy for this new intervention. To examine the effect of this new intervention, non-invasive, quantitative magnetic resonance imaging (MRI) methods at corrected age and standardized neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development third edition at a corrected age of 24 months and Kaufman Assessment Battery for Children at 5 years will be performed. All assessments will be performed and analyzed by blinded experts. To our knowledge, this is the first randomized controlled clinical trial to systematically examine possible

  8. Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial.

    Science.gov (United States)

    Lee, Seunghoon; Kim, Joo-Hee; Shin, Kyung-Min; Kim, Jung-Eun; Kim, Tae-Hun; Kang, Kyung-Won; Lee, Minhee; Jung, So-Young; Shin, Mi-Suk; Kim, Ae-Ran; Park, Hyo-Ju; Hong, Kwon-Eui; Choi, Sun-Mi

    2013-07-18

    The purpose of this study is to conduct a basic analysis of the effectiveness and safety of electroacupuncture in the treatment of painful diabetic neuropathy (PDN) as compared to placebo and usual care and to evaluate the feasibility of large-scale clinical research. This study is a protocol for a three-armed, randomized, patient-assessor-blinded (to the type of treatment), controlled pilot trial. Forty-five participants with a ≥ six month history of PDN and a mean weekly pain score of ≥ 4 on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) will be assigned to the electroacupuncture group (n = 15), sham group (n = 15) or usual care group (n = 15). The participants assigned to the electroacupuncture group will receive electroacupuncture (remaining for 30 minutes with a mixed current of 2 Hz/120 Hz and 80% of the bearable intensity) at 12 standard acupuncture points (bilateral ST36, GB39, SP9, SP6, LR3 and GB41) twice per week for eight weeks (a total of 16 sessions) as well as the usual care. The participants in the sham group will receive sham electroacupuncture (no electrical current will be passed to the needle, but the light will be seen, and the sound of the pulse generator will be heard by the participants) at non-acupuncture points as well as the usual care. The participants in the usual care group will not receive electroacupuncture treatment during the study period and will receive only the usual care. The follow-up will be in the 5th, 9th and 17th weeks after random allocation. The PI-NRS score assessed at the ninth week will be the primary outcome measurement used in this study. The Short-Form McGill Pain Questionnaire (SF-MPQ), a sleep disturbance score (11-point Likert scale), the Short-Form 36v2 Health Survey (SF-36), the Beck Depression Inventory (BDI) and the Patient Global Impression of Change (PGIC) will be used as outcome variables to evaluate the effectiveness of the acupuncture. Safety will be assessed at every visit. The result

  9. Knowledge Translation Interventions to Improve the Timing of Dialysis Initiation: Protocol for a Cluster Randomized Trial.

    Science.gov (United States)

    Chau, Elaine M T; Manns, Braden J; Garg, Amit X; Sood, Manish M; Kim, S Joseph; Naimark, David; Nesrallah, Gihad E; Soroka, Steven D; Beaulieu, Monica; Dixon, Stephanie; Alam, Ahsan; Tangri, Navdeep

    2016-01-01

    Early initiation of chronic dialysis (starting dialysis with higher vs lower kidney function) has risen rapidly in the past 2 decades in Canada and internationally, despite absence of established health benefits and higher costs. In 2014, a Canadian guideline on the timing of dialysis initiation, recommending an intent-to-defer approach, was published. The objective of this study is to evaluate the efficacy and safety of a knowledge translation intervention to promote the intent-to-defer approach in clinical practice. This study is a multicenter, 2-arm parallel, cluster randomized trial. The study involves 55 advanced chronic kidney disease clinics across Canada. Patients older than 18 years who are managed by nephrologists for more than 3 months, and initiate dialysis in the follow-up period are included in the study. Outcomes will be measured at the patient-level and enumerated within a cluster. Data on characteristics of each dialysis start will be determined by linkages with the Canadian Organ Replacement Register. Primary outcomes include the proportion of patients who start dialysis early with an estimated glomerular filtration rate greater than 10.5 mL/min/1.73 m 2 and start dialysis in hospital as inpatients or in an emergency room setting. Secondary outcomes include the rate of change in early dialysis starts; rates of hospitalizations, deaths, and cost of predialysis care (wherever available); quarterly proportion of new starts; and acceptability of the knowledge translation materials. We randomized 55 multidisciplinary chronic disease clinics (clusters) in Canada to receive either an active knowledge translation intervention or no intervention for the uptake of the guideline on the timing of dialysis initiation. The active knowledge translation intervention consists of audit and feedback as well as patient- and provider-directed educational tools delivered at a comprehensive in-person medical detailing visit. Control clinics are only exposed to guideline

  10. Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial

    Directory of Open Access Journals (Sweden)

    Kate Fetterplace

    2018-02-01

    Full Text Available Abstract Background Current guidelines for the provision of protein for critically ill patients are based on incomplete evidence, due to limited data from randomised controlled trials. The present pilot randomised controlled trial is part of a program of work to expand knowledge about the clinical effects of protein delivery to critically ill patients. The primary aim of this pilot study is to determine whether an enteral feeding protocol using a volume target, with additional protein supplementation, delivers a greater amount of protein and energy to mechanically ventilated critically ill patients than a standard nutrition protocol. The secondary aims are to evaluate the potential effects of this feeding strategy on muscle mass and other patient-centred outcomes. Methods This prospective, single-centred, pilot, randomised control trial will include 60 participants who are mechanically ventilated and can be enterally fed. Following informed consent, the participants receiving enteral nutrition in the intensive care unit (ICU will be allocated using a randomisation algorithm in a 1:1 ratio to the intervention (high-protein daily volume-based feeding protocol, providing 25 kcal/kg and 1.5 g/kg protein or standard care (hourly rate-based feeding protocol providing 25 kcal/kg and 1 g/kg protein. The co-primary outcomes are the average daily protein and energy delivered to the end of day 15 following randomisation. The secondary outcomes include change in quadriceps muscle layer thickness (QMLT from baseline (prior to randomisation to ICU discharge and other nutritional and patient-centred outcomes. Discussion This trial aims to examine whether a volume-based feeding protocol with supplemental protein increases protein and energy delivery. The potential effect of such increases on muscle mass loss will be explored. These outcomes will assist in formulating larger randomised control trials to assess mortality and morbidity. Trial registration

  11. The Relationship of a Pilot's Educational Background, Aeronautical Experience and Recency of Experience to Performance In Initial Training at a Regional Airline

    Science.gov (United States)

    Shane, Nancy R.

    The purpose of this study was to determine how a pilot's educational background, aeronautical experience and recency of experience relate to their performance during initial training at a regional airline. Results show that variables in pilots' educational background, aeronautical experience and recency of experience do predict performance in training. The most significant predictors include years since graduation from college, multi-engine time, total time and whether or not a pilot had military flying experience. Due to the pilot shortage, the pilots entering regional airline training classes since August 2013 have varied backgrounds, aeronautical experience and recency of experience. As explained by Edward Thorndike's law of exercise and the law of recency, pilots who are actively using their aeronautical knowledge and exercising their flying skills should exhibit strong performance in those areas and pilots who have not been actively using their aeronautical knowledge and exercising their flying skills should exhibit degraded performance in those areas. Through correlation, chi-square and multiple regression analysis, this study tests this theory as it relates to performance in initial training at a regional airline.

  12. A Pilot Initiative to Deliver Community-based Psychiatric Services in Rural Haiti After the 2010 Earthquake.

    Science.gov (United States)

    Grelotti, David J; Lee, Amy C; Fils-Aimé, Joseph Reginald; Jean, Jacques Solon; Therosmé, Tatiana; Petit-Homme, Handy; Oswald, Catherine M; Raviola, Giuseppe; Eustache, Eddy

    2015-01-01

    Worldwide, there is a gap between the burden of mental distress and disorder and access to mental health care. This gap is particularly large in low- and middle-income countries (LMICs). After the 2010 earthquake in Haiti, the international health care organizations Partners in Health and Zanmi Lasante worked to expand local mental health services in rural Haiti. The aims of this study are to describe clinical characteristics of the patients served during a pilot project to deliver community-based psychiatric services in rural Haiti and to show how this experience complements the Mental Health Gap Action Programme ("mhGAP"), a tool developed by the World Health Organization to support mental health care delivery by nonspecialists in LMICs. The pilot was conducted in March 2011. A visiting psychiatrist traveled to rural Haiti and paired with local clinicians to evaluate patients and to support quality improvement practices in psychiatric care. Patients received a standard neuropsychiatric evaluation. mhGAP was an important clinical reference. To assess the experience, we conducted a retrospective chart review of outpatient encounters. Sixty-five patients presented with a wide range of common psychiatric, neurologic, and general medical conditions. Forty-nine of these patients (75%) reported primary problems subsumed by an mhGAP module. Fifteen patients (23%) reported headache as their chief complain, a condition that is not currently covered by mhGAP. Surprisingly, only 3 patients (5%), reported earthquake-related distress. Our clinical data reinforce the need for provision of standard psychiatric and neurologic services in LMICs. Such services ought to accompany interventions targeted specifically at disaster-related problems. Clinical situations falling outside existing mhGAP modules inspired the development of supplemental treatment protocols. These observations informed coordinated efforts at Zanmi Lasante to build a sustainable, integrated mental health system

  13. Heart and Stroke Foundation of Ontario (HSFO high blood pressure strategy's hypertension management initiative study protocol

    Directory of Open Access Journals (Sweden)

    Von Sychowski Shirley

    2008-12-01

    Full Text Available Abstract Background Achieving control of hypertension prevents target organ damage at both the micro and macrovascular level and is a highly cost effective means of lowering the risk for heart attack and stroke particularly in people with diabetes. Clinical trials demonstrate that blood pressure control can be achieved in a large proportion of people. Translating this knowledge into widespread practice is the focus of the Hypertension Management Initiative, which began in 2004 with the goal of improving the management of this chronic health condition by primary care providers and patients in the community. Methods This study will test the effect of a systems change on the management of high blood pressure in real world practice in primary care in Ontario, Canada. The systems change intervention involves an interprofessional educational program bringing together physicians, nurses and pharmacists with tools for both providers and patients to facilitate blood pressure management. Each of two waves of subjects were enrolled over a 6 month period with the initial enrollment between waves separated by 9 months. Blood pressure will be measured with the BpTru ® automated blood pressure device. To determine the effectiveness of the intervention, a before and after analysis within all subjects will compare blood pressure at baseline to annual measurements for the three year study. To assess whether the intervention has an impact on blood pressure control independent of community trends, a betwen group comparison of baseline blood pressures in the delayed wave will be made with the immediate wave during the same time period, so that the immediate wave has experienced the intervention for at least 9 months. The total enrollment goal is 5,000 subjects. The practice locations include 10 Family Health Teams (FHTs and 1 Community Health Centre (CHC and approximately 49 primary care physicians, 15 nurse practitioners, 37 registered nurses and over 150

  14. Fortification of Indonesian unbranded vegetable oil: public-private initiative, from pilot to large scale.

    Science.gov (United States)

    Soekirman; Soekarjo, Damayanti; Martianto, Drajat; Laillou, Arnaud; Moench-Pfanner, Regina

    2012-12-01

    Despite improved economic conditions, vitamin A deficiency remains a public health problem in Indonesia. This paper aims to describe the development of the Indonesian unbranded cooking oil fortification program and to discuss lessons learned to date and future steps necessary for implementation of mandatory, large-scale oil fortification with vitamin A. An historic overview of the steps involved in developing the Indonesian unbranded cooking oil fortification program is given, followed by a discussion of lessons learned and next steps needed. Indonesia's low-income groups generally consume unbranded vegetable oil, with an average consumption of approximately 25 g/day. Unbranded oil constitutes approximately 70% of the total oil traded in the country. In 2007-10, a pilot project to fortify unbranded vegetable oil was carried out in Makassar, and an effectiveness study found that the project significantly improved the serum retinol concentrations of schoolchildren. In 2010, the pilot was expanded to two provinces (West Java and North Sumatra) involving the biggest two national refineries. In 2011, a draft national standard for fortified oil was developed, which is currently under review by the National Standard Body and is expected to be mandated nationally in 2013 as announced officially by the Government of Indonesia in national and international meetings. Indonesia is a leading world supplier of cooking oil. With stakeholder support, the groundwork has been laid and efforts are moving forward to implement mandatory fortification. This project could encourage Indonesian industry to fortify more edible oils for export, thus expanding their market potential and potentially reducing vitamin A deficiency in the region.

  15. Using brothel leadership to promote condom use among brothel-based female sex workers in Abuja, Nigeria: study protocol for a cluster randomized pilot trial

    Directory of Open Access Journals (Sweden)

    Uchenna Okafor

    2017-02-01

    negotiation with all partner types will be the primary outcomes for the main study, and the feasibility of their measurement will be determined in this pilot trial. Discussion The manuscript describes the protocol for a pilot study to determine the feasibility of a behavioral intervention to improve consistent condom use among BB FSWs. The results of this pilot will inform a larger intervention for HIV prevention for this target group in Nigeria. Trial registration The Institutional Review Board (IRB of the Institute of Human Virology, Nigeria; Protocol Number NHREC/10/15/2014a-026.

  16. Using brothel leadership to promote condom use among brothel-based female sex workers in Abuja, Nigeria: study protocol for a cluster randomized pilot trial.

    Science.gov (United States)

    Okafor, Uchenna; Crutzen, Rik; Okekearu, Ifeanyi; Adebajo, Sylvia; Uzoh, Adaora; Awo, Egbe Aneotah; Chima, Chukwuemeka; Agwagwa, Ogechukwu; van den Borne, Bart

    2017-01-01

    outcomes for the main study, and the feasibility of their measurement will be determined in this pilot trial. The manuscript describes the protocol for a pilot study to determine the feasibility of a behavioral intervention to improve consistent condom use among BB FSWs. The results of this pilot will inform a larger intervention for HIV prevention for this target group in Nigeria. The Institutional Review Board (IRB) of the Institute of Human Virology, Nigeria; Protocol Number NHREC/10/15/2014a-026.

  17. Effects of hydrophilicity and microtopography of titanium implant surfaces on initial supragingival plaque biofilm formation. A pilot study.

    Science.gov (United States)

    Schwarz, F; Sculean, A; Wieland, M; Horn, N; Nuesry, E; Bube, C; Becker, J

    2007-12-01

    The aim of the present pilot study is to investigate the effects of hydrophilicity and microtopography of titanium implant surfaces on initial supragingival plaque biofilm formation. Test specimens were manufactured from commercially pure grade 2 titanium according to one of the following procedures: polished (P), acid-etched (A), chemically modified (mod) A (modA), sand-blasted large grit and A (SLA), and modSLA. Intraoral splints were used to collect an in vivo supragingival plaque biofilm in each group at 12, 24, and 48 h. Stained plaque biofilm (PB) areas (%) were morphometrically assessed. All groups exhibited significant increases of mean PB areas over time (p P > A =modA (p modSLA = P > A = modA (p A = modA (p < 0.001; respectively). Within the limits of a pilot study, it could be concluded that hydrophilicity had no apparent effect, while microtopography had a highly uneven and unpredictable influence on supragingival plaque biofilm formation.

  18. Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Van Dorn, Richard A; Desmarais, Sarah L; Rade, Candalyn B; Burris, Elizabeth N; Cuddeback, Gary S; Johnson, Kiersten L; Tueller, Stephen J; Comfort, Megan L; Mueser, Kim T

    2017-08-04

    Adults with co-occurring mental and substance use disorders (CODs) are overrepresented in jails. In-custody barriers to treatment, including a lack of evidence-based treatment options and the often short periods of incarceration, and limited communication between jails and community-based treatment agencies that can hinder immediate enrollment into community care once released have contributed to a cycle of limited treatment engagement, unaddressed criminogenic risks, and (re)arrest among this vulnerable and high-risk population. This paper describes a study that will develop research and communication protocols and adapt two evidence-based treatments, dual-diagnosis motivational interviewing (DDMI) and integrated group therapy (IGT), for delivery to adults with CODs across a jail-to-community treatment continuum. Adaptations to DDMI and IGT were guided by the Risk-Need-Responsivity model and the National Institute of Corrections' implementation competencies; the development of the implementation framework and communication protocols were guided by the Evidence-Based Interagency Implementation Model for community corrections and the Inter-organizational Relationship model, respectively. Implementation and evaluation of the protocols and adapted interventions will occur via an open trial and a pilot randomized trial. The clinical intervention consists of two in-jail DDMI sessions and 12 in-community IGT sessions. Twelve adults with CODs and four clinicians will participate in the open trial to evaluate the acceptability and feasibility of, and fidelity to, the interventions and research and communication protocols. The pilot controlled trial will be conducted with 60 inmates who will be randomized to either DDMI-IGT or treatment as usual. A baseline assessment will be conducted in jail, and four community-based assessments will be conducted during a 6-month follow-up period. Implementation, clinical, public health, and treatment preference outcomes will be evaluated

  19. The Adolescent Girls Initiative-Kenya (AGI-K: study protocol

    Directory of Open Access Journals (Sweden)

    Karen Austrian

    2016-03-01

    Full Text Available Abstract Background Many adolescent girls in Kenya and elsewhere face considerable risks and vulnerabilities that affect their well-being and hinder a safe, healthy, and productive transition into early adulthood. Early adolescence provides a critical window of opportunity to intervene at a time when girls are experiencing many challenges, but before those challenges have resulted in deleterious outcomes that may be irreversible. The Adolescent Girls Initiative-Kenya (AGI-K is built on these insights and designed to address these risks for young adolescent girls. The long-term goal of AGI-K is to delay childbearing for adolescent girls by improving their well-being. Intervention AGI-K comprises nested combinations of different single-sector interventions (violence prevention, education, health, and wealth creation. It will deliver interventions to over 6000 girls between the ages of 11 and 14 years in two marginalized areas of Kenya: 1 Kibera in Nairobi and 2 Wajir County in Northeastern Kenya. The program will use a combination of girl-, household- and community-level interventions. The violence prevention intervention will use community conversations and planning focused on enhancing the value of girls in the community. The educational intervention includes a cash transfer to the household conditioned on school enrollment and attendance. The health intervention is culturally relevant, age-appropriate sexual and reproductive health education delivered in a group setting once a week over the course of 2 years. Lastly, the wealth creation intervention provides savings and financial education, as well as start-up savings. Methods/Design A randomized trial will be used to compare the impact of four different packages of interventions, in order to assess if and how intervening in early adolescence improves girls’ lives after four years. The project will be evaluated using data from behavioural surveys conducted before the start of the program

  20. Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Ritvo, Paul; Obadia, Maya; Santa Mina, Daniel; Alibhai, Shabbir; Sabiston, Catherine; Oh, Paul; Campbell, Kristin; McCready, David; Auger, Leslie; Jones, Jennifer Michelle

    2017-08-24

    Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors. This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention and will inform development of a full-scale pragmatic RCT. We will enroll 107 physically inactive breast cancer survivors and randomly assign them to intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto, Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than 55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week. Both intervention and control groups receive the 12-week physical activity program with weekly group sessions and an individualized, progressive, home-based exercise program. The intervention group will additionally receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3) supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting device linked to a smartphone program. We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews; and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The primary clinical outcome will be directly

  1. Online and smartphone based cognitive behavioral therapy for bariatric surgery patients: Initial pilot study.

    Science.gov (United States)

    Zhang, Melvyn W B; Ho, Roger C M; Cassin, Stephanie E; Hawa, Raed; Sockalingam, Sanjeev

    2015-01-01

    The respective rates of obesity in Canada and the United states are estimated to be 24.1% and 34.1%. Due to the increased incidence of obesity, Bariatric surgery has been recognized as one of the treatment options. Despite the success of Bariatric surgery, studies have proposed that it has neglected the contributions of other factors, such as psychological factors in the causation as well as the maintenance of obesity amongst individuals. Cognitive behavioral therapy (CBT) is largely a psychosocial intervention that has been shown to be efficacious, as studies have demonstrated that even brief CBT interventions could help in the reduction of binge eating and maintenance of weight loss. Previously identified problems with regards to the integration and the provision of such interventions include that of geographical barriers. In order to overcome the geographical barriers, telephone-based CBT has been conceptualized. Over the past decade, there has been massive advancement and development in Internet, Web-based and smartphone technologies, but there is still a paucity of applications in this area. Our current research objective is to determine if bariatric surgery patients will be receptive towards an online and smartphone based CBT intervention. The Bariatric Surgery Online CBT portal and Smartphone companion application was developed between July 2013 and December 2013. A low-cost methodology of developing the online portal was adopted. In terms of development, 4 core development phases were adopted. These included that of: a) Formulation of users' requirements, b) System design and development, c) System evaluation and d) System deployment and pilot application. The bariatric surgery workgroup from the Toronto Western Hospital helped with the recruitment of the subjects from the outpatient specialist service. Links to the web-portal was provided to each of the participants recruited. Since the inception of the online portal to date, in terms of usage rates, there

  2. Pilot program: NRC severe reactor accident incident response training manual: Public protective actions: Predetermined criteria and initial actions

    International Nuclear Information System (INIS)

    Martin, J.A. Jr.; McKenna, T.J.; Miller, C.W.; Hively, L.M.; Sharpe, R.W.; Giitter, J.G.; Watkins, R.M.

    1987-02-01

    This pilot training manual has been written to fill the need for a general text on NRC response to reactor accidents. The manual is intended to be the foundation for a course for all NRC response personnel. Public Protective Actions - Predetermined Criteria and Initial Actions is the fourth in a series of volumes that collectively summarize the US Nuclear Regulatory Commission (NRC) emergency response during severe power reactor accidents and provide necessary background information. This volume reviews public protective action criteria and objectives, their bases and implementation, and the expected public response. Each volume serves, respectively, as the text for a course of instruction in a series of courses for NRC response personnel. These materials do not provide guidance or license requirements for NRC licensees. Each volume is accompanied by an appendix of slides that can be used to present this material. The slides are called out in the text

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

    Directory of Open Access Journals (Sweden)

    Inhwa Jung

    2018-02-01

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

  4. Initial computer modeling of WIPP [Waste Isolation Pilot Plant] underground ventilation system, September 1985--March 1986

    International Nuclear Information System (INIS)

    Sethi, S.

    1986-11-01

    Provision of a good ventilation system has been and continues to be a major priority here of those responsible for its design, management, and operation. As an ongoing effort in this direction, development of computer simulated models for the system was initiated in September, 1985. It was decided to utilize Dravo's 'MINEVENT' computer program for this purpose. Accordingly, initial computer models of the mine's ventilation system have been developed for various modes of operation. Specifically, they include: Simulation of the current ventilation system, and Simulation of the designed ventilation system for modes: mine construction mode/shift, waste storage mode/shift, and air reversal mode. 5 figs

  5. Framework and indicator testing protocol for developing and piloting quality indicators for the UK quality and outcomes framework

    NARCIS (Netherlands)

    Campbell, S.M.; Kontopantelis, E.; Hannon, K.; Burke, M.; Barber, A.; Lester, H.E.

    2011-01-01

    BACKGROUND: Quality measures should be subjected to a testing protocol before being used in practice using key attributes such as acceptability, feasibility and reliability, as well as identifying issues derived from actual implementation and unintended consequences. We describe the methodologies

  6. A School-Located Vaccination Adolescent Pilot Initiative in Chicago: Lessons Learned.

    Science.gov (United States)

    Caskey, Rachel N; Macario, Everly; Johnson, Daniel C; Hamlish, Tamara; Alexander, Kenneth A

    2013-09-01

    Many adolescents underutilize preventive services and are underimmunized. To promote medical homes and increase immunization rates, we conceptualized and implemented a 3-year, 8-school pilot school-located vaccination collaborative program. We sought community, parent, and school nurse input the year prior to implementation. We selected schools with predominantly Medicaid-enrolled or Medicaid-eligible students to receive Vaccines For Children stock vaccines. Nurses employed by a mass immunizer delivered these vaccines at participating schools 3 times a year. Over 3 years, we delivered approximately 1800 vaccines at schools. School administrators, health centers, and neighboring private physicians generally welcomed the program. Parents did not express overt concerns about school-located vaccination. School nurses were not able to participate because of multiple school assignments. Obtaining parental consent via backpack mail was an inefficient process, and classroom incentives did not increase consent form return rate. The influenza vaccine had the most prolific uptake. The optimal time for administering vaccines was during regular school hours. Although school-located vaccination for adolescents is feasible, this is a paradigm shift for community members and thus accompanies challenges in implementation. High principal or school personnel turnover led to a consequent lack of institutional memory. It was difficult to communicate directly with parents. Because we were uncertain about the proportion of parents who received consent forms, we are exploring Internet-based and back-to-school registration options for making the consent form distribution and return process more rigorous. Securing an immunization champion at each school helped the immunization processes. Identifying a financially sustainable school-located vaccination model is critical for national expansion of school-located vaccination. © The Author 2013. Published by Oxford University Press on behalf of

  7. Attitudes toward E-Cigarettes, Reasons for Initiating E-Cigarette Use, and Changes in Smoking Behavior after Initiation: A Pilot Longitudinal Study of Regular Cigarette Smokers.

    Science.gov (United States)

    Berg, Carla J; Barr, Dana Boyd; Stratton, Erin; Escoffery, Cam; Kegler, Michelle

    2014-10-01

    We examined 1) changes in smoking and vaping behavior and associated cotinine levels and health status among regular smokers who were first-time e-cigarette purchasers and 2) attitudes, intentions, and restrictions regarding e-cigarettes. We conducted a pilot longitudinal study with assessments of the aforementioned factors and salivary cotinine at weeks 0, 4, and 8. Eligibility criteria included being ≥18 years old, smoking ≥25 of the last 30 days, smoking ≥5 cigarettes per day (cpd), smoking regularly ≥1 year, and not having started using e-cigarettes. Of 72 individuals screened, 40 consented, 36 completed the baseline survey, and 83.3% and 72.2% were retained at weeks 4 and 8, respectively. Participants reduced cigarette consumption from baseline to week 4 and 8 (p's e-cigarettes versus regular cigarettes have fewer health risks (97.2%) and that e-cigarettes have been shown to help smokers quit (80.6%) and reduce cigarette consumption (97.2%). In addition, the majority intended to use e-cigarettes as a complete replacement for regular cigarettes (69.4%) and reported no restriction on e-cigarette use in the home (63.9%) or car (80.6%). Future research is needed to document the long-term impact on smoking behavior and health among cigarette smokers who initiate use of e-cigarettes.

  8. Is Home-Based, High-Intensity Interval Training Cycling Feasible and Safe for Patients With Knee Osteoarthritis?: Study Protocol for a Randomized Pilot Study.

    Science.gov (United States)

    Keogh, Justin W L; Grigg, Josephine; Vertullo, Christopher J

    2017-03-01

    Osteoarthritis (OA) is a degenerative joint disease affecting the knee joint of many middle-aged and older adults. As OA symptoms typically involve knee pain and stiffness, individuals with knee OA are often insufficiently physically active, have low levels of physical function, and are at increased risk of other comorbidities and reduced quality of life. While moderate-intensity continuous training (MICT) cycling is often recommended, little is known about the feasibility, safety, and benefits of high-intensity interval training (HIIT) cycling for this population, even though the feasibility, safety, and benefits of HIIT have been demonstrated in other chronic disease groups. The primary objective of this pilot study was to examine the feasibility and safety of home-based HIIT and MICT cycling in middle-aged and older adults with knee OA. A secondary objective was to gain some insight into the relative efficacy of HIIT and MICT for improving health status (pain, stiffness, and disability), muscle function, and body composition in this population. This study protocol is being published separately to allow a detailed description of the research methods, explain the rationale for choosing the methodological details, and to stimulate consideration of the best means to simulate a research protocol that is relevant to a real-life treatment environment. Randomized pilot study protocol. This trial sought to recruit 40 middle-aged and older adults with knee OA. Participants were randomly allocated to either continuous (MICT) or HIIT home-based cycle training programs, with both programs requiring the performance of 4 cycling sessions (approximately 25 minutes per session) each week. Participants were measured at baseline and postintervention (8 weeks). Feasibility and safety were assessed by adherence rate, dropout rate, and number of adverse events. The relative efficacy of the cycling programs was investigated by 2 knee OA health status questionnaires (Western Ontario

  9. Cognitive training of self-initiation of semantic encoding strategies in schizophrenia: A pilot study.

    Science.gov (United States)

    Guimond, Synthia; Lepage, Martin

    2016-01-01

    Available cognitive remediation interventions have a significant but relatively small to moderate impact on episodic memory in schizophrenia. The present study aimed to evaluate the efficacy and feasibility of a brief novel episodic memory training targeting the self-initiation of semantic encoding strategies. To select patients with such deficits, 28 participants with schizophrenia performed our Semantic Encoding Memory Task (SEMT) that provides a measure of self-initiated semantic encoding strategies. This task identified a deficit in 13 participants who were then offered two 60-minute training sessions one week apart. After the training, patients performed an alternate version of the SEMT. The CVLT-II (a standardised measure of semantic encoding strategies) and the BVMT-R (a control spatial memory task) were used to quantify memory pre- and post-training. After the training, participants were significantly better at self-initiating semantic encoding strategies in the SEMT (p = .004) and in the CVLT-II (p = .002). No significant differences were found in the BVMT-R. The current study demonstrates that a brief and specific training in memory strategies can help patients to improve a deficient memory process in schizophrenia. Future studies will need to test this intervention further using a randomised controlled trial, and to explore its functional impact.

  10. A Prospective Pilot Study to Validate the Management Protocol for Patients Presenting with Acute Urinary Retention: A Community-Based, Nonhospitalised Protocol

    Directory of Open Access Journals (Sweden)

    Shyamala S. Gopi

    2006-01-01

    Full Text Available Acute urinary retention (AUR in males is managed conventionally by hospital admission, alpha-adrenergic therapy, and trial without catheter. To reduce inpatient bed pressures, we set up a protocol to manage such patients in the community. We review our results in this paper. We performed a prospective study of male patients presenting to our acute admissions ward and Accident and Emergency department over 6 months. Patients with chronic urinary retention, macroscopic haematuria, sepsis, urinary tract infection, and/or serum creatinine >130 mmol/l were excluded from the study. Those enrolled were catheterised, commenced on alfuzosin (10 mg nocte, and discharged to the community. A trial without catheter (TWOC was performed 5—7 days later. QoL/IPSS, peak flow rate, and residual volume assessment were performed following successful TWOC 3 months later.Thirty-one male patients with a median age of 69 years were studied and the median residual volume following catheterisation was 900 ml. The aetiology of AUR was benign prostatic hyperplasia (BPH in 29 patients and constipation in the remaining 2 patients. TWOC was successful in 19 patients (61.3% following first TWOC, 26 (83.9% following second trial of voiding. The mean peak flow rate was 6.5 ml/sec and postvoid scan 165 ml, following an immediate TWOC. At 3 months follow-up, mean peak flow rate was 13.2 ml/sec, postvoid scan 26.5 ml, IPSS 4.5, and QoL score was 2. This study has shown that AUR can be managed safely and effectively in the community. Effective communication with the nurse urology specialist, general practitioner, and emergency department are crucial for the successful implementation of the protocol.

  11. Validation of Alzheimer's disease CSF and plasma biological markers: the multicentre reliability study of the pilot European Alzheimer's Disease Neuroimaging Initiative (E-ADNI)

    DEFF Research Database (Denmark)

    Buerger, Katharina; Frisoni, Giovanni; Uspenskaya, Olga

    2009-01-01

    BACKGROUND: Alzheimer's Disease Neuroimaging Initiatives ("ADNI") aim to validate neuroimaging and biochemical markers of Alzheimer's disease (AD). Data of the pilot European-ADNI (E-ADNI) biological marker programme of cerebrospinal fluid (CSF) and plasma candidate biomarkers are reported. METHO...

  12. Piloting the use of accelerometry devices to capture energy expenditure in agricultural and rural livelihoods: Protocols and findings from northern Ghana

    Directory of Open Access Journals (Sweden)

    Giacomo Zanello

    Full Text Available In this study we report on the protocols adopted and the findings from a pilot study in northern Ghana involving 40 respondents wearing accelerometry devices for a week. We show how integrating energy expenditure data from wearable accelerometry devices with data on activity and time-use can provide a window into agricultural and rural livelihoods in developing country contexts that has not been previously available for empirical research. Our findings confirm some of the stylised facts of agricultural and rural livelihoods, but the study also provides several new insights that come from the triangulation of energy expenditure, time use, and activity data. We report findings and explore the potential applications of using accelerometry devices for a better understanding of agriculture-nutrition linkages in developing countries. Keywords: Energy expenditure, Wearable accelerometry devices, Time-use, Ghana

  13. Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa.

    Science.gov (United States)

    McNaghten, Ad; Kearns, Rachel; Siegler, Aaron J; Phaswana-Mafuya, Nancy; Bekker, Linda-Gail; Stephenson, Rob; Baral, Stefan D; Brookmeyer, Ron; Yah, Clarence S; Lambert, Andrew J; Brown, Benjamin; Rosenberg, Eli; Blalock Tharp, Mondie; de Voux, Alex; Beyrer, Chris; Sullivan, Patrick S

    2014-10-16

    -negative men. Formative qualitative research consisted of 79 in-depth interviews, and six focus group discussions in Cape Town and Port Elizabeth. Analysis of these data has informed pilot study protocol development and has been documented in peer-reviewed manuscripts. Qualitative work regarding stigma faced by South African MSM resulted in finalized scales for use in the pilot study questionnaire. A total of 37 health care providers completed training designed to facilitate clinically and culturally competent care for MSM in the Eastern Cape. The design of a future, larger study of the HIV prevention package will be conducted at the end of the pilot study, powered to detect efficacy of the prevention package. Data from the updated mathematical model, results of the pilot study, acceptability data, and advancements in HIV prevention sciences will be considered in developing the final proposed package and study design. ClinicalTrials.gov NCT02043015; http://clinicaltrials.gov/show/NCT02043015 (Archived by WebCite at http://www.webcitation.org/6THvp7rAj).

  14. International programme on the health effects of the Chernobyl accidents (IPHECA). Protocol for the pilot project ''Thyroid''

    International Nuclear Information System (INIS)

    1994-01-01

    The protocol document for the Thyroid Project of International Programme on the Health Effects of the Chernobyl Accidents (IPHECA) describes the main aims of the project, namely 1) to detect and describe selected diseases of the thyroid among children and adolescents in population centres assigned earlier as ''strictly controlled zones'' and, 2) to determine, if possible, the link between the prevalence of the diseases and radiation doses received by the thyroid. Population to be investigated, medical and laboratory examinations and advanced diagnostics for thyroid diseases to be undertaken are enlisted in the protocol

  15. Assurance of Myeloid Growth Factor Administration in an Infusion Center: Pilot Quality Improvement Initiative.

    Science.gov (United States)

    Ramirez, Pamela Maree; Peterson, Barry; Holtshopple, Christine; Borja, Kristina; Torres, Vincent; Valdivia-Peppers, Lucille; Harriague, Julio; Joe, Melanie D

    2017-12-01

    Four incident reports involving missed doses of myeloid growth factors (MGFs) triggered the need for an outcome-driven initiative. From March 1, 2015, to February 29, 2016, at University of California Irvine Health Chao Infusion Center, 116 of 3,300 MGF doses were missed (3.52%), including pegfilgrastim, filgrastim, and sargramostim. We hypothesized that with the application of Lean Six Sigma methodology, we would achieve our primary objective of reducing the number of missed MGF doses to < 0.5%. This quality improvement initiative was conducted at Chao Infusion Center as part of a Lean Six Sigma Green Belt Certification Program. Therefore, Lean Six Sigma principles and tools were used throughout each phase of the project. Retrospective and prospective medical record reviews and data analyses were performed to evaluate the extent of the identified problem and impact of the process changes. Improvements included systems applications, practice changes, process modifications, and safety-net procedures. Preintervention, 24 missed doses (20.7%) required patient supportive care measures, resulting in increased hospital costs and decreased quality of care. Postintervention, from June 8, 2016, to August 7, 2016, zero of 489 MGF doses were missed after 2 months of intervention ( P < .001). Chao Infusion Center reduced missed doses from 3.52% to 0%, reaching the goal of < 0.5%. The establishment of simplified and standardized processes with safety checks for error prevention increased quality of care. Lean Six Sigma methodology can be applied by other institutions to produce positive outcomes and implement similar practice changes.

  16. Approaches to quality improvement in nursing homes: Lessons learned from the six-state pilot of CMS's Nursing Home Quality Initiative

    OpenAIRE

    Kissam, Stephanie; Gifford, David; Parks, Peggy; Patry, Gail; Palmer, Laura; Wilkes, Linda; Fitzgerald, Matthew; Petrulis, Alice Stollenwerk; Barnette, Leslie

    2003-01-01

    Abstract Background In November 2002, the Centers for Medicare & Medicaid Services (CMS) launched a Nursing Home Quality Initiative that included publicly reporting a set of Quality Measures for all nursing homes in the country, and providing quality improvement assistance to nursing homes nationwide. A pilot of this initiative occurred in six states for six months prior to the launch. Methods Review and analysis of the lessons learned from the six Quality Improvement Organizations (QIOs) tha...

  17. Safety and feasibility of transcranial direct current stimulation (tDCS) combined with sensorimotor retraining in chronic low back pain: a protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Ouellette, Adam Louis; Liston, Matthew B; Chang, Wei-Ju; Walton, David M; Wand, Benedict Martin; Schabrun, Siobhan M

    2017-08-21

    Chronic low back pain (LBP) is a common and costly health problem yet current treatments demonstrate at best, small effects. The concurrent application of treatments with synergistic clinical and mechanistic effects may improve outcomes in chronic LBP. This pilot trial aims to (1) determine the feasibility, safety and perceived patient response to a combined transcranial direct current stimulation (tDCS) and sensorimotor retraining intervention in chronic LBP and (2) provide data to support a sample size calculation for a fully powered trial should trends of effectiveness be present. A pilot randomised, assessor and participant-blind, sham-controlled trial will be conducted. Eighty participants with chronic LBP will be randomly allocated to receive either (1) active tDCS + sensorimotor retraining or (2) sham tDCS + sensorimotor retraining. tDCS (active or sham) will be applied to the primary motor cortex for 20 min immediately prior to 60 min of supervised sensorimotor retraining twice per week for 10 weeks. Participants in both groups will complete home exercises three times per week. Feasibility, safety, pain, disability and pain system function will be assessed immediately before and after the 10-week intervention. Analysis of feasibility and safety will be performed using descriptive statistics. Statistical analyses will be conducted based on intention-to-treat and per protocol and will be used to determine trends for effectiveness. Ethical approval has been gained from the institutional human research ethics committee (H10184). Written informed consent will be provided by all participants. Results from this pilot study will be submitted for publication in peer-reviewed journals. ACTRN12616000624482. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  18. Acupuncture at Houxi (SI 3) acupoint for acute neck pain caused by stiff neck: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Sun, Zhong-ren; Yue, Jin-huan; Tian, Hong-zhao; Zhang, Qin-hong

    2014-12-23

    The use of acupuncture has been suggested for the treatment of acute neck pain caused by stiff neck in China. However, current evidence is insufficient to draw any conclusions about its efficacy. Therefore this pilot study was designed to evaluate the feasibility and efficacy of acupuncture at the Houxi (SI3) acupoint for treatment of acute neck pain. This pilot study will be a two-parallel-group, assessor-blinded, randomised controlled trial. Thirty-six stiff neck participants with acute neck pain will be recruited and randomly divided into two groups in a 1:1 ratio. Participants in the control group will receive massage on the local neck region (5 min each session, three times a day for 3 days). In addition to massage, patients in the treatment group will receive acupuncture (one session a day for 3 days). Measures will be taken at 0, 3 and 15 days. The primary outcome is the Northwick Park Neck Pain Questionnaire (NPQ). The secondary outcome is the Short Form of the McGill Pain Questionnaire (SF-MPQ). The protocol for this pilot randomised clinical trial has undergone ethics scrutiny and been approved by the ethics review boards of the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine (Permission number: HZYLL201303502). The findings of this study will provide important clinical evidence on the feasibility and efficacy of acupuncture treatment for stiff neck patients with acute neck pain. In addition, it will explore the feasibility of further acupuncture research. ChiCTR-TRC-13003911. 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.

  19. Approaches to quality improvement in nursing homes: Lessons learned from the six-state pilot of CMS's Nursing Home Quality Initiative

    Directory of Open Access Journals (Sweden)

    Palmer Laura

    2003-05-01

    Full Text Available Abstract Background In November 2002, the Centers for Medicare & Medicaid Services (CMS launched a Nursing Home Quality Initiative that included publicly reporting a set of Quality Measures for all nursing homes in the country, and providing quality improvement assistance to nursing homes nationwide. A pilot of this initiative occurred in six states for six months prior to the launch. Methods Review and analysis of the lessons learned from the six Quality Improvement Organizations (QIOs that led quality improvement efforts in nursing homes from the six pilot states. Results QIOs in the six pilot states found several key outcomes of the Nursing Home Quality Initiative that help to maximize the potential of public reporting to leverage effective improvement in nursing home quality of care. First, public reporting focuses the attention of all stakeholders in the nursing home industry on achieving good quality outcomes on a defined set of measures, and creates an incentive for partnership formation. Second, publicly reported quality measures motivate nursing home providers to improve in certain key clinical areas, and in particular to seek out new ways of changing processes of care, such as engaging physicians and the medical director more directly. Third, the lessons learned by QIOs in the pilot of this Initiative indicate that certain approaches to providing quality improvement assistance are key to guiding nursing home providers' desire and enthusiasm to improve towards a using a systematic approach to quality improvement. Conclusion The Nursing Home Quality Initiative has already demonstrated the potential of public reporting to foster collaboration and coordination among nursing home stakeholders and to heighten interest of nursing homes in quality improvement techniques. The lessons learned from this pilot project have implications for any organizations or individuals planning quality improvement projects in the nursing home setting.

  20. Reference-based digital concept to restore partially edentulous patients following an immediate loading protocol: a pilot study

    NARCIS (Netherlands)

    Tahmaseb, A.; de Clerck, R.; Eckert, S.; Wismeijer, D.

    2011-01-01

    PURPOSE: To describe the use of a computer-aided three-dimensional planning protocol in combination with previously placed reference elements and computer-aided design/computer-assisted manufacture (CAD/CAM) technology to restore the partially edentulous patient. MATERIALS AND METHODS: Mini-implants

  1. A Pilot Physical Activity Initiative to Improve Mental Health Status amongst Iranian Institutionalized Older People

    Directory of Open Access Journals (Sweden)

    Hossein Matlabi

    2014-07-01

    Full Text Available Background: Sufficient level of physical activity may promote overall and mental health of old people. This study was carried out to investigate the practicability of a physical activity promotion initiative amongst institutionalized older people in Tabriz, Iran. Methods: Purposive sampling method was used in this semi-experimental study to recruit 31 older people living in a selected residential care in Tabriz. Moderate-intensity aerobic and muscle-strengthening activity was planned for those who had not severe baseline cognitive impairment or were not too frail to undertake the survey. The General Health Questionnaire (GHQ-28 was used to measure mental health status before and after intervention through a face-to-face interview. Descriptive statistics, Wilkcoxon rank-sum, Mann–Whitney U and Chi-Square tests were employed to analyses the data. Results: The applied intervention was significantly improved status of physical health, anxiety and insomnia, social dysfunction and severe depression. Conclusion: Incorporation of physical activity promotion programs into routines of older people residential care homes in Iran is feasible but may need training of physical activity specialists to work with older people based on their physical endurance and limitations.

  2. Physical micro-environment interventions for healthier eating in the workplace: protocol for a stepped wedge randomised controlled pilot trial.

    Science.gov (United States)

    Vasiljevic, Milica; Cartwright, Emma; Pechey, Rachel; Hollands, Gareth J; Couturier, Dominique-Laurent; Jebb, Susan A; Marteau, Theresa M

    2017-01-01

    An estimated one third of energy is consumed in the workplace. The workplace is therefore an important context in which to reduce energy consumption to tackle the high rates of overweight and obesity in the general population. Altering environmental cues for food selection and consumption-physical micro-environment or 'choice architecture' interventions-has the potential to reduce energy intake. The first aim of this pilot trial is to estimate the potential impact upon energy purchased of three such environmental cues (size of portions, packages and tableware; availability of healthier vs. less healthy options; and energy labelling) in workplace cafeterias. A second aim of this pilot trial is to examine the feasibility of recruiting eligible worksites, and identify barriers to the feasibility and acceptability of implementing the interventions in preparation for a larger trial. Eighteen worksite cafeterias in England will be assigned to one of three intervention groups to assess the impact on energy purchased of altering (a) portion, package and tableware size ( n  = 6); (b) availability of healthier options ( n  = 6); and (c) energy (calorie) labelling ( n  = 6). Using a stepped wedge design, sites will implement allocated interventions at different time periods, as randomised. This pilot trial will examine the feasibility of recruiting eligible worksites, and the feasibility and acceptability of implementing the interventions in preparation for a larger trial. In addition, a series of linear mixed models will be used to estimate the impact of each intervention on total energy (calories) purchased per time frame of analysis (daily or weekly) controlling for the total sales/transactions adjusted for calendar time and with random effects for worksite. These analyses will allow an estimate of an effect size of each of the three proposed interventions, which will form the basis of the sample size calculations necessary for a larger trial. ISRCTN52923504.

  3. A pilot randomised double blind controlled trial of the efficacy of purified fatty acids for the treatment of women with endometriosis-associated pain (PurFECT): study protocol.

    Science.gov (United States)

    Abokhrais, Ibtisam M; Saunders, Philippa T K; Denison, Fiona C; Doust, Ann; Williams, Linda; Horne, Andrew W

    2018-01-01

    Endometriosis affects 6-10% of women and is associated with debilitating pelvic pain. It costs the UK > £2.8 billion per year in loss of productivity. Endometriosis can be managed by surgical excision or medically by ovarian suppression. However, ~ 75% symptoms recur after surgery and available medical treatments have undesirable side effects and are contraceptive. Omega-3 purified fatty acids (PUFA) have been shown in animal models to reduce factors that are thought to lead to endometriosis-associated pain, have minimal side effects, and no effects on fertility. This paper presents a protocol for a two-arm, pilot parallel randomised controlled trial (RCT) which aims to inform the planning of a future multicentre trial to evaluate the efficacy of Omega-3 PUFA in the management of endometriosis-associated pain in women. The study will recruit women with endometriosis over a 12-month period in the National Health Service (NHS) Lothian, UK, and randomise them to 8 weeks of treatment with Omega-3 PUFA or comparator (olive oil). The primary objective is to assess recruitment and retention rates. The secondary objectives are to determine the effectiveness/acceptability to participants of the proposed methods of recruitment/randomisation/treatments/questionnaires, to inform the sample size calculation and to refine the research methodology for a future large randomised controlled trial. Response to treatment will be monitored by pain scores and questionnaires assessing physical and emotional function compared at baseline and 8 weeks. We recognise that there may be potential difficulties in mounting a large randomised controlled trial for endometriosis to assess Omega-3 PUFA because they are a dietary supplement readily available over the counter and already used by women with endometriosis. We have therefore designed this pilot study to assess practical feasibility and following the 'Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials

  4. Waste Isolation Pilot Plant Initial Report for PCB Disposal Authorization (40 CFR (section) 761.75[c])

    International Nuclear Information System (INIS)

    Westinghouse TRU Solutions

    2002-01-01

    This initial report is being submitted pursuant to Title 40 Code of Federal Regulations (CFR) (section) 761.75(c) to request authorization to allow the disposal of transuranic (TRU) wastes containing polychlorinated biphenyls (PCBs) which are duly regulated under the Toxic Substances Control Act (TSCA). Approval of this initial report will not affect the disposal of TRU or TRU mixed wastes that do not contain PCBs. This initial report also demonstrates how the Waste Isolation Pilot Plant (WIPP) meets or exceeds the technical standards for a Chemical Waste Landfill. Approval of this request will allow the U.S. Department of Energy (DOE) to dispose of approximately 88,000 cubic feet (ft3) (2,500 cubic meters [m3]) of TRU wastes containing PCBs subject to regulation under the TSCA. This approval will include only those PCB/TRU wastes, which the TSCA regulations allow for disposal of the PCB component in municipal solid waste facilities or chemical waste landfills (e.g., PCB remediation waste, PC B articles, and bulk PCB product waste). Disposal of TRU waste by the DOE is congressionally mandated in Public Law 102-579 (as amended by the National Defense Authorization Act for Fiscal Year 1997, Pub. L. 104-201, referred to as the WIPP Land Withdrawal Act [LWA]). Portions of the TRU waste inventory contain hazardous waste constituents regulated under 40 CFR Parts 260 through 279, and/or PCBs and PCB Items regulated under 40 CFR Part 761. Therefore, the DOE TRU waste program must address the disposal requirements for these hazardous waste constituents and PCBs. To facilitate the disposal of TRU wastes containing hazardous waste constituents, the owner/operators received a Hazardous Waste Facility Permit (HWFP) from the New Mexico Environment Department (NMED) on October 27, 1999. The permit allows the disposal of TRU wastes subject to hazardous waste disposal requirements (TRU mixed waste). Informational copies of this permit and other referenced documents are available

  5. INfluence of Successful Periodontal Intervention in REnal Disease (INSPIRED): study protocol for a randomised controlled pilot clinical trial.

    Science.gov (United States)

    Sharma, Praveen; Cockwell, Paul; Dietrich, Thomas; Ferro, Charles; Ives, Natalie; Chapple, Iain L C

    2017-11-13

    Patients with chronic kidney disease (CKD) exhibit increased morbidity and mortality which is associated with an increased systemic inflammatory burden. Identifying and managing comorbid diseases that contribute to this load may inform novel care pathways that could have a beneficial impact on the morbidity/mortality associated with CKD. Periodontitis, a highly prevalent, chronic inflammatory disease affecting the supporting structures of teeth, is associated with an increased systemic inflammatory and oxidative stress burden and the successful treatment of periodontitis has been shown to reduce both. This pilot study aims to gather data to inform a definitive study into the impact of successful periodontal treatment on the cardio-renal health of patients with CKD. This pilot study will employ a randomised, controlled, parallel-group design. Sixty adult patients, with CKD with a high risk of progression and with periodontitis, from the Queen Elizabeth Hospital, Birmingham, will be randomised to receive either immediate, intensive periodontal treatment (n = 30) or treatment at a delay of 12 months (n = 30). Patients will be excluded if they have reached end-stage renal disease or have received specialist periodontal treatment in the previous year. Periodontal treatment will be delivered under local anaesthetic, on an outpatient basis, over several visits by a qualified dental hygienist at the Birmingham Dental Hospital, UK. Patients in the delayed-treatment arm will continue to receive the standard community level of periodontal care for a period of 12 months followed by the intensive periodontal treatment. Randomization will occur using a centralised telephone randomisation service, following baseline assessments. The assessor of periodontal health will be blinded to the patients' treatment allocation. Patients in either arm will be followed up at 3-monthly intervals for 18 months. Aside from the pilot outcomes to inform the practicalities of a larger

  6. Training conversation partners of persons with communication disorders related to Parkinson's disease--a protocol and a pilot study.

    Science.gov (United States)

    Forsgren, Emma; Antonsson, Malin; Saldert, Charlotta

    2013-07-01

    This paper reports on the adaptation of a training programme for conversation partners of persons with Parkinson's disease, and a protocol for assessment of possible changes in conversational interaction as a result of intervention. We present data from an explorative multiple case study with three individuals with Parkinson's disease and their spouses. Repeated analysis of natural conversational interaction and measures of the participants' perception of communication as well as measures of different cognitive abilities were obtained. The results show that the communication in all three dyads was affected by both speech and language problems and that the conversation training model and the assessment protocol may work well after minor adjustments. Influence of different aspects of cognition on communication is discussed.

  7. Developing a comprehensive presurgical functional MRI protocol for patients with intractable temporal lobe epilepsy: a pilot study

    International Nuclear Information System (INIS)

    Deblaere, K.; Vandemaele, P.; Achten, E.; Backes, W.H.; Hofman, P.; Wilmink, J.; Boon, P.A.; Vonck, K.; Boon, P.; Troost, J.; Vermeulen, J.; Aldenkamp, A.

    2002-01-01

    Our aim was to put together and test a comprehensive functional MRI (fMRI) protocol which could compete with the intracarotid amytal (IAT) or Wada test for the localisation of language and memory function in patients with intractable temporal lobe epilepsy. The protocol was designed to be performed in under 1 h on a standard 1.5 tesla imager. We used five paradigms to test nine healthy right-handed subjects: complex scene-encoding, picture-naming, reading, word-generation and semantic-decision tasks. The combination of these tasks generated two activation maps related to memory in the mesial temporal lobes, and three language-related maps of activation in a major part of the known language network. The functional maps from the encoding and naming tasks showed typical and symmetrical posterior mesial temporal lobe activation related to memory in all subjects. Only four of nine subjects also showed symmetrical anterior hippocampal activation. Language lateralisation was best with the word generation and reading paradigms and proved possible in all subjects. The reading paradigm enables localisation of language function in the left anterior temporal pole and middle temporal gyrus, areas typically resected during epilepsy surgery. The combined results of this comprehensive f MRI protocol are adequate for a comparative study with the IAT in patients with epilepsy being assessed for surgery. (orig.)

