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Sample records for residue prevention protocol

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

    Science.gov (United States)

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

    2010-03-01

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

  2. Emergency Protocol and Violence Prevention in a University Setting

    Science.gov (United States)

    Rust, Dylan

    2012-01-01

    This study analyzed the emergency protocol and violence prevention methods utilized at an American university. The four research questions were: (1) What are the sources of violence at the university? a. How has the university addressed these sources? (2) What constitutes an emergency in the eyes of the university? (3) How do emergency protocols…

  3. Prevention of damage and 'residual risk' in nuclear power laws

    International Nuclear Information System (INIS)

    Greipl, C.

    1992-01-01

    The concept of prevention of damage within the framework of nuclear power laws includes averting danger for the protection of third parties and preventing risks for the partial protection of third parties with the proviso that still a desire to use the concept 'residual risk' in addition, it should be limited, on the grounds of what can be reasonably expected, to those risks which cannot be reduced any further by the government, i.e. to risks which the public in general and third parties ('actually') must accept. In the future, questions regarding safety systems should be taken into account exclusively withing the context of 'what is necessary for protection against damage in keeping with the latest developments in science and technology' and not at the discretion of the law in denying permission according to Article 7 Paragraph 2 Atomic Energy Law. (orig.) [de

  4. FAO/IAEA model protocol for the determination of bound residues in soil

    International Nuclear Information System (INIS)

    1986-01-01

    A protocol for determining bound pesticide residue content in soils was developed and collaboratively tested by 11 members of the FAO/IAEA Research Co-ordination Committee. The method assumes prior incubation of soil with a radioactive pesticide or related organic compound. The major process steps of the protocol include: (a) Soxhlet extraction of air-dry soil with methanol for 24 h; (b) determination of radioactivity in unextracted soil, in methanol-extracted soil (yielding bound residue content), and in the methanol extract (yielding extractable residue content); and (c) use of triplicate samples per analysis. The participants received lysimeter soils treated six to seven years earlier with 14 C-allyl alcohol (Soil A) or 14 C-hexachloro-benzene (Soil H). The inter-laboratory results first indicated non-homogeneity of Soil A sub-samples, since the initial and bound radioactivity for four laboratories was about half of that found by the remaining seven laboratories. Intra-laboratory (in one laboratory) analyses of sub-subsamples from six 'high-group' laboratories, two 'low-group' laboratories and two additional laboratories confirmed the homogeneity of Soil A and implicated error in the combustion methods at 'low-group' laboratories. The intra- and inter-laboratory coefficients of variation for initial 14 C-content were 4.7% and 7.0%, respectively. Of the residual 14 C in Soil A, 95% was bound; in contrast, only 15% of 14 C in Soil H was bound. The coefficients of variation among ten laboratories, for Soil H, were 8.4% and 18.1% for percentage extractable residue and percentage bound residue, respectively. Some limited testing of alternative protocols, using other solvents or batch extraction, confirmed that the IAEA protocol was most efficient in the extraction of non-bound radioactivity; pre-wetting Soil A may, however, improve extraction. (author)

  5. Effectiveness of protocols for preventing occupational exposure to blood and body fluids in Dutch hospitals

    NARCIS (Netherlands)

    van Gemert-Pijnen, Julia E.W.C.; Hendrix, M.G.R.; van der Palen, Jacobus Adrianus Maria; Schellens, P.J.

    2006-01-01

    Compliance of different healthcare workers (HCWs) (nurses, physicians, laboratory technicians and cleaners) with protocols to prevent exposure to blood and body fluids (BBF) was studied. Questionnaires were used to assess perception of risks, familiarity with protocols, motivation and actual

  6. 77 FR 24671 - Compliance Guide for Residue Prevention and Agency Testing Policy for Residues

    Science.gov (United States)

    2012-04-25

    ... Hazard Analysis and Critical Control Points (HACCP) inspection system, another important component of the NRP is to provide verification of residue control in HACCP systems. As part of the HACCP regulation... guide, and FSIS finds violative residues, the establishment's HACCP system may be inadequate under 9 CFR...

  7. Incidence of intraoperative hypothermia: adopting protocol for its prevention

    International Nuclear Information System (INIS)

    Al-Qahtani, Ali S.; Messahel, Farouk M.

    2003-01-01

    To determine the incidence of hypothermia during surgical procedures when adequate methods of preserving normothermia are applied .For this was a study in which patients ASA I-IV presented for surgery at the Armed Forces Hospital, Wadi Al- Dawasir, kingdom of Saudi Arabia ,during the period from July 2000 to February 2003 in whom body core temprature was between 35-37C ,were included. Ambient temperature of the operating room was thermostatically adjusted to record 26C and 24C if patents were < 10 year-old or above .Depending on type of surgery ;the patients were provided with space blankents and were lying on warm mattresses. Fluid or blood warmers and forced-air surface were used when needed for this. = Aggressive measures must be adopted to preserve normothermia as prevention of intraoperative hypothermia improves patients outcome .All patients shoud have their body temprature monitored during surgery .However application of available methods of keeping normothermia reduces the the incidence of intraoperative hypothermia but does not abolish it completely . Hypothermia patients should be closely moniterd during gradual rewarming preferably in the intensive care setting. A protocol for prevention of intraoperative hypothermia must be adopted by all operating theatres. (author)

  8. Development of a field testing protocol for identifying Deepwater Horizon oil spill residues trapped near Gulf of Mexico beaches

    Science.gov (United States)

    Han, Yuling

    2018-01-01

    The Deepwater Horizon (DWH) accident, one of the largest oil spills in U.S. history, contaminated several beaches located along the Gulf of Mexico (GOM) shoreline. The residues from the spill still continue to be deposited on some of these beaches. Methods to track and monitor the fate of these residues require approaches that can differentiate the DWH residues from other types of petroleum residues. This is because, historically, the crude oil released from sources such as natural seeps and anthropogenic discharges have also deposited other types of petroleum residues on GOM beaches. Therefore, identifying the origin of these residues is critical for developing effective management strategies for monitoring the long-term environmental impacts of the DWH oil spill. Advanced fingerprinting methods that are currently used for identifying the source of oil spill residues require detailed laboratory studies, which can be cost-prohibitive. Also, most agencies typically use untrained workers or volunteers to conduct shoreline monitoring surveys and these worker will not have access to advanced laboratory facilities. Furthermore, it is impractical to routinely fingerprint large volumes of samples that are collected after a major oil spill event, such as the DWH spill. In this study, we propose a simple field testing protocol that can identify DWH oil spill residues based on their unique physical characteristics. The robustness of the method is demonstrated by testing a variety of oil spill samples, and the results are verified by characterizing the samples using advanced chemical fingerprinting methods. The verification data show that the method yields results that are consistent with the results derived from advanced fingerprinting methods. The proposed protocol is a reliable, cost-effective, practical field approach for differentiating DWH residues from other types of petroleum residues. PMID:29329313

  9. Development of a field testing protocol for identifying Deepwater Horizon oil spill residues trapped near Gulf of Mexico beaches.

    Science.gov (United States)

    Han, Yuling; Clement, T Prabhakar

    2018-01-01

    The Deepwater Horizon (DWH) accident, one of the largest oil spills in U.S. history, contaminated several beaches located along the Gulf of Mexico (GOM) shoreline. The residues from the spill still continue to be deposited on some of these beaches. Methods to track and monitor the fate of these residues require approaches that can differentiate the DWH residues from other types of petroleum residues. This is because, historically, the crude oil released from sources such as natural seeps and anthropogenic discharges have also deposited other types of petroleum residues on GOM beaches. Therefore, identifying the origin of these residues is critical for developing effective management strategies for monitoring the long-term environmental impacts of the DWH oil spill. Advanced fingerprinting methods that are currently used for identifying the source of oil spill residues require detailed laboratory studies, which can be cost-prohibitive. Also, most agencies typically use untrained workers or volunteers to conduct shoreline monitoring surveys and these worker will not have access to advanced laboratory facilities. Furthermore, it is impractical to routinely fingerprint large volumes of samples that are collected after a major oil spill event, such as the DWH spill. In this study, we propose a simple field testing protocol that can identify DWH oil spill residues based on their unique physical characteristics. The robustness of the method is demonstrated by testing a variety of oil spill samples, and the results are verified by characterizing the samples using advanced chemical fingerprinting methods. The verification data show that the method yields results that are consistent with the results derived from advanced fingerprinting methods. The proposed protocol is a reliable, cost-effective, practical field approach for differentiating DWH residues from other types of petroleum residues.

  10. Team Training and Institutional Protocols to Prevent Shoulder Dystocia Complications.

    Science.gov (United States)

    Smith, Samuel

    2016-12-01

    Shoulder dystocia is an obstetrical emergency that may result in significant neonatal complications. It requires rapid recognition and a coordinated response. Standardization of care, teamwork and communication, and clinical simulation are the key components of patient safety programs in obstetrics. Simulation-based team training and institutional protocols for the management of shoulder dystocia are emerging as integral components of many labor and delivery safety initiatives because of their impact on technical skills and team performance.

  11. South African Research Ethics Committee Review of Standards of Prevention in HIV Vaccine Trial Protocols.

    Science.gov (United States)

    Essack, Zaynab; Wassenaar, Douglas R

    2018-04-01

    HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prevention research. For this reason, it is critical to study the implementation of relevant ethical-legal frameworks for such research in South Africa. This qualitative study used in-depth interviews to explore the practices and perspectives of eight members of South African research ethics committees (RECs) who have reviewed protocols for HIV vaccine trials. Their practices and perspectives are compared with ethics guideline requirements for standards of prevention.

  12. The FLASSH study: protocol for a randomised controlled trial evaluating falls prevention after stroke and two sub-studies

    Directory of Open Access Journals (Sweden)

    Mackintosh Shylie F

    2009-03-01

    Full Text Available Abstract Background Falls are common in stroke survivors returning home after rehabilitation, however there is currently a lack of evidence about preventing falls in this population. This paper describes the study protocol for the FLASSH (FaLls prevention After Stroke Survivors return Home project. Methods and design This randomised controlled trial aims to evaluate the effectiveness of a multi-factorial falls prevention program for stroke survivors who are at high risk of falling when they return home after rehabilitation. Intervention will consist of a home exercise program as well as individualised falls prevention and injury minimisation strategies based on identified risk factors for falls. Additionally, two sub-studies will be implemented in order to explore other key areas related to falls in this population. The first of these is a longitudinal study evaluating the relationship between fear of falling, falls and function over twelve months, and the second evaluates residual impairment in gait stability and obstacle crossing twelve months after discharge from rehabilitation. Discussion The results of the FLASSH project will inform falls prevention practice for stroke survivors. If the falls prevention program is shown to be effective, low cost strategies to prevent falls can be implemented for those at risk around the time of discharge from rehabilitation, thus improving safety and quality of life for stroke survivors. The two sub-studies will contribute to the overall understanding and management of falls risk in stroke survivors. Trial registration This trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN012607000398404.

  13. Use of protocol and evaluation of postoperative residual curarization incidence in the absence of intraoperative acceleromyography - Randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Filipe Nadir Caparica Santos

    Full Text Available Abstract Objective Evaluate the incidence of postoperative residual curarization (PORC in the post-anesthesia care unit (PACU after the use of protocol and absence of intraoperative acceleromyography (AMG. Methods Randomized clinical trial with 122 patients allocated into two groups (protocol and control. Protocol group received initial and additional doses of rocuronium (0.6 mg·kg-1 and 10 mg, respectively; the use of rocuronium was avoided in the final 45 min; blockade reversal with neostigmine (50 µg·kg-1; time ≥15 min between reversion and extubation. Control: initial and additional doses of rocuronium, blockade reversal, neostigmine dose, and extubation time, all at the discretion of the anesthesiologist. AMG was used in the PACU and PORC considered at T4/T1 ratio <1.0. Results The incidence of PORC was lower in protocol group than in control group (25% vs. 45.2%, p = 0.02. In control group, total dose of rocuronium was higher in patients with PORC than without PORC (0.43 vs. 0.35 mg·kg-1·h-1, p = 0.03 and the time interval between the last administration of rocuronium and neostigmine was lower (75.0 vs. 101.0 min, p < 0.01. In protocol group, there was no difference regarding the analyzed parameters (with PORC vs. without PORC. Considering the entire study population and the presence or absence of PORC, total dose of rocuronium was higher in patients with PORC (0.42 vs. 0.31 mg·kg-1·h-1, p = 0.01, while the time interval between the last administration of rocuronium and neostigmine was lower (72.5 vs. 99.0 min, p ≤ 0.01. Conclusion The proposed systematization reduced PORC incidence in PACU in the absence of intraoperative AMG.

  14. The effects of a tailored intensive care unit delirium prevention protocol: A randomized controlled trial.

    Science.gov (United States)

    Moon, Kyoung-Ja; Lee, Sun-Mi

    2015-09-01

    A decreased incidence of delirium following the application of non-pharmacologic intervention protocols to several patient populations has been previously reported. However, few studies have been conducted to examine the effects of their application to intensive care unit (ICU) patients. To examine the effects of applying a tailored delirium preventive protocol, developed by the authors, to ICU patients by analyzing its effects on delirium incidence, in-hospital mortality, ICU readmission, and length of ICU stay in a Korean hospital. A single-blind randomized controlled trial. A 1049-bed general hospital with a 105-bed ICU. Sixty and 63 ICU patients were randomly assigned to the intervention and control groups, respectively. The researchers applied the delirium prevention protocol to the intervention group every day for the first 7 days of ICU hospitalization. Delirium incidence, mortality, and re-admission to the ICU during the same hospitalization period were analyzed by logistic regression analysis; the 7- and 30-day in-hospital mortality by Kaplan-Meier survival and Cox proportional hazard regression analysis; and length of ICU stay was assessed by linear regression analysis. Application of the protocol had no significant effect on delirium incidence, in-hospital mortality, re-admission to the ICU, or length of ICU stay. Whereas the risk of 30-day in-hospital mortality was not significantly lower in the intervention than in the control group (OR: 0.33; 95% CI: 0.10-1.09), we found a significantly decreased 7-day in-hospital mortality in the intervention group after protocol application (HR: 0.09; 95% CI: 0.01-0.72). Application of a tailored delirium prevention protocol to acute stage patients during the first 7 days of ICU hospitalization appeared to reduce the 7-day in-hospital risk of mortality only for this patient population. Copyright © 2015 Elsevier Ltd. All rights reserved.

  15. Optimisation of recovery protocols for double-base smokeless powder residues analysed by total vaporisation (TV) SPME/GC-MS.

    Science.gov (United States)

    Sauzier, Georgina; Bors, Dana; Ash, Jordan; Goodpaster, John V; Lewis, Simon W

    2016-09-01

    The investigation of explosive events requires appropriate evidential protocols to recover and preserve residues from the scene. In this study, a central composite design was used to determine statistically validated optimum recovery parameters for double-base smokeless powder residues on steel, analysed using total vaporisation (TV) SPME/GC-MS. It was found that maximum recovery was obtained using isopropanol-wetted swabs stored under refrigerated conditions, then extracted for 15min into acetone on the same day as sample collection. These parameters were applied to the recovery of post-blast residues deposited on steel witness surfaces following a PVC pipe bomb detonation, resulting in detection of all target components across the majority of samples. Higher overall recoveries were obtained from plates facing the sides of the device, consistent with the point of first failure occurring in the pipe body as observed in previous studies. The methodology employed here may be readily applied to a variety of other explosive compounds, and thus assist in establishing 'best practice' procedures for explosive investigations. Copyright © 2016 Elsevier B.V. All rights reserved.

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

    Science.gov (United States)

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

    2017-05-25

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

  17. 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.

  18. Impact-disrupted gunshot residue: A sub-micron analysis using a novel collection protocol

    Directory of Open Access Journals (Sweden)

    V. Spathis

    2017-06-01

    Full Text Available The analysis of gunshot residue (GSR has played an integral role within the legal system in relation to shooting cases. With a characteristic elemental composition of lead, antimony, barium, and a typically discriminative spheroidal morphology, the presence and distribution of GSR can aid in firearm investigations. In this experiment, three shots of low velocity rim-fire ammunition were fired over polished silicon collection substrates placed at six intervals over a 100 cm range. The samples were analysed using a Field Emission Gun Scanning Electron Microscope (FEG-SEM in conjunction with an X-flash Energy Dispersive X-ray (EDX detector, allowing for GSR particle analyses of composition and structure at the sub-micron level. The results of this experiment indicate that although classic spheroidal particles are present consistently throughout the entire range of samples their sizes vary significantly, and at certain distances from the firearm particles with an irregular morphology were discerned, forming “impact-disrupted” GSR particles, henceforth colloquially referred to as “splats”. Upon further analysis, trends with regards to the formation of these splat particles were distinguished. An increase in splat frequency was observed starting at 10 cm from the firearm, with 147 mm−2 splat density, reaching a maximal flux at 40 cm (451 mm−2, followed by a gradual decrease to the maximum range sampled. Moreover, the structural morphology of the splats changes throughout the sampling range. At the distances closest to the firearm, molten-looking particles were formed, demonstrating the metallic residues were in a liquid state when their flight path was disrupted. However, at increased distances-primarily where the discharge plume was at maximum dispersion and moving away from the firearm, the residues have had time to cool in-fight resulting in semi-congealed and solid particles that subsequently disrupted upon impact, forming more

  19. Manual hyperinflation partly prevents reductions of functional residual capacity in cardiac surgical patients--a randomized controlled trial

    NARCIS (Netherlands)

    Paulus, Frederique; Veelo, Denise P.; de Nijs, Selma B.; Beenen, Ludo F. M.; Bresser, Paul; de Mol, Bas A. J. M.; Binnekade, Jan M.; Schultz, Marcus J.

    2011-01-01

    Cardiac surgery is associated with post-operative reductions of functional residual capacity (FRC). Manual hyperinflation (MH) aims to prevent airway plugging, and as such could prevent the reduction of FRC after surgery. The main purpose of this study was to determine the effect of MH on

  20. Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial

    Directory of Open Access Journals (Sweden)

    Neto José

    2011-03-01

    Full Text Available Abstract Background Blood pressure (BP within pre-hypertensive levels confers higher cardiovascular risk and is an intermediate stage for full hypertension, which develops in an annual rate of 7 out of 100 individuals with 40 to 50 years of age. Non-drug interventions to prevent hypertension have had low effectiveness. In individuals with previous cardiovascular disease or diabetes, the use of BP-lowering agents reduces the incidence of major cardiovascular events. In the absence of higher baseline risk, the use of BP agents reduces the incidence of hypertension. The PREVER-prevention trial aims to investigate the efficacy, safety and feasibility of a population-based intervention to prevent the incidence of hypertension and the development of target-organ damage. Methods This is a randomized, double-blind, placebo-controlled clinical trial, with participants aged 30 to 70 years, with pre-hypertension. The trial arms will be chlorthalidone 12.5 mg plus amiloride 2.5 mg or identical placebo. The primary outcomes will be the incidence of hypertension, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new sub-clinical atherosclerosis, and sudden death. The study will last 18 months. The sample size was calculated on the basis of an incidence of hypertension of 14% in the control group, a size effect of 40%, power of 85% and P alpha of 5%, resulting in 625 participants per group. The project was approved by the Ethics committee of each participating institution. Discussion The early use of blood pressure-lowering drugs, particularly diuretics, which act on the main mechanism of blood pressure rising with age, may prevent cardiovascular events and the incidence of hypertension in individuals with hypertension. If this intervention shows to be effective and safe

  1. Prevention of cervical cancer in HIV-seropositive women from developing countries: a systematic review protocol.

    Science.gov (United States)

    Mapanga, Witness; Elhakeem, Ahmed; Feresu, Shingairai A; Maseko, Fresier; Chipato, Tsungai

    2017-04-24

    Over 85% of cervical cancer cases and deaths occur in developing countries. HIV-seropositive women are more likely to develop precancerous lesions that lead to cervical cancer than HIV-negative women. However, the literature on cervical cancer prevention in seropositive women in developing countries has not been reviewed. The aim of this study is to systematically review cervical cancer prevention modalities available for HIV-seropositive women in developing countries. This protocol was developed by following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement, and the systematic review will be reported in accordance with the PRISMA guidelines. Embase, MEDLINE, PubMed, CINAHL and Cochrane Library will be searched from inception up to date of final search, and additional studies will be located through citation and reference list tracking. Eligible studies will be randomised controlled trials, prospective and retrospective cohort studies, case-control and cross-sectional studies carried out in developing countries. Studies will be included if they are published in English and examine cervical cancer prevention modalities in HIV-seropositive women. Results will be summarised in tables and, where appropriate, combined using meta-analysis. This review will address the gap in evidence by systematically reviewing the published literature on the different prevention modalities being used to prevent cervical cancer in HIV-seropositive women in developing countries. The findings may be used to inform evidence-based guidelines for prevention of cervical cancer in seropositive women as well as future research. PROSPERO CRD42017054678 .

  2. Suicide Risk Protocols: Addressing the Needs of High Risk Youths Identified through Suicide Prevention Efforts and in Clinical Settings

    Science.gov (United States)

    Heilbron, Nicole; Goldston, David; Walrath, Christine; Rodi, Michael; McKeon, Richard

    2013-01-01

    Several agencies have emphasized the importance of establishing clear protocols or procedures to address the needs of youths who are identified as suicidal through suicide prevention programs or in emergency department settings. What constitutes optimal guidelines for developing and implementing such protocols, however, is unclear. At the request…

  3. Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade With E-Learning: Protocol for the Multicenter Interrupted Time Series INVERT Study.

    Science.gov (United States)

    Thomsen, Jakob Louis Demant; Mathiesen, Ole; Hägi-Pedersen, Daniel; Skovgaard, Lene Theil; Østergaard, Doris; Engbaek, Jens; Gätke, Mona Ring

    2017-10-06

    Muscle relaxants facilitate endotracheal intubation under general anesthesia and improve surgical conditions. Residual neuromuscular blockade occurs when the patient is still partially paralyzed when awakened after surgery. The condition is associated with subjective discomfort and an increased risk of respiratory complications. Use of an objective neuromuscular monitoring device may prevent residual block. Despite this, many anesthetists refrain from using the device. Efforts to increase the use of objective monitoring are time consuming and require the presence of expert personnel. A neuromuscular monitoring e-learning module might support consistent use of neuromuscular monitoring devices. The aim of the study is to assess the effect of a neuromuscular monitoring e-learning module on anesthesia staff's use of objective neuromuscular monitoring and the incidence of residual neuromuscular blockade in surgical patients at 6 Danish teaching hospitals. In this interrupted time series study, we are collecting data repeatedly, in consecutive 3-week periods, before and after the intervention, and we will analyze the effect using segmented regression analysis. Anesthesia departments in the Zealand Region of Denmark are included, and data from all patients receiving a muscle relaxant are collected from the anesthesia information management system MetaVision. We will assess the effect of the module on all levels of potential effect: staff's knowledge and skills, patient care practice, and patient outcomes. The primary outcome is use of neuromuscular monitoring in patients according to the type of muscle relaxant received. Secondary outcomes include last recorded train-of-four value, administration of reversal agents, and time to discharge from the postanesthesia care unit as well as a multiple-choice test to assess knowledge. The e-learning module was developed based on a needs assessment process, including focus group interviews, surveys, and expert opinions. The e

  4. A feasible repetitive transcranial magnetic stimulation clinical protocol in migraine prevention.

    Science.gov (United States)

    Zardouz, Shawn; Shi, Lei; Leung, Albert

    2016-01-01

    This case series was conducted to determine the clinical feasibility of a repetitive transcranial magnetic stimulation protocol for the prevention of migraine (with and without aura). Five patients with migraines underwent five repetitive transcranial magnetic stimulation sessions separated in 1- to 2-week intervals for a period of 2 months at a single tertiary medical center. Repetitive transcranial magnetic stimulation was applied to the left motor cortex with 2000 pulses (20 trains with 1s inter-train interval) delivered per session, at a frequency of 10 Hz and 80% resting motor threshold. Pre- and post-treatment numerical rating pain scales were collected, and percent reductions in intensity, frequency, and duration were generated. An average decrease in 37.8%, 32.1%, and 31.2% were noted in the intensity, frequency, and duration of migraines post-repetitive transcranial magnetic stimulation, respectively. A mean decrease in 1.9±1.0 (numerical rating pain scale ± standard deviation; range: 0.4-2.8) in headache intensity scores was noted after the repetitive transcranial magnetic stimulation sessions. The tested repetitive transcranial magnetic stimulation protocol is a well-tolerated, safe, and effective method for migraine prevention.