  8. Developing a comprehensive presurgical functional MRI protocol for patients with intractable temporal lobe epilepsy: a pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Deblaere, K.; Vandemaele, P.; Achten, E. [MRI Department -1 K12, Department of Radiology, Ghent University Hospital, De Pintelaan 185, 9000 Ghent (Belgium); Backes, W.H.; Hofman, P.; Wilmink, J. [Department of Neuroradiology, University Hospital Maastricht, Postbus 5800, 6202 AZ Maastricht (Netherlands); Boon, P.A.; Vonck, K. [Department of Neurology, Ghent University Hospital, De Pintelaan 185, 9000 Ghent (Belgium); Boon, P. [Department of Medical Psychology, University Hospital Maastricht (Netherlands); Troost, J. [Department of Neurology, University Hospital Maastricht (Netherlands); Vermeulen, J. [S.E.I.N Heemstede, Psychological Laboratory, Achterweg 5, 2103 SW Heemstede (Netherlands); Aldenkamp, A. [Epilepsy Center ' Kempenhaeghe' , Postbus 61, 5900 AB Heeze (Netherlands)

    2002-08-01

    Our aim was to put together and test a comprehensive functional MRI (fMRI) protocol which could compete with the intracarotid amytal (IAT) or Wada test for the localisation of language and memory function in patients with intractable temporal lobe epilepsy. The protocol was designed to be performed in under 1 h on a standard 1.5 tesla imager. We used five paradigms to test nine healthy right-handed subjects: complex scene-encoding, picture-naming, reading, word-generation and semantic-decision tasks. The combination of these tasks generated two activation maps related to memory in the mesial temporal lobes, and three language-related maps of activation in a major part of the known language network. The functional maps from the encoding and naming tasks showed typical and symmetrical posterior mesial temporal lobe activation related to memory in all subjects. Only four of nine subjects also showed symmetrical anterior hippocampal activation. Language lateralisation was best with the word generation and reading paradigms and proved possible in all subjects. The reading paradigm enables localisation of language function in the left anterior temporal pole and middle temporal gyrus, areas typically resected during epilepsy surgery. The combined results of this comprehensive f MRI protocol are adequate for a comparative study with the IAT in patients with epilepsy being assessed for surgery. (orig.)

  9. Pilot testing and protocol development of giant applesnail suppression at Mandalay National Wildlife Refuge, Louisiana—July–October 2017

    Science.gov (United States)

    Carter, Jacoby; Merino, Sergio

    2018-03-19

    This report provides an overview of the pilot study and description of the techniques developed for a future mitigation study of Pomacea maculata (giant applesnail) at the U.S. Fish and Wildlife Service Mandalay National Wildlife Refuge, Louisiana (MNWR). Egg mass suppression is a potential strategy for the mitigation of the invasive giant applesnail. In previous studies at Langan Municipal Park in Mobile, Alabama (LMP), and National Park Service Jean Lafitte National Park-Barataria Unit, Louisiana (JLNP), we determined that spraying food-grade oil (coconut oil or Pam™ spray) on egg masses significantly reduced egg hatching. At JLNP we also developed methods to estimate snail population size. The purpose of this pilot study was to adapt techniques developed for previous studies to the circumstances of MNWR in preparation for a larger experiment whereby we will test the effectiveness of egg mass suppression as an applesnail mitigation tool. We selected four canals that will be used as treatment and control sites for the experiment (two each). We established that an efficient way to destroy egg masses is to knock them down with a high-velocity stream of water pumped directly from the canal. The traps used at JLNP had to be modified to accommodate the greater range of water-level fluctuation at MNWR. One of the three marking methods used at JLNP was selected for use at MNWR.

  10. Early Maladaptive Schemas in a Sample of Airline Pilots seeking Residential Substance Use Treatment: An Initial Investigation.

    Science.gov (United States)

    Shorey, Ryan C; Brasfield, Hope; Anderson, Scott; Stuart, Gregory L

    2014-01-01

    Recent research has begun to examine the early maladaptive schemas of substance abusers, as it is believed that targeting these core beliefs in treatment may result in improved substance use outcomes. One special population that has received scant attention in the research literature, despite high levels of substance use, is airline pilots. The current study examined the early maladaptive schemas of a sample of airline pilots ( n = 64) who were seeking residential treatment for alcohol dependence and whether they differed in early maladaptive schemas from non-pilot substance abusers who were also seeking residential treatment for alcohol dependence ( n = 45). Pre-existing medical records from patients of a residential substance abuse treatment facility were reviewed for the current study. Of the 18 early maladaptive schemas, results demonstrated that pilots scored higher than non-pilots on the early maladaptive schema of unrelenting standards (high internalized standards of behavior), whereas non-pilots scored higher on insufficient self-control (low frustration tolerance and self-control). Early maladaptive schemas may be a relevant treatment target for substance abuse treatment seeking pilots and non-pilots.

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    Lv, Peijie; Liu, Jie; Chai, Yaru; Yan, Xiaopeng; Gao, Jianbo; Dong, Junqiang [The First Affiliated Hospital of Zhengzhou University, Department of Radiology, Zhengzhou, Henan Province (China)

    2017-01-15

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

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

    International Nuclear Information System (INIS)

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

    2017-01-01

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

  14. Online CBT life skills programme for low mood and anxiety: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Williams, Christopher; McClay, Carrie-Anne; Martinez, Rebeca; Morrison, Jill; Haig, Caroline; Jones, Ray; Farrand, Paul

    2016-04-27

    Low mood is a common mental health problem with significant health consequences. Studies have shown that cognitive behavioural therapy (CBT) is an effective treatment for low mood and anxiety when delivered one-to-one by an expert practitioner. However, access to this talking therapy is often limited and waiting lists can be long, although a range of low-intensity interventions that can increase access to services are available. These include guided self-help materials delivered via books, classes and online packages. This project aims to pilot a randomized controlled trial of an online CBT-based life skills course with community-based individuals experiencing low mood and anxiety. Individuals with elevated symptoms of depression will be recruited directly from the community via online and newspaper advertisements. Participants will be remotely randomized to receive either immediate access or delayed access to the Living Life to the Full guided online CBT-based life skills package, with telephone or email support provided whilst they use the online intervention. The primary end point will be at 3 months post-randomization, at which point the delayed-access group will be offered the intervention. Levels of depression, anxiety, social functioning and satisfaction will be assessed. This pilot study will test the trial design, and ability to recruit and deliver the intervention. Drop-out rates will be assessed and the completion and acceptability of the package will be investigated. The study will also inform a sample size power calculation for a subsequent substantive randomized controlled trial. ISRCTN ISRCTN12890709.

  15. Improving the care of people with long-term conditions in primary care: protocol for the ENHANCE pilot trial

    Directory of Open Access Journals (Sweden)

    Emma L. Healey

    2015-12-01

    Full Text Available Background: Long-term conditions (LTCs are important determinants of quality of life and healthcare expenditure worldwide. Whilst multimorbidity is increasingly the norm in primary care, clinical guidelines and the delivery of care remain focused on single diseases, resulting in poorer clinical outcomes. Osteoarthritis, and anxiety and/or depression frequently co-occur with other LTCs, yet are seldom prioritized by the patient or clinician, resulting in higher levels of disability, poorer prognosis, and increased healthcare costs. Objective: To examine the feasibility and acceptability of an integrated approach to LTC management, tackling the under-diagnosis and under-management of osteoarthritis-related pain and anxiety and/or depression in older adults with other LTCs in primary care. Design: The ENHANCE study is a pilot stepped-wedge cluster randomized controlled trial to test the feasibility and acceptability of a nurse-led ENHANCE LTC review consultation for identifying, assessing, and managing joint pain, and anxiety and/or depression in patients attending LTC reviews. Specific objectives (process evaluation and research outcomes will be achieved through a theoretically informed mixed-methods approach using participant self-reported questionnaires, a medical record review, an ENHANCE EMIS template, qualitative interviews, and audio recordings of the ENHANCE LTC review. Discussion: Success of the pilot trial will be measured against the level of the primary care team engagement, assessment of training delivery, and degree of patient recruitment and retention. Patient satisfaction and treatment fidelity will also be explored. ISRCTN registry number: 12154418. Journal of Comorbidity 2015;5(1:135–149

  16. Does training family physicians in shared decision making promote optimal use of antibiotics for acute respiratory infections? Study protocol of a pilot clustered randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Côté Luc

    2007-11-01

    Full Text Available Abstract Background In North America, although it varies according to the specific type of acute respiratory infections (ARI, use of antibiotics is estimated to be well above the expected prevalence of bacterial infections. The objective of this pilot clustered randomized controlled trial (RCT is to assess the feasibility of a larger clustered RCT aiming at evaluating the impact of DECISION+, a continuing professional development (CPD program in shared decision making, on the optimal use of antibiotics in the context of ARI. Methods/design This pilot study is a cluster RCT conducted with family physicians from Family Medicine Groups (FMG in the Quebec City area, Canada. Participating FMG are randomised to an immediate DECISION+ group, a CPD program in shared decision making, (experimental group, or a delayed DECISION+ group (control group. Data collection involves recruiting five patients consulting for ARI per physician from both study groups before (Phase 1 and after (Phase 2 exposure of the experimental group to the DECISION+ program, and after exposure of the control group to the DECISION+ program (Phase 3. The primary outcome measures to assess the feasibility of a larger RCT include: 1 proportion of contacted FMG that agree to participate; 2 proportion of recruited physicians who participate in the DECISION+ program; 3 level of satisfaction of physicians regarding DECISION+; and 4 proportion of missing data in each data collection phase. Levels of agreement of the patient-physician dyad on the Decisional Conflict Scale and physicians' prescription profile for ARI are performed as secondary outcome measures. Discussion This study protocol is informative for researchers and clinicians interested in designing and/or conducting clustered RCT with FMG regarding training of physicians in shared decision making. Trial Registration ClinicalTrials.gov Identifier: NCT00354315

  17. Transcranial direct current stimulation (tDCS) for treatment of major depression during pregnancy: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Vigod, Simone; Dennis, Cindy-Lee; Daskalakis, Zafiris; Murphy, Kellie; Ray, Joel; Oberlander, Tim; Somerton, Sarah; Hussain-Shamsy, Neesha; Blumberger, Daniel

    2014-09-18

    Women with depression in pregnancy are faced with difficult treatment decisions. Untreated, antenatal depression has serious negative implications for mothers and children. While antidepressant drug treatment is likely to improve depressive symptoms, it crosses the placenta and may pose risks to the unborn child. Transcranial direct current stimulation is a focal brain stimulation treatment that improves depressive symptoms within 3 weeks of treatment by inducing changes to brain areas involved in depression, without impacting any other brain areas, and without inducing changes to heart rate, blood pressure or core body temperature. The localized nature of transcranial direct current stimulation makes it an ideal therapeutic approach for treating depression during pregnancy, although it has never previously been evaluated in this population. We describe a pilot randomized controlled trial of transcranial direct current stimulation among women with depression in pregnancy to assess the feasibility of a larger, multicentre efficacy study. Women over 18 years of age and between 14 and 32 weeks gestation can be enrolled in the study provided they meet diagnostic criteria for a major depressive episode of at least moderate severity and have been offered but refused antidepressant medication. Participants are randomized to receive active transcranial direct current stimulation or a sham condition that is administered in 15 30-minute treatments over three weeks. Women sit upright during treatment and receive obstetrical monitoring prior to, during and after each treatment session. Depressive symptoms, treatment acceptability, and pregnancy outcomes are assessed at baseline (prior to randomization), at the end of each treatment week, every four weeks post-treatment until delivery, and at 4 and 12 weeks postpartum. Transcranial direct current stimulation is a novel therapeutic option for treating depression during pregnancy. This protocol allows for assessment of the

  18. WELLFOCUS PPT - modified positive psychotherapy to improve well-being in psychosis: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Schrank, Beate; Riches, Simon; Coggins, Tony; Rashid, Tayyab; Tylee, Andre; Slade, Mike

    2014-06-03

    The promotion of well-being is an important goal of recovery oriented mental health services. No structured, evidence-based intervention exists that aims to increase the well-being in people with severe mental illness such as psychosis. Positive psychotherapy (PPT) is a promising intervention for this goal. Standard PPT was adapted for use with people with psychosis in the UK following the Medical Research Council framework for developing and testing complex interventions, resulting in the WELLFOCUS Model describing the intended impact of WELLFOCUS PPT. This study aims to test the WELLFOCUS Model, by piloting the intervention, trial processes, and evaluation strategy. This study is a non-blinded pragmatic pilot RCT comparing WELLFOCUS PPT provided as an 11-session group therapy in addition to treatment as usual to treatment as usual alone. Inclusion criteria are adults (aged 18-65 years) with a main diagnosis of psychosis who use mental health services. A target sample of 80 service users with psychosis are recruited from mental health services across the South London and Maudsley NHS Foundation Trust. Participants are randomised in blocks to the intervention and control group. WELLFOCUS PPT is provided to groups by specifically trained and supervised local therapists and members of the research team. Assessments are conducted before randomisation and after the group intervention. The primary outcome measure is well-being assessed by the Warwick-Edinburgh Mental Well-being Scale. Secondary outcomes include good feelings, symptom relief, connectedness, hope, self-worth, empowerment, and meaning. Process evaluation using data collected during the group intervention, post-intervention individual interviews and focus groups with participants, and interviews with trial therapists will complement quantitative outcome data. This study will provide data on the feasibility of the intervention and identify necessary adaptations. It will allow optimisation of trial processes

  19. Feasibility and acceptability of a beverage intervention for Hispanic adults: a protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Morrill, Kristin E; Aceves, Benjamin; Valdez, Luis A; Thomson, Cynthia A; Hakim, Iman A; Bell, Melanie L; Martinez, Jessica A; Garcia, David O

    2018-02-09

    In the U.S., Hispanics have among the highest rates of overweight and obesity when compared to other racial/ethnic groups placing them at a greater risk for obesity-related disease. Identifying intervention strategies to reduce caloric intake and/or improve cardiometabolic health in Hispanics is critical to reducing morbidity and mortality among this large and growing population. Evidence exists to support diet-specific behavioral interventions, including beverage modifications, in reducing obesity-related health risks. However, the acceptability and feasibility of a beverage intervention in obese Hispanic adults has not been robustly evaluated. The objective of this pilot study is to assess the feasibility and acceptability of a randomized, controlled beverage intervention in 50 obese Hispanic adults ages 18-64 over 8-weeks. Eligible participants were obese (30-50.0 kg/m 2 ), between the ages 18-64, self-identified as Hispanic, and were able to speak, read, and write in either English and/or Spanish. Study recruitment was completed August 2017. Upon the completion of baseline assessments, participants will be randomized to either Mediterranean lemonade, Green Tea, or flavored water control. After completing a 2-week washout period, participants will be asked to consume 32 oz. per day of study beverage for 6-weeks while avoiding all other sources of tea, lemonade, citrus, juice, and other sweetened beverages; water is permissible. Primary outcomes will be recruitment, retention, and acceptability of the intervention strategies. Our study will also evaluate participant-reported tolerance and as an exploratory aim, assess safety/toxicity-related to renal and/or liver function. Fasting blood samples will be collected at baseline and 8-weeks to assess the primary efficacy outcomes: total cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL). Secondary outcomes include fasting glucose, hemoglobin A1c (HbA1c), and high-sensitivity C

  20. Protocol for a pilot randomised controlled trial of an intervention to increase the use of traffic light food labelling in UK shoppers (the FLICC trial).

    Science.gov (United States)

    Scarborough, Peter; Hodgkins, Charo; Raats, Monique M; Harrington, Richard A; Cowburn, Gill; Dean, Moira; Doherty, Aiden; Foster, Charlie; Juszczak, Edmund; Matthews, Anne; Mizdrak, Anja; Mhurchu, Cliona Ni; Shepherd, Richard; Tiomotijevic, Lada; Winstone, Naomi; Rayner, Mike

    2015-01-01

    Traffic light labelling of foods-a system that incorporates a colour-coded assessment of the level of total fat, saturated fat, sugar and salt on the front of packaged foods-has been recommended by the UK Government and is currently in use or being phased in by many UK manufacturers and retailers. This paper describes a protocol for a pilot randomised controlled trial of an intervention designed to increase the use of traffic light labelling during real-life food purchase decisions. The objectives of this two-arm randomised controlled pilot trial are to assess recruitment, retention and data completion rates, to generate potential effect size estimates to inform sample size calculations for the main trial and to assess the feasibility of conducting such a trial. Participants will be recruited by email from a loyalty card database of a UK supermarket chain. Eligible participants will be over 18 and regular shoppers who frequently purchase ready meals or pizzas. The intervention is informed by a review of previous interventions encouraging the use of nutrition labelling and the broader behaviour change literature. It is designed to impact on mechanisms affecting belief and behavioural intention formation as well as those associated with planning and goal setting and the adoption and maintenance of the behaviour of interest, namely traffic light label use during purchases of ready meals and pizzas. Data will be collected using electronic sales data via supermarket loyalty cards and web-based questionnaires and will be used to estimate the effect of the intervention on the nutrition profile of purchased ready meals and pizzas and the behavioural mechanisms associated with label use. Data collection will take place over 48 weeks. A process evaluation including semi-structured interviews and web analytics will be conducted to assess feasibility of a full trial. The design of the pilot trial allows for efficient recruitment and data collection. The intervention could be

  1. Initiating change locally in bullying and aggression through the school environment (INCLUSIVE): a pilot randomised controlled trial.

    Science.gov (United States)

    Bonell, Chris; Fletcher, Adam; Fitzgerald-Yau, Natasha; Hale, Daniel; Allen, Elizabeth; Elbourne, Diana; Jones, Rebecca; Bond, Lyndal; Wiggins, Meg; Miners, Alec; Legood, Rosa; Scott, Stephen; Christie, Deborah; Viner, Russell

    2015-07-01

    Youth bullying and other aggressive behaviours are a major public health concern owing to their impact on adolescent physical and mental health and well-being. Whole-school restorative approaches have been identified as a promising method of addressing aggressive behaviour but there have been no randomised trials undertaken to examine their effects. To examine the feasibility and acceptability of implementing and trialling the INCLUSIVE (initiating change locally in bullying and aggression through the school environment) intervention in English secondary schools. Cluster randomised controlled pilot trial in eight schools (1 : 1 computer-generated random allocation post baseline by a statistician blind to the identity of clusters) and process evaluation. Secondary schools in England (purposively sampled to ensure diversity). Year 8 students (aged 12-13 years), teachers, other school staff and intervention providers. Whole-school restorative approach to address bullying and aggression, involving the following standard processes: school action group formation and external facilitation to review needs assessment data, identify priorities, and plan and monitor school-level actions; staff training in restorative practices; and a new social and emotional skills curriculum. Standard practice. (1) The primary outcome of interest was the feasibility and acceptability of delivering and trialling the intervention according to prespecified criteria; (2) process data were analysed to explore participants' experiences of implementing and trialling the intervention and how these varied according to school context; and (3) indicative primary outcomes (aggressive behaviour measures), secondary outcomes, intermediate outcomes and economic evaluation methods were piloted. Students (n = 1144 baseline; n = 1114 follow-up) and teachers (n = 387 baseline; n = 336 follow-up) were surveyed at the start and end of the 2011-12 academic year (baseline September 2011; follow

  2. Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: A Randomized Pilot Study in ICU.

    Science.gov (United States)

    Frazzitta, Giuseppe; Zivi, Ilaria; Valsecchi, Roberto; Bonini, Sara; Maffia, Sara; Molatore, Katia; Sebastianelli, Luca; Zarucchi, Alessio; Matteri, Diana; Ercoli, Giuseppe; Maestri, Roberto; Saltuari, Leopold

    2016-01-01

    Verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI) and to be safe in ICU. We evaluated the effectiveness of a very early stepping verticalization protocol on their functional and neurological outcome. Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU on the third day after an ABI. They were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. Once stabilized, patients were transferred to our Neurorehabilitation unit for an individualized treatment. Outcome measures (Glasgow Coma Scale, Coma Recovery Scale revised -CRSr-, Disability Rating Scale-DRS- and Levels of Cognitive Functioning) were assessed on the third day from the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2). Between- and within-group comparisons were performed by the Mann-Whitney U test and Wilcoxon signed-rank test, respectively. Of the 40 patients enrolled, 31 completed the study without adverse events (15 in the verticalization group and 16 in the conventional physiotherapy). Early verticalization started 12.4±7.3 (mean±SD) days after ABI. The length of stay in ICU was longer for the verticalization group (38.8 ± 15.7 vs 25.1 ± 11.2 days, p = 0.01), while the total length of stay (ICU+Neurorehabilitation) was not significantly different (153.2 ± 59.6 vs 134.0 ± 61.0 days, p = 0.41). All outcome measures significantly improved in both groups after the overall period (T2 vs T0, pverticalization protocol, started since the acute stages, improves the short-term and long-term functional and neurological outcome of ABI patients. clinicaltrials.gov NCT02828371.

  3. A Small Randomized Controlled Pilot Trial Comparing Mobile and Traditional Pain Coping Skills Training Protocols for Cancer Patients with Pain

    Directory of Open Access Journals (Sweden)

    Tamara J. Somers

    2016-01-01

    Full Text Available Psychosocial pain management interventions are efficacious for cancer pain but are underutilized. Recent advances in mobile health (mHealth technologies provide new opportunities to decrease barriers to access psychosocial pain management interventions. The objective of this study was to gain information about the accessibility and efficacy of mobile pain coping skills training (mPCST intervention delivered to cancer patients with pain compared to traditional in-person pain coping skills training intervention. This study randomly assigned participants (N=30 to receive either mobile health pain coping skills training intervention delivered via Skype or traditional pain coping skills training delivered face-to-face (PCST-trad. This pilot trial suggests that mPCST is feasible, presents low burden to patients, may lead to high patient engagement, and appears to be acceptable to patients. Cancer patients with pain in the mPCST group reported decreases in pain severity and physical symptoms as well as increases in self-efficacy for pain management that were comparable to changes in the PCST-trad group (p’s < 0.05. These findings suggest that mPCST, which is a highly accessible intervention, may provide benefits similar to an in-person intervention and shows promise for being feasible, acceptable, and engaging to cancer patients with pain.

  4. Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: A Randomized Pilot Study in ICU.

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    Giuseppe Frazzitta

    Full Text Available Verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI and to be safe in ICU. We evaluated the effectiveness of a very early stepping verticalization protocol on their functional and neurological outcome.Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU on the third day after an ABI. They were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. Once stabilized, patients were transferred to our Neurorehabilitation unit for an individualized treatment. Outcome measures (Glasgow Coma Scale, Coma Recovery Scale revised -CRSr-, Disability Rating Scale-DRS- and Levels of Cognitive Functioning were assessed on the third day from the injury (T0, at ICU discharge (T1 and at Rehab discharge (T2. Between- and within-group comparisons were performed by the Mann-Whitney U test and Wilcoxon signed-rank test, respectively.Of the 40 patients enrolled, 31 completed the study without adverse events (15 in the verticalization group and 16 in the conventional physiotherapy. Early verticalization started 12.4±7.3 (mean±SD days after ABI. The length of stay in ICU was longer for the verticalization group (38.8 ± 15.7 vs 25.1 ± 11.2 days, p = 0.01, while the total length of stay (ICU+Neurorehabilitation was not significantly different (153.2 ± 59.6 vs 134.0 ± 61.0 days, p = 0.41. All outcome measures significantly improved in both groups after the overall period (T2 vs T0, p<0.001 all, as well as after ICU stay (T1 vs T0, p<0.004 all and after Neurorehabilitation (T2 vs T1, p<0.004 all. The improvement was significantly better in the experimental group for CRSr (T2-T0 p = 0.033, T1-T0 p = 0.006 and (borderline for DRS (T2-T0 p = 0.040, T1-T0 p = 0.058.A stepping verticalization protocol, started since the acute stages, improves the

  5. Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: A Randomized Pilot Study in ICU

    Science.gov (United States)

    Bonini, Sara; Maffia, Sara; Molatore, Katia; Sebastianelli, Luca; Zarucchi, Alessio; Matteri, Diana; Ercoli, Giuseppe; Maestri, Roberto

    2016-01-01

    Background and Objective Verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI) and to be safe in ICU. We evaluated the effectiveness of a very early stepping verticalization protocol on their functional and neurological outcome. Methods Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU on the third day after an ABI. They were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. Once stabilized, patients were transferred to our Neurorehabilitation unit for an individualized treatment. Outcome measures (Glasgow Coma Scale, Coma Recovery Scale revised -CRSr-, Disability Rating Scale–DRS- and Levels of Cognitive Functioning) were assessed on the third day from the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2). Between- and within-group comparisons were performed by the Mann-Whitney U test and Wilcoxon signed-rank test, respectively. Results Of the 40 patients enrolled, 31 completed the study without adverse events (15 in the verticalization group and 16 in the conventional physiotherapy). Early verticalization started 12.4±7.3 (mean±SD) days after ABI. The length of stay in ICU was longer for the verticalization group (38.8 ± 15.7 vs 25.1 ± 11.2 days, p = 0.01), while the total length of stay (ICU+Neurorehabilitation) was not significantly different (153.2 ± 59.6 vs 134.0 ± 61.0 days, p = 0.41). All outcome measures significantly improved in both groups after the overall period (T2 vs T0, p<0.001 all), as well as after ICU stay (T1 vs T0, p<0.004 all) and after Neurorehabilitation (T2 vs T1, p<0.004 all). The improvement was significantly better in the experimental group for CRSr (T2-T0 p = 0.033, T1-T0 p = 0.006) and (borderline) for DRS (T2-T0 p = 0.040, T1-T0 p = 0.058). Conclusions A stepping verticalization

  6. Coping-Infused Dialogue through Patient-Preferred Live Music: A Medical Music Therapy Protocol and Randomized Pilot Study for Hospitalized Organ Transplant Patients.

    Science.gov (United States)

    Hogan, Tyler James; Silverman, Michael J

    2015-01-01

    Solid organ transplant patients often experience a variety of psychosocial stressors that can lead to distress and may hinder successful recovery. Using coping-infused dialogue (CID) through patient- preferred live music (PPLM) music therapy sessions may improve mood and decrease pain while also imparting psychoeducational knowledge concerning the identification of local and global problems and coping skills. The purpose of this pilot study was to develop a coping-based medical music therapy protocol that combines coping-infused dialogue (CID) with patient-preferred live music (PPLM) and measure the effects of the resulting CID-PPLM protocol on mood (positive and negative affect) and pain in hospitalized transplant patients. Our study used a pre-/posttest single-session wait-list control design. Participants (N=25) were randomly assigned to experimental (CID-PPLM) or control (usual care) conditions. Participants in the CID-PPLM condition received a single 30-minute session that integrated stressor identification and knowledge of coping skills (CID) with patient-preferred live music (PPLM). Results indicated no between-group differences at pretest and significant correlations between pre- and posttest measures. Concerning posttest ANCOVA analyses, there were significant between-group differences in positive affect, negative affect, and pain, with experimental participants having more favorable posttest scores than control participants. Effect sizes were in the medium-to-large range for positive affect (η2=.198), negative affect (η2=.422), and pain (η2=.303). CID through receptive PPLM may be an effective protocol for improving mood and decreasing pain in organ transplant recipients. MT interventions can be an important tool to develop rapport and enhance outcomes with patients. As greater engagement during interventions may have stronger treatment effects, we recommend future research examining patient engagement as a potential mediator of intervention effects

  7. Cognitive remediation therapy (CRT) in a specialist inpatient eating disorder service for children and adolescents: CAN-CRT study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Giombini, Lucia; Nesbitt, Sophie; Cox, Hannah; Foxall, Anna; Sharia, Teo; Easter, Abigail; Tchanturia, Kate

    2018-03-26

    Research on treatments for young people (YP) with anorexia nervosa (AN) is scarce. Evidence supports the use of cognitive remediation therapy (CRT) to improve central coherence and set-shifting, inefficiencies that can negatively impact on prognosis. The study aims to evaluate the feasibility of individual CRT in an inpatient setting for YP aged 10-18 years with AN and to qualitatively examine YP's and their parents experiences. In a single-centre, pilot, randomised controlled trial, 80 patients aged 10-18 years with AN will be randomly allocated to the immediate or delayed CRT group, in addition to standard treatment. A repeated measures design will be conducted across 3 time points. The data will provide evidence regarding the feasibility of individual CRT in YP with AN, informing directions of further development of CRT. The study is in preparation for a definitive randomised controlled trial. The aim of this manuscript is to describe the study protocol. Copyright © 2018 John Wiley & Sons, Ltd and Eating Disorders Association.

  8. THE BIAS (BULLYING IN SICILIAN SCHOOL PILOT STUDY: INVESTIGATING THE PREVALENCE OF BULLYING IN SCHOOL OF PALERMO CITY. A RESEARCH STUDY PROTOCOL.

    Directory of Open Access Journals (Sweden)

    Claudio Costantino

    2017-12-01

    Full Text Available Bullying in school, being a serious threat to physical and emotional health of children and adolescents all over the world, represents an important public health issue. In Italy, since 2007, the Italian Ministry of Education promotes activities to fight against and to prevent bullying in schools of all levels and, at the same time, also Health Authorities are trying to implement effective social-health responses. However, to date, the lack of consistent data, from national to local level, that could help in describing the problem in a proper manner, does not allow a systematic bullying surveillance and so also measuring the effectiveness of the public health strategy that could be implemented. The Bias pilot study’s aim is to evaluate the prevalence of bullying in a sample of schools in the city of Palermo, the largest in Sicily, and to investigate its characteristics in relation to different types of school. Finally, the Bias study aim to evaluate the feasibility of alternative methods for the detection of the prevalence of bullying phenomenon in schools. Here we present the research protocol and the questionnaires that will be used.

  9. The Happy Older Latinos are Active (HOLA) health promotion and prevention study: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Jimenez, Daniel E; Reynolds, Charles F; Alegría, Margarita; Harvey, Philip; Bartels, Stephen J

    2015-12-18

    Results of previous studies attest to the greater illness burden of common mental disorders (anxiety and depression) in older Latinos and the need for developing preventive interventions that are effective, acceptable, and scalable. Happy Older Latinos are Active (HOLA) is a newly developed intervention that uses a community health worker (CHW) to lead a health promotion program in order to prevent common mental disorders among at-risk older Latinos. This pilot study tests the feasibility and acceptability of delivering HOLA to older, at-risk Latinos. HOLA is a multi-component, health promotion intervention funded by the National Institute of Mental Health (NIMH). This prevention approach will be tested against a fotonovela, an enhanced psychoeducation control condition, in a sample of Latino elderly with minor or subthreshold depression or anxiety. A total of 60 older Latinos (aged 60+) will be randomized to receive HOLA or the fotonovela. The primary outcomes of interest are recruitment, adherence, retention, and acceptability. Data will also be collected on: preemption of incident and recurrent major depression, generalized anxiety, and social phobia; reduction in depression and anxiety symptom severity; physical functioning; sedentary behaviors; social engagement; and self-efficacy. The results of this study could have implications for other high-risk, highly disadvantaged populations. The development of a health promotion intervention designed to prevent common mental disorders could be a means of addressing multiple disparities (for example, mental health outcomes, mental health service use, stigma) among racial/ethnic minority elderly. CLINICALTRIALS. NCT02371954 . Date of registration: 21 January 2015.

  10. 'Huang Qi Elixir' for proteinuria in patients with diabetic nephropathy: a study protocol for a randomized controlled pilot trial.

    Science.gov (United States)

    Tu, Xiang; Liu, Fang; Jordan, James B; Ye, Xue Feng; Fu, Ping; Wang, Fei; Zhong, Sen

    2013-07-18

    Diabetic nephropathy (DN) is the major complication of diabetes; proteinuria is the hall mark of DN. Currently, the treatment for proteinuria is mainly limited to angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). According to Traditional Chinese Medicine (TCM) theory, Chinese medicinals 'securing essence and tonifying the kidney' may be appropriate for proteinuria. The most promising Chinese medicinals and formulae are introduced in the present study to form a potent formula for DN proteinuria. To make oral administration convenient, the formula will be processed in the form of granules. A randomized, multi-center pilot trial will be conducted. Forty eight participants with DN will be randomly assigned to one of four treatment groups: 1. A granule group, at 10 grams, three times daily (G10 group, n = 12); 2. A granule group, at 20 grams, three times daily (G20 group, n = 12); 3. A decoction group (D group, n = 12); and 4. An irbesartan group (Aprovel group, n = 12).The following outcome measures will be used: the percentage change of the albumin-to-creatinine ratio; and the changes in serum creatinine, glomerular filtration rate, fasting plasma glucose and hemoglobulin from baseline to the end of the trial. It is notable that most published clinical trials which assessed the efficacy of TCM on DN were of poor methodology and, therefore, their results have been invalidated. It is necessary to carry out well-designed clinical trials to provide sound evidence. The present trial is a study with potentially great value, for it will provide the parameters for future randomized, placebo-controlled, clinical trials with large sample sizes. The trial is registered on the Chinese Clinical Trial Registry: ChiCTR-TRC-12002718 (http://www.chictr.org/cn/proj/show.aspx?proj=3820).

  11. Pacing, Conventional Physical Activity and Active Video Games to Increase Physical Activity for Adults with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Protocol for a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Ferrar, Katia Elizabeth; Smith, Ashleigh E; Davison, Kade

    2017-08-01

    of the intervention. Health-related outcomes (eg, physical activity, blood samples, quality of life, and functioning) will be collected at baseline, end of intervention, and 6 months after intervention completion. This protocol was developed after 6 months of extensive stakeholder and community consultation. Enrollment began in January 2017; as of publication, 12 participants were enrolled. Baseline testing is scheduled to commence in mid-2017. This pilot study will provide essential feasibility and acceptability data which will guide the use of active video games for people with ME/CFS to increase their physical activity levels. Physical activity promotion in this clinical population has been poorly and under-researched, and any exploration of alternative physical activity options for this population is much needed. Australia New Zealand Clinical Trials Registry: ACTRN12616000285459; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370224 (Archived by WebCite at http://www.webcitation.org/6qgOLhWWf). ©Katia Elizabeth Ferrar, Ashleigh E Smith, Kade Davison. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.08.2017.

  12. Reduction and technical simplification of testing protocol for walking based on repeatability analyses: An Interreg IVa pilot study

    Directory of Open Access Journals (Sweden)

    Nejc Sarabon

    2010-12-01

    Full Text Available The aim of this study was to define the most appropriate gait measurement protocols to be used in our future studies in the Mobility in Ageing project. A group of young healthy volunteers took part in the study. Each subject carried out a 10-metre walking test at five different speeds (preferred, very slow, very fast, slow, and fast. Each walking speed was repeated three times, making a total of 15 trials which were carried out in a random order. Each trial was simultaneously analysed by three observers using three different technical approaches: a stop watch, photo cells and electronic kinematic dress. In analysing the repeatability of the trials, the results showed that of the five self-selected walking speeds, three of them (preferred, very fast, and very slow had a significantly higher repeatability of the average walking velocity, step length and cadence than the other two speeds. Additionally, the data showed that one of the three technical methods for gait assessment has better metric characteristics than the other two. In conclusion, based on repeatability, technical and organizational simplification, this study helped us to successfully define a simple and reliable walking test to be used in the main study of the project.

  13. Preliminary pilot fMRI study of neuropostural optimization with a noninvasive asymmetric radioelectric brain stimulation protocol in functional dysmetria

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    Mura M

    2012-04-01

    Full Text Available Marco Mura1, Alessandro Castagna2, Vania Fontani2, Salvatore Rinaldi21Institute of Radiology, University of Cagliari, 2Rinaldi Fontani Institute – Department of Neuro Psycho Physical Optimization, Florence, ItalyPurpose: This study assessed changes in functional dysmetria (FD and in brain activation observable by functional magnetic resonance imaging (fMRI during a leg flexion-extension motor task following brain stimulation with a single radioelectric asymmetric conveyer (REAC pulse, according to the precisely defined neuropostural optimization (NPO protocol.Population and methods: Ten healthy volunteers were assessed using fMRI conducted during a simple motor task before and immediately after delivery of a single REAC-NPO pulse. The motor task consisted of a flexion-extension movement of the legs with the knees bent. FD signs and brain activation patterns were compared before and after REAC-NPO.Results: A single 250-millisecond REAC-NPO treatment alleviated FD, as evidenced by patellar asymmetry during a sit-up motion, and modulated activity patterns in the brain, particularly in the cerebellum, during the performance of the motor task.Conclusion: Activity in brain areas involved in motor control and coordination, including the cerebellum, is altered by administration of a REAC-NPO treatment and this effect is accompanied by an alleviation of FD.Keywords: motor behavior, motor control, cerebellum, dysmetria, functional dysmetria, fluctuating asymmetry

  14. Prevention of neural hypersensitivity after acute upper limb burns: Development and pilot of a cortical training protocol.

    Science.gov (United States)

    Edgar, Dale; Zorzi, Lisa M; Wand, Ben M; Brockman, Nathalie; Griggs, Carolyn; Clifford, Matthew; Wood, Fiona

    2011-06-01

    Acute burn patients suffer pain and secondary hyperalgesia. This alters movement patterns and impairs function. Non-pharmacological methods of treatment are limited and lack rigorous testing and evidence for use. The treatment in this case series was designed to direct conscious attention to, and normalise sensation of, the injured limb in pain free way. The aim of the study was to describe a cortical training programme (CTP) in acute upper limb burn patients and to investigate the efficacy, safety and feasibility of the protocol. The study is a descriptive case series (n=6). Study tasks engaged sensory and motor nerves to influence the perception of the injured area. Visual and tactile inputs to maintain and, or normalise the homuncular map were central to the intervention. One patient, who commenced the study without resting pain, responded negatively. The remaining five patients had reduced pain and fear avoidance behaviours with associated improvement in arm function. The CTP approach is safe and feasible for use with acute burn patients where pain is reported at rest. Comparative studies are required to determine the relative efficacy of the program to usual interventions and the patients who may benefit from the technique. Copyright © 2011 Elsevier Ltd and ISBI. All rights reserved.

  15. Attitudes toward E-Cigarettes, Reasons for Initiating E-Cigarette Use, and Changes in Smoking Behavior after Initiation: A Pilot Longitudinal Study of Regular Cigarette Smokers

    OpenAIRE

    Berg, Carla J.; Barr, Dana Boyd; Stratton, Erin; Escoffery, Cam; Kegler, Michelle

    2014-01-01

    Objectives We examined 1) changes in smoking and vaping behavior and associated cotinine levels and health status among regular smokers who were first-time e-cigarette purchasers and 2) attitudes, intentions, and restrictions regarding e-cigarettes. Methods We conducted a pilot longitudinal study with assessments of the aforementioned factors and salivary cotinine at weeks 0, 4, and 8. Eligibility criteria included being ?18 years old, smoking ?25 of the last 30 days, smoking ?5 cigarettes pe...

  16. Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Howarth, Ana; Perkins-Porras, Linda; Smith, Jared G; Subramaniam, Jeevakan; Copland, Claire; Hurley, Mike; Beith, Iain; Riaz, Muhammad; Ussher, Michael

    2016-06-02

    The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral to the care of patients with chronic pain; home-based interventions can be very acceptable, making a compelling argument for investigating brief, self-management interventions. The aim of this study is two-fold: to assess the immediate effects of a brief self-help mindfulness intervention for coping with chronic pain and to assess the feasibility of conducting a definitive randomized controlled trial to determine the effectiveness of such an intervention. A randomized controlled pilot study will be conducted to evaluate a brief mindfulness intervention for those with chronic pain. Ninety chronic pain patients who attend hospital outpatient clinics will be recruited and allocated randomly to either the control or treatment group on a 1:1 basis using the computer-generated list of random numbers. The treatment group receives mindfulness audios and the control group receives audios of readings from a non-fiction book, all of which are 15 minutes in length. Immediate effects of the intervention are assessed with brief psychological measures immediately before and after audio use. Mindfulness, mood, health-related quality of life, pain catastrophizing and experience of the intervention are assessed with standardized measures, brief ratings and brief telephone follow-ups, at baseline and after one week and one month. Feasibility is assessed by estimation of effect sizes for outcomes, patient adherence and experience, and appraisal of resource allocation in provision of the intervention. This trial will assess whether a brief mindfulness-based intervention is effective for immediately reducing perceived distress and pain with the side effect of increasing relaxation

  17. The influence of a biopsychosocial-based treatment approach to primary overt hypothyroidism: a protocol for a pilot study

    Directory of Open Access Journals (Sweden)

    Pollard Henry

    2010-11-01

    Full Text Available Abstract Background Hypothyroidism is a prevalent endocrine condition. Individuals with this disease are commonly managed through supplementation with synthetic thyroid hormone, with the aim of alleviating symptoms and restoring normal thyroid stimulating hormone levels. Generally this management strategy is effective and well tolerated. However, there is research to suggest that a significant proportion of hypothyroid sufferers are being inadequately managed. Furthermore, hypothyroid patients are more likely to have a decreased sense of well-being and more commonly experience constitutional and neuropsychiatric complaints, even with pharmacological intervention. The current management of hypothyroidism follows a biomedical model. Little consideration has been given to a biopsychosocial approach to this condition. Within the chiropractic profession there is growing support for the use of a biopsychosocial-based intervention called Neuro-Emotional Technique (NET for this population. Methods/Design A placebo-controlled, single-blinded, randomised clinical pilot-trial has been designed to assess the influence of Neuro-Emotional Technique on a population with primary overt hypothyroidism. A sample of 102 adults (≥18 years who meet the inclusion criteria will be randomised to either a treatment group or a placebo group. Each group will receive ten treatments (NET or placebo over a six week period, and will be monitored for six months. The primary outcome will involve the measurement of depression using the Depression, Anxiety and Stress Scale (DASS. The secondary outcome measures to be used are; serum thyroid stimulating hormone, serum free-thyroxine, serum free-triiodothyronine, serum thyroid peroxidase auto-antibodies, serum thyroglobulin auto-antibodies as well as the measurement of functional health and well-being using the Short-Form-36 Version 2. The emotional states of anxiety and stress will be measured using the DASS. Self-measurement of

  18. The influence of a biopsychosocial-based treatment approach to primary overt hypothyroidism: a protocol for a pilot study.

    Science.gov (United States)

    Brown, Benjamin T; Bonello, Rod; Pollard, Henry; Graham, Petra

    2010-11-15

    Hypothyroidism is a prevalent endocrine condition. Individuals with this disease are commonly managed through supplementation with synthetic thyroid hormone, with the aim of alleviating symptoms and restoring normal thyroid stimulating hormone levels. Generally this management strategy is effective and well tolerated. However, there is research to suggest that a significant proportion of hypothyroid sufferers are being inadequately managed. Furthermore, hypothyroid patients are more likely to have a decreased sense of well-being and more commonly experience constitutional and neuropsychiatric complaints, even with pharmacological intervention.The current management of hypothyroidism follows a biomedical model. Little consideration has been given to a biopsychosocial approach to this condition. Within the chiropractic profession there is growing support for the use of a biopsychosocial-based intervention called Neuro-Emotional Technique (NET) for this population. A placebo-controlled, single-blinded, randomised clinical pilot-trial has been designed to assess the influence of Neuro-Emotional Technique on a population with primary overt hypothyroidism. A sample of 102 adults (≥18 years) who meet the inclusion criteria will be randomised to either a treatment group or a placebo group. Each group will receive ten treatments (NET or placebo) over a six week period, and will be monitored for six months. The primary outcome will involve the measurement of depression using the Depression, Anxiety and Stress Scale (DASS). The secondary outcome measures to be used are; serum thyroid stimulating hormone, serum free-thyroxine, serum free-triiodothyronine, serum thyroid peroxidase auto-antibodies, serum thyroglobulin auto-antibodies as well as the measurement of functional health and well-being using the Short-Form-36 Version 2. The emotional states of anxiety and stress will be measured using the DASS. Self-measurement of basal heart rate and basal temperature will also be

  19. Iowa CASAS Pilot Project Reports: An Initial Evaluation of CASAS Effectiveness in Iowa's Adult Basic Education Programs.

    Science.gov (United States)

    Strom, Mary L.

    In fall 1992, the Iowa Department of Education began pilot tests of the Comprehensive Adult Student Assessment System (CASAS), an assessment system evaluating reading, math, and problem solving in a life skills context for adult remedial programs. This document provides reports from the nine community colleges that served as test sites, describing…

  20. A pilot, quasi-experimental, mixed methods investigation into the efficacy of a group psychotherapy intervention for caregivers of outpatients with cancer: the COPE study protocol.

    Science.gov (United States)

    Mahendran, Rathi; Tan, Joyce Yi Siang; Griva, Konstadina; Lim, Haikel Asyraf; Ng, Hui Ying; Chua, Joanne; Lim, Siew Eng; Kua, Ee Heok

    2015-11-19

    Despite the rising trend of cancer prevalence and increase in family caregiving, little attention has been paid to the efficacy of psychosocial interventions among Asian caregiver samples, particularly support groups, given the benefits that have been shown in studies on Western populations. This trial aims to evaluate the effectiveness of a pilot 4-week group psychotherapy for Singaporean family caregivers of patients receiving outpatient care. Facilitated by a clinical psychologist, this intervention is primarily based on the brief integrative psychological therapy with a supportive-expressive intent. Participants will be recruited while they are accompanying their care recipients for outpatient consultations. Since this is a pilot study, a sample size of 120 participants is targeted on the basis of sample sizes of previous studies. The study adopts a quasi-experimental design, as participants are assigned the intervention or control arms based on their availability to attend the intervention. A mixed methods approach is used to evaluate the outcomes of the intervention. A self-administered battery of tests is completed at four time points: baseline, postintervention and follow-up at 1-month and 2-month postinterventions; semi-structured interviews are conducted at baseline and post-intervention. Primary outcomes are quality of life and anxious and depressive symptoms; secondary outcomes are stress and basic psychological needs. Analysis using analysis of covariance would be conducted to determine the effectiveness of the intervention. This study protocol has ethics approval from the National Healthcare Group Domain Specific Review Board (NHG DSRB Ref: 2013/00662). Written informed consent is obtained from every participant. Results will be disseminated through journals and conferences, and will be particularly relevant for clinicians intending to implement similar support groups to address the psychosocial concerns of caregivers, as well as for researchers

  1. A Self-Paced, Web-Based, Positive Emotion Skills Intervention for Reducing Symptoms of Depression: Protocol for Development and Pilot Testing of MARIGOLD.

    Science.gov (United States)

    Cheung, Elaine O; Addington, Elizabeth L; Bassett, Sarah M; Schuette, Stephanie A; Shiu, Eva W; Cohn, Michael A; Leykin, Yan; Saslow, Laura R; Moskowitz, Judith T

    2018-06-05

    Living with elevated symptoms of depression can have debilitating consequences for an individual's psychosocial and physical functioning, quality of life, and health care utilization. A growing body of evidence demonstrates that skills for increasing positive emotion can be helpful to individuals with depression. Although Web-based interventions to reduce negative emotion in individuals with depression are available, these interventions frequently suffer from poor retention and adherence and do not capitalize on the potential benefits of increasing positive emotion. The aim of this study was to develop and test a Web-based positive emotion skills intervention tailored for individuals living with elevated depressive symptoms, as well as to develop and test enhancement strategies for increasing retention and adherence to that intervention. This study protocol describes the development and testing for Mobile Affect Regulation Intervention with the Goal of Lowering Depression (MARIGOLD), a Web-based positive emotion skills intervention, adapted for individuals with elevated depressive symptomatology. The intervention development is taking place in three phases. In phase 1, we are tailoring an existing positive emotion skills intervention for individuals with elevated symptoms of depression and are pilot testing the tailored version of the intervention in a randomized controlled trial with two control conditions (N=60). In phase 2, we are developing and testing three enhancements aimed at boosting retention and adherence to the Web-based intervention (N=75): facilitator contact, an online discussion board, and virtual badges. In phase 3, we are conducting a multifactorial, nine-arm pilot trial (N=600) to systematically test these enhancement strategies, individually and in combination. The primary outcome is depressive symptom severity. Secondary outcomes include positive and negative emotion, psychological well-being, and coping resources. The project was funded in

  2. A randomized waitlist-controlled pilot trial of voice over Internet protocol-delivered behavior therapy for youth with chronic tic disorders.

    Science.gov (United States)

    Ricketts, Emily J; Goetz, Amy R; Capriotti, Matthew R; Bauer, Christopher C; Brei, Natalie G; Himle, Michael B; Espil, Flint M; Snorrason, Ívar; Ran, Dagong; Woods, Douglas W

    2016-04-01

    Comprehensive Behavioral Intervention for Tics (CBIT) has been shown to be efficacious for chronic tic disorders (CTDs), but utilization is limited by a lack of treatment providers and perceived financial and time burden of commuting to treatment. A promising alternative to in-person delivery is voice over Internet protocol (VoIP), allowing for remote, real-time treatment delivery to patients' homes. However, little is known about the effectiveness of VoIP for CTDs. Therefore, the present study examined the preliminary efficacy, feasibility, and acceptability of VoIP-delivered CBIT (CBIT-VoIP). Twenty youth (8-16 years) with CTDs participated in a randomized, waitlist-controlled pilot trial of CBIT-VoIP. The main outcome was pre- to post-treatment change in clinician-rated tic severity (Yale Global Tic Severity Scale). The secondary outcome was clinical responder rate (Clinical Global Impressions - Improvement Scale), assessed using ratings of 'very much improved' or 'much improved' indicating positive treatment response. Intention-to-treat analyses with the last observation carried forward were performed. At post-treatment (10-weeks), significantly greater reductions in clinician-rated, (F(1,18) = 3.05, p tic severity, (F(1,18) = 6.37, p < 0.05, partial η(2 )= 0.26) were found in CBIT-VoIP relative to waitlist. One-third (n = 4) of those in CBIT-VoIP were considered treatment responders. Treatment satisfaction and therapeutic alliance were high. CBIT can be delivered via VoIP with high patient satisfaction, using accessible, low-cost equipment. CBIT-VoIP was generally feasible to implement, with some audio and visual challenges. Modifications to enhance treatment delivery are suggested. © The Author(s) 2015.

  3. Does modifying the timing of meal intake improve cardiovascular risk factors? Protocol of an Australian pilot intervention in night shift workers with abdominal obesity.

    Science.gov (United States)

    Bonham, Maxine P; Leung, Gloria K W; Davis, Rochelle; Sletten, Tracey L; Murgia, Chiara; Young, Morag J; Eikelis, Nina; Lambert, Elisabeth A; Huggins, Catherine E

    2018-03-14

    Shift work is an independent risk factor for cardiovascular disease (CVD). Shift workers who are awake overnight and sleep during the day are misaligned with their body's endogenous circadian rhythm. Eating at night contributes to this increased risk of CVD by forcing the body to actively break down and process nutrients at night. This pilot study aims to determine whether altering meal timing overnight, in a shift working population, will impact favourably on modifiable risk factors for CVD (postprandial bplasma lipids and glucose concentration). A randomised cross-over study with two 4-week test periods, separated by a minimum of a 2-week washout will be undertaken. The effectiveness of redistributing energy intake overnight versus ad libitum eating patterns on CVD risk factors will be examined in night shift workers (n=20), using a standard acute test meal challenge protocol. Primary outcomes (postprandial lipids and glucose) will be compared between the two conditions: post-intervention and post-control period using analysis of variance. Potential effect size estimates to inform sample size calculations for a main trial will also be generated. Ethics approval has been granted by the Monash University Human Research Ethics Committee (2017-8619-10329). Outcomes from this study will determine whether eliminating food intake for a defined period at night (1-6 am) impacts favourably on metabolic risk factors for CVD in night shift workers. Collective results from this novel trial will be disseminated through peer-reviewed journals, and national and international presentations. The results are essential to inform health promotion policies and guidelines for shift workers, especially those who aim to improve their metabolic health. ACTRN12617000791336; 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.

  4. A pilot double-blind randomised placebo-controlled dose-response trial assessing the effects of melatonin on infertility treatment (MIART): study protocol.

    Science.gov (United States)

    Fernando, Shavi; Osianlis, Tiki; Vollenhoven, Beverley; Wallace, Euan; Rombauts, Luk

    2014-09-01

    High levels of oxidative stress can have considerable impact on the outcomes of in vitro fertilisation (IVF). Recent studies have reported that melatonin, a neurohormone secreted from the pineal gland in response to darkness, has significant antioxidative capabilities which may protect against the oxidative stress of infertility treatment on gametes and embryos. Early studies of oral melatonin (3-4 mg/day) in IVF have suggested favourable outcomes. However, most trials were poorly designed and none have addressed the optimum dose of melatonin. We present a proposal for a pilot double-blind randomised placebo-controlled dose-response trial aimed to determine whether oral melatonin supplementation during ovarian stimulation can improve the outcomes of assisted reproductive technology. We will recruit 160 infertile women into one of four groups: placebo (n=40); melatonin 2 mg twice per day (n=40); melatonin 4 mg twice per day (n=40) and melatonin 8 mg twice per day (n=40). The primary outcome will be clinical pregnancy rate. Secondary clinical outcomes include oocyte number/quality, embryo number/quality and fertilisation rate. We will also measure serum melatonin and the oxidative stress marker, 8-hydroxy-2'-deoxyguanosine at baseline and after treatment and levels of these in follicular fluid at egg pick-up. We will investigate follicular blood flow with Doppler ultrasound, patient sleepiness scores and pregnancy complications, comparing outcomes between groups. This protocol has been designed in accordance with the SPIRIT 2013 Guidelines. Ethical approval has been obtained from Monash Health HREC (Ref: 13402B), Monash University HREC (Ref: CF14/523-2014000181) and Monash Surgical Private Hospital HREC (Ref: 14107). Data analysis, interpretation and conclusions will be presented at national and international conferences and published in peer-reviewed journals. ACTRN12613001317785. Published by the BMJ Publishing Group Limited. For permission to use (where

  5. Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system.

    Science.gov (United States)

    Saposnik, G; Mamdani, M; Bayley, M; Thorpe, K E; Hall, J; Cohen, L G; Teasell, R

    2010-02-01

    Evidence suggests that increasing intensity of rehabilitation results in better motor recovery. Limited evidence is available on the effectiveness of an interactive virtual reality gaming system for stroke rehabilitation. EVREST was designed to evaluate feasibility, safety and efficacy of using the Nintendo Wii gaming virtual reality (VRWii) technology to improve arm recovery in stroke patients. Pilot randomized study comparing, VRWii versus recreational therapy (RT) in patients receiving standard rehabilitation within six months of stroke with a motor deficit of > or =3 on the Chedoke-McMaster Scale (arm). In this study we expect to randomize 20 patients. All participants (age 18-85) will receive customary rehabilitative treatment consistent of a standardized protocol (eight sessions, 60 min each, over a two-week period). The primary feasibility outcome is the total time receiving the intervention. The primary safety outcome is the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, will be measured by the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at the four-week follow-up visit. From November, 2008 to September, 2009 21 patients were randomized to VRWii or RT. Mean age, 61 (range 41-83) years. Mean time from stroke onset 25 (range 10-56) days. EVREST is the first randomized parallel controlled trial assessing the feasibility, safety, and efficacy of virtual reality using Wii gaming technology in stroke rehabilitation. The results of this study will serve as the basis for a larger multicentre trial. ClinicalTrials.gov registration# NTC692523.

  6. Rehab-let: touchscreen tablet for self-training impaired dexterity post stroke: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Rand, Debbie; Zeilig, Gabi; Kizony, Rachel

    2015-06-18

    Impaired dexterity of the weaker upper extremity is common post stroke and it is recommended that these individuals practice many repetitions of movement to regain function. However, stroke rehabilitation methods do not achieve the required intensity to be effective. Touchscreen tablet technology may be used as a motivating tool for self-training impaired dexterity of the weaker upper extremity post stroke. Rehab-let is a self-training protocol utilizing game apps on a touchscreen for practicing movement of the weaker upper extremity. We will conduct a pilot randomized controlled trial to assess Rehab-let compared to traditional self-training to improve dexterity of the weaker hand, and to increase self-training time and satisfaction in individuals with subacute stroke. Forty individuals with stroke undergoing subacute rehabilitation will be randomly allocated to Rehab-let or a traditional self-training program using therapeutic aids such as balls, blocks and pegs. All participants will be requested to perform self-training for 60 minutes a day, 5 times a week for 4 weeks. Dexterity assessed by The Nine Hole Peg Test is the main outcome measure. Assessments will be administered pre and post the self-training intervention by assessors blind to the group allocation. The outcomes of this study will inform the design of a fully powered randomized controlled trial to evaluate the effectiveness of Rehab-let. If found to be effective, Rehab-let can be used during subacute rehabilitation to increase treatment intensity and improve dexterity. Potentially, Rehab-let can also be used after discharge and might be ideal for individuals with mild stroke who are often not referred to formal rehabilitation. Current Controlled Trials NCT02136433 registered on 17 September 2014.

  7. Transdiagnostic treatment of bipolar disorder and comorbid anxiety using the Unified Protocol for Emotional Disorders: A pilot feasibility and acceptability trial.

    Science.gov (United States)

    Ellard, Kristen K; Bernstein, Emily E; Hearing, Casey; Baek, Ji Hyun; Sylvia, Louisa G; Nierenberg, Andrew A; Barlow, David H; Deckersbach, Thilo

    2017-09-01

    Comorbid anxiety in bipolar disorder (BD) is associated with greater illness severity, reduced treatment response, and greater impairment. Treating anxiety in the context of BD is crucial for improving illness course and outcomes. The current study examined the feasibility, acceptability and preliminary efficacy of the Unified Protocol (UP), a transdiagnostic cognitive behavioral therapy, as an adjunctive treatment to pharmacotherapy for BD and comorbid anxiety disorders. Twenty-nine patients with BD and at least one comorbid anxiety disorder were randomized to pharmacotherapy treatment-as-usual (TAU) or TAU with 18 sessions of the UP (UP+TAU). All patients completed assessments every four weeks to track symptoms, functioning, emotion regulation and temperament. Linear mixed-model regressions were conducted to track symptom changes over time and to examine the relationship between emotion-related variables and treatment response. Satisfaction ratings were equivalent for both treatment groups. Patients in the UP+TAU group evidenced significantly greater reductions over time in anxiety and depression symptoms (Cohen's d's>0.80). Baseline levels of neuroticism, perceived affective control, and emotion regulation ability predicted magnitude of symptom change for the UP+TAU group only. Greater change in perceived control of emotions and emotion regulation skills predicted greater change in anxiety related symptoms. This was a pilot feasibility and acceptability trial; results should be interpreted with caution. Treatment with the UP+TAU was rated high in patient satisfaction, and resulted in significantly greater improvement on indices of anxiety and depression relative to TAU. This suggests that the UP may be a feasible treatment approach for BD with comorbid anxiety. Copyright © 2017 Elsevier B.V. All rights reserved.

  8. Phenol Removal by a Novel Non-Photo-Dependent Semiconductor Catalyst in a Pilot-Scaled Study: Effects of Initial Phenol Concentration, Light, and Catalyst Loading

    Directory of Open Access Journals (Sweden)

    Xiao Chen

    2014-01-01

    Full Text Available A novel non-photo-dependent semiconductor catalyst (CT was employed to degrade phenol in the present pilot-scaled study. Effect of operational parameters such as phenol initial concentration, light area, and catalyst loading on phenol degradation, was compared between CT catalyst and the conventional photocatalyst titanium dioxide. CT catalyst excelled titanium dioxide in treating and mineralizing low-level phenol, under both mild UV radiation and thunder conditions of nonphoton. The result suggested that CT catalyst could be applied in circumstances when light is not easily accessible in pollutant-carrying media (e.g., particles, cloudy water, and colored water.

  9. Initiating change locally in bullying and aggression through the school environment (INCLUSIVE) trial: update to cluster randomised controlled trial protocol.

    Science.gov (United States)

    Bonell, Chris; Mathiot, Anne; Allen, Elizabeth; Bevilacqua, Leonardo; Christie, Deborah; Elbourne, Diana; Fletcher, Adam; Grieve, Richard; Legood, Rosa; Scott, Stephen; Warren, Emily; Wiggins, Meg; Viner, Russell M

    2017-05-25

    Systematic reviews suggest that multi-component interventions are effective in reducing bullying victimisation and perpetration. We are undertaking a phase III randomised trial of the INCLUSIVE multi-component intervention. This trial aims to assess the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying victimisation in English secondary schools. This paper updates the original trial protocol published in 2014 (Trials 15:381, 2014) and presents the changes in the process evaluation protocol and the secondary outcome data collection. The methods are summarised as follows. cluster randomised trial. 40 state secondary schools. Outcomes assessed among the cohort of students at the end of year 7 (n = 6667) at baseline. INCLUSIVE is a multi-component school intervention including a social and emotional learning curriculum, changes to school environment (an action group comprising staff and students reviews local data on needs to review rules and policies and determine other local actions) and staff training in restorative practice. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third intervention year involving no external facilitation but all other elements. Comparator: normal practice. Primary: Two primary outcomes at student level assessed at baseline and at 36 months: 1. Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC) 2. Bullying and victimisation: Gatehouse Bullying Scale (GBS) Secondary outcomes assessed at baseline, 24 and 36 months will include measures relating to the economic evaluation, psychosocial outcomes in students and staff and school-level truancy and exclusion rates. 20 schools per arm will provide 90% power to identify an effect size of 0.25 SD with a 5% significance level. Randomisation: eligible consenting schools were

  10. Implementation of the Enhanced Moderated Online Social Therapy (MOST+) Model Within a National Youth E-Mental Health Service (eheadspace): Protocol for a Single Group Pilot Study for Help-Seeking Young People.

    Science.gov (United States)

    Rice, Simon; Gleeson, John; Leicester, Steven; Bendall, Sarah; D'Alfonso, Simon; Gilbertson, Tamsyn; Killackey, Eoin; Parker, Alexandra; Lederman, Reeva; Wadley, Greg; Santesteban-Echarri, Olga; Pryor, Ingrid; Mawren, Daveena; Ratheesh, Aswin; Alvarez-Jimenez, Mario

    2018-02-22

    using MOST+. Recruitment for the study commenced in October 2017. We expect to have initial results in March 2018, with more detailed qualitative and quantitative analyses to follow. This is the first Australia-wide research trial to pilot an online social media platform merging real-time clinical support, expert and peer moderation, interactive online therapy, and peer-to-peer social networking. The importance of the project stems from the need to develop innovative new models for the efficient delivery of responsive evidence-based online support to help-seeking young people. If successful, this research stands to complement and enhance e-mental health services in Australia. ©Simon Rice, John Gleeson, Steven Leicester, Sarah Bendall, Simon D'Alfonso, Tamsyn Gilbertson, Eoin Killackey, Alexandra Parker, Reeva Lederman, Greg Wadley, Olga Santesteban-Echarri, Ingrid Pryor, Daveena Mawren, Aswin Ratheesh, Mario Alvarez-Jimenez. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.02.2018.

  11. Initiating change locally in bullying and aggression through the school environment (INCLUSIVE): study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Bonell, Chris; Allen, Elizabeth; Christie, Deborah; Elbourne, Diana; Fletcher, Adam; Grieve, Richard; LeGood, Rosa; Mathiot, Anne; Scott, Stephen; Wiggins, Meg; Viner, Russell M

    2014-09-30

    Systematic reviews suggest that interventions that address school organisation are effective in reducing victimisation and bullying. We successfully piloted a school environment intervention modified from international studies to incorporate 'restorative justice' approaches. This trial aims to establish the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying in English secondary schools. cluster randomised trial. 40 state-supported secondary schools. OUTCOMES assessed among the cohort of students in year 8 (n = approximately 6,000) in intervention year 1. INCLUSIVE is a school-led intervention which combines changes to the school environment with the promotion of social and emotional skills and restorative practices through: the formation of a school action group involving students and staff supported by an external facilitator to review local data on needs, determine priorities, and develop and implement an action plan for revising relevant school policies/rules and other actions to improve relationships at school and reduce aggression; staff training in restorative practices; and a new social and emotional skills curriculum. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third locally facilitated intervention year.Comparator: normal practice. primary: 2 primary outcomes at student level assessed at baseline and at 36 months:1. Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC)2. Bullying and victimisation: Gatehouse Bullying Scale (GBS)Secondary outcomes assessed at baseline, 24 and 36 months will include measures relating to the economic evaluation, psychosocial outcomes in students and staff and school-level truancy and exclusion rates. 20 schools per arm will provide 90% power to identify an effect size of 0.25 SD with a 5% significance level

  12. Bioengineered Temporomandibular Joint Disk Implants: Study Protocol for a Two-Phase Exploratory Randomized Preclinical Pilot Trial in 18 Black Merino Sheep (TEMPOJIMS)

    Science.gov (United States)

    Monje, Florencio Gil; González-García, Raúl; Little, Christopher B; Mónico, Lisete; Pinho, Mário; Santos, Fábio Abade; Carrapiço, Belmira; Gonçalves, Sandra Cavaco; Morouço, Pedro; Alves, Nuno; Moura, Carla; Wang, Yadong; Jeffries, Eric; Gao, Jin; Sousa, Rita; Neto, Lia Lucas; Caldeira, Daniel; Salvado, Francisco

    2017-01-01

    Background Preclinical trials are essential to test efficacious options to substitute the temporomandibular joint (TMJ) disk. The contemporary absence of an ideal treatment for patients with severe TMJ disorders can be related to difficulties concerning the appropriate study design to conduct preclinical trials in the TMJ field. These difficulties can be associated with the use of heterogeneous animal models, the use of the contralateral TMJ as control, the absence of rigorous randomized controlled preclinical trials with blinded outcomes assessors, and difficulties involving multidisciplinary teams. Objective This study aims to develop a new, reproducible, and effective study design for preclinical research in the TMJ domain, obtaining rigorous data related to (1) identify the impact of bilateral discectomy in black Merino sheep, (2) identify the impact of bilateral discopexy in black Merino sheep, and (3) identify the impact of three different bioengineering TMJ discs in black Merino sheep. Methods A two-phase exploratory randomized controlled preclinical trial with blinded outcomes is proposed. In the first phase, nine sheep are randomized into three different surgical bilateral procedures: bilateral discectomy, bilateral discopexy, and sham surgery. In the second phase, nine sheep are randomized to bilaterally test three different TMJ bioengineering disk implants. The primary outcome is the histological gradation of TMJ. Secondary outcomes are imaging changes, absolute masticatory time, ruminant time per cycle, ruminant kinetics, ruminant area, and sheep weight. Results Previous preclinical studies in this field have used the contralateral unoperated side as a control, different animal models ranging from mice to a canine model, with nonrandomized, nonblinded and uncontrolled study designs and limited outcomes measures. The main goal of this exploratory preclinical protocol is to set a new standard for future preclinical trials in oromaxillofacial surgery

  13. Pharmacy-based interventions for initiating effective contraception following the use of emergency contraception: a pilot study.

    Science.gov (United States)

    Michie, L; Cameron, S T; Glasier, A; Larke, N; Muir, A; Lorimer, A

    2014-10-01

    In Scotland most women get emergency contraception (EC) from pharmacies. Pharmacists currently cannot provide effective ongoing contraception after EC. In this pilot study, we aimed to determine the feasibility of a larger study designed to ascertain if pharmacy-based interventions can increase the uptake of effective contraception after EC. This is a pilot study of women presenting for levonorgestrel EC to community pharmacies in Edinburgh, UK, in 2012. Pharmacies were cluster randomized to provide either standard care or one of two interventions: (a) one packet of progestogen-only pills (POPs), giving women 1 month to arrange ongoing contraception; (b) invitation to present the empty EC packet to a family planning clinic (FPC) for contraceptive advice (rapid access). One hundred sixty-eight women were recruited from 11 pharmacies to POP (n=56), rapid access (n=58) and standard care (N=54) groups, respectively. Telephone follow-up was conducted successfully in 102 women (61%) 6-8 weeks later to determine current contraceptive use. In the POP arm, 35/39 (90%) women used the pills provided, and 9/28 women (32%) in the rapid access arm attended the FPC. The proportion of women using effective contraception at follow-up was significantly greater in both POP [56% (22/39), p=contraception versus barrier/no method, after use of EC, was 3.13 [95% confidence interval (CI), 1.90-5.13] in the POP group and 2.57 (95% CI, 1.55-4.27) in the rapid access group. This promising pilot study suggests that simple pharmacy-based interventions may increase the uptake of effective contraception after EC. A larger study is required to provide further validation of these findings. For women obtaining EC from a pharmacy, simple interventions such as supplying 1 month of a POP, or offering rapid access to a FPC, hold promise as strategies to increase the uptake of effective contraception after EC. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Provider Training to Screen and Initiate Evidence-Based Pediatric Obesity Treatment in Routine Practice Settings: A Randomized Pilot Trial.

    Science.gov (United States)

    Kolko, Rachel P; Kass, Andrea E; Hayes, Jacqueline F; Levine, Michele D; Garbutt, Jane M; Proctor, Enola K; Wilfley, Denise E

    This randomized pilot trial evaluated two training modalities for first-line, evidence-based pediatric obesity services (screening and goal setting) among nursing students. Participants (N = 63) were randomized to live interactive training or Web-facilitated self-study training. Pretraining, post-training, and 1-month follow-up assessments evaluated training feasibility, acceptability, and impact (knowledge and skill via simulation). Moderator (previous experience) and predictor (content engagement) analyses were conducted. Nearly all participants (98%) completed assessments. Both types of training were acceptable, with higher ratings for live training and participants with previous experience (ps pediatric obesity services. Copyright © 2016 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

  15. Field-Metered Data from Portable Unit Dehumidifiers in the U.S. Residential Sector: Initial Results of a Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Willem, Henry [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States). Environmental Energy Technologies Division; Beraki, Bereket [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States). Environmental Energy Technologies Division; Burke, Tom [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States). Environmental Energy Technologies Division; Melody, Moya [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States). Environmental Energy Technologies Division; Nagaraju, Mythri [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States). Environmental Energy Technologies Division; Ni, Chun Chun [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States). Environmental Energy Technologies Division; Pratt, Stacy [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States). Environmental Energy Technologies Division; Dominique Yang, Hung-Chia [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States). Environmental Energy Technologies Division

    2013-01-29

    The work described herein is intended to enrich the body of literature regarding dehumidifiers in residential settings—in particular the hours of use and energy consumption of various types of dehumidifiers. In the United States, portable unit dehumidifiers most commonly are used in basements during humid summer days in northern climates. Dehumidifier energy consumption differs among households depending on settings selected by the user, frequency of use, and conditions of operation. Although some estimates of dehumidifier use have been developed, and a few metering studies performed, there remains a paucity of metered data collected from individual households that use dehumidifiers. For this study we obtained field data on the energy consumption of dehumidifiers to supplement currently available analyses. Our goal was to obtain data from a pilot study that we could use to develop initial distributions describing the capacities and applications of dehumidifiers used in individual homes. More precisely characterizing the use of dehumidifiers in real-world applications will enable a more accurate estimate of the range of energy use in various operational modes. Our pilot field-metering exercise was aimed at compiling real-time data on the energy consumption of portable dehumidifiers in residential households in the New England and Mid-Atlantic areas. Our analysis furthers the process of developing a more precise estimate of dehumidifier energy use, which will support the evaluation of the potential energy savings and attendant costs associated with more energy efficient dehumidifiers.

  16. Motor Phenotype in Neurodegenerative Disorders: Gait and Balance Platform Study Design Protocol for the Ontario Neurodegenerative Research Initiative (ONDRI).

    Science.gov (United States)

    Montero-Odasso, Manuel; Pieruccini-Faria, Frederico; Bartha, Robert; Black, Sandra E; Finger, Elizabeth; Freedman, Morris; Greenberg, Barry; Grimes, David A; Hegele, Robert A; Hudson, Christopher; Kleinstiver, Peter W; Lang, Anthony E; Masellis, Mario; McLaughlin, Paula M; Munoz, Douglas P; Strother, Stephen; Swartz, Richard H; Symons, Sean; Tartaglia, Maria Carmela; Zinman, Lorne; Strong, Michael J; McIlroy, William

    2017-01-01

    The association of cognitive and motor impairments in Alzheimer's disease and other neurodegenerative diseases is thought to be related to damage in the common brain networks shared by cognitive and cortical motor control processes. These common brain networks play a pivotal role in selecting movements and postural synergies that meet an individual's needs. Pathology in this "highest level" of motor control produces abnormalities of gait and posture referred to as highest-level gait disorders. Impairments in cognition and mobility, including falls, are present in almost all neurodegenerative diseases, suggesting common mechanisms that still need to be unraveled. To identify motor-cognitive profiles across neurodegenerative diseases in a large cohort of patients. Cohort study that includes up to 500 participants, followed every year for three years, across five neurodegenerative disease groups: Alzheimer's disease/mild cognitive impairment, frontotemporal degeneration, vascular cognitive impairment, amyotrophic lateral sclerosis, and Parkinson's disease. Gait and balance will be assessed using accelerometers and electronic walkways, evaluated at different levels of cognitive and sensory complexity, using the dual-task paradigm. Comparison of cognitive and motor performances across neurodegenerative groups will allow the identification of motor-cognitive phenotypes through the standardized evaluation of gait and balance characteristics. As part of the Ontario Neurodegenerative Research Initiative (ONDRI), the gait and balance platform aims to identify motor-cognitive profiles across neurodegenerative diseases. Gait assessment, particularly while dual-tasking, will help dissect the cognitive and motor contribution in mobility and cognitive decline, progression to dementia syndromes, and future adverse outcomes including falls and mortality.

  17. Impact of coil design on the contrast-to-noise ratio, precision, and consistency of quantitative cartilage morphometry at 3 Tesla: a pilot study for the osteoarthritis initiative.

    Science.gov (United States)

    Eckstein, Felix; Kunz, Manuela; Hudelmaier, Martin; Jackson, Rebecca; Yu, Joseph; Eaton, Charles B; Schneider, Erika

    2007-02-01

    Phased-array (PA) coils generally provide higher signal-to-noise ratios (SNRs) than quadrature knee coils. In this pilot study for the Osteoarthritis Initiative (OAI) we compared these two types of coils in terms of contrast-to-noise ratio (CNR), precision, and consistency of quantitative femorotibial cartilage measurements. Test-retest measurements were acquired using coronal fast low-angle shot with water excitation (FLASHwe) and coronal multiplanar reconstruction (MPR) of sagittal double-echo steady state with water excitation (DESSwe) at 3T. The precision errors for cartilage volume and thickness were coil and coil with FLASHwe, and coil and sequence. The PA coil measurements did not always fully agree with the quadrature coil measurements, and some differences were significant. The higher CNR of the PA coil did not translate directly into improved precision of cartilage measurement; however, summing up cartilage plates within the medial and lateral compartment reduced precision errors. Copyright (c) 2007 Wiley-Liss, Inc.

  18. Developing community-driven quality improvement initiatives to enhance chronic disease care in Indigenous communities in Canada: the FORGE AHEAD program protocol.

    Science.gov (United States)

    Naqshbandi Hayward, Mariam; Paquette-Warren, Jann; Harris, Stewart B

    2016-07-26

    Given the dramatic rise and impact of chronic diseases and gaps in care in Indigenous peoples in Canada, a shift from the dominant episodic and responsive healthcare model most common in First Nations communities to one that places emphasis on proactive prevention and chronic disease management is urgently needed. The Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD) Program partners with 11 First Nations communities across six provinces in Canada to develop and evaluate community-driven quality improvement (QI) initiatives to enhance chronic disease care. FORGE AHEAD is a 5-year research program (2013-2017) that utilizes a pre-post mixed-methods observational design rooted in participatory research principles to work with communities in developing culturally relevant innovations and improved access to available services. This intensive program incorporates a series of 10 inter-related and progressive program activities designed to foster community-driven initiatives with type 2 diabetes mellitus as the action disease. Preparatory activities include a national community profile survey, best practice and policy literature review, and readiness tool development. Community-level intervention activities include community and clinical readiness consultations, development of a diabetes registry and surveillance system, and QI activities. With a focus on capacity building, all community-level activities are driven by trained community members who champion QI initiatives in their community. Program wrap-up activities include readiness tool validation, cost-analysis and process evaluation. In collaboration with Health Canada and the Aboriginal Diabetes Initiative, scale-up toolkits will be developed in order to build on lessons-learned, tools and methods, and to fuel sustainability and spread of successful innovations. The outcomes of this research program, its related cost and the subsequent policy recommendations, will have the potential to

  19. The Quality Initiative in Rectal Cancer (QIRC trial: study protocol of a cluster randomized controlled trial in surgery

    Directory of Open Access Journals (Sweden)

    Thabane Lehana

    2008-02-01

    Full Text Available Abstract Background Two unfortunate outcomes for patients treated surgically for rectal cancer are placement of a permanent colostomy and local tumor recurrence. Total mesorectal excision is a new technique for rectal cancer surgery that can lead to improved patient outcomes. We describe a cluster randomized controlled trial that is testing if the above patient outcomes can be improved through a knowledge translation strategy called the Quality Initiative in Rectal Cancer (QIRC strategy. The strategy is designed to optimize the use of total mesorectal excision techniques. Methods and Design Hospitals were randomized to the QIRC strategy (experimental group versus normal practice environment (control group. Participating hospitals, and the respective surgeon group operating in them, are from Ontario, Canada and have an annual procedure volume for major rectal cancer resections of 15 or greater. Patients were eligible if they underwent major rectal surgery for a diagnosis of primary rectal cancer. The surgeon-directed QIRC interventions included a workshop, use of opinion leaders, operative demonstrations, a post-operative questionnaire, and, audit and feedback. For an operative demonstration participating surgeons invited a study team surgeon to assist them with a case of rectal cancer surgery. The intent was to demonstrate total mesorectal excision techniques. Control arm surgeons received no intervention. Sample size calculations were two-sided, considered the clustering of data at the hospital level, and were driven by requirements for the outcome local recurrence. To detect an improvement in local recurrence from 20% to 8% with confidence we required 16 hospitals and 672 patients – 8 hospitals and 336 patients in each arm. Outcomes data are collected via chart review for at least 30 months after surgery. Analyses will use an intention-to-treat principle and will consider the clustering of data. Data collection will be complete by the end of

  20. A Qualitative Approach: Evaluating the Childhood Health and Obesity Initiative Communities Empowered for Success (CHOICES) Pilot Study.

    Science.gov (United States)

    Brown, Cynthia Williams; Alexander, Dayna S; Warren, Claudia A; Anderson-Booker, Marian

    2017-08-01

    Low-income and minority children are susceptible to obesity due to the social and environmental barriers that influence their health behaviors. Many programs and interventions fail to account for these aforementioned barriers among this population. Given what we know about the complexity of childhood obesity, low-income and minority children require innovative prevention strategies from those used in traditional childhood obesity interventions. The purpose of this study was to describe the evaluation of a 6-week summer childhood obesity pilot intervention designed for low-income and minority children. Focus groups and interviews (N = 29) were conducted among caregivers. Overall, caregivers indicated that the experience was mostly positive for their children who obtained small amounts of knowledge and behavioral changes. Caregivers also noted several perceived barriers for intervention completion. The CHOICES intervention is a promising approach that warrants attention in future childhood obesity intervention design. Interventions involving low-income and minority children should aim to help participants make healthier choices given the environmental and social barriers that cannot be overlooked or changed.

  1. Improving Health-Related Quality of Life of Patients With an Ostomy Using a Novel Digital Wearable Device: Protocol for a Pilot Study.

    Science.gov (United States)

    Rouholiman, Dara; Gamble, Jamison G; Dobrota, Sylvie D; Encisco, Ellen M; Shah, Ashish G; Grajales Iii, Francisco J; Chu, Larry F

    2018-03-26

    Ostomy surgeries involving the placement of an ostomy bag (eg, colostomy, ileostomy, urostomy, etc) have been shown to have a negative impact on health-related quality of life. To date, no studies have been conducted examining what impact, if any, wearable biosensors have on the health-related quality of life of ostomy patients. In the present study, we plan to assess the quality of life of ostomy patients using the Ostom-i alert sensor, a portable, wearable, Bluetooth-linked biosensor that facilitates easier ostomy bag output measurements. We hypothesize that using the Ostom-i alert sensor will result in an improved, ostomy-specific, health-related quality of life as compared to baseline measurement before the use of the sensor. A total of 20 ostomy patients will be screened and recruited to participate in this prospective, observational, cross-over pilot study using an Ostom-i alert sensor for one month. The primary outcome of this study will compare ostomy-specific, health-related quality of life at baseline (prior to Ostom-i alert sensor use) to ostomy-specific, health-related quality of life after 2 and 4 weeks of Ostom-i use by utilizing the City of Hope Quality of Life Questionnaire for Patients with an Ostomy. Secondary outcomes of general health-related quality of life and adjustment to ostomy will be evaluated using the Medical Outcomes Study 36-item short form health survey and the Olbrisch Ostomy Adjustment Scale Short Form 2. The project was funded by the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University School of Medicine. Enrollment is currently underway and data analysis is expected to be completed in 2018. Proposed benefits of mobile, internet-linked personal health monitors, such as the Ostom-i, include a reduction in the cost of care by reducing resource utilization and infection rates, improving patient-provider communication, reducing time spent as an inpatient as well as improved quality of life. Prior

  2. Initial Development of a Cultural Values and Beliefs Scale among Dakota/Nakota/Lakota People: A Pilot Study

    Science.gov (United States)

    Reynolds, W. Rusty; Quevillon, Randal P.; Boyd, Beth; Mackey, Duane

    2006-01-01

    This study was the initial phase in the development of a mental health assessment tool. The Native American Cultural Values and Beliefs Scale is a 12-item instrument that assesses three dimensions of American Indian/Alaska Native values and beliefs: 1) the importance, 2) the frequency of practicing, and 3) the amount of distress caused by not…

  3. Acceptability and challenges of rapid ART initiation among pregnant women in a pilot programme, Cape Town, South Africa.

    Science.gov (United States)

    Black, Samantha; Zulliger, Rose; Marcus, Rebecca; Mark, Daniella; Myer, Landon; Bekker, Linda-Gail

    2014-01-01

    Maternal antiretroviral therapy (ART) is a critical intervention in the prevention-of-mother-to child transmission (PMTCT) of HIV. In South Africa, many HIV-infected pregnant women commence ART late in pregnancy, and as a result, the duration of ART prior to delivery is often insufficient to prevent vertical transmission. To address this, we designed an intervention for the rapid initiation of ART in pregnancy (RAP), where patient's ART preparation occurred during rather than before treatment commencement. Here we report on the acceptability and the challenges of the RAP programme. We conducted 7 key informant and 27 semi-structured interviews with RAP participants. Participants were purposefully selected based on ART-eligibility and stage in the pregnancy to post-partum continuum. Interviews were conducted in participants' home language by trained fieldworkers, with key informant interviews conducted by the study investigators. The data were analysed using a framework analysis approach. Rapid initiation in pregnancy was acceptable to the majority of programme participants and protection of the woman's unborn child was the primary motivation for starting treatment. The key barrier was the limited time to accept the dual challenges of being diagnosed HIV-positive and eligible for life-long ART. Truncated time also limited the opportunity for disclosure to others. Despite these and other barriers, most women found the benefits of rapid ART commencement outweighed the challenges, with 91% of women initiated onto ART starting the same day treatment eligibility was determined. Many participants and key informants identified the importance of counseling and the need to make an informed, independent choice on the timing of ART initiation, based on individual circumstances. Acceptance of ART-eligibility improved with time on the programme, however, as women's principal reason for initiating ART was protection of the unborn child, monitoring and supporting adherence during

  4. Initial Experience with "Honoring Choices Wisconsin": Implementation of an Advance Care Planning Pilot in a Tertiary Care Setting.

    Science.gov (United States)

    Peltier, Wendy L; Gani, Faiz; Blissitt, Jennifer; Walczak, Katherine; Opper, Kristi; Derse, Arthur R; Johnston, Fabian M

    2017-09-01

    Although previous research on advance care planning (ACP) has associated ACP with improved quality of care at the end of life, the appropriate use of ACP remains limited. To evaluate the impact of a pilot program using the "Honoring Choices Wisconsin" (HCW) model for ACP in a tertiary care setting, and to understand barriers to system-wide implementation. Retrospective review of prospectively collected data. Patients who received medical or surgical oncology care at Froedtert and the Medical College of Wisconsin. Patient demographics, disease characteristics, patient satisfaction, and clinical outcomes. Data from 69 patients who died following the implementation of the HCW program were reviewed; 24 patients were enrolled in the HCW program while 45 were not. Patients enrolled in HCW were proportionally less likely to be admitted to the ICU (12.5% vs. 17.8%) and were more likely to be "do not resuscitate" (87.5% vs. 80.0%), as well as have a completed ACP (83.3% vs. 79.1%). Furthermore, admission to a hospice was also higher among patients who were enrolled in the HCW program (79.2% vs. 25.6%), with patients enrolled in HCW more likely to die in hospice (70.8% vs. 53.3%). The HCW program was favorably viewed by patients, patient caregivers, and healthcare providers. Implementation of a facilitator-based ACP care model was associated with fewer ICU admissions, and a higher use of hospice care. System-level changes are required to overcome barriers to ACP that limit patients from receiving end-of-life care in accordance with their preferences.

  5. An Approach to Monitor and Initiate Community Led Actions for Antenatal Care in Rural India – A Pilot Study

    Directory of Open Access Journals (Sweden)

    Dongre AR

    2009-09-01

    Full Text Available Background and Objective: Utilization of antenatal care in rural India is far from universal. It requires monitoring and identification of specific needs at field level for timely corrective actions. To pilot test the triangulation of rapid quantitative (Lot Quality Assurance Sampling and qualitative (Focus Group Discussion monitoring tools for ensuring antenatal care in a community based program. Methods: The present study was undertaken in surrounding 23 villages of Kasturba Rural Health Training Centre (KRHTC, Anji, which is also a field practice area of Mahatma Gandhi Institute of Medical Sciences (MGIMS, Sewagram. The monthly monitoring and action system of the study was based on the rapid quantitative monitoring tool (Lot Quality Assurance Sampling, LQASto find out poor performing supervision areas and overall antenatal service coverage and the qualitative methods (Focus group discussions (FGDs, and free listing for exploring ongoing operational constraints in the processes for timely decision making at program and community level. A trained program supervisor paid house visit to 95 randomly selected pregnant women from 5 supervision areas by using pre-designed and pre-tested questionnaire. For poor performing indicators, semi structured FGDs and free listing exercise were undertaken to identify unmet service needs and reasons for its poor performance. Results: Registration of pregnancy within 12 weeks improved from 22.8% to 29.6%. The consumption of 100 or more IFA tablets during pregnancy significantly improved from 6.3% to 17.3%. There was significant improvement in awareness among pregnant women regarding danger signs and symptoms during pregnancy. Over three months period, the overall antenatal registration improved from 253 (67% to 327 (86.7%. Conclusion: The present field based monitoring and action approach constructively identified the reasons for failures and directed specific collective actions to achieve the targets.

  6. The impact of a workplace catering initiative on dietary intakes of salt and other nutrients: a pilot study.

    Science.gov (United States)

    Geaney, F; Harrington, J; Fitzgerald, Ap; Perry, Ij

    2011-08-01

    Owing to modern lifestyles, individuals are dependent on out-of-home eating. The catering sector can have a pivotal role in influencing our food choices. The objective of the present study was to examine the impact of a structured catering initiative on food choices in a public sector workplace setting. A cross-sectional comparison study in two hospitals, one of which had implemented a catering initiative designed to provide nutritious food while reducing sugar, fat and salt intakes. Two public sector hospitals in Cork, Ireland. A total of 100 random participants aged 18-64 years (fifty intervention, fifty non-intervention) who consumed at least one main meal in the hospital staff canteen daily. Each respondent was asked to complete one anonymous 24 h dietary recall and questionnaire. Food and nutrient analysis was conducted using WISP (Weighed Intake Software Program). Reported mean intakes of total sugars (P catering initiatives in the workplace are a potentially important option in the promotion of healthy food choices. Targeted public health programmes and health policy changes are needed to motivate caterers in the public sector and other industries to develop interventions that promote a healthy diet.

  7. TextTB: A Mixed Method Pilot Study Evaluating Acceptance, Feasibility, and Exploring Initial Efficacy of a Text Messaging Intervention to Support TB Treatment Adherence

    Directory of Open Access Journals (Sweden)

    Sarah Iribarren

    2013-01-01

    Full Text Available Objective. To assess a text messaging intervention to promote tuberculosis (TB treatment adherence. Methods. A mixed-methods pilot study was conducted within a public pulmonary-specialized hospital in Argentina. Patients newly diagnosed with TB who were 18 or older, and had mobile phone access were recruited and randomized to usual care plus either medication calendar (n=19 or text messaging intervention (n=18 for the first two months of treatment. Primary outcomes were feasibility and acceptability; secondary outcomes explored initial efficacy. Results. Feasibility was evidenced by high access to mobile phones, familiarity with texting, most phones limited to basic features, a low rate of participant refusal, and many describing suboptimal TB understanding. Acceptability was evidenced by participants indicating feeling cared for, supported, responsible for their treatment, and many self-reporting adherence without a reminder. Participants in the texting group self-reported adherence on average 77% of the days whereas only 53% in calendar group returned diaries. Exploring initial efficacy, microscopy testing was low and treatment outcomes were similar in both groups. Conclusion. The texting intervention was well accepted and feasible with greater reporting of adherence using text messaging than the diary. Further evaluation of the texting intervention is warranted.

  8. Effect of early use of AbobotulinumtoxinA after stroke on spasticity progression: Protocol for a randomised controlled pilot study in adult subjects with moderate to severe upper limb spasticity (ONTIME pilot

    Directory of Open Access Journals (Sweden)

    Keng He Kong

    2017-06-01

    Discussion: This pilot study will facilitate the design and sample size calculation of further confirmatory studies, and is expected to provide insights into the optimal management of post-stroke patients, including timing of BoNT-A therapy and follow-up duration.

  9. Role of chemical carcinogens in epithelial and mesenchymal neoplasms with tumor initiation-promotion protocol and the effect of 13-cis retinoic acid in chemo prevention

    International Nuclear Information System (INIS)

    Bukhari, S.M.H.; Shahzad, S.Q.; Naeem, S.; Qureshi, G.R.; Naveed, I.A.

    2002-01-01

    Objective: To study the effects of chemical carcinogens on epithelial and mesenchymal tumorigenesis with tumor initiation-promotion protocol and the use of 13-cis retinoic acid as a chemo preventive agent. Design: It was an experimental study. Place and Duration of Study: The study was conducted at Postgraduate Medical Institute (PGML) Lahore for 20 weeks. Materials and Methods: Sixty albino rats were divided into six groups of ten of animals each. First group of animals (control) was not given carcinogens and 13-cis retinoic acid in second group DMBA was applied on the dorsal skin in repeated dos of 100 mu g/ml in acetone, twice a weak. In the third group DMBA was given 100 mu g/ml as single dose while TPA was given 10 mu g//ml in acetone, twice a weak after two weeks of DMBA applications. In fourth group only DMBA 100 mu g/ml in acetone was applied as a single dose. In fifth and sixth groups 13-cis retinoic acid was given topically before and after the application of DMBA and TPA. Results: First and fourth groups did not develop any tumor. In second groups 2 animals developed malignant fibrous histiocytoma, 4 squamous cell carcinoma while 1 dysphasia and 1 carcinoma in situ. Third group developed osteoma (3 animals), papilloma (3 animals, squamous cell carcinoma (01) and dysplasia (01). Conclusion: Our results showed that DMBA acts as tumor initiator while TPA as promoter. DMBA also produces tumors itself when given alone in repeated doses. The chemical carcinogens are not only a cause of epithelial carcinogenesis but also responsible for mesenchymal tumorigenesis. 13 cis retinoic acid was equally effective in both stages of tumorigenesis. It also prevents malignant conversion of chemically induced benign tumors. (author)

  10. An interdisciplinary knowledge translation intervention in long-term care: Study protocol for the vitamin D and osteoporosis study (ViDOS pilot cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kennedy Courtney C

    2012-05-01

    Full Text Available Abstract Background Knowledge translation (KT research in long-term care (LTC is still in its early stages. This protocol describes the evaluation of a multifaceted, interdisciplinary KT intervention aimed at integrating evidence-based osteoporosis and fracture prevention strategies into LTC care processes. Methods and design The Vitamin D and Osteoporosis Study (ViDOS is underway in 40 LTC homes (n = 19 intervention, n = 21 control across Ontario, Canada. The primary objectives of this study are to assess the feasibility of delivering the KT intervention, and clinically, to increase the percent of LTC residents prescribed ≥800 IU of vitamin D daily. Eligibility criteria are LTC homes that are serviced by our partner pharmacy provider and have more than one prescribing physician. The target audience within each LTC home is the Professional Advisory Committee (PAC, an interdisciplinary team who meets quarterly. The key elements of the intervention are three interactive educational sessions led by an expert opinion leader, action planning using a quality improvement cycle, audit and feedback reports, nominated internal champions, and reminders/point-of-care tools. Control homes do not receive any intervention, however both intervention and control homes received educational materials as part of the Ontario Osteoporosis Strategy. Primary outcomes are feasibility measures (recruitment, retention, attendance at educational sessions, action plan items identified and initiated, internal champions identified, performance reports provided and reviewed, and vitamin D (≥800 IU/daily prescribing at 6 and 12 months. Secondary outcomes include the proportion of residents prescribed calcium supplements and osteoporosis medications, and falls and fractures. Qualitative methods will examine the experience of the LTC team with the KT intervention. Homes are centrally randomized to intervention and control groups in blocks of variable size using

  11. Incidence and severity of gingival invaginations associated with early versus late initiation of orthodontic space closure after tooth extraction : A multicenter pilot and randomized controlled trial.

    Science.gov (United States)

    Reichert, Christoph; Kutschera, Eric; Plötz, Christina; Scharf, Sven; Gölz, Lina; Fimmers, Rolf; Fuhrmann, Christine; Wahl, Gerhard; Braumann, Bert; Jäger, Andreas

    2017-09-01

    Gingival invaginations are a common side effect of orthodontic extraction-space closure. The timing of initiating the closure of an extraction space varies greatly in clinical practice. In this multicenter pilot and randomized controlled trial, we prospectively investigated whether initiating space closure in the early stage of wound healing would benefit the incidence and severity of invaginations developing in the extraction sites. A total of 368 patients were screened for indications to extract at least one mandibular premolar. Those recruited were randomly assigned to one of two treatment arms: initiation of space closure either 2-4 weeks (arm A) or ≥12 weeks (arm B) after tooth extraction. Clinical data regarding treatment process and periodontal tissue response were recorded during and after space closure and analyzed by a specialized biometrics unit. The study was performed under continuous surveillance by an independent study control center. A total of 74 extraction sites were analyzed. Regarding the incidence of gingival invaginations, there were no significant intergroup differences [p = 0.13; group A comprising 37/44 (84.1%) and group B 29/30 (96.7%) invaginated sites]. The same was true based on either maxillary (p = 0.52) or mandibular (p = 0.21) sites only, and the severity of the invaginations did not differ between the treatment arms. As to the incidence and severity of gingival invaginations, we did not notice any statistically significant differences between the two timeframes. Our data do, however, provide a basis to identify additional confounders and to improve the accuracy of case-load estimations for future trials.

  12. Study protocol of a pragmatic, randomised controlled pilot trial: clinical effectiveness on smoking cessation of traditional and complementary medicine interventions, including acupuncture and aromatherapy, in combination with nicotine replacement therapy.

    Science.gov (United States)

    Jang, Soobin; Park, Sunju; Jang, Bo-Hyoung; Park, Yu Lee; Lee, Ju Ah; Cho, Chung-Sik; Go, Ho-Yeon; Shin, Yong Cheol; Ko, Seong-Gyu

    2017-06-02

    Nicotine dependence is a disease, and tobacco use is related to 6 million deaths annually worldwide. Recently, in many countries, there has been growing interest in the use of traditional and complementary medicine (T&CM) methods, especially acupuncture, as therapeutic interventions for smoking cessation. The aim of this pilot study is to investigate the effectiveness of T&CM interventions on smoking cessation. The STOP (Stop Tobacco Programme using traditional Korean medicine) study is designed to be a pragmatic, open-label, randomised pilot trial. This trial will evaluate whether adding T&CM methods (ie, ear and body acupuncture, aromatherapy) to conventional cessation methods (ie, nicotine replacement therapy (NRT), counselling) increases smoking cessation rates. Forty participants over 19 years old who are capable of communicating in Korean will be recruited. They will be current smokers who meet one of the following criteria: (1) smoke more than 10 cigarettes a day, (2) smoke less than 10 cigarettes a day and previously failed to cease smoking, or (3) smoke fewer than 10 cigarettes a day and have a nicotine dependence score (Fagerstrom Test for Nicotine Dependence) of 4 points or more. The trial will consist of 4 weeks of treatment and a 20 week follow-up period. A statistician will perform the statistical analyses for both the intention-to-treat (all randomly assigned participants) and per-protocol (participants who completed the trial without any protocol deviations) data using SAS 9.1.3. This study has been approved by the Institutional Review Board (IRB) of the Dunsan Korean Medicine Hospital of Daejeon University (IRB reference no: DJDSKH-15-BM-11-1, Protocol No. version 4.1.).The protocol will be reapproved by IRB if it requires amendment. The trial will be conducted according to the Declaration of Helsinki, 7th version (2013). This study is designed to minimise the risk to participants, and the investigators will explain the study to the

  13. Study protocol of a pragmatic, randomised controlled pilot trial: clinical effectiveness on smoking cessation of traditional and complementary medicine interventions, including acupuncture and aromatherapy, in combination with nicotine replacement therapy

    Science.gov (United States)

    Jang, Soobin; Park, Sunju; Jang, Bo-Hyoung; Park, Yu Lee; Lee, Ju Ah; Cho, Chung-Sik; Go, Ho-Yeon; Shin, Yong Cheol; Ko, Seong-Gyu

    2017-01-01

    Introduction Nicotine dependence is a disease, and tobacco use is related to 6 million deaths annually worldwide. Recently, in many countries, there has been growing interest in the use of traditional and complementary medicine (T&CM) methods, especially acupuncture, as therapeutic interventions for smoking cessation. The aim of this pilot study is to investigate the effectiveness of T&CM interventions on smoking cessation. Methods and analysis The STOP (Stop Tobacco Programme using traditional Korean medicine) study is designed to be a pragmatic, open-label, randomised pilot trial. This trial will evaluate whether adding T&CM methods (ie, ear and body acupuncture, aromatherapy) to conventional cessation methods (ie, nicotine replacement therapy (NRT), counselling) increases smoking cessation rates. Forty participants over 19 years old who are capable of communicating in Korean will be recruited. They will be current smokers who meet one of the following criteria: (1) smoke more than 10 cigarettes a day, (2) smoke less than 10 cigarettes a day and previously failed to cease smoking, or (3) smoke fewer than 10 cigarettes a day and have a nicotine dependence score (Fagerstrom Test for Nicotine Dependence) of 4 points or more. The trial will consist of 4 weeks of treatment and a 20 week follow-up period. A statistician will perform the statistical analyses for both the intention-to-treat (all randomly assigned participants) and per-protocol (participants who completed the trial without any protocol deviations) data using SAS 9.1.3. Ethics and dissemination This study has been approved by the Institutional Review Board (IRB) of the Dunsan Korean Medicine Hospital of Daejeon University (IRB reference no: DJDSKH-15-BM-11–1, Protocol No. version 4.1.).The protocol will be reapproved by IRB if it requires amendment. The trial will be conducted according to the Declaration of Helsinki, 7th version (2013). This study is designed to minimise the risk to participants

  14. Adapting, Pilot Testing and Evaluating the Kick.it App to Support Smoking Cessation for Smokers with Severe Mental Illness: A Study Protocol

    Directory of Open Access Journals (Sweden)

    Sharon Lawn

    2018-02-01

    Full Text Available (1 Background: While the prevalence of tobacco smoking in the general population has declined, it remains exceptionally high for smokers with severe mental illness (SMI, despite significant public health measures. This project aims to adapt, pilot test and evaluate a novel e-health smoking cessation intervention to assist relapse prevention and encourage sustained smoking cessation for young adults (aged 18–29 years with SMI. (2 Methods: Using co-design principles, the researchers will adapt the Kick.it smartphone App in collaboration with a small sample of current and ex-smokers with SMI. In-depth interviews with smokers with SMI who have attempted to quit in the past 12 months and ex-smokers (i.e., those having not smoked in the past seven days will explore their perceptions of smoking cessation support options that have been of value to them. Focus group participants will then give their feedback on the existing Kick.it App and any adaptations needed. The adapted App will then be pilot-tested with a small sample of young adult smokers with SMI interested in attempting to cut down or quit smoking, measuring utility, feasibility, acceptability, and preliminary outcomes in supporting their quit efforts. (3 Conclusions: This pilot work will inform a larger definitive trial. Dependent on recruitment success, the project may extend to also include smokers with SMI who are aged 30 years or more.

  15. NanoRelease: Pilot interlaboratory comparison of a weathering protocol applied to resilient and labile polymers with and without embedded carbon nanotubes

    Science.gov (United States)

    A major use of multi-walled carbon nanotubes (MWCNTs) is as functional fillers embedded in a solid matrix, such as plastics or coatings. Weathering and abrasion of the solid matrix during use can lead to environmental releases of the MWCNTs. Here we focus on a protocol to identif...

  16. "Not just another Wii training": a graded Wii protocol to increase physical fitness in adolescent girls with probable developmental coordination disorder-a pilot study.

    Science.gov (United States)

    Bonney, Emmanuel; Rameckers, Eugene; Ferguson, Gillian; Smits-Engelsman, Bouwien

    2018-02-22

    Adolescents with low motor competence participate less in physical activity and tend to exhibit decreased physical fitness compared to their peers with high motor competence. It is therefore essential to identify new methods of enhancing physical fitness in this population. Active video games (AVG) have been shown to improve motor performance, yet investigations of its impact on physical fitness are limited. The objective of this study was to examine the impact of the graded Wii protocol in adolescent girls with probable Developmental Coordination Disorder (p-DCD). A single-group pre-post design was conducted to assess the impact of a newly developed Wii protocol in adolescent girls attending school in a low income community of Cape Town, South Africa. Sixteen participants (aged 13-16 years) with p-DCD (≤16th percentile on the MABC-2 test) were recruited. Participants received 45 min Wii training for 14 weeks. Outcome measures included the six-minute walk distance and repeated sprint ability. Information on heart rate, enjoyment and perceived exertion ratings were also collected. Significant improvements in aerobic and anaerobic fitness were observed. The participants reported high enjoyment scores and low perceived exertion ratings. The graded Wii protocol was easily adaptable and required little resources (space, equipment and expertise) to administer. The findings provide preliminary evidence to support the use of the graded Wii protocol for promoting physical fitness in adolescent girls with p-DCD. Further studies are needed to confirm these results and to validate the clinical efficacy of the protocol in a larger sample with a more robust design.

  17. A national evaluation of a dissemination and implementation initiative to enhance primary care practice capacity and improve cardiovascular disease care: the ESCALATES study protocol.

    Science.gov (United States)

    Cohen, Deborah J; Balasubramanian, Bijal A; Gordon, Leah; Marino, Miguel; Ono, Sarah; Solberg, Leif I; Crabtree, Benjamin F; Stange, Kurt C; Davis, Melinda; Miller, William L; Damschroder, Laura J; McConnell, K John; Creswell, John

    2016-06-29

    The Agency for Healthcare Research and Quality (AHRQ) launched the EvidenceNOW Initiative to rapidly disseminate and implement evidence-based cardiovascular disease (CVD) preventive care in smaller primary care practices. AHRQ funded eight grantees (seven regional Cooperatives and one independent national evaluation) to participate in EvidenceNOW. The national evaluation examines quality improvement efforts and outcomes for more than 1500 small primary care practices (restricted to those with fewer than ten physicians per clinic). Examples of external support include practice facilitation, expert consultation, performance feedback, and educational materials and activities. This paper describes the study protocol for the EvidenceNOW national evaluation, which is called Evaluating System Change to Advance Learning and Take Evidence to Scale (ESCALATES). This prospective observational study will examine the portfolio of EvidenceNOW Cooperatives using both qualitative and quantitative data. Qualitative data include: online implementation diaries, observation and interviews at Cooperatives and practices, and systematic assessment of context from the perspective of Cooperative team members. Quantitative data include: practice-level performance on clinical quality measures (aspirin prescribing, blood pressure and cholesterol control, and smoking cessation; ABCS) collected by Cooperatives from electronic health records (EHRs); practice and practice member surveys to assess practice capacity and other organizational and structural characteristics; and systematic tracking of intervention delivery. Quantitative, qualitative, and mixed methods analyses will be conducted to examine how Cooperatives organize to provide external support to practices, to compare effectiveness of the dissemination and implementation approaches they implement, and to examine how regional variations and other organization and contextual factors influence implementation and effectiveness. ESCALATES is

  18. Study protocol for the FITR Heart Study: Feasibility, safety, adherence, and efficacy of high intensity interval training in a hospital-initiated rehabilitation program for coronary heart disease.

    Science.gov (United States)

    Taylor, Jenna; Keating, Shelley E; Leveritt, Michael D; Holland, David J; Gomersall, Sjaan R; Coombes, Jeff S

    2017-12-01

    For decades, moderate intensity continuous training (MICT) has been the cornerstone of exercise prescription for cardiac rehabilitation (CR). High intensity interval training (HIIT) is now recognized in CR exercise guidelines as an appropriate and efficient modality for improving cardiorespiratory fitness, a strong predictor of mortality. However, the clinical application of HIIT in a real world CR setting, in terms of feasibility, safety, and long-term adherence, needs further investigation to address ongoing reservations. Furthermore, studies using objective measures of exercise intensity (such as heart rate; HR) have produced variable outcomes. Therefore we propose investigating the use of subjective measures (such as rating of perceived exertion (RPE)) for prescribing exercise intensity. One hundred adults with coronary artery disease (CAD) attending a hospital-initiated CR program will be randomized to 1) HIIT: 4 × 4 min high intensity intervals at 15-18 RPE interspersed with 3-min active recovery periods or 2) MICT: usual care exercise including 40 min continuous exercise at a moderate intensity corresponding to 11-13 RPE. Primary outcome is change in exercise capacity (peak VO 2 ) following 4 weeks of exercise training. Secondary outcome measures are: feasibility, safety, exercise adherence, body composition, vascular function, inflammatory markers, intrahepatic lipid, energy intake, and dietary behavior over 12-months; and visceral adipose tissue (VAT) following 12 weeks of exercise training. This study aims to address the ongoing concerns regarding the practicality and safety of HIIT in CR programs. We anticipate study findings will lead to the development of a standardized protocol to facilitate CR programs to incorporate HIIT as a standard exercise option for appropriate patients.

  19. Application of QC_DR software for acceptance testing and routine quality control of direct digital radiography systems: initial experiences using the Italian Association of Physicist in Medicine quality control protocol.

    Science.gov (United States)

    Nitrosi, Andrea; Bertolini, Marco; Borasi, Giovanni; Botti, Andrea; Barani, Adriana; Rivetti, Stefano; Pierotti, Luisa

    2009-12-01

    Ideally, medical x-ray imaging systems should be designed to deliver maximum image quality at an acceptable radiation risk to the patient. Quality assurance procedures are employed to ensure that these standards are maintained. A quality control protocol for direct digital radiography (DDR) systems is described and discussed. Software to automatically process and analyze the required images was developed. In this paper, the initial results obtained on equipment of different DDR manufacturers were reported. The protocol was developed to highlight even small discrepancies in standard operating performance.

  20. 49 CFR 381.400 - What is a pilot program?

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false What is a pilot program? 381.400 Section 381.400... PILOT PROGRAMS Initiation of Pilot Programs § 381.400 What is a pilot program? (a) A pilot program is a... that would be subject to the regulations. (b) During a pilot program, the participants would be given...

  1. Study protocol for the optimisation, feasibility testing and pilot cluster randomised trial of Positive Choices: a school-based social marketing intervention to promote sexual health, prevent unintended teenage pregnancies and address health inequalities in England.

    Science.gov (United States)

    Ponsford, Ruth; Allen, Elizabeth; Campbell, Rona; Elbourne, Diana; Hadley, Alison; Lohan, Maria; Melendez-Torres, G J; Mercer, Catherine H; Morris, Steve; Young, Honor; Bonell, Chris

    2018-01-01

    Since the introduction of the Teenage Pregnancy Strategy (TPS), England's under-18 conception rate has fallen by 55%, but a continued focus on prevention is needed to maintain and accelerate progress. The teenage birth rate remains higher in the UK than comparable Western European countries. Previous trials indicate that school-based social marketing interventions are a promising approach to addressing teenage pregnancy and improving sexual health. Such interventions are yet to be trialled in the UK. This study aims to optimise and establish the feasibility and acceptability of one such intervention: Positive Choices. Design: Optimisation, feasibility testing and pilot cluster randomised trial.Interventions: The Positive Choices intervention comprises a student needs survey, a student/staff led School Health Promotion Council (SHPC), a classroom curriculum for year nine students covering social and emotional skills and sex education, student-led social marketing activities, parent information and a review of school sexual health services.Systematic optimisation of Positive Choices will be carried out with the National Children's Bureau Sex Education Forum (NCB SEF), one state secondary school in England and other youth and policy stakeholders.Feasibility testing will involve the same state secondary school and will assess progression criteria to advance to the pilot cluster RCT.Pilot cluster RCT with integral process evaluation will involve six different state secondary schools (four interventions and two controls) and will assess the feasibility and utility of progressing to a full effectiveness trial.The following outcome measures will be trialled as part of the pilot:Self-reported pregnancy and unintended pregnancy (initiation of pregnancy for boys) and sexually transmitted infections,Age of sexual debut, number of sexual partners, use of contraception at first and last sex and non-volitional sexEducational attainmentThe feasibility of linking administrative

  2. A newly designed radiation therapy protocol in combination with prednisolone as treatment for meningoencephalitis of unknown origin in dogs: a prospective pilot study introducing magnetic resonance spectroscopy as monitor tool.