  5. A protocol to prevent and deal with aggressive behavior against health workers.

    Science.gov (United States)

    Altemir, María; Arteaga, Alfonso

    Violence against health workers is a highly prevalent phenomenon with serious psychological and labour consequences among professionals. This paper aims, first, to find out the main studies undertaken to date to describe and analyse the phenomenon, as well as to present different initiatives and protocols of action carried out. The second objective is to offer a procedure of action both to prevent aggression and to intervene in the event of receiving an aggression at work. After a bibliographic search in PubMed, Scopus and SciELO databases, the impact of the aggressions suffered by health professionals, the contexts in which aggressions are more frequent, their main consequences and different strategies and protocols conducted in Spain are reviewed. Given that rigorous reviews supporting such procedures are lacking in scientific journals, different action guidelines for professionals to prevent and to deal with hostile behaviour based on available evidence are developed and proposed. Finally, an easily consultable and applicable action procedure for health workers attacked in the workplace is presented. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  6. Distribution of Estimated 10-Year Risk of Recurrent Vascular Events and Residual Risk in a Secondary Prevention Population

    NARCIS (Netherlands)

    Kaasenbrood, Lotte; Boekholdt, S. Matthijs; van der Graaf, Yolanda; Ray, Kausik K.; Peters, Ron J. G.; Kastelein, John J. P.; Amarenco, Pierre; LaRosa, John C.; Cramer, Maarten J. M.; Westerink, Jan; Kappelle, L. Jaap; de Borst, Gert J.; Visseren, Frank L. J.

    2016-01-01

    Among patients with clinically manifest vascular disease, the risk of recurrent vascular events is likely to vary. We assessed the distribution of estimated 10-year risk of recurrent vascular events in a secondary prevention population. We also estimated the potential risk reduction and residual

  7. Policies and protocols for preventing transmission of HIV infection in oral health care in South Africa.

    Science.gov (United States)

    Ogunbodede, E O; Rudolph, M J

    2002-12-01

    Human immunodeficiency virus (HIV) infection constitutes an unparalleled public health challenge. The unique nature of most oral health procedures, instrumentation and patient-care settings requires specific strategies and protocols aimed at preventing the transmission of HIV/AIDS between oral health care providers and patients, as well as between patients themselves. The present study investigated the level of information and training about protocols and policies for preventing the transmission of HIV/AIDS in oral health care settings in South Africa. The data collection techniques utilised available information, in-depth interviews and an open-ended questionnaire. The respondents were 20 purposively selected key informants who were senior officers for HIV/AIDS programmes and/or oral health organisations. Sixteen (80%) of the respondents reported that there were no existing oral health policies on HIV/AIDS in their health care institutions or organisations. None of the interviewees knew of any specific protocols on HIV/AIDS in the oral health care setting that emanated from South Africa. In addition, none of the dental professional associations had established an infection control committee or a support system for members who might become infected with HIV and develop AIDS. Territorial boundaries existed between sectors within the medical disciplines, as well as between the medical and oral health disciplines. Numerous general impediments were identified, such as prejudice, denial and fear, inadequate training and/or information about the infection, lack of representation and resources for policy planning, a lack of interest from the business sector, and approaching HIV/AIDS in the workplace as a 'one-time issue' Other obstacles identified included unemployment, poverty, illiteracy, disempowerment of women and inadequate communication of policies to service providers. Additional issues raised included the migrant labour systeM, complexities of language and culture

  8. An iPTH based protocol for the prevention and treatment of symptomatic hypocalcemia after thyroidectomy

    Science.gov (United States)

    Carter, Yvette; Chen, Herbert; Sippel, Rebecca S.

    2013-01-01

    Background Symptomatic hypocalcemia after thyroidectomy is a barrier to same day surgery, and the cause of ER visits. A standard protocol of calcium and vitamin D supplementation, dependent on intact parathyroid hormone (iPTH) levels, can address this issue. How effective is it? When does it fail? Methods We performed a retrospective review of the prospective Thyroid Database from January 2006 to December 2010. 620 patients underwent completion (CT) or total thyroidectomy (TT), and followed our post-operative protocol of calcium carbonate administration for iPTH levels ≥10pg/ml and calcium carbonate and 0.25μg calcitriol BID for iPTH hypocalcemia. The symptomatic (SX) and asymptomatic (ASX) groups were similar with regard to gender, cancer diagnosis, and pre-operative calcium and iPTH. The symptomatic group was significantly younger (39.6 ± 2.8 vs. 49 ± 0.6 years, p=0.01), with lower post-operative iPTH levels. 33% (n=8) of SX patients had an iPTH ≤5 pg/ml vs. only 6% (n=37) of ASX patients. While the majority of patients with a PTH hypocalcemia after thyroidectomy. An iPTH ≤ 5pg/ml may warrant higher initial doses of calcitriol in order to prevent symptoms. PMID:24144426

  9. Using the intervention mapping protocol to develop a maintenance programme for the SLIMMER diabetes prevention intervention.

    Science.gov (United States)

    Elsman, Ellen B M; Leerlooijer, Joanne N; Ter Beek, Josien; Duijzer, Geerke; Jansen, Sophia C; Hiddink, Gerrit J; Feskens, Edith J M; Haveman-Nies, Annemien

    2014-10-27

    Although lifestyle interventions have shown to be effective in reducing the risk for type 2 diabetes mellitus, maintenance of achieved results is difficult, as participants often experience relapse after the intervention has ended. This paper describes the systematic development of a maintenance programme for the extensive SLIMMER intervention, an existing diabetes prevention intervention for high-risk individuals, implemented in a real-life setting in the Netherlands. The maintenance programme was developed using the Intervention Mapping protocol. Programme development was informed by a literature study supplemented by various focus group discussions and feedback from implementers of the extensive SLIMMER intervention. The maintenance programme was designed to sustain a healthy diet and physical activity pattern by targeting knowledge, attitudes, subjective norms and perceived behavioural control of the SLIMMER participants. Practical applications were clustered into nine programme components, including sports clinics at local sports clubs, a concluding meeting with the physiotherapist and dietician, and a return session with the physiotherapist, dietician and physical activity group. Manuals were developed for the implementers and included a detailed time table and step-by-step instructions on how to implement the maintenance programme. The Intervention Mapping protocol provided a useful framework to systematically plan a maintenance programme for the extensive SLIMMER intervention. The study showed that planning a maintenance programme can build on existing implementation structures of the extensive programme. Future research is needed to determine to what extent the maintenance programme contributes to sustained effects in participants of lifestyle interventions.

  10. Mobile Health Technology Interventions for Suicide Prevention: Protocol for a Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Melia, Ruth; Francis, Kady; Duggan, Jim; Bogue, John; O'Sullivan, Mary; Chambers, Derek; Young, Karen

    2018-01-26

    Previous research has reported that two of the major barriers to help-seeking for individuals at risk of suicide are stigma and geographical isolation. Mobile technology offers a potential means of delivering evidence-based interventions with greater specificity to the individual, and at the time that it is needed. Despite documented motivation by at-risk individuals to use mobile technology to track mental health and to support psychological interventions, there is a shortfall of outcomes data on the efficacy of mobile health (mHealth) technology on suicide-specific outcomes. The objective of this study is to develop a protocol for a systematic review and meta-analysis that aims to evaluate the effectiveness of mobile technology-based interventions for suicide prevention. The search includes the Cochrane Central Register of Controlled Trials (CENTRAL: The Cochrane Library), MEDLINE, Embase, PsycINFO, CRESP and relevant sources of gray literature. Studies that have evaluated psychological or nonpsychological interventions delivered via mobile computing and communication technology, and have suicidality as an outcome measure will be included. Two authors will independently extract data and assess the study suitability in accordance with the Cochrane Collaboration Risk of Bias Tool. Studies will be included if they measure at least one suicide outcome variable (ie, suicidal ideation, suicidal intent, nonsuicidal self-injurious behavior, suicidal behavior). Secondary outcomes will be measures of symptoms of depression. Where studies are sufficiently homogenous and reported outcomes are amenable for pooled synthesis, meta-analysis will be performed. A narrative synthesis will be conducted if the data is unsuitable for a meta-analysis. The review is in progress, with findings expected by summer 2018. To date, evaluations of mobile technology-based interventions in suicide prevention have focused on evaluating content as opposed to efficacy. Indeed, previous research has

  11. School-based intervention to prevent overweight and disordered eating in secondary school Malaysian adolescents: a study protocol

    OpenAIRE

    Sharif Ishak, Sharifah Intan Zainun; Chin, Yit Siew; Mohd. Taib, Mohd. Nasir; Mohd. Shariff, Zalilah

    2016-01-01

    Abstract Background Obesity, eating disorders and unhealthy weight-loss practices have been associated with diminished growth in adolescents worldwide. Interventions that address relevant behavioural dimensions have been lacking in Malaysia. This paper describes the protocol of an integrated health education intervention namely ‘Eat Right, Be Positive About Your Body and Live Actively’ (EPaL), a primary prevention which aimed to promote healthy lifestyle in preventing overweight and disordere...

  12. Behavioral counseling to prevent childhood obesity – study protocol of a pragmatic trial in maternity and child health care

    OpenAIRE

    Mustila, Taina; Keskinen, Päivi; Luoto, Riitta

    2012-01-01

    Abstract Background Prevention is considered effective in combating the obesity epidemic. Prenatal environment may increase offspring's risk for obesity. A child starts to adopt food preferences and other behavioral habits affecting weight gain during preschool years. We report the study protocol of a pragmatic lifestyle intervention aiming at primary prevention of childhood obesity. Methods/Design A non-randomized controlled pragmatic trial in maternity and child health care clinics. The con...

  13. Compressive residual stresses as a preventive measure against stress corrosion cracking on turbine components

    International Nuclear Information System (INIS)

    Berger, C.; Ewald, J.; Fischer, K.; Gruendler, O.; Potthast, E.; Stuecker, E.; Winzen, G.

    1987-01-01

    Disk type low pressure turbine rotors have been designed for a large variety of power plant applications. Developing disk type rotors required a concerted effort to design a shaft/disk shrink fit with a minimum of tensile stress concentrations in order to aim for the lowest possible susceptibility to corrosive attack, i.e. stress corrosion cracking. As a result of stresses, the regions of greatest concern are the shrink fit boundaries and the keyways of turbine disks. These stresses are caused by service loading, i.e. centrifugal and shrinkage stresses and by manufacturing procedure, i.e. residual stresses. The compressive residual stresses partly compensate the tensile service stresses so that an increase of compressive residual stresses decreases the whole stress state of the component. Special manufacturing procedures, e.g. accelerated cooling after tempering can induce compressive residual stresses up to about 400 MPa in the hub bore region of turbine disk

  14. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Block, Gladys; Azar, Kristen Mj; Block, Torin J; Romanelli, Robert J; Carpenter, Heather; Hopkins, Donald; Palaniappan, Latha; Block, Clifford H

    2015-01-21

    In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or

  15. Tailoring International Pressure Ulcer Prevention Guidelines for Nigeria: A Knowledge Translation Study Protocol.

    Science.gov (United States)

    Ilesanmi, Rose Ekama; Gillespie, Brigid M; Adejumo, Prisca Olabisi; Chaboyer, Wendy

    2015-07-28

    The 2014 International Pressure Ulcer Prevention (PUP) Clinical Practice Guidelines (CPG) provides the most current evidence based strategies to prevent Pressure Ulcer (PU). The evidence upon which these guidelines have been developed has predominantly been generated from research conducted in developed countries. Some of these guidelines may not be feasible in developing countries due to structural and resource issues; therefore there is a need to adapt these guidelines to the context thus making it culturally acceptable. To present a protocol detailing the tailoring of international PUPCPG into a care bundle for the Nigerian context. Guided by the Knowledge to Action (KTA) framework, a two phased study will be undertaken. In Phase 1, the Delphi technique with stakeholder leaders will be used to review the current PUPCPG, identifying core strategies that are feasible to be adopted in Nigeria. These core strategies will become components of a PUP care bundle. In Phase 2, key stakeholder interviews will be used to identify the barriers, facilitators and potential implementation strategies to promote uptake of the PUP care bundle. A PUP care bundle, with three to eight components is expected to be developed from Phase 1. Implementation strategies to promote adoption of the PUP care bundle into clinical practice in selected Nigerian hospitals, is expected to result from Phase 2. Engagement of key stakeholders and consumers in the project should promote successful implementation and translate into better patient care. Using KTA, a knowledge translation framework, to guide the implementation of PUPCPG will enhance the likelihood of successful adoption in clinical practice. In implementing a PUP care bundle, developing countries face a number of challenges such as the feasibility of its components and the required resources.

  16. Tailoring International Pressure Ulcer Prevention Guidelines for Nigeria: A Knowledge Translation Study Protocol

    Directory of Open Access Journals (Sweden)

    Rose Ekama Ilesanmi

    2015-07-01

    Full Text Available Background: The 2014 International Pressure Ulcer Prevention (PUP Clinical Practice Guidelines (CPG provides the most current evidence based strategies to prevent Pressure Ulcer (PU. The evidence upon which these guidelines have been developed has predominantly been generated from research conducted in developed countries. Some of these guidelines may not be feasible in developing countries due to structural and resource issues; therefore there is a need to adapt these guidelines to the context thus making it culturally acceptable. Aim: To present a protocol detailing the tailoring of international PUPCPG into a care bundle for the Nigerian context. Methods: Guided by the Knowledge to Action (KTA framework, a two phased study will be undertaken. In Phase 1, the Delphi technique with stakeholder leaders will be used to review the current PUPCPG, identifying core strategies that are feasible to be adopted in Nigeria. These core strategies will become components of a PUP care bundle. In Phase 2, key stakeholder interviews will be used to identify the barriers, facilitators and potential implementation strategies to promote uptake of the PUP care bundle. Results: A PUP care bundle, with three to eight components is expected to be developed from Phase 1. Implementation strategies to promote adoption of the PUP care bundle into clinical practice in selected Nigerian hospitals, is expected to result from Phase 2. Engagement of key stakeholders and consumers in the project should promote successful implementation and translate into better patient care. Conclusion: Using KTA, a knowledge translation framework, to guide the implementation of PUPCPG will enhance the likelihood of successful adoption in clinical practice. In implementing a PUP care bundle, developing countries face a number of challenges such as the feasibility of its components and the required resources.

  17. Caries risk assessment tool and prevention protocol for public health nurses in mother and child health centers, Israel.

    Science.gov (United States)

    Natapov, Lena; Dekel-Markovich, Dan; Granit-Palmon, Hadas; Aflalo, Efrat; Zusman, Shlomo Paul

    2018-01-01

    Dental caries is the most prevalent chronic disease in children. Caries risk assessment tools enable the dentists, physicians, and nondental health care providers to assess the individual's risk. Intervention by nurses in primary care settings can contribute to the establishment of oral health habits and prevention of dental disease. In Israel, Mother and Child Health Centers provide free preventive services for pregnant women and children by public health nurses. A caries prevention program in health centers started in 2015. Nurses underwent special training regarding caries prevention. A customized Caries Risk Assessment tool and Prevention Protocol for nurses, based on the AAPD tool, was introduced. A two-step evaluation was conducted which included a questionnaire and in-depth phone interviews. Twenty-eight (out of 46) health centers returned a completed questionnaire. Most nurses believed that oral health preventive services should be incorporated into their daily work. In the in-depth phone interviews, nurses stated that the integration of the program into their busy daily schedule was realistic and appropriate. The lack of specific dental module for computer program was mentioned as an implementation difficulty. The wide use of our tool by nurses supports its simplicity and feasibility which enables quick calculation and informed decision making. The nurses readily embraced the tool and it became an integral part of their toolkit. We provide public health nurses with a caries risk assessment tool and prevention protocol thus integrating oral health into general health of infants and toddlers. © 2017 Wiley Periodicals, Inc.

  18. 78 FR 32235 - Availability of Compliance Guide for Residue Prevention and Response to Comments

    Science.gov (United States)

    2013-05-29

    ... discrimination in all its programs and activities on the basis of race, color, national origin, gender, religion... residue during the past 12 months, and asked for comment on recent revisions to the list. FSIS also... at 202-720-2600 (voice and TTY). To file a written complaint of discrimination, write USDA, Office of...

  19. Review of Agricultural Plastic Mulching and Its Residual Pollution and Prevention Measures In China

    Directory of Open Access Journals (Sweden)

    YAN Chang-rong

    2014-04-01

    Full Text Available Agricultural plastic film mulching is one of important technologies, but the plastic film pollution has been a serious issue for agri-cultural sustainable development in China. System analysis of this technique and its residue pollution and control ways have vital practicalsignificance for rational application of agricultural plastil film. In this paper, on the basis of our previous work,agricultural plastic filmmulching, its residue pollution and control technologies were concluded. Some important conclusions were found that, the amount of plasticfilm and mulching area had kept increasing with annual increasing rate about 8% since the 80s of the 20th century. From 1991 to 2011, thedensity of plastic film utilized increased 3-10 times, but it has very sharply different spatial pattern in different province. In general, the northand west China has high value, and the increase rate is also huge in the past 20 years. The crops of utilized mulching plastic film have extendedfrom cash crops to grain crops, and the order of crop area is followed by maize, vegetable, cotton, tobacco and peanut. The main functions ofmulching plastic film are keeping soil moisture and increasing soil temperature, against weeds and insect. At the same time, its side effectsappear with continuous utilization. The main problems are residues left in soil to destroy soil structure, impress soil permeability, impede seedgermination as well as water and nutrients uptaking, and block crop root system development. It has very serious pollution for the field utilizedplastic mulching film for long term. The residual amount in soil is about 71.9-259.1 kg·hm-2, and has sharply spatial difference. The residualamount in soil. In Northwest China, is more serious than that in North China and Southwest China. Because of difference of tillage and appli-canon ways, there are great differences on the area and shape of the plastic film piece left in soil. The main types of shapes are flaky

  20. Vaccines for preventing hepatitis B in healthcare workers (an updated protocol)

    DEFF Research Database (Denmark)

    Borch, Anders; Kolster, Chastine; Gluud, Christian

    2017-01-01

    This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the beneficial and harmful effects of hepatitis B vaccines in healthcare workers.......This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the beneficial and harmful effects of hepatitis B vaccines in healthcare workers....

  1. Study Protocol: Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma (Gamma-GBM).

    Science.gov (United States)

    Brehmer, Stefanie; Grimm, Mario Alexander; Förster, Alex; Seiz-Rosenhagen, Marcel; Welzel, Grit; Stieler, Florian; Wenz, Frederik; Groden, Christoph; Mai, Sabine; Hänggi, Daniel; Giordano, Frank Anton

    2018-04-24

    Glioblastoma (GBM) is the most common malignant brain tumor in adult patients. Tumor recurrence commonly occurs around the resection cavity, especially after subtotal resection (STR). Consequently, the extent of resection correlates with overall survival (OS), suggesting that depletion of postoperative tumor remnants will improve outcome. To assess safety and efficacy of adding stereotactic radiosurgery (SRS) to the standard treatment of GBM in patients with postoperative residual tumor. Gamma-GBM is a single center, open-label, prospective, single arm, phase II study that includes patients with newly diagnosed GBM (intraoperative via frozen sections) who underwent STR (residual tumor will be identified by native and contrast enhanced T1-weighted magnetic resonance imaging scans). All patients will receive SRS with 15 Gy (prescribed to the 50% isodose enclosing all areas of residual tumor) early (within 24-72 h) after surgery. Thereafter, all patients undergo standard-of-care therapy for GBM (radiochemotherapy with 60 Gy external beam radiotherapy [EBRT] plus concomitant temozolomide and 6 cycles of adjuvant temozolomide chemotherapy). The primary outcome is median progression-free survival, secondary outcomes are median OS, occurrence of radiation induced acute (3 mo post-SRS) neurotoxicity and incidence of symptomatic radionecrosis. We expect to detect efficacy and safety signals by the immediate application of SRS to standard-of-care therapy in newly diagnosed GBM. Early postoperative SRS to areas of residual tumor could bridge the therapeutic gap between surgery and adjuvant therapies.

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

    Science.gov (United States)

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

    2014-01-01

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

  3. Effectiveness of muscle strengthening and description of protocols for preventing falls in the elderly: a systematic review

    Directory of Open Access Journals (Sweden)

    Erika Y. Ishigaki

    2014-05-01

    Full Text Available Background: Falls are a geriatric syndrome that is considered a significant public health problem in terms of morbidity and mortality because they lead to a decline in functional capacity and an impaired quality of life in the elderly. Lower limb muscle strengthening seems to be an effective intervention for preventing falls; however, there is no consensus regarding the best method for increasing lower limb muscle strength. Objectives: To analyze the effectiveness of lower limb muscle strengthening and to investigate and describe the protocols used for preventing falls in elderly subjects. Method: We performed a systematic review of randomized and controlled clinical trials published between 2002 and 2012 in the databases PubMed, EMBASE, Scopus, Web of Science, and PEDro that cited some type of lower limb muscle strengthening protocol and that evaluated the incidence of falls as the primary outcome exclusively in elderly subjects. Twelve studies met the inclusion criteria. Qualitative analysis was performed by independent reviewers applying the PEDro scale. Results: The data obtained from the selected studies showed lower fall rates in the intervention groups compared to controls. Six studies described the lower limb muscle strengthening protocol in detail. High methodological quality was found in 6 studies (PEDro score ≥7/10 points. Conclusions: The methodological quality of the studies in this area appears to leave little doubt regarding the effectiveness of lower limb strengthening exercises for preventing falls in elderly subjects, however the interventions in these studies were poorly reported.

  4. WHY DO YOU NEED TO USE A CARIES RISK ASSESSMENT PROTOCOL TO PROVIDE AN EFFECTIVE CARIES PREVENTIVE REGIME?

    Science.gov (United States)

    Afuakwah, Charles; Welbury, Richard

    2015-11-01

    Clinical guidelines recommend an individual is given a caries risk status based on analysis of defined clinical and social criteria before implementing a tailored preventive plan. Improve documentation of caries risk assessment (CRA) in a general dental practice setting, using a systems-based approach to quality improvement methods. Investigate the impact of quality improvement efforts on subsequent design and delivery of preventive care. Identify barriers to delivery of CRA and provision of preventive care. Data for patients aged 0-16 years was collected over two cycles using standard audit methodology. The first cycle was a retrospective analysis (n = 400) using random sampling. The second cycle a prospective analysis (n = 513) using consecutive sampling over a 15-week period. Five staff meetings with feedback occurred between cycles. In cycle one, no specific CRA system was identified. CRA status was not stated widely, risk factors were not analysed and there was variation with respect to the prescription and delivery of preventive strategies. These discrepancies were demonstrable for all four participating dentists and at all ages. In cycle two, 100% recorded CRA. All risk factors were analysed and individual caries risk was correctly annotated. There was 100% compliance with the protocol for preventive plans. The use of CRA improved documentation of caries risk status. This has improved subsequent prescription of age specific evidence-based preventive care appropriate to the risk status of that individual. Barriers were identified to the delivery of CRA and the provision of comprehensive preventive care by the dentists and other healthcare professionals.

  5. Falls prevention among older people and care providers: protocol for an integrative review

    OpenAIRE

    Cuesta Benjumea, Carmen de la; Henriques, Maria Adriana; Abad Corpa, Eva; Roe, Brenda; Orts-Cortés, María Isabel; Lidón-Cerezuela, Beatriz; Avendaño-Céspedes, Almudena; Oliver-Carbonell, José Luis; Sánchez Ardila, Carmen

    2017-01-01

    Aim. To review the evidence about the role of care providers in fall prevention in older adults aged ≥ 65 years, this includes their views, strategies, and approaches on falls prevention and effectiveness of nursing interventions. Background. Some fall prevention programmes are successfully implemented and led by nurses and it is acknowledged the vital role they play in developing plans for fall prevention. Nevertheless, there has not been a systematic review of the literature that describes ...

  6. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial

    NARCIS (Netherlands)

    Veldhuis, L.; Struijk, M.K.; Kroeze, W.; Oenema, A.; Renders, C.M.; Bunschoten, A.M.W.; Hira Sing, R.A.; Raat, H.

    2009-01-01

    Background. The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of

  7. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children : Design of a cluster randomised controlled trial

    NARCIS (Netherlands)

    L. Veldhuis (Lydian); M.K. Struijk (Mirjam); W. Kroeze (Willemieke); A. Oenema (Anke); C.M. Renders (Carry); A.M.W. Bulk-Bunschoten (Anneke); R.A. Hirasing (Remy); H. Raat (Hein)

    2009-01-01

    textabstractBACKGROUND: The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence

  8. Formative research to develop theory-based messages for a Western Australian child drowning prevention television campaign: study protocol.

    Science.gov (United States)

    Denehy, Mel; Crawford, Gemma; Leavy, Justine; Nimmo, Lauren; Jancey, Jonine

    2016-05-20

    Worldwide, children under the age of 5 years are at particular risk of drowning. Responding to this need requires the development of evidence-informed drowning prevention strategies. Historically, drowning prevention strategies have included denying access, learning survival skills and providing supervision, as well as education and information which includes the use of mass media. Interventions underpinned by behavioural theory and formative evaluation tend to be more effective, yet few practical examples exist in the drowning and/or injury prevention literature. The Health Belief Model and Social Cognitive Theory will be used to explore participants' perspectives regarding proposed mass media messaging. This paper describes a qualitative protocol to undertake formative research to develop theory-based messages for a child drowning prevention campaign. The primary data source will be focus group interviews with parents and caregivers of children under 5 years of age in metropolitan and regional Western Australia. Qualitative content analysis will be used to analyse the data. This study will contribute to the drowning prevention literature to inform the development of future child drowning prevention mass media campaigns. Findings from the study will be disseminated to practitioners, policymakers and researchers via international conferences, peer and non-peer-reviewed journals and evidence summaries. The study was submitted and approved by the Curtin University Human Research Ethics Committee. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  9. The Achilles' heel of prevention to mother-to-child transmission of HIV: Protocol implementation, uptake, and sustainability.