    Science.gov (United States)

    Beckmann, Katrin; Carrera, Inés; Steffen, Frank; Golini, Lorenzo; Kircher, Patrick R; Schneider, Uwe; Bley, Carla Rohrer

    2015-01-31

    A plethora of treatment options have been described for canine meningoencephalitis of unknown origin (MUO), yet a gold standard has not been established. The aim of this prospective pilot study was to document the effect of a newly designed 30 Gray (Gy) radiation therapy (RT) protocol plus corticosteroids as treatment for focal and multifocal MUO, to monitor clinical and imaging changes during the course of the disease with conventional magnetic resonance imaging (MRI) and proton MR Spectroscopy (H-1 MRS) and to detect the occurrence of radiation related side effects. Six dogs (3 with focal and 3 with multifocal lesions) were included in the study. The RT protocol used consisted of 30 Gy in 10 fractions. The neurological status of all six dogs improved during RT, with 3 of 6 cases returning to a normal condition. One dog was euthanized early during follow-up (dog and improved in 3 dogs and H-1 MRS normalized in 4. In the dog without improvement of the MRI lesions, the N-acetyl aspartate continued to decrease, while choline and creatine concentrations remained stable during that time. This dog was euthanized 18 month after the end of RT due to relapse. One dog was lost to follow up 12 month after completion of RT. The other 3 dogs are still alive at the time of writing. RT with 30 Gy in 10 fractions can provide an additional option for anti-inflammatory treatment of focal and multifocal MUO. The protocol used for treatment monitoring was feasible while no side effects of RT could be observed during the follow up period. Moreover, H-1 MRS could represent a new and non-invasive tool to control the progression of the disease during the treatment course.

  3. Changes in co-contraction during stair descent after manual therapy protocol in knee osteoarthritis: A pilot, single-blind, randomized study.

    Science.gov (United States)

    Cruz-Montecinos, Carlos; Flores-Cartes, Rodrigo; Montt-Rodriguez, Agustín; Pozo, Esteban; Besoaín-Saldaña, Alvaro; Horment-Lara, Giselle

    2016-10-01

    Manual therapy has shown clinical results in patients with knee osteoarthritis. However, the biomechanical aspects during functional tasks have not been explored in depth. Through surface electromyography, the medial and lateral co-contractions of the knee were measured while descending stairs, prior and posterior to applying a manual therapy protocol in the knee, with emphasis on techniques of joint mobilization and soft-tissue management. Sixteen females with slight or moderate knee osteoarthritis were recruited (eight experimental, eight control). It was observed that the lateral co-contraction index of the experimental group, posterior to intervention, increased by 11.7% (p = 0.014). The application of a manual therapy protocol with emphasis on techniques of joint mobilization and soft-tissue management modified lateral co-contraction, which would have a protective effect on the joint. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. Reducing stigma among healthcare providers to improve mental health services (RESHAPE): protocol for a pilot cluster randomized controlled trial of a stigma reduction intervention for training primary healthcare workers in Nepal.

    Science.gov (United States)

    Kohrt, Brandon A; Jordans, Mark J D; Turner, Elizabeth L; Sikkema, Kathleen J; Luitel, Nagendra P; Rai, Sauharda; Singla, Daisy R; Lamichhane, Jagannath; Lund, Crick; Patel, Vikram

    2018-01-01

    Non-specialist healthcare providers, including primary and community healthcare workers, in low- and middle-income countries can effectively treat mental illness. However, scaling-up mental health services within existing health systems has been limited by barriers such as stigma against people with mental illness. Therefore, interventions are needed to address attitudes and behaviors among non-specialists. Aimed at addressing this gap, RE ducing S tigma among H ealthc A re P roviders to Improv E mental health services (RESHAPE) is an intervention in which social contact with mental health service users is added to training for non-specialist healthcare workers integrating mental health services into primary healthcare. This protocol describes a mixed methods pilot and feasibility study in primary care centers in Chitwan, Nepal. The qualitative component will include key informant interviews and focus group discussions. The quantitative component consists of a pilot cluster randomized controlled trial (c-RCT), which will establish parameters for a future effectiveness study of RESHAPE compared to training as usual (TAU). Primary healthcare facilities (the cluster unit, k  = 34) will be randomized to TAU or RESHAPE. The direct beneficiaries of the intervention are the primary healthcare workers in the facilities ( n  = 150); indirect beneficiaries are their patients ( n  = 100). The TAU condition is existing mental health training and supervision for primary healthcare workers delivered through the Programme for Improving Mental healthcarE (PRIME) implementing the mental health Gap Action Programme (mhGAP). The primary objective is to evaluate acceptability and feasibility through qualitative interviews with primary healthcare workers, trainers, and mental health service users. The secondary objective is to collect quantitative information on health worker outcomes including mental health stigma (Social Distance Scale), clinical knowledge (mh

  5. Single-Pilot Workload Management

    Science.gov (United States)

    Rogers, Jason; Williams, Kevin; Hackworth, Carla; Burian, Barbara; Pruchnicki, Shawn; Christopher, Bonny; Drechsler, Gena; Silverman, Evan; Runnels, Barry; Mead, Andy

    2013-01-01

    Integrated glass cockpit systems place a heavy cognitive load on pilots (Burian Dismukes, 2007). Researchers from the NASA Ames Flight Cognition Lab and the FAA Flight Deck Human Factors Lab examined task and workload management by single pilots. This poster describes pilot performance regarding programming a reroute while at cruise and meeting a waypoint crossing restriction on the initial descent.

  6. Pilot study

    International Nuclear Information System (INIS)

    Hofmeester, G.H.; Swart, A.; Dijk, E. van

    1984-01-01

    In May 1980 it was decided to organize an intercomparison of personal dosimeters for photon radiations. The Commission of the European Communities initiated the intercomparison by starting a pilot study in which three laboratories NPL (United Kingdom), PTB (Germany) and RIV (The Netherlands) were asked to irradiate a series of personal dosemeters from institutes, GSF (Muenchen), CEA (Fontenay-aux-Roses), CNEN (Bologna) and CEGB (Berkeley). The latter institutes are secondary standard laboratories and have a radiation protection service as well. A new aspect of this pilot study is the fact that the irradiations also take place in front of a phantom. Irradiations took place in July and August 1980. The results of 4 institutes show that the personal dosemeters are quite capable of measuring the backscattered photon components

  7. Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial.

    Science.gov (United States)

    Miller, Jordan; Barber, David; Donnelly, Catherine; French, Simon; Green, Michael; Hill, Jonathan; MacDermid, Joy; Marsh, Jacquelyn; Norman, Kathleen; Richardson, Julie; Taljaard, Monica; Wideman, Timothy; Cooper, Lynn; McPhee, Colleen

    2017-11-09

    Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs

  8. 'Seizure First Aid Training' for people with epilepsy who attend emergency departments, and their family and friends: study protocol for intervention development and a pilot randomised controlled trial.

    Science.gov (United States)

    Noble, A J; Marson, A G; Tudur-Smith, C; Morgan, M; Hughes, D A; Goodacre, S; Ridsdale, L

    2015-07-24

    People with chronic epilepsy (PWE) often make costly but clinically unnecessary emergency department (ED) visits. Offering them and their carers a self-management intervention that improves confidence and ability to manage seizures may lead to fewer visits. As no such intervention currently exists, we describe a project to develop and pilot one. To develop the intervention, an existing group-based seizure management course that has been offered by the Epilepsy Society within the voluntary sector to a broader audience will be adapted. Feedback from PWE, carers and representatives from the main groups caring for PWE will help refine the course so that it addresses the needs of ED attendees. Its behaviour change potential will also be optimised. A pilot randomised controlled trial will then be completed. 80 PWE aged ≥16 who have visited the ED in the prior 12 months on ≥2 occasions, along with one of their family members or friends, will be recruited from three NHS EDs. Dyads will be randomised to receive the intervention or treatment as usual alone. The proposed primary outcome is ED use in the 12 months following randomisation. For the pilot, this will be measured using routine hospital data. Secondary outcomes will be measured by patients and carers completing questionnaires 3, 6 and 12 months postrandomisation. Rates of recruitment, retention and unblinding will be calculated, along with the ED event rate in the control group and an estimate of the intervention's effect on the outcome measures. Ethical approval: NRES Committee North West-Liverpool East (Reference number 15/NW/0225). The project's findings will provide robust evidence on the acceptability of seizure management training and on the optimal design of a future definitive trial. The findings will be published in peer-reviewed journals and presented at conferences. ISRCTN13 871 327. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

  9. Distant delivery of a mindfulness-based intervention for people with Parkinson's disease: the study protocol of a randomised pilot trial.

    Science.gov (United States)

    Bogosian, A; Hurt, C S; Vasconcelos E Sa, D; Hindle, J V; McCracken, L; Cubi-Molla, P

    2017-01-01

    Psychological difficulties, especially depression and anxiety, are the most prevalent non-motor symptoms in Parkinson's disease. Pharmacological treatments for these conditions appear relatively ineffective in Parkinson's disease. Mindfulness courses are increasingly popular and recognised as effective for managing emotional states, and there is growing evidence for the effectiveness of mindfulness courses for people with long-term medical conditions. With this exploratory pilot trial, we want to assess the feasibility of the procedures and processes, including recruitment, most appropriate outcome measure(s), acceptability of type and number of measures, potential nocebo effects, and potential effectiveness and cost-effectiveness of a specially adapted distance-delivered mindfulness-based intervention in people affected by Parkinson's disease. This is a pilot two-arm randomised parallel group controlled trial. Sixty participants who meet eligibility criteria will be randomly assigned either to an 8-week mindfulness-based intervention group or a wait-list control group. The mindfulness intervention will include 1-h weekly sessions delivered by a health psychologist trained to facilitate mindfulness courses. Participants in both groups will complete standardised questionnaires assessing anxiety, depression, pain, insomnia, fatigue, and daily activities at four time points (baseline, 4, 8, and 20 weeks). The analysis will also consider potential mechanisms of change, such as acceptance, self-compassion, and tolerance of uncertainty, as well as health economic outcomes. Participants' experiences of the mindfulness interventions will be explored via in-depth interviews. A mindfulness-based intervention for people with Parkinson's delivered remotely, through Skype group videoconferences, may represent a viable, more accessible, intervention for people with mobility limitations and people who live in rural areas. The trial will provide important information about the

  10. Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting

    Science.gov (United States)

    Wiangkham, Taweewat; Duda, Joan; Haque, M Sayeed; Price, Jonathan; Rushton, Alison

    2016-01-01

    Introduction Whiplash-associated disorder (WAD) causes substantial social and economic burden internationally. Up to 60% of patients with WAD progress to chronicity. Research therefore needs to focus on effective management in the acute stage to prevent the development of chronicity. Approximately 93% of patients are classified as WADII (neck complaint and musculoskeletal sign(s)), and in the UK, most are managed in the private sector. In our recent systematic review, a combination of active and behavioural physiotherapy was identified as potentially effective in the acute stage. An Active Behavioural Physiotherapy Intervention (ABPI) was developed through combining empirical (modified Delphi study) and theoretical (social cognitive theory focusing on self-efficacy) evidence. This pilot and feasibility trial has been designed to inform the design of an adequately powered definitive randomised controlled trial. Methods and analysis Two parallel phases. (1) An external pilot and feasibility cluster randomised double-blind (assessor and participants), parallel two-arm (ABPI vs standard physiotherapy) clinical trial to evaluate procedures and feasibility. Six UK private physiotherapy clinics will be recruited and cluster randomised by a computer-generated randomisation sequence. Sixty participants (30 each arm) will be assessed at recruitment (baseline) and at 3 months postbaseline. The planned primary outcome measure is the neck disability index. (2) An embedded exploratory qualitative study using semistructured indepth interviews (n=3–4 physiotherapists) and a focus group (n=6–8 patients) and entailing the recruitment of purposive samples will explore perceptions of the ABPI. Quantitative data will be analysed descriptively. Qualitative data will be coded and analysed deductively (identify themes) and inductively (identify additional themes). Ethics and dissemination This trial is approved by the University of Birmingham Ethics Committee (ERN_15-0542). Trial

  11. Evaluation and treatment of low and anxious mood in Chinese-speaking international students studying in Scotland: study protocol of a pilot randomised controlled trial.

    Science.gov (United States)

    Zheng, Mengyi; McClay, Carrie-Anne; Wilson, Sarah; Williams, Christopher

    2015-01-01

    Low mood is a common mental health problem affecting up to 121 million people worldwide and is common in students, particularly international students. Cognitive behavioural therapy (CBT) is known to be effective as a treatment for low mood and anxiety when delivered one to one by an expert practitioner, however this can be expensive and many services have waiting lists and delayed access. A range of additional ways of increasing access to services includes the offer of online courses such as computerised CBT as a possible additional pathway for care. This project aims to test the feasibility of a pilot randomised controlled trial of an online CBT-based life skills course with Chinese-speaking international students experiencing low mood and anxiety. Chinese-speaking international students with symptoms of low mood and/or anxiety will be recruited from the University of Glasgow, Scotland. Participants will be remotely randomised to receive either immediate access (IA) or delayed access (DA) to a guided/supported online CBT-based life skills package, the "Living Life" package (Chinese version). Participants will be randomly assigned to IA or DA to the intervention. The primary end point will be at 3 months when the delayed group will be offered the intervention. Levels of depression, anxiety, social functioning and satisfaction will be assessed. This pilot study will test the trial design, ability to recruit, gather completed questionnaires, test drop-out rates and investigate completion and acceptability of the package. The study aims to reduce uncertainties about the delivery of a future substantive study and will also inform a sample size calculation for that subsequent substantive randomised controlled trial (RCT) which will be carried out to determine the effectiveness of the online package in improving low mood and anxiety in the Chinese-speaking student population. Current Controlled Trials ISRCTN30816908.

  12. Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial

    Science.gov (United States)

    Ritvo, Paul; Obadia, Maya; Santa Mina, Daniel; Alibhai, Shabbir; Sabiston, Catherine; Oh, Paul; Campbell, Kristin; McCready, David; Auger, Leslie

    2017-01-01

    Background Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors. Objective This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention and will inform development of a full-scale pragmatic RCT. Methods We will enroll 107 physically inactive breast cancer survivors and randomly assign them to intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto, Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than 55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week. Both intervention and control groups receive the 12-week physical activity program with weekly group sessions and an individualized, progressive, home-based exercise program. The intervention group will additionally receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3) supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting device linked to a smartphone program. Results We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews; and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The primary

  13. Strengths-Based Behavioral Intervention for Parents of Adolescents With Type 1 Diabetes Using an mHealth App (Type 1 Doing Well): Protocol for a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Hilliard, Marisa E; Eshtehardi, Sahar S; Minard, Charles G; Saber, Rana; Thompson, Debbe; Karaviti, Lefkothea P; Rojas, Yuliana; Anderson, Barbara J

    2018-03-13

    Supportive parent involvement for adolescents' type 1 diabetes (T1D) self-management promotes optimal diabetes outcomes. However, family conflict is common and can interfere with collaborative family teamwork. Few interventions have used explicitly strengths-based approaches to help reinforce desired management behaviors and promote positive family interactions around diabetes care. The aim of this protocol was to describe the development of a new, strengths-based behavioral intervention for parents of adolescents with T1D delivered via a mobile-friendly Web app called Type 1 Doing Well. Ten adolescent-parent dyads and 5 diabetes care providers participated in a series of qualitative interviews to inform the design of the app. The 3- to 4-month pilot intervention will involve 82 parents receiving daily prompts to use the app, in which they will mark the diabetes-related strength behaviors (ie, positive attitudes or behaviors related to living with or managing T1D) their teen engaged in that day. Parents will also receive training on how to observe diabetes strengths and how to offer teen-friendly praise via the app. Each week, the app will generate a summary of the teen's most frequent strengths from the previous week based on parent reports, and parents will be encouraged to praise their teen either in person or from a library of reinforcing text messages (short message service, SMS). The major outcomes of this pilot study will include intervention feasibility and satisfaction data. Clinical and behavioral outcomes will include glycemic control, regimen adherence, family relationships and conflict, diabetes burden, and health-related quality of life. This strengths-based, mobile health (mHealth) intervention aims to help parents increase their awareness of and efforts to support their adolescents' engagement in positive diabetes-related behaviors. If efficacious, this intervention has the potential to reduce the risk of family conflict, enhance collaborative

  14. Deep brain stimulation of the basolateral amygdala for treatment-refractory combat post-traumatic stress disorder (PTSD): study protocol for a pilot randomized controlled trial with blinded, staggered onset of stimulation.

    Science.gov (United States)

    Koek, Ralph J; Langevin, Jean-Philippe; Krahl, Scott E; Kosoyan, Hovsep J; Schwartz, Holly N; Chen, James W Y; Melrose, Rebecca; Mandelkern, Mark J; Sultzer, David

    2014-09-10

    Combat post-traumatic stress disorder (PTSD) involves significant suffering, impairments in social and occupational functioning, substance use and medical comorbidity, and increased mortality from suicide and other causes. Many veterans continue to suffer despite current treatments. Deep brain stimulation (DBS) has shown promise in refractory movement disorders, depression and obsessive-compulsive disorder, with deep brain targets chosen by integration of clinical and neuroimaging literature. The basolateral amygdala (BLn) is an optimal target for high-frequency DBS in PTSD based on neurocircuitry findings from a variety of perspectives. DBS of the BLn was validated in a rat model of PTSD by our group, and limited data from humans support the potential safety and effectiveness of BLn DBS. We describe the protocol design for a first-ever Phase I pilot study of bilateral BLn high-frequency DBS for six severely ill, functionally impaired combat veterans with PTSD refractory to conventional treatments. After implantation, patients are monitored for a month with stimulators off. An electroencephalographic (EEG) telemetry session will test safety of stimulation before randomization to staggered-onset, double-blind sham versus active stimulation for two months. Thereafter, patients will undergo an open-label stimulation for a total of 24 months. Primary efficacy outcome is a 30% decrease in the Clinician Administered PTSD Scale (CAPS) total score. Safety outcomes include extensive assessments of psychiatric and neurologic symptoms, psychosocial function, amygdala-specific and general neuropsychological functions, and EEG changes. The protocol requires the veteran to have a cohabiting significant other who is willing to assist in monitoring safety and effect on social functioning. At baseline and after approximately one year of stimulation, trauma script-provoked 18FDG PET metabolic changes in limbic circuitry will also be evaluated. While the rationale for studying DBS

  15. Evaluation of the efficacy of animal-assisted therapy based on the reality orientation therapy protocol in Alzheimer's disease patients: a pilot study.

    Science.gov (United States)

    Menna, Lucia Francesca; Santaniello, Antonio; Gerardi, Federica; Di Maggio, Annamaria; Milan, Graziella

    2016-07-01

    The aim of this study was to evaluate the efficacy of animal-assisted therapy (AAT) in elderly patients affected by Alzheimer's disease based on the formal reality orientation therapy (ROT) protocol. Our study was carried out at an Alzheimer's centre for 6 months. A homogeneous sample (age, Mini-Mental State Examination (MMSE), 15-item Geriatric Depression Scale (GDS)) of 50 patients was selected at random and successively. Patients were divided into three groups: (i) 20 patients received a course of AAT (AAT group) based on the ROT protocol; (ii) 20 patients were engaged exclusively in activities based on the ROT group; and (iii) 10 patients (control group) participated in no stimulations. MMSE and GDS were administered at time 0 (T0 ) and time 1 (T1 ) to all three groups. Differences within groups between T0 and T1 for GDS and MMSE scores were analyzed by Student's t-test. Differences between group means were analyzed using an anova test with the Bonferroni-Dunn test for post-hoc comparisons. Both the AAT group and ROT group had improved GDS scores and showed a slight improvement in terms of mood. On the GDS, the AAT group improved from 11.5 (T0 ) to 9.5 (T1 ), and the ROT group improved from 11.6 (T0 ) to 10.5 (T1 ). At the same time, a slight improvement in cognitive function, as measured by the MMSE, was observed. In the AAT group, mean MMSE was 20.2 at T0 and 21.5 at T1 , and in the ROT group, it was 19.9 at T0 and 20.0 at T1 . In the control group, the average values of both the GDS and MMSE remained unchanged. The Bonferroni-Dunn results showed statistically significant differences between groups, particularly between the AAT group and the other two (P therapy interventions based on the formal ROT protocol were effective and, compared to the ROT, provided encouraging and statistically significant results. © 2015 The Authors. Psychogeriatrics © 2015 Japanese Psychogeriatric Society.

  16. Piloting a manualised weight management programme (Shape Up-LD) for overweight and obese persons with mild-moderate learning disabilities: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Beeken, Rebecca J; Spanos, Dimitrios; Fovargue, Sally; Hunter, Rachael; Omar, Rumana; Hassiotis, Angela; King, Michael; Wardle, Jane; Croker, Helen

    2013-03-12

    National obesity rates have dramatically risen over the last decade. Being obese significantly reduces life expectancy, increases the risk of a range of diseases, and compromises quality of life. Costs to both the National Health Service and society are high. An increased prevalence of obesity in people with learning disabilities has been demonstrated. The consequences of obesity are particularly relevant to people with learning disabilities who are already confronted by health and social inequalities. In order to provide healthcare for all, and ensure equality of treatment for people with learning disabilities, services must be developed specifically with this population in mind. The aim of this project is to pilot the evaluation of a manualised weight management programme for overweight and obese persons with mild-moderate learning disabilities (Shape Up-LD). An individually randomised, controlled pilot trial in 60 overweight and obese (body mass index ≥ 25) adults (age ≥ 18) with mild-moderate learning disabilities and their carers will be carried out, comparing "Shape Up-LD" with usual care. The manualised Shape Up-LD intervention will involve 12 weekly sessions, which include healthy eating messages, advice on physical activity and use of behaviour change techniques to help people manage their weight. Assessments of participants will be conducted at baseline, 12 weeks and 6 months. Service users and their carers and service providers will also give their perspectives on the experience of Shape Up-LD in qualitative interviews at 12 weeks. Feasibility outcomes will include recruitment rates, loss to follow-up, compliance rates, completion rates, collection of information for a cost-effectiveness analysis and an estimation of the treatment effect on weight. The findings from this study will inform our preparation for a definitive randomised controlled trial to test the efficacy of the programme with respect to weight loss and maintenance in this population

  17. WELLFOCUS PPT – modified positive psychotherapy to improve well-being in psychosis: study protocol for a pilot randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background The promotion of well-being is an important goal of recovery oriented mental health services. No structured, evidence-based intervention exists that aims to increase the well-being in people with severe mental illness such as psychosis. Positive psychotherapy (PPT) is a promising intervention for this goal. Standard PPT was adapted for use with people with psychosis in the UK following the Medical Research Council framework for developing and testing complex interventions, resulting in the WELLFOCUS Model describing the intended impact of WELLFOCUS PPT. This study aims to test the WELLFOCUS Model, by piloting the intervention, trial processes, and evaluation strategy. Methods/Design This study is a non-blinded pragmatic pilot RCT comparing WELLFOCUS PPT provided as an 11-session group therapy in addition to treatment as usual to treatment as usual alone. Inclusion criteria are adults (aged 18–65 years) with a main diagnosis of psychosis who use mental health services. A target sample of 80 service users with psychosis are recruited from mental health services across the South London and Maudsley NHS Foundation Trust. Participants are randomised in blocks to the intervention and control group. WELLFOCUS PPT is provided to groups by specifically trained and supervised local therapists and members of the research team. Assessments are conducted before randomisation and after the group intervention. The primary outcome measure is well-being assessed by the Warwick-Edinburgh Mental Well-being Scale. Secondary outcomes include good feelings, symptom relief, connectedness, hope, self-worth, empowerment, and meaning. Process evaluation using data collected during the group intervention, post-intervention individual interviews and focus groups with participants, and interviews with trial therapists will complement quantitative outcome data. Discussion This study will provide data on the feasibility of the intervention and identify necessary adaptations. It will

  18. An alcohol-focused intervention versus a healthy living intervention for problem drinkers identified in a general hospital setting (ADAPTA): study protocol for a randomized, controlled pilot trial.

    Science.gov (United States)

    Watson, Judith; Tober, Gillian; Raistrick, Duncan; Mdege, Noreen; Dale, Veronica; Crosby, Helen; Godfrey, Christine; Lloyd, Charlie; Toner, Paul; Parrott, Steve

    2013-04-30

    Alcohol misuse is a major cause of premature mortality and ill health. Although there is a high prevalence of alcohol problems among patients presenting to general hospital, many of these people are not help seekers and do not engage in specialist treatment. Hospital admission is an opportunity to steer people towards specialist treatment, which can reduce health-care utilization and costs to the public sector and produce substantial individual health and social benefits. Alcohol misuse is associated with other lifestyle problems, which are amenable to intervention. It has been suggested that the development of a healthy or balanced lifestyle is potentially beneficial for reducing or abstaining from alcohol use, and relapse prevention. The aim of the study is to test whether or not the offer of a choice of health-related lifestyle interventions is more acceptable, and therefore able to engage more problem drinkers in treatment, than an alcohol-focused intervention. This is a pragmatic, randomized, controlled, open pilot study in a UK general hospital setting with concurrent economic evaluation and a qualitative component. Potential participants are those admitted to hospital with a diagnosis likely to be responsive to addiction interventions who score equal to or more than 16 on the Alcohol Use Disorders Identification Test (AUDIT). The main purpose of this pilot study is to evaluate the acceptability of two sorts of interventions (healthy living related versus alcohol focused) to the participants and to assess the components and processes of the design. Qualitative research will be undertaken to explore acceptability and the impact of the approach, assessment, recruitment and intervention on trial participants and non-participants. The effectiveness of the two treatments will be compared at 6 months using AUDIT scores as the primary outcome measure. There will be additional economic, qualitative and secondary outcome measurements. Development of the study was a

  19. Guided self-help interventions for mental health disorders in children with neurological conditions: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Bennett, Sophie; Heyman, Isobel; Coughtrey, Anna; Simmonds, Jess; Varadkar, Sophia; Stephenson, Terence; DeJong, Margaret; Shafran, Roz

    2016-11-04

    Rates of mental health disorders are significantly greater in children with physical illnesses than in physically well children. Children with neurological conditions, such as epilepsy, are known to have particularly high rates of mental health disorders. Despite this, mental health problems in children with neurological conditions have remained under-recognised and under-treated in clinical settings. Evidence-based guided self-help interventions are efficacious in reducing symptoms of mental health disorders in children, but their efficacy in reducing symptoms of common mental health disorders in children with neurological conditions has not been investigated. We aim to pilot a guided self-help intervention for the treatment of mental health disorders in children with neurological conditions. A pilot randomised controlled trial with 18 patients with neurological conditions and mental health disorders will be conducted. Participants attending specialist neurology clinics at a National UK Children's Hospital will be randomised to receive guided self-help for common mental health disorders or to a 12-week waiting list control. Participants in the treatment group will receive 10 sessions of guided self-help delivered over the telephone. The waiting list control group will receive the intervention after a waiting period of 12 weeks. The primary outcome measure is reduction in symptoms of mental health disorders. Exclusion criteria are limited to those at significant risk of harm to self or others, the presence of primary mental health disorder other than anxiety, depression or disruptive behaviour (e.g. psychosis, eating disorder, obsessive-compulsive disorder) or intellectual disability at a level meaning potential participants would be unable to access the intervention. The study has ethical approval from the Camden and Islington NHS Research Ethics Committee, registration number 14.LO.1353. Results will be disseminated to patients, the wider public, clinicians and

  20. A mobile phone-based program to promote healthy behaviors among adults with prediabetes: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Griauzde, Dina H; Kullgren, Jeffrey T; Liestenfeltz, Brad; Richardson, Caroline; Heisler, Michele

    2018-01-01

    Rates of participation in Diabetes Prevention Programs (DPPs) are low. This may be due, in part, to low levels of autonomous motivation (i.e., motivation that arises from internal sources and sustains healthy behaviors over time) to prevent type 2 diabetes (T2DM) among many individuals with prediabetes. Mobile health (mHealth) technologies that incorporate principles from the Self-Determination Theory offer an effective and scalable approach to increase autonomous motivation levels. One promising mobile phone-based application is JOOL Health, which aims to help users connect certain health behaviors (e.g., sleep and diet) with personal values in specific life domains (e.g., family and work). The first aim of this study is to estimate whether JOOL Health can increase autonomous motivation to prevent T2DM among individuals with prediabetes who declined DPP participation. The second aim of this pilot study is to examine the intervention's feasibility and acceptability. This is a 12-week, three-arm pilot randomized controlled trial. We will recruit 105 individuals with prediabetes who did not engage in a DPP despite invitation from their health plan to participate in face-to-face or web-based programs at no out-of-pocket-cost. Participants will be randomized to one of three study arms: (1) a group that receives information on prediabetes, evidence-based strategies to decrease progression to T2DM, and a list of resources for mHealth tools for monitoring diet, physical activity, and weight (comparison group); (2) a group that receives the JOOL Health application; and (3) a group that receives the JOOL Health application as well as a Fitbit activity tracker and wireless-enabled scale. Our primary outcome is change in autonomous motivation to prevent T2DM (measured using the Treatment Self-Regulation Questionnaire). We will also collect data related to the intervention's feasibility (recruitment and retention rates) and acceptability (adherence and qualitative experience

  1. Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial.

    Science.gov (United States)

    Stoller, Oliver; de Bruin, Eling D; Schuster-Amft, Corina; Schindelholz, Matthias; de Bie, Rob A; Hunt, Kenneth J

    2013-09-22

    After experiencing a stroke, most individuals also suffer from cardiac disease, are immobile and thus have low endurance for exercise. Aerobic capacity is seriously reduced in these individuals and does not reach reasonable levels after conventional rehabilitation programmes. Cardiovascular exercise is beneficial for improvement of aerobic capacity in mild to moderate stroke. However, less is known about its impact on aerobic capacity, motor recovery, and quality-of-life in severely impaired individuals. The aim of this pilot study is to explore the clinical efficacy and feasibility of cardiovascular exercise with regard to aerobic capacity, motor recovery, and quality-of-life using feedback-controlled robotics-assisted treadmill exercise in non-ambulatory individuals soon after experiencing a stroke. This will be a single-centred single blind, randomised control trial with a pre-post intervention design. Subjects will be recruited early after their first stroke (≤20 weeks) at a neurological rehabilitation clinic and will be randomly allocated to an inpatient cardiovascular exercise programme that uses feedback-controlled robotics-assisted treadmill exercise (experimental) or to conventional robotics-assisted treadmill exercise (control). Intervention duration depends on the duration of each subject's inpatient rehabilitation period. Aerobic capacity, as the primary outcome measure, will be assessed using feedback-controlled robotics-assisted treadmill-based cardiopulmonary exercise testing. Secondary outcome measures will include gait speed, walking endurance, standing function, and quality-of-life. Outcome assessment will be conducted at baseline, after each 4-week intervention period, and before clinical discharge. Ethical approval has been obtained. Whether cardiovascular exercise in non-ambulatory individuals early after stroke has an impact on aerobic capacity, motor recovery, and quality-of-life is not yet known. Feedback-controlled robotics

  2. Clinical, Radiographic and Microbiological Evaluation of High Level Laser Therapy, a New Photodynamic Therapy Protocol, in Peri-Implantitis Treatment; a Pilot Experience

    Directory of Open Access Journals (Sweden)

    Gianluigi Caccianiga

    2016-01-01

    Full Text Available Aim. Endosseous implants are widely used to replace missing teeth but mucositis and peri-implantitis are the most frequent long-term complications related with dental implants. Removing all bacterial deposits on contaminated implant surface is very difficult due to implant surface morphology. The aim of this study was to evaluate the bactericidal potential of photodynamic therapy by using a new high level laser irradiation protocol associated with hydrogen peroxide in peri-implantitis. Materials and Methods. 10 patients affected by peri-implantitis were selected for this study. Medical history, photographic documentation, periodontal examination, and periapical radiographs were collected at baseline and 6 months after surgery. Microbiological analysis was performed with PCR Real Time. Each patient underwent nonsurgical periodontal therapy and surgery combined with photodynamic therapy according to High Level Laser Therapy protocol. Results. All peri-implant pockets were treated successfully, without having any complication and not showing significant differences in results. All clinical parameters showed an improvement, with a decrease of Plaque Index (average decrease of 65%, range 23–86%, bleeding on probing (average decrease of 66%, range 26–80%, and probing depth (average decrease of 1,6 mm, range 0,46–2,6 mm. Periapical radiographs at 6 months after surgery showed a complete radiographic filling of peri-implant defect around implants treated. Results showed a decrease of total bacterial count and of all bacterial species, except for Eikenella corrodens, 6 months after surgery. Conclusion. Photodynamic therapy using HLLT appears to be a good adjunct to surgical treatment of peri-implantitis.

  3. Impact of reduced-radiation dual-energy protocols using 320-detector row computed tomography for analyzing urinary calculus components: initial in vitro evaluation.

    Science.gov (United States)

    Cai, Xiangran; Zhou, Qingchun; Yu, Juan; Xian, Zhaohui; Feng, Youzhen; Yang, Wencai; Mo, Xukai

    2014-10-01

    To evaluate the impact of reduced-radiation dual-energy (DE) protocols using 320-detector row computed tomography on the differentiation of urinary calculus components. A total of 58 urinary calculi were placed into the same phantom and underwent DE scanning with 320-detector row computed tomography. Each calculus was scanned 4 times with the DE protocols using 135 kV and 80 kV tube voltage and different tube current combinations, including 100 mA and 570 mA (group A), 50 mA and 290 mA (group B), 30 mA and 170 mA (group C), and 10 mA and 60 mA (group D). The acquisition data of all 4 groups were then analyzed by stone DE analysis software, and the results were compared with x-ray diffraction analysis. Noise, contrast-to-noise ratio, and radiation dose were compared. Calculi were correctly identified in 56 of 58 stones (96.6%) using group A and B protocols. However, only 35 stones (60.3%) and 16 stones (27.6%) were correctly diagnosed using group C and D protocols, respectively. Mean noise increased significantly and mean contrast-to-noise ratio decreased significantly from groups A to D (P calculus component analysis while reducing patient radiation exposure to 1.81 mSv. Further reduction of tube currents may compromise diagnostic accuracy. Copyright © 2014 Elsevier Inc. All rights reserved.

  4. Study protocol for the FITR Heart Study: Feasibility, safety, adherence, and efficacy of high intensity interval training in a hospital-initiated rehabilitation program for coronary heart disease

    Directory of Open Access Journals (Sweden)

    Jenna Taylor

    2017-12-01

    Conclusions: This study aims to address the ongoing concerns regarding the practicality and safety of HIIT in CR programs. We anticipate study findings will lead to the development of a standardized protocol to facilitate CR programs to incorporate HIIT as a standard exercise option for appropriate patients.

  5. Initial experience on protocol optimization for integrated PET/MR%PET/MR一体机操作优化的初步经验

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    刘家金; 陈英茂; 张雄伟; 富丽萍; 田嘉禾; 尹大一; 徐白萱

    2014-01-01

    目的 通过比较PET/CT和PET/MR,初步探索PET/MR一体机的操作流程和成像优化方案.方法 228例患者同日内接受PET/CT和PET/MR检查,通过6种不同MR序列与PET采集组合方案,比较图像质量的优劣,以在保证诊断信息基础上缩短患者扫描时间的原则分析判断,并初步确定最优PET/MR一体机采集方案.结果 PET/MR结果与PET/CT相近,但其操作流程和注意事项有独特之处;在6种方案中,以躯干和头部各有独立序列组合、兼顾各向同性结构显示与突出病灶特点的方案6效果最优;PET/MR比PET/CT更易产生伪影.结论 在优化方案基础上,PET/MR可获得与PET/CT一致的诊断级图像,但PET/MR采集时间长、伪影多,有待进一步完善.%Objective To investigate the optimal workflow and protocol for integrated PET/MR by comparison with PET/CT.Methods A total of 228 patients were enrolled in this study for PET/CT and PET/MR evaluation on the same day.Six PET/MR protocols with different MR sequences but the same PET acquisition protocol were investigated and the optimal protocol was identified based on image quality,acquisition time and diagnostic performance.Results PET/MR workflow was similar to PET/CT,however,some special issues needed to be considered for PET/MR.Among the 6 protocols,protocol No.6 outperformed others for body and head regions.Types of artifacts were found more often in PET/MR than in PET/CT.Conclusions By optimizing the protocol,PET/MR could achieve almost the same diagnostic performance as PET/CT.However,the issues of long acquisition time and artifacts on PET/MR need to be further improved.

  6. Inorganic nitrate as a treatment for acute heart failure: a protocol for a single center, randomized, double-blind, placebo-controlled pilot and feasibility study.

    Science.gov (United States)

    Falls, Roman; Seman, Michael; Braat, Sabine; Sortino, Joshua; Allen, Jason D; Neil, Christopher J

    2017-08-08

    Acute heart failure (AHF) is a frequent reason for hospitalization worldwide and effective treatment options are limited. It is known that AHF is a condition characterized by impaired vasorelaxation, together with reduced nitric oxide (NO) bioavailability, an endogenous vasodilatory compound. Supplementation of inorganic sodium nitrate (NaNO 3 ) is an indirect dietary source of NO, through bioconversion. It is proposed that oral sodium nitrate will favorably affect levels of circulating NO precursors (nitrate and nitrite) in AHF patients, resulting in reduced systemic vascular resistance, without significant hypotension. We propose a single center, randomized, double-blind, placebo-controlled pilot trial, evaluating the feasibility of sodium nitrate as a treatment for AHF. The primary hypothesis that sodium nitrate treatment will result in increased systemic levels of nitric oxide pre-cursors (nitrate and nitrite) in plasma, in parallel with improved vasorelaxation, as assessed by non-invasively derived systemic vascular resistance index. Additional surrogate measures relevant to the known pathophysiology of AHF will be obtained in order to assess clinical effect on dyspnea and renal function. The results of this study will provide evidence of the feasibility of this novel approach and will be of interest to the heart failure community. This trial may inform a larger study.

  7. Smartphone-based ecological momentary assessment and intervention in a coping-focused intervention for hearing voices (SAVVy): study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Bell, Imogen H; Fielding-Smith, Sarah F; Hayward, Mark; Rossell, Susan L; Lim, Michelle H; Farhall, John; Thomas, Neil

    2018-05-02

    Smartphone-based ecological momentary assessment and intervention (EMA/I) show promise for enhancing psychological treatments for psychosis. EMA has the potential to improve assessment and formulation of experiences which fluctuate day-to-day, and EMI may be used to prompt use of therapeutic strategies in daily life. The current study is an examination of these capabilities in the context of a brief, coping-focused intervention for distressing voice hearing experiences. This is a rater-blinded, pilot randomised controlled trial comparing a four-session intervention in conjunction with use of smartphone EMA/I between sessions, versus treatment-as-usual. The recruitment target is 34 participants with persisting and distressing voice hearing experiences, recruited through a Voices Clinic based in Melbourne, Australia, and via wider advertising. Allocation will be made using minimisation procedure, balancing of the frequency of voices between groups. Assessments are completed at baseline and 8 weeks post-baseline. The primary outcomes of this trial will focus on feasibility and acceptability of the intervention and trial methodology, with secondary outcomes examining preliminary clinical effects related to overall voice severity, the emotional and functional impact of the voices, and emotional distress. This study offers a highly novel examination of specific smartphone capabilities and their integration with traditional psychological treatment for distressing voices. Such technology has potential to enhance psychological interventions and promote adaptation to distressing experiences. Australian New Zealand Clinical Trial Registry, ACTRN12617000348358 . Registered on 7 March 2017.

  8. Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: Study Protocol of a Pilot Multicentered, Randomized, Parallel, Sham-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Seungwon Shin

    2016-01-01

    Full Text Available This pilot multicentered, randomized, parallel, sham-controlled trial is intended to evaluate the effectiveness and safety of electroacupuncture therapy for poststroke patients with urinary incontinence. Forty stroke survivors aged >19 years will be recruited in 2 hospitals in the Republic of Korea. Patients who experienced stroke within 2 years and satisfy criteria of urinary frequencies ≥2 with either 3 to 4 points on the Patient Perception of Intensity of Urgency Scale or 13 points or more on the Korean version of the International Prostate Symptom Scale (K-IPSS will be identified, along with other eligibility criteria. Patients will be randomly allocated to either a treatment or control group to receive 10 sessions of electroacupuncture or sham therapies, respectively. Patients and outcome assessors will be blinded. The primary outcome is the change of Total Urgency and Frequency Score between the baseline and the trial endpoint. The K-IPSS, the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form, and the Lower Urinary Tract Symptoms Outcome Score will be evaluated for effectiveness assessment. Adverse events will be reported after every session. The Blinding Index will also be calculated. Data will be statistically analyzed with 0.05 significance levels by 2-sided testing.

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

    Science.gov (United States)

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

    2016-08-31

    Tobacco control policies that lead to a significant reduction in tobacco industry marketing can improve public health by reducing consumption of tobacco and preventing initiation of tobacco use. Laws that ban or restrict advertising and promotion in point-of-sale (POS) environments, in the moment when consumers decide whether or not to purchase a tobacco product, must be correctly implemented to achieve the desired public health benefits. POS policy compliance assessments can support implementation; however, there are challenges to conducting evaluations that are rigorous, cost-effective, and timely. Data collection must be discreet, accurate, and systematic, and ideally collected both before and after policies take effect. The use of mobile phones and other mobile technology provide opportunities to efficiently collect data and support effective tobacco control policies. The Russian Federation (Russia) passed a comprehensive national tobacco control law that included a ban on most forms of tobacco advertising and promotion, effective November 15, 2013. The legislation further prohibited the display of tobacco products at retail trade sites and eliminated kiosks as a legal trade site, effective June 1, 2014. The objective of the study was to develop and test a mobile data collection protocol including: (1) retailer sampling, (2) adaptation of survey instruments for mobile phones, and (3) data management protocols. Two waves of observations were conducted; wave 1 took place during April-May 2014, after the advertising and promotion bans were effective, and again in August-September 2014, after the product display ban and elimination of tobacco sales in kiosks came into effect. Sampling took place in 5 Russian cities: Moscow, St. Petersburg, Novosibirsk, Yekaterinburg, and Kazan. Lack of access to a comprehensive list of licensed tobacco retailers necessitated a sampling approach that included the development of a walking protocol to identify tobacco retailers to

  10. An intervention for pulmonary rehabilitators to develop a social identity for patients attending exercise rehabilitation: a feasibility and pilot randomised control trial protocol.

    Science.gov (United States)

    Levy, Andrew R; Matata, Bashir; Pilsworth, Sam; Mcgonigle, Adrian; Wigelsworth, Lyndsey; Jones, Linda; Pott, Nicola; Bettany, Max; Midgley, Adrian W

    2018-01-01

    Chronic obstructive pulmonary disease (COPD) is a degenerative condition that can impair health-related quality of life (HRQoL). A number of self-management interventions, employing a variety of behavioural change techniques (BCTs), have been adopted to improve HRQoL for COPD patients. However, a lack of attention has been given to group management interventions with an emphasis on incorporating BCTs into rehabilitators' practice. This study aims to pilot and feasibly explore a social identity group management intervention, delivered by COPD rehabilitation staff to patients attending exercise pulmonary rehabilitation. Doing so will help inform the plausibility of the intervention before conducting a full trial to evaluate its effectiveness to improve HRQoL. This is a two-centre, randomised cross-over controlled trial. Two pulmonary rehabilitation centres based in the UK will be randomly allocated to two treatment arms (standard care and intervention). Outcome measurements relating to HRQoL and social identity will be completed pre- and post-exercise rehabilitation. Focus group interviews will be conducted at the end of exercise rehabilitation to capture participants' contextualised experiences of the intervention. COPD rehabilitators will undertake semi-structured interviews at the end of the trial to garner their holistic perspectives of intervention fidelity and implementation. This is the first study to adopt a social identity approach to develop a rehabilitator-led, group management intervention for COPD patients attending exercise pulmonary rehabilitation. The results of this study will provide evidence for the feasibility and sample size requirements to inform a larger study, which can ascertain the intervention's effectiveness for improving HRQoL for COPD patients. ClinicalTrials.gov NCT02288039. Date 31 October 2014.

  11. Task-oriented training with computer gaming in people with rheumatoid arthritisor osteoarthritis of the hand: study protocol of a randomized controlled pilot trial.

    Science.gov (United States)

    Srikesavan, Cynthia Swarnalatha; Shay, Barbara; Robinson, David B; Szturm, Tony

    2013-03-09

    Significant restriction in the ability to participate in home, work and community life results from pain, fatigue, joint damage, stiffness and reduced joint range of motion and muscle strength in people with rheumatoid arthritis or osteoarthritis of the hand. With modest evidence on the therapeutic effectiveness of conventional hand exercises, a task-oriented training program via real life object manipulations has been developed for people with arthritis. An innovative, computer-based gaming platform that allows a broad range of common objects to be seamlessly transformed into therapeutic input devices through instrumentation with a motion-sense mouse has also been designed. Personalized objects are selected to target specific training goals such as graded finger mobility, strength, endurance or fine/gross dexterous functions. The movements and object manipulation tasks that replicate common situations in everyday living will then be used to control and play any computer game, making practice challenging and engaging. The ongoing study is a 6-week, single-center, parallel-group, equally allocated and assessor-blinded pilot randomized controlled trial. Thirty people with rheumatoid arthritis or osteoarthritis affecting the hand will be randomized to receive either conventional hand exercises or the task-oriented training. The purpose is to determine a preliminary estimation of therapeutic effectiveness and feasibility of the task-oriented training program. Performance based and self-reported hand function, and exercise compliance are the study outcomes. Changes in outcomes (pre to post intervention) within each group will be assessed by paired Student t test or Wilcoxon signed-rank test and between groups (control versus experimental) post intervention using unpaired Student t test or Mann-Whitney U test. The study findings will inform decisions on the feasibility, safety and completion rate and will also provide preliminary data on the treatment effects of the task

  12. Interaction and efficacy of Keigai-rengyo-to extract and acupuncture in male patients with acne vulgaris: A study protocol for a randomized controlled pilot trial

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    Kim Yoon-Bum

    2011-03-01

    Full Text Available Abstract Background In consideration of patients seeking to use traditional Chinese medicine, an evidence-based potentiality for safe and effective use of herbal medicine and acupuncture in treatment of acne vulgaris has been suggested. However, despite common use of a combination of herbal medicine and acupuncture in clinical practice, the current level of evidence is insufficient to draw a conclusion for an interaction and efficacy of herbal medicine and acupuncture. Therefore, considering these methodological flaws, this study was designed to assess the interaction and efficacy of an available herbal medicine, Keigai-rengyo-to extract (KRTE, and acupuncture for treatment of acne using the 2 × 2 factorial design and the feasibility of a large clinical trial. Methods/Design A randomized, assessor single blinded, 2 × 2 factorial pilot trial will be conducted. Forty four participants with acne vulgaris will be randomized into one of four groups: waiting list group (WL, KRTE only group (KO, acupuncture only group (AO, and KRTE and acupuncture combined treatment group (KA. After randomization, a total of 8 sessions of acupuncture treatment will be performed twice a week in the AO- and KA groups, respectively. Patients in the KO- and KA groups will be prescribed KRTE 3 times a day at a dose of 7.4 g after meals for 4 weeks. The following outcome measurements will be used in examination of subjects: the mean percentage change and the count change of inflammatory and non-inflammatory acne lesions, the Skindex 29, visual analogue scale (VAS and investigator global assessment (IGA from baseline to the end of the trial. Trial Registration The trial is registered with the Clinical Research Information Service (CRiS, Republic of Korea: KCT0000071.

  13. Noninvasive detection of coronary vasospastic angina using a double-acquisition coronary CT angiography protocol in the presence and absence of an intravenous nitrate: a pilot study

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    Kang, Eun-Ju; Kim, Dong Won; Yoon, Seong Kuk; Lee, Ki-Nam [Dong-A University, Department of Radiology, College of Medicine, Busan (Korea, Republic of); Kim, Moo Hyun; Jin, Cai De [Dong-A University, Department of Cardiology, College of Medicine, Busan (Korea, Republic of); Dong-A University Hospital, Global Clinical Trial Center, Busan (Korea, Republic of); Seo, Jeongmin; Park, Tae-Ho [Dong-A University, Department of Cardiology, College of Medicine, Busan (Korea, Republic of); Choi, Sang Il [Seoul National University Bundang Hospital, Department of Radiology, Seongnam-si (Korea, Republic of); Yoon, Yeonyee Elizabeth [Seoul National University Bundang Hospital, Department of Cardiology, Seongnam-si (Korea, Republic of)

    2017-03-15

    To evaluate the feasibility of a double-acquisition coronary CT angiography (CCTA) protocol in the presence and absence of an intravenous (IV) vasodilator infusion for detecting vasospastic angina. Twenty patients with a high clinical probability of vasospastic angina were enrolled. All subjects underwent baseline CCTA without a vasodilator in the early morning followed by a catheterized coronary angiography with ergonovine provocation test. Within 3 days, all subjects underwent repeat CCTA during a continuous IV infusion of nitrate. Vasospastic angina as detected by CCTA was defined as significant stenosis (≥50 %) with negative remodelling without definite plaques or diffuse small diameter (<2 mm) of a major coronary artery with a beaded appearance on baseline CT that completely dilated on IV nitrate CT. The CCTA results were compared to the catheterized ergonovine provocation test as the reference standard. Among 20 patients, the catheterized ergonovine provocation test detected vasospasm in 15 patients. The sensitivity, specificity, positive predictive value and negative predictive value of CCTA in a per-patient-based analysis were 73, 100, 100 and 56 %, respectively. Double-acquisition CCTA in the presence and absence of IV infusion of nitrate allows noninvasive detection of vasospastic angina with moderate sensitivity and high specificity. (orig.)