    Science.gov (United States)

    Rodriguez, Violeta J; LaCabe, Richard P; Privette, C Kyle; Douglass, K Marie; Peltzer, Karl; Matseke, Gladys; Mathebula, Audrey; Ramlagan, Shandir; Sifunda, Sibusiso; Prado, Guillermo Willy; Horigian, Viviana; Weiss, Stephen M; Jones, Deborah L

    2017-12-01

    The Joint United Nations Programme on HIV and AIDS proposed to reduce the vertical transmission of HIV from ∼72,200 to ∼8300 newly infected children by 2015 in South Africa (SA). However, cultural, infrastructural, and socio-economic barriers hinder the implementation of the prevention of mother-to-child transmission (PMTCT) protocol, and research on potential solutions to address these barriers in rural areas is particularly limited. This study sought to identify challenges and solutions to the implementation, uptake, and sustainability of the PMTCT protocol in rural SA. Forty-eight qualitative interviews, 12 focus groups discussions (n = 75), and one two-day workshop (n = 32 participants) were conducted with district directors, clinic leaders, staff, and patients from 12 rural clinics. The delivery and uptake of the PMTCT protocol was evaluated using the Consolidated Framework for Implementation Research (CFIR); 15 themes associated with challenges and solutions emerged. Intervention characteristics themes included PMTCT training and HIV serostatus disclosure. Outer-setting themes included facility space, health record management, and staff shortage; inner-setting themes included supply use and availability, staff-patient relationship, and transportation and scheduling. Themes related to characteristics of individuals included staff relationships, initial antenatal care visit, adherence, and culture and stigma. Implementation process themes included patient education, test results delivery, and male involvement. Significant gaps in care were identified in rural areas. Information obtained from participants using the CFIR framework provided valuable insights into solutions to barriers to PMTCT implementation. Continuously assessing and correcting PMTCT protocol implementation, uptake and sustainability appear merited to maximize HIV prevention.

  10. The Achilles’ heel of prevention to mother-to-child transmission of HIV: Protocol implementation, uptake, and sustainability

    Science.gov (United States)

    Rodriguez, Violeta J.; LaCabe, Richard P.; Privette, C. Kyle; Douglass, K. Marie; Peltzer, Karl; Matseke, Gladys; Mathebula, Audrey; Ramlagan, Shandir; Sifunda, Sibusiso; Prado, Guillermo “Willy”; Horigian, Viviana; Weiss, Stephen M.; Jones, Deborah L.

    2017-01-01

    Abstract The Joint United Nations Programme on HIV and AIDS proposed to reduce the vertical transmission of HIV from ∼72,200 to ∼8300 newly infected children by 2015 in South Africa (SA). However, cultural, infrastructural, and socio-economic barriers hinder the implementation of the prevention of mother-to-child transmission (PMTCT) protocol, and research on potential solutions to address these barriers in rural areas is particularly limited. This study sought to identify challenges and solutions to the implementation, uptake, and sustainability of the PMTCT protocol in rural SA. Forty-eight qualitative interviews, 12 focus groups discussions (n = 75), and one two-day workshop (n = 32 participants) were conducted with district directors, clinic leaders, staff, and patients from 12 rural clinics. The delivery and uptake of the PMTCT protocol was evaluated using the Consolidated Framework for Implementation Research (CFIR); 15 themes associated with challenges and solutions emerged. Intervention characteristics themes included PMTCT training and HIV serostatus disclosure. Outer-setting themes included facility space, health record management, and staff shortage; inner-setting themes included supply use and availability, staff–patient relationship, and transportation and scheduling. Themes related to characteristics of individuals included staff relationships, initial antenatal care visit, adherence, and culture and stigma. Implementation process themes included patient education, test results delivery, and male involvement. Significant gaps in care were identified in rural areas. Information obtained from participants using the CFIR framework provided valuable insights into solutions to barriers to PMTCT implementation. Continuously assessing and correcting PMTCT protocol implementation, uptake and sustainability appear merited to maximize HIV prevention. PMID:28922974

  11. A tiered analytical protocol for the characterization of heavy oil residues at petroleum-contaminated hazardous waste sites

    International Nuclear Information System (INIS)

    Pollard, S.J.T.; Kenefick, S.L.; Hrudey, S.E.; Fuhr, B.J.; Holloway, L.R.; Rawluk, M.

    1994-01-01

    The analysis of hydrocarbon-contaminated soils from abandoned refinery sites in Alberta, Canada is used to illustrate a tiered analytical approach to the characterization of complex hydrocarbon wastes. Soil extracts isolated from heavy oil- and creosote-contaminated sites were characterized by thin layer chromatography with flame ionization detection (TLC-FID), ultraviolet fluorescence, simulated distillation (GC-SIMDIS) and chemical ionization GC-MS analysis. The combined screening and detailed analytical methods provided information essential to remedial technology selection including the extent of contamination, the class composition of soil extracts, the distillation profile of component classes and the distribution of individual class components within various waste fractions. Residual contamination was characteristic of heavy, degraded oils, consistent with documented site operations and length of hydrocarbon exposure at the soil surface

  12. Compliance with the national palestinian infection prevention and control protocol at governmental paediatric hospitals in gaza governorates.

    Science.gov (United States)

    Eljedi, Ashraf; Dalo, Shareef

    2014-08-01

    Nosocomial infections are a significant burden for both patients and the healthcare system. For this reason, infection prevention and control (IPC) practices are extremely important. The Palestinian Ministry of Health adopted the national IPC Protocol in 2004. This study aimed to assess the compliance of healthcare providers (HCPs) with the Protocol in three governmental paediatric hospitals in Gaza governorates. This descriptive cross-sectional study was conducted from February to November 2010. Data were collected from a sample of doctors, nurses and physiotherapists (N = 334) using a self-administered questionnaire and observation checklists to record HCP practices and assess the hospital environment. The response rate was 92%. The most important reasons for non-compliance with the IPC Protocol were the absence of an education programme (61.5%), lack of knowledge (52.4%) and the scarcity of required supplies (46.9%). Only 2.3% of respondents had a copy of the IPC Protocol, while 65.8% did not know of its existence. Only 16.9% had participated in training sessions regarding general IPC practices. The observation checklist regarding HCP practices revealed low levels of compliance in hand washing (45.9%), wearing gloves (40.7%) and using antiseptics/disinfectants (49.16%). The health facilities checklist indicated that there was a lack of certain essential equipment and materials, such as covered waste containers and heavy-duty gloves. Due to the lack of HPC knowledge, the authors recommend that the IPC Protocol be made available in all hospitals. In addition, a qualified team should implement intensive IPC education and training programmes and facilities should provide the required equipment and materials.

  13. Compliance With Protocols for Prevention of Neonatal Group B Streptococcal Sepsis: Practicalities and Limitations

    Directory of Open Access Journals (Sweden)

    Gwendolyn L. Gilbert

    2003-01-01

    Full Text Available Objective: To compare two protocols for intrapartum antibiotic prophylaxis (IAP against neonatal group B streptococcal (GBS sepsis, with respect to staff compliance, in a prospective cohort study in the obstetric units of a community hospital (A and a university teaching hospital (B.

  14. 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...

  15. J-UNIO protocol used for NMR structure determination of the 206-residue protein NP-346487.1 from Streptococcus pneumoniae TIGR4

    Energy Technology Data Exchange (ETDEWEB)

    Jaudzems, Kristaps [Latvian Institute of Organic Synthesis (Latvia); Pedrini, Bill [Paul Scherrer Institute (PSI), SwissFEL Project (Switzerland); Geralt, Michael; Serrano, Pedro; Wüthrich, Kurt, E-mail: wuthrich@scripps.edu [The Scripps Research Institute, Department of Integrative Structural and Computational Biology (United States)

    2015-01-15

    The NMR structure of the 206-residue protein NP-346487.1 was determined with the J-UNIO protocol, which includes extensive automation of the structure determination. With input from three APSY-NMR experiments, UNIO-MATCH automatically yielded 77 % of the backbone assignments, which were interactively validated and extended to 97 %. With an input of the near-complete backbone assignments and three 3D heteronuclear-resolved [{sup 1}H,{sup 1}H]-NOESY spectra, automated side chain assignment with UNIO-ATNOS/ASCAN resulted in 77 % of the expected assignments, which was extended interactively to about 90 %. Automated NOE assignment and structure calculation with UNIO-ATNOS/CANDID in combination with CYANA was used for the structure determination of this two-domain protein. The individual domains in the NMR structure coincide closely with the crystal structure, and the NMR studies further imply that the two domains undergo restricted hinge motions relative to each other in solution. NP-346487.1 is so far the largest polypeptide chain to which the J-UNIO structure determination protocol has successfully been applied.

  16. Financial incentive policies at workplace cafeterias for preventing obesity--a systematic review and meta-analysis (Protocol).

    Science.gov (United States)

    Sawada, Kimi; Ota, Erika; Shahrook, Sadequa; Mori, Rintaro

    2014-10-28

    Various studies are currently investigating ways to prevent lifestyle-related diseases and obesity among workers through interventions using incentive strategies, including price discounts for low-fat snacks and sugar-free beverages at workplace cafeterias or vending machines, and the provision of a free salad bar in cafeterias. Rather than assessing individual or group interventions, we will focus on the effectiveness of nutrition education programs at the population level, which primarily incorporate financial incentive strategies to prevent obesity. This paper describes the protocol of a systematic review that will examine the effectiveness of financial incentive programs at company cafeterias in improving dietary habits, nutrient intake, and obesity prevention. We will conduct searches in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO. Interventions will be assessed using data from randomized control trials (RCTs) and cluster RCTs. However, if few such trials exist, we will include quasi-RCTs. We will exclude controlled before-and-after studies and crossover RCTs. We will assess food-based interventions that include financial incentive strategies (discount strategies or social marketing) for workplace cafeterias, vending machines, and kiosks. Two authors will independently review studies for inclusion and will resolve differences by discussion and, if required, through consultation with a third author. We will assess the risk of bias of included studies according to the Cochrane Collaboration's "risk of bias" tool. The purpose of this paper is to outline the study protocol for a systematic review and meta-analysis that will investigate the effectiveness of population-level, incentive-focused interventions at the workplace cafeteria that aim to promote and prevent obesity. This review will give an important overview of the available evidence about the effectiveness of incentive-based environmental interventions to

  17. [Orthoses and assistive devices in rheumatology : Prevention of disability, support of residual function].

    Science.gov (United States)

    Fikentscher, T; Springorum, H R; Grifka, J; Götz, J

    2017-04-01

    Due to the frequent presence of comorbidities in patients suffering from rheumatism with increased perioperative risk factors, conservative treatment is often needed. Besides pharmacological treatment, physiotherapy and occupational therapy, a variety of orthoses are available depending on the individual indications. They can be used to stabilize or support joints, limit the range of motion, prevent unphysiological movements or provide relief for affected limbs. In order to choose the right kind of orthosis, the physician should know the underlying cause of disease. Furthermore, for patients with rheumatism many devices are available for daily living that use ergonomic handles or improved leverage effects to compensate for the often severe limitations and to improve the quality of life.

  18. Network Based Intrusion Detection and Prevention Systems in IP-Level Security Protocols

    OpenAIRE

    R. Kabila

    2008-01-01

    IPsec has now become a standard information security technology throughout the Internet society. It provides a well-defined architecture that takes into account confidentiality, authentication, integrity, secure key exchange and protection mechanism against replay attack also. For the connectionless security services on packet basis, IETF IPsec Working Group has standardized two extension headers (AH&ESP), key exchange and authentication protocols. It is also working on l...

  19. Implementation of a protocol for the prevention and management of extravasation injuries in the neonatal intensive care patient.

    Science.gov (United States)

    Warren, Diane

    2011-06-01

    This project sought to determine nurses' understanding and management of infants with intravenous (IV) therapy. There were three specific aims: • To improve identification and management of extravasation injuries in neonates • To ensure management of extravasation injuries in neonates is classified according to IV extravasation staging guidelines • To develop a protocol that outlined actions required to manage extravasation injuries. This project utilised a pre- and post-implementation audit strategy using the Joanna Briggs Institute (JBI) Getting Research into Practice (GRIP) program. This method has been used to improve clinical practice by utilising an audit, feedback and re-audit sequence. The project was implemented in four stages over a 7-month period from 21 October 2009 to 30 May 2010. Initially, there was poor compliance with all four criteria, ranging from zero to 63%. The GRIP phase of the project identified five barriers which were addressed throughout this project. These related to education of staff and the development of a protocol for the prevention and management of extravasation injuries in the neonatal population. Following implementation of best practice, the second audit showed a marked improvement in all four criteria, ranging from 70 to 100% compliance. Overall, this project has led to improvements in clinical practice in line with current evidence. This has resulted in enhanced awareness of the risks associated with IV therapy and of measures to prevent an injury occurring within this clinical setting. © 2011 The Author. International Journal of Evidence-Based Healthcare © 2011 The Joanna Briggs Institute.

  20. Improving Suicide Prevention in Dutch Regions by Creating Local Suicide Prevention Action Networks (SUPRANET): A Study Protocol.

    Science.gov (United States)

    Gilissen, Renske; De Beurs, Derek; Mokkenstorm, Jan; Mérelle, Saskia; Donker, Gé; Terpstra, Sanne; Derijck, Carla; Franx, Gerdien

    2017-03-28

    The European Alliance against Depression (EAAD) program is to be introduced in The Netherlands from 2017 onwards. This program to combat suicide consists of interventions on four levels: (1) increasing the awareness of suicide by local media campaigns; (2) training local gatekeepers, such as teachers or police officers; (3) targeting high-risk persons in the community; and (4) training and support of professionals in primary care settings. The implementation starts in seven Dutch pilot regions. Each region is designated as a Suicide Prevention Action NETwork (SUPRANET). This paper describes the SUPRANET program components and the evaluation of its feasibility and impact. The findings will be used to facilitate the national implementation of EAAD in The Netherlands and to add new findings to the existing literature on EAAD.

  1. Interventions for preventing mother-to-child HIV transmission: protocol of an overview of systematic reviews.

    Science.gov (United States)

    Wariki, Windy Mariane Virenia; Ota, Erika; Mori, Rintaro; Wiysonge, Charles S; Horvath, Hacsi; Read, Jennifer S

    2017-06-21

    Various interventions to prevent mother-to-child-transmission (MTCT) of HIV have been investigated and implemented. A number of systematic reviews assessing the efficacy of interventions for the prevention of MTCT of HIV reported antiretroviral prophylaxis, caesarean section before labour and before ruptured membranes, and complete avoidance of breastfeeding were efficacious for preventing MTCT of HIV. Recent WHO guidelines recommend lifelong antiretroviral therapy for all pregnant women for treatment of the woman's own HIV infection and for prevention of MTCT of HIV. Therefore, the objective of this overview is to evaluate the currently available systematic reviews of interventions for preventing MTCT of HIV, and to identify the current best evidence-based interventions for reducing the risk of MTCT of HIV. We will include only peer-reviewed systematic reviews of randomised or quasi-randomised controlled trials assessing the effects of interventions for preventing MTCT of HIV that target both HIV-infected women and children aged 2 years and younger born to HIV-infected women. We will search the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effectiveness, Ovid MEDLINE and EMBASE. We will assess review eligibility, the methodological quality of included systematic reviews using A Measurement Tool to Assess The Systematic Reviews and will extract data, comparing our results and resolving discrepancies by consensus. Finally, we will independently assess the certainty of the evidence using Grades of Recommendation, Assessment, Development and Evaluation. Ethics approval is not required. We will publish the results in a peer-reviewed journal and present at conferences, which will inform future research and will be useful for healthcare managers, administrators and policymakers to guide resource allocation decisions and optimisation of interventions to prevent the MTCT of HIV. © Article author(s) (or their employer(s) unless

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

    Science.gov (United States)

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

    2010-07-01

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

  3. Pharmacokinetic-Pharmacodynamic Model To Evaluate Intramuscular Tetracycline Treatment Protocols To Prevent Antimicrobial Resistance in Pigs

    DEFF Research Database (Denmark)

    Ahmad, Amais; Græsbøll, Kaare; Christiansen, Lasse Engbo

    2015-01-01

    High instances of antimicrobial resistance are linked to both routine and excessive antimicrobial use, but excessive or inappropriate use represents an unnecessary risk. The competitive growth advantages of resistant bacteria may be amplified by the strain dynamics; in particular, the extent...... to which resistant strains outcompete susceptible strains under antimicrobial pressure may depend not only on the antimicrobial treatment strategies but also on the epidemiological parameters, such as the composition of the bacterial strains in a pig. This study evaluated how variation in the dosing...... protocol for intramuscular administration of tetracycline and the composition of bacterial strains in a pig affect the level of resistance in the intestine of a pig. Predictions were generated by a mathematical model of competitive growth of Escherichia coli strains in pigs under specified plasma...

  4. Pharmacokinetic-Pharmacodynamic Model To Evaluate Intramuscular Tetracycline Treatment Protocols To Prevent Antimicrobial Resistance in Pigs

    DEFF Research Database (Denmark)

    Ahmad, Amais; Græsbøll, Kaare; Christiansen, Lasse Engbo

    2015-01-01

    protocol for intramuscular administration of tetracycline and the composition of bacterial strains in a pig affect the level of resistance in the intestine of a pig. Predictions were generated by a mathematical model of competitive growth of Escherichia coli strains in pigs under specified plasma......High instances of antimicrobial resistance are linked to both routine and excessive antimicrobial use, but excessive or inappropriate use represents an unnecessary risk. The competitive growth advantages of resistant bacteria may be amplified by the strain dynamics; in particular, the extent...... to which resistant strains outcompete susceptible strains under antimicrobial pressure may depend not only on the antimicrobial treatment strategies but also on the epidemiological parameters, such as the composition of the bacterial strains in a pig. This study evaluated how variation in the dosing...

  5. Prophylactic Residual Aneurysmal Sac Embolization with Expandable Hydrogel Embolic Devices for Endoleak Prevention: Preliminary Study in Dogs

    International Nuclear Information System (INIS)

    Hiraki, Takao; Pavcnik, Dusan; Uchida, Barry T.; Timmermans, Hans A.; Yin Qiang; Wu Renghong; Niyyati, Mahtab; Keller, Frederick S.; Roesch, Josef

    2005-01-01

    Objective. To explore the feasibility and efficacy of residual aneurysmal sac (RAS) embolization with the expandable hydrogel embolic device (EHED) in prevention of endoleaks in a surgically created and endoluminally treated abdominal aortic aneurysm (AAA). Methods. In eight dogs, an AAA was created by means of side-to-side anastomosis between the infrarenal abdominal aorta and inferior vena cava (IVC) with ligation of the IVC above and below the anastomotic end, followed by deployment of an endograft with holes. The RAS was then embolized with the EHED. One animal was killed immediately after RAS embolization and one animal died 12 hr after the procedure. Follow-up aortograms were obtained in six animals after 1 day (1 animal), 2 weeks and 6 months (1 animal), and 8 weeks (4 animals). Results. Four animals had no endoleaks on the follow-up aortograms. The remaining two animals with incomplete RAS embolization had moderate type III endoleaks. Type I or II endoleaks were not seen in any animals. Complications included RAS wall penetration by the devices with platinum wires in two animals (nos. 1 and 2), device migration into an aortic circulation through the endograft holes in two animals (nos. 2 and 3) or through distal interstices between the aortic wall and endograft in one animal (no. 8), aortic occlusion in three animals (nos. 3, 7, and 8), and RAS rupture in one animal (no. 7). Histologic examination showed expanded hydrogels occupying the RAS with associated mature or immature organized thrombus, fibrinous thrombus, or degenerate blood cells. Conclusion. RAS embolization was feasible with the EHED, although additional modifications to the device are required to avoid complications. Angiographic and histologic results suggested that RAS embolization with the EHED may help in the prevention of endoleaks

  6. Effects of falls prevention interventions on falls outcomes for hospitalised adults: protocol for a systematic review with meta-analysis.

    Science.gov (United States)

    Slade, Susan C; Carey, David L; Hill, Anne-Marie; Morris, Meg E

    2017-11-12

    Falls are a major global public health problem and leading cause of accidental or unintentional injury and hospitalisation. Falls in hospital are associated with longer length of stay, readmissions and poor outcomes. Falls prevention is informed by knowledge of reversible falls risk factors and accurate risk identification. The extent to which hospital falls are prevented by evidence-based practice, patient self-management initiatives, environmental modifications and optimisation of falls prevention systems awaits confirmation. Published reviews have mainly evaluated community settings and residential care facilities. A better understanding of hospital falls and the most effective strategies to prevent them is vital to keeping people safe. To evaluate the effectiveness of falls prevention interventions on reducing falls in hospitalised adults (acute and subacute wards, rehabilitation, mental health, operating theatre and emergency departments). We also summarise components of effective falls prevention interventions. This protocol has been registered. The systematic review will be informed by Cochrane guidelines and reported according to the Preferred Reporting Items for Systematic review and Meta-Analysis statement. randomised controlled trials, quasi-randomised trials or controlled clinical trials that evaluate falls prevention interventions for use by hospitalised adults or employees. Electronic databases will be searched using key terms including falls, accidental falls, prevention, hospital, rehabilitation, emergency, mental health, acute and subacute. Pairs of independent reviewers will conduct all review steps. Included studies will be evaluated for risk of bias. Data for variables such as age, participant characteristics, settings and interventions will be extracted and analysed with descriptive statistics and meta-analysis where possible. The results will be presented textually, with flow charts, summary tables, statistical analysis (and meta

  7. Intervention development for the indicated prevention of depression in later life: The “DIL” protocol in Goa, India

    Directory of Open Access Journals (Sweden)

    Amit Dias, MD

    2017-06-01

    Full Text Available Because depression is a major source of the global burden of illness-related disability, developing effective strategies for reducing its incidence is an important public health priority, especially in low-income countries, where resources for treating depression are scarce. We describe in this report an intervention development project, funded by the US National Institute of Mental Health, to address “indicated” prevention of depression in older adults attending rural and urban primary care clinics in Goa, India. Specifically, participants in the “DIL” (“Depression in Later Life” trial were older adults living with mild, subsyndromal symptoms of depression and anxiety and thus at substantial risk for transitioning to fully syndromal major depression and anxiety disorders. Building upon the MANAS treatment trial (“Promoting Mental Health” led by Patel et al. in the same locale, we present here lessons learned in the development and implementation of a protocol utilizing lay health counsellors (LHCs who deliver a multi-component depression prevention intervention organized conceptually around Problem Solving Therapy for Primary Care (PST, with additional components addressing brief behavioural treatment of sleep disturbances such as insomnia, meeting basic social casework needs, and education in self-management of prevalent comorbid chronic diseases, such as diabetes mellitus. To our knowledge, DIL is the first randomized clinical trial addressing the prevention of depressive disorders ever conducted in a low- or middle-income country.

  8. PAAPPAS community trial protocol: a randomized study of obesity prevention for adolescents combining school with household intervention

    Directory of Open Access Journals (Sweden)

    Michele R. Sgambato

    2016-08-01

    Full Text Available Abstract Background The prevalence of childhood obesity is increasing at a high rate in Brazil, making prevention a health priority. Schools are the central focus of interventions aiming the prevention and treatment of childhood obesity, however, randomized trials and cohort studies have not yet provided clear evidence of strategies to reduce prevalence of obesity. The aim of this study is to present a protocol to evaluate the efficacy of combining school and household level interventions to reduce excessive weight gain among students. Methods The intervention target fifth and sixth graders from 18 public schools (9 interventions and 9 controls in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. A sample size of 2500 students will be evaluated at school for their weight status and those from the intervention group who are overweight or obese will be followed monthly at home by community health agents. Demographic, socioeconomic, anthropometric, eating behavior and food consumption data will be collected at school using a standardized questionnaire programmed in personal digital assistant. At school, all students from the intervention group will be encouraged to change eating habits and food consumption and to increase physical activity and reducing sedentary behavior. Discussion This study will provide evidence whether integration of school with primary health care can prevent excessive weight gain among adolescents. Positive results will inform a sustainable strategy to be disseminated in the health care system in Brazil. Trial registration ClinicalTrials.gov, NCT02711488 . Date of registration: March 11, 2016.

  9. A randomized controlled trial to prevent glycemic relapse in longitudinal diabetes care: Study protocol (NCT00362193

    Directory of Open Access Journals (Sweden)

    Davis Dianne

    2006-10-01

    Full Text Available Abstract Background Diabetes is a common disease with self-management a key aspect of care. Large prospective trials have shown that maintaining glycated hemoglobin less than 7% greatly reduces complications but translating this level of control into everyday clinical practice can be difficult. Intensive improvement programs are successful in attaining control in patients with type 2 diabetes, however, many patients experience glycemic relapse once returned to routine care. This early relapse is, in part, due to decreased adherence in self-management behaviors. Objective This paper describes the design of the Glycemic Relapse Prevention study. The purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse. The primary endpoint is glycemic relapse, which is defined as glycated hemoglobin greater than 8% and an increase of 1% from baseline. Methods The intervention consists of telephonic contact by a nurse practitioner with a referral to a dietitian if indicated. This intervention was designed to provide early identification of self-care problems, understanding the rationale behind the self-care lapse and problem solve to find a negotiated solution. A total of 164 patients were randomized to routine care (least intensive, routine care with phone contact every three months (moderate intensity or routine care with phone contact every month (most intensive. Conclusion The baseline patient characteristics are similar across the treatment arms. Intervention fidelity analysis showed excellent reproducibility. This study will provide insight into the important but poorly understood area of glycemic relapse prevention.

  10. A childhood obesity prevention programme in Barcelona (POIBA Project): Study protocol of the intervention

    Science.gov (United States)

    Sánchez-Martínez, Francesca; Juárez, Olga; Serral, Gemma; Valmayor, Sara; Puigpinós, Rosa; Pasarín, María Isabel; Díez, Élia; Ariza, Carles

    2018-01-01

    Background Childhood obesity preventive interventions should promote a healthy diet and physical activity at home and school. This study aims to describe a school-based childhood obesity preventive programme (POIBA Project) targeting 8-to-12- year-olds. Design and methods Evaluation study of a school-based intervention with a pre-post quasi-experimental design and a comparison group. Schools from disadvantaged neighbourhoods are oversampled. The intervention consists of 9 sessions, including 58 activities of a total duration between 9 and 13 hours, and the booster intervention of 2 sessions with 8 activities lasting 3 or 4 hours. They are multilevel (individual, family and school) and multicomponent (classroom, physical activity and family). Data are collected through anthropometric measurements, physical fitness tests and lifestyle surveys before and after the intervention and the booster intervention. In the intervention group, families complete two questionnaires about their children’s eating habits and physical activity. The outcome variable is the cumulative incidence rate of obesity, obtained from body mass index values and body fat assessed by triceps skinfold thickness. The independent variables are socio-demographic, contextual, eating habits, food frequency, intensity of physical activity and use of new technologies. Expected impact for public health It is essential to implement preventive interventions at early ages and to follow its effects over time. Interventions involving diet and physical activity are the most common, being the most effective setting the school. The POIBA Project intervenes in both the school and family setting and focuses on the most disadvantaged groups, in which obesity is most pronounced and difficult to prevent. Significance for public health Overweight and obesity are a major public health concern that predispose affected individuals to the development of chronic diseases. Of importance, obesity is more common among

  11. Analysis of Pre-participation Screening Protocols for Football Players in Europe, USA, and Libya: Possible Implications for Preventing Sudden Cardiac Death

    Directory of Open Access Journals (Sweden)

    Salaheddin Sharif

    2017-06-01

    Full Text Available Sudden cardiac death is the leading cause of death in sport participants and may result from undiagnosed cardiac diseases. It has been universally agreed upon that pre-participation screening can identify those athletes at risk of sudden cardiac death, and yet, there is no commonly accepted protocol to screen athletes. Although the European Society of Cardiology (ESC and the American Heart Association (AHA recommend the routine screening of athletes to prevent sudden death, there is significant disagreement regarding the guidelines of the protocols. The American Heart Association protocol includes a detailed medical history and a physical examination, whereas the European Society of Cardiology protocol includes 12-lead electrocardiography with a detailed medical history and a physical examination. The cost benefit of using electrocardiography is debatable, particularly if the screening is used to prevent sudden death associated with uncommon diseases. The Libyan Football Federation established a new seasonal pre-competition medical assessment protocol for Libyan football athletes during the 2013-2014 season, which includes a medical history, physical examination, 12 lead electrocardiography, echocardiography, and blood test. Regardless of cost and differences in protocol, there is a significant value in pre-participation screening for athletes in order to decrease the incidence of sudden cardiac death, and this report examines some of these different protocols as well as their potential for identifying athletes at risk for sudden cardiac death.

  12. Rationale, design, and protocol for the prevention of low back pain in the military (POLM trial (NCT00373009

    Directory of Open Access Journals (Sweden)

    Dugan Jessica L

    2007-09-01

    . Soldiers will receive a monthly email that queries whether any LBP was experienced in the previous calendar month. Soldiers reporting LBP will enter episode-specific data related to pain intensity, pain-related disability, fear-avoidance beliefs, and pain catastrophizing. We are hypothesizing that Soldiers receiving the CSEP and PSEP will report the longest duration to first episode of LBP, the lowest frequency of LBP, and the lowest severity of LBP episodes. Statistical comparisons will be made between each of the randomly assigned prevention programs to test our hypotheses related to determining which of the 4 programs is most effective. Discussion We have presented the design and protocol for the POLM trial. Completion of this trial will provide important information on how to effectively train Soldiers for the prevention of LBP. Trial registration NCT00373009

  13. Trial protocol OPPTIMUM– Does progesterone prophylaxis for the prevention of preterm labour improve outcome?

    Directory of Open Access Journals (Sweden)

    Norman Jane E

    2012-08-01

    Full Text Available Abstract Background Preterm birth is a global problem, with a prevalence of 8 to 12% depending on location. Several large trials and systematic reviews have shown progestogens to be effective in preventing or delaying preterm birth in selected high risk women with a singleton pregnancy (including those with a short cervix or previous preterm birth. Although an improvement in short term neonatal outcomes has been shown in some trials these have not consistently been confirmed in meta-analyses. Additionally data on longer term outcomes is limited to a single trial where no difference in outcomes was demonstrated at four years of age of the child, despite those in the “progesterone” group having a lower incidence of preterm birth. Methods/Design The OPPTIMUM study is a double blind randomized placebo controlled trial to determine whether progesterone prophylaxis to prevent preterm birth has long term neonatal or infant benefit. Specifically it will study whether, in women with singleton pregnancy and at high risk of preterm labour, prophylactic vaginal natural progesterone, 200 mg daily from 22 – 34 weeks gestation, compared to placebo, improves obstetric outcome by lengthening pregnancy thus reducing the incidence of preterm delivery (before 34 weeks, improves neonatal outcome by reducing a composite of death and major morbidity, and leads to improved childhood cognitive and neurosensory outcomes at two years of age. Recruitment began in 2009 and is scheduled to close in Spring 2013. As of May 2012, over 800 women had been randomized in 60 sites. Discussion OPPTIMUM will provide further evidence on the effectiveness of vaginal progesterone for prevention of preterm birth and improvement of neonatal outcomes in selected groups of women with singleton pregnancy at high risk of preterm birth. Additionally it will determine whether any reduction in the incidence of preterm birth is accompanied by improved childhood outcome. Trial

  14. Compliant flooring to prevent fall-related injuries: a scoping review protocol.

    Science.gov (United States)

    Lachance, Chantelle C; Jurkowski, Michal P; Dymarz, Ania C; Mackey, Dawn C

    2016-08-16

    Fall-related injuries can have serious consequences for older adults, including increased risk of dependence in daily activities and mortality. Compliant flooring is a passive intervention that may reduce the incidence and severity of fall-related injuries in healthcare settings, including acute and long-term care, but few sites have implemented compliant flooring, in part because synthesised evidence about key performance aspects has not been available. We will conduct a scoping review to address the question: what is presented about the biomechanical efficacy, clinical effectiveness, cost-effectiveness, and workplace safety associated with compliant flooring systems that aim to prevent fall-related injuries? We will conduct a comprehensive and systematic literature search of academic databases (AgeLine, CINAHL, EBM Reviews, MEDLINE (Ovid), SportDiscus and Web of Science) and grey literature (clinical trial registries, theses/dissertations, abstracts/conference proceedings and relevant websites). 2 team members will independently screen records (first titles and abstracts, then full text) and extract data from included records. Numerical and narrative analyses will be presented by theme (biomechanical efficacy, clinical effectiveness, cost-effectiveness, workplace safety). This scoping review responds to the information needs of healthcare decision-makers tasked with preventing fall-related injuries. This review will summarise evidence about compliant flooring as a potential intervention for preventing fall-related injuries in older adults and identify gaps in evidence and new avenues for research. Results will be especially useful in long-term care, but also applicable in acute care, assisted living and home care. We will disseminate the review's findings via open-access publications, conference presentations, a webinar, a Stakeholder Symposium and a Knowledge-to-Action Report. Published by the BMJ Publishing Group Limited. For permission to use (where not

  15. Randomised trial of neonatal hypoglycaemia prevention with oral dextrose gel (hPOD): study protocol.

    Science.gov (United States)

    Harding, Jane E; Hegarty, Joanne E; Crowther, Caroline A; Edlin, Richard; Gamble, Greg; Alsweiler, Jane M

    2015-09-16

    Neonatal hypoglycaemia is common, affecting up to 15% of newborn babies and 50% of those with risk factors (preterm, infant of a diabetic, high or low birthweight). Hypoglycaemia can cause brain damage and death, and babies born at risk have an increased risk of developmental delay in later life. Treatment of hypoglycaemia usually involves additional feeding, often with infant formula, and admission to Neonatal Intensive Care for intravenous dextrose. This can be costly and inhibit the establishment of breast feeding. Prevention of neonatal hypoglycaemia would be desirable, but there are currently no strategies, beyond early feeding, for prevention of neonatal hypoglycaemia. Buccal dextrose gel is safe and effective in treatment of hypoglycaemia. The aim of this trial is to determine whether 40% dextrose gel given to babies at risk prevents neonatal hypoglycaemia and hence reduces admission to Neonatal Intensive Care. Randomised, multicentre, placebo controlled trial. Babies at risk of hypoglycaemia (preterm, infant of a diabetic, small or large), less than 1 h old, with no apparent indication for Neonatal Intensive Care Unit admission and mother intends to breastfeed. Trial entry & randomisation: Eligible babies of consenting parents will be allocated by online randomisation to the dextrose gel group or placebo group, using a study number and corresponding trial intervention pack. Babies will receive a single dose of 0.5 ml/kg study gel at 1 h after birth; either 40% dextrose gel (200 mg/kg) or 2% hydroxymethylcellulose placebo. Gel will be massaged into the buccal mucosal and followed by a breast feed. Primary study outcome: Admission to Neonatal Intensive Care. 2,129 babies are required to detect a decrease in admission to Neonatal Intensive Care from 10-6% (two-sided alpha 0.05, 90% power, 5% drop-out rate). This study will investigate whether admission to Neonatal Intensive Care can be prevented by prophylactic oral dextrose gel; a simple, cheap and painless

  16. Economic evidence for the prevention and treatment of atopic eczema: a protocol for a systematic review.

    Science.gov (United States)

    Sach, Tracey Helen; McManus, Emma; Mcmonagle, Christopher; Levell, Nick

    2016-05-27

    Eczema, synonymous with atopic eczema or atopic dermatitis, is a chronic skin disease that has a similar impact on health-related quality of life as other chronic diseases. The proposed research aims to provide a comprehensive systematic assessment of the economic evidence base available to inform economic modelling and decision making on interventions to prevent and treat eczema at any stage of the life course. Whilst the Global Resource of Eczema Trials (GREAT) database collects together the effectiveness evidence for eczema, there is currently no such systematic resource on the economics of eczema. It is important to gain an overview of the current state of the art of economic methods in the field of eczema in order to strengthen the economic evidence base further. The proposed study is a systematic review of the economic evidence surrounding interventions for the prevention and treatment of eczema. Relevant search terms will be used to search MEDLINE, EMBASE, Database of Abstracts of Reviews of Effects, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, National Health Service (NHS) Economic Evaluation Database, Health Technology Assessment, Cumulative Index to Nursing and Allied Health Literature, EconLit, Scopus, Cost-Effectiveness Analysis Registry and Web of Science in order to identify relevant evidence. To be eligible for inclusion studies will be primary empirical studies evaluating the cost, utility or full economic evaluation of interventions for preventing or treating eczema. Two reviewers will independently assess studies for eligibility and perform data abstraction. Evidence tables will be produced presenting details of study characteristics, costing methods, outcome methods and quality assessment. The methodological quality of studies will be assessed using accepted checklists. The systematic review is being undertaken to identify the type of economic evidence available, summarise the results of the available

  17. Behavioral counseling to prevent childhood obesity – study protocol of a pragmatic trial in maternity and child health care

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    Mustila Taina

    2012-07-01

    Full Text Available Abstract Background Prevention is considered effective in combating the obesity epidemic. Prenatal environment may increase offspring's risk for obesity. A child starts to adopt food preferences and other behavioral habits affecting weight gain during preschool years. We report the study protocol of a pragmatic lifestyle intervention aiming at primary prevention of childhood obesity. Methods/Design A non-randomized controlled pragmatic trial in maternity and child health care clinics. The control group was recruited among families who visited the same clinics one year earlier. Eligibility criteria was mother at risk for gestational diabetes: body mass index ≥ 25 kg/m2, macrosomic newborn in any previous pregnancy, immediate family history of diabetes and/or age ≥ 40 years. All maternity clinics in town involved in recruitment. The gestational intervention consisted of individual counseling on diet and physical activity by a public health nurse, and of two group counseling sessions. Intervention continues until offspring’s age of five years. An option to participate a group counseling at child’s age 1 to 2 years was offered. The intervention includes advice on healthy diet, physical activity, sedentary behavior and sleeping pattern. The main outcome measure is offspring BMI z-score and its changes by the age of six years. Discussion Early childhood is a critical time period for prevention of obesity. Pragmatic trials targeting this period are necessary in order to find effective obesity prevention programs feasible in normal health care practice. Trial registration Clinical Trials gov NCT00970710

  18. Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Matsuoka, Yutaka; Nishi, Daisuke; Yonemoto, Naohiro; Hamazaki, Kei; Matsumura, Kenta; Noguchi, Hiroko; Hashimoto, Kenji; Hamazaki, Tomohito

    2013-01-05

    Preclinical and clinical studies suggest that supplementation with omega-3 fatty acids after trauma might reduce subsequent posttraumatic stress disorder (PTSD). To date, we have shown in an open trial that PTSD symptoms in critically injured patients can be reduced by taking omega-3 fatty acids, hypothesized to stimulate hippocampal neurogenesis. The primary aim of the present randomized controlled trial is to examine the efficacy of omega-3 fatty acid supplementation in the secondary prevention of PTSD following accidental injury, as compared with placebo. This paper describes the rationale and protocol of this trial. The Tachikawa Project for Prevention of Posttraumatic Stress Disorder with Polyunsaturated Fatty Acid (TPOP) is a double-blinded, parallel group, randomized controlled trial to assess whether omega-3 fatty acid supplementation can prevent PTSD symptoms among accident-injured patients consecutively admitted to an intensive care unit. We plan to recruit accident-injured patients and follow them prospectively for 12 weeks. Enrolled patients will be randomized to either the omega-3 fatty acid supplement group (1,470 mg docosahexaenoic acid and 147 mg eicosapentaenoic acid daily) or placebo group. Primary outcome is score on the Clinician-Administered PTSD Scale (CAPS). We will need to randomize 140 injured patients to have 90% power to detect a 10-point difference in mean CAPS scores with omega-3 fatty acid supplementation compared with placebo. Secondary measures are diagnosis of PTSD and major depressive disorder, depressive symptoms, physiologic response in the experiment using script-driven imagery and acoustic stimulation, serum brain-derived neurotrophic factor, health-related quality of life, resilience, and aggression. Analyses will be by intent to treat. The trial was initiated on December 13 2008, with 104 subjects randomized by November 30 2012. This study promises to be the first trial to provide a novel prevention strategy for PTSD among

  19. A web-based computer-tailored smoking prevention programme for primary school children: intervention design and study protocol

    Science.gov (United States)

    2012-01-01

    Background Although the number of smokers has declined in the last decade, smoking is still a major health problem among youngsters and adolescents. For this reason, there is a need for effective smoking prevention programmes targeting primary school children. A web-based computer-tailored feedback programme may be an effective intervention to stimulate youngsters not to start smoking, and increase their knowledge about the adverse effects of smoking and their attitudes and self-efficacy regarding non-smoking. Methods & design This paper describes the development and evaluation protocol of a web-based out-of-school smoking prevention programme for primary school children (age 10-13 years) entitled ‘Fun without Smokes’. It is a transformation of a postal mailed intervention to a web-based intervention. Besides this transformation the effects of prompts will be examined. This web-based intervention will be evaluated in a 2-year cluster randomised controlled trial (c-RCT) with three study arms. An intervention and intervention + prompt condition will be evaluated for effects on smoking behaviour, compared with a no information control condition. Information about pupils’ smoking status and other factors related to smoking will be obtained using a web-based questionnaire. After completing the questionnaire pupils in both intervention conditions will receive three computer-tailored feedback letters in their personal e-mail box. Attitudes, social influences and self-efficacy expectations will be the content of these personalised feedback letters. Pupils in the intervention + prompt condition will - in addition to the personalised feedback letters - receive e-mail and SMS messages prompting them to revisit the ‘Fun without Smokes’ website. The main outcome measures will be ever smoking and the utilisation of the ‘Fun without Smokes’ website. Measurements will be carried out at baseline, 12 months and 24 months of follow-up. Discussion The present study

  20. A web-based computer-tailored smoking prevention programme for primary school children: intervention design and study protocol

    Directory of Open Access Journals (Sweden)

    Cremers Henricus-Paul

    2012-06-01

    Full Text Available Abstract Background Although the number of smokers has declined in the last decade, smoking is still a major health problem among youngsters and adolescents. For this reason, there is a need for effective smoking prevention programmes targeting primary school children. A web-based computer-tailored feedback programme may be an effective intervention to stimulate youngsters not to start smoking, and increase their knowledge about the adverse effects of smoking and their attitudes and self-efficacy regarding non-smoking. Methods & design This paper describes the development and evaluation protocol of a web-based out-of-school smoking prevention programme for primary school children (age 10-13 years entitled ‘Fun without Smokes’. It is a transformation of a postal mailed intervention to a web-based intervention. Besides this transformation the effects of prompts will be examined. This web-based intervention will be evaluated in a 2-year cluster randomised controlled trial (c-RCT with three study arms. An intervention and intervention + prompt condition will be evaluated for effects on smoking behaviour, compared with a no information control condition. Information about pupils’ smoking status and other factors related to smoking will be obtained using a web-based questionnaire. After completing the questionnaire pupils in both intervention conditions will receive three computer-tailored feedback letters in their personal e-mail box. Attitudes, social influences and self-efficacy expectations will be the content of these personalised feedback letters. Pupils in the intervention + prompt condition will - in addition to the personalised feedback letters - receive e-mail and SMS messages prompting them to revisit the ‘Fun without Smokes’ website. The main outcome measures will be ever smoking and the utilisation of the ‘Fun without Smokes’ website. Measurements will be carried out at baseline, 12 months and 24 months of follow

  1. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

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    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  2. Impact of the implementation of electronic guidelines for cardiovascular prevention in primary care: study protocol

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    Eva Comin

    2013-03-01

    Full Text Available Background The electronic medical records software of the Catalan Institute of Health has recently incorporated an electronic version of clinical practice guidelines (e-CPGs. This study aims to assess the impact of the implementation of e-CPGs on the diagnosis, treatment, control and management of hypercholesterolaemia, diabetes mellitus type 2 and hypertension.Methods Eligible study participants are those aged 35–74 years assigned to family practitioners (FPs of the Catalan Institute of Health. Routinely collected data from electronic primary care registries covering 80% of the Catalan population will be analysed using two approaches: (1 a cross-sectional study to describe the characteristics of the sample before e-CPG implementation; (2 a controlled before-and-after study with 1-year follow-up to ascertain the effect of e-CPG implementation. Patients of FPs who regularly use the e-CPGs will constitute the intervention group; the control group will comprise patients assigned to FPs not regularly using the e-CPG. The outcomes are: (1 suspected and confirmed diagnoses, (2 control of clinical variables, (3 requests for tests and (4 proportions of patients with adequate drug prescriptions.Results This protocol should represent a reproducible process to assess the impact of the implementation of e-CPGs. We anticipate reporting results in late 2013.Conclusion This project will assess the effectiveness of e-CPGs to improve clinical decisions and healthcare procedures in the three disorders analysed. The results will shed light on the use of evidence-based medicine to improve clinical practice of FPs.

  3. Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kunneman, Marleen; Branda, Megan E; Noseworthy, Peter A; Linzer, Mark; Burnett, Bruce; Dick, Sara; Spencer-Bonilla, Gabriela; Fernandez, Cara A; Gorr, Haeshik; Wambua, Mike; Keune, Shelly; Zeballos-Palacios, Claudia; Hargraves, Ian; Shah, Nilay D; Montori, Victor M

    2017-09-29

    Nonvalvular atrial fibrillation (AF) is a common ongoing health problem that places patients at risk of stroke. Whether and how a patient addresses this risk depends on each patient's goals, context, and values. Consequently, leading cardiovascular societies recommend using shared decision making (SDM) to individualize antithrombotic treatment in patients with AF. The aim of this study is to assess the extent to which the ANTICOAGULATION CHOICE conversation tool promotes high-quality SDM and influences anticoagulation uptake and adherence in patients with AF at risk of strokes. This study protocol describes a multicenter, encounter-level, randomized trial to assess the effect of using the ANTICOAGULATION CHOICE conversation tool in the clinical encounter, compared to usual care. The participating centers include an academic hospital system, a suburban community group practice, and an urban safety net hospital, all in Minnesota, USA. Patients with ongoing nonvalvular AF at risk of strokes (CHA 2 DS 2 -VASc score ≥ 1 in men, or ≥ 2 in women) will be eligible for participation. We aim to include 999 patients and their clinicians. The primary outcome is the quality of SDM as perceived by participants, and as assessed by a post-encounter survey that ascertains (a) knowledge transfer, (b) concordance of the decision made, (c) quality of communication, and (d) satisfaction with the decision-making process. Recordings of encounters will be reviewed to assess the extent of patient involvement and how participants use the tool (fidelity). Anticoagulant use, choice of agent, and adherence will be drawn from patients' medical and pharmacy records. Strokes and bleeding events will be drawn from patient records. This study will provide a valid and precise measure of the effect of the ANTICOAGULATION CHOICE conversation tool on SDM quality and processes, and on the treatment choices and adherence to therapy among AF patients at risk of stroke. ClinicalTrials.gov, NCT

  4. Stress Prevention@Work: a study protocol for the evaluation of a multifaceted integral stress prevention strategy to prevent employee stress in a healthcare organization: a cluster controlled trial

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    Rianne J. A. Hoek

    2017-07-01

    Full Text Available Abstract Background Adequate implementation of work-related stress management interventions can reduce or prevent work-related stress and sick leave in organizations. We developed a multifaceted integral stress-prevention strategy for organizations from several sectors that includes a digital platform and collaborative learning network. The digital platform contains a stepwise protocol to implement work-related stress-management interventions. It includes stress screeners, interventions and intervention providers to facilitate access to and the selection of matching work-related stress-management interventions. The collaborative learning network, including stakeholders from various organizations, plans meetings focussing on an exchange of experiences and good practices among organizations for the implementation of stress prevention measures. This paper describes the design of an integral stress-prevention strategy, Stress Prevention@Work, and the protocol for the evaluation of: 1 the effects of the strategy on perceived stress and work-related outcomes, and 2 the barriers and facilitators for implementation of the strategy. Methods The effectiveness of Stress Prevention@Work will be evaluated in a cluster controlled trial, in a large healthcare organization in the Netherlands, at six and 12 months. An independent researcher will match teams on working conditions and size and allocate the teams to the intervention or control group. Teams in the intervention group will be offered Stress Prevention@Work. For each intervention team, one employee is responsible for applying the strategy within his/her team using the digital platform and visiting the collaborative learning network. Using a waiting list design, the control group will be given access to the strategy after 12 months. The primary outcome is the employees’ perceived stress measured by the stress subscale of the Depression, Anxiety, and Stress Scale (DASS-21. Secondary outcome measures

  5. Stress Prevention@Work: a study protocol for the evaluation of a multifaceted integral stress prevention strategy to prevent employee stress in a healthcare organization: a cluster controlled trial.