  14. Preventative tele-health supported services for early stage chronic obstructive pulmonary disease: a protocol for a pragmatic randomized controlled trial pilot

    Directory of Open Access Journals (Sweden)

    Mountain Gail A

    2011-01-01

    Full Text Available Abstract Background Chronic Obstructive Pulmonary Disease (COPD is a prevalent debilitating long term condition. It is the second most common cause of emergency admission to hospital in the UK and remains one of the most costly conditions to treat through acute care. Tele-health monitoring offers potential to reduce the rates of re-hospitalisation and emergency department visits and improve quality of life for people with COPD. However, the current evidence base to support technology adoption and implementation is limited and the resource implications for implementing tele-health in practice can be very high. This trial will employ tele-health monitoring in a preventative capacity for patients diagnosed with early stage COPD following discharge from hospital to determine whether it reduces their need for additional health service support or hospital admission and improves their quality of life. Methods/Design We describe a pilot study for a two arm, one site randomized controlled trial (RCT to determine the effect of tele-health monitoring on self-management, quality of life and patient satisfaction. Sixty patients who have been discharged from one acute trust with a primary diagnosis of COPD and who have agreed to receive community clinical support following discharge from acute care will be randomly assigned to one of two groups: (a Tele-health supported Community COPD Service; or (b Usual Care. The tele-health supported service involves the patient receiving two home visits with a specialist COPD clinician (nurse or physiotherapist then participating in daily tele-monitoring over an eight week period. Usual care consists of six home visits to the patient by specialist COPD clinicians again over eight successive weeks. Health status and quality of life data for all participants will be measured at baseline, on discharge from the service and at six months post discharge from the service. Discussion The tele-health service under study is a

  15. A web delivered intervention for depression combining Behavioural Activation with physical activity promotion: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Jeffrey David Lambert

    2015-10-01

    Full Text Available Background: Physical activity (PA yields moderate effect sizes for treating depression (Cooney et al., 2013. PA may also help reduce depressive relapse, providing additional psychological benefits such as positive self-regard and a sense of competence (Babyak et al., 2000. Behavioural Activation (BA is an evidence-based psychological therapy for depression, which aims to get people more engaged with activities that provide positive reinforcement for non-depressed behaviours (Hopko, Lejuez, LePage, Hopko, & McNeil, 2003. The structured nature of BA is consistent with the use of good behaviour change techniques (specific goal-setting, self-regulation offering a potential platform for promoting PA alongside depression treatment. BA may also be useful for gradually increasing PA in people who are more sedentary than the general population. Aims: This pilot randomised controlled trial aims to assess the feasibility, acceptability, and fidelity of a web-delivered intervention combining BA and PA (eBAcPAc to enhance mental and physical health, and assess the trial methods. Method: A community sample of 120 people exhibiting symptoms of depression and who are participating in less than 150 minutes of moderate to vigorous physical activity per week will be randomized to receive eBAcPAc or be put on a wait list control group. eBAcPAc is informed by previous work (Farrand et al., 2014; Pentecost et al., 2015 and further developed using the Centre for eHealth Research and Disease management Roadmap (CeHReS (van Gemert-Pijnen et al., 2011 in order to be applied in an web-based setting. A platform hosted by the University of Glasgow which has been used to deliver a wide range of successful web-delivered interventions for mental health, will be used to deliver eBAcPAc. Feasibility measures will include data on recruitment, attrition and acceptability. Pre-post outcome measures will include the PHQ-9, and self-reported and accelerometer measured PA. Process and

  16. Pilot study of a social network intervention for heroin users in opiate substitution treatment: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Day, Edward; Copello, Alex; Seddon, Jennifer L; Christie, Marilyn; Bamber, Deborah; Powell, Charlotte; George, Sanju; Ball, Andrew; Frew, Emma; Freemantle, Nicholas

    2013-08-19

    Research indicates that 3% of people receiving opiate substitution treatment (OST) in the UK manage to achieve abstinence from all prescribed and illicit drugs within 3 years of commencing treatment, and there is concern that treatment services have become skilled at engaging people but not at helping them to enter a stage of recovery and drug abstinence. The National Treatment Agency for Substance Misuse recommends the involvement of families and wider social networks in supporting drug users' psychological treatment, and this pilot randomized controlled trial aims to evaluate the impact of a social network-focused intervention for patients receiving OST. In this two-site, early phase, randomized controlled trial, a total of 120 patients receiving OST will be recruited and randomized to receive one of three treatments: 1) Brief Social Behavior and Network Therapy (B-SBNT), 2) Personal Goal Setting (PGS) or 3) treatment as usual. Randomization will take place following baseline assessment. Participants allocated to receive B-SBNT or PGS will continue to receive the same treatment that is routinely provided by drug treatment services, plus four additional sessions of either intervention. Outcomes will be assessed at baseline, 3 and 12 months. The primary outcome will be assessment of illicit heroin use, measured by both urinary analysis and self-report. Secondary outcomes involve assessment of dependence, psychological symptoms, social satisfaction, motivation to change, quality of life and therapeutic engagement. Family members (n = 120) of patients involved in the trial will also be assessed to measure the level of symptoms, coping and the impact of the addiction problem on the family member at baseline, 3 and 12 months. This study will provide experimental data regarding the feasibility and efficacy of implementing a social network intervention within routine drug treatment services in the UK National Health Service. The study will explore the impact of the

  17. Effectiveness of two web-based cognitive bias modification interventions targeting approach and attentional bias in gambling problems: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Boffo, Marilisa; Willemen, Ronny; Pronk, Thomas; Wiers, Reinout W; Dom, Geert

    2017-10-03

    Disordered gamblers have phenotypical and pathological similarities to those with substance use disorders (SUD), including exaggerated automatic cognitive processing of motivationally salient gambling cues in the environment (i.e., attentional and approach bias). Cognitive bias modification (CBM) is a family of computerised interventions that have proved effective in successfully re-training these automatic cognitive biases in SUD. CBM interventions can, in principle, be administered online, thus showing potential of being a low-cost, low-threshold addition to conventional treatments. This paper presents the design of a pilot randomised controlled trial exploring the effectiveness of two web-based CBM interventions targeting attentional and approach bias towards gambling cues in a sample of Dutch and Belgian problematic and pathological gamblers. Participants (N = 182) are community-recruited adults experiencing gambling problems, who have gambled at least twice in the past 6 months and are motivated to change their gambling behaviour. After a baseline assessment session, participants are randomly assigned to one of four experimental conditions (attentional or approach bias training, or the placebo version of the two trainings) and complete six sessions of training. At baseline and before each training session, participants receive automated personalised feedback on their gambling motives and reasons to quit or reduce gambling. The post-intervention, 1-month, and 3-month follow-up assessments will examine changes in gambling behaviour, with frequency and expenditure as primary outcomes, and depressive symptoms and gambling-related attentional and approach biases as secondary outcomes. Secondary analyses will explore possible moderators (interference control capacity and trait impulsivity) and mediators (change in cognitive bias) of training effects on the primary outcomes. This study is the first to explore the effectiveness of an online CBM intervention for

  18. High-speed resistance training and balance training for people with knee osteoarthritis to reduce falls risk: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Levinger, Pazit; Dunn, Jeremy; Bifera, Nancy; Butson, Michael; Elias, George; Hill, Keith D

    2017-08-18

    The number of falls experienced by people with knee osteoarthritis (OA) is almost double the number experienced by people with no OA. The neuromuscular elements required to arrest a fall are more impaired in people with knee OA compared to their asymptomatic counterparts. Therefore, these elements may need to be incorporated into an exercise intervention to reduce the risk of falling. The aim of this study will be to examine the feasibility, safety and patient satisfaction of a high-speed resistance-training program, with and without balance exercises, in people with knee OA compared to a control group. The effect of these exercise programs on lower-limb muscle strength and physiological and functional risk factors for falls will also be examined. This study will be a pilot randomized controlled trial with a pre- and post-intervention design (outcome assessments at baseline and 8 weeks after participation commencement) comparing three groups: a control group (no intervention), a high-speed resistance-training group and a high-speed resistance-training plus balance exercises group. Thirty people with knee osteoarthritis aged 60-90 years will be recruited and randomized to one of the three groups. Feasibility and safety will be assessed by examining adherence to the exercise program, dropout rate, pain level during and following exercise, number of exercises stopped due to pain, and any adverse event or any incident that prevents the participant from completing the prescribed exercise. Secondary measures of lower-limb strength, physical function, self-reported pain and function, fear of falls, and executive function and quality of life will also be assessed. To determine statistical trends of effectiveness and hence to inform sample size for a fully powered study, analyses of the secondary outcomes will be performed to assess the changes within and between groups over time (pre-post) using repeated measure ANOVA. The results of this study will improve understanding

  19. Hockey Fans in Training (Hockey FIT) pilot study protocol: a gender-sensitized weight loss and healthy lifestyle program for overweight and obese male hockey fans.

    Science.gov (United States)

    Gill, Dawn P; Blunt, Wendy; De Cruz, Ashleigh; Riggin, Brendan; Hunt, Kate; Zou, Guangyong; Sibbald, Shannon; Danylchuk, Karen; Zwarenstein, Merrick; Gray, Cindy M; Wyke, Sally; Bunn, Christopher; Petrella, Robert J

    2016-10-19

    Effective approaches that engage men in weight loss and lifestyle change are important because of worldwide increases, including in Canada, in obesity and chronic diseases. Football Fans in Training (FFIT), developed in Scotland, successfully tackled these problems by engaging overweight/obese male football fans in sustained weight loss and positive health behaviours, through program deliveries at professional football stadia. Aims: 1) Adapt FFIT to hockey within the Canadian context and integrate with HealtheSteps™ (evidence-based lifestyle program) to develop Hockey Fans in Training (Hockey FIT); 2) Explore potential for Hockey FIT to help overweight/obese men lose weight and improve other outcomes by 12 weeks, and retain these improvements to 12 months; 3) Evaluate feasibility of recruiting and retaining overweight/obese men; 4) Evaluate acceptability of Hockey FIT; and 5) Conduct program optimization via a process evaluation. We conducted a two-arm pilot pragmatic randomized controlled trial (pRCT) whereby 80 overweight/obese male hockey fans (35-65 years; body-mass index ≥28 kg/m 2 ) were recruited through their connection to two junior A hockey teams (London and Sarnia, ON) and randomized to Intervention (Hockey FIT) or Comparator (Wait-List Control). Hockey FIT includes a 12-week Active Phase (classroom instruction and exercise sessions delivered weekly by trained coaches) and a 40-week Maintenance Phase. Data collected at baseline and 12 weeks (both groups), and 12 months (Intervention only), will inform evaluation of the potential of Hockey FIT to help men lose weight and improve other health outcomes. Feasibility and acceptability will be assessed using data from self-reports at screening and baseline, program fidelity (program observations and coach reflections), participant focus group discussions, coach interviews, as well as program questionnaires and interviews with participants. This information will be analyzed to inform program

  20. Clinical efficacy and prognostic indicators for lower limb pedalling exercise early after stroke: Study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Myint Phyo

    2011-03-01

    Full Text Available Abstract Background It is known that repetitive, skilled, functional movement is beneficial in driving functional reorganisation of the brain early after stroke. This study will investigate a whether pedalling an upright, static exercise cycle, to provide such beneficial activity, will enhance recovery and b which stroke survivors might be able to participate in pedalling. Methods/Design Participants (n = 24 will be up to 30 days since stroke onset, with unilateral weakness and unable to walk without assistance. This study will use a modified exercise bicycle fitted with a UniCam crank. All participants will give informed consent, then undergo baseline measurements, and then attempt to pedal. Those able to pedal will be entered into a single-centre, observer-blinded randomised controlled trial (RCT. All participants will receive routine rehabilitation. The experimental group will, in addition, pedal daily for up to ten minutes, for up to ten working days. Prognostic indicators, measured at baseline, will be: site of stroke lesion, trunk control, ability to ambulate, and severity of lower limb paresis. The primary outcome for the RCT is ability to voluntarily contract paretic lower limb muscle, measured by the Motricity Index. Secondary outcomes include ability to ambulate and timing of onset and offset of activity in antagonist muscle groups during pedalling, measured by EMG. Discussion This protocol is for a trial of a novel therapy intervention. Findings will establish whether there is sufficient evidence of benefit to justify proceeding with further research into clinical efficacy of upright pedalling exercise early after stroke. Information on potential prognostic indicators will suggest which stroke survivors could benefit from the intervention. Trial Registration ISRCTN: ISRCTN45392701

  1. A Peer-Led Electronic Mental Health Recovery App in an Adult Mental Health Service: Study Protocol for a Pilot Trial.

    Science.gov (United States)

    Gulliver, Amelia; Banfield, Michelle; Reynolds, Julia; Miller, Sarah; Galati, Connie; Morse, Alyssa R

    2017-12-07

    There is growing demand for peer workers (people who use their own lived experience to support others in their recovery) to work alongside consumers to improve outcomes and recovery. Augmenting the workforce with peer workers has strong capacity to enhance mental health and recovery outcomes and make a positive contribution to the workforce within mental health systems and to the peer workers themselves. Technology-based applications are highly engaging and desirable methods of service delivery. This project is an exploratory proof-of-concept study, which aims to determine if a peer worker-led electronic mental (e-mental) health recovery program is a feasible, acceptable, and effective adjunct to usual treatment for people with moderate to severe mental illness. The study design comprises a recovery app intervention delivered by a peer worker to individual consumers at an adult mental health service. Evaluation measures will be conducted at post-intervention. To further inform the acceptability and feasibility of the model, consumers will be invited to participate in a focus group to discuss the program. The peer worker, peer supervisor, and key staff at the mental health service will also be individually interviewed to further evaluate the feasibility of the program within the health service and further inform its future development. The program will be delivered over a period of approximately 4 months, commencing June 2017. If the peer worker-led recovery app is found to be feasible, acceptable, and effective, it could be used to improve recovery in mental health service consumers. ©Amelia Gulliver, Michelle Banfield, Julia Reynolds, Sarah Miller, Connie Galati, Alyssa R Morse. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.12.2017.

  2. Exploring synergistic effects of aerobic exercise and mindfulness training on cognitive function in older adults: Protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Salmoirago-Blotcher, Elena; DeCosta, Julie; Harris, Kristie; Breault, Christopher; Dunsiger, Shira; Santos, Claudia; Snyder, Peter

    2018-05-01

    Despite increasing evidence that aerobic exercise and cognitive training improve cognitive function among patients with cognitive impairment and dementia, few studies have focused on the effect of a combination of these approaches. This study will explore whether combining aerobic training (AT) with mindfulness training (MT), an intervention promoting the moment-to-moment awareness of physical sensations, affective states, and thoughts, improves cognitive function in individuals at risk of dementia. The primary objective is to determine the feasibility and acceptability of the intervention(s). The secondary objective is to obtain estimates of effect sizes on cognitive function and on possible mediators. Forty participants with at least 2 risk factors for dementia will be randomized (2 × 2 factorial design) to either AT (3 sessions/week for 12 weeks), MT (1 session/week for 8 weeks), both, or usual care. Assessments of cognitive function (attention, executive function, episodic, and working memory); physical activity (accelerometry), aerobic capacity (6-minute walk test), waist-to-hip ratio, blood pressure, social support (Multidimensional Scale of Perceived Social Support), depression (Hospital Anxiety and Depression Scale), and mindfulness (Five Facets of Mindfulness) will be conducted at baseline, end of treatment, and 6-months postbaseline. Rates of retention, attendance, and program satisfaction will be calculated for each of the 4 groups to determine the feasibility and acceptability of each intervention. This study has full ethical approval by The Miriam Hospital Institutional Review Board and adheres to the Standard Protocol Items: Recommendations for Interventional Trials reporting recommendations. If results from this exploratory, proof-of-concept study support our hypotheses, we will conduct a large randomized controlled trial (RCT) to determine the efficacy of combined MT and AT in improving cognitive function in individuals at risk of dementia

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

    Energy Technology Data Exchange (ETDEWEB)

    Schwartz, David L., E-mail: david.schwartz@utsw.edu [Department of Radiation Oncology, University of Texas Southwestern School of Medicine, Dallas, Texas (United States); Harris, Jonathan [Radiation Therapy Oncology Group Statistical Center, Philadelphia, Pennsylvania (United States); Yao, Min [Department of Radiation Oncology, Case Western Reserve University School of Medicine, Cleveland, Ohio (United States); Rosenthal, David I. [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Opanowski, Adam; Levering, Anthony [American College of Radiology Imaging Network, Philadelphia, Pennsylvania (United States); Ang, K. Kian [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Trotti, Andy M. [Department of Radiation Oncology, Moffitt Cancer Center, Tampa, Florida (United States); Garden, Adam S. [Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Jones, Christopher U. [Sutter Medical Group, Sacramento, California (United States); Harari, Paul [Department of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin (United States); Foote, Robert [Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota (United States); Holland, John [Department of Radiation Medicine, Oregon Health & Science University, Portland, Oregon (United States); Zhang, Qiang [Radiation Therapy Oncology Group Statistical Center, Philadelphia, Pennsylvania (United States); Le, Quynh-Thu [Department of Radiation Oncology, Stanford University School of Medicine, Palo Alto, California (United States)

    2015-03-15

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

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

    Science.gov (United States)

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

    2016-12-01

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

  5. Bioremediation protocols

    National Research Council Canada - National Science Library

    Sheehan, David

    1997-01-01

    ..., .. . . . . .. ,. . . .. . . . . . . . .. . . . . .. . . .. . .. 3 2 Granular Nina Sludge Christiansen, Consortia lndra for Bioremediation, M. Mathrani, and Birgitte K. Ahring . 23 PART II PROTOCOLS...

  6. Stand Out in Class: restructuring the classroom environment to reduce sedentary behaviour in 9-10-year-olds - study protocol for a pilot cluster randomised controlled trial.

    Science.gov (United States)

    Clemes, Stacy A; Bingham, Daniel D; Pearson, Natalie; Chen, Yu-Ling; Edwardson, Charlotte; McEachan, Rosemary; Tolfrey, Keith; Cale, Lorraine; Richardson, Gerry; Fray, Mike; Bandelow, Stephan; Jaicim, Nishal Bhupendra; Salmon, Jo; Dunstan, David; Barber, Sally E

    2018-01-01

    Sedentary behaviour (sitting) is a highly prevalent negative health behaviour, with individuals of all ages exposed to environments that promote prolonged sitting. Excessive sedentary behaviour adversely affects health in children and adults. As sedentary behaviour tracks from childhood into adulthood, the reduction of sedentary time in young people is key for the prevention of chronic diseases that result from excessive sitting in later life. The sedentary school classroom represents an ideal setting for environmental change, through the provision of sit-stand desks. Whilst the use of sit-stand desks in classrooms demonstrates positive effects in some key outcomes, evidence is currently limited by small samples and/or short intervention durations, with few studies adopting randomised controlled trial (RCT) designs. This paper describes the protocol of a pilot cluster RCT of a sit-stand desk intervention in primary school classrooms. A two-arm pilot cluster RCT will be conducted in eight primary schools (four intervention, four control) with at least 120 year 5 children (aged 9-10 years). Sit-stand desks will replace six standard desks in the intervention classrooms. Teachers will be encouraged to ensure all pupils are exposed to the sit-stand desks for at least 1 h/day on average using a rotation system. Schools assigned to the control arm will continue with their usual practice, no environmental changes will be made to their classrooms. Measurements will be taken at baseline, before randomisation, and at the end of the schools' academic year. In this study, the primary outcomes of interest will be school and participant recruitment and attrition, acceptability of the intervention, and acceptability and compliance to the proposed outcome measures (including activPAL-measured school-time and school-day sitting, accelerometer-measured physical activity, adiposity, blood pressure, cognitive function, academic progress, engagement, and behaviour) for inclusion in a

  7. Vývoj protokolu o pozorování dovedností pro sledge hokej - pilotní studie Development of a skills observation protocol for sledge ice hockey - pilot study

    Directory of Open Access Journals (Sweden)

    Yves Vanlandewijck

    2007-02-01

    consulted and their feedback enabled the construction of the instrument. Once this protocol was complete a pilot evaluation was done in which players were selected on the basis of statistics from the Paralympics and then evaluated using the protocol. It was determined that the protocol could successfully differentiate between higher and lower level players.

  8. Design of a Channel Error Simulator using Virtual Instrument Techniques for the Initial Testing of TCP/IP and SCPS Protocols

    Science.gov (United States)

    Horan, Stephen; Wang, Ru-Hai

    1999-01-01

    There exists a need for designers and developers to have a method to conveniently test a variety of communications parameters for an overall system design. This is no different when testing network protocols as when testing modulation formats. In this report, we discuss a means of providing a networking test device specifically designed to be used for space communications. This test device is a PC-based Virtual Instrument (VI) programmed using the LabVIEW(TM) version 5 software suite developed by National Instruments(TM)TM. This instrument was designed to be portable and usable by others without special, additional equipment. The programming was designed to replicate a VME-based hardware module developed earlier at New Mexico State University (NMSU) and to provide expanded capabilities exceeding the baseline configuration existing in that module. This report describes the design goals for the VI module in the next section and follows that with a description of the design of the VI instrument. This is followed with a description of the validation tests run on the VI. An application of the error-generating VI to networking protocols is then given.

  9. A Self-Directed Mobile Intervention (WaznApp) to Promote Weight Control Among Employees at a Lebanese University: Protocol for a Feasibility Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Bardus, Marco; Hamadeh, Ghassan; Hayek, Bouchra; Al Kherfan, Rawan

    2018-05-16

    and waist circumference), behavioral outcomes (physical activity and diet), and cognitive factors (motivation to participate in the trial and to manage weight). WaznApp was funded in June 2017, and recruitment started in March 2018. This study will provide information as to whether the selected mobile apps offer a feasible solution for promoting weight management in an academic workplace. The results will inform a larger trial whose results might be replicated in similar workplaces in Lebanon and the Middle East and North Africa region, and will be used as a benchmark for further investigations in other settings and similar target groups. ClinicalTrials.gov NCT03321331; https://clinicaltrials.gov/ct2/show/NCT03321331 (Archived by WebCite at http://www.webcitation.org/6ys9NOLo5). RR1-10.2196/9793. ©Marco Bardus, Ghassan Hamadeh, Bouchra Hayek, Rawan Al Kherfan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.05.2018.

  10. Coded Splitting Tree Protocols

    DEFF Research Database (Denmark)

    Sørensen, Jesper Hemming; Stefanovic, Cedomir; Popovski, Petar

    2013-01-01

    This paper presents a novel approach to multiple access control called coded splitting tree protocol. The approach builds on the known tree splitting protocols, code structure and successive interference cancellation (SIC). Several instances of the tree splitting protocol are initiated, each...... instance is terminated prematurely and subsequently iterated. The combined set of leaves from all the tree instances can then be viewed as a graph code, which is decodable using belief propagation. The main design problem is determining the order of splitting, which enables successful decoding as early...

  11. Playing With Population Protocols

    Directory of Open Access Journals (Sweden)

    Xavier Koegler

    2009-06-01

    Full Text Available Population protocols have been introduced as a model of sensor networks consisting of very limited mobile agents with no control over their own movement: A collection of anonymous agents, modeled by finite automata, interact in pairs according to some rules. Predicates on the initial configurations that can be computed by such protocols have been characterized under several hypotheses. We discuss here whether and when the rules of interactions between agents can be seen as a game from game theory. We do so by discussing several basic protocols.

  12. Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Lambert, Justin; Ghadry-Tavi, Rouzbeh; Knuff, Kate; Jutras, Marc; Siever, Jodi; Mick, Paul; Roque, Carolyn; Jones, Gareth; Little, Jonathan; Miller, Harry; Van Bergen, Colin; Kurtz, Donna; Murphy, Mary Ann; Jones, Charlotte Ann

    2017-01-28

    Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of this pilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improve functional fitness, social connectedness, hearing and health-related quality of life in older adults with HL. This 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample of ambulatory adults aged 65 years or older with self-reported HL. Following baseline assessments, participants will be randomized to either intervention (exercise, health education, socialization and group auditory rehabilitation (GAR)) or control (GAR only) groups. The intervention group will attend a local YMCA twice a week and the control group once a week. Intervention sessions will include 45 min of strengthening, balance and resistance exercises, 30 min of group walking at a self-selected pace and 60 min of interactive health education or GAR. The control group will attend 60-min GAR sessions. GAR sessions will include education about hearing, hearing technologies, enhancing communication skills, and psychosocial support. Pre-post trial data collection and measures will include: functional fitness (gait speed, 30-s Sit to Stand Test), hearing and health-related quality of life, loneliness, depression, social participation and social support. At trial end, feasibility (recruitment, randomization, retention, acceptability) and GAR will be evaluated. Despite evidence suggesting that HL is associated with declines in functional fitness, there are no studies aimed at addressing functional fitness declines associated with the disability of HL. This pilot trial will provide knowledge about the physical, mental and social impacts on health related to HL as a disability. This will inform the feasibility of a

  13. Developmental trajectories of infants and toddlers with good initial presentation following moderate or severe traumatic brain injury: a pilot clinical assessment project.

    Science.gov (United States)

    Pomerleau, Geneviève; Hurteau, Anne-Marie; Parent, Line; Doucet, Katrine; Corbin-Berrigan, Laurie-Ann; Gagnon, Isabelle

    2012-01-01

    The purpose of this study was to review the feasibility and usefulness of instituting a clinical protocol of scheduled assessments for children after a moderate or severe traumatic brain injury (TBI) sustained before the age of 2 years and showing no immediate deficits at hospital discharge, as well as to explore the early developmental trajectories of these children. Exploratory analytical cohort study. Pediatric Trauma Center Out-patient services. 31 children were followed within the clinical protocol of scheduled assessments. The protocol included an immediate post-injury clinical assessment of infants who sustained a TBI and follow-up assessments at the ages of 9 months, 18 months (if injured prior to that age), 30 months, and 42 months. Domains assessed at each scheduled visit included hearing, speech and language, motor performance, personal social abilities, and adaptive behaviors. Clinicians reported few difficulties with scheduling or administering the assessments, maintaining a 67% participation rate at the end of the follow-up period, thus demonstrating the feasibility of the protocol in this population. Scores on the majority of formal tests showed high variability and 15-20% of children presented with clinically significant motor and/or language delays. By 42 months of age, difficulties with adaptive behavior and personal social abilities were identified in our sample of children when compared to published norms. Qualitative clinical findings from professionals identified between 25-50% of children with potential attentional difficulties throughout the follow-up period. Findings from this study demonstrate the feasibility of implementing a clinical protocol of assessment for infants and toddlers who sustain a TBI before the age of 2 years and present with no impairments at the time of discharge from hospital. Developmental problems in this population appear to be easier to identify later in the toddler years as opposed to immediately following the TBI

  14. Adjuvant whole abdominal intensity modulated radiotherapy (IMRT) for high risk stage FIGO III patients with ovarian cancer (OVAR-IMRT-01) – Pilot trial of a phase I/II study: study protocol

    International Nuclear Information System (INIS)

    Rochet, Nathalie; Jensen, Alexandra D; Sterzing, Florian; Munter, Marc W; Eichbaum, Michael H; Schneeweiss, Andreas; Sohn, Christof; Debus, Juergen; Harms, Wolfgang

    2007-01-01

    The prognosis for patients with advanced epithelial ovarian cancer remains poor despite aggressive surgical resection and platinum-based chemotherapy. More than 60% of patients will develop recurrent disease, principally intraperitoneal, and die within 5 years. The use of whole abdominal irradiation (WAI) as consolidation therapy would appear to be a logical strategy given its ability to sterilize small tumour volumes. Despite the clinically proven efficacy of whole abdominal irradiation, the use of radiotherapy in ovarian cancer has profoundly decreased mainly due to high treatment-related toxicity. Modern intensity-modulated radiation therapy (IMRT) could allow to spare kidneys, liver, and bone marrow while still adequately covering the peritoneal cavity with a homogenous dose. The OVAR-IMRT-01 study is a single center pilot trial of a phase I/II study. Patients with advanced ovarian cancer stage FIGO III (R1 or R2< 1 cm) after surgical resection and platinum-based chemotherapy will be treated with whole abdomen irradiation as consolidation therapy using intensity modulated radiation therapy (IMRT) to a total dose of 30 Gy in 1.5 Gy fractions. A total of 8 patients will be included in this trial. For treatment planning bone marrow, kidneys, liver, spinal cord, vertebral bodies and pelvic bones are defined as organs at risk. The planning target volume includes the entire peritoneal cavity plus pelvic and para-aortic node regions. The primary endpoint of the study is the evaluation of the feasibility of intensity-modulated WAI and the evaluation of the study protocol. Secondary endpoint is evaluation of the toxicity of intensity modulated WAI before continuing with the phase I/II study. The aim is to explore the potential of IMRT as a new method for WAI to decrease the dose to kidneys, liver, bone marrow while covering the peritoneal cavity with a homogenous dose, and to implement whole abdominal intensity-modulated radiotherapy into the adjuvant multimodal

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

    Science.gov (United States)

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

    2016-01-01

    Background Tobacco control policies that lead to a significant reduction in tobacco industry marketing can improve public health by reducing consumption of tobacco and preventing initiation of tobacco use. Laws that ban or restrict advertising and promotion in point-of-sale (POS) environments, in the moment when consumers decide whether or not to purchase a tobacco product, must be correctly implemented to achieve the desired public health benefits. POS policy compliance assessments can support implementation; however, there are challenges to conducting evaluations that are rigorous, cost-effective, and timely. Data collection must be discreet, accurate, and systematic, and ideally collected both before and after policies take effect. The use of mobile phones and other mobile technology provide opportunities to efficiently collect data and support effective tobacco control policies. The Russian Federation (Russia) passed a comprehensive national tobacco control law that included a ban on most forms of tobacco advertising and promotion, effective November 15, 2013. The legislation further prohibited the display of tobacco products at retail trade sites and eliminated kiosks as a legal trade site, effective June 1, 2014. Objective The objective of the study was to develop and test a mobile data collection protocol including: (1) retailer sampling, (2) adaptation of survey instruments for mobile phones, and (3) data management protocols. Methods Two waves of observations were conducted; wave 1 took place during April-May 2014, after the advertising and promotion bans were effective, and again in August-September 2014, after the product display ban and elimination of tobacco sales in kiosks came into effect. Sampling took place in 5 Russian cities: Moscow, St. Petersburg, Novosibirsk, Yekaterinburg, and Kazan. Lack of access to a comprehensive list of licensed tobacco retailers necessitated a sampling approach that included the development of a walking protocol to

  16. Assessment of a robust model protocol with accelerated throughput for a human recombinant full length estrogen receptor-alpha binding assay: protocol optimization and intralaboratory assay performance as initial steps towards validation.

    Science.gov (United States)

    Freyberger, Alexius; Wilson, Vickie; Weimer, Marc; Tan, Shirlee; Tran, Hoai-Son; Ahr, Hans-Jürgen

    2010-08-01

    Despite about two decades of research in the field of endocrine active compounds, still no validated human recombinant (hr) estrogen receptor-alpha (ERalpha) binding assay is available, although hr-ERalpha is available from several sources. In a joint effort, US EPA and Bayer Schering Pharma with funding from the EU-sponsored 6th framework project, ReProTect, developed a model protocol for such a binding assay. Important features of this assay are the use of a full length hr-ERalpha and performance in a 96-well plate format. A full length hr-ERalpha was chosen, as it was considered to provide the most accurate and human-relevant results, whereas truncated receptors could perform differently. Besides three reference compounds [17beta-estradiol, norethynodrel, dibutylphthalate] nine test compounds with different affinities for the ERalpha [diethylstilbestrol (DES), ethynylestradiol, meso-hexestrol, equol, genistein, o,p'-DDT, nonylphenol, n-butylparaben, and corticosterone] were used to explore the performance of the assay. Three independent experiments per compound were performed on different days, and dilutions of test compounds from deep-frozen stocks, solutions of radiolabeled ligand and receptor preparation were freshly prepared for each experiment. The ERalpha binding properties of reference and test compounds were well detected. As expected dibutylphthalate and corticosterone were non-binders in this assay. In terms of the relative ranking of binding affinities, there was good agreement with published data obtained from experiments using a human recombinant ERalpha ligand binding domain. Irrespective of the chemical nature of the compound, individual IC(50)-values for a given compound varied by not more than a factor of 2.5. Our data demonstrate that the assay was robust and reliably ranked compounds with strong, weak, and no affinity for the ERalpha with high accuracy. It avoids the manipulation and use of animals, i.e., the preparation of uterine cytosol as

  17. Pilot Implementations

    DEFF Research Database (Denmark)

    Manikas, Maria Ie

    by conducting a literature review. The concept of pilot implementation, although commonly used in practice, is rather disregarded in research. In the literature, pilot implementations are mainly treated as secondary to the learning outcomes and are presented as merely a means to acquire knowledge about a given...... objective. The prevalent understanding is that pilot implementations are an ISD technique that extends prototyping from the lab and into test during real use. Another perception is that pilot implementations are a project multiple of co-existing enactments of the pilot implementation. From this perspective......This PhD dissertation engages in the study of pilot (system) implementation. In the field of information systems, pilot implementations are commissioned as a way to learn from real use of a pilot system with real data, by real users during an information systems development (ISD) project and before...

  18. Simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE): protocol for a randomised evaluation.

    Science.gov (United States)

    Rosen, Sydney; Fox, Matthew P; Larson, Bruce A; Brennan, Alana T; Maskew, Mhairi; Tsikhutsu, Isaac; Bii, Margaret; Ehrenkranz, Peter D; Venter, Wd Francois

    2017-05-28

    African countries are rapidly adopting guidelines to offer antiretroviral therapy (ART) to all HIV-infected individuals, regardless of CD4 count. For this policy of 'treat all' to succeed, millions of new patients must be initiated on ART as efficiently as possible. Studies have documented high losses of treatment-eligible patients from care before they receive their first dose of antiretrovirals (ARVs), due in part to a cumbersome, resource-intensive process for treatment initiation, requiring multiple clinic visits over a several-week period. The Simplified Algorithm for Treatment Eligibility (SLATE) study is an individually randomised evaluation of a simplified clinical algorithm for clinicians to reliably determine a patient's eligibility for immediate ART initiation without waiting for laboratory results or additional clinic visits. SLATE will enrol and randomise (1:1) 960 adult, HIV-positive patients who present for HIV testing or care and are not yet on ART in South Africa and Kenya. Patients randomised to the standard arm will receive routine, standard of care ART initiation from clinic staff. Patients randomised to the intervention arm will be administered a symptom report, medical history, brief physical exam and readiness assessment. Patients who have positive (satisfactory) results for all four components of SLATE will be dispensed ARVs immediately, at the same clinic visit. Patients who have any negative results will be referred for further clinical investigation, counselling, tests or other services prior to being dispensed ARVs. After the initial visit, follow-up will be by passive medical record review. The primary outcomes will be ART initiation ≤28 days and retention in care 8 months after study enrolment. Ethics approval has been provided by the Boston University Institutional Review Board, the University of the Witwatersrand Human Research Ethics Committee (Medical) and the KEMRI Scientific and Ethics Review Unit. Results will be published in

  19. Simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE): protocol for a randomised evaluation

    OpenAIRE

    Rosen, Sydney; Fox, Matthew P; Larson, Bruce A; Brennan, Alana T; Maskew, Mhairi; Tsikhutsu, Isaac; Bii, Margaret; Ehrenkranz, Peter D; Venter, WD Francois

    2017-01-01

    Introduction African countries are rapidly adopting guidelines to offer antiretroviral therapy (ART) to all HIV-infected individuals, regardless of CD4 count. For this policy of ‘treat all’ to succeed, millions of new patients must be initiated on ART as efficiently as possible. Studies have documented high losses of treatment-eligible patients from care before they receive their first dose of antiretrovirals (ARVs), due in part to a cumbersome, resource-intensive process for treatment initia...

  20. A national evaluation of a dissemination and implementation initiative to enhance primary care practice capacity and improve cardiovascular disease care: the ESCALATES study protocol

    OpenAIRE

    Cohen, Deborah J.; Balasubramanian, Bijal A.; Gordon, Leah; Marino, Miguel; Ono, Sarah; Solberg, Leif I.; Crabtree, Benjamin F.; Stange, Kurt C.; Davis, Melinda; Miller, William L.; Damschroder, Laura J.; McConnell, K. John; Creswell, John

    2016-01-01

    Background The Agency for Healthcare Research and Quality (AHRQ) launched the EvidenceNOW Initiative to rapidly disseminate and implement evidence-based cardiovascular disease (CVD) preventive care in smaller primary care practices. AHRQ funded eight grantees (seven regional Cooperatives and one independent national evaluation) to participate in EvidenceNOW. The national evaluation examines quality improvement efforts and outcomes for more than 1500 small primary care practices (restricted to...

  1. The influence of contextual factors on healthcare quality improvement initiatives: what works, for whom and in what setting? Protocol for a realist review.

    Science.gov (United States)

    Coles, Emma; Wells, Mary; Maxwell, Margaret; Harris, Fiona M; Anderson, Julie; Gray, Nicola M; Milner, Gill; MacGillivray, Stephen

    2017-08-23

    Context shapes the effectiveness of knowledge implementation and influences health improvement. Successful healthcare quality improvement (QI) initiatives frequently fail to transfer to different settings, with local contextual factors often cited as the cause. Understanding and overcoming contextual barriers is therefore crucial to implementing effective improvement; yet context is still poorly understood. There is a paucity of information on the mechanisms underlying how and why QI projects succeed or fail in given settings. A realist review of empirical studies of healthcare QI initiatives will be undertaken to examine the influence and impact of contextual factors on quality improvement in healthcare settings and explore whether QI initiatives can work in all contexts. The review will explore which contextual factors are important, and how, why, when and for whom they are important, within varied settings. The dynamic nature of context and change over time will be explored by examining which aspects of context impact at key points in the improvement trajectory. The review will also consider the influence of context on improvement outcomes (provider- and patient-level), spread and sustainability. The review process will follow five iterative steps: (1) clarify scope, (2) search for evidence, (3) appraise primary studies and extract data, (4) synthesise evidence and draw conclusions and (5) disseminate findings. The reviewers will consult with experts and stakeholders in the early stages to focus the review and develop a programme theory consisting of explanatory 'context-mechanism-outcome' configurations. Searches for primary evidence will be conducted iteratively. Data will be extracted and tested against the programme theory. A review advisory group will oversee the review process. Review findings will follow RAMESES guidelines and will be disseminated via a report, presentations and peer-reviewed publications. The review will update and consolidate evidence

  2. Pre-post, mixed-methods feasibility study of the WorkingWell mobile support tool for individuals with serious mental illness in the USA: a pilot study protocol.

    Science.gov (United States)

    Nicholson, Joanne; Wright, Spenser M; Carlisle, Alyssa M

    2018-02-06

    Successful competitive employment has been found to be related to enhanced self-esteem, higher quality of life and reduced mental health service use for individuals living with serious mental illnesses (SMIs) including schizophrenia, bipolar disorder and major depression. The effectiveness of the individual placement and support model has been demonstrated in multiple randomised controlled trials in many countries. The management of stress, depression and anxiety in the workplace may be effectively enhanced through digital mental health interventions. The WorkingWell mobile support tool ('app') is specifically designed to meet the need for illness management support for individuals with SMI in the workplace, as an adjunct to professional treatment. The WorkingWell app, grounded in evidence-based supported employment, is informed by user experience design. It will be tested in a pre-post design, mixed-methods pilot study to explore issues of feasibility, acceptability and usefulness, and to provide preliminary data on the impact of use. Putative mediators of improved job tenure and psychological well-being, including postintervention changes in social support, self-efficacy and work-related motivation, will be investigated. Forty individuals at least 18 years of age, meeting the eligibility requirements for supported employment services (ie, diagnosed with a mental illness meeting the criteria for severity, duration and treatment), working a minimum of 10 hours per week at study enrolment, and speaking, reading and writing in English will be recruited for the pilot study. Research staff will recruit individuals at community-based mental health agencies; provide orientation to the study, the study smartphones and the WorkingWell app; conduct research interviews including standardised measures as well as semistructured items; and provide technical assistance in telephone calls and inperson meetings. A sample of 10 agency staff will be recruited to obtain further

  3. A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT: study protocol and design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kruger Peter

    2011-03-01

    Full Text Available Abstract Background Swine origin influenza A/H1N1 infection (H1N1 emerged in early 2009 and rapidly spread to humans. For most infected individuals, symptoms were mild and self-limited; however, a small number developed a more severe clinical syndrome characterized by profound respiratory failure with hospital mortality ranging from 10 to 30%. While supportive care and neuraminidase inhibitors are the main treatment for influenza, data from observational and interventional studies suggest that the course of influenza can be favorably influenced by agents not classically considered as influenza treatments. Multiple observational studies have suggested that HMGCoA reductase inhibitors (statins can exert a class effect in attenuating inflammation. The Collaborative H1N1 Adjuvant Treatment (CHAT Pilot Trial sought to investigate the feasibility of conducting a trial during a global pandemic in critically ill patients with H1N1 with the goal of informing the design of a larger trial powered to determine impact of statins on important outcomes. Methods/Design A multi-national, pilot randomized controlled trial (RCT of once daily enteral rosuvastatin versus matched placebo administered for 14 days for the treatment of critically ill patients with suspected, probable or confirmed H1N1 infection. We propose to randomize 80 critically ill adults with a moderate to high index of suspicion for H1N1 infection who require mechanical ventilation and have received antiviral therapy for ≤ 72 hours. Site investigators, research coordinators and clinical pharmacists will be blinded to treatment assignment. Only research pharmacy staff will be aware of treatment assignment. We propose several approaches to informed consent including a priori consent from the substitute decision maker (SDM, waived and deferred consent. The primary outcome of the CHAT trial is the proportion of eligible patients enrolled in the study. Secondary outcomes will evaluate adherence to

  4. Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA)

    Science.gov (United States)

    Jolly, Kate; Ingram, Jenny; Clarke, Joanne; Johnson, Debbie; Trickey, Heather; Thomson, Gill; Dombrowski, Stephan U; Sitch, Alice; Dykes, Fiona; Feltham, Max G; Darwent, Kirsty; MacArthur, Christine; Roberts, Tracy

    2018-01-01

    intervention fidelity. Ethics and dissemination Study results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee approved the study protocol. Trial registration number ISRCTN14760978; Pre-results. PMID:29362263

  5. A research protocol for a pilot randomized controlled trial designed to examine the feasibility of a couple-based mind-body intervention for patients with metastatic lung cancer and their partners.

    Science.gov (United States)

    Milbury, Kathrin; Tsao, Anne S; Liao, Zhongxing; Owns, April; Engle, Rosalinda; Gonzalez, Edrea A; Bruera, Eduardo; Cohen, Lorenzo

    2018-01-01

    Given the generally incurable nature of metastatic non-small cell lung cancer (mNSCLC), patients and their romantic partners are at risk for existential/spiritual distress. Although a handful of dyadic psychosocial interventions for lung cancer patients and their caregivers exist, none of them target spiritual well-being. Informed by the mindfulness-based intervention literature and our pilot work in couples affected by lung cancer, we developed a brief couple-based mind-body (CBMB) intervention. The primary aim of this research protocol is to determine the feasibility of implementing the CBMB intervention versus an active control (AC) or wait list control (WLC) group in patients with mNSCLC and their partners using a randomized controlled trial design. Seventy-five patients with mNSCLC receiving treatment and their partners are randomized to the CBMB intervention, an AC or a WLC group. Those in the CBMB intervention and AC groups receive four intervention sessions of 60 min each over 4 weeks and complete weekly homework assignments. The first session is delivered in person, and the remaining sessions are delivered via videoconference. The dyads in the AC group discuss cancer-related and personal growth concerns with the interventionist but are not taught coping skills. Patients and partners in all groups complete baseline assessments of quality of life (QOL) prior to randomization. Follow-up assessments are performed 4 weeks and then again 3 months later. The primary outcome is feasibility (i.e., ≥ 30% of eligible couples consent, ≥ 70% of enrolled couples are retained, and ≥ 50% of all CBMB and AC sessions are attended). We will also perform primarily descriptive analyses of the self-reported outcomes (e.g., spiritual well-being and psychological distress) and explore potential intervention mediators (i.e., compassion, communication, mindfulness, and closeness) to inform a larger, future trial. This trial will provide important information

  6. Improving detection and initial management of gestational diabetes through the primary level of care in Morocco: protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Utz, Bettina; Assarag, Bouchra; Essolbi, Amina; Barkat, Amina; El Ansari, Nawal; Fakhir, Bouchra; Delamou, Alexandre; De Brouwere, Vincent

    2017-06-19

    Morocco is facing a growing prevalence of diabetes and according to latest figures of the World Health Organization, already 12.4% of the population are affected. A similar prevalence has been reported for gestational diabetes (GDM) and although it is not yet high on the national agenda, immediate and long-term complications threaten the health of mothers and future generations. A situational analysis on GDM conducted in 2015 revealed difficulties in access to screening and delays in receiving appropriate care. This implementation study has as objective to evaluate a decentralized GDM detection and management approach through the primary level of care and assess its potential for scaling up. We will conduct a hybrid effectiveness-implementation research using a cluster randomized controlled trial design in two districts of Morocco. Using the health center as unit of randomization we randomly selected 20 health centers with 10 serving as intervention and 10 as control facilities. In the intervention arm, providers will screen pregnant women attending antenatal care for GDM by capillary glucose testing during antenatal care. Women tested positive will receive nutritional counselling and will be followed up through the health center. In the control facilities, screening and initial management of GDM will follow standard practice. Primary outcome will be birthweight with weight gain during pregnancy, average glucose levels and pregnancy outcomes including mode of delivery, presence or absence of obstetric or newborn complications and the prevalence of GDM at health center level as secondary outcomes. Furthermore we will assess the quality of life /care experienced by the women in both arms. Qualitative methods will be applied to evaluate the feasibility of the intervention at primary level and its adoption by the health care providers. In Morocco, gestational diabetes screening and its initial management is fragmented and coupled with difficulties in access and

  7. The Moment Study: protocol for a mixed method observational cohort study of the Alternative Nicotine Delivery Systems (ANDS) initiation process among adult cigarette smokers.

    Science.gov (United States)

    Pearson, Jennifer L; Smiley, Sabrina L; Rubin, Leslie F; Anesetti-Rothermel, Andrew; Elmasry, Hoda; Davis, Megan; DeAtley, Teresa; Harvey, Emily; Kirchner, Thomas; Abrams, David B

    2016-04-22

    Alternative Nicotine Delivery Systems (ANDS) such as e-cigarettes are battery-powered devices that aerosolize nicotine and other substances to simulate smoking without using tobacco. Little is known about the ANDS initiation process among adult smokers. The aims of this research are threefold to: (1) examine how ANDS use affects cigarette use; (2) examine how the immediate environmental and psychosocial contexts of cigarette and ANDS use vary within-and between-participants in general and by menthol preference and race; and, (3) examine participants' 'lived experience' of the subjective perceptions, meaning, influences and utility of cigarette and ANDS use. This study's mixed method, 6-week longitudinal design will produce a detailed description of the ANDS initiation process among adult smokers (N=100). Qualitative and quantitative data collection will include 3 weeks of: (1) ecological momentary assessment of patterns of cigarette/ANDS use, satisfaction, mood and craving; (2) geospatial assessment of participants' environment, including indoor and outdoor cigarette/ANDS norms and rules; (3) in-depth interviews about the meaning and utility of cigarette smoking and ANDS use; and, (4) saliva cotinine and exhaled carbon monoxide (CO) biomarkers. A diverse sample will be recruited with an equal number of menthol and non-menthol cigarette smokers. As the primary independent variable, we will investigate how ANDS use affects cigarette consumption. We will also examine how smoking-related and ANDS-related rules and norms surrounding product use influence cigarette and ANDS product use, and how the subjective effects of ANDS use affect ANDS perceptions, beliefs and use. This study was funded by the National Institute on Drug Abuse of the US National Institutes of Health (1R21DA036472), registered at ClinicalTrials.gov (NCT02261363), and approved by the Chesapeake IRB (Pro00008526). Findings will be disseminated to the scientific and lay community through presentations

  8. Long-term prognosis of young breast cancer patients (≤40 years) who did not receive adjuvant systemic treatment: protocol for the PARADIGM initiative cohort study.

    Science.gov (United States)

    Dackus, Gwen Mhe; Ter Hoeve, Natalie D; Opdam, Mark; Vreuls, Willem; Varga, Zsuzsanna; Koop, Esther; Willems, Stefan M; Van Deurzen, Carolien Hm; Groen, Emilie J; Cordoba, Alicia; Bart, Jos; Mooyaart, Antien L; van den Tweel, Jan G; Zolota, Vicky; Wesseling, Jelle; Sapino, Anna; Chmielik, Ewa; Ryska, Ales; Amant, Frederic; Broeks, Annegien; Kerkhoven, Ron; Stathonikos, Nikolas; Veta, Mitko; Voogd, Adri; Jozwiak, Katarzyna; Hauptmann, Michael; Hoogstraat, Marlous; Schmidt, Marjanka K; Sonke, Gabe; van der Wall, Elsken; Siesling, Sabine; van Diest, Paul J; Linn, Sabine C

    2017-11-14

    Currently used tools for breast cancer prognostication and prediction may not adequately reflect a young patient's prognosis or likely treatment benefit because they were not adequately validated in young patients. Since breast cancers diagnosed at a young age are considered prognostically unfavourable, many treatment guidelines recommend adjuvant systemic treatment for all young patients. Patients cured by locoregional treatment alone are, therefore, overtreated. Lack of prognosticators for young breast cancer patients represents an unmet medical need and has led to the initiation of the PAtients with bReAst cancer DIaGnosed preMenopausally (PARADIGM) initiative. Our aim is to reduce overtreatment of women diagnosed with breast cancer aged ≤ 40 years. All young, adjuvant systemic treatment naive breast cancer patients, who had no prior malignancy and were diagnosed between 1989 and 2000, were identified using the population based Netherlands Cancer Registry (n=3525). Archival tumour tissues were retrieved through linkage with the Dutch nationwide pathology registry. Tissue slides will be digitalised and placed on an online image database platform for clinicopathological revision by an international team of breast pathologists. Immunohistochemical subtype will be assessed using tissue microarrays. Tumour RNA will be isolated and subjected to next-generation sequencing. Differences in gene expression found between patients with a favourable and those with a less favourable prognosis will be used to establish a prognostic classifier, using the triple negative patients as proof of principle. Observational data from the Netherlands Cancer Registry and left over archival patient material are used. Therefore, the Dutch law on Research Involving Human Subjects Act (WMO) is not applicable. The PARADIGM study received a 'non-WMO' declaration from the Medical Ethics Committee of the Netherlands Cancer Institute - Antoni van Leeuwenhoek hospital, waiving individual patient

  9. Poly(allyl methacrylate) functionalized hydroxyapatite nanocrystals via the combination of surface-initiated RAFT polymerization and thiol-ene protocol: a potential anticancer drug nanocarrier.

    Science.gov (United States)

    Bach, Long Giang; Islam, Md Rafiqul; Vo, Thanh-Sang; Kim, Se-Kwon; Lim, Kwon Taek

    2013-03-15

    Hydroxyapatite nanocrystals (HAP NCs) were encapsulated by poly(allyl methacrylate) (PolyAMA) employing controlled surface-initiated reversible addition-fragmentation chain transfer (SI-RAFT) polymerization of allyl methacrylate to afford HAP-PolyAMA nanohybrids. The subsequent thiol-ene coupling of nanohybrids with 2-mercaptosuccinic acid resulted HAP-Poly(AMA-COOH) possessing multicarboxyl group. The formation of the nanohybrids was confirmed by FT-IR and EDS analyses. The TGA and FE-SEM investigation were further suggested the grafting of PolyAMA onto HAP NCs. The utility of the HAP-PolyAMA nanohybrid as drug carrier was also explored. The pendant carboxyl groups on the external layers of nanohybrids were conjugated with anticancer drug cisplatin to afford HAP-Poly(AMA-COOH)/Pt complex. The formation of the complex was confirmed by FT-IR, XPS, and FE-SEM. In vitro evaluation of the synthesized complex as nanomedicine revealed its potential chemotherapeutic efficacy against cancer cell lines. Copyright © 2012 Elsevier Inc. All rights reserved.

  10. Coupling between high-frequency ultrasound and solar photo-Fenton at pilot scale for the treatment of organic contaminants: an initial approach.

    Science.gov (United States)

    Papoutsakis, Stefanos; Miralles-Cuevas, Sara; Gondrexon, Nicolas; Baup, Stéphane; Malato, Sixto; Pulgarin, César

    2015-01-01

    This study aims to evaluate the performance of a novel pilot-scale coupled system consisting of a high frequency ultrasonic reactor (400kHz) and a compound parabolic collector (CPC). The benefits of the concurrent application of ultrasound and the photo-Fenton process were studied in regard to the degradation behavior of a series of organic pollutants. Three compounds (phenol, bisphenol A and diuron) with different physicochemical properties have been chosen in order to identify possible synergistic effects and to obtain a better estimate of the general feasibility of such a system at field scale (10L). Bisphenol A and diuron were specifically chosen due to their high hydrophobicity, and thus their assumed higher affinity towards the cavitation bubble. Experiments were conducted under ultrasonic, photo-Fenton and combined treatments. Enhanced degradation kinetics were observed during the coupled treatment and synergy factors clearly in excess of 1 have been calculated for phenol as well as for saturated solutions of bisphenol A and diuron. Although the relatively high cost of ultrasound compared to photo-Fenton still presents a significant challenge towards mainstream industrial application, the observed behavior suggests that its prudent use has the potential to significantly benefit the photo-Fenton process, via the decrease of both treatment time and H2O2 consumption. Copyright © 2014 Elsevier B.V. All rights reserved.

  11. Improving the Teaching Skills of Residents in a Surgical Training Program: Results of the Pilot Year of a Curricular Initiative in an Ophthalmology Residency Program.

    Science.gov (United States)

    Chee, Yewlin E; Newman, Lori R; Loewenstein, John I; Kloek, Carolyn E

    2015-01-01

    To design and implement a teaching skills curriculum that addressed the needs of an ophthalmology residency training program, to assess the effect of the curriculum, and to present important lessons learned. A teaching skills curriculum was designed for the Harvard Medical School (HMS) Residency Training Program in Ophthalmology. Results of a needs assessment survey were used to guide curriculum objectives. Overall, 3 teaching workshops were conducted between October 2012 and March 2013 that addressed areas of need, including procedural teaching. A postcurriculum survey was used to assess the effect of the curriculum. Massachusetts Eye and Ear Infirmary, a tertiary care institution in Boston, MA. Overall, 24 residents in the HMS Residency Training Program in Ophthalmology were included. The needs assessment survey demonstrated that although most residents anticipated that teaching would be important in their future career, only one-third had prior formal training in teaching. All residents reported they found the teaching workshops to be either very or extremely useful. All residents reported they would like further training in teaching, with most residents requesting additional training in best procedural teaching practices for future sessions. The pilot year of the resident-as-teacher curriculum for the HMS Residency Training Program in Ophthalmology demonstrated a need for this curriculum and was perceived as beneficial by the residents, who reported increased comfort in their teaching skills after attending the workshops. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  12. Volunteer trials of a novel improvised dry decontamination protocol for use during mass casualty incidents as part of the UK'S Initial Operational Response (IOR.

    Directory of Open Access Journals (Sweden)

    Richard Amlôt

    Full Text Available Previous studies have demonstrated that rapid evacuation, disrobing and emergency decontamination can enhance the ability of emergency services and acute hospitals to effectively manage chemically-contaminated casualties. The purpose of this human volunteer study was to further optimise such an "Initial Operational Response" by (1 identifying an appropriate method for performing improvised skin decontamination and (2 providing guidance for use by first responders and casualties. The study was performed using two readily available, absorbent materials (paper towels and incontinence pads. The decontamination effectiveness of the test materials was measured by quantifying the amount of a chemical warfare agent simulant (methyl salicylate removed from each volunteer's forearm skin. Results from the first study demonstrated that simulant recovery was lower in all of the dry decontamination conditions when compared to matched controls, suggesting that dry decontamination serves to reduce chemical exposure. Blotting in combination with rubbing was the most effective form of decontamination. There was no difference in effectiveness between the two absorbent materials. In the following study, volunteers performed improvised dry decontamination, either with or without draft guidelines. Volunteers who received the guidance were able to carry out improvised dry decontamination more effectively, using more of the absorbent product (blue roll to ensure that all areas of the body were decontaminated and avoiding cross-contamination of other body areas by working systematically from the head downwards. Collectively, these two studies suggest that absorbent products that are available on ambulances and in acute healthcare settings may have generic applicability for improvised dry decontamination. Wherever possible, emergency responders and healthcare workers should guide casualties through decontamination steps; in the absence of explicit guidance and

  13. Volunteer trials of a novel improvised dry decontamination protocol for use during mass casualty incidents as part of the UK'S Initial Operational Response (IOR).

    Science.gov (United States)

    Amlôt, Richard; Carter, Holly; Riddle, Lorna; Larner, Joanne; Chilcott, Robert P

    2017-01-01

    Previous studies have demonstrated that rapid evacuation, disrobing and emergency decontamination can enhance the ability of emergency services and acute hospitals to effectively manage chemically-contaminated casualties. The purpose of this human volunteer study was to further optimise such an "Initial Operational Response" by (1) identifying an appropriate method for performing improvised skin decontamination and (2) providing guidance for use by first responders and casualties. The study was performed using two readily available, absorbent materials (paper towels and incontinence pads). The decontamination effectiveness of the test materials was measured by quantifying the amount of a chemical warfare agent simulant (methyl salicylate) removed from each volunteer's forearm skin. Results from the first study demonstrated that simulant recovery was lower in all of the dry decontamination conditions when compared to matched controls, suggesting that dry decontamination serves to reduce chemical exposure. Blotting in combination with rubbing was the most effective form of decontamination. There was no difference in effectiveness between the two absorbent materials. In the following study, volunteers performed improvised dry decontamination, either with or without draft guidelines. Volunteers who received the guidance were able to carry out improvised dry decontamination more effectively, using more of the absorbent product (blue roll) to ensure that all areas of the body were decontaminated and avoiding cross-contamination of other body areas by working systematically from the head downwards. Collectively, these two studies suggest that absorbent products that are available on ambulances and in acute healthcare settings may have generic applicability for improvised dry decontamination. Wherever possible, emergency responders and healthcare workers should guide casualties through decontamination steps; in the absence of explicit guidance and instructions, improvised

  14. Volunteer trials of a novel improvised dry decontamination protocol for use during mass casualty incidents as part of the UK’S Initial Operational Response (IOR)

    Science.gov (United States)

    Riddle, Lorna; Larner, Joanne

    2017-01-01

    Previous studies have demonstrated that rapid evacuation, disrobing and emergency decontamination can enhance the ability of emergency services and acute hospitals to effectively manage chemically-contaminated casualties. The purpose of this human volunteer study was to further optimise such an “Initial Operational Response” by (1) identifying an appropriate method for performing improvised skin decontamination and (2) providing guidance for use by first responders and casualties. The study was performed using two readily available, absorbent materials (paper towels and incontinence pads). The decontamination effectiveness of the test materials was measured by quantifying the amount of a chemical warfare agent simulant (methyl salicylate) removed from each volunteer’s forearm skin. Results from the first study demonstrated that simulant recovery was lower in all of the dry decontamination conditions when compared to matched controls, suggesting that dry decontamination serves to reduce chemical exposure. Blotting in combination with rubbing was the most effective form of decontamination. There was no difference in effectiveness between the two absorbent materials. In the following study, volunteers performed improvised dry decontamination, either with or without draft guidelines. Volunteers who received the guidance were able to carry out improvised dry decontamination more effectively, using more of the absorbent product (blue roll) to ensure that all areas of the body were decontaminated and avoiding cross-contamination of other body areas by working systematically from the head downwards. Collectively, these two studies suggest that absorbent products that are available on ambulances and in acute healthcare settings may have generic applicability for improvised dry decontamination. Wherever possible, emergency responders and healthcare workers should guide casualties through decontamination steps; in the absence of explicit guidance and instructions

  15. Study protocol for the Integra Initiative to assess the benefits and costs of integrating sexual and reproductive health and HIV services in Kenya and Swaziland

    Directory of Open Access Journals (Sweden)

    Warren Charlotte E

    2012-11-01

    Full Text Available Abstract Background In sub-Saharan Africa (SSA there are strong arguments for the provision of integrated sexual and reproductive health (SRH and HIV services. Most HIV transmissions are sexually transmitted or associated with pregnancy, childbirth, and breastfeeding. Many of the behaviours that prevent HIV transmission also prevent sexually transmitted infections and unintended pregnancies. There is potential for integration to increase the coverage of HIV services, as individuals who use SRH services can benefit from HIV services and vice-versa, as well as increase cost-savings. However, there is a dearth of empirical evidence on effective models for integrating HIV/SRH services. The need for robust evidence led a consortium of three organizations – International Planned Parenthood Federation, Population Council and the London School of Hygiene & Tropical Medicine – to design/implement the Integra Initiative. Integra seeks to generate rigorous evidence on the feasibility, effectiveness, cost and impact of different models for delivering integrated HIV/SRH services in high and medium HIV prevalence settings in SSA. Methods/design A quasi-experimental study will be conducted in government clinics in Kenya and Swaziland – assigned into intervention/comparison groups. Two models of service delivery are investigated: integrating HIV care/treatment into 1 family planning and 2 postnatal care. A full economic-costing will be used to assess the costs of different components of service provision, and the determinants of variations in unit costs across facilities/service models. Health facility assessments will be conducted at four time-periods to track changes in quality of care and utilization over time. A two-year cohort study of family planning/postnatal clients will assess the effect of integration on individual outcomes, including use of SRH services, HIV status (known/unknown and pregnancy (planned/unintended. Household surveys within some

  16. Internet-delivered cognitive behavioural therapy with and without an initial face-to-face psychoeducation session for social anxiety disorder: A pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Magnus Nordmo

    2015-11-01

    Conclusions: Notwithstanding limitations due to the small sample size, the findings indicate that guided ICBT is an effective treatment for students with SAD. Adding an initial face-to-face PE session to the guided ICBT did not lead to enhanced outcomes in the present study.

  17. Inhaled PGE1 in neonates with hypoxemic respiratory failure: two pilot feasibility randomized clinical trials.

    Science.gov (United States)

    Sood, Beena G; Keszler, Martin; Garg, Meena; Klein, Jonathan M; Ohls, Robin; Ambalavanan, Namasivayam; Cotten, C Michael; Malian, Monica; Sanchez, Pablo J; Lakshminrusimha, Satyan; Nelin, Leif D; Van Meurs, Krisa P; Bara, Rebecca; Saha, Shampa; Das, Abhik; Wallace, Dennis; Higgins, Rosemary D; Shankaran, Seetha

    2014-12-12

    Inhaled nitric oxide (INO), a selective pulmonary vasodilator, has revolutionized the treatment of neonatal hypoxemic respiratory failure (NHRF). However, there is lack of sustained improvement in 30 to 46% of infants. Aerosolized prostaglandins I2 (PGI2) and E1 (PGE1) have been reported to be effective selective pulmonary vasodilators. The objective of this study was to evaluate the feasibility of a randomized controlled trial (RCT) of inhaled PGE1 (IPGE1) in NHRF. Two pilot multicenter phase II RCTs are included in this report. In the first pilot, late preterm and term neonates with NHRF, who had an oxygenation index (OI) of ≥15 and <25 on two arterial blood gases and had not previously received INO, were randomly assigned to receive two doses of IPGE1 (300 and 150 ng/kg/min) or placebo. The primary outcome was the enrollment of 50 infants in six to nine months at 10 sites. The first pilot was halted after four months for failure to enroll a single infant. The most common cause for non-enrollment was prior initiation of INO. In a re-designed second pilot, co-administration of IPGE1 and INO was permitted. Infants with suboptimal response to INO received either aerosolized saline or IPGE1 at a low (150 ng/kg/min) or high dose (300 ng/kg/min) for a maximum duration of 72 hours. The primary outcome was the recruitment of an adequate number of patients (n = 50) in a nine-month-period, with fewer than 20% protocol violations. No infants were enrolled in the first pilot. Seven patients were enrolled in the second pilot; three in the control, two in the low-dose IPGE1, and two in the high-dose IPGE1 groups. The study was halted for recruitment futility after approximately six months as enrollment targets were not met. No serious adverse events, one minor protocol deviation and one pharmacy protocol violation were reported. These two pilot RCTs failed to recruit adequate eligible newborns with NHRF. Complex management RCTs of novel therapies for persistent pulmonary

  18. A novel diagnostic aid for intra-abdominal adhesion detection in cine-MR imaging: Pilot study and initial diagnostic impressions.

    Science.gov (United States)

    Randall, David; Joosten, Frank; ten Broek, Richard; Gillott, Richard; Bardhan, Karna Dev; Strik, Chema; Prins, Wiesje; van Goor, Harry; Fenner, John

    2017-07-14

    A non-invasive diagnostic technique for abdominal adhesions is not currently available. Capture of abdominal motion due to respiration in cine-MRI has shown promise, but is difficult to interpret. This article explores the value of a complimentary diagnostic aid to facilitate the non-invasive detection of abdominal adhesions using cine-MRI. An image processing technique was developed to quantify the amount of sliding that occurs between the organs of the abdomen and the abdominal wall in sagittal cine-MRI slices. The technique produces a 'sheargram' which depicts the amount of sliding which has occurred over 1-3 respiratory cycles. A retrospective cohort of 52 patients, scanned for suspected adhesions, made 281 cine-MRI sagittal slices available for processing. The resulting sheargrams were reported by two operators and compared to expert clinical judgement of the cine-MRI scans. The sheargram matched clinical judgement in 84% of all sagittal slices and 93-96% of positive adhesions were identified on the sheargram. The sheargram displayed a slight skew towards sensitivity over specificity, with a high positive adhesion detection rate but at the expense of false positives. Good correlation between sheargram and absence/presence of inferred adhesions indicates quantification of sliding motion has potential to aid adhesion detection in cine-MRI. Advances in Knowledge: This is the first attempt to clinically evaluate a novel image processing technique quantifying the sliding motion of the abdominal contents against the abdominal wall. The results of this pilot study reveal its potential as a diagnostic aid for detection of abdominal adhesions.

  19. The Belgian trial with azithromycin for acute COPD exacerbations requiring hospitalization: an investigator-initiated study protocol for a multicenter, randomized, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Vermeersch K

    2016-03-01

    3 days, followed by a maintenance dose of 250 mg once every 2 days. The primary endpoint is the time-to-treatment failure during the treatment phase (ie, from the moment of randomization until the end of intervention. Treatment failure is a novel composite endpoint defined as either death, the admission to intensive care or the requirement of additional systemic steroids or new antibiotics for respiratory reasons, or the diagnosis of a new AE after discharge.Discussion: We investigate whether azithromycin initiated at the onset of a severe exacerbation, with a limited duration and at a low dose, might be effective and safe in the highest risk period during and immediately after the acute event. If proven effective and safe, this targeted approach may improve the treatment of severe AEs and redirect the preventive use of azithromycin in COPD to a temporary intervention in the subgroup with the highest unmet needs. Keywords: COPD, acute exacerbation, macrolide antibiotics, azithromycin, physical activity, RCT

  20. Initial Weight Loss after Restrictive Bariatric Procedures May Predict Mid-Term Weight Maintenance: Results From a 12-Month Pilot Trial

    OpenAIRE

    Nikolić, Marko; Kruljac, Ivan; Kirigin, Lora; Mirošević, Gorana; Ljubičić, Neven; Nikolić, Borka Pezo; Bekavac-Bešlin, Miroslav; Budimir, Ivan; Vrkljan, Milan

    2015-01-01

    Background: Bariatric procedures are effective options for weight loss (WL) in the morbidly obese. However, some patients fail to lose any weight after bariatric surgery, and mid-term weight maintenance is variable. The aim of this study was to investigate whether initial WL could predict mid-term weight maintenance. ----- Methods: Eighty patients were enrolled, of whom 44 were treated with the BioEnterics Intragastric Balloon (BIB), 21 with laparoscopic adjustable gastric lap-banding (LAGB),...

  1. A Pilot Review of Gradual Versus Goal Re-initiation of Enteral Nutrition after Burn Surgery in the Hemodynamically Stable Patient

    Science.gov (United States)

    2014-01-01

    nutrition after burn surgery in the hemodynamically stable patient 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Shields...specific recommendations on the rate of delivery at initiation [6]. Once a patient is considered hemodynamically stable (HDS), common practice is to...differences in these practices were largely due to new residents and/or nursing staff. GRVs were monitored every 4 h. When GRVs were greater than 500 mL with EN

  2. Pilot implementation

    DEFF Research Database (Denmark)

    Hertzum, Morten; Bansler, Jørgen P.; Havn, Erling C.

    2012-01-01

    A recurrent problem in information-systems development (ISD) is that many design shortcomings are not detected during development, but first after the system has been delivered and implemented in its intended environment. Pilot implementations appear to promise a way to extend prototyping from...... the laboratory to the field, thereby allowing users to experience a system design under realistic conditions and developers to get feedback from realistic use while the design is still malleable. We characterize pilot implementation, contrast it with prototyping, propose a iveelement model of pilot...... implementation and provide three empirical illustrations of our model. We conclude that pilot implementation has much merit as an ISD technique when system performance is contingent on context. But we also warn developers that, despite their seductive conceptual simplicity, pilot implementations can be difficult...

  3. Cryptographic Protocols:

    DEFF Research Database (Denmark)

    Geisler, Martin Joakim Bittel

    cryptography was thus concerned with message confidentiality and integrity. Modern cryptography cover a much wider range of subjects including the area of secure multiparty computation, which will be the main topic of this dissertation. Our first contribution is a new protocol for secure comparison, presented...... implemented the comparison protocol in Java and benchmarks show that is it highly competitive and practical. The biggest contribution of this dissertation is a general framework for secure multiparty computation. Instead of making new ad hoc implementations for each protocol, we want a single and extensible...... in Chapter 2. Comparisons play a key role in many systems such as online auctions and benchmarks — it is not unreasonable to say that when parties come together for a multiparty computation, it is because they want to make decisions that depend on private information. Decisions depend on comparisons. We have...

  4. PULSE Pilot Certification Results

    Directory of Open Access Journals (Sweden)

    Pamela Pape-Lindstrom

    2015-08-01

    Full Text Available The pilot certification process is an ambitious, nationwide endeavor designed to motivate important changes in life sciences education that are in line with the recommendations of the 2011 Vision and Change Report: A Call to Action (American Association for the Advancement of Science [AAAS], 2011.  It is the goal of the certification process to acknowledge departments that have progressed towards full implementation of the tenets of Vision and Change and to motivate departments that have not begun to adopt the recommendations to consider doing so.  More than 70 life science departments applied to be part of the pilot certification process, funded by a National Science Foundation grant, and eight were selected based on initial evidence of transformed and innovative educational practices.  The programs chosen represent a wide variety of schools, including two-year colleges, liberal-arts institutions, regional comprehensive colleges, research universities and minority serving institutions.  Outcomes from this pilot were released June 1, 2015 (www.pulsecommunity.org, with all eight programs being recognized as having progressed along a continuum of change.  Five levels of achievement were defined as PULSE Pilot Progression Levels.  Of the eight departments in the pilot, one achieved “PULSE Progression Level III: Accomplished”.  Six departments achieved “PULSE Progression Level II: Developing” and one pilot department achieved “PULSE Progression Level I: Beginning”.  All of the schools have made significant movement towards the recommendations of Vision and Change relative to a traditional life sciences curriculum.  Overall, the response from the eight pilot schools has been positive. 

  5. In silico toxicology protocols.

    Science.gov (United States)

    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

    2018-04-17

    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. Published by Elsevier Inc.

  6. Pilot randomized trial of therapeutic hypothermia with serial cranial ultrasound and 18-22 month follow-up for neonatal encephalopathy in a low resource hospital setting in uganda: study protocol

    Directory of Open Access Journals (Sweden)

    Costello Anthony

    2011-06-01

    Full Text Available Abstract Background There is now convincing evidence that in industrialized countries therapeutic hypothermia for perinatal asphyxial encephalopathy increases survival with normal neurological function. However, the greatest burden of perinatal asphyxia falls in low and mid-resource settings where it is unclear whether therapeutic hypothermia is safe and effective. Aims Under the UCL Uganda Women's Health Initiative, a pilot randomized controlled trial in infants with perinatal asphyxia was set up in the special care baby unit in Mulago Hospital, a large public hospital with ~20,000 births in Kampala, Uganda to determine: (i The feasibility of achieving consent, neurological assessment, randomization and whole body cooling to a core temperature 33-34°C using water bottles (ii The temperature profile of encephalopathic infants with standard care (iii The pattern, severity and evolution of brain tissue injury as seen on cranial ultrasound and relation with outcome (iv The feasibility of neurodevelopmental follow-up at 18-22 months of age Methods/Design Ethical approval was obtained from Makerere University and Mulago Hospital. All infants were in-born. Parental consent for entry into the trial was obtained. Thirty-six infants were randomized either to standard care plus cooling (target rectal temperature of 33-34°C for 72 hrs, started within 3 h of birth or standard care alone. All other aspects of management were the same. Cooling was performed using water bottles filled with tepid tap water (25°C. Rectal, axillary, ambient and surface water bottle temperatures were monitored continuously for the first 80 h. Encephalopathy scoring was performed on days 1-4, a structured, scorable neurological examination and head circumference were performed on days 7 and 17. Cranial ultrasound was performed on days 1, 3 and 7 and scored. Griffiths developmental quotient, head circumference, neurological examination and assessment of gross motor function were

  7. Feasibility and pilot study of the effects of microfinance on mortality and nutrition in children under five amongst the very poor in India: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Ojha, Shalini; Szatkowski, Lisa; Sinha, Ranjeet; Yaron, Gil; Fogarty, Andrew; Allen, Stephen; Choudhary, Sunil; Smyth, Alan R

    2014-07-23

    The United Nations Millennium Development Goals include targets for the health of children under five years old. Poor health is linked to poverty and microfinance initiatives are economic interventions that may improve health by breaking the cycle of poverty. However, there is a lack of reliable evidence to support this. In addition, microfinance schemes may have adverse effects on health, for example due to increased indebtedness. Rojiroti UK and the Centre for Promoting Sustainable Livelihood run an innovative microfinance scheme that provides microcredit via women's self-help groups (SHGs). This pilot study, conducted in rural Bihar (India), will establish whether it is feasible to collect anthropometric and mortality data on children under five years old and to conduct a limited cluster randomized trial of the Rojiroti intervention. We have designed a cluster randomized trial in which participating tolas (small communities within villages) will be randomized to either receive early (SHGs and microfinance at baseline) or late intervention (SHGs and microfinance after 18 months). Using predesigned questionnaires, demographic, and mortality data for the last year and information about participating mothers and their children will be collected and the weight, height, and mid upper arm circumference (MUAC) of children will be measured at baseline and at 18 months. The late intervention group will establish SHGs and microfinance support at this point and data collection will be repeated at 36 months.The primary outcome measure will be the mean weight for height z-score of children under five years old in the early and late intervention tolas at 18 months. Secondary outcome measures will be the mortality rate, mean weight for age, height for age, prevalence of underweight, stunting, and wasting among children under five years of age. Despite economic progress, marked inequalities in child health persist in India and Bihar is one of the worst affected states. There

  8. PlenadrEMA: effect of dual-release versus conventional hydrocortisone on fatigue, measured by ecological momentary assessments: a study protocol for an open-label switch pilot study.

    Science.gov (United States)

    Boesen, Victor Brun; Christoffersen, Thea; Watt, Torquil; Borresen, Stina Willemoes; Klose, Marianne; Feldt-Rasmussen, Ulla

    2018-01-23

    Patients with adrenal insufficiency have impaired health-related quality of life (QoL). The dual-release hydrocortisone preparation, Plenadren, has been developed to mimic the physiological cortisol release more closely than conventional hydrocortisone treatment. Plenadren has been shown to improve QoL, in particular fatigue, in patients with primary adrenal insufficiency. However, the effect has not been investigated in patients with secondary adrenal insufficiency; furthermore, no study has taken the diurnal variation of fatigue into account. To assess diurnal variations, it is necessary to use repeated daily measurements, such as ecological momentary assessments (EMAs). This study aims to evaluate EMAs of fatigue as outcome in future large-scale randomised clinical trials. The PlenadrEMA trial is an investigator-initiated open-label switch pilot trial of the effect of Plenadren versus conventional hydrocortisone on fatigue in patients with secondary adrenal insufficiency. The trial will include 30 participants. After 5 weeks on their usual hydrocortisone treatment, patients will be shifted to Plenadren for 16 weeks. Fatigue will be assessed using momentary versions of the Multidimensional Fatigue Inventory (MFI-20). Items will be administered to participants via a smartphone application four times daily during 20 days. Assessments will be performed before treatment shift and repeated after 12.5 weeks on Plenadren. The study will identify the best suited outcome for future randomised clinical trials, and in addition, estimate the variability and difference in fatigue between the two treatments to perform power calculations. The trial will be conducted in accordance with the Declaration of Helsinki and has been approved by the Regional Scientific Ethical Committee in Copenhagen (ID: H-1-2014-073). All patients will receive written and verbal information about the trial and will give informed consent before enrolment. Findings will be published in peer

  9. The Lung Screen Uptake Trial (LSUT): protocol for a randomised controlled demonstration lung cancer screening pilot testing a targeted invitation strategy for high risk and 'hard-to-reach' patients.

    Science.gov (United States)

    Quaife, Samantha L; Ruparel, Mamta; Beeken, Rebecca J; McEwen, Andy; Isitt, John; Nolan, Gary; Sennett, Karen; Baldwin, David R; Duffy, Stephen W; Janes, Samuel M; Wardle, Jane

    2016-04-20

    Participation in low-dose CT (LDCT) lung cancer screening offered in the trial context has been poor, especially among smokers from socioeconomically deprived backgrounds; a group for whom the risk-benefit ratio is improved due to their high risk of lung cancer. Attracting high risk participants is essential to the success and equity of any future screening programme. This study will investigate whether the observed low and biased uptake of screening can be improved using a targeted invitation strategy. A randomised controlled trial design will be used to test whether targeted invitation materials are effective at improving engagement with an offer of lung cancer screening for high risk candidates. Two thousand patients aged 60-75 and recorded as a smoker within the last five years by their GP, will be identified from primary care records and individually randomised to receive either intervention invitation materials (which take a targeted, stepped and low burden approach to information provision prior to the appointment) or control invitation materials. The primary outcome is uptake of a nurse-led 'lung health check' hospital appointment, during which patients will be offered a spirometry test, an exhaled carbon monoxide (CO) reading, and an LDCT if eligible. Initial data on demographics (i.e. age, sex, ethnicity, deprivation score) and smoking status will be collected in primary care and analysed to explore differences between attenders and non-attenders with respect to invitation group. Those who attend the lung health check will have further data on smoking collected during their appointment (including pack-year history, nicotine dependence and confidence to quit). Secondary outcomes will include willingness to be screened, uptake of LDCT and measures of informed decision-making to ensure the latter is not compromised by either invitation strategy. If effective at improving informed uptake of screening and reducing bias in participation, this invitation

  10. Immunochemical protocols

    National Research Council Canada - National Science Library

    Pound, John D

    1998-01-01

    ... easy and important refinements often are not published. This much anticipated 2nd edition of Immunochemzcal Protocols therefore aims to provide a user-friendly up-to-date handbook of reliable techniques selected to suit the needs of molecular biologists. It covers the full breadth of the relevant established immunochemical methods, from protein blotting and immunoa...

  11. ORGANIC EMISSIONS FROM PILOT-SCALE INCINERATION OF CFCS

    Science.gov (United States)

    The paper gives results of the characterization of organic emissions resulting from the pilot-scale incineration of trichlorofluoromethane (CFC-11) and dichlorodifluoromethane (CFC-12) under varied feed concentrations. (NOTE: As a result of the Montreal Protocol, an international...

  12. Identification of Relationships Between Patients Through Elements in a Data Warehouse Using the Familial, Associational, and Incidental Relationship (FAIR) Initiative: A Pilot Study.

    Science.gov (United States)

    English, Thomas M; Kinney, Rebecca L; Davis, Michael J; Kamberi, Ariana; Chan, Wayne; Sadasivam, Rajani S; Houston, Thomas K

    2015-02-13

    Over the last several years there has been widespread development of medical data warehouses. Current data warehouses focus on individual cases, but lack the ability to identify family members that could be used for dyadic or familial research. Currently, the patient's family history in the medical record is the only documentation we have to understand the health status and social habits of their family members. Identifying familial linkages in a phenotypic data warehouse can be valuable in cohort identification and in beginning to understand the interactions of diseases among families. The goal of the Familial, Associational, & Incidental Relationships (FAIR) initiative is to identify an index set of patients' relationships through elements in a data warehouse. Using a test set of 500 children, we measured the sensitivity and specificity of available linkage algorithm identifiers (eg, insurance identification numbers and phone numbers) and validated this tool/algorithm through a manual chart audit. Of all the children, 52.4% (262/500) were male, and the mean age of the cohort was 8 years old (SD 5). Of the children, 51.6% (258/500) were identified as white in race. The identifiers used for FAIR were available for the majority of patients: insurance number (483/500, 96.6%), phone number (500/500, 100%), and address (497/500, 99.4%). When utilizing the FAIR tool and various combinations of identifiers, sensitivity ranged from 15.5% (62/401) to 83.8% (336/401), and specificity from 72% (71/99) to 100% (99/99). The preferred method was matching patients using insurance or phone number, which had a sensitivity of 72.1% (289/401) and a specificity of 94% (93/99). Using the Informatics for Integrating Biology and the Bedside (i2b2) warehouse infrastructure, we have now developed a Web app that facilitates FAIR for any index population. FAIR is a valuable research and clinical resource that extends the capabilities of existing data warehouses and lays the groundwork for

  13. The Automated Breast Volume Scanner (ABVS: initial experiences in lesion detection compared with conventional handheld B-mode ultrasound: a pilot study of 50 cases

    Directory of Open Access Journals (Sweden)

    Wojcinski S

    2011-10-01

    Full Text Available Sebastian Wojcinski1, Andre Farrokh1, Ursula Hille2, Jakub Wiskirchen3, Samuel Gyapong1, Amr A Soliman1,4, Friedrich Degenhardt1, Peter Hillemanns21Department of OB/GYN, Franziskus Hospital, Bielefeld, Germany; 2Department of OB/GYN, Hannover Medical School, Hannover, Germany; 3Department of Radiology, Franziskus Hospital, Bielefeld, Germany; 4Department of OB/GYN, Faculty of Medicine, University of Alexandria, Alexandria, EgyptAbstract: The idea of an automated whole breast ultrasound was developed three decades ago. We present our initial experiences with the latest technical advance in this technique, the automated breast volume scanner (ABVS ACUSON S2000TM. Volume data sets were collected from 50 patients and a database containing 23 women with no detectable lesions in conventional ultrasound (BI-RADS®-US 1, 13 women with clearly benign lesions (BI-RADS®-US 2, and 14 women with known breast cancer (BI-RADS®-US 5 was created. An independent examiner evaluated the ABVS data on a separate workstation without any prior knowledge of the patients’ histories. The diagnostic accuracy for the experimental ABVS was 66.0% (95% confidence interval [CI]: 52.9–79.1. The independent examiner detected all breast cancers in the volume data resulting in a calculated sensitivity of 100% in the described setting (95% CI: 73.2%–100%. After the ABVS examination, there were a high number of requests for second-look ultrasounds in 47% (95% CI: 30.9–63.5 of the healthy women (with either a clearly benign lesion or no breast lesions at all in conventional handheld ultrasound. Therefore, the specificity remained at 52.8% (95% CI: 35.7–69.2. When comparing the concordance of the ABVS with the gold standard (conventional handheld ultrasound, Cohen’s Kappa value as an estimation of the inter-rater reliability was κ = 0.37, indicating fair agreement. In conclusion, the ABVS must still be regarded as an experimental technique for breast ultrasound, which

  14. A Youth-Led, Social Marketing Intervention Run by Adolescents to Encourage Healthy Lifestyles among Younger School Peers (EYTO-Kids Project): A Protocol for Pilot Cluster Randomized Controlled Trial (Spain)

    OpenAIRE

    Tarro, Lucia; Aceves-Martins, Magaly; Papell-Garcia, Ignasi; Arola, Llu?s; Giralt, Montse; Llaurad?, Elisabet; Sol?, Rosa

    2017-01-01

    Introduction: The EYTO-kids (European Youth Tackling Obesity in Adolescents and Children) study aims to increase fruit and/or vegetable consumption and physical activity, decrease sedentary lifestyles, and reduce the intake of sugary drinks and fast food using an innovative methodology based on social marketing and youth involvement. Methods: This study is a pilot school-based cluster randomized controlled 10-month intervention spanning two academic years (2015?2016 and 2016?2017), with eight...

  15. Study protocol

    DEFF Research Database (Denmark)

    Smith, Benjamin E; Hendrick, Paul; Bateman, Marcus

    2017-01-01

    avoidance behaviours, catastrophising, self-efficacy, sport and leisure activity participation, and general quality of life. Follow-up will be 3 and 6 months. The analysis will focus on descriptive statistics and confidence intervals. The qualitative components will follow a thematic analysis approach....... DISCUSSION: This study will evaluate the feasibility of running a definitive large-scale trial on patients with patellofemoral pain, within the NHS in the UK. We will identify strengths and weaknesses of the proposed protocol and the utility and characteristics of the outcome measures. The results from...... this study will inform the design of a multicentre trial. TRIAL REGISTRATION: ISRCTN35272486....

  16. A pilot randomized controlled trial of Dialectical Behavior Therapy with and without the Dialectical Behavior Therapy Prolonged Exposure protocol for suicidal and self-injuring women with borderline personality disorder and PTSD.

    Science.gov (United States)

    Harned, Melanie S; Korslund, Kathryn E; Linehan, Marsha M

    2014-04-01

    This study evaluates the efficacy of integrating PTSD treatment into Dialectical Behavior Therapy (DBT) for women with borderline personality disorder, PTSD, and intentional self-injury. Participants were randomized to DBT (n=9) or DBT with the DBT Prolonged Exposure (DBT PE) protocol (n=17) and assessed at 4-month intervals during the treatment year and 3-months post-treatment. Treatment expectancies, satisfaction, and completion did not differ by condition. In DBT+DBT PE, the DBT PE protocol was feasible to implement for a majority of treatment completers. Compared to DBT, DBT+DBT PE led to larger and more stable improvements in PTSD and doubled the remission rate among treatment completers (80% vs. 40%). Patients who completed the DBT PE protocol were 2.4 times less likely to attempt suicide and 1.5 times less likely to self-injure than those in DBT. Among treatment completers, moderate to large effect sizes favored DBT+DBT PE for dissociation, trauma-related guilt cognitions, shame, anxiety, depression, and global functioning. DBT with the DBT PE protocol is feasible, acceptable, and safe to administer, and may lead to larger improvements in PTSD, intentional self-injury, and other outcomes than DBT alone. The findings require replication in a larger sample. Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. Model Additional Protocol

    International Nuclear Information System (INIS)

    Rockwood, Laura

    2001-01-01

    Since the end of the cold war a series of events has changed the circumstances and requirements of the safeguards system. The discovery of a clandestine nuclear weapons program in Iraq, the continuing difficulty in verifying the initial report of Democratic People's Republic of Korea upon entry into force of their safeguards agreement, and the decision of the South African Government to give up its nuclear weapons program and join the Treaty on the Non-Proliferation of Nuclear Weapons have all played a role in an ambitious effort by IAEA Member States and the Secretariat to strengthen the safeguards system. A major milestone in this effort was reached in May 1997 when the IAEA Board of Governors approved a Model Protocol Additional to Safeguards Agreements. The Model Additional Protocol was negotiated over a period of less than a year by an open-ended committee of the Board involving some 70 Member States and two regional inspectorates. The IAEA is now in the process of negotiating additional protocols, State by State, and implementing them. These additional protocols will provide the IAEA with rights of access to information about all activities related to the use of nuclear material in States with comprehensive safeguards agreements and greatly expanded physical access for IAEA inspectors to confirm or verify this information. In conjunction with this, the IAEA is working on the integration of these measures with those provided for in comprehensive safeguards agreements, with a view to maximizing the effectiveness and efficiency, within available resources, the implementation of safeguards. Details concerning the Model Additional Protocol are given. (author)

  18. Pilot Greenhouse

    CERN Multimedia

    1983-01-01

    This pilot greenhouse was built in collaboration with the "Association des Maraichers" of Geneva in the frame of the study for making use of the heat rejected as warm water by CERN accelerators and experiments. Among other improvements, more automated and precise regulation systems for heating and ventilation were developed. See also 8305598X.

  19. Beyond protocols

    DEFF Research Database (Denmark)

    Vanderhoeven, Sonia; Branquart, Etienne; Casaer, Jim

    2017-01-01

    Risk assessment tools for listing invasive alien species need to incorporate all available evidence and expertise. Beyond the wealth of protocols developed to date, we argue that the current way of performing risk analysis has several shortcomings. In particular, lack of data on ecological impact...... information on risk and the exploration of improved methods for decision making on biodiversity management. This is crucial for efficient conservation resource allocation and uptake by stakeholders and the public......., transparency and repeatability of assessments as well as the incorporation of uncertainty should all be explicitly considered. We recommend improved quality control of risk assessments through formalized peer review with clear feedback between assessors and reviewers. Alternatively, a consensus building...

  20. 76 FR 56868 - Pilot Project on NAFTA Trucking Provisions

    Science.gov (United States)

    2011-09-14

    ...-0097] Pilot Project on NAFTA Trucking Provisions AGENCY: Federal Motor Carrier Safety Administration... that have applied to participate in the Agency's long- haul pilot program to test and demonstrate the... proceed with the initiation of a U.S.-Mexico cross-border long-haul trucking pilot program to test and...

  1. 77 FR 40938 - Pilot Program on NAFTA Trucking Provisions

    Science.gov (United States)

    2012-07-11

    ...-0097] Pilot Program on NAFTA Trucking Provisions AGENCY: Federal Motor Carrier Safety Administration... Morales Guevara (DBA Fletes Morales) which applied to participate in the Agency's long-haul pilot program...] its intent to proceed with the initiation of a U.S.-Mexico cross-border long-haul trucking pilot...

  2. 77 FR 27837 - Pilot Program on NAFTA Trucking Provisions

    Science.gov (United States)

    2012-05-11

    ...-0097] Pilot Program on NAFTA Trucking Provisions AGENCY: Federal Motor Carrier Safety Administration... carriers that applied to participate in the Agency's long- haul pilot program to test and demonstrate the... intent to proceed with the initiation of a U.S.-Mexico cross-border long-haul trucking pilot program to...

  3. 76 FR 73765 - Pilot Project on NAFTA Trucking Provisions

    Science.gov (United States)

    2011-11-29

    ...-0097] Pilot Project on NAFTA Trucking Provisions AGENCY: Federal Motor Carrier Safety Administration... that have applied to participate in the Agency's long- haul pilot program to test and demonstrate the... proceed with the initiation of a U.S.-Mexico cross-border long-haul trucking pilot program to test and...

  4. Effects of a tele-prehabilitation program or an in-person prehabilitation program in surgical candidates awaiting total hip or knee arthroplasty: Protocol of a pilot single blind randomized controlled trial.

    Science.gov (United States)

    Doiron-Cadrin, Patrick; Kairy, Dahlia; Vendittoli, Pascal-André; Lowry, Véronique; Poitras, Stéphane; Desmeules, François

    2016-12-15

    The accessibility for total joint arthroplasty often comes up against long wait lists, and may lead to deleterious effects for the awaiting patients. This pilot single blind randomized controlled trial aims to evaluate the impact of a telerehabilitation prehabilitation program before a hip or knee arthroplasty compared to in-person prehabilitation or to usual wait for surgery. Thirty-six patients on a wait list for a total hip or knee arthroplasty will be recruited and randomly assigned to one of three groups. The in-person prehabilitation group (n = 12) will receive a 12-week rehabilitation program (2 sessions/week) including education, exercises of the lower limb and cardiovascular training. Patients in the tele-prehabilitation group (n = 12) will receive the same intervention using a telecommunication software. The control group (n = 12) will be provided with the hospital's usual documentation before surgery. The Lower Extremity Functional Scale (LEFS) will be the primary outcome measure taken at baseline and at 12 weeks. Secondary measures will include self-reported function and quality of life as well as performance tests. A mixed-model, 2-way repeated-measure ANOVA will be used to analyse the effects of the rehabilitation programs. This pilot study is the first to evaluate the feasibility and the impact of a telerehabilitation prehabilitation program for patients awaiting a total joint arthroplasty. The results of this pilot-RCT will set the foundations for further research in the fields of rehabilitation and tele-medicine for patients suffering from lower limb osteoarthritis. ClinicalTrials.gov: NCT02636751.

  5. Effectiveness of oxaliplatin desensitization protocols.

    Science.gov (United States)

    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.

  6. Evaluation report. Pilot - Trondheim and Elverum : Energy labeling of houses; Evalueringsrapport. Pilot - Trondheim og Elverum : Energimerking av boliger

    Energy Technology Data Exchange (ETDEWEB)

    2009-05-15

    This report is an evaluation of the pilot project related to energy labeling of buildings. The document provides reviews of communication initiatives that have been implemented in the pilot. In addition, comments on the usability of the Online Energy Label system. Last in the document the recommendations for national roll-out of energy labeling of buildings, based on experiences from the pilot. (AG)

  7. The CUPCIG (CAM-Use in Primary Care in Germany) Study:Part I-Pain. Study Protocol of a Pilot-trial to Assess Feasibility, Acceptability and Perceived Effectiveness of CAM in Pain Disorders in Primary Care.

    Science.gov (United States)

    Schencking, Martin; Sönnichsen, Andreas; Bassüner, Susanne; Redaelli, Marcus

    2015-01-01

    There is limited valid data available on CAM procedures for chronic joint and neuropathic pain in primary care in Germany. Indiviual CAM qualifications of the general practitioners (GPs) and the potential of cost reduction through CAM treatment are almost unknown. The aim of this pilot trial preceding the main study is to examine the survey mode, to estimate the response rate by GPs with or without an additional qualification for CAM, and to identify the status quo in therapeutic approaches for chronic pain disorders in primary care. This is a cross-sectional study with an ex post facto design among German GPs consisting of 2 parts: In a first step, a pilot trial precedes the main study targeting 200 GPs with and 200 GPs without additional qualification in CAM in a selected region. The results of the CUPCIG study comprise the distribution of pain types treated in primary care practices, the GPs' attitude toward complementary pain therapy, pharmacological or CAM treatment, the estimate of cost reduction through CAM treatment of pain, the application of diverse CAM procedures, and biographical data. The CUPCIG study serves to compile pain therapy approaches in primary care in Germany with respect to the individual CAM expertise of the GPs. © 2015 S. Karger GmbH, Freiburg.

  8. Efficiency and effectiveness of the use of an acenocoumarol pharmacogenetic dosing algorithm versus usual care in patients with venous thromboembolic disease initiating oral anticoagulation: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Carcas Antonio J

    2012-12-01

    Full Text Available Abstract Background Hemorrhagic events are frequent in patients on treatment with antivitamin-K oral anticoagulants due to their narrow therapeutic margin. Studies performed with acenocoumarol have shown the relationship between demographic, clinical and genotypic variants and the response to these drugs. Once the influence of these genetic and clinical factors on the dose of acenocoumarol needed to maintain a stable international normalized ratio (INR has been demonstrated, new strategies need to be developed to predict the appropriate doses of this drug. Several pharmacogenetic algorithms have been developed for warfarin, but only three have been developed for acenocoumarol. After the development of a pharmacogenetic algorithm, the obvious next step is to demonstrate its effectiveness and utility by means of a randomized controlled trial. The aim of this study is to evaluate the effectiveness and efficiency of an acenocoumarol dosing algorithm developed by our group which includes demographic, clinical and pharmacogenetic variables (VKORC1, CYP2C9, CYP4F2 and ApoE in patients with venous thromboembolism (VTE. Methods and design This is a multicenter, single blind, randomized controlled clinical trial. The protocol has been approved by La Paz University Hospital Research Ethics Committee and by the Spanish Drug Agency. Two hundred and forty patients with VTE in which oral anticoagulant therapy is indicated will be included. Randomization (case/control 1:1 will be stratified by center. Acenocoumarol dose in the control group will be scheduled and adjusted following common clinical practice; in the experimental arm dosing will be following an individualized algorithm developed and validated by our group. Patients will be followed for three months. The main endpoints are: 1 Percentage of patients with INR within the therapeutic range on day seven after initiation of oral anticoagulant therapy; 2 Time from the start of oral anticoagulant treatment

  9. Efficiency and effectiveness of the use of an acenocoumarol pharmacogenetic dosing algorithm versus usual care in patients with venous thromboembolic disease initiating oral anticoagulation: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Carcas, Antonio J; Borobia, Alberto M; Velasco, Marta; Abad-Santos, Francisco; Díaz, Manuel Quintana; Fernández-Capitán, Carmen; Ruiz-Giménez, Nuria; Madridano, Olga; Sillero, Pilar Llamas

    2012-12-13

    Hemorrhagic events are frequent in patients on treatment with antivitamin-K oral anticoagulants due to their narrow therapeutic margin. Studies performed with acenocoumarol have shown the relationship between demographic, clinical and genotypic variants and the response to these drugs. Once the influence of these genetic and clinical factors on the dose of acenocoumarol needed to maintain a stable international normalized ratio (INR) has been demonstrated, new strategies need to be developed to predict the appropriate doses of this drug. Several pharmacogenetic algorithms have been developed for warfarin, but only three have been developed for acenocoumarol. After the development of a pharmacogenetic algorithm, the obvious next step is to demonstrate its effectiveness and utility by means of a randomized controlled trial. The aim of this study is to evaluate the effectiveness and efficiency of an acenocoumarol dosing algorithm developed by our group which includes demographic, clinical and pharmacogenetic variables (VKORC1, CYP2C9, CYP4F2 and ApoE) in patients with venous thromboembolism (VTE). This is a multicenter, single blind, randomized controlled clinical trial. The protocol has been approved by La Paz University Hospital Research Ethics Committee and by the Spanish Drug Agency. Two hundred and forty patients with VTE in which oral anticoagulant therapy is indicated will be included. Randomization (case/control 1:1) will be stratified by center. Acenocoumarol dose in the control group will be scheduled and adjusted following common clinical practice; in the experimental arm dosing will be following an individualized algorithm developed and validated by our group. Patients will be followed for three months. The main endpoints are: 1) Percentage of patients with INR within the therapeutic range on day seven after initiation of oral anticoagulant therapy; 2) Time from the start of oral anticoagulant treatment to achievement of a stable INR within the therapeutic

  10. Dysphonia risk screening protocol

    Directory of Open Access Journals (Sweden)

    Katia Nemr

    2016-03-01

    Full Text Available 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.

  11. Dysphonia risk screening protocol

    Science.gov (United States)

    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

  12. Local initiative extrapolated to nation

    DEFF Research Database (Denmark)

    Wittchen, Kim Bjarne; Kragh, Jesper; Brøgger, Morten

    In the municipality of Sønderborg, in the southern part of Jutland, there is a shining example initiated in 2007, ProjectZero, of a local initiative that have resulted in extensive energy savings in residential buildings and at the same time created local workplaces. The intension with the pilot...

  13. The effectiveness of the Incredible Years Parents and Babies Program as a universal prevention intervention for parents of infants in Denmark: study protocol for a pilot randomized controlled trial

    DEFF Research Database (Denmark)

    Pontoppidan, Maiken W.

    2015-01-01

    support parents in providing sensitive and responsive care, and reinforce healthy development for their infants. This study aims to evaluate the impact of the Incredible Years™ Parents and Babies Program in a universal setting for parents with infants. Methods/Design: This is a pragmatic, two......-arm, parallel, pilot, randomized controlled trial (RCT) where 128 families with newborn infants up to four-months-old are recruited in two municipalities in Denmark. Families are randomized to the Incredible Years Parents and Babies Program or usual care with a 2:1 allocation ratio. The primary outcome....... Discussion: This is the first RCT of the Incredible Years Parents and Babies Program, and one of the first rigorous evaluations of a universally offered preventive intervention for parents with infants. The trial will provide important information on the effectiveness of a relatively brief, universally...

  14. Testing the feasibility and acceptability of using the Nintendo Wii in the home to increase activity levels, vitality and well-being in people with multiple sclerosis (Mii-vitaliSe): protocol for a pilot randomised controlled study.

    Science.gov (United States)

    Thomas, Sarah; Fazakarley, Louise; Thomas, Peter W; Brenton, Sarah; Collyer, Sarah; Perring, Steve; Scott, Rebecca; Galvin, Kathleen; Hillier, Charles

    2014-05-07

    The benefits of physical activity for people with multiple sclerosis (pwMS) have been recognised. However, exercise regimens can be difficult to maintain over the longer term and pwMS may face unique barriers to physical activity engagement. Pilot research suggests the Nintendo Wii can be used safely at home by pwMS with minimal mobility/balance issues and may confer benefits. We have developed a home-based physiotherapist supported Wii intervention ('Mii-vitaliSe') for pwMS that uses commercial software. This is a pilot study to explore the feasibility of conducting a full scale clinical and cost-effectiveness trial of Mii-vitaliSe. 30 ambulatory, relatively inactive pwMS will be randomised to receive Mii-vitaliSe immediately, or after 6 months. Outcomes, measured at baseline and 6 and 12 months later, will include balance, gait, mobility, hand dexterity and self-reported physical activity levels, fatigue, self-efficacy, mood and quality of life. Interviews conducted on a purposive sample of participants will explore experiences of participation in the study and barriers and facilitators to using the Wii. Mean recruitment, adherence rate and standard deviations (SDs) of potential primary outcomes for the full trial will be estimated and precision summarised using 95% confidence intervals (CIs). Interview transcripts will be thematically analysed using a generic qualitative approach. National Health Service (NHS; ref 12/SC/0420) and university ethical approvals have been obtained as has NHS Research and Development permission from the relevant trust. A home risk assessment will be undertaken for all potential participants. All adverse events will be closely monitored, documented and reported to the study Safety Monitoring Committee. At least one publication in a peer reviewed journal will be produced and research findings presented at a national and international conference. With service users, we will coproduce a summary of the findings for dissemination on our

  15. Can qualitatively similar temperature-histories be obtained in different pilot HP units?

    NARCIS (Netherlands)

    Landfeld, A.; Matser, A.M.; Strohalm, J.; Oey, I.; Plancken, van der I.; Grauwet, T.; Hendrickx, M.; Moates, G.; Furfaro, M.E.; Waldron, K.W.; Betz, M.; Halama, R.; Houska, M.

    2011-01-01

    An experimental protocol to harmonize the pressure and temperature-histories of model samples treated in different individual high pressure pilot units was developed. This protocol was based on the endpoint strategy. Step zero of this protocol consisted of an exploratory measurement of the pressure,

  16. Priming a Pilot Implementation

    DEFF Research Database (Denmark)

    Hansen, Magnus; Ie Pedersen, Maria

    Abstract. We report on the initial findings of an action research study about effects specifications. It is a part of larger IS pilot implementation project conducted in the Danish healthcare sector. Through interviews and a workshop we have identified and specified the main effects that comprise...... the basis for the evaluation of the project. The study indicates that cross-organisational effects specifications cause a significant number of effects. To further prioritize these we argue that both interview and workshop must be facilitated as mutual learning processes between interviewer and interviewee....

  17. A comparison between r-LH and urinary supplements containing LH activity in patients undergoing the microdose GnRH agonist flare protocol for in-vitro fertilization: a pilot study.

    Science.gov (United States)

    Shavit, Tal; Agdi, Mohammed; Son, Weon Y; Hasson, Josseph; Dahan, Michael H

    2016-08-01

    The aim of this study was to compare pregnancy rates and stimulation parameters in patients with diminished ovarian reserve, who were treated with recombinant human luteinizing hormone (r-LH) or menopausal gonadotropins (hMG), as part of a microdose flare protocol. A retrospective cohort study was performed. Comparisons between the group that was stimulated with r-LH plus follicle stimulating hormone (FSH) to those treated with hMG and FSH, were performed. Measurements included: medication doses, number of oocyte collected, number of embryos obtained, pregnancy and clinical pregnancy rates. Patients in the r-LH group (N.=40) had significant higher clinical pregnancy rates (33% vs. 14%; P=0.04) and used lower dose of LH (1938 IU vs. 2807 IU; P=0.02) compared to patients that were stimulated with hMG (N.=39). r-LH may offer advantages for the treatment of diminished ovarian reserve when performing a microdose flare protocol when compared to hMG. Both larger and prospective studies should be carried out to confirm these findings.

  18. Oxygen tolerance test : A standardised protocol

    Directory of Open Access Journals (Sweden)

    D K Ghosh

    2015-01-01

    Conclusion: By following a standardised protocol for Oxygen Tolerance Test, an objective assessment and recordkeeping is possible. This shall entail a more effective screening during the initial diving medical examination.

  19. Combined staging at one stop using MR mammography. Evaluation of an extended protocol to screen for distant metastasis in primary breast cancer. Initial results and diagnostic accuracy in a prospective study

    Energy Technology Data Exchange (ETDEWEB)

    Dietzel, M.; Zoubi, R.; Burmeister, H.P.; Kaiser, W.A.; Baltzer, P.A.T. [Jena Univ. (Germany). Inst. of Diagnostic and Interventional Radiology; Runnebaum, I.B. [University Hospital Jena (Germany). Dept. of Gynecology and Obstetrics

    2012-07-15

    Purpose: Accurate staging of primary breast cancer is essential for the therapeutic approach. Modern whole-body MR scanners would allow local and distant staging during a single examination. Accordingly, we designed a dedicated protocol for this purpose and prospectively evaluated the diagnostic accuracy. Materials and Methods: 65 consecutive breast cancer patients underwent pre-therapeutic MRI (1.5 T). A bilateral breast protocol (axial: T1w/GRE dynamic contrast-enhanced, T2w/TSE; TA: 10 min) was extended to screen for distant metastasis at one stop without repositioning (coronal: T2w/HASTE, T1w/VIBE; FOV: thorax, abdomen and spine; TA: 90 sec; multichannel surface coils). The standard of reference was S3 guideline-compliant staging examinations. Global assessment regarding the presence of distant metastasis was performed independently by two experienced and blinded radiologists (five-level confidence score). Inter-rater agreement (weighted kappa) and observer scoring were analyzed (contingency tables). Results: The prevalence of synchronous metastases was 7.7 % (n = 5). The protocol enabled global assessment regarding the presence of distant metastasis with high accuracy (sensitivity: 100 %; specificity: 98.3 %) and inter-rater agreement (kappa: 0.92). Conclusion: Applying the extended MRI protocol, accurate screening for distant metastasis was possible in combination with a dedicated breast examination. (orig.)

  20. Testing the feasibility of a knowledge translation intervention designed to improve chiropractic care for adults with neck pain disorders: study protocol for a pilot cluster-randomized controlled trial.

    Science.gov (United States)

    Dhopte, Prakash; Ahmed, Sara; Mayo, Nancy; French, Simon; Quon, Jeffrey A; Bussières, André

    2016-01-01

    Neck pain in adults is common and a leading cause of physical disability. Recently, a guideline was developed for the management of non-specific neck pain (NSNP) with an aim to improve the quality of the delivery of chiropractic care. One key guideline recommendation is to undertake multimodal care for patients with NSNP. The aim of this pilot study is to determine the feasibility of implementing a multifaceted knowledge translation intervention by promoting the use of multimodal care by chiropractors managing patients with NSNP. The design is a cluster-randomized controlled pilot and feasibility trial. Chiropractors in private practice in Canada will be approached to participate in the study. Thirty consenting chiropractors will be randomized to receive either a theory-based educational intervention in the experimental group or simply a printed copy of the guideline in the control group. Each chiropractor will recruit five neck pain patients (a total of 150 patients) into the study. Development of the multifaceted intervention was informed by the results of a related qualitative study based on the Theoretical Domains Framework and consists of a series of three webinars, two online case scenarios, a self-management video on Brief Action Planning, and a printed copy of the practice guideline. Primary feasibility outcomes for both chiropractors and patients include rates of (1) recruitment, (2) retention, and (3) adherence to the intervention. A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations (e.g. exercise and self-care prescriptions) at study onset and at 3 months. Secondary outcomes include scores of behavioural constructs (level of knowledge and self-efficacy) for recommended multimodal care. Clinical outcomes include pain intensity and neck pain-specific disability. Analyses from this study will focus on generating point estimates and corresponding 95

  1. "Pre-schoolers in the playground" an outdoor physical activity intervention for children aged 18 months to 4 years old: study protocol for a pilot cluster randomised controlled trial.

    Science.gov (United States)

    Barber, Sally E; Jackson, Cath; Akhtar, Shaheen; Bingham, Daniel D; Ainsworth, Hannah; Hewitt, Catherine; Richardson, Gerry; Summerbell, Carolyn D; Pickett, Kate E; Moore, Helen J; Routen, Ash C; O'Malley, Claire L; Brierley, Shirley; Wright, John

    2013-10-09

    The pre-school years are considered critical for establishing healthy lifestyle behaviours such as physical activity. Levels of physical activity track through childhood into adulthood, thus establishing habitual physical activity early in life is vital. Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school aged children. There are few pre-school, playground-based interventions, and evaluations of these have found mixed results. A recent report published by the UK Chief Medical Officer (CMO) highlighted that new interventions to promote movement in the early years (0-5 years old) are needed. The aim of this study is to undertake a pilot cluster randomised controlled trial (RCT) of an outdoor playground-based physical activity intervention for parents and their children aged 18 months to 4 years old ("Pre-schoolers in the Playground"; PiP) and to assess the feasibility of conducting a full scale cluster RCT. The PiP intervention is grounded in behavioural theory (Social Cognitive Theory), and is in accordance with the CMO guidance for physical activity in the early years. It is informed by existing literature and data collected from focus groups with parents. One hundred and fifty pre-school children affiliated to 10 primary schools will be recruited. Schools will be randomised to either the PiP intervention arm or the control arm (usual practice). Children in the intervention arm will be invited to attend three 30 minute outdoor play sessions per week for 30 weeks (3 school terms) at the school. Feasibility will be assessed by examining recruitment rates, attendance, attrition, acceptability of the trial and of the PiP intervention to parents, fidelity of intervention implementation, capability and capacity for schools to deliver the intervention. Health outcomes and the feasibility of outcome measurement tools will be assessed. These include physical activity via

  2. “Pre-schoolers in the playground” an outdoor physical activity intervention for children aged 18 months to 4 years old: study protocol for a pilot cluster randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background The pre-school years are considered critical for establishing healthy lifestyle behaviours such as physical activity. Levels of physical activity track through childhood into adulthood, thus establishing habitual physical activity early in life is vital. Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school aged children. There are few pre-school, playground-based interventions, and evaluations of these have found mixed results. A recent report published by the UK Chief Medical Officer (CMO) highlighted that new interventions to promote movement in the early years (0–5 years old) are needed. The aim of this study is to undertake a pilot cluster randomised controlled trial (RCT) of an outdoor playground-based physical activity intervention for parents and their children aged 18 months to 4 years old (“Pre-schoolers in the Playground”; PiP) and to assess the feasibility of conducting a full scale cluster RCT. The PiP intervention is grounded in behavioural theory (Social Cognitive Theory), and is in accordance with the CMO guidance for physical activity in the early years. It is informed by existing literature and data collected from focus groups with parents. Methods/Design One hundred and fifty pre-school children affiliated to 10 primary schools will be recruited. Schools will be randomised to either the PiP intervention arm or the control arm (usual practice). Children in the intervention arm will be invited to attend three 30 minute outdoor play sessions per week for 30 weeks (3 school terms) at the school. Feasibility will be assessed by examining recruitment rates, attendance, attrition, acceptability of the trial and of the PiP intervention to parents, fidelity of intervention implementation, capability and capacity for schools to deliver the intervention. Health outcomes and the feasibility of outcome measurement tools will be assessed. These

  3. Internet-based support for self-management strategies for people with COPD-protocol for a controlled pragmatic pilot trial of effectiveness and a process evaluation in primary healthcare.