    Science.gov (United States)

    Hoek, Rianne J A; Havermans, Bo M; Houtman, Irene L D; Brouwers, Evelien P M; Heerkens, Yvonne F; Zijlstra-Vlasveld, Moniek C; Anema, Johannes R; van der Beek, Allard J; Boot, Cécile R L

    2017-07-17

    Adequate implementation of work-related stress management interventions can reduce or prevent work-related stress and sick leave in organizations. We developed a multifaceted integral stress-prevention strategy for organizations from several sectors that includes a digital platform and collaborative learning network. The digital platform contains a stepwise protocol to implement work-related stress-management interventions. It includes stress screeners, interventions and intervention providers to facilitate access to and the selection of matching work-related stress-management interventions. The collaborative learning network, including stakeholders from various organizations, plans meetings focussing on an exchange of experiences and good practices among organizations for the implementation of stress prevention measures. This paper describes the design of an integral stress-prevention strategy, Stress Prevention@Work, and the protocol for the evaluation of: 1) the effects of the strategy on perceived stress and work-related outcomes, and 2) the barriers and facilitators for implementation of the strategy. The effectiveness of Stress Prevention@Work will be evaluated in a cluster controlled trial, in a large healthcare organization in the Netherlands, at six and 12 months. An independent researcher will match teams on working conditions and size and allocate the teams to the intervention or control group. Teams in the intervention group will be offered Stress Prevention@Work. For each intervention team, one employee is responsible for applying the strategy within his/her team using the digital platform and visiting the collaborative learning network. Using a waiting list design, the control group will be given access to the strategy after 12 months. The primary outcome is the employees' perceived stress measured by the stress subscale of the Depression, Anxiety, and Stress Scale (DASS-21). Secondary outcome measures are job demands, job resources and the number

  6. Alcohol prevention at sporting events: study protocol for a quasi-experimental control group study

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    Natalie Durbeej

    2016-06-01

    Full Text Available Abstract Background Alcohol intoxication and overserving of alcohol at sporting events are of great concern, given the relationships between alcohol consumption, public disturbances, and violence. During recent years this matter has been on the agenda for Swedish policymakers, authorities and key stakeholders, with demands that actions be taken. There is promising potential for utilizing an environmental approach to alcohol prevention as a strategy to reduce the level of alcohol intoxication among spectators at sporting events. Examples of prevention strategies may be community mobilization, Responsible Beverage Service training, policy work, and improved controls and sanctions. This paper describes the design of a quasi-experimental control group study to examine the effects of a multi-component community-based alcohol intervention at matches in the Swedish Premier Football League. Methods A baseline assessment was conducted during 2015 and at least two follow-up assessments will be conducted in 2016 and 2017. The two largest cities in Sweden are included in the study, with Stockholm as the intervention area and Gothenburg as the control area. The setting is Licensed Premises (LP inside and outside Swedish football arenas, in addition to arena entrances. Spectators are randomly selected and invited to participate in the study by providing a breath alcohol sample as a proxy for Blood Alcohol Concentration (BAC. Actors are hired and trained by an expert panel to act out a standardized scene of severe pseudo-intoxication. Four types of cross-sectional data are generated: (i BAC levels among ≥ 4 200 spectators, frequency of alcohol service to pseudo-intoxicated patrons attempting to purchase alcohol at LP (ii outside the arenas (≥200 attempts and (iii inside the arenas (≥ 200 attempts, and (iv frequency of security staff interventions towards pseudo-intoxicated patrons attempting to enter the arenas (≥ 200 attempts. Discussion There

  7. Preventing diabetes in obese Latino youth with prediabetes: a study protocol for a randomized controlled trial

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    Erica G. Soltero

    2017-03-01

    Full Text Available Abstract Background Obese Latino adolescents are disproportionately impacted by insulin resistance and type 2 diabetes. Prediabetes is an intermediate stage in the pathogenesis of type 2 diabetes and represents a critical opportunity for intervention. However, to date, no diabetes prevention studies have been conducted in obese Latino youth with prediabetes, a highly vulnerable and underserved group. Therefore, we propose a randomized-controlled trial to test the short-term (6-month and long-term (12-month efficacy of a culturally-grounded, lifestyle intervention, as compared to usual care, for improving glucose tolerance and reducing diabetes risk in 120 obese Latino adolescents with prediabetes. Methods Participants will be randomized to a lifestyle intervention or usual care group. Participants in the intervention group will attend weekly nutrition and wellness sessions and physical activity sessions twice a week for six months, followed by three months of booster sessions. The overall approach of the intervention is framed within a multilevel Ecodevelopmental model that leverages community, family, peer, and individual factors during the critical transition period of adolescence. The intervention is also guided by Social Cognitive Theory and employs key behavioral modification strategies to enhance self-efficacy and foster social support for making and sustaining healthy behavior changes. We will test intervention effects on quality of life, explore the potential mediating effects of changes in body composition, total, regional, and organ fat on improving glucose tolerance and increasing insulin sensitivity, and estimate the initial incremental cost effectiveness of the intervention as compared with usual care for improving glucose tolerance. Discussion The proposed trial builds upon extant collaborations of a transdisciplinary team of investigators working in concert with local community agencies to address critical gaps in how diabetes

  8. Effectiveness of the home-based alcohol prevention program "In control: No alcohol!": study protocol of a randomized controlled trial

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    Verdurmen Jacqueline EE

    2011-08-01

    Full Text Available Abstract Background In the Netherlands, children start to drink at an early age; of the Dutch 12-year olds, 40% reports lifetime alcohol use, while 9.7% reports last-month drinking. Starting to drink at an early age puts youth at risk of developing several alcohol-related problems later in life. Recently, a home-based prevention program called "In control: No alcohol!" was developed to delay the age of alcohol onset in children. The main aim of this project is to conduct a Randomized Controlled Trial (RCT to evaluate the effectiveness of the program. Methods/Design The prevention program will be tested with an RCT among mothers and their 6 grade primary school children (11-12 years old, randomly assigned to the prevention or control condition. The program consists of five printed magazines and an activity book designed to improve parental alcohol-specific socialization. Parent-child dyads in the control group receive a factsheet information brochure, which is the standard alcohol brochure of the Trimbos Institute (the Netherlands Institute for Mental Health and Addiction. Outcome measures are initiation of alcohol use (have been drinking at least one glass of alcohol, alcohol-specific parenting, susceptibility to drinking alcohol, alcohol expectancies, self-efficacy, and frequency and intensity of child alcohol use. Questionnaires will be administered online on secured Internet webpages, with personal login codes for both mothers and children. Mothers and children in both the experimental and control condition will be surveyed at baseline and after 6, 12, and 18 months (follow-ups. Discussion The present study protocol presents the design of an RCT evaluating the effectiveness of the home-based "In control: No alcohol!" program for 6 grade primary school children (11-12 years old. It is hypothesized that children in the prevention condition will be less likely to have their first glass of alcohol, compared to the control condition. When the

  9. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial.

    Science.gov (United States)

    Veldhuis, Lydian; Struijk, Mirjam K; Kroeze, Willemieke; Oenema, Anke; Renders, Carry M; Bulk-Bunschoten, Anneke Mw; Hirasing, Remy A; Raat, Hein

    2009-06-08

    The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children. A cluster randomised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams randomised within 9 Municipal Health Services. The teams are randomly allocated to the intervention or control group. The teams measure the weight and height of all children. When a child in the intervention group is detected with overweight according to the international age and gender specific cut-off points of BMI, the prevention protocol is applied. According to this protocol parents of overweight children are invited for up to three counselling sessions during which they receive personal advice about a healthy lifestyle, and are motivated for and assisted in behavioural change.The primary outcome measures are Body Mass Index and waist circumference of the children. Parents will complete questionnaires to assess secondary outcome measures: levels of overweight inducing/reducing behaviours (i.e. being physically active, having breakfast, drinking sweet beverages and watching television/playing computer games), parenting styles, parenting practices, and attitudes of parents regarding these behaviours, health-related quality of life of the children, and possible negative side effects of the prevention protocol. Data will be collected at baseline (when the children are aged 5 years), and after 12 and 24 months of follow-up. Additionally, a process and a cost-effectiveness evaluation will be conducted. In this study called 'Be active, eat right' we evaluate an overweight prevention protocol for use in the setting of Youth Health Care. It is hypothesized that the use of this protocol will result in a healthier lifestyle of the

  10. Effectiveness of the universal prevention program 'Healthy School and Drugs': Study protocol of a randomized clustered trial

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    Malmberg Monique

    2010-09-01

    Full Text Available Abstract Background Substance use is highly prevalent among Dutch adolescents. The Healthy School and Drugs program is a nationally implemented school-based prevention program aimed at reducing early and excessive substance use among adolescents. Although the program's effectiveness was tested in a quasi-experimental design before, many program changes were made afterwards. The present study, therefore, aims to test the effects of this widely used, renewed universal prevention program. Methods/Design A randomized clustered trial will be conducted among 3,784 adolescents of 23 secondary schools in The Netherlands. The trial has three conditions; two intervention conditions (i.e., e-learning and integral and a control condition. The e-learning condition consists of three digital learning modules (i.e., about alcohol, tobacco, and marijuana that are sequentially offered over the course of three school years (i.e., grade 1, grade 2, and grade 3. The integral condition consists of parental participation in a parental meeting on substance use, regulation of substance use, and monitoring and counseling of students' substance use at school, over and above the three digital modules. The control condition is characterized as business as usual. Participating schools were randomly assigned to either an intervention or control condition. Participants filled out a digital questionnaire at baseline and will fill out the same questionnaire three more times at follow-up measurements (8, 20, and 32 months after baseline. Outcome variables included in the questionnaire are the percentage of binge drinking (more than five drinks per occasion, the average weekly number of drinks, and the percentage of adolescents who ever drunk a glass of alcohol and the percentage of adolescents who ever smoked a cigarette or a joint respectively for tobacco and marijuana. Discussion This study protocol describes the design of a randomized clustered trial that evaluates the

  11. 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

  12. 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).

  13. Melatonin and melatonin agonists to prevent and treat delirium in critical illness: a systematic review protocol

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    Jennifer Foster

    2016-11-01

    Full Text Available Abstract Background Delirium is a syndrome characterized by acute fluctuations and alterations in attention and arousal. Critically ill patients are at particularly high risk, and those that develop delirium are more likely to experience poor clinical outcomes such as prolonged duration of ICU and hospital length of stay, and increased mortality. Melatonin and melatonin agonists (MMA have the potential to decrease the incidence and severity of delirium through their hypnotic and sedative-sparing effects, thus improving health-related outcomes. The objective of this review is to synthesize the available evidence pertaining to the efficacy and safety of MMA for the prevention and treatment of ICU delirium. Methods We will search Ovid MEDLINE, Web of Science, EMBASE, PsycINFO, the Cochrane Central Register of Controlled Trials (CENTRAL, and CINAHL to identify studies evaluating MMA in critically ill populations. We will also search http://apps.who.int/trialsearch for ongoing and unpublished studies and PROSPERO for registered reviews. We will not impose restrictions on language, date, or journal of publication. Authors will independently screen for eligible studies using pre-defined criteria; data extraction from eligible studies will be performed in duplicate. The Cochrane Risk of Bias Scale and the Newcastle-Ottawa Scale will be used to assess the risk of bias and quality of randomized and non-randomized studies, respectively. Our primary outcome of interest is delirium incidence, and secondary outcomes include duration of delirium, number of delirium- and coma-free days, use of physical and chemical (e.g., antipsychotics or benzodiazepines restraints, duration of mechanical ventilation, ICU and hospital length of stay, mortality, long-term neurocognitive outcomes, hospital discharge disposition, and adverse events. We will use Review Manager (RevMan to pool effect estimates from included studies. We will present results as relative risks with

  14. School-based intervention to prevent overweight and disordered eating in secondary school Malaysian adolescents: a study protocol

    Directory of Open Access Journals (Sweden)

    Sharifah Intan Zainun Sharif Ishak

    2016-10-01

    Full Text Available Abstract Background Obesity, eating disorders and unhealthy weight-loss practices have been associated with diminished growth in adolescents worldwide. Interventions that address relevant behavioural dimensions have been lacking in Malaysia. This paper describes the protocol of an integrated health education intervention namely ‘Eat Right, Be Positive About Your Body and Live Actively’ (EPaL, a primary prevention which aimed to promote healthy lifestyle in preventing overweight and disordered eating among secondary school adolescents aged 13–14 years old. Methods/Design Following quasi-experimental design, the intervention is conducted in two secondary schools located in the district of Hulu Langat, Selangor, Malaysia. Adolescents aged 13–14 years will be included in the study. A peer-education strategy is adopted to convey knowledge and teach skills relevant to achieving a healthy lifestyle. The intervention mainly promoted: healthy eating, positive body image and active lifestyle. The following parameters will be assessed: body weight, disordered eating status, stages of change (for healthy diet, breakfast, food portion size, screen viewing and physical activity, body image, health-related quality of life, self-esteem, eating and physical activity behaviours; and knowledge, attitude and practice towards a healthy lifestyle. Assessment will be conducted at three time points: baseline, post-intervention and 3-month follow-up. Discussion It is hypothesized that EPaL intervention will contribute in preventing overweight and disordered eating by giving the positive effects on body weight status, healthy lifestyle behaviour, as well as health-related quality of life of peer educators and participants. It may serve as a model for similar future interventions designed for the Malaysian community, specifically adolescents. Trial registration UMIN Clinical Trial Registration UMIN000024349 (Date of registration: 11th. October 2016

  15. School-based intervention to prevent overweight and disordered eating in secondary school Malaysian adolescents: a study protocol.

    Science.gov (United States)

    Sharif Ishak, Sharifah Intan Zainun; Chin, Yit Siew; Mohd Taib, Mohd Nasir; Mohd Shariff, Zalilah

    2016-10-20

    Obesity, eating disorders and unhealthy weight-loss practices have been associated with diminished growth in adolescents worldwide. Interventions that address relevant behavioural dimensions have been lacking in Malaysia. This paper describes the protocol of an integrated health education intervention namely 'Eat Right, Be Positive About Your Body and Live Actively' (EPaL), a primary prevention which aimed to promote healthy lifestyle in preventing overweight and disordered eating among secondary school adolescents aged 13-14 years old. Following quasi-experimental design, the intervention is conducted in two secondary schools located in the district of Hulu Langat, Selangor, Malaysia. Adolescents aged 13-14 years will be included in the study. A peer-education strategy is adopted to convey knowledge and teach skills relevant to achieving a healthy lifestyle. The intervention mainly promoted: healthy eating, positive body image and active lifestyle. The following parameters will be assessed: body weight, disordered eating status, stages of change (for healthy diet, breakfast, food portion size, screen viewing and physical activity), body image, health-related quality of life, self-esteem, eating and physical activity behaviours; and knowledge, attitude and practice towards a healthy lifestyle. Assessment will be conducted at three time points: baseline, post-intervention and 3-month follow-up. It is hypothesized that EPaL intervention will contribute in preventing overweight and disordered eating by giving the positive effects on body weight status, healthy lifestyle behaviour, as well as health-related quality of life of peer educators and participants. It may serve as a model for similar future interventions designed for the Malaysian community, specifically adolescents. UMIN Clinical Trial Registration UMIN000024349 (Date of registration: 11th. October 2016, retrospectively registered).

  16. Efficacy of long-acting release octreotide for preventing chemotherapy-induced diarrhoea: protocol for a systematic review.

    Science.gov (United States)

    Deng, Chao; Deng, Bo; Jia, Liqun; Tan, Huangying

    2017-06-21

    Diarrhoea is a common adverse effect induced by chemotherapy that can reduce the dose of chemotherapeutic drugs or interrupt the chemotherapy schedule. The current treatment strategies have various limitations. It has been shown that long-acting release octreotide (octreotide LAR) can decrease the occurrence and severity of diarrhoea, yet the efficacy of octreotide LAR in preventing chemotherapy-induced diarrhoea (CID) remains to be assessed. The main objective of this paper was to draw up a protocol for systematic review to evaluate the protective effects of octreotide LAR on CID. We searched Medline, EMBASE, the Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Data and the VIP Database without language restrictions from inception until 1 September 2016. The references of relevant studies were also manually searched. Two investigators independently accessed the selected studies, extracted data and assessed the reliability of the studies. Any discrepancies were resolved by a third investigator. The effect size of the selected studies was assessed by different measures based on the type of data. The selected studies were descriptively analysed. We then chose a fixed-effect model or a random-effect model based on statistical homogeneity, and pooled data from the studies for meta-analysis, if possible. The primary outcome was the incidence of diarrhoea. The secondary outcomes were the duration of diarrhoea, incidence of diarrhoea-associated symptoms, physical function and quality of life. All statistical analyses were performed by Review Manager V.5.3. This systematic review did not require ethics approval, because it included aggregated published data, and not individual patient data. The review was published in a peer-reviewed journal. This systematic review protocol was registered with PROSPERO (registration number: CRD 42016048573). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights

  17. Pain education to prevent chronic low back pain: a study protocol for a randomised controlled trial.

    Science.gov (United States)

    Traeger, Adrian C; Moseley, G Lorimer; Hübscher, Markus; Lee, Hopin; Skinner, Ian W; Nicholas, Michael K; Henschke, Nicholas; Refshauge, Kathryn M; Blyth, Fiona M; Main, Chris J; Hush, Julia M; Pearce, Garry; McAuley, James H

    2014-06-02

    Low back pain (LBP) is the leading cause of disability worldwide. Of those patients who present to primary care with acute LBP, 40% continue to report symptoms 3 months later and develop chronic LBP. Although it is possible to identify these patients early, effective interventions to improve their outcomes are not available. This double-blind (participant/outcome assessor) randomised controlled trial will investigate the efficacy of a brief educational approach to prevent chronic LBP in 'at-risk' individuals. Participants will be recruited from primary care practices in the Sydney metropolitan area. To be eligible for inclusion participants will be aged 18-75 years, with acute LBP (education or 2×1 h sessions of sham education from a specially trained study physiotherapist. The study requires 101 participants per group to detect a 1-point difference in pain intensity 3 months after pain onset. Secondary outcomes include the incidence of chronic LBP, disability, pain intensity, depression, healthcare utilisation, pain attitudes and beliefs, global recovery and recurrence and are measured at 1 week post-intervention, and at 3, 6 and 12 months post LBP onset. Ethical approval was obtained from the University of New South Wales Human Ethics Committee in June 2013 (ref number HC12664). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808. 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.

  18. Exploring facilitating factors and barriers to the nationwide dissemination of a Dutch school-based obesity prevention program "DOiT": a study protocol

    NARCIS (Netherlands)

    van Nassau, F.; Singh, A.S.; van Mechelen, W.; Paulussen, T.G.; Brug, J.; Chinapaw, M.J.

    2013-01-01

    Background: The evidence-based Dutch Obesity Intervention in Teenagers (DOiT) program is a school-based obesity prevention program for 12 to 14-year olds attending the first two years of prevocational education. This paper describes the study protocol applied to evaluate (a) the nationwide

  19. Effective communication network structures for hospital infection prevention: a study protocol.

    Science.gov (United States)

    Rangachari, Pavani

    2013-01-01

    Many hospitals are unable to successfully implement "evidence-based practices" at the unit level. For example, consistent implementation of the central line bundle (CLB), proven to prevent catheter-related bloodstream infections (CRBSIs) is often difficult. This problem has been broadly characterized as "change implementation failure" in health care organizations. Several studies have used retrospective designs to examine the problem; however, there are few prospective studies examining communication dynamics underlying successful implementation of change (eg, evidence-based practices). This prospective study will be set in 2 intensive care units at an academic medical center. At baseline, both units have low compliance with CLB and higher-than-expected CRBSIs. Periodic quality improvement (QI) interventions will be conducted over a 52-week period to promote implementation of CLB in both units. Simultaneously, the following parameters will be examined: (1) Structure and content of communication related to CLB in both units through "communication logs" completed weekly by nurses, physicians, and managers; and (2) outcomes, that is, CLB adherence in both units through weekly chart review. Catheter utilization and CRBSI (infection) rates will serve as additional unit-level outcome measures. The aim is 2-fold: (1) to examine associations between QI interventions and structure and content of communication at the unit level; and (2) to examine associations between structure and content of communication and outcomes at the unit level. The periodic QI interventions are expected to increase CLB adherence and reduce CRBSIs through their influence on structure and content of communication. The prospective design would help examine dynamics in unit-level communication structure and content related to CLB, as well as unit-level outcomes. The study has potential to make significant contributions to theory and practice, particularly if interventions are found to be effective in

  20. Preventive evidence into practice (PEP study: implementation of guidelines to prevent primary vascular disease in general practice protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Harris Mark F

    2013-01-01

    Full Text Available Abstract Background There are significant gaps in the implementation and uptake of evidence-based guideline recommendations for cardiovascular disease (CVD and diabetes in Australian general practice. This study protocol describes the methodology for a cluster randomised trial to evaluate the effectiveness of a model that aims to improve the implementation of these guidelines in Australian general practice developed by a collaboration between researchers, non-government organisations, and the profession. Methods We hypothesise that the intervention will alter the behaviour of clinicians and patients resulting in improvements of recording of lifestyle and physiological risk factors (by 20% and increased adherence to guideline recommendations for: the management of CVD and diabetes risk factors (by 20%; and lifestyle and physiological risk factors of patients at risk (by 5%. Thirty-two general practices will be randomised in a 1:1 allocation to receive either the intervention or continue with usual care, after stratification by state. The intervention will be delivered through: small group education; audit of patient records to determine preventive care; and practice facilitation visits adapted to the needs of the practices. Outcome data will be extracted from electronic medical records and patient questionnaires, and qualitative evaluation from provider and patient interviews. Discussion We plan to disseminate study findings widely and directly inform implementation strategies by governments, professional bodies, and non-government organisations including the partner organisations.

  1. Protocol for a randomised controlled trial of treatment of asymptomatic candidiasis for the prevention of preterm birth [ACTRN12610000607077

    Directory of Open Access Journals (Sweden)

    Rickard Kristen R

    2011-03-01

    Full Text Available Abstract Background Prevention of preterm birth remains one of the most important challenges in maternity care. We propose a randomised trial with: a simple Candida testing protocol that can be easily incorporated into usual antenatal care; a simple, well accepted, treatment intervention; and assessment of outcomes from validated, routinely-collected, computerised databases. Methods/Design Using a prospective, randomised, open-label, blinded-endpoint (PROBE study design, we aim to evaluate whether treating women with asymptomatic vaginal candidiasis early in pregnancy is effective in preventing spontaneous preterm birth. Pregnant women presenting for antenatal care The study protocol draws on the usual antenatal care schedule, has been pilot-tested and the intervention involves only a minor modification of current practice. Women who agree to participate will self-collect a vaginal swab and those who are culture positive for Candida will be randomised (central, telephone to open-label treatment or usual care (screening result is not revealed, no treatment, routine antenatal care. Outcomes will be obtained from population databases. A sample size of 3,208 women with Candida colonisation (1,604 per arm is required to detect a 40% reduction in the spontaneous preterm birth rate among women with asymptomatic candidiasis from 5.0% in the control group to 3.0% in women treated with clotrimazole (significance 0.05, power 0.8. Analyses will be by intention to treat. Discussion For our hypothesis, a placebo-controlled trial had major disadvantages: a placebo arm would not represent current clinical practice; knowledge of vaginal colonisation with Candida may change participants' behaviour; and a placebo with an alcohol preservative may have an independent affect on vaginal flora. These disadvantages can be overcome by the PROBE study design. This trial will provide definitive evidence on whether screening for and treating asymptomatic candidiasis in

  2. Mobile Health Technology (mDiab) for the Prevention of Type 2 Diabetes: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Muralidharan, Shruti; Mohan, Viswanathan; Anjana, Ranjit Mohan; Jena, Sidhant; Tandon, Nikhil; Allender, Steven; Ranjani, Harish

    2017-12-12

    The prevalence of type 2 diabetes is increasing in epidemic proportions in low- and middle-income countries. There is an urgent need for novel methods to tackle the increasing incidence of diabetes. The ubiquity of mobile phone use and access to Internet makes mobile health (mHealth) technology a viable tool to prevent and manage diabetes. The objective of this randomized controlled trial is to implement and evaluate the feasibility, cost-effectiveness, and sustainability of a reality television-based lifestyle intervention program. This intervention program is delivered via a mobile phone app (mDiab) to approximately 1500 Android smartphone users who are adults at a high risk for type 2 diabetes from three cities in India, namely, Chennai, Bengaluru, and New Delhi. The mDiab intervention would be delivered via a mobile phone app along with weekly coach calls for 12 weeks. Each participant will go through a maintenance phase of 6 to 8 months post intervention. Overall, there would be 3 testing time points in the study: baseline, post intervention, and the end of follow-up. The app will enable individuals to track their weight, physical activity, and diet alongside weekly video lessons on type 2 diabetes prevention. The study outcomes are weight loss (primary measure of effectiveness); improvement in cardiometabolic risk factors (ie, waist circumference, blood pressure, glucose, insulin, and lipids); and improvement in physical activity, quality of life, and dietary habits. Sustainability will be assessed through focus group discussions. If successful, mDiab can be used as a model for translational and implementation research in the use of mHealth technology for diabetes prevention and may be further expanded for the prevention of other noncommunicable diseases such as hypertension and cardiovascular diseases. Clinical Trials Registry of India CTRI/2015/07/006011 http://ctri.nic.in/Clinicaltrials/pdf_generate.php? trialid=11841 (Archived by WebCite at http

  3. Application of the Intervention Mapping protocol to develop Keys, a family child care home intervention to prevent early childhood obesity.