    Science.gov (United States)

    Nyberg, André; Wadell, Karin; Lindgren, Helena; Tistad, Malin

    2017-08-01

    The use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) reduces healthcare use, improves health-related quality of life (HRQoL) and recovery after acute exacerbations. However, not many people with COPD receive support that promotes the use of such strategies and therefore new methods to facilitate and promote the use of self-management strategies are highly warranted. This pilot trial aims to evaluate the feasibility of the study design and study procedures considering effectiveness of the novel intervention, the COPD-web. METHODS AND ANALYSIS: The overall design is a pragmatic controlled pilot trial with preassessments and postassessments and a parallel process evaluation. Patients with the diagnosis of COPD will be eligible for the study. The intervention group will be recruited when visiting one of the six participating primary care units in Sweden. The control group will be identified from the unit's computerised registers. The intervention, the COPD-web, is an interactive web page with two sections; one directed at people with COPD and one at healthcare professionals. The sections aim to support patients' self-management skills-and to facilitate the provision of support for self-management strategies, respectively. Effectiveness with regard to patients' symptoms, HRQoL, knowledge of and readiness for COPD-related self-management, health literacy, self-efficacy for physical activity and time spent in physical activity and time being sedentary, and further, healthcare professionals' knowledge of and readiness to support COPD-related self-management strategies will be assessed using questionnaires at 3 and 12 months. The process evaluation will include observations and interviews. Ethical approval has been obtained. Findings will be presented at conferences, submitted for publication in peer-reviewed publications and presented to the involved healthcare professionals, patients and to patient organisations

  4. Evaluating Protocol Lifecycle Time Intervals in HIV/AIDS Clinical Trials

    Science.gov (United States)

    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

  5. Pilot-scale continuous recycling of growth medium for the mass culture of a halotolerant Tetraselmis sp. in raceway ponds under increasing salinity: a novel protocol for commercial microalgal biomass production.

    Science.gov (United States)

    Fon Sing, S; Isdepsky, A; Borowitzka, M A; Lewis, D M

    2014-06-01

    The opportunity to recycle microalgal culture medium for further cultivation is often hampered by salinity increases from evaporation and fouling by dissolved and particulate matter. In this study, the impact of culture re-use after electro-flocculation of seawater-based medium on growth and biomass productivity of the halotolerant green algal strain Tetraselmis sp., MUR 233, was investigated in pilot-scale open raceway ponds over 5months. Despite a salinity increase from 5.5% to 12% (w/v) NaCl, Tetraselmis MUR 233 grown on naturally DOC-enriched recycled medium produced 48-160% more ash free dry weight (AFDW) biomass daily per unit pond area than when grown on non-recycled medium. A peak productivity of 37.5±3.1gAFDWm(-2)d(-1) was reached in the recycled medium upon transition from ∼14% to ∼7% NaCl. The combination of high biomass-yielding mixotrophic growth under high salinity has been proven to be a successful sustainable cultivation strategy. Copyright © 2014 Elsevier Ltd. All rights reserved.

  6. Alberta Learning: Early Development Instrument Pilot Project Evaluation.

    Science.gov (United States)

    Meaney, Wanda; Harris-Lorenze, Elayne

    The Early Development Instrument (EDI) was designed by McMaster University to measure the outcomes of childrens early years as they influence their readiness to learn at school. The EDI was piloted in several Canadian cities in recent years through two national initiatives. Building on these initiatives, Alberta Learning piloted the EDI as a…

  7. Develop and Implement Operational Ground Testing Protocols to Individualize Astronaut Sleep Medication Efficacy and Individual Effects

    Data.gov (United States)

    National Aeronautics and Space Administration — The study protocol was successfully pilot tested with N=7 subjects (6 NASA flight surgeons and 1 Behavioral Health and Performance element Operations professional)...

  8. Tablet computers versus optical aids to support education and learning in children and young people with low vision: protocol for a pilot randomised controlled trial, CREATE (Children Reading with Electronic Assistance To Educate).

    Science.gov (United States)

    Crossland, Michael D; Thomas, Rachel; Unwin, Hilary; Bharani, Seelam; Gothwal, Vijaya K; Quartilho, Ana; Bunce, Catey; Dahlmann-Noor, Annegret

    2017-06-21

    Low vision and blindness adversely affect education and independence of children and young people. New 'assistive' technologies such as tablet computers can display text in enlarged font, read text out to the user, allow speech input and conversion into typed text, offer document and spreadsheet processing and give access to wide sources of information such as the internet. Research on these devices in low vision has been limited to case series. We will carry out a pilot randomised controlled trial (RCT) to assess the feasibility of a full RCT of assistive technologies for children/young people with low vision. We will recruit 40 students age 10-18 years in India and the UK, whom we will randomise 1:1 into two parallel groups. The active intervention will be Apple iPads; the control arm will be the local standard low-vision aid care. Primary outcomes will be acceptance/usage, accessibility of the device and trial feasibility measures (time to recruit children, lost to follow-up). Exploratory outcomes will be validated measures of vision-related quality of life for children/young people as well as validated measures of reading and educational outcomes. In addition, we will carry out semistructured interviews with the participants and their teachers. NRES reference 15/NS/0068; dissemination is planned via healthcare and education sector conferences and publications, as well as via patient support organisations. NCT02798848; IRAS ID 179658, UCL reference 15/0570. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  9. A pilot study to evaluate the efficacy of adding a structured home visiting intervention to improve outcomes for high-risk families attending the Incredible Years Parent Programme: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Lees, Dianne G; Fergusson, David M; Frampton, Christopher M; Merry, Sally N

    2014-02-25

    Antisocial behaviour and adult criminality often have their origins in childhood and are best addressed early in the child's life using evidence-based treatments such as the 'Incredible Years Parent Programme'. However, families with additional risk factors who are at highest risk for poor outcomes do not always make sufficient change while attending such programmes. Additional support to address barriers and improve implementation of positive parenting strategies while these families attend the Incredible Years Programme may improve overall outcomes.The study aims to evaluate the efficacy of adding a structured home visiting intervention (Home Parent Support) to improve outcomes in families most at risk of poor treatment response from the Incredible Years intervention. This study will inform the design of a larger prospective randomised controlled trial. A pilot single-blind, parallel, superiority, randomised controlled trial. Randomisation will be undertaken using a computer-generated sequence in a 1:1 ratio to the two treatments arranged in permuted blocks with stratification by age, sex, and ethnicity. One hundred and twenty six participants enrolled in the Incredible Years Parent Programme who meet the high-risk criteria will be randomly allocated to receive either Incredible Years Parent Programme and Home Parent Support, or the Incredible Years Parent Programme alone. The Home Parent Support is a 10-session structured home visiting intervention provided by a trained therapist, alongside the usual Incredible Years Parent Programme, to enhance the adoption of key parenting skills. The primary outcome is the change in child behaviour from baseline to post-intervention in parent reported Eyberg Child Behavior Inventory Problem Scale. This is the first formal evaluation of adding Home Parent Support alongside Incredible Years Parent Programme for families with risk factors who typically have poorer treatment outcomes. We anticipate that the intervention will help

  10. Protocol for the residents in action pilot cluster randomised controlled trial (RiAT): evaluating a behaviour change intervention to promote walking, reduce sitting and improve mental health in physically inactive older adults in retirement villages.

    Science.gov (United States)

    Thøgersen-Ntoumani, Cecilie; Wright, Ashlene; Quested, Eleanor; Burton, Elissa; Hill, Keith D; Cerin, Ester; Biddle, Stuart J H; Ntoumanis, Nikos

    2017-06-23

    Ageing is accompanied by increased risks of chronic disease, declined functioning and increased dependency. Physical activity is critical to retaining health and independence, but the majority of older people are insufficiently physically active to achieve these benefits and have high levels of sedentary (sitting) time. Activity programmes are often offered in retirement villages; however, their uptake is limited. Furthermore, although the physical environment in and around these villages can play an important role in decisions to be physically active, its role is often overlooked by research in these settings. We aim to develop, implement and evaluate a proof-of-concept motivationally embellished intervention designed to increase walking, reduce sitting and improve mental health in residents in retirement villages. This will be a 16-week pilot intervention using a cluster randomised design with retirement villages as the unit of randomisation and residents as the unit of assessment. Fourteen retirement villages around Perth, Western Australia, will be recruited for the intervention. Objective audits of neighbourhood environments around each village will be completed using the Pathway Environmental Audit Tool. Seven villages will be randomised to the experimental arm and seven to the control arm. Only participants in the experimental arm will receive motivational training. All outcomes will be assessed at baseline, end of intervention and 6-month follow-up. Changes in physical activity levels, sitting time and mental health will be examined. Multilevel modelling will be used to analyse the data. A mixed methods process evaluation will also be conducted. Ethics approval was granted by Curtin University's Human Research Ethics Committee (HREC2016-0187). The results of the study will be disseminated via peer-reviewed publications, conference presentations and reports to, and seminars with, stakeholders. The trial is registered with the Australian New Zealand Clinical

  11. Study protocol: The development of a pilot study employing a randomised controlled design to investigate the feasibility and effects of a peer support program following discharge from a specialist first-episode psychosis treatment centre

    Directory of Open Access Journals (Sweden)

    Francey Shona

    2010-05-01

    Full Text Available Abstract Background Young people with first-episode psychosis (FEP are at risk of a range of negative outcomes. Specialist FEP services have been developed to provide comprehensive, multi-disciplinary treatment. However, these services are often available for a restricted period and the services that young people may be transferred to are less comprehensive. This represents a risk of drop out from treatment services in a group already considered to be at risk of disengagement. Peer support groups have been shown to improve social relationships among people with psychosis however individual peer support programs have not been tested on young people with first-episode psychosis; nor have they been tested at the point of discharge from services. Methods/design The study is an 18-month randomised controlled trial being conducted at Orygen Youth Health Research Centre in Melbourne, Australia. The aim of the study is to test the feasibility and effects of a 6-month peer support intervention delivered to young people with FEP over the period of discharge. Participants are young people aged 15-24 who are being discharged from a specialist first-episode psychosis treatment centre. There is a 6-month recruitment period. The intervention comprises two hours of contact per fortnight during which peer support workers can assist participants to engage with their new services, or other social and community activities. Participants will be assessed at baseline and post intervention (6 months. Discussion This paper describes the development of a randomised-controlled trial which aims to pilot a peer support program among young people who are being discharged from a specialist FEP treatment centre. If effective, the intervention could lead to benefits not only for participants over the discharge period, but for peer support workers as well. Trial registration The study was registered with the Australian New Zealand Clinical Trials Registry; number: ACTRN

  12. Security and SCADA protocols

    International Nuclear Information System (INIS)

    Igure, V. M.; Williams, R. D.

    2006-01-01

    Supervisory control and data acquisition (SCADA) networks have replaced discrete wiring for many industrial processes, and the efficiency of the network alternative suggests a trend toward more SCADA networks in the future. This paper broadly considers SCADA to include distributed control systems (DCS) and digital control systems. These networks offer many advantages, but they also introduce potential vulnerabilities that can be exploited by adversaries. Inter-connectivity exposes SCADA networks to many of the same threats that face the public internet and many of the established defenses therefore show promise if adapted to the SCADA differences. This paper provides an overview of security issues in SCADA networks and ongoing efforts to improve the security of these networks. Initially, a few samples from the range of threats to SCADA network security are offered. Next, attention is focused on security assessment of SCADA communication protocols. Three challenges must be addressed to strengthen SCADA networks. Access control mechanisms need to be introduced or strengthened, improvements are needed inside of the network to enhance security and network monitoring, and SCADA security management improvements and policies are needed. This paper discusses each of these challenges. This paper uses the Profibus protocol as an example to illustrate some of the vulnerabilities that arise within SCADA networks. The example Profibus security assessment establishes a network model and an attacker model before proceeding to a list of example attacks. (authors)

  13. Pilot Implementations as an Approach to Infrastructure

    DEFF Research Database (Denmark)

    Manikas, Maria Ie; Torkilsheyggi, Arnvør Martinsdóttir á

    In this paper we introduce pilot implementation, a supplement to information systems development, as an approach to study and design work infrastructures. We report from two pilot implementations in the Danish healthcare, which showed signs of grappling with aligning the past, present...... and the future while using a pilot system in real use situations and with real users. Based on our initial findings we believe that pilot implementations can address some of the challenges of studying infrastructures, because they make the infrastructure visible and because they can integrate the long......-term with the short-term aspects. The paper is based on work-in-progress and the purpose is not as much to make conclusions as to spark discussion about whether pilot implementations could offer a way to study and design work infrastructures during information system development....

  14. Sincalide - the final protocol

    International Nuclear Information System (INIS)

    Clarke, E.A.; Notghi, A.; Hesslewood, S.R.; Harding, L.K.

    2002-01-01

    Full text: HIDA biliary studies examine the gallbladder (GB) to give a percentage ejection fraction (EF). Porcine CCK was an accepted agent for stimulating the GB prior to being withdrawn in the UK from 1998. Sincalide (a synthetic CCK) was the suggested replacement. We have tried many administration regimes in an attempt to get results comparable with our established CCK protocols. Dose concentration and length of infusion times have been studied. Initially a dose of 10 ngm/kg/min given over 2 minutes (manufacturer's recommended dose) was used. This gave falsely low ejection fractions. The dose was reduced to 3 ngm/kg/min over 3 minutes as it was felt the higher dose may be causing constriction of the sphincter of Oddi. This gave a slight improvement with 22 % of patients having normal EF (>35 %). The length of infusion was extended to 15 minutes and the dose concentration reduced again to 0.6 ngm/kg/min. 62 % of patients had a normal EF. However, on many of the curves the gallbladder was still contracting on completion of the 15 minute infusion and began to refill immediately after stopping Sincalide. A further change of protocol was indicated. The infusion time was extended to 30 minutes and the dose concentration per minute kept the same. Imaging began at 30 minutes post HIDA injection and continued for a total of 50 minutes. Sincalide infusion began at 35 minutes if a GB was visualized. This protocol has been performed on 17 patients. 53 % of these had a normal result (comparable with a normal rate of 40 % previously established with CCK) with a mean EF of 60 %. The mean EF of patients with abnormal studies was 15 %. Curves showed a plateau by 30 minutes in 94 % of patients indicating that gallbladder contraction was complete. No normal range is available so results were compared with ultrasound (US). All patients who had an abnormal US scan also had abnormal HIDA results. Three patients had a normal US scan and abnormal HIDA study. These are currently

  15. Physical Therapy Protocols for Arthroscopic Bankart Repair.

    Science.gov (United States)

    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

  16. Increasing engagement with, and effectiveness of, an online CBT-based stress management intervention for employees through the use of an online facilitated bulletin board: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Carolan, Stephany; Harris, Peter R; Greenwood, Kathryn; Cavanagh, Kate

    2016-12-15

    The evidence for the benefits of online cognitive behaviour therapy (CBT)-based programmes delivered in a clinical context is clear, but this evidence does not translate to online CBT-based stress management programmes delivered within a workplace context. One of the challenges to the delivery of online interventions is programme engagement; this challenge is even more acute for interventions delivered in real-world settings such as the workplace. The purpose of this pilot study is to explore the effect of an online facilitated discussion group on engagement, and to estimate the potential effectiveness of an online CBT-based stress management programme. This study is a three-arm randomised controlled trial (RCT) comparing a minimally guided, online, CBT-based stress management intervention delivered with and without an online facilitated bulletin board, and a wait list control group. Up to 90 employees from six UK-based organisations will be recruited to the study. Inclusion criteria will include age 18 years or over, elevated levels of stress (as measured on the PSS-10 scale), access to a computer or a tablet and the Internet. The primary outcome measure will be engagement, as defined by the number of logins to the site; secondary outcome measures will include further measures of engagement (the number of pages visited, the number of modules completed and self-report engagement) and measures of effectiveness (psychological distress and subjective wellbeing). Possible moderators will include measures of intervention quality (satisfaction, acceptability, credibility, system usability), time pressure, goal conflict, levels of distress at baseline and job autonomy. Measures will be taken at baseline, 2 weeks (credibility and expectancy measures only), 8 weeks (completion of intervention) and 16 weeks (follow-up). Primary analysis will be conducted on intention-to-treat principles. To our knowledge this is the first study to explore the effect of an online

  17. A pilot randomised controlled trial of personalised care for depressed patients with symptomatic coronary heart disease in South London general practices: the UPBEAT-UK RCT protocol and recruitment

    Directory of Open Access Journals (Sweden)

    Tylee André

    2012-06-01

    Full Text Available Abstract Background Community studies reveal people with coronary heart disease (CHD are twice as likely to be depressed as the general population and that this co-morbidity negatively affects the course and outcome of both conditions. There is evidence for the efficacy of collaborative care and case management for depression treatment, and whilst NICE guidelines recommend these approaches only where depression has not responded to psychological, pharmacological, or combined treatments, these care approaches may be particularly relevant to the needs of people with CHD and depression in the earlier stages of stepped care in primary care settings. Methods This pilot randomised controlled trial will evaluate whether a simple intervention involving a personalised care plan, elements of case management and regular telephone review is a feasible and acceptable intervention that leads to better mental and physical health outcomes for these patients. The comparator group will be usual general practitioner (GP care. 81 participants have been recruited from CHD registers of 15 South London general practices. Eligible participants have probable major depression identified by a score of ≥8 on the Hospital Anxiety and Depression Scale depression subscale (HADS-D together with symptomatic CHD identified using the Modified Rose Angina Questionnaire. Consenting participants are randomly allocated to usual care or the personalised care intervention which involves a comprehensive assessment of each participant’s physical and mental health needs which are documented in a care plan, followed by regular telephone reviews by the case manager over a 6-month period. At each review, the intervention participant’s mood, function and identified problems are reviewed and the case manager uses evidence based behaviour change techniques to facilitate achievement of goals specified by the patient with the aim of increasing the patient’s self efficacy to solve their

  18. A healthy diet with and without cereal grains and dairy products in patients with type 2 diabetes: study protocol for a random-order cross-over pilot study--Alimentation and Diabetes in Lanzarote--ADILAN.

    Science.gov (United States)

    Fontes-Villalba, Maelán; Jönsson, Tommy; Granfeldt, Yvonne; Frassetto, Lynda A; Sundquist, Jan; Sundquist, Kristina; Carrera-Bastos, Pedro; Fika-Hernándo, María; Picazo, Óscar; Lindeberg, Staffan

    2014-01-02

    Research on the role of nutrition in type 2 diabetes has largely focused on macro/micronutrient composition and dietary fiber intake, while fewer studies have tested the effects of differing food choice. Some observational studies and short-term intervention studies suggest that a food pattern mimicking the diet with which humans evolved positively influences glucose control and associated endocrine systems. Such a food pattern mainly differs from other common healthy food patterns in its absence of cereal grains and dairy products. The primary aim of this pilot study is to determine the effect of two healthy diets with or without cereal grains and dairy products on glucose control, while keeping participants' weight stable and other food parameters, such as macro/micronutrient composition, dietary fiber and glycemic load, the same in both diets. We intend to include 15 adult patients with a medical diagnosis of type 2 diabetes mellitus with or without medication and with an increased waist circumference (≥ 80 cm for women and ≥ 94 cm for men) in a random-order cross-over diet intervention study during two periods of four-weeks separated by a six-week washout period. Patients will be instructed to eat two healthy diets according to official dietary guidelines with respect to macro/micronutrient composition and fiber content, but differing in the type of food included, with one diet being without cereal grains and dairy products. Lunch will be served in a hospital kitchen for control of nutrient intake, while the rest of the meals will be eaten at home according to specific directions. The energy content of the diets will be individually adjusted to maintain a stable body weight during the two four-week intervention periods. Primary outcomes will be change in fasting plasma glucagon and fructosamine, while secondary outcomes include change in fasting glucose and glycated hemoglobin, glucose and glucagon response during oral glucose tolerance test, blood

  19. A healthy diet with and without cereal grains and dairy products in patients with type 2 diabetes: study protocol for a random-order cross-over pilot study - Alimentation and Diabetes in Lanzarote -ADILAN

    Science.gov (United States)

    2014-01-01

    Background Research on the role of nutrition in type 2 diabetes has largely focused on macro/micronutrient composition and dietary fiber intake, while fewer studies have tested the effects of differing food choice. Some observational studies and short-term intervention studies suggest that a food pattern mimicking the diet with which humans evolved positively influences glucose control and associated endocrine systems. Such a food pattern mainly differs from other common healthy food patterns in its absence of cereal grains and dairy products. The primary aim of this pilot study is to determine the effect of two healthy diets with or without cereal grains and dairy products on glucose control, while keeping participants’ weight stable and other food parameters, such as macro/micronutrient composition, dietary fiber and glycemic load, the same in both diets. Methods/Design We intend to include 15 adult patients with a medical diagnosis of type 2 diabetes mellitus with or without medication and with an increased waist circumference (≥ 80 cm for women and ≥ 94 cm for men) in a random-order cross-over diet intervention study during two periods of four-weeks separated by a six-week washout period. Patients will be instructed to eat two healthy diets according to official dietary guidelines with respect to macro/micronutrient composition and fiber content, but differing in the type of food included, with one diet being without cereal grains and dairy products. Lunch will be served in a hospital kitchen for control of nutrient intake, while the rest of the meals will be eaten at home according to specific directions. The energy content of the diets will be individually adjusted to maintain a stable body weight during the two four-week intervention periods. Primary outcomes will be change in fasting plasma glucagon and fructosamine, while secondary outcomes include change in fasting glucose and glycated hemoglobin, glucose and glucagon response during oral

  20. Vertical Protocol Composition

    DEFF Research Database (Denmark)

    Groß, Thomas; Mödersheim, Sebastian Alexander

    2011-01-01

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

  1. Effectiveness of implementing a best practice primary healthcare model for low back pain (BetterBack) compared with current routine care in the Swedish context: an internal pilot study informed protocol for an effectiveness-implementation hybrid type 2 trial

    Science.gov (United States)

    Abbott, Allan; Schröder, Karin; Enthoven, Paul; Nilsen, Per; Öberg, Birgitta

    2018-01-01

    implementation in Sweden and associated national quality register data collection are potential future developments of the project. Date and version identifier 13 December 2017, protocol version 3. Trial registration number NCT03147300; Pre-results. PMID:29691246

  2. The impact of transition training on adapting to Technically Advanced Aircraft at regional airlines: Perceptions of pilots and instructor pilots

    Science.gov (United States)

    di Renzo, John Carl, Jr.

    Scope and method of study. The purpose of this study was to test a hypothesis about pilot and instructor pilot perceptions of how effectively pilots learn and use new technology, found in Technically Advanced Aircraft (TAA), given initial type of instrumentation training. New aviation technologies such as Glass Cockpits in technically advanced aircraft are complex and can be difficult to learn and use. The research questions focused on the type of initial instrumentation training to determine the differences among pilots trained using various types of instrumentation ranging from aircraft equipped with traditional analog instrumentation to aircraft equipped with glass cockpits. A convenience sample of Pilots in Training (PT) and Instructor Pilots (IP) was selected from a regional airline. The research design used a mixed methodology. Pilots in training completed a thirty-two question quantitative questionnaire and instructor pilots completed a five question qualitative questionnaire. Findings and conclusions. This investigation failed to disprove the null hypothesis. The type of instrumentation training has no significant effect on newly trained regional airline pilot perceived ability to adapt to advanced technology cockpits. Therefore, no evidence exists from this investigation to support the early introduction and training of TAA. While the results of this investigation were surprising, they are nonetheless, instructive. Even though it would seem that there would be a relationship between exposure to and use of technically advanced instrumentation, apparently there was no perceived relationship for this group of airline transport pilots. However, a point of interest is that these pilots were almost evenly divided in their opinion of whether or not their previous training had prepared them for transition to TAA. The majority also believed that the type of initial instrumentation training received does make a difference when transitioning to TAA. Pilots believed

  3. 75 FR 56857 - Pilot, Flight Instructor, and Pilot School Certification

    Science.gov (United States)

    2010-09-17

    ...-2006-26661; Amendment No., 141-14] RIN 2120-AI86 Pilot, Flight Instructor, and Pilot School..., certification, and operating requirements for pilots, flight instructors, ground instructors, and pilot schools...: Background On August 21, 2009, the FAA published the ``Pilot, Flight Instructor, and Pilot School...

  4. Priming a Pilot Implementation

    DEFF Research Database (Denmark)

    Hansen, Magnus Rotvit Perlt; Pedersen, Maria Ie

    2011-01-01

    Abstract. We report on the initial findings of an exploratory action research study about effects specifications using the systems development method Effects-driven IT development. It is part of a larger IS pilot implementation project conducted in the Danish healthcare sector. Through interviews...... and a workshop we have identified and specified effects that comprise the basis for an evaluation of the project between several organisational agents with diverse professional backgrounds. Gathering organisational participants at a workshop with a common goal of discussing and prioritizing a finished list...... of effects has proved to be a valuable approach to create mutual learning process amongst the participants and the facilitators of the workshop. The challenges we experienced during the effects specification process were to balance a dichotomous focus between on one hand the visions of the participants...

  5. The French dosimetry protocol

    International Nuclear Information System (INIS)

    Dutreix, A.

    1985-01-01

    After a general introduction the protocol is divided in five sections dealing with: determination of the quality of X-ray, γ-ray and electron beams; the measuring instrument; calibration of the reference instrument; determination of the reference absorbed dose in the user's beams; determination of the absorbed dose in water at other points, in other conditions. The French protocol is not essentially different from the Nordic protocol and it is based on the experience gained in using both the American and the Nordic protocols. Therefore, only the main difference with the published protocols are discussed. (Auth.)

  6. Implementation of remote video auditing with feedback and compliance for manual-cleaning protocols of endoscopic retrograde cholangiopancreatography endoscopes.

    Science.gov (United States)

    Armellino, Donna; Cifu, Kelly; Wallace, Maureen; Johnson, Sherly; DiCapua, John; Dowling, Oonagh; Jacobs, Mitchel; Browning, Susan

    2018-05-01

    A pilot initiative to assess the use of remote video auditing in monitoring compliance with manual-cleaning protocols for endoscopic retrograde cholangiopancreatography (ERCP) endoscopes was performed. Compliance with manual-cleaning steps following the initiation of feedback was measured. A video feed of the ERCP reprocessing room was provided to remote auditors who scored items of an ERCP endoscope manual-cleaning checklist. Compliance feedback was provided in the form of reports and reeducation. Outcomes were reported as checklist compliance. The use of remote video auditing to document manual processing is a feasible approach and feedback and reeducation increased manual-cleaning compliance from 53.1% (95% confidence interval, 34.7-71.6) to 98.9% (95.0% confidence interval, 98.1-99.6). Copyright © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

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

    OpenAIRE

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

    2009-01-01

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

  8. Pilot Boarding Areas

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Pilot boarding areas are locations at sea where pilots familiar with local waters board incoming vessels to navigate their passage to a destination port. Pilotage is...

  9. Protocol Implementation Generator

    DEFF Research Database (Denmark)

    Carvalho Quaresma, Jose Nuno; Probst, Christian W.

    2010-01-01

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

  10. Initiating statistical maintenance optimization

    International Nuclear Information System (INIS)

    Doyle, E. Kevin; Tuomi, Vesa; Rowley, Ian

    2007-01-01

    Since the 1980 s maintenance optimization has been centered around various formulations of Reliability Centered Maintenance (RCM). Several such optimization techniques have been implemented at the Bruce Nuclear Station. Further cost refinement of the Station preventive maintenance strategy includes evaluation of statistical optimization techniques. A review of successful pilot efforts in this direction is provided as well as initial work with graphical analysis. The present situation reguarding data sourcing, the principle impediment to use of stochastic methods in previous years, is discussed. The use of Crowe/AMSAA (Army Materials Systems Analysis Activity) plots is demonstrated from the point of view of justifying expenditures in optimization efforts. (author)

  11. Should I stay or should I go? Understanding families’ decisions regarding initiating, continuing, and terminating health services for managing pediatric obesity: the protocol for a multi-center, qualitative study

    Directory of Open Access Journals (Sweden)

    Ball Geoff DC

    2012-12-01

    Full Text Available Abstract Background At least two million Canadian children meet established criteria for weight management. Due to the adverse health consequences of obesity, most pediatric weight management research has examined the efficacy and effectiveness of interventions to improve lifestyle behaviors, reduce co-morbidities, and enable weight management. However, little information is available on families’ decisions to initiate, continue, and terminate weight management care. This is an important knowledge gap since a substantial number of families fail to initiate care after being referred for weight management while many families who initiate care discontinue it after a brief period of time. This research aims to understand the interplay between individual, family, environmental, and systemic factors that influence families’ decisions regarding the management of pediatric obesity. Methods/Design Individual interviews will be conducted with children and youth with obesity (n = 100 and their parents (n = 100 for a total number of 200 interviews with 100 families. Families will be recruited from four Canadian multi-disciplinary pediatric weight management centers in Vancouver, Edmonton, Hamilton, and Montreal. Participants will be purposefully-sampled into the following groups: (i Non-Initiators (5 families/site: referred for weight management within the past 6 months and did not follow-up the referral; (ii Initiators (10 families/site: referred for weight management within the past 6 months and did follow-up the referral with at least one clinic appointment; and (iii Continuers (10 families/site: participated in a formal weight management intervention within the past 12 months and did continue with follow-up care for at least 6 months. Interviews will be digitally recorded and analyzed using an ecological framework, which will enable a multi-level evaluation of proximal and distal factors that underlie families’ decisions regarding

  12. 38 CFR 20.1500 - Rule 1500. Expedited Claims Adjudication Initiative.

    Science.gov (United States)

    2010-07-01

    ... Claims Adjudication Initiative. 20.1500 Section 20.1500 Pensions, Bonuses, and Veterans' Relief... Adjudication Initiative-Pilot Program § 20.1500 Rule 1500. Expedited Claims Adjudication Initiative. (a) Purpose. The Expedited Claims Adjudication Initiative is a pilot program designed to streamline the claims...

  13. Rehabilitation robotics: pilot trial of a spatial extension for MIT-Manus

    Directory of Open Access Journals (Sweden)

    Krebs Hermano

    2004-10-01

    Full Text Available Abstract Background Previous results with the planar robot MIT-MANUS demonstrated positive benefits in trials with over 250 stroke patients. Consistent with motor learning, the positive effects did not generalize to other muscle groups or limb segments. Therefore we are designing a new class of robots to exercise other muscle groups or limb segments. This paper presents basic engineering aspects of a novel robotic module that extends our approach to anti-gravity movements out of the horizontal plane and a pilot study with 10 outpatients. Patients were trained during the initial six-weeks with the planar module (i.e., performance-based training limited to horizontal movements with gravity compensation. This training was followed by six-weeks of robotic therapy that focused on performing vertical arm movements against gravity. The 12-week protocol includes three one-hour robot therapy sessions per week (total 36 robot treatment sessions. Results Pilot study demonstrated that the protocol was safe and well tolerated with no patient presenting any adverse effect. Consistent with our past experience with persons with chronic strokes, there was a statistically significant reduction in tone measurement from admission to discharge of performance-based planar robot therapy and we have not observed increases in muscle tone or spasticity during the anti-gravity training protocol. Pilot results showed also a reduction in shoulder-elbow impairment following planar horizontal training. Furthermore, it suggested an additional reduction in shoulder-elbow impairment following the anti-gravity training. Conclusion Our clinical experiments have focused on a fundamental question of whether task specific robotic training influences brain recovery. To date several studies demonstrate that in mature and damaged nervous systems, nurture indeed has an effect on nature. The improved recovery is most pronounced in the trained limb segments. We have now embarked on

  14. 76 FR 63988 - Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits

    Science.gov (United States)

    2011-10-14

    ...-0097] Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits AGENCY: Federal Motor... motor carriers that applied to participate in the Agency's long-haul pilot program to test and... intent to proceed with the initiation of a United States- Mexico cross-border long-haul trucking pilot...

  15. Cost effective pilot scale production of biofertilizer using Rhizobium ...

    African Journals Online (AJOL)

    We standardized the protocol for pilot scale production of Rhizobium and Azotobacter biofertilizer technology using region specific and environmental stress compatible strains isolated from various agro climatic regions of Odisha, India. The cost benefit of biofertilizer production through a cottage industry is also presented.

  16. Evaluation of community-level interventions to increase early initiation of antenatal care in pregnancy: protocol for the Community REACH study, a cluster randomised controlled trial with integrated process and economic evaluations.

    Science.gov (United States)

    Sawtell, Mary; Sweeney, Lorna; Wiggins, Meg; Salisbury, Cathryn; Eldridge, Sandra; Greenberg, Lauren; Hunter, Rachael; Kaur, Inderjeet; McCourt, Christine; Hatherall, Bethan; Findlay, Gail; Morris, Joanne; Reading, Sandra; Renton, Adrian; Adekoya, Ruth; Green, Belinda; Harvey, Belinda; Latham, Sarah; Patel, Kanta; Vanlessen, Logan; Harden, Angela

    2018-03-05

    The provision of high-quality maternity services is a priority for reducing inequalities in health outcomes for mothers and infants. Best practice includes women having their initial antenatal appointment within the first trimester of pregnancy in order to provide screening and support for healthy lifestyles, well-being and self-care in pregnancy. Previous research has identified inequalities in access to antenatal care, yet there is little evidence on interventions to improve early initiation of antenatal care. The Community REACH trial will assess the effectiveness and cost-effectiveness of engaging communities in the co-production and delivery of an intervention that addresses this issue. The study design is a matched cluster randomised controlled trial with integrated process and economic evaluations. The unit of randomisation is electoral ward. The intervention will be delivered in 10 wards; 10 comparator wards will have normal practice. The primary outcome is the proportion of pregnant women attending their antenatal booking appointment by the 12th completed week of pregnancy. This and a number of secondary outcomes will be assessed for cohorts of women (n = approximately 1450 per arm) who give birth 2-7 and 8-13 months after intervention delivery completion in the included wards, using routinely collected maternity data. Eight hospitals commissioned to provide maternity services in six NHS trusts in north and east London and Essex have been recruited to the study. These trusts will provide anonymised routine data for randomisation and outcomes analysis. The process evaluation will examine intervention implementation, acceptability, reach and possible causal pathways. The economic evaluation will use a cost-consequences analysis and decision model to evaluate the intervention. Targeted community engagement in the research process was a priority. Community REACH aims to increase early initiation of antenatal care using an intervention that is co-produced and

  17. Lung-protective ventilation initiated in the emergency department (LOV-ED): a study protocol for a quasi-experimental, before-after trial aimed at reducing pulmonary complications.

    Science.gov (United States)

    Fuller, Brian M; Ferguson, Ian; Mohr, Nicholas M; Stephens, Robert J; Briscoe, Cristopher C; Kolomiets, Angelina A; Hotchkiss, Richard S; Kollef, Marin H

    2016-04-11

    In critically ill patients, acute respiratory distress syndrome (ARDS) and ventilator-associated conditions (VACs) are associated with increased mortality, survivor morbidity and healthcare resource utilisation. Studies conclusively demonstrate that initial ventilator settings in patients with ARDS, and at risk for it, impact outcome. No studies have been conducted in the emergency department (ED) to determine if lung-protective ventilation in patients at risk for ARDS can reduce its incidence. Since the ED is the entry point to the intensive care unit for hundreds of thousands of mechanically ventilated patients annually in the USA, this represents a knowledge gap in this arena. A lung-protective ventilation strategy was instituted in our ED in 2014. It aims to address the parameters in need of quality improvement, as demonstrated by our previous research: (1) prevention of volutrauma; (2) appropriate positive end-expiratory pressure setting; (3) prevention of hyperoxia; and (4) aspiration precautions. The lung-protective ventilation initiated in the emergency department (LOV-ED) trial is a single-centre, quasi-experimental before-after study testing the hypothesis that lung-protective ventilation, initiated in the ED, is associated with reduced pulmonary complications. An intervention cohort of 513 mechanically ventilated adult ED patients will be compared with over 1000 preintervention control patients. The primary outcome is a composite outcome of pulmonary complications after admission (ARDS and VACs). Multivariable logistic regression with propensity score adjustment will test the hypothesis that ED lung-protective ventilation decreases the incidence of pulmonary complications. Approval of the study was obtained prior to data collection on the first patient. As the study is a before-after observational study, examining the effect of treatment changes over time, it is being conducted with waiver of informed consent. This work will be disseminated by

  18. ORIGINAL ARTICLE ORIG ORIGI A pilot study evaluating erect chest ...

    African Journals Online (AJOL)

    2009-11-19

    Nov 19, 2009 ... South African Tuberculosis Vaccine Initiative, Institute of Infectious Diseases ... After obtaining consent from departmental and institutional ethics com- mittees, a pilot study ... informed consent from parents or legal guardians.

  19. The Development of Korea Additional Protocol System

    International Nuclear Information System (INIS)

    Shim, Hye Won; Yeo, Jin Kyun

    2008-01-01

    The Agreement between the Republic of Korea (ROK) and the IAEA for the Application of Safeguards in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons (the Safeguards Agreement) entered into force on 14 November 1975. The Additional Protocol to the Safeguards Agreement (the Additional Protocol) was signed on 21 June 1999 and entered into force on 19 February 2004. ROK has been submitting annual updated reports of initial declaration on every May 15th since August 2004. Additional protocol reports were submitted through Protocol Reporter provided by IAEA. Annual declarations were simply uploaded and stored in the Accounting Information Treatment System of KINAC, which did not provide data analysis and management function. There have been demands for improvement to handle ever-increasing information. KAPS (Korea Additional Protocol System) has been developed to assist and administrate the additional protocol related works effectively. The new system enables integrated management including composition of additional protocol report and version control, periodical update of related information, results of IAEA complementary access to each facility

  20. Randomised comparison of the effectiveness of the laryngeal mask airway supreme, i-gel and current practice in the initial airway management of prehospital cardiac arrest (REVIVE-Airways): a feasibility study research protocol.

    Science.gov (United States)

    Benger, Jonathan Richard; Voss, Sarah; Coates, David; Greenwood, Rosemary; Nolan, Jerry; Rawstorne, Steven; Rhys, Megan; Thomas, Matthew

    2013-01-01

    Effective cardiopulmonary resuscitation with appropriate airway management improves outcomes following out-of-hospital cardiac arrest (OHCA). Historically, tracheal intubation has been accepted as the optimal form of OHCA airway management in the UK. The Joint Royal Colleges Ambulance Liaison Committee recently concluded that newer supraglottic airway devices (SADs) are safe and effective devices for hospital procedures and that their use in OHCA should be investigated. This study will address an identified gap in current knowledge by assessing whether it is feasible to use a cluster randomised design to compare SADs with current practice, and also to each other, during OHCA. The primary objective of this study is to assess the feasibility of a cluster randomised trial to compare the ventilation success of two newer SADs: the i-gel and the laryngeal mask airway supreme to usual practice during the initial airway management of OHCA. The secondary objectives are to collect data on ventilation success, further airway interventions required, loss of a previously established airway during transport, airway management on arrival at hospital (or termination of the resuscitation attempt), initial resuscitation success, survival to intensive care admission, survival to hospital discharge and patient outcome at 3 months. Ambulance paramedics will be randomly allocated to one of the three methods of airway management. Adults in medical OHCA attended by a trial paramedic will be eligible for the study. Approval for the study has been obtained from a National Health Service Research Ethics Committee with authority to review proposals for trials of a medical device in incapacitated adults. The results will be made publicly available on an open access website, and we will publish the findings in appropriate journals and present them at national and international conferences relevant to the subject field. ISRCTN: 18528625.

  1. Treatment strategies in colorectal cancer patients with initially unresectable liver-only metastases, a study protocol of the randomised phase 3 CAIRO5 study of the Dutch Colorectal Cancer Group (DCCG)

    International Nuclear Information System (INIS)

    Huiskens, Joost; Gulik, Thomas M van; Lienden, Krijn P van; Engelbrecht, Marc RW; Meijer, Gerrit A; Grieken, Nicole CT van; Schriek, Jonne; Keijser, Astrid; Mol, Linda; Molenaar, I Quintus; Verhoef, Cornelis; Jong, Koert P de; Dejong, Kees HC; Kazemier, Geert; Ruers, Theo M; Wilt, Johanus HW de; Tinteren, Harm van; Punt, Cornelis JA

    2015-01-01

    Colorectal cancer patients with unresectable liver-only metastases may be cured after downsizing of metastases by neoadjuvant systemic therapy. However, the optimal neoadjuvant induction regimen has not been defined, and the lack of consensus on criteria for (un)resectability complicates the interpretation of published results. CAIRO5 is a multicentre, randomised, phase 3 clinical study. Colorectal cancer patients with initially unresectable liver-only metastases are eligible, and will not be selected for potential resectability. The (un)resectability status is prospectively assessed by a central panel consisting of at least one radiologist and three liver surgeons, according to predefined criteria. Tumours of included patients will be tested for RAS mutation status. Patients with RAS wild type tumours will be treated with doublet chemotherapy (FOLFOX or FOLFIRI) and randomised between the addition of either bevacizumab or panitumumab, and patients with RAS mutant tumours will be randomised between doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab or triple chemotherapy (FOLFOXIRI) plus bevacizumab. Radiological evaluation to assess conversion to resectability will be performed by the central panel, at an interval of two months. The primary study endpoint is median progression-free survival. Secondary endpoints are the R0/1 resection rate, median overall survival, response rate, toxicity, pathological response of resected lesions, postoperative morbidity, and correlation of baseline and follow-up evaluation with respect to outcomes by the central panel. CAIRO5 is a prospective multicentre trial that investigates the optimal systemic induction therapy for patients with initially unresectable, liver-only colorectal cancer metastases. CAIRO 5 is registered at European Clinical Trials Database (EudraCT) (2013-005435-24). CAIRO 5 is registered at ClinicalTrials.gov: NCT02162563, June 10, 2014

  2. Saudi Arabia and CERN sign protocol

    CERN Multimedia

    2008-01-01

    On 9 May 2008, Mohammed I. Al Suwaiyel, President of the King Abdulaziz City of Science and Technology, representing the Government of Saudi Arabia, and CERN Director-General, Robert Aymar, signed a protocol to the 2006 cooperation agreement between CERN and Saudi Arabia. Members of the Saudi Arabian Government visit ATLAS.The purpose of the protocol is to define the operational framework needed to carry out various specific tasks provided for in the cooperation agreement in order to promote the development of a high energy particle physics community in Saudi Arabia and its ultimate visible participation as a member of the global CERN community. Signing the protocol, Mohammed I. Al-Suwaiyel said: "The Saudi Arabian Government has taken a number of initiatives to promote R&D in the interests of our country’s development and the advancement of science. Thanks to this protocol, Saudi scientists will be able to work towards this go...

  3. Implementation of the Additional Protocol in Japan

    International Nuclear Information System (INIS)

    Ogawa, T.

    2001-01-01

    The Additional Protocol between Japan and the IAEA entered into force in December 1999. To come into force a series of implementation trials of Additional Protocol was carried out at two Japanese representative nuclear research centers, i.e. Tokai Research Establishment of Japan Atomic Energy Research Institute (JAERI) and Oarai Engineering Center of Japan Nuclear Fuel Cycle Development Institute (JNC). These trials were proposed by Japan and were conducted in cooperation with the IAEA Secretariat. In addition, Japan amended 'the Law for the Regulation of Reactors etc.', to collect adequate information to submit to the IAEA, to arrange the surrounding for the complementary access, etc. In addition, Japan Submitted the Initial Declaration of the Additional Protocol within 180 days of the entry into force of the Protocol, in the middle of June, 2000

  4. RADIOLOGY EDUCATION: A PILOT STUDY TO ASSESS KNOWLEDGE OF MEDICAL STUDENTS REGARDING IMAGING IN TRAUMA.

    Science.gov (United States)

    Siddiqui, Saad; Saeed, Muhammad Anwar; Shah, Noreen; Nadeem, Naila

    2015-01-01

    Trauma remains one of the most frequent presentations in emergency departments. Imaging has established role in setting of acute trauma with ability to identify potentially fatal conditions. Adequate knowledge of health professionals regarding trauma imaging is vital for improved healthcare. In this work we try to assess knowledge of medical students regarding imaging in trauma as well as identify most effective way of imparting radiology education. This cross-sectional pilot study was conducted at Aga Khan University Medical College & Khyber Girls Medical College, to assess knowledge of medical students regarding imaging protocols practiced in initial management of trauma patients. Only 40 & 20% respectively were able to identify radiographs included in trauma series. Very few had knowledge of correct indication for Focused abdominal sonography in trauma. Clinical radiology rotation was reported as best way of learning radiology. Change in curricula & restructuring of clinical radiology rotation structure is needed to improve knowledge regarding Trauma imaging.

  5. A systematic approach for designing a HBM Pilot Study for Europe

    DEFF Research Database (Denmark)

    Becker, Kerstin; Seiwert, Margarete; Casteleyn, Ludwine

    2014-01-01

    of a human biomonitoring study. Furthermore, it provides an example for a systematic approach that may be useful to other research groups or pan-European research initiatives. In the study protocol that will be published elsewhere these aspects are elaborated and additional aspects are covered (Casteleyn et...... biomonitoring (HBM) study and for the implementation of the fieldwork procedures. The approach gave the basis for discussion of the main aspects of study design and conduct, and provided a decision making tool which can be applied to many other studies. Each decision that had to be taken was listed in a table......The objective of COPHES (Consortium to Perform Human biomonitoring on a European Scale) was to develop a harmonised approach to conduct human biomonitoring on a European scale. COPHES developed a systematic approach for designing and conducting a pilot study for an EU-wide cross-sectional human...

  6. Optical protocols for terabit networks

    Science.gov (United States)

    Chua, P. L.; Lambert, J. L.; Morookian, J. M.; Bergman, L. A.

    1991-01-01

    This paper describes a new fiber-optic local area network technology providing 100X improvement over current technology, has full crossbar funtionality, and inherent data security. Based on optical code-division multiple access (CDMA), using spectral phase encoding/decoding of optical pulses, networking protocols are implemented entirely in the optical domain and thus conventional networking bottlenecks are avoided. Component and system issues for a proof-of-concept demonstration are discussed, as well as issues for a more practical and commercially exploitable system. Possible terrestrial and aerospace applications of this technology, and its impact on other technologies are explored. Some initial results toward realization of this concept are also included.

  7. Development of USPS Laboratory and pilot-scale testing protocols

    Science.gov (United States)

    Carl Houtman; Nancy Ross Sutherland; David Bormett; Donald Donermeyer

    2000-01-01

    The ultimate goal of the US Postal Service (USPS) Environmentally Benign Stamp Program is to develop stamp adhesives that can be removed by unit operations found in recycling mills. The maintenance of final product quality specifications for a recycling mill while loading the feedstock with a significant quantity of adhesive is the criterion for success of this program...

  8. The Effects of Individual Upper Alpha Neurofeedback in ADHD: An Open-Label Pilot Study

    OpenAIRE

    Escolano , Carlos; Navarro-Gil , Mayte; Garcia-Campayo , Javier; Congedo , Marco; Minguez , Javier

    2014-01-01

    International audience; Standardized neurofeedback (NF) protocols have been extensively evaluated in attention-deficit/hyperactivity disorder (ADHD). However, such protocols do not account for the large EEG heterogeneity in ADHD. Thus, individualized approaches have been suggested to improve the clinical outcome. In this direction, an open-label pilot study was designed to evaluate a NF protocol of relative upper alpha power enhancement in fronto-central sites. Upper alpha band was individual...

  9. Network protocols and sockets

    OpenAIRE

    BALEJ, Marek

    2010-01-01

    My work will deal with network protocols and sockets and their use in programming language C#. It will therefore deal programming network applications on the platform .NET from Microsoft and instruments, which C# provides to us. There will describe the tools and methods for programming network applications, and shows a description and sample applications that work with sockets and application protocols.

  10. Quantum secret sharing protocol using modulated doubly entangled photons

    International Nuclear Information System (INIS)

    Chuan, Wang; Yong, Zhang

    2009-01-01

    In this paper, we propose a quantum secret sharing protocol utilizing polarization modulated doubly entangled photon pairs. The measurement devices are constructed. By modulating the polarizations of entangled photons, the boss could encode secret information on the initial state and share the photons with different members to realize the secret sharing process. This protocol shows the security against intercept-resend attack and dishonest member cheating. The generalized quantum secret sharing protocol is also discussed. (general)

  11. Increasing walking in patients with intermittent claudication: Protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    O'Carroll Ronan E

    2010-10-01

    Full Text Available Abstract Background People with intermittent claudication are at increased risk of death from heart attack and stroke compared to matched controls. Surgery for intermittent claudication is for symptom management and does not reduce the risk of cardiovascular morbidity and mortality. Increasing physical activity can reduce claudication symptoms and may improve cardiovascular health. This paper presents the pilot study protocol for a randomised controlled trial to test whether a brief psychological intervention leads to increased physical activity, improvement in quality of life, and a reduction in the demand for surgery, for patients with intermittent claudication. Methods/Design We aim to recruit 60 patients newly diagnosed with intermittent claudication, who will be randomised into two groups. The control group will receive usual care, and the treatment group will receive usual care and a brief 2-session psychological intervention to modify illness and walking beliefs and develop a walking action plan. The primary outcome will be walking, measured by pedometer. Secondary outcomes will include quality of life and uptake of surgery for symptom management. Participants will be followed up after (a 4 months, (b 1 year and (c 2 years. Discussion This study will assess the acceptability and efficacy of a brief psychological intervention to increase walking in patients with intermittent claudication, both in terms of the initiation, and maintenance of behaviour change. This is a pilot study, and the results will inform the design of a larger multi-centre trial. Trial Registration Current Controlled Trials ISRCTN28051878

  12. An Authentication Protocol for Future Sensor Networks.

    Science.gov (United States)

    Bilal, Muhammad; Kang, Shin-Gak

    2017-04-28

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

  13. NAMA 80/20 DEFERRED PAYMENT INITIATIVE PARTICIPATION FORM

    OpenAIRE

    2012-01-01

    Brochure detailing the Deferred Payment Initiative key features and information on how to apply for the initiative: "NAMA has launched a Deferred Payment Initiative (the ‘Initiative’) on a pilot basis. The Initiative is aimed at potential owner-occupiers who are interested in purchasing residential property but are concerned at the risk of further price declines."

  14. A self-management approach using self-initiated action plans for symptoms with ongoing nurse support in patients with Chronic Obstructive Pulmonary Disease (COPD) and comorbidities: the COPE-III study protocol.

    Science.gov (United States)

    Lenferink, Anke; Frith, Peter; van der Valk, Paul; Buckman, Julie; Sladek, Ruth; Cafarella, Paul; van der Palen, Job; Effing, Tanja

    2013-09-01

    Chronic Obstructive Pulmonary Disease (COPD) frequently coexists with other diseases. Whereas COPD action plans are currently part of usual care, they are less suitable and potentially unsafe for use in the presence of comorbidities. This study evaluates whether an innovative treatment approach directed towards COPD and frequently existing comorbidities can reduce COPD exacerbation days. We hypothesise that this approach, which combines self-initiated action plans and nurse support, will accelerate proper treatment actions and lead to better control of deteriorating symptoms. In this multicenter randomised controlled trial we aim to include 300 patients with COPD (GOLD II-IV), and with at least one comorbidity (cardiovascular disease, diabetes, anxiety and/or depression). Patients will be recruited from hospitals in the Netherlands (n = 150) and Australia (n = 150) and will be assigned to an intervention or control group. All patients will learn to complete daily symptom diaries for 12-months. Intervention group patients will participate in self-management training sessions to learn the use of individualised action plans for COPD and comorbidities, linked to the diary. The primary outcome is the number of COPD exacerbation days. Secondary outcomes include hospitalisations, quality of life, self-efficacy, adherence, patient's satisfaction and confidence, health care use and cost data. Intention-to-treat analyses (random effect negative binomial regression and random effect mixed models) and cost-effectiveness analyses will be performed. Prudence should be employed before extrapolating the use of COPD specific action plans in patients with comorbidities. This study evaluates the efficacy of tailored action plans for both COPD and common comorbidities. Copyright © 2013 Elsevier Inc. All rights reserved.

  15. Electrocoagulation project: Pilot study testwork

    Energy Technology Data Exchange (ETDEWEB)

    Donini, J.C.; Garand, D.K.; Hassan, T.A.; Kar, K.L.; Thind, S.S.

    1991-09-01

    When a suspension or emulsion flows between two sacrificial metal electrodes excited by ac, the dispersed phase is consolidated and then settles. Laboratory-scale investigation of this mechanism, called electrocoagulation, and of its areas of application to water treatment were previously completed and a subsequent project was initiated to design and construct pilot-scale equipment consisting of an electrocoagulation cell, power supply, and computerized control system. The constructed pilot plant was used to test the effectiveness of electrocoagulation to clarify coal processing plant effluent. Results obtained with clay suspensions showed that flow conditions in the cell have a major effect on electric power consumption, and a reduction by a factor of three on this crucial cost parameter appeared possible compared to a previously tested batch-scale electrocoagulation system. Results obtained using the coal plant thickener feed closely duplicated those obtained with the clay mixtures. Aluminum electrode consumption, however, remained unchanged compared to the bench-scale tests. Supernatant clarity far exceeded requirements, while settling rate was too low. The settling could be speeded up by appropriate use of chemicals, but such addition affects the coagulation mechanism and reduces supernatant clarity. A tradeoff between settling rate and clarity was thus established. The total cost of treatment was deemed to be in excess of coal company requirements, but the pilot tests revealed much about the electrocoagulation system under continuous flow conditions. The technology is seen as having application in other areas such as municipal and industrial waste treatment. 22 refs., 6 figs., 2 tabs.

  16. The Biomarker Knowledge System Informatics Pilot Project Supplement To The Biomarker Development Laboratory at Moffitt (Bedlam) — EDRN Public Portal

    Science.gov (United States)

    The Biomarker Knowledge System Informatics Pilot Project goal will develop network interfaces among databases that contain information about existing clinical populations and biospecimens and data relating to those specimens that are important in biomarker assay validation. This protocol comprises one of two that will comprise the Moffitt participation in the Biomarker Knowledge System Informatics Pilot Project. THIS PROTOCOL (58) is the Sput-Epi Database.

  17. Manufacturing Initiative

    Data.gov (United States)

    National Aeronautics and Space Administration — The Advanced Manufacturing Technologies (AMT) Project supports multiple activities within the Administration's National Manufacturing Initiative. A key component of...