    Science.gov (United States)

    Mann, Courtney M; Ward, Dianne S; Vaughn, Amber; Benjamin Neelon, Sara E; Long Vidal, Lenita J; Omar, Sakinah; Namenek Brouwer, Rebecca J; Østbye, Truls

    2015-12-10

    Many families rely on child care outside the home, making these settings important influences on child development. Nearly 1.5 million children in the U.S. spend time in family child care homes (FCCHs), where providers care for children in their own residences. There is some evidence that children in FCCHs are heavier than those cared for in centers. However, few interventions have targeted FCCHs for obesity prevention. This paper will describe the application of the Intervention Mapping (IM) framework to the development of a childhood obesity prevention intervention for FCCHs Following the IM protocol, six steps were completed in the planning and development of an intervention targeting FCCHs: needs assessment, formulation of change objectives matrices, selection of theory-based methods and strategies, creation of intervention components and materials, adoption and implementation planning, and evaluation planning Application of the IM process resulted in the creation of the Keys to Healthy Family Child Care Homes program (Keys), which includes three modules: Healthy You, Healthy Home, and Healthy Business. Delivery of each module includes a workshop, educational binder and tool-kit resources, and four coaching contacts. Social Cognitive Theory and Self-Determination Theory helped guide development of change objective matrices, selection of behavior change strategies, and identification of outcome measures. The Keys program is currently being evaluated through a cluster-randomized controlled trial The IM process, while time-consuming, enabled rigorous and systematic development of intervention components that are directly tied to behavior change theory and may increase the potential for behavior change within the FCCHs.

  4. A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kuhlmann, Sophie Merle; Bürger, Arne; Esser, Günter; Hammerle, Florian

    2015-02-08

    Medical training is very demanding and associated with a high prevalence of psychological distress. Compared to the general population, medical students are at a greater risk of developing a psychological disorder. Various attempts of stress management training in medical school have achieved positive results on minimizing psychological distress; however, there are often limitations. Therefore, the use of a rigorous scientific method is needed. The present study protocol describes a randomized controlled trial to examine the effectiveness of a specifically developed mindfulness-based stress prevention training for medical students that includes selected elements of cognitive behavioral strategies (MediMind). This study protocol presents a prospective randomized controlled trial, involving four assessment time points: baseline, post-intervention, one-year follow-up and five-year follow-up. The aims include evaluating the effect on stress, coping, psychological morbidity and personality traits with validated measures. Participants are allocated randomly to one of three conditions: MediMind, Autogenic Training or control group. Eligible participants are medical or dental students in the second or eighth semester of a German university. They form a population of approximately 420 students in each academic term. A final total sample size of 126 (at five-year follow-up) is targeted. The trainings (MediMind and Autogenic Training) comprise five weekly sessions lasting 90 minutes each. MediMind will be offered to participants of the control group once the five-year follow-up is completed. The allotment is randomized with a stratified allocation ratio by course of studies, semester, and gender. After descriptive statistics have been evaluated, inferential statistical analysis will be carried out with a repeated measures ANOVA-design with interactions between time and group. Effect sizes will be calculated using partial η-square values. Potential limitations of this study

  5. Protocol for systematic review of school-based interventions to prevent and control obesity in African learners.

    Science.gov (United States)

    Adom, Theodosia; Puoane, Thandi; De Villiers, Anniza; Kengne, André Pascal

    2017-03-27

    The increasing prevalence of obesity and overweight in childhood in developing countries is a public health concern to many governments. Schools play a significant role in the obesity epidemic as well as provide favourable environments for change in behaviours in childhood which can be carried on into adulthood. There is dearth of information on intervention studies in poor-resource settings. This review will summarise the available evidence on school-based interventions that focused on promoting healthy eating and physical activity among learners aged 6-15 years in Africa and to identify factors that lead to successful interventions or potential barriers to success of these programmes within the African context. This protocol is developed following the guidelines of PRIMSA-P 2015. Relevant search terms and keywords generated from the subject headings and the African search filter will be used to conduct a comprehensive search of MEDLINE (PubMed), MEDLINE (EbscoHost), CINAHL (EbscoHost), Register Academic Search Complete (EbscoHost) and ISI Web of Science (Science Citation Index) for published literature on school-based interventions to prevent and control obesity in learners in Africa. Grey literature will be also be obtained. The searches will cover 1 January 2000 to 30 June 2016. No language limitations will be applied. Full-text articles of eligible studies will be screened. Risk of bias and quality of reporting will be assessed. Data will be extracted, synthesised and presented by country and major regional groupings. Meta-analysis will be conducted for identical variables across studies, where data allow. This protocol is developed following the guidelines of PRISMA-P 2015. No primary data will be collected hence ethics is not a requirement. The findings will be submitted for publication in peer-reviewed journals, in conferences and in policy documents for decision-making, where needed. Published by the BMJ Publishing Group Limited. For permission to use

  6. Project of law authorizing the adhesion to the protocol of 1997 modifying the international convention of 1973 for the prevention of the pollution by ships, such as modified by the related protocol of 1978; Projet de loi autorisant l'adhesion au protocole de 1997 modifiant la convention internationale de 1973 pour la prevention de la pollution par les navires, telle que modifiee par le protocole de 1978 y relatif

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2004-04-01

    The first international agreement of May 12, 1954, for the protection of the marine and coastal environments against pollution was replaced on November 2, 1973 by a more detailed convention for the prevention of the pollution by ships. The 25 rules defined in the appendix 1 of this last document were modified and completed by the protocol of February 17, 1978. To make this system even more constraining for the atmospheric pollution, a diplomatic conference took place in September 1997 at the head office of the international maritime organization in London (UK). This conference has adopted a protocol which introduced a new appendix no. 6 in the text of the 1973 convention for the abatement of the emissions of sulfur compounds and other polluting combustion products in case of oil-tank burning. This document is a project of law authorizing the adhesion of France to the protocol of 1997. It summarizes the main content of the articles of this protocol, and in particular the rules introduced in the new appendix. The full text of the protocol and of its appendixes are also attached. (J.S.)

  7. Prevention of nosocomial infections in critically ill patients with lactoferrin (PREVAIL study): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Muscedere, John; Maslove, David; Boyd, John Gordon; O'Callaghan, Nicole; Lamontagne, Francois; Reynolds, Steven; Albert, Martin; Hall, Rick; McGolrick, Danielle; Jiang, Xuran; Day, Andrew G

    2016-09-29

    Nosocomial infections remain an important source of morbidity, mortality, and increased health care costs in hospitalized patients. This is particularly problematic in intensive care units (ICUs) because of increased patient vulnerability due to the underlying severity of illness and increased susceptibility from utilization of invasive therapeutic and monitoring devices. Lactoferrin (LF) and the products of its breakdown have multiple biological effects, which make its utilization of interest for the prevention of nosocomial infections in the critically ill. This is a phase II randomized, multicenter, double-blinded trial to determine the effect of LF on antibiotic-free days in mechanically ventilated, critically ill, adult patients in the ICU. Eligible, consenting patients will be randomized to receive either LF or placebo. The treating clinician will remain blinded to allocation during the study; blinding will be maintained by using opaque syringes and containers. The primary outcome will be antibiotic-free days, defined as the number of days alive and free of antibiotics 28 days after randomization. Secondary outcomes will include: antibiotic utilization, adjudicated diagnosis of nosocomial infection (longer than 72 h of admission to ICU), hospital and ICU length of stay, change in organ function after randomization, hospital and 90-day mortality, incidence of tracheal colonization, changes in gastrointestinal permeability, and immune function. Outcomes to inform the conduct of a larger definitive trial will also be evaluated, including feasibility as determined by recruitment rates and protocol adherence. The results from this study are expected to provide insight into a potential novel therapeutic use for LF in critically ill adult patients. Further, analysis of study outcomes will inform a future, large-scale phase III randomized controlled trial powered on clinically important outcomes related to the use of LF. The trial was registered at www

  8. Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial.

    Science.gov (United States)

    Du, Yu-Zheng; Gao, Xin-Xin; Wang, Cheng-Ting; Zheng, Hai-Zhen; Lei, Yun; Wu, Meng-Han; Shi, Xue-Min; Ban, Hai-Peng; Gu, Wen-Long; Meng, Xiang-Gang; Wei, Mao-Ti; Hu, Chun-Xiao

    2017-09-15

    Stroke is the prime cause of morbidity and mortality in the general population, and hypertension will increase the recurrence and mortality of stroke. We report a protocol of a pragmatic randomized controlled trial (RCT) using blood pressure (BP)-lowering acupuncture add-on treatment to treat patients with hypertension and stroke. This is a large-scale, multicenter, subject-, assessor- and analyst-blinded, pragmatic RCT. A total of 480 patients with hypertension and ischemic stroke will be randomly assigned to two groups: an experimental group and a control group. The experimental group will receive "HuoXueSanFeng" acupuncture combined with one antihypertensive medication in addition to routine ischemic stroke treatment. The control group will only receive one antihypertensive medication and basic treatments for ischemic stroke. HuoXueSanFeng acupuncture will be given for six sessions weekly for the first 6 weeks and three times weekly for the next 6 weeks. A 9-month follow-up will, thereafter, be conducted. Antihypertensive medication will be adjusted based on BP levels. The primary outcome will be the recurrence of stroke. The secondary outcomes including 24-h ambulatory BP, the TCM syndrome score, the Short Form 36-item Health Survey (SF-36), the National Institute of Health Stroke Scale (NIHSS), as well as the Barthel Index (BI) scale will be assessed at baseline, 6 weeks and 12 weeks post initiating treatments; cardiac ultrasound, carotid artery ultrasound, transcranial Doppler, and lower extremity ultrasound will be evaluated at baseline and 12 weeks after treatment. The safety of acupuncture will also be assessed. We aim to determine the clinical effects of controlling BP for secondary prevention of stroke with acupuncture add-on treatment. ClinicalTrials.gov, ID: NCT02967484 . Registered on 13 February 2017; last updated on 27 June 2017.

  9. [A Group Cognitive-Behavioural Intervention to Prevent Depression Relapse in Individuals Having Recently Returned to Work: Protocol and Feasibility].

    Science.gov (United States)

    Lecomte, Tania; Corbière, Marc

    Workplace depression is one of the major causes for sick leave and loss of productivity at work. Many studies have investigated factors predicting return to work for people with depression, including studies evaluating return to work programs and organizational factors. Yet, a paucity of studies have targeted the prevention of depressive relapses at work, even though more than half of those having had a depression will have a depressive relapse in the near future.Objectives This article describes a research protocol involving a novel group intervention based on cognitive behavioural principles with the aim to optimize return to work and diminish risk of depressive relapses.Method This pilot study follows a randomized controlled trial design, with half the participants (N=25) receiving the group intervention and the other half (N=25) receiving usual services. The theoretical and empirical underpinnings of the intervention are described, along with a detailed presentation of the intervention and of the study's objectives. The group intervention consists of 8 sessions whereby Cognitive behavioural therapy (CBT) principles and techniques are applied to the following themes: (1) Coping with stress at work; (2) Recognizing and modifying my dysfunctional beliefs linked to work; (3) Overcoming obstacles linked to work functioning and maintaining work; (4) Negotiating needed work adjustments with the support of the immediate supervisor; (5) Finding my strengths and competencies related to work; (6) Accepting criticism and asserting myself appropriately at work; (7) Uncovering my best coping strategies for work.Results Qualitative information pertaining to the first two cohorts' participants' subjective appreciation of the group experience revealed that the intervention was perceived as very useful by all, with group support, namely harmony and interpersonal support, as well as CBT strategies being mentioned specifically.Conclusion Finally, the potential relevance of the

  10. Exercise intervention to prevent falls and enhance mobility in community dwellers after stroke: a protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Barker Ruth N

    2009-07-01

    Full Text Available Abstract Background Stroke is the most common disabling neurological condition in adults. Falls and poor mobility are major contributors to stroke-related disability. Falls are more frequent and more likely to result in injury among stroke survivors than among the general older population. Currently there is good evidence that exercise can enhance mobility after stroke, yet ongoing exercise programs for general community-based stroke survivors are not routinely available. This randomised controlled trial will investigate whether exercise can reduce fall rates and increase mobility and physical activity levels in stroke survivors. Methods and design Three hundred and fifty community dwelling stroke survivors will be recruited. Participants will have no medical contradictions to exercise and be cognitively and physically able to complete the assessments and exercise program. After the completion of the pre-test assessment, participants will be randomly allocated to one of two intervention groups. Both intervention groups will participate in weekly group-based exercises and a home program for twelve months. In the lower limb intervention group, individualised programs of weight-bearing balance and strengthening exercises will be prescribed. The upper limb/cognition group will receive exercises aimed at management and improvement of function of the affected upper limb and cognition carried out in the seated position. The primary outcome measures will be falls (measured with 12 month calendars and mobility. Secondary outcome measures will be risk of falling, physical activity levels, community participation, quality of life, health service utilisation, upper limb function and cognition. Discussion This study aims to establish and evaluate community-based sustainable exercise programs for stroke survivors. We will determine the effects of the exercise programs in preventing falls and enhancing mobility among people following stroke. This program, if

  11. Using the Intervention Mapping Protocol to develop an online video intervention for parents to prevent childhood obesity: Movie Models.

    Science.gov (United States)

    De Lepeleere, Sara; Verloigne, Maïté; Brown, Helen Elizabeth; Cardon, Greet; De Bourdeaudhuij, Ilse

    2016-08-08

    The increasing prevalence of childhood overweight/obesity caused by an unhealthy diet, insufficient physical activity (PA) and high levels of sedentary behaviour (SB) is a prominent public health concern. Parenting practices may contribute to healthy behaviour change in children, but well-researched examples are limited. The aim of this study is to describe the systematic development of an intervention for parents to prevent childhood overweight/obesity through the improvement of parenting practices. The six steps of the Intervention Mapping Protocol (IMP), a theory- and evidence-based tool to develop health-related interventions, were used as a framework to develop the 'Movie Models' programme. In Step 1, a needs assessment was performed to better understand the health problem of overweight/obesity in children and its association with diet, PA and SB. In Step 2, the programme goal (increasing the adoption of effective parenting practices) was sub-divided into performance objectives. Change objectives, which specify explicit actions required to accomplish the performance objectives, were also identified. Step 3 included the selection of theoretical methods (e.g. 'modelling' and 'images'), which were then translated into the practical strategy of online parenting videos. Step 4 comprised the development of a final intervention framework, and Step 5 included the planning of programme adoption and implementation. The final phase, Step 6, included the development of an effect- and process-evaluation plan. The IMP was used to structure the development of 'Movie Models', an intervention targeting specific parenting practices related to children's healthy diet, PA, SB, and parental self-efficacy. A clear framework for process analyses is offered, which aims to increase the potential effectiveness of an intervention and can be useful for those developing health promotion programmes. © The Author(s) 2016.

  12. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Veldhuis Lydian

    2009-06-01

    Full Text Available Abstract Background The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children. Methods and design A cluster randomised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams randomised within 9 Municipal Health Services. The teams are randomly allocated to the intervention or control group. The teams measure the weight and height of all children. When a child in the intervention group is detected with overweight according to the international age and gender specific cut-off points of BMI, the prevention protocol is applied. According to this protocol parents of overweight children are invited for up to three counselling sessions during which they receive personal advice about a healthy lifestyle, and are motivated for and assisted in behavioural change. The primary outcome measures are Body Mass Index and waist circumference of the children. Parents will complete questionnaires to assess secondary outcome measures: levels of overweight inducing/reducing behaviours (i.e. being physically active, having breakfast, drinking sweet beverages and watching television/playing computer games, parenting styles, parenting practices, and attitudes of parents regarding these behaviours, health-related quality of life of the children, and possible negative side effects of the prevention protocol. Data will be collected at baseline (when the children are aged 5 years, and after 12 and 24 months of follow-up. Additionally, a process and a cost-effectiveness evaluation will be conducted. Discussion In this study called 'Be active, eat right' we evaluate an overweight prevention protocol for use in the setting of Youth Health Care. It is hypothesized that the

  13. Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: an update to the study protocol for a randomized controlled trial.

    Science.gov (United States)

    Shih, Sophy T F; Davis-Lameloise, Nathalie; Janus, Edward D; Wildey, Carol; Versace, Vincent L; Hagger, Virginia; Asproloupos, Dino; O'Reilly, Sharleen L; Phillips, Paddy A; Ackland, Michael; Skinner, Timothy; Oats, Jeremy; Carter, Rob; Best, James D; Dunbar, James A

    2014-06-30

    The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial (RCT) that aims to assess the effectiveness of a structured diabetes prevention intervention for women who had gestational diabetes. The original protocol was published in Trials (http://www.trialsjournal.com/content/14/1/339). This update reports on an additional exclusion criterion and change in first eligibility screening to provide greater clarity. The new exclusion criterion "surgical or medical intervention to treat obesity" has been added to the original protocol. The risks of developing diabetes will be affected by any medical or surgical intervention as its impact on obesity will alter the outcomes being assessed by MAGDA-DPP. The screening procedures have also been updated to reflect the current recruitment operation. The first eligibility screening is now taking place either during or after pregnancy, depending on recruitment strategy. Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066.

  14. Study protocol of a cluster randomized controlled trial evaluating the efficacy of a comprehensive pressure ulcer prevention programme for private for-profit nursing homes.

    Science.gov (United States)

    Kwong, Enid Wai-yung; Lee, Paul Hong; Yeung, Kwan-mo

    2016-01-18

    Because the demand for government-subsidized nursing homes in Hong Kong outstrips the supply, the number of for-profit private nursing homes has been increasing rapidly. However, the standard of care in such homes is always criticized. Pressure ulcers are a major long-term care issue that is closely associated with the quality of care delivered in nursing home settings. The aim of this study is to evaluate the effectiveness of a pressure ulcer prevention programme for residents in private for-profit nursing homes. This is a two-arm cluster randomized controlled trial with an estimated sample size of 1088 residents and 74 care staff from eight for-profit private nursing homes. Eligible nursing homes will be those classified as category A2 homes in the Enhanced Bought Place Scheme (EBPS), having a capacity of around 130-150 beds, and no structured PU prevention protocol and/or programmes in place. Care staff will be health workers, personal care workers, and nurses who are front-line staff providing direct care to residents. Eight nursing homes will be randomly assigned to either an experimental or control group. The experimental group will be provided with an intensive training programme and will be involved in the implementation of a 16-week pressure ulcer prevention protocol, while the control group will deliver the usual pressure ulcer prevention care. The study outcomes are the pressure ulcer prevention knowledge and skills of the care staff and the prevalence and incidence of pressure ulcers. Data on the knowledge and skills of care staff, and prevalence of pressure ulcer will be collected at the base line, and then at the 8(th) week and at completion of the implementation of the protocol. The assessment of the incidence of pressures will start from before the commencement of the intensive training course to the end of the implementation of the protocol. In view of the negative impact of pressure ulcers, it is important to have an effective and evidence

  15. Background of the implementation of the Protocol the Convention against Torture: Monitoring places of detention and prevention of torture in Uruguay

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    Álvaro Garcé García y Santos

    2014-07-01

    Full Text Available The ratification of the Optional Protocol of the Convention against Torture had for our country, the significance of an ethical and juridical commitment of giving priority to the prevention of abuses for all the people deprived from liberty who are in jails or in other places of detention, as a consequence of a judicial decision or by virtue of an administrative mandate. Among the obligations established by the said Protocol it is found the one of setting up a National Mechanism of Prevention, technically and economically independent, in charge of the systematic monitoring of the detention centers. The creation of the National Institution of Human Rights, together with the legal mandate the same bears to coordinate its duties with the pre-existing Parliamentary Commissioner, finally brings the certain possibility of fulfilling with the obligations arising from the Protocol. At the same time, the original national solution, unparalleled in the region, implies a series of juridical complexities approached in this work. The cooperation between the two State Institutions involved in the matter, so as to avoid a useless overlapping of duties, brings up a promising future in relation to the prevention of torture in Uruguay.

  16. Minimal intervention dentistry: part 3. Paediatric dental care--prevention and management protocols using caries risk assessment for infants and young children.

    Science.gov (United States)

    Ramos-Gomez, F J; Crystal, Y O; Domejean, S; Featherstone, J D B

    2012-11-01

    Recent increases in caries prevalence in young children throughout the world highlight the need for a simple but effective infant oral care programme. This programme needs to include a medical disease prevention management model with an early establishment of a dental home and a treatment approach based on individual patient risk. This article presents an updated approach with practical forms and tools based on the principles of caries management by risk assessment, CAMBRA. This method will aid the general practitioner to develop and maintain a comprehensive protocol adequate for infant and young children oral care visits. Perinatal oral health is vitally important in preventing early childhood caries (ECC) in young children. Providing dental treatment to expectant mothers and their young children in a 'dual parallel track' is an effective innovative strategy and an efficient practice builder. It promotes prevention rather than intervention, and this may be the best way to achieve long-lasting oral health for young patients. General dental practice can adopt easy protocols that will promote early preventive visits and anticipatory guidance/counselling rather than waiting for the need for restorative treatment.

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

    Science.gov (United States)

    Barber-Westin, Sue D; Noyes, Frank R

    2017-12-01

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

  18. HIV prevention in favour of the choice-disabled in southern Africa: study protocol for a randomised controlled trial

    OpenAIRE

    Andersson, Neil; Cockcroft, Anne; Thabane, Lehana; Marokoane, Nobantu; Laetsang, Ditiro; Masisi, Mokgweetsi

    2013-01-01

    Background Most HIV prevention strategies assume beneficiaries can act on their prevention decisions. But some people are unable to do so. They are ?choice-disabled?. Economic and educational interventions can reduce sexual violence, but there is less evidence that they can reduce HIV. There is little research on complex interventions in HIV prevention, yet all countries in southern Africa implement combination prevention programmes. Methods/Design The primary objective is to reduce HIV infec...

  19. Distribution of Estimated 10-Year Risk of Recurrent Vascular Events and Residual Risk in a Secondary Prevention Population

    NARCIS (Netherlands)

    Kaasenbrood, Lotte; Boekholdt, S. Matthijs; Van Der Graaf, Yolanda; Ray, Kausik K.; Peters, Ron J G; Kastelein, John J P; Amarenco, Pierre; Larosa, John C.; Cramer, Maarten J M; Westerink, Jan; Kappelle, L. Jaap; De Borst, Gert J.; Visseren, Frank L J

    2016-01-01

    Background: Among patients with clinically manifest vascular disease, the risk of recurrent vascular events is likely to vary. We assessed the distribution of estimated 10-year risk of recurrent vascular events in a secondary prevention population. We also estimated the potential risk reduction and

  20. Depression and anxiety, an Indicated Prevention (DIP protocol in homes for the elderly: feasibility and (cost effectiveness of a stepped care programme

    Directory of Open Access Journals (Sweden)

    Beekman Aartjan TF

    2007-03-01

    Full Text Available Abstract Background Depressive and anxiety disorders are a very common, serious and underdetected problem in homes for the elderly. Elderly persons in residential homes are at high risk for developing major depressive and anxiety disorders, and, therefore, deserve attention with regard to prevention. Methods/Design This protocol describes a randomised trial on the feasibility and (cost effectiveness of a stepped-care programme for prevention of depressive and anxiety disorders in homes for the elderly. The main outcome measure is the incidence of depressive and anxiety disorder in one year with a two years follow up. Secondary outcomes are symptoms of depression and anxiety, quality of life, direct health care costs and satisfaction with treatment. Discussion The number of studies examining the effects of preventive interventions on the incidence of mental disorders in the elderly population is very small. However, indicated prevention by means of a stepped-care programme seems to be an important option for decreasing the burden of illness for residents and their caregivers. This study contributes to the body of knowledge in this field. Positive effects may contribute to further use and development of tailored, (cost- effective and easy to use interventions in a preventive stepped-care programme. Trial Registration The Dutch Cochrane Centre, ISRCTN27540731

  1. Alternative waste residue materials for passive in situ prevention of sulfide-mine tailings oxidation: a field evaluation.

    Science.gov (United States)

    Nason, Peter; Johnson, Raymond H; Neuschütz, Clara; Alakangas, Lena; Öhlander, Björn

    2014-02-28

    Novel solutions for sulfide-mine tailings remediation were evaluated in field-scale experiments on a former tailings repository in northern Sweden. Uncovered sulfide-tailings were compared to sewage-sludge biosolid amended tailings over 2 years. An application of a 0.2m single-layer sewage-sludge amendment was unsuccessful at preventing oxygen ingress to underlying tailings. It merely slowed the sulfide-oxidation rate by 20%. In addition, sludge-derived metals (Cu, Ni, Fe, and Zn) migrated and precipitated at the tailings-to-sludge interface. By using an additional 0.6m thick fly-ash sealing layer underlying the sewage sludge layer, a solution to mitigate oxygen transport to the underlying tailings and minimize sulfide-oxidation was found. The fly-ash acted as a hardened physical barrier that prevented oxygen diffusion and provided a trap for sludge-borne metals. Nevertheless, the biosolid application hampered the application, despite the advances in the effectiveness of the fly-ash layer, as sludge-borne nitrate leached through the cover system into the underlying tailings, oxidizing pyrite. This created a 0.3m deep oxidized zone in 6-years. This study highlights that using sewage sludge in unconventional cover systems is not always a practical solution for the remediation of sulfide-bearing mine tailings to mitigate against sulfide weathering and acid rock drainage formation. Copyright © 2014 Elsevier B.V. All rights reserved.

  2. A randomized efficacy trial of a cognitive-behavioral group intervention to prevent Internet Use Disorder onset in adolescents: The PROTECT study protocol.

    Science.gov (United States)

    Lindenberg, Katajun; Halasy, Katharina; Schoenmaekers, Sophie

    2017-06-01

    The reduction of prevalence rates of Internet Use Disorder (IUD) and its effective treatment are at high priority in both public health and educational policies. School-based preventive interventions facilitate a low-threshold approach for individuals with IUD, who are typically characterized by high therapy avoidance. Moreover, indicated approaches which target adolescents at high-risk show larger effects than universal prevention programs. Simultaneously, they reduce unnecessary burden for the majority of high-school students that is not at-risk. The PROTECT group intervention for indicated prevention of IUD in school settings was developed based on these preventive strategies. Three-hundred and forty adolescents, aged 12-18 years, from 40 secondary schools in Germany, screened for high-risk of IUD onset, are randomly assigned to a) PROTECT preventive intervention group or b) assessment only control group. The tested intervention consists of a cognitive-behavioral 4-session brief-protocol. Follow-up assessments are at 1, 4 and 12 months after admission. Primary outcome is the 12-months incidence rate of IUD. Secondary outcomes are the reduction of IUD and comorbid symptoms as well as the promotion of problem solving, cognitive restructuring and emotion regulation skills. The indicated preventive intervention PROTECT follows the APA-guidelines for psychological prevention, i.e., it is theory- and evidence-based and addresses both risk-reduction and strength-promotion, it considers current research and epidemiology and ethical standards such as professional secrecy and is designed as a systemic intervention at the school-level. It is expected that the intervention decreases risk of IUD onset (incidence rate). ClinicalTrials.gov: NCT02907658.

  3. A police education programme to integrate occupational safety and HIV prevention: protocol for a modified stepped-wedge study design with parallel prospective cohorts to assess behavioural outcomes

    Science.gov (United States)

    Strathdee, Steffanie A; Arredondo, Jaime; Rocha, Teresita; Abramovitz, Daniela; Rolon, Maria Luisa; Patiño Mandujano, Efrain; Rangel, Maria Gudelia; Olivarria, Horcasitas Omar; Gaines, Tommi; Patterson, Thomas L; Beletsky, Leo

    2015-01-01

    Introduction Policing practices are key drivers of HIV among people who inject drugs (PWID). This paper describes the protocol for the first study to prospectively examine the impact of a police education programme (PEP) to align law enforcement and HIV prevention. PEPs incorporating HIV prevention (including harm reduction programmes like syringe exchange) have been successfully piloted in several countries but were limited to brief pre–post assessments; the impact of PEPs on policing behaviours and occupational safety is unknown. Objectives Proyecto ESCUDO (SHIELD) aims to evaluate the efficacy of the PEP on uptake of occupational safety procedures, as assessed through the incidence of needle stick injuries (NSIs) (primary outcome) and changes in knowledge of transmission, prevention and treatment of HIV and viral hepatitis; attitudes towards PWID, adverse behaviours that interfere with HIV prevention and protective behaviours (secondary outcomes). Methods/analysis ESCUDO is a hybrid type I design that simultaneously tests an intervention and an implementation strategy. Using a modified stepped-wedge design involving all active duty street-level police officers in Tijuana (N=∼1200), we will administer one 3 h PEP course to groups of 20–50 officers until the entire force is trained. NSI incidence and geocoded arrest data will be assessed from department-wide de-identified data. Of the consenting police officers, a subcohort (N=500) will be randomly sampled from each class to undergo pre-PEP and post-PEP surveys with a semiannual follow-up for 2 years to assess self-reported NSIs, attitudes and behaviour changes. The impact on PWIDs will be externally validated through a parallel cohort of Tijuana PWIDs. Ethics/dissemination Research ethics approval was obtained from the USA and Mexico. Findings will be disseminated through open access to protocol materials through the Law Enforcement and HIV Network. Trial registration number NCT02444403. PMID:26260350

  4. Preventing falls in older multifocal glasses wearers by providing single-lens distance glasses: the protocol for the VISIBLE randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Lee Bonsan B

    2009-03-01

    Full Text Available Abstract Background Recent research has shown that wearing multifocal glasses increases the risk of trips and falls in older people. The aim of this study is to determine whether the provision of single-lens distance glasses to older multifocal glasses wearers, with recommendations for wearing them for walking and outdoor activities, can prevent falls. We will also measure the effect of the intervention on health status, lifestyle activities and fear of falling, as well as the extent of adherence to the program. Methods/Design Approximately 580 older people who are regular wearers of multifocal glasses people will be recruited. Participants will be randomly allocated to either an intervention group (provision of single lens glasses, with counselling and advice about appropriate use or a control group (usual care. The primary outcome measure will be falls (measured with 13 monthly calendars. Secondary measures will be quality of life, falls efficacy, physical activity levels and adverse events. Discussions The study will determine the impact of providing single-lens glasses, with advice about appropriate use, on preventing falls in older regular wearers of multifocal glasses. This pragmatic intervention, if found to be effective, will guide practitioners with regard to recommending appropriate glasses for minimising the risk of falls in older people. Trial Registration The protocol for this study was registered with the Clinical Trials.gov Protocol Registration System on June 7th 2006 (#350855.

  5. A parenting programme to prevent abuse of adolescents in South Africa: study protocol for a randomized controlled trial

    OpenAIRE

    Cluver, L; Meinck, F; Shenderovich, Y; Ward, CL; Herrero Romero, R; Lombard, C; Doubt, JS; Steinert, J; Catanho, R; Wittesaele, C; DeStone, S; Salah, N; Mpimilashe, P; Lachman, J; Loening, H

    2016-01-01

    Background An estimated one billion children experience child abuse each year, with the highest rates in low- and middle-income countries. The Sinovuyo Teen programme is part of Parenting for Lifelong Health, a WHO/UNICEF initiative to develop and test violence-prevention programmes for implementation in low-resource contexts. The objectives of this parenting support programme are to prevent the abuse of adolescents, improve parenting and reduce adolescent behavioural problems. This trial aim...

  6. Performance analysis and implementation of proposed mechanism for detection and prevention of security attacks in routing protocols of vehicular ad-hoc network (VANET

    Directory of Open Access Journals (Sweden)

    Parul Tyagi

    2017-07-01

    Full Text Available Next-generation communication networks have become widely popular as ad-hoc networks, broadly categorized as the mobile nodes based on mobile ad-hoc networks (MANET and the vehicular nodes based vehicular ad-hoc networks (VANET. VANET is aimed at maintaining safety to vehicle drivers by begin autonomous communication with the nearby vehicles. Each vehicle in the ad-hoc network performs as an intelligent mobile node characterized by high mobility and formation of dynamic networks. The ad-hoc networks are decentralized dynamic networks that need efficient and secure communication requirements due to the vehicles being persistently in motion. These networks are more susceptible to various attacks like Warm Hole attacks, denial of service attacks and Black Hole Attacks. The paper is a novel attempt to examine and investigate the security features of the routing protocols in VANET, applicability of AODV (Ad hoc On Demand protocol to detect and tackle a particular category of network attacks, known as the Black Hole Attacks. A new algorithm is proposed to enhance the security mechanism of AODV protocol and to introduce a mechanism to detect Black Hole Attacks and to prevent the network from such attacks in which source node stores all route replies in a look up table. This table stores the sequences of all route reply, arranged in ascending order using PUSH and POP operations. The priority is calculated based on sequence number and discard the RREP having presumably very high destination sequence number. The result show that proposed algorithm for detection and prevention of Black Hole Attack increases security in Intelligent Transportation System (ITS and reduces the effect of malicious node in the VANET. NCTUNs simulator is used in this research work.

  7. A cluster randomised controlled trial of advice, exercise or multifactorial assessment to prevent falls and fractures in community-dwelling older adults: protocol for the prevention of falls injury trial (PreFIT).

    Science.gov (United States)

    Bruce, Julie; Lall, Ranjit; Withers, Emma J; Finnegan, Susanne; Underwood, Martin; Hulme, Claire; Sheridan, Ray; Skelton, Dawn A; Martin, Finbarr; Lamb, Sarah E

    2016-01-18

    Falls are the leading cause of accident-related mortality in older adults. Injurious falls are associated with functional decline, disability, healthcare utilisation and significant National Health Service (NHS)-related costs. The evidence base for multifactorial or exercise interventions reducing fractures in the general population is weak. This protocol describes a large-scale UK trial investigating the clinical and cost-effectiveness of alternative falls prevention interventions targeted at community dwelling older adults. A three-arm, pragmatic, cluster randomised controlled trial, conducted within primary care in England, UK. Sixty-three general practices will be randomised to deliver one of three falls prevention interventions: (1) advice only; (2) advice with exercise; or (3) advice with multifactorial falls prevention (MFFP). We aim to recruit over 9000 community-dwelling adults aged 70 and above. Practices randomised to deliver advice will mail out advice booklets. Practices randomised to deliver 'active' interventions, either exercise or MFFP, send all trial participants the advice booklet and a screening survey to identify participants with a history of falling or balance problems. Onward referral to 'active' intervention will be based on falls risk determined from balance screen. The primary outcome is peripheral fracture; secondary outcomes include number with at least one fracture, falls, mortality, quality of life and health service resource use at 18 months, captured using self-report and routine healthcare activity data. The study protocol has approval from the National Research Ethics Service (REC reference 10/H0401/36; Protocol V.3.1, 21/May/2013). User groups and patient representatives were consulted to inform trial design. Results will be reported at conferences and in peer-reviewed publications. A patient-friendly summary of trial findings will be published on the prevention of falls injury trial (PreFIT) website. This protocol adheres to the

  8. Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Arabi, Yaseen; Al-Hameed, Fahad; Burns, Karen E A; Mehta, Sangeeta; Alsolamy, Sami; Almaani, Mohammed; Mandourah, Yasser; Almekhlafi, Ghaleb A; Al Bshabshe, Ali; Finfer, Simon; Alshahrani, Mohammed; Khalid, Imran; Mehta, Yatin; Gaur, Atul; Hawa, Hassan; Buscher, Hergen; Arshad, Zia; Lababidi, Hani; Al Aithan, Abdulsalam; Jose, Jesna; Abdukahil, Sheryl Ann I; Afesh, Lara Y; Dbsawy, Maamoun; Al-Dawood, Abdulaziz

    2018-03-15

    The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults. In this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group. The primary outcome is "incident" proximal lower-extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation, whereas the patients and treating team will be unblinded. The trial has 80% power to detect a 3% absolute risk reduction in the rate of proximal DVT from 7% to 4%. Consistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data. ClinicalTrials.gov , ID: NCT02040103 . Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506 . Registered on 30 October 2013.

  9. PREvention STudy On preventing or reducing disability from musculoskeletal complaints in music school students (PRESTO): protocol of a randomised controlled trial.

    Science.gov (United States)

    Baadjou, Vera A E; Verbunt, Jeanine A M C F; Eijsden-Besseling, Marjon D F van; Samama-Polak, Ans L W; Bie, Rob A D E; Smeets, Rob J E M

    2014-12-01

    Up to 87% of professional musicians develop work-related complaints of the musculoskeletal system during their careers. Music school students are at specific risk for developing musculoskeletal complaints and disabilities. This study aims to evaluate the effectiveness of a biopsychosocial prevention program to prevent or reduce disabilities from playing-related musculoskeletal disorders. Secondary objectives are evaluation of cost-effectiveness and feasibility. Healthy, first or second year students (n=150) will be asked to participate in a multicentre, single-blinded, parallel-group randomised controlled trial. Students randomised to the intervention group (n=75) will participate in a biopsychosocial prevention program that addresses playing-related health problems and provides postural training according to the Mensendieck or Cesar methods of postural exercise therapy, while incorporating aspects from behavioural change theories. A control group (n=75) will participate in a program that stimulates a healthy physical activity level using a pedometer, which conforms to international recommendations. No long-term effects are expected from this control intervention. Total follow-up duration is two years. The primary outcome measure is disability (Disabilities of Arm, Shoulder and Hand questionnaire). The secondary outcome measures are pain, quality of life and changes in health behaviour. Multilevel mixed-effect logistic or linear regression analyses will be performed to analyse the effects of the program on the aforementioned outcome measurements. Furthermore, cost-effectiveness, cost-utility and feasibility will be analysed. It is believed that this is the first comprehensive randomised controlled trial on the effect and rationale of a biopsychosocial prevention program for music students. Copyright © 2014 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

  10. The preventing recurrent vascular events and neurological worsening through intensive organized case-management (PREVENTION trial protocol [clinicaltrials.gov identifier: NCT00931788

    Directory of Open Access Journals (Sweden)

    Tsuyuki Ross

    2010-04-01

    Full Text Available Abstract Background Survivors of transient ischemic attack (TIA or stroke are at high risk for recurrent vascular events and aggressive treatment of vascular risk factors can reduce this risk. However, vascular risk factors, especially hypertension and high cholesterol, are not managed optimally even in those patients seen in specialized clinics. This gap between the evidence for secondary prevention of stroke and the clinical reality leads to suboptimal patient outcomes. In this study, we will be testing a pharmacist case manager for delivery of stroke prevention services. We hypothesize this new structure will improve processes of care which in turn should lead to improved outcomes. Methods We will conduct a prospective, randomized, controlled open-label with blinded ascertainment of outcomes (PROBE trial. Treatment allocation will be concealed from the study personnel, and all outcomes will be collected in an independent and blinded manner by observers who have not been involved in the patient's clinical care or trial participation and who are masked to baseline measurements. Patients will be randomized to control or a pharmacist case manager treating vascular risk factors to guideline-recommended target levels. Eligible patients will include all adult patients seen at stroke prevention clinics in Edmonton, Alberta after an ischemic stroke or TIA who have uncontrolled hypertension (defined as systolic blood pressure (BP > 140 mm Hg or dyslipidemia (fasting LDL-cholesterol > 2.00 mmol/L and who are not cognitively impaired or institutionalized. The primary outcome will be the proportion of subjects who attain 'optimal BP and lipid control'(defined as systolic BP Conclusions Nearly one-quarter of those who survive a TIA or minor stroke suffer another vascular event within a year. If our intervention improves the provision of secondary prevention therapies in these patients, the clinical (and financial implications will be enormous.

  11. Rationale and protocol of a trial for prevention of diabetic atherosclerosis by using antiplatelet drugs: study of Diabetic Atherosclerosis Prevention by Cilostazol (DAPC study

    Directory of Open Access Journals (Sweden)

    Kawamori Ryuzo

    2006-08-01

    Full Text Available Abstract Background Secondary treatment of arteriosclerosis may be applicable for the primary prevention of atherosclerosis in diabetic patients. This prospective, 2-year follow-up study was designed to determine the efficacy and safety of antiplatelet therapy in the prevention of atherosclerosis of diabetic subjects. Methods Patients with type 2 diabetes and arteriosclerosis obliterans from the Eastern Asian countries were registered online and randomly assigned either to the aspirin group (81–100 mg/day or the cilostazol group (100–200 mg/day in this international, 2-year, prospective follow-up interventional study. Results The primary study endpoint was changes in right and left maximum intima-media thickness of the common carotid artery. Secondary endpoints include changes in right and left maximum intima-media thickness of the internal carotid artery; semiquantitative evaluation of cerebral infarction by magnetic resonance imaging; cardiovascular events including sudden death, stroke, transient cerebral ischemic attacks, acute myocardial infarction, angina, and progression of arteriosclerosis obliterans; overall death; withdrawal; and change in ankle-brachial pressure index. Conclusion This is the first study to use an online system that was developed in Asian countries for pooling data from an international clinical trial. These findings are expected to help in the prevention of diabetic atherosclerosis and subsequent cardiovascular and cerebrovascular disease.

  12. Partnership for fragility bone fracture care provision and prevention program (P4Bones: study protocol for a secondary fracture prevention pragmatic controlled trial

    Directory of Open Access Journals (Sweden)

    Gaboury Isabelle

    2013-01-01

    Full Text Available Abstract Background Fractures associated with bone fragility in older adults signal the potential for secondary fracture. Fragility fractures often precipitate further decline in health and loss of mobility, with high associated costs for patients, families, society and the healthcare system. Promptly initiating a coordinated, comprehensive pharmacological bone health and falls prevention program post-fracture may improve osteoporosis treatment compliance; and reduce rates of falls and secondary fractures, and associated morbidity, mortality and costs. Methods/design This pragmatic, controlled trial at 11 hospital sites in eight regions in Quebec, Canada, will recruit community-dwelling patients over age 50 who have sustained a fragility fracture to an intervention coordinated program or to standard care, according to the site. Site study coordinators will identify and recruit 1,596 participants for each study arm. Coordinators at intervention sites will facilitate continuity of care for bone health, and arrange fall prevention programs including physical exercise. The intervention teams include medical bone specialists, primary care physicians, pharmacists, nurses, rehabilitation clinicians, and community program organizers. The primary outcome of this study is the incidence of secondary fragility fractures within an 18-month follow-up period. Secondary outcomes include initiation and compliance with bone health medication; time to first fall and number of clinically significant falls; fall-related hospitalization and mortality; physical activity; quality of life; fragility fracture-related costs; admission to a long term care facility; participants’ perceptions of care integration, expectations and satisfaction with the program; and participants’ compliance with the fall prevention program. Finally, professionals at intervention sites will participate in focus groups to identify barriers and facilitating factors for the integrated

  13. Obesity and eating disorders in integrative prevention programmes for adolescents: Protocol for a systematic review and meta-analysis

    Science.gov (United States)

    Obesity and eating disorders are public health problems that have lifelong financial and personal costs and common risk factors, for example, body dissatisfaction, weight teasing and disordered eating. Obesity prevention interventions might lead to the development of an eating disorder since focusin...

  14. Efficacy of oxytocin administration early after psychotrauma in preventing the development of PTSD: study protocol of a randomized controlled trial

    NARCIS (Netherlands)

    Frijling, Jessie L.; van Zuiden, Mirjam; Koch, Saskia B. J.; Nawijn, Laura; Goslings, J. Carel; Luitse, Jan S.; Biesheuvel, Tessa H.; Honig, Adriaan; Bakker, Fred C.; Denys, Damiaan; Veltman, Dick J.; Olff, Miranda

    2014-01-01

    Currently few evidence based interventions are available for the prevention of PTSD within the first weeks after trauma. Increased risk for PTSD development is associated with dysregulated fear and stress responses prior to and shortly after trauma, as well as with a lack of perceived social support

  15. Efficacy of oxytocin administration early after psychotrauma in preventing the development of PTSD : study protocol of a randomized controlled trial

    NARCIS (Netherlands)

    Frijling, Jessie L; van Zuiden, Mirjam; Koch, Saskia B J; Nawijn, Laura; Goslings, J Carel; Luitse, Jan S; Biesheuvel, Tessa H; Honig, Adriaan; Bakker, Fred C; Denys, D.; Veltman, Dick J; Olff, Miranda

    2014-01-01

    BACKGROUND: Currently few evidence based interventions are available for the prevention of PTSD within the first weeks after trauma. Increased risk for PTSD development is associated with dysregulated fear and stress responses prior to and shortly after trauma, as well as with a lack of perceived

  16. Effectiveness of the universal prevention program 'Healthy School and Drugs': study protocol of a randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, M.; Overbeek, G.J.; Kleinjan, M.; Vermulst, A.; Monshouwer, K.; Lammers, J.; Vollebergh, W.A.M.; Engels, R.C.M.E.

    2010-01-01

    Background: Substance use is highly prevalent among Dutch adolescents. The Healthy School and Drugs program is a nationally implemented school-based prevention program aimed at reducing early and excessive substance use among adolescents. Although the program's effectiveness was tested in a

  17. Effectiveness of the universal prevention program 'Healthy School and Drugs': Study protocol of a randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, M.; Overbeek, G.J.; Kleinjan, M.; Vermulst, A.A.; Monshouwer, K.; Lammers, J.; Vollebergh, W.A.M.; Engels, R.C.M.E.

    2010-01-01

    Background: Substance use is highly prevalent among Dutch adolescents. The Healthy School and Drugs program is a nationally implemented school-based prevention program aimed at reducing early and excessive substance use among adolescents. Although the program's effectiveness was tested in a

  18. HIV prevention in favour of the choice-disabled in southern Africa: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Andersson, Neil; Cockcroft, Anne; Thabane, Lehana; Marokoane, Nobantu; Laetsang, Ditiro; Masisi, Mokgweetsi

    2013-08-29

    Most HIV prevention strategies assume beneficiaries can act on their prevention decisions. But some people are unable to do so. They are 'choice-disabled'. Economic and educational interventions can reduce sexual violence, but there is less evidence that they can reduce HIV. There is little research on complex interventions in HIV prevention, yet all countries in southern Africa implement combination prevention programmes. The primary objective is to reduce HIV infections among women aged 15 to 29 years. Secondary objectives are reduction in gender violence and improvement in HIV-related knowledge, attitudes and practices among youth aged 15 to 29 years.A random sample of 77 census enumeration areas in three countries (Botswana, Namibia and Swaziland) was allocated randomly to three interventions, alone or in combination, in a factorial design stratified by country, HIV rates (above or below average for country), and urban/rural location. A baseline survey of youth aged 15 to 29 years provided cluster specific rates of HIV. All clusters continue existing prevention efforts and have a baseline and follow-up survey. Cluster is the unit of allocation, intervention and analysis, using generalised estimating equations, on an intention-to-treat basis.One intervention discusses evidence about choice disability with local HIV prevention services, to help them to serve the choice-disabled. Another discusses an eight-episode audio-docudrama with community groups, of all ages and both sexes, to generate endogenous strategies to reduce gender violence and develop an enabling environment. A third supports groups of women aged 18 to 25 years to build self-esteem and life skills and to set up small enterprises to generate income.A survey in all clusters after 3 years will measure outcomes, with interviewers unaware of group assignment of the clusters. The primary outcome is HIV infection in women aged 15 to 29 years. Secondary outcomes in youth aged 15 to 29 years are gender

  19. ForgIng New paths in DIabetes PrevenTion (FINDIT): Study Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Kullgren, Jeffrey T; Youles, Bradley; Shetty, Shaina; Richardson, Caroline; Fagerlin, Angela; Heisler, Michele

    2017-04-08

    Prediabetes is an asymptomatic condition in which patients' blood glucose levels are higher than normal but do not meet diagnostic criteria for type 2 diabetes mellitus (T2DM). A key window of opportunity to increase engagement of patients with prediabetes in strategies to prevent T2DM is when they are screened for T2DM and found to have prediabetes, yet the effects of this screening and brief counseling are unknown. In this parallel-design randomized controlled trial we will recruit 315 non-diabetic patients from the Ann Arbor VA Medical Center (AAVA) who have one or major risk factors for T2DM and an upcoming primary care appointment at the AAVA, but have not had a hemoglobin A1c (HbA1c) test to screen for T2DM in the previous 12 months. After informed consent, participants will complete a baseline survey and be randomly assigned to, at the time of their next primary care appointment, one of two arms: (1) to have a hemoglobin A1c (HbA1c) test to screen for T2DM and receive brief, standardized counseling about these results or (2) to review a brochure about clinical preventive services. Participants will complete surveys 2 weeks, 3 months, and 12 months after their primary care appointment, and a weight measurement 12 months after their primary care appointment. The primary outcome is weight change after 12 months. The secondary outcomes are changes in perception of risk for T2DM; knowledge of T2DM prevention; self-efficacy and motivation to prevent T2DM; use of pharmacotherapy for T2DM prevention; physical activity; participation in weight management programs; and mental health. Quantitative analyses will compare outcomes among participants in the HbA1c test arm found to have prediabetes with participants in the brochure arm. Among participants in the HbA1c test arm found to have prediabetes we will conduct semi-structured interviews about their understanding of and reactions to receiving a prediabetes diagnosis. This trial will generate foundational data

  20. An optimized single chain TCR scaffold relying on the assembly with the native CD3-complex prevents residual mispairing with endogenous TCRs in human T-cells

    Science.gov (United States)

    Knies, Diana; Klobuch, Sebastian; Xue, Shao-An; Birtel, Matthias; Echchannaoui, Hakim; Yildiz, Oezlem; Omokoko, Tana; Guillaume, Philippe; Romero, Pedro; Stauss, Hans; Sahin, Ugur; Herr, Wolfgang; Theobald, Matthias; Thomas, Simone; Voss, Ralf-Holger