  18. River Basin Standards Interoperability Pilot

    Science.gov (United States)

    Pesquer, Lluís; Masó, Joan; Stasch, Christoph

    2016-04-01

    There is a lot of water information and tools in Europe to be applied in the river basin management but fragmentation and a lack of coordination between countries still exists. The European Commission and the member states have financed several research and innovation projects in support of the Water Framework Directive. Only a few of them are using the recently emerging hydrological standards, such as the OGC WaterML 2.0. WaterInnEU is a Horizon 2020 project focused on creating a marketplace to enhance the exploitation of EU funded ICT models, tools, protocols and policy briefs related to water and to establish suitable conditions for new market opportunities based on these offerings. One of WaterInnEU's main goals is to assess the level of standardization and interoperability of these outcomes as a mechanism to integrate ICT-based tools, incorporate open data platforms and generate a palette of interchangeable components that are able to use the water data emerging from the recently proposed open data sharing processes and data models stimulated by initiatives such as the INSPIRE directive. As part of the standardization and interoperability activities in the project, the authors are designing an experiment (RIBASE, the present work) to demonstrate how current ICT-based tools and water data can work in combination with geospatial web services in the Scheldt river basin. The main structure of this experiment, that is the core of the present work, is composed by the following steps: - Extraction of information from river gauges data in OGC WaterML 2.0 format using SOS services (preferably compliant to the OGC SOS 2.0 Hydrology Profile Best Practice). - Model floods using a WPS 2.0, WaterML 2.0 data and weather forecast models as input. - Evaluation of the applicability of Sensor Notification Services in water emergencies. - Open distribution of the input and output data as OGC web services WaterML, / WCS / WFS and with visualization utilities: WMS. The architecture

  19. Protocol Fuel Mix reporting

    International Nuclear Information System (INIS)

    2002-07-01

    The protocol in this document describes a method for an Electricity Distribution Company (EDC) to account for the fuel mix of electricity that it delivers to its customers, based on the best available information. Own production, purchase and sale of electricity, and certificates trading are taken into account. In chapter 2 the actual protocol is outlined. In the appendixes additional (supporting) information is given: (A) Dutch Standard Fuel Mix, 2000; (B) Calculation of the Dutch Standard fuel mix; (C) Procedures to estimate and benchmark the fuel mix; (D) Quality management; (E) External verification; (F) Recommendation for further development of the protocol; (G) Reporting examples

  20. ATM and Internet protocol

    CERN Document Server

    Bentall, M; Turton, B

    1998-01-01

    Asynchronous Transfer Mode (ATM) is a protocol that allows data, sound and video being transferred between independent networks via ISDN links to be supplied to, and interpreted by, the various system protocols.ATM and Internet Protocol explains the working of the ATM and B-ISDN network for readers with a basic understanding of telecommunications. It provides a handy reference to everyone working with ATM who may not require the full standards in detail, but need a comprehensive guide to ATM. A substantial section is devoted to the problems of running IP over ATM and there is some discussion o

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

    NARCIS (Netherlands)

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

    BACKGROUND AND AIM: 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

  2. Piezoelectrically Initiated Pyrotechnic Igniter

    Science.gov (United States)

    Quince, Asia; Dutton, Maureen; Hicks, Robert; Burnham, Karen

    2013-01-01

    This innovation consists of a pyrotechnic initiator and piezoelectric initiation system. The device will be capable of being initiated mechanically; resisting initiation by EMF, RF, and EMI (electromagnetic field, radio frequency, and electromagnetic interference, respectively); and initiating in water environments and space environments. Current devices of this nature are initiated by the mechanical action of a firing pin against a primer. Primers historically are prone to failure. These failures are commonly known as misfires or hang-fires. In many cases, the primer shows the dent where the firing pin struck the primer, but the primer failed to fire. In devices such as "T" handles, which are commonly used to initiate the blowout of canopies, loss of function of the device may result in loss of crew. In devices such as flares or smoke generators, failure can result in failure to spot a downed pilot. The piezoelectrically initiated ignition system consists of a pyrotechnic device that plugs into a mechanical system (activator), which on activation, generates a high-voltage spark. The activator, when released, will strike a stack of electrically linked piezo crystals, generating a high-voltage, low-amperage current that is then conducted to the pyro-initiator. Within the initiator, an electrode releases a spark that passes through a pyrotechnic first-fire mixture, causing it to combust. The combustion of the first-fire initiates a primary pyrotechnic or explosive powder. If used in a "T" handle, the primary would ramp the speed of burn up to the speed of sound, generating a shock wave that would cause a high explosive to go "high order." In a flare or smoke generator, the secondary would produce the heat necessary to ignite the pyrotechnic mixture. The piezo activator subsystem is redundant in that a second stack of crystals would be struck at the same time with the same activation force, doubling the probability of a first strike spark generation. If the first

  3. The "Technical and Vocational Education Initiative": Enclaves in British Schools.

    Science.gov (United States)

    Saunders, Murray

    The Technical and Vocational Education Initiative (TVEI) is intended as a pilot, on a massive scale, of particular approaches, with a systematic need to identify TVEI effects on students, staff, resources, and curricula. TVEI has a strong tendency toward the development of pilot enclaves in terms of its administrative, curricular,…

  4. Mobile Internet Protocol Analysis

    National Research Council Canada - National Science Library

    Brachfeld, Lawrence

    1999-01-01

    ...) and User Datagram Protocol (UDP). Mobile IP allows mobile computers to send and receive packets addressed with their home network IP address, regardless of the IP address of their current point of attachment on the Internet...

  5. USA-USSR protocol

    CERN Multimedia

    1970-01-01

    On 30 November the USA Atomic Energy Commission and the USSR State Committee for the Utilization of Atomic Energy signed, in Washington, a protocol 'on carrying out of joint projects in the field of high energy physics at the accelerators of the National Accelerator Laboratory (Batavia) and the Institute for High Energy Physics (Serpukhov)'. The protocol will be in force for five years and can be extended by mutual agreement.

  6. Preparing Pilots for Takeoff

    Science.gov (United States)

    Ravage, Barbara

    2012-01-01

    Why would schools consider partnering with a vendor to operate a pilot? Why not just wait until the final product is released? For starters, pilots provide schools with a golden opportunity to get an early look at the software, take it for a test flight, and ask for changes tailored to their operating environment and business needs. In some cases,…

  7. An evaluation of safety culture initiatives at BNSF Railway

    Science.gov (United States)

    2015-04-01

    Major safety culture (SC) initiatives initiated in the FRA Office of Research, Technology and Development (RT&D), such as Clear Signal for Action (CSA), the Investigation of Safety Related Occurrences Protocol (ISROP), the Participative Safety Rules ...

  8. Protocols for second-generation business satellites systems

    Science.gov (United States)

    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.

  9. Unilateral initiatives

    International Nuclear Information System (INIS)

    Anon.

    1988-01-01

    This paper reports on arms control which is generally thought of in terms of formal negotiations with an opponent, with the resulting agreements embodied in a treaty. This is not surprising, since arms control discussions between opponents are both important and politically visible. There are, however, strong reasons for countries to consider and frequently take unilateral initiatives. To do so is entirely consistent with the established major precepts of arms control which state that arms control is designed to reduce the risk of war, the costs of preparing for war, and the death and destruction if war should come. Unilateral initiatives on what weapons are purchased, which ones are eliminated and how forces are deployed can all relate to these objectives. There are two main categories of motives for unilateral initiatives in arms control. In one category, internal national objectives are the dominant, often sole, driving force; the initiative is undertaken for our own good

  10. Ports Initiative

    Science.gov (United States)

    EPA's Ports Initiative works in collaboration with the port industry, communities, and government to improve environmental performance and increase economic prosperity. This effort helps people near ports breath cleaner air and live better lives.

  11. APMP Pilot Study on Transmittance Haze

    Science.gov (United States)

    Liu, Wen-Chun; Hwang, Jisoo; Koo, Annette; Wu, Houping; Leecharoen, Rojana; Yu, Hsueh-Ling

    2018-02-01

    Five NMIs within APMP, including CMS/ITRI, MSL, NIM, NIMT and KRISS from TCPR applied to the APMP technical committee initiative project for funding to carry out a pilot comparison of transmittance haze in 2012. The project started in 2014 and the final report was completed at the end of 2016. In this pilot comparison, three different haze standards were adopted, and transmittance haze for each standard was measured according to ASTM D1003 or ISO 14782. This paper presents the first results of an APMP pilot study of transmittance haze and the analysis of the variation among different haze measurement systems which are commonly used. The study shows that the variables such as sphere multiplier, transmittance distribution, fluorescence of samples and optical path of the incident beam cause discrepancies among NMIs and highlight deficiencies in current documentary standards.

  12. Recommendations for Enhancing Implementation of Additional Protocol Declarations

    International Nuclear Information System (INIS)

    Niina, Toshiaki; Nidaira, Kazuo; Aono, Yosuke

    2010-01-01

    Japan signed the Additional Protocol (hereafter, AP) in December 1998. The domestic law and regulation had been revised to implement the initial and annual declarations for the Agency and the Additional Protocol came into force in December 1999. Since initial declaration in 2000, Japan has submitted the annual declaration in every May. Until 2010, Japan has made 10 annual declarations. This paper gives recommendations to enhance implementation of Additional Protocol declarations based on 10-year experience in Japan and addresses the following: Current status of additional protocol declaration in Japan; Outline of processing method; AP Information Management System; Recommendations for improving quality of declaration. Preparation of additional protocol declaration in NMCC has been conducted in the course of contract with Japan Safeguards Office (hereafter, JSGO) for safeguards information treatment. (author)

  13. Child Directed Interaction Training for young children in kinship care: A pilot study.

    Science.gov (United States)

    N'zi, Amanda M; Stevens, Monica L; Eyberg, Sheila M

    2016-05-01

    This pilot study used a randomized controlled trial design to examine the feasibility and explore initial outcomes of a twice weekly, 8-session Child Directed Interaction Training (CDIT) program for children living in kinship care. Participants included 14 grandmothers and great-grandmothers with their 2- to 7-year-old children randomized either to CDIT or a waitlist control condition. Training was delivered at a local, community library with high fidelity to the training protocol. There was no attrition in either condition. After training, kinship caregivers in the CDIT condition demonstrated more positive relationships with their children during behavioral observation. The caregivers in the CDIT condition also reported clinically and statistically significant decreases in parenting stress and caregiver depression, as well as fewer externalizing child behavior problems than waitlist controls. Parent daily report measures indicated significant changes in disciplining that included greater use of limit-setting and less use of critical verbal force. Results appeared stable at 3-month follow-up. Changes in child internalizing behaviors and caregiver use of non-critical verbal force were not seen until 3-month follow-up. Results of this pilot study suggest both the feasibility of conducting full scale randomized clinical trials of CDIT in the community and the promise of this approach for providing effective parent training for kinship caregivers. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Personalized Treatment of Mothers With ADHD and Their Young At-Risk Children: A SMART Pilot.

    Science.gov (United States)

    Chronis-Tuscano, Andrea; Wang, Christine H; Strickland, Jennifer; Almirall, Daniel; Stein, Mark A

    2016-01-01

    Young children of mothers with adult attention-deficit/hyperactivity disorder (ADHD) are at risk for ADHD by virtue of genetics and environmental factors. Moreover, parent ADHD is associated with maladaptive parenting and poor child behavioral treatment response. Thus, a combined approach consisting of behavioral parent training (BPT) and maternal stimulant medication (MSM) may be needed to effectively treat ADHD within families. However, providing combined BPT+MSM initially to all families may be unnecessarily burdensome because not all families likely need combined treatment. The purpose of this study is to examine how to combine, sequence, and personalize treatment for these multiplex families in order to yield benefits to both the parent and child, thereby impacting the course of child ADHD and disruptive behavior symptoms. This article presents our rationale for, design of, and preliminary experiences (based on 26 participants) with an ongoing pilot Sequential Multiple Assessment Randomized Trial (SMART) designed to answer questions regarding the feasibility and acceptability of study protocols and interventions. This article also describes how the subsequent full-scale SMART might change based on what is learned in the SMART pilot and illustrates how the full-scale SMART could be used to inform clinical decision making about how to combine, sequence, and personalize treatment for complex children and families in which a parent has ADHD.

  15. Longitudinal sensitivity to change of MRI-based muscle cross-sectional area versus isometric strength analysis in osteoarthritic knees with and without structural progression: pilot data from the Osteoarthritis Initiative.

    Science.gov (United States)

    Dannhauer, Torben; Sattler, Martina; Wirth, Wolfgang; Hunter, David J; Kwoh, C Kent; Eckstein, Felix

    2014-08-01

    Biomechanical measurement of muscle strength represents established technology in evaluating limb function. Yet, analysis of longitudinal change suffers from relatively large between-measurement variability. Here, we determine the sensitivity to change of magnetic resonance imaging (MRI)-based measurement of thigh muscle anatomical cross sectional areas (ACSAs) versus isometric strength in limbs with and without structural progressive knee osteoarthritis (KOA), with focus on the quadriceps. Of 625 "Osteoarthritis Initiative" participants with radiographic KOA, 20 had MRI cartilage and radiographic joint space width loss in the right knee isometric muscle strength measurement and axial T1-weighted spin-echo acquisitions of the thigh. Muscle ACSAs were determined from manual segmentation at 33% femoral length (distal to proximal). In progressor knees, the reduction in quadriceps ACSA between baseline and 2-year follow-up was -2.8 ± 7.9 % (standardized response mean [SRM] = -0.35), and it was -1.8 ± 6.8% (SRM = -0.26) in matched, non-progressive KOA controls. The decline in extensor strength was more variable than that in ACSAs, both in progressors (-3.9 ± 20%; SRM = -0.20) and in non-progressive controls (-4.5 ± 28%; SRM = -0.16). MRI-based analysis of quadriceps muscles ACSAs appears to be more sensitive to longitudinal change than isometric extensor strength and is suggestive of greater loss in limbs with structurally progressive KOA than in non-progressive controls.

  16. PyPedia: using the wiki paradigm as crowd sourcing environment for bioinformatics protocols.

    Science.gov (United States)

    Kanterakis, Alexandros; Kuiper, Joël; Potamias, George; Swertz, Morris A

    2015-01-01

    Today researchers can choose from many bioinformatics protocols for all types of life sciences research, computational environments and coding languages. Although the majority of these are open source, few of them possess all virtues to maximize reuse and promote reproducible science. Wikipedia has proven a great tool to disseminate information and enhance collaboration between users with varying expertise and background to author qualitative content via crowdsourcing. However, it remains an open question whether the wiki paradigm can be applied to bioinformatics protocols. We piloted PyPedia, a wiki where each article is both implementation and documentation of a bioinformatics computational protocol in the python language. Hyperlinks within the wiki can be used to compose complex workflows and induce reuse. A RESTful API enables code execution outside the wiki. Initial content of PyPedia contains articles for population statistics, bioinformatics format conversions and genotype imputation. Use of the easy to learn wiki syntax effectively lowers the barriers to bring expert programmers and less computer savvy researchers on the same page. PyPedia demonstrates how wiki can provide a collaborative development, sharing and even execution environment for biologists and bioinformaticians that complement existing resources, useful for local and multi-center research teams. PyPedia is available online at: http://www.pypedia.com. The source code and installation instructions are available at: https://github.com/kantale/PyPedia_server. The PyPedia python library is available at: https://github.com/kantale/pypedia. PyPedia is open-source, available under the BSD 2-Clause License.

  17. Business protocol in integrated Europe

    OpenAIRE

    Pavelová, Nina

    2009-01-01

    The first chapter devotes to definitions of basic terms such as protocol or business protocol, to differences between protocol and etiquette, and between social etiquette and business etiquette. The second chapter focuses on the factors influencing the European business protocol. The third chapter is devoted to the etiquette of business protocol in the European countries. It touches the topics such as punctuality and planning of business appointment, greeting, business cards, dress and appear...

  18. Security Protocols in a Nutshell

    OpenAIRE

    Toorani, Mohsen

    2016-01-01

    Security protocols are building blocks in secure communications. They deploy some security mechanisms to provide certain security services. Security protocols are considered abstract when analyzed, but they can have extra vulnerabilities when implemented. This manuscript provides a holistic study on security protocols. It reviews foundations of security protocols, taxonomy of attacks on security protocols and their implementations, and different methods and models for security analysis of pro...

  19. DNA repair protocols

    DEFF Research Database (Denmark)

    Bjergbæk, Lotte

    In its 3rd edition, this Methods in Molecular Biology(TM) book covers the eukaryotic response to genomic insult including advanced protocols and standard techniques in the field of DNA repair. Offers expert guidance for DNA repair, recombination, and replication. Current knowledge of the mechanisms...... that regulate DNA repair has grown significantly over the past years with technology advances such as RNA interference, advanced proteomics and microscopy as well as high throughput screens. The third edition of DNA Repair Protocols covers various aspects of the eukaryotic response to genomic insult including...... recent advanced protocols as well as standard techniques used in the field of DNA repair. Both mammalian and non-mammalian model organisms are covered in the book, and many of the techniques can be applied with only minor modifications to other systems than the one described. Written in the highly...

  20. Quality of cancer family history and referral for genetic counseling and testing among oncology practices: a pilot test of quality measures as part of the American Society of Clinical Oncology Quality Oncology Practice Initiative.

    Science.gov (United States)

    Wood, Marie E; Kadlubek, Pamela; Pham, Trang H; Wollins, Dana S; Lu, Karen H; Weitzel, Jeffrey N; Neuss, Michael N; Hughes, Kevin S

    2014-03-10

    Family history of cancer (CFH) is important for identifying individuals to receive genetic counseling/testing (GC/GT). Prior studies have demonstrated low rates of family history documentation and referral for GC/GT. CFH quality and GC/GT practices for patients with breast (BC) or colon cancer (CRC) were assessed in 271 practices participating in the American Society of Clinical Oncology Quality Oncology Practice Initiative in fall 2011. A total of 212 practices completed measures regarding CFH and GC/GT practices for 10,466 patients; 77.4% of all medical records reviewed documented presence or absence of CFH in first-degree relatives, and 61.5% of medical records documented presence or absence of CFH in second-degree relatives, with significantly higher documentation for patients with BC compared with CRC. Age at diagnosis was documented for all relatives with cancer in 30.7% of medical records (BC, 45.2%; CRC, 35.4%; P ≤ .001). Referall for GC/GT occurred in 22.1% of all patients with BC or CRC. Of patients with increased risk for hereditary cancer, 52.2% of patients with BC and 26.4% of those with CRC were referred for GC/GT. When genetic testing was performed, consent was documented 77.7% of the time, and discussion of results was documented 78.8% of the time. We identified low rates of complete CFH documentation and low rates of referral for those with BC or CRC meeting guidelines for referral among US oncologists. Documentation and referral were greater for patients with BC compared with CRC. Education and support regarding the importance of accurate CFH and the benefits of proactive high-risk patient management are clearly needed.

  1. Initial Study

    DEFF Research Database (Denmark)

    Torp, Kristian

    2009-01-01

    increased. In the initial study presented here, the time it takes to pass an intersection is studied in details. Two major signal-controlled four-way intersections in the center of the city Aalborg are studied in details to estimate the congestion levels in these intersections, based on the time it takes...

  2. Breast cancer and personal environmental risk factors in Marin County - Pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Erdmann, C.A.; Farren, G.; Baltzell, K.; Chew, T.; Clarkson, C.; Fleshman, R.; Leary, C.; Mizroch, M.; Orenstein, F.; Russell, M.L.; Souders-Mason, V.; Wrensch, M.

    2003-02-01

    The purpose of the Personal Environmental Risk Factor Study (PERFS) pilot project was to develop methodologies and a questionnaire for a future population-based case-control study to investigate the role of selected environmental exposures in breast cancer development. Identification of etiologically relevant exposures during a period of potential vulnerability proximate to disease onset offers the possibility of clinical disease prevention even when disease initiation may have already occurred many years earlier. Certain personal environmental agents or combinations of agents may influence disease promotion. Therefore, this pilot study focused on exposures that occurred during the ten-year period prior to diagnosis for cases and the last ten years for controls, rather than more historic exposures. For this pilot study, they used a community-based research approach. In the collaborative efforts, community members participated with academic researchers in all phases of the research, including research question identification, study design, development of research tools, development of the human subjects protocol, and report writing. Community member inclusion was based upon the concept that community participation could improve the relevance of scientific studies and ultimate success of the research by encouraging an ongoing dialogue between community members and academic representatives. Early activities of this project focused on the collection of input from the community regarding the possible role of environmental factors in the incidence of breast cancer in Marin County. The intent was to inform the scientists of community concerns, enhance the research team's understanding of the community being studied, and provide interested community members with a better understanding of the strengths and weaknesses of traditional research methods through active participation in the research process.

  3. WDM Network and Multicasting Protocol Strategies

    Directory of Open Access Journals (Sweden)

    Pinar Kirci

    2014-01-01

    Full Text Available Optical technology gains extensive attention and ever increasing improvement because of the huge amount of network traffic caused by the growing number of internet users and their rising demands. However, with wavelength division multiplexing (WDM, it is easier to take the advantage of optical networks and optical burst switching (OBS and to construct WDM networks with low delay rates and better data transparency these technologies are the best choices. Furthermore, multicasting in WDM is an urgent solution for bandwidth-intensive applications. In the paper, a new multicasting protocol with OBS is proposed. The protocol depends on a leaf initiated structure. The network is composed of source, ingress switches, intermediate switches, edge switches, and client nodes. The performance of the protocol is examined with Just Enough Time (JET and Just In Time (JIT reservation protocols. Also, the paper involves most of the recent advances about WDM multicasting in optical networks. WDM multicasting in optical networks is given as three common subtitles: Broadcast and-select networks, wavelength-routed networks, and OBS networks. Also, in the paper, multicast routing protocols are briefly summarized and optical burst switched WDM networks are investigated with the proposed multicast schemes.

  4. Efficacy of hypnosis-based treatment in amyotrophic lateral sclerosis: a pilot study.

    Science.gov (United States)

    Palmieri, Arianna; Kleinbub, Johann Roland; Calvo, Vincenzo; Sorarù, Gianni; Grasso, Irene; Messina, Irene; Sambin, Marco

    2012-01-01

    Amyotrophic lateral sclerosis (ALS) and its devastating neurodegenerative consequences have an inevitably psychological impact on patients and their caregivers: however, although it would be strongly needed, there is a lack of research on the efficacy of psychological intervention. Our aim was to investigate the effect of hypnosis-based intervention on psychological and perceived physical wellbeing in patients and the indirect effect on caregivers. We recruited eight ALS volunteers patients as a pilot sample for an hypnosis intervention and self-hypnosis training protocol lasting 1 month. Anxiety and depression level was measured in patients and caregivers at pre and post treatment phase. Quality of life and perceived physical symptoms changes were also investigated in patients. One month pre-post treatment improvement in depression, anxiety, and quality of life was clearly clinically observed and confirmed by psychometric analyses on questionnaire data. Moreover, decreases in physical symptoms such as pain, sleep disorders, emotional lability, and fasciculations were reported by our patients. Improvements in caregiver psychological wellbeing, likely as a consequence of patients psychological and perceived physical symptomatology improvement, were also observed. To the best of our knowledge, even if at a preliminary level, this is the first report on efficacy psychological intervention protocol on ALS patients. The findings provide initial support for using hypnosis and self-hypnosis training to manage some ALS physical consequences and mainly to cope its dramatic psychological implications for patients and, indirectly, for their caregivers.

  5. Efficacy of hypnosis-based treatment in Amyotrophic Lateral Sclerosis: A pilot study

    Directory of Open Access Journals (Sweden)

    Arianna ePalmieri

    2012-11-01

    Full Text Available Background: Amyotrophic lateral sclerosis (ALS and its devastating neurodegenerative consequences have an inevitably psychological impact on patients and their caregivers: however, although it would be strongly needed, there is a lack of research on the efficacy of psychological intervention. Our aim was to investigate the effect of hypnosis-based intervention on psychological and perceived physical wellbeing in patients and the indirect effect on caregivers. Methods: We recruited 8 ALS volunteers patients as a pilot sample for an hypnosis intervention and self-hypnosis training protocol lasting one month. Anxiety and depression level was measured in patients and caregivers at pre and post treatment phase. Quality of life and perceived physical symptoms changes were also investigated in patients. Results: One month pre-post treatment improvement in depression, anxiety and quality of life was clearly clinically observed and confirmed by psychometric analyses on questionnaire data. Moreover, decreases in physical symptoms such as pain, sleep disorders, emotional lability and fasciculations were reported by our patients. Improvements in caregiver psychological wellbeing, likely as a consequence of patients psychological and perceived physical symptomatology improvement, were also observed. Conclusions: To the best of our knowledge, even if at a preliminary level, this is the first report on efficacy psychological intervention protocol on ALS patients. The findings provide initial support for using hypnosis and self-hypnosis training to manage some ALS physical consequences and mainly to cope its dramatic psychological implications for patients and, indirectly, for their caregivers.

  6. The initial development of an instrument to assess the psychosocial needs and unmet needs of young people who have a parent with cancer: piloting the offspring cancer needs instrument (OCNI).

    Science.gov (United States)

    Patterson, Pandora; Pearce, Angela; Slawitschka, Emma

    2011-08-01

    This study aimed to identify the psychosocial needs of young people (12-24 years) who have a parent with cancer and to assess whether these needs are being met. This paper also presented the initial steps in the development of a need-based measure-the Offspring Cancer Needs Instrument (OCNI). Study 1 used qualitative methods to identify the needs of the target population, including a focus group (n = 6), telephone interviews (n = 8) and staff survey (n = 26). In study 2, a quantitative survey design was employed where 116 young people completed the 67-item OCNI and either the total difficulties score of the Strengths and Difficulties Questionnaire (SDQ-TD; 12-17-year-old) or Depression, Anxiety, Stress Scale-21 (DASS-21) (18-24-year-old). Tests of reliability (Cronbach's alpha) were used to assess the properties of each domain, where a level of 0.70 was deemed satisfactory as per scale guidelines. Construct validity was assessed by testing the proposed relationship between unmet needs and functioning where a coefficient of 0.03 was deemed satisfactory. The qualitative data yielded eight need domains (information, peer support, feelings, carer support, family, school/work environment, access to support and respite and recreation), which were subsequently used to inform the item content of the OCNI. The survey data revealed that 90% of young people endorsed 10 or more needs, and nearly a quarter indicated >50 needs. It was also found that these needs often go unmet: 87% of the participants had at least one unmet need, 43% reported >10 and just under a quarter had >20 unmet needs. The two highest reported unmet needs related to understanding from friends and assistance with concentrating and staying on task. The OCNI exhibited face and content validity and acceptable reliability for most of the domains. Cronbach's alpha ranged from 0.64 (access to support) to 0.92 (information). Preliminary construct validity was assessed through the hypothesised positive

  7. Pilot Weather Reports

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Aviation weather reports relayed from pilots to FAA air traffic controllers or National Weather Service personnel. Elements include sky cover, turbulence, wind...

  8. Agile Web Pilot Program

    National Research Council Canada - National Science Library

    Lang, Mark

    1997-01-01

    ... in an increasingly competitive global marketplace. The pilot program allowed 18 small and medium sized enterprises to experiment with new agile business practices in competitive manufacturing environments by forming virtual organizations within...

  9. CERN pilot greenhouse

    CERN Multimedia

    1983-01-01

    This pilot installation was situated near Bld. BA6 opposite to the main entrance of the Meyrin site, with respect to Route de Meyrin. See Weekly Bulletin 3/83, and also photo 8305594X, 8505898X, 8302200.

  10. Protocol Monitoring Energy Conservation; Protocol Monitoring Energiebesparing

    Energy Technology Data Exchange (ETDEWEB)

    Boonekamp, P.G.M. [ECN Beleidsstudies, Petten (Netherlands); Mannaerts, H. [Centraal Planburea CPB, Den Haag (Netherlands); Tinbergen, W. [Centraal Bureau voor de Statistiek CBS, Den Haag (Netherlands); Vreuls, H.H.J. [Nederlandse onderneming voor energie en milieu Novem, Utrecht (Netherlands); Wesselink, B. [Rijksinstituut voor Volksgezondheid en Milieuhygiene RIVM, Bilthoven (Netherlands)

    2001-12-01

    On request of the Dutch ministry of Economic Affairs five institutes have collaborated to create a 'Protocol Monitoring Energy Conservation', a common method and database to calculate the amount of energy savings realised in past years. The institutes concerned are the Central Bureau of Statistics (CBS), the Netherlands Bureau for Economic Policy Analysis (CPB), the Energy research Centre of the Netherlands (ECN), the National Agency for Energy and Environment (Novem) and the Netherlands Institute of Public Health and the Environment (RIVM). The institutes have agreed upon a clear definition of energy use and energy savings. The demarcation with renewable energy, the saving effects of substitution between energy carriers and the role of import and export of energy have been elaborated. A decomposition method is used to split up the observed change in energy use in a number of effects, on a national and sectoral level. This method includes an analysis of growth effects, effects of structural changes in production and consumption activities and savings on end use or with more efficient conversion processes. To calculate these effects the total energy use is desegregated as much as possible. For each segment a reference energy use is calculated according to the trend in a variable which is supposed to be representative for the use without savings. The difference with the actual energy use is taken as the savings realised. Results are given for the sectors households, industry, agriculture, services and government, transportation and the energy sector; as well as a national figure. A special feature of the protocol method is the application of primary energy use figures in the determination of savings for end users. This means that the use of each energy carrier is increased with a certain amount, according to the conversion losses caused elsewhere in the energy system. The losses concern the base year energy sector and losses abroad for imports of secondary

  11. Immunocytochemical methods and protocols

    National Research Council Canada - National Science Library

    Javois, Lorette C

    1999-01-01

    ... monoclonal antibodies to study cell differentiation during embryonic development. For a select few disciplines volumes have been published focusing on the specific application of immunocytochemical techniques to that discipline. What distinguished Immunocytochemical Methods and Protocols from earlier books when it was first published four years ago was i...

  12. Critical Response Protocol

    Science.gov (United States)

    Ellingson, Charlene; Roehrig, Gillian; Bakkum, Kris; Dubinsky, Janet M.

    2016-01-01

    This article introduces the Critical Response Protocol (CRP), an arts-based technique that engages students in equitable critical discourse and aligns with the "Next Generation Science Standards" vision for providing students opportunities for language learning while advancing science learning (NGSS Lead States 2013). CRP helps teachers…

  13. Linear Logical Voting Protocols

    DEFF Research Database (Denmark)

    DeYoung, Henry; Schürmann, Carsten

    2012-01-01

    Current approaches to electronic implementations of voting protocols involve translating legal text to source code of an imperative programming language. Because the gap between legal text and source code is very large, it is difficult to trust that the program meets its legal specification. In r...

  14. Principles of Protocol Design

    DEFF Research Database (Denmark)

    Sharp, Robin

    This is a new and updated edition of a book first published in 1994. The book introduces the reader to the principles used in the construction of a large range of modern data communication protocols, as used in distributed computer systems of all kinds. The approach taken is rather a formal one...

  15. The MEGAPIE Initiative

    International Nuclear Information System (INIS)

    Salvatores, M.; Bauer, G.S.; Heusener, G.

    2000-10-01

    MEGAPIE (Megawatt Pilot Experiment) is a joint initiative by Commissariat a l'Energie Atomique (CEA), France, Forschungszentrum Karlsruhe (FZK), Germany, and Paul Scherrer Institut (PSI), Switzerland, to design, build, operate and explore a liquid lead-bismuth spallation target for 1MW of beam power, taking advantage of the existing spallation neutron facility SINQ at PSI. Such a target based on an eutectic mixture with a melting point as low as 125 o C and a boiling point as high as 1670 o C is the preferred concept in several studies aiming at utilising accelerators to drive subcritical assemblies in order to transmute long lived nuclear waste into shorter lived isotopes in an effort to ease problems of long term storage and final disposal. MEGAPIE will be an essential step towards demonstrating the feasibility of the coupling of a high power accelerator, a spallation target and a subcritical assembly. It will specifically address one of the most critical issues, namely the behaviour of a liquid metal target under realistic operating conditions. As an intensely instrumented pilot experiment it will provide valuable data for benchmarking of frequently used computer codes and will allow to gain important experience in the safe handling of components that have been irradiated with PbBi. It will be installed at the ring cyclotron at PSI with 590 MeV proton energy and a continuous current of 1.8 mA. The basic concept of the MEGAPIE target as well as the definition of the project phases and of the supporting research and development activities at the participating laboratories are described in the present report

  16. Portable Weather Applications for General Aviation Pilots.

    Science.gov (United States)

    Ahlstrom, Ulf; Ohneiser, Oliver; Caddigan, Eamon

    2016-09-01

    The objective of this study was to examine the potential benefits and impact on pilot behavior from the use of portable weather applications. Seventy general aviation (GA) pilots participated in the study. Each pilot was randomly assigned to an experimental or a control group and flew a simulated single-engine GA aircraft, initially under visual meteorological conditions (VMC). The experimental group was equipped with a portable weather application during flight. We recorded measures for weather situation awareness (WSA), decision making, cognitive engagement, and distance from the aircraft to hazardous weather. We found positive effects from the use of the portable weather application, with an increased WSA for the experimental group, which resulted in credibly larger route deviations and credibly greater distances to hazardous weather (≥30 dBZ cells) compared with the control group. Nevertheless, both groups flew less than 20 statute miles from hazardous weather cells, thus failing to follow current weather-avoidance guidelines. We also found a credibly higher cognitive engagement (prefrontal oxygenation levels) for the experimental group, possibly reflecting increased flight planning and decision making on the part of the pilots. Overall, the study outcome supports our hypothesis that portable weather displays can be used without degrading pilot performance on safety-related flight tasks, actions, and decisions as measured within the constraints of the present study. However, it also shows that an increased WSA does not automatically translate to enhanced flight behavior. The study outcome contributes to our knowledge of the effect of portable weather applications on pilot behavior and decision making. © 2016, Human Factors and Ergonomics Society.

  17. Report on the Fermilab pilot N ampersand S closure process

    International Nuclear Information System (INIS)

    Coulson, L.

    1995-01-01

    This document outlines the plans and protocols for conducting a pilot of the Department of Energy's Necessary ampersand Sufficient Closure Process (Attachment A) at Fermilab National Accelerator Laboratory (FNAL) in Batavia, Illinois. The result of this pilot will be a set of standards which will serve as the agreed upon basis for providing FNAL with adequate Environment, Safety and Health Protection at the lowest possible cost. This pilot will seek out and emulate compatible industry practices which have been proven successful both in terms of safety performance and cost-effectiveness. This charter has been developed as a partnership effort by the parties to this agreement (see ''Responsibilities'' below), and is considered to be a living document

  18. Protocol for Communication Networking for Formation Flying

    Science.gov (United States)

    Jennings, Esther; Okino, Clayton; Gao, Jay; Clare, Loren

    2009-01-01

    diverse local-area networks, this protocol offers both (1) a random- access mode needed for the early PFF deployment phase and (2) a time-bounded-services mode needed during PFF-maintenance operations. Switching between these two modes could be controlled by upper-layer entities using standard link-management mechanisms. Because the early deployment phase of a PFF mission can be expected to involve multihop relaying to achieve network connectivity (see figure), the proposed protocol includes the open shortest path first (OSPF) network protocol that is commonly used in the Internet. Each spacecraft in a PFF network would be in one of seven distinct states as the mission evolved from initial deployment, through coarse formation, and into precise formation. Reconfiguration of the formation to perform different scientific observations would also cause state changes among the network nodes. The application protocol provides for recognition and tracking of the seven states for each node and for protocol changes under specified conditions to adapt the network and satisfy communication requirements associated with the current PFF mission phase. Except during early deployment, when peer-to-peer random access discovery methods would be used, the application protocol provides for operation in a centralized manner.

  19. DIRAC universal pilots

    Science.gov (United States)

    Stagni, F.; McNab, A.; Luzzi, C.; Krzemien, W.; Consortium, DIRAC

    2017-10-01

    In the last few years, new types of computing models, such as IAAS (Infrastructure as a Service) and IAAC (Infrastructure as a Client), gained popularity. New resources may come as part of pledged resources, while others are in the form of opportunistic ones. Most but not all of these new infrastructures are based on virtualization techniques. In addition, some of them, present opportunities for multi-processor computing slots to the users. Virtual Organizations are therefore facing heterogeneity of the available resources and the use of an Interware software like DIRAC to provide the transparent, uniform interface has become essential. The transparent access to the underlying resources is realized by implementing the pilot model. DIRAC’s newest generation of generic pilots (the so-called Pilots 2.0) are the “pilots for all the skies”, and have been successfully released in production more than a year ago. They use a plugin mechanism that makes them easily adaptable. Pilots 2.0 have been used for fetching and running jobs on every type of resource, being it a Worker Node (WN) behind a CREAM/ARC/HTCondor/DIRAC Computing element, a Virtual Machine running on IaaC infrastructures like Vac or BOINC, on IaaS cloud resources managed by Vcycle, the LHCb High Level Trigger farm nodes, and any type of opportunistic computing resource. Make a machine a “Pilot Machine”, and all diversities between them will disappear. This contribution describes how pilots are made suitable for different resources, and the recent steps taken towards a fully unified framework, including monitoring. Also, the cases of multi-processor computing slots either on real or virtual machines, with the whole node or a partition of it, is discussed.

  20. Linking the Pilot Structural Model and Pilot Workload

    Science.gov (United States)

    Bachelder, Edward; Hess, Ronald; Aponso, Bimal; Godfroy-Cooper, Martine

    2018-01-01

    Behavioral models are developed that closely reproduced pulsive control response of two pilots using markedly different control techniques while conducting a tracking task. An intriguing find was that the pilots appeared to: 1) produce a continuous, internally-generated stick signal that they integrated in time; 2) integrate the actual stick position; and 3) compare the two integrations to either issue or cease a pulse command. This suggests that the pilots utilized kinesthetic feedback in order to sense and integrate stick position, supporting the hypothesis that pilots can access and employ the proprioceptive inner feedback loop proposed by Hess's pilot Structural Model. A Pilot Cost Index was developed, whose elements include estimated workload, performance, and the degree to which the pilot employs kinesthetic feedback. Preliminary results suggest that a pilot's operating point (parameter values) may be based on control style and index minimization.

  1. 76 FR 54095 - Pilot in Command Proficiency Check and Other Changes to the Pilot and Pilot School Certification...

    Science.gov (United States)

    2011-08-31

    ... [Docket No.: FAA-2008-0938; Amendment Nos. 61-128, 91-324, 141-15, and 142-7] RIN 2120-AJ18 Pilot in Command Proficiency Check and Other Changes to the Pilot and Pilot School Certification Rules AGENCY... regulations concerning pilot, flight instructor, and pilot school certification. This rule will require pilot...

  2. Satellite Communications Using Commercial Protocols

    Science.gov (United States)

    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.

  3. A protocol using coho salmon to monitor Tongass National Forest Land and Resource Management Plan standards and guidelines for fish habitat.

    Science.gov (United States)

    M.D. Bryant; Trent McDonald; R. Aho; B.E. Wright; Michelle Bourassa Stahl

    2008-01-01

    We describe a protocol to monitor the effectiveness of the Tongass Land Management Plan (TLMP) management standards for maintaining fish habitat. The protocol uses juvenile coho salmon (Oncorhynchus kisutch) in small tributary streams in forested watersheds. We used a 3-year pilot study to develop detailed methods to estimate juvenile salmonid...

  4. Epistemic Protocols for Distributed Gossiping

    Directory of Open Access Journals (Sweden)

    Krzysztof R. Apt

    2016-06-01

    Full Text Available Gossip protocols aim at arriving, by means of point-to-point or group communications, at a situation in which all the agents know each other's secrets. We consider distributed gossip protocols which are expressed by means of epistemic logic. We provide an operational semantics of such protocols and set up an appropriate framework to argue about their correctness. Then we analyze specific protocols for complete graphs and for directed rings.

  5. A Secured Authentication Protocol for SIP Using Elliptic Curves Cryptography

    Science.gov (United States)

    Chen, Tien-Ho; Yeh, Hsiu-Lien; Liu, Pin-Chuan; Hsiang, Han-Chen; Shih, Wei-Kuan

    Session initiation protocol (SIP) is a technology regularly performed in Internet Telephony, and Hyper Text Transport Protocol (HTTP) as digest authentication is one of the major methods for SIP authentication mechanism. In 2005, Yang et al. pointed out that HTTP could not resist server spoofing attack and off-line guessing attack and proposed a secret authentication with Diffie-Hellman concept. In 2009, Tsai proposed a nonce based authentication protocol for SIP. In this paper, we demonstrate that their protocol could not resist the password guessing attack and insider attack. Furthermore, we propose an ECC-based authentication mechanism to solve their issues and present security analysis of our protocol to show that ours is suitable for applications with higher security requirement.

  6. Symmetric cryptographic protocols

    CERN Document Server

    Ramkumar, Mahalingam

    2014-01-01

    This book focuses on protocols and constructions that make good use of symmetric pseudo random functions (PRF) like block ciphers and hash functions - the building blocks for symmetric cryptography. Readers will benefit from detailed discussion of several strategies for utilizing symmetric PRFs. Coverage includes various key distribution strategies for unicast, broadcast and multicast security, and strategies for constructing efficient digests of dynamic databases using binary hash trees.   •        Provides detailed coverage of symmetric key protocols •        Describes various applications of symmetric building blocks •        Includes strategies for constructing compact and efficient digests of dynamic databases

  7. NSTAR Smart Grid Pilot

    Energy Technology Data Exchange (ETDEWEB)

    Rabari, Anil [NSTAR Electric, Manchester, NH (United States); Fadipe, Oloruntomi [NSTAR Electric, Manchester, NH (United States)

    2014-03-31

    NSTAR Electric & Gas Corporation (“the Company”, or “NSTAR”) developed and implemented a Smart Grid pilot program beginning in 2010 to demonstrate the viability of leveraging existing automated meter reading (“AMR”) deployments to provide much of the Smart Grid functionality of advanced metering infrastructure (“AMI”), but without the large capital investment that AMI rollouts typically entail. In particular, a central objective of the Smart Energy Pilot was to enable residential dynamic pricing (time-of-use “TOU” and critical peak rates and rebates) and two-way direct load control (“DLC”) by continually capturing AMR meter data transmissions and communicating through customer-sited broadband connections in conjunction with a standardsbased home area network (“HAN”). The pilot was supported by the U.S. Department of Energy’s (“DOE”) through the Smart Grid Demonstration program. NSTAR was very pleased to not only receive the funding support from DOE, but the guidance and support of the DOE throughout the pilot. NSTAR is also pleased to report to the DOE that it was able to execute and deliver a successful pilot on time and on budget. NSTAR looks for future opportunities to work with the DOE and others in future smart grid projects.

  8. Diplomacy and Diplomatic Protocol

    Directory of Open Access Journals (Sweden)

    Lect. Ph.D Oana Iucu

    2008-12-01

    Full Text Available The present study aims to observe relationships and determining factors between diplomacyand diplomatic protocol as outlined by historical and contextual analyses. The approach is very dynamic,provided that concepts are able to show their richness, antiquity and polyvalence at the level of connotations,semantics, grammatical and social syntax. The fact that this information is up to date determines anattitude of appreciation and a state of positive contamination.

  9. Automatic Validation of Protocol Narration

    DEFF Research Database (Denmark)

    Bodei, Chiara; Buchholtz, Mikael; Degano, Pierpablo

    2003-01-01

    We perform a systematic expansion of protocol narrations into terms of a process algebra in order to make precise some of the detailed checks that need to be made in a protocol. We then apply static analysis technology to develop an automatic validation procedure for protocols. Finally, we...

  10. User Participation in Pilot Implementation

    DEFF Research Database (Denmark)

    Torkilsheyggi, Arnvør Martinsdóttir á; Hertzum, Morten

    2014-01-01

    Pilot implementations provide users with real-work experiences of how a system will affect their daily work before the design of the system is finalized. On the basis of a pilot implementation of a system for coordinating the transport of patients by hospital porters, we investigate pilot...... implementation as a method for participatory design. We find that to foster participation and learning about user needs a pilot implementation must create a space for reflecting on use, in addition to the space for using the pilot system. The space for reflection must also exist during the activities preparing...... the use of the pilot system because the porters and nurses learned about their needs throughout the pilot implementation, not just during use. Finally, we discuss how the scope and duration of a pilot implementation influence the conditions for participation....

  11. Air Force Female Pilots Program: Initial Performance and Attitudes

    Science.gov (United States)

    1979-02-01

    you conduct most of your training? a. Controlled (Control Tower) b. FSS (Airport Advisory Service) c. Unicorn d. Uncontrolled (No Unicom or FSS) 9...Travel_____ b. Business c, Employment _____ d. Sport_____ e. Education_____ f. Other (Specify) ____________________ 26...Ceiling 6. High Winds 3. Turbulence 7. Mud or Snow 4. Airframe Icing 8. Darkness d. Equipment Failure 1. Engine Operations 3. Malfunction(s): Equipment

  12. Green marketing in the Massachusetts electric company retail competition pilot program

    Energy Technology Data Exchange (ETDEWEB)

    Rothstein, S.M.; Fang, J.M.

    1997-10-01

    With electric industry restructuring initiatives being introduced on the state and federal levels, retail access pilot programs serve an important function for examining competitive market issues, as well as marketing strategies and customer reactions to different power supply options. The experience gained through these pilots provides important insights into future power market operations, including the market for green power. The Massachusetts Electric Company`s (MECo`s) Choice: New England pilot for residential and small-business customers was a voluntary program developed primarily to test the billing and metering logistics that distribution companies will need in the competitive market. The pilot also offered a preview of program implementation and marketing under customer choice. It was the first retail competition pilot to explicitly include green power options in program design. The MECo pilot`s energy suppliers were selected through the issuance of a request for proposals (RFP). Respondents were asked to submit bids in one or more of three energy supply categories-price, green, and other options. These options were developed by the pilot administrator through internal meetings, discussions with state officials and other stakeholders, and a review of information from other similar pilots. For the green option, the pilot administrator did not establish a green standard. Instead, suppliers were allowed to submit offers that promoted environmental stewardship. Customer response to the different green options are reported. The pilot results clearly demonstrate that, in a competitive situation, there is interest in a variety of energy supply options, including green options. 2 tabs.

  13. 14 CFR 61.73 - Military pilots or former military pilots: Special rules.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Military pilots or former military pilots... Ratings and Pilot Authorizations § 61.73 Military pilots or former military pilots: Special rules. (a... a disciplinary action involving aircraft operations, a U.S. military pilot or former military pilot...

  14. Pilot project as enabler?

    DEFF Research Database (Denmark)

    Neisig, Margit; Glimø, Helle; Holm, Catrine Granzow

    This article deals with a systemic perspective on transition. The field of study addressed is a pilot project as enabler of transition in a highly complex polycentric context. From a Luhmannian systemic approach, a framework is created to understand and address barriers of change occurred using...... pilot projects as enabler of transition. Aspects of how to create trust and deal with distrust during a transition are addressed. The transition in focus is the concept of New Public Management and how it is applied in the management of the Employment Service in Denmark. The transition regards...

  15. Pilot pulsar surveys with LOFAR

    NARCIS (Netherlands)

    Coenen, T.

    2013-01-01

    We are performing two complementary pilot pulsar surveys as part of LOFAR commissioning. The LOFAR Pilot Pulsar Survey (LPPS) is a shallow all-sky survey using an incoherent combination of LOFAR stations. The LOFAR Tied-Array Survey (LOTAS) is a deeper pilot survey using 19 simultaneous tied-array

  16. A pilot study on the feasibility of European harmonized human biomonitoring: Strategies towards a common approach, challenges and opportunities

    Energy Technology Data Exchange (ETDEWEB)

    Casteleyn, L., E-mail: Ludwine.Casteleyn@med.kuleuven.be [KU Leuven (Belgium); Dumez, B. [KU Leuven (Belgium); Becker, K.; Kolossa-Gehring, M. [Federal Environment Agency (UBA) (Germany); Den Hond, E.; Schoeters, G. [VITO (Belgium); Castaño, A. [Instituto de Salud Carlos III (Spain); Koch, H.M.; Angerer, J. [Ruhr Universität Bochum (Germany); Esteban, M. [Instituto de Salud Carlos III (Spain); Exley, K.; Sepai, O. [Public Health England (United Kingdom); Bloemen, L. [Environmental Health Sciences International (Netherlands); Horvat, M. [Jožef Stefan Institute (Slovenia); Knudsen, L.E. [Kobenhavns Universitet (Denmark); Joas, A.; Joas, R. [BiPRO (Germany); Biot, P. [Federal Public Service Health, Food chain safety and Environment (Belgium); Koppen, G. [VITO (Belgium); Dewolf, M-C. [Hainaut Vigilance Sanitaire (HVS) and Hygiene Publique in Hainaut (HPH) (Belgium); and others

    2015-08-15

    In 2004 the European Commission and Member States initiated activities towards a harmonized approach for Human Biomonitoring surveys throughout Europe. The main objective was to sustain environmental health policy by building a coherent and sustainable framework and by increasing the comparability of data across countries. A pilot study to test common guidelines for setting up surveys was considered a key step in this process. Through a bottom-up approach that included all stakeholders, a joint study protocol was elaborated. From September 2011 till February 2012, 17 European countries collected data from 1844 mother–child pairs in the frame of DEMOnstration of a study to COordinate and Perform Human Biomonitoring on a European Scale (DEMOCOPHES). Mercury in hair and urinary cadmium and cotinine were selected as biomarkers of exposure covered by sufficient analytical experience. Phthalate metabolites and Bisphenol A in urine were added to take into account increasing public and political awareness for emerging types of contaminants and to test less advanced markers/markers covered by less analytical experience. Extensive efforts towards chemo-analytical comparability were included. The pilot study showed that common approaches can be found in a context of considerable differences with respect to experience and expertize, socio-cultural background, economic situation and national priorities. It also evidenced that comparable Human Biomonitoring results can be obtained in such context. A European network was built, exchanging information, expertize and experiences, and providing training on all aspects of a survey. A key challenge was finding the right balance between a rigid structure allowing maximal comparability and a flexible approach increasing feasibility and capacity building. Next steps in European harmonization in Human Biomonitoring surveys include the establishment of a joint process for prioritization of substances to cover and biomarkers to develop

  17. A pilot study on the feasibility of European harmonized human biomonitoring: Strategies towards a common approach, challenges and opportunities

    International Nuclear Information System (INIS)

    Casteleyn, L.; Dumez, B.; Becker, K.; Kolossa-Gehring, M.; Den Hond, E.; Schoeters, G.; Castaño, A.; Koch, H.M.; Angerer, J.; Esteban, M.; Exley, K.; Sepai, O.; Bloemen, L.; Horvat, M.; Knudsen, L.E.; Joas, A.; Joas, R.; Biot, P.; Koppen, G.; Dewolf, M-C.

    2015-01-01

    In 2004 the European Commission and Member States initiated activities towards a harmonized approach for Human Biomonitoring surveys throughout Europe. The main objective was to sustain environmental health policy by building a coherent and sustainable framework and by increasing the comparability of data across countries. A pilot study to test common guidelines for setting up surveys was considered a key step in this process. Through a bottom-up approach that included all stakeholders, a joint study protocol was elaborated. From September 2011 till February 2012, 17 European countries collected data from 1844 mother–child pairs in the frame of DEMOnstration of a study to COordinate and Perform Human Biomonitoring on a European Scale (DEMOCOPHES). Mercury in hair and urinary cadmium and cotinine were selected as biomarkers of exposure covered by sufficient analytical experience. Phthalate metabolites and Bisphenol A in urine were added to take into account increasing public and political awareness for emerging types of contaminants and to test less advanced markers/markers covered by less analytical experience. Extensive efforts towards chemo-analytical comparability were included. The pilot study showed that common approaches can be found in a context of considerable differences with respect to experience and expertize, socio-cultural background, economic situation and national priorities. It also evidenced that comparable Human Biomonitoring results can be obtained in such context. A European network was built, exchanging information, expertize and experiences, and providing training on all aspects of a survey. A key challenge was finding the right balance between a rigid structure allowing maximal comparability and a flexible approach increasing feasibility and capacity building. Next steps in European harmonization in Human Biomonitoring surveys include the establishment of a joint process for prioritization of substances to cover and biomarkers to develop

  18. Openness initiative

    International Nuclear Information System (INIS)

    Duncan, S.S.

    1995-01-01

    Although antinuclear campaigns seem to be effective, public communication and education efforts on low-level radioactive waste have mixed results. Attempts at public information programs on low-level radioactive waste still focus on influencing public opinion. A question then is: open-quotes Is it preferable to have a program focus on public education that will empower individuals to make informed decisions rather than trying to influence them in their decisions?close quotes To address this question, a case study with both quantitative and qualitative data will be used. The Ohio Low-Level Radioactive Waste Education Program has a goal to provide people with information they want/need to make their own decisions. The program initiated its efforts by conducting a statewide survey to determine information needed by people and where they turned for that information. This presentation reports data from the survey and then explores the program development process in which programs were designed and presented using the information. Pre and post data from the programs reveal attitude and knowledge shifts

  19. Openness initiative

    Energy Technology Data Exchange (ETDEWEB)

    Duncan, S.S. [Los Alamos National Lab., NM (United States)

    1995-12-31

    Although antinuclear campaigns seem to be effective, public communication and education efforts on low-level radioactive waste have mixed results. Attempts at public information programs on low-level radioactive waste still focus on influencing public opinion. A question then is: {open_quotes}Is it preferable to have a program focus on public education that will empower individuals to make informed decisions rather than trying to influence them in their decisions?{close_quotes} To address this question, a case study with both quantitative and qualitative data will be used. The Ohio Low-Level Radioactive Waste Education Program has a goal to provide people with information they want/need to make their own decisions. The program initiated its efforts by conducting a statewide survey to determine information needed by people and where they turned for that information. This presentation reports data from the survey and then explores the program development process in which programs were designed and presented using the information. Pre and post data from the programs reveal attitude and knowledge shifts.

  20. Removing Ambiguities of IP Telephony Traffic Using Protocol Scrubbers

    Directory of Open Access Journals (Sweden)

    Bazara I. A. Barry

    2012-10-01

    Full Text Available Network intrusion detection systems (NID