    2016-01-01

    Immunotherapy of cancer envisions the adoptive transfer of T-cells genetically engineered with tumor-specific heterodimeric α/β T-cell receptors (TCRα/β). However, potential mispairing of introduced TCRα/β-chains with endogenous β/α-ones may evoke unpredictable autoimmune reactivities. A novel single chain (sc)TCR format relies on the fusion of the Vα-Linker-Vβ-fragment to the TCR Cβ-domain and coexpression of the TCR Cα-domain capable of recruiting the natural CD3-complex for full and hence, native T-cell signaling. Here, we tested whether such a gp100(280-288)- or p53(264-272) tumor antigen-specific scTCR is still prone to mispairing with TCRα. In a human Jurkat-76 T-cell line lacking endogenous TCRs, surface expression and function of a scTCR could be reconstituted by any cointroduced TCRα-chain indicating mispairing to take place on a molecular basis. In contrast, transduction into human TCRα/β-positive T-cells revealed that mispairing is largely reduced. Competition experiments in Jurkat-76 confirmed the preference of dcTCR to selfpair and to spare scTCR. This also allowed for the generation of dc/scTCR-modified cytomegalovirus/tumor antigen-bispecific T-cells to augment T-cell activation in CMV-infected tumor patients. Residual mispairing was prevented by strenghtening the Vα-Li-Vβ-fragment through the design of a novel disulfide bond between a Vα- and a linker-resident residue close to Vβ. Multimer-stainings, and cytotoxicity-, IFNγ-secretion-, and CFSE-proliferation-assays, the latter towards dendritic cells endogenously processing RNA-electroporated gp100 antigen proved the absence of hybrid scTCR/TCRα-formation without impairing avidity of scTCR/Cα in T-cells. Moreover, a fragile cytomegalovirus pp65(495-503)-specific scTCR modified this way acquired enhanced cytotoxicity. Thus, optimized scTCR/Cα inhibits residual TCR mispairing to accomplish safe adoptive immunotherapy for bulk endogenous TCRα/β-positive T-cells. PMID:27028870

  1. Effect on attendance by including focused information on spirometry in preventive health checks: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ørts, Lene Maria; Løkke, Anders; Bjerregaard, Anne-Louise; Maindal, Helle Terkildsen; Sandbæk, Annelli

    2016-12-01

    Early detection of lung diseases can help to reduce their severity. Lung diseases are among the most frequently occurring and serious diseases worldwide; nonetheless, many patients remain undiagnosed. Preventive health checks including spirometry can detect lung diseases at early stages; however, recruitment for health checks remains a challenge, and little is known about what motivates the attendance. The aim of the study is to examine whether focused information on spirometry in the invitation compared to general information will impact the attendance rate in preventive health checks. This randomized, controlled trial tests the effect of information on spirometry embedded in the Check your Health Preventive Program (CHPP). The CHPP is an open-label, household cluster-randomized, controlled trial offering a preventive health check to 30- to -49-year-olds in a Danish municipality from 2012 to 2017 (n = 26,216). During 2015-2016, 4356 citizens aged 30-49 years will be randomized into two groups. The intervention group receives an invitation which highlights the value and contents of spirometry as part of a health check and information about lung diseases. The comparison group receives a standard invitation containing practical information and specifies the contents of the general health check. Outcomes are (1) differences in attendance rates measured by the proportion of citizens attending each of the two study groups and (2) proportion of persons at risk defined by smoking status and self-reported lung symptoms in the study groups. The proportion of participants with abnormal spirometry assessed at the preventive health check will be compared between the two study groups. The results from the present study will inform future recruitment strategies to health checks. The developed material on content, value, and information about lung disease is feasible and transferable to other populations, making it easy to implement if effective. ClinicalTrials.gov: NCT

  2. The CAP study, evaluation of integrated universal and selective prevention strategies for youth alcohol misuse: study protocol of a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Newton Nicola C

    2012-08-01

    Full Text Available Abstract Background Alcohol misuse amongst young people is a serious concern. The need for effective prevention is clear, yet there appear to be few evidenced-based programs that prevent alcohol misuse and none that target both high and low-risk youth. The CAP study addresses this gap by evaluating the efficacy of an integrated approach to alcohol misuse prevention, which combines the effective universal internet-based Climate Schools program with the effective selective personality-targeted Preventure program. This article describes the development and protocol of the CAP study which aims to prevent alcohol misuse and related harms in Australian adolescents. Methods/Design A cluster randomized controlled trial (RCT is being conducted with Year 8 students aged 13 to 14-years-old from 27 secondary schools in New South Wales and Victoria, Australia. Blocked randomisation was used to assign schools to one of four groups; Climate Schools only, Preventure only, CAP (Climate Schools and Preventure, or Control (alcohol, drug and health education as usual. The primary outcomes of the trial will be the uptake and harmful use of alcohol and alcohol related harms. Secondary outcomes will include alcohol and cannabis related knowledge, cannabis related harms, intentions to use, and mental health symptomatology. All participants will complete assessments on five occasions; baseline; immediately post intervention, and at 12, 24 and 36 months post baseline. Discussion This study protocol presents the design and current implementation of a cluster RCT to evaluate the efficacy of the CAP study; an integrated universal and selective approach to prevent alcohol use and related harms among adolescents. Compared to students who receive the stand-alone universal Climate Schools program or alcohol and drug education as usual (Controls, we expect the students who receive the CAP intervention to have significantly less uptake of alcohol use, a reduction in average

  3. Protocol for a randomised controlled trial investigating the effectiveness of an online e health application for the prevention of Generalised Anxiety Disorder

    Directory of Open Access Journals (Sweden)

    Kenardy Justin

    2010-03-01

    Full Text Available Abstract Background Generalised Anxiety Disorder (GAD is a highly prevalent psychiatric disorder. Effective prevention in young adulthood has the potential to reduce the prevalence of the disorder, to reduce disability and lower the costs of the disorder to the community. The present trial (the WebGAD trial aims to evaluate the effectiveness of an evidence-based online prevention website for GAD. Methods/Design The principal clinical question under investigation is the effectiveness of an online GAD intervention (E-couch using a community-based sample. We examine whether the effect of the intervention can be maximised by either human support, in the form of telephone calls, or by automated support through emails. The primary outcome will be a reduction in symptoms on the GAD-7 in the active arms relative to the non active intervention arms. Discussion The WebGAD trial will be the first to evaluate the use of an internet-based cognitive behavioural therapy (CBT program contrasted with a credible control condition for the prevention of GAD and the first formal RCT evaluation of a web-based program for GAD using community recruitment. In general, internet-based CBT programs have been shown to be effective for the treatment of other anxiety disorders such as Post Traumatic Stress Disorder, Social Phobia, Panic Disorder and stress in clinical trials; however there is no evidence for the use of internet CBT in the prevention of GAD. Given the severe shortage of therapists identified in Australia and overseas, and the low rates of treatment seeking in those with a mental illness, the successful implementation of this protocol has important practical outcomes. If found to be effective, WebGAD will provide those experiencing GAD with an easily accessible, free, evidence-based prevention tool which can be promoted and disseminated immediately. Trial Registration Controlled-trials.com: ISRCTN76298775

  4. Randomised controlled trial of a secondary prevention program for myocardial infarction patients ('ProActive Heart': study protocol. Secondary prevention program for myocardial infarction patients

    Directory of Open Access Journals (Sweden)

    Taylor C Barr

    2009-05-01

    Full Text Available Abstract Background Coronary heart disease (CHD is a significant cause of health and economic burden. Secondary prevention programs play a pivotal role in the treatment and management of those affected by CHD although participation rates are poor due to patient, provider, health system and societal-level barriers. As such, there is a need to develop innovative secondary prevention programs to address the treatment gap. Telephone-delivered care is convenient, flexible and has been shown to improve behavioural and clinical outcomes following myocardial infarction (MI. This paper presents the design of a randomised controlled trial to evaluate the efficacy of a six-month telephone-delivered secondary prevention program for MI patients (ProActive Heart. Methods 550 adult MI patients have been recruited over a 14 month period (December 2007 to January 2009 through two Brisbane metropolitan hospitals, and randomised to an intervention or control group (n = 225 per group. The intervention commences within two weeks of hospital discharge delivered by study-trained health professionals ('health coaches' during up to 10 × 30 minute scripted telephone health coaching sessions. Participants also receive a ProActive Heart handbook and an educational resource to use during the health coaching sessions. The intervention focuses on appropriate modification of CHD risk factors, compliance with pharmacological management, and management of psychosocial issues. Data collection occurs at baseline or prior to commencement of the intervention (Time 1, six months follow-up or the completion of the intervention (Time 2, and at 12 months follow-up for longer term outcomes (Time 3. Primary outcome measures include quality of life (Short Form-36 and physical activity (Active Australia Survey. A cost-effective analysis of the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the

  5. DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial ? study protocol

    OpenAIRE

    Jelsma, Judith GM; van Poppel, Mireille NM; Galjaard, Sander; Desoye, Gernot; Corcoy, Rosa; Devlieger, Roland; van Assche, Andre; Timmerman, Dirk; Jans, Goele; Harreiter, Jurgen; Kautzky-Willer, Alexandra; Damm, Peter; Mathiesen, Elisabeth R; Jensen, Dorte M; Andersen, Liselotte

    2013-01-01

    Background Gestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women. Methods/design Pregnant women at risk of GDM (BMI?29 (kg/m2)) from 9 European countries will be invited to participate and consent obtained before 19+6 weeks of gestation. After giving informed consent, women without GDM will be included (based on IADPSG criteria: fasting glucose

  6. 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.

  7. Interventions for Preventing Childhood Obesity with Smartphones and Wearable Device: A Protocol for a Non-Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hye Jung Yang

    2017-02-01

    Full Text Available Background: Childhood obesity is a critical health issue, both currently and for the foreseeable future. To prevent obesity, behavior changes are essential. Smartphones can be a good tool, as the number of child smartphone users is rapidly increasing. We have developed a mobile platform system named “HAPPY ME,” which is a smartphone application coupled with a wearable device, designed to improve healthy behaviors to prevent childhood obesity. This study aimed to evaluate the effectiveness of obesity prevention among children 10–12 years of age using HAPPY ME. Methods: A total of 1000 participants, all fifth and sixth graders from four schools, were assigned to either control or intervention groups by school. Students in the intervention group used HAPPY ME. The study comprises a safety test, a 12-week efficacy test, and a six-month follow-up test to determine the long-term effects of preventive intervention via the integrated service platform. The integrated service platform aims to facilitate child-parent-school participation, involving the child-parent mobile application, a child-teacher mobile web, and a school website. Primary outcome measures are behavioral changes, including healthy eating, increased physical activity, and fitness. Secondary outcome measures are changes in anthropometric parameters (body weight, height, body mass index z-score, and waist circumference, body mass index (BMI percentiles (obesity rate, and psychological perceptions among participants. Conclusions: The results of this study will offer evidence of the effectiveness of a mobile platform service with a multi-component intervention program based on a comprehensive approach.

  8. Obesity and eating disorders in integrative prevention programmes for adolescents: protocol for a systematic review and meta-analysis.

    Science.gov (United States)

    Leme, Ana Carolina Barco; Thompson, Debbe; Lenz Dunker, Karin Louise; Nicklas, Theresa; Tucunduva Philippi, Sonia; Lopez, Tabbetha; Vézina-Im, Lydi-Anne; Baranowski, Tom

    2018-04-19

    Obesity and eating disorders are public health problems that have lifelong financial and personal costs and common risk factors, for example, body dissatisfaction, weight teasing and disordered eating. Obesity prevention interventions might lead to the development of an eating disorder since focusing on weight may contribute to excessive concern with diet and weight. Therefore, the proposed research will assess whether integrating obesity and eating disorder prevention procedures ('integrated approach') do better than single approach interventions in preventing obesity among adolescents, and if integrated approaches influence weight-related outcomes. Integrated obesity and eating disorder prevention interventions will be identified. Randomised controlled trials and quasi-experimental trials reporting data on adolescents ranging from 10 to 19 years of age from both sexes will be included. Outcomes of interest include body composition, unhealthy weight control behaviours and body satisfaction measurements. MEDLINE/PubMed, PsycINFO, Web of Science and SciELO will be searched. Data will be extracted independently by two reviewers using a standardised data extraction form. Trial quality will be assessed using the Cochrane Collaboration criteria. The effects of integrated versus single approach intervention studies will be compared using systematic review procedures. If an adequate number of studies report data on integrated interventions among similar populations (k>5), a meta-analysis with random effects will be conducted. Sensitivity analyses and meta-regression will be performed only if between-study heterogeneity is high (I 2 ≥75%). Ethics approval will not be required as this is a systematic review of published studies. The findings will be disseminated through conference presentations and peer-reviewed journals. © 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

  9. Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Giovancarli, Camille; Malbos, Eric; Baumstarck, Karine; Parola, Nathalie; Pélissier, Marie-Florence; Lançon, Christophe; Auquier, Pascal; Boyer, Laurent

    2016-02-19

    Successful interventions have been developed for smoking cessation, but the success of smoking relapse prevention interventions has been limited. In particular, cognitive behavioural therapy (CBT) has been hampered by a high relapse rate. Because relapses can be due to the presence of conditions associated with tobacco consumption (such as drinking in bars with friends), virtual reality exposure therapy (VRET) can generate synthetic environments that represent risk situations for the patient in the context of relapse prevention. The primary objective of this study is to evaluate the effectiveness of CBT coupled with VRET, in comparison to CBT alone, in the prevention of smoking relapse. The secondary objectives are to assess the impact of CBT coupled with VRET on anxiety, depression, quality of life, self-esteem and addictive comorbidities (such as alcohol, cannabis, and gambling). A third objective examines the feasibility and acceptability of VR use considering elements such as presence, cybersickness and number of patients who complete the VRET program. The present study is a 14-month (2 months of therapy followed by 12 months of follow-up), prospective, comparative, randomized and open clinical trial, involving two parallel groups (CBT coupled with VRET versus CBT alone). The primary outcome is the proportion of individuals with tobacco abstinence at 6 months after the end of the therapy. Abstinence is defined by the total absence of tobacco consumption assessed during a post-test interview and with an apparatus that measures the carbon monoxide levels expired. A total of 60 individuals per group will be included. This study is the first to examine the efficacy of CBT coupled with VRET in the prevention of smoking relapse. Because VRET is simple to use and has a low cost, this interactive therapeutic method might be easily implemented in clinical practice if the study confirms its efficacy. ClinicalTrials.gov Identifier: NCT02205060 (registered 25 July 2014).

  10. Interventions for the prevention of cardiovascular diseases: a protocol for a systematic review of economic evaluations in low-income and middle-income countries.

    Science.gov (United States)

    Aminde, Leopold Ndemnge; Veerman, Lennert

    2016-12-21

    Low-income and middle-income countries (LMICs) are experiencing a growing disease burden due to cardiovascular and other chronic non-communicable diseases. Interventions for the control of these diseases are paramount; however, these countries are faced with competing health and financial needs. There is an urgent need for quality evidence on cost-effective strategies to address these chronic diseases. We aim to synthesise the current literature on economic evaluations of interventions for primary and secondary cardiovascular disease prevention in LMICs. A systematic review of studies (published and unpublished) in LMICs up to 30 October 2016 will be conducted. The following databases will be searched: PubMed/MEDLINE, EMBASE, SCOPUS, CINAHL, Web of Science, EconLit, NHS Economic Evaluations Database (NHS EED). Data sources specific to African literature, such as the WHO AFROLIB, Africa Index Medicus and African Journals online (AJOL) as well as grey literature, will also be searched. 2 reviewers shall independently screen potential articles for inclusion and disagreements shall be resolved by consensus. Quality appraisal of studies shall be done using Drummond's checklist for economic evaluation of studies. A descriptive synthesis of the evidence obtained is planned. The primary outcomes will be costs per life years gained or unit of clinical outcome, cost per quality-adjusted life years or disability-adjusted life years. This systematic review protocol has been prepared according to the Preferred Reporting Items for Systematic reviews and Meta-analyses for Protocols (PRISMA-P) 2015 statement. Ethics approval is not required considering that this is a protocol for a systematic review of published studies. Results from this review will be disseminated via conference presentations and peer-reviewed journal publications. CRD42016043510. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  11. Translational study of obesity management using the Diabetes Prevention Program "Group Lifestyle Balance" in primary care clinics and public hospitals from Mexico: study protocol

    Directory of Open Access Journals (Sweden)

    Rolando Giovanni Díaz-Zavala

    2017-12-01

    Full Text Available Introduction: Obesity is the main modifiable risk factor for the development of chronic diseases in Mexico. Several randomized controlled trials have shown that intensive lifestyle programs are efficacious for the management of obesity. These programs include frequent sessions (14 or more contacts in the first 6 months focused on diet and physical activity and use a behavior change protocol. However, most Mexican primary care clinics and public hospitals apply traditional treatments for obesity management with limited results on weight loss. The purpose of the study is to evaluate the effectiveness of the Diabetes Prevention Program (DPP “Group Lifestyle Balance” for weight loss among adults with overweight and obesity from baseline to 6 months and from baseline to 12 months in primary care clinics and public hospitals from Sonora, Mexico. Material and Methods: This is a translational, multi-center, non-controlled, 6 and 12-month follow-up clinical study with a pre-test and post-test design. Healthcare providers from two primary care clinics, two hospitals and one university clinic will be trained with the DPP protocol to implement on their patients with overweight and obesity. Body weight, body mass index, waist circumference, systolic and diastolic blood pressure, depression, quality of life and stress scales will be measured in participants receiving the program at baseline, 6 and 12 months. Biochemical parameters will be measured at baseline and 12 months. The primary outcome is the change in body weight at 6 and 12 months. Discussion: This study will provide scientific evidence of the effectiveness of the DPP protocol as a model for obesity management in real world clinical practice among the adult Mexican population.

  12. Prevention

    DEFF Research Database (Denmark)

    Halken, S; Høst, A

    2001-01-01

    , breastfeeding should be encouraged for 4-6 months. In high-risk infants a documented extensively hydrolysed formula is recommended if exclusive breastfeeding is not possible for the first 4 months of life. There is no evidence for preventive dietary intervention neither during pregnancy nor lactation...... populations. These theories remain to be documented in proper, controlled and prospective studies. Breastfeeding and the late introduction of solid foods (>4 months) is associated with a reduced risk of food allergy, atopic dermatitis, and recurrent wheezing and asthma in early childhood. In all infants....... Preventive dietary restrictions after the age of 4-6 months are not scientifically documented....

  13. 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

  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. Healthy School, Happy School: Design and Protocol for a Randomized Clinical Trial Designed to Prevent Weight Gain in Children

    Directory of Open Access Journals (Sweden)

    Daniela Schneid Schuh

    Full Text Available Abstract Background: Schools have become a key figure for the promotion of health and obesity interventions, bringing the development of critical awareness to the construction and promotion of a healthy diet, physical activity, and the monitoring of the nutritional status in childhood and adolescence. Objectives: To describe a study protocol to evaluate the effectiveness of an intervention designed to improve knowledge of food choices in the school environment. Methods: This is a cluster-randomized, parallel, two-arm study conducted in public elementary and middle schools in Brazil. Participants will be children and adolescents between the ages of 5 and 15 years, from both genders. The interventions will be focusing on changes in lifestyle, physical activities and nutritional education. Intervention activities will occur monthly in the school’s multimedia room or sports court. The control group arm will receive usual recommendations by the school. The primary outcome variable will be anthropometric measures, such as body mass index percentiles and levels of physical activity by the International Physical Activity Questionnaire. Results: We expect that after the study children will increase the ingestion of fresh food, reduce excessive consumption of sugary and processed foods, and reduce the hours of sedentary activities. Conclusion: The purpose of starting the dietary intervention at this stage of life is to develop a knowledge that will enable for healthy choices, providing opportunities for a better future for this population.

  16. Assessing a risk tailored intervention to prevent disabling low back pain - protocol of a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marnitz Ulf

    2010-01-01

    Full Text Available Abstract Background Although most patients with low back pain (LBP recover within a few weeks a significant proportion has recurrent episodes or will develop chronic low back pain. Several mainly psychosocial risk factors for developing chronic LBP have been identified. However, effects of preventive interventions aiming at behavioural risk factors and unfavourable cognitions have yielded inconsistent results. Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking. Methods/Design This study will be a cluster-randomised controlled trial comparing screening and a subsequent risk tailored intervention for patients with low back pain to prevent chronic low back pain compared to treatment as usual in primary care. A total of 600 patients from 20 practices in each study arm will be recruited in Berlin and Goettingen. The intervention comprises the following elements: Patients will be assigned to one of four risk groups based on a screening questionnaire. Subsequently they receive an educational intervention including information and counselling tailored to the risk group. A telephone/email consulting service for back pain related problems are offered independent of risk group assignment. The primary outcomes will be functional capacity and sick leave. Discussion This trial will evaluate the effectiveness of screening for risk factors for chronic low back pain followed by a risk tailored intervention to prevent chronic low back pain. This trial will contribute new evidence regarding the flexible use of individual physical and psychosocial risk factors in general practice. Trial registration ISRCTN 68205910

  17. Protocol for a scoping review of existing policies on the prevention and control of obesity across countries in Africa.

    Science.gov (United States)

    Adom, Theodosia; Puoane, Thandi; De Villiers, Anniza; Kengne, André Pascal

    2017-02-22

    The obesity epidemic is a public health challenge for all, including low-income countries. The behavioural patterns known to contribute to the rise in obesity prevalence occur in an environmental context which is not conducive for healthy choices. A policy approach to obesity prevention constitutes a form of public intervention in that it extends beyond individuals to influence entire populations and is a mechanism for creating healthier environments. Little is known about obesity prevention policies in Africa. This scoping review seeks to examine the nature, extent and range of policies covering obesity prevention in Africa in order to assess how they align with international efforts in creating less obesogenic environments. This will help identify gaps in the approaches that are adopted in Africa. Using the Arksey and O'Malley's scoping methodological framework as a guide, a comprehensive search of MEDLINE (PubMed), MEDLINE (EbscoHost) CINAHL (EbscoHost), Academic Search Complete (EbscoHost) and ISI Web of Science (Science Citation Index) databases will be carried out for peer reviewed journal articles related to obesity prevention policies using the African search filter. A grey literature search for policy documents and reports will also be conducted. There will be no language and date restrictions. Eligible policy documents and reports will be obtained and screened using the inclusion criteria. Data will be extracted and results analysed using descriptive numerical summary analysis and qualitative thematic analysis. No primary data will be collected since all data that will be presented in this review are based on published articles and publicly available documents, and therefore ethics committee approval is not a requirement. The findings of this systematic review will be presented at workshops and conferences; and will be submitted for publication in peer-reviewed journal. This will also form a chapter of a PhD thesis. Published by the BMJ Publishing Group

  18. A mixed methods protocol for developing and testing implementation strategies for evidence-based obesity prevention in childcare: a cluster randomized hybrid type III trial.

    Science.gov (United States)

    Swindle, Taren; Johnson, Susan L; Whiteside-Mansell, Leanne; Curran, Geoffrey M

    2017-07-18

    Despite the potential to reach at-risk children in childcare, there is a significant gap between current practices and evidence-based obesity prevention in this setting. There are few investigations of the impact of implementation strategies on the uptake of evidence-based practices (EBPs) for obesity prevention and nutrition promotion. This study protocol describes a three-phase approach to developing and testing implementation strategies to support uptake of EBPs for obesity prevention practices in childcare (i.e., key components of the WISE intervention). Informed by the i-PARIHS framework, we will use a stakeholder-driven evidence-based quality improvement (EBQI) process to apply information gathered in qualitative interviews on barriers and facilitators to practice to inform the design of implementation strategies. Then, a Hybrid Type III cluster randomized trial will compare a basic implementation strategy (i.e., intervention as usual) with an enhanced implementation strategy informed by stakeholders. All Head Start centers (N = 12) within one agency in an urban area in a southern state in the USA will be randomized to receive the basic or enhanced implementation with approximately 20 classrooms per group (40 educators, 400 children per group). The educators involved in the study, the data collectors, and the biostastician will be blinded to the study condition. The basic and enhanced implementation strategies will be compared on outcomes specified by the RE-AIM model (e.g., Reach to families, Effectiveness of impact on child diet and health indicators, Adoption commitment of agency, Implementation fidelity and acceptability, and Maintenance after 6 months). Principles of formative evaluation will be used throughout the hybrid trial. This study will test a stakeholder-driven approach to improve implementation, fidelity, and maintenance of EBPs for obesity prevention in childcare. Further, this study provides an example of a systematic process to develop

  19. Can social dancing prevent falls in older adults? a protocol of the Dance, Aging, Cognition, Economics (DAnCE) fall prevention randomised controlled trial.

    Science.gov (United States)

    Merom, Dafna; Cumming, Robert; Mathieu, Erin; Anstey, Kaarin J; Rissel, Chris; Simpson, Judy M; Morton, Rachael L; Cerin, Ester; Sherrington, Catherine; Lord, Stephen R

    2013-05-15

    Falls are one of the most common health problems among older people and pose a major economic burden on health care systems. Exercise is an accepted stand-alone fall prevention strategy particularly if it is balance training or regular participation in Tai chi. Dance shares the 'holistic' approach of practices such as Tai chi. It is a complex sensorimotor rhythmic activity integrating multiple physical, cognitive and social elements. Small-scale randomised controlled trials have indicated that diverse dance styles can improve measures of balance and mobility in older people, but none of these studies has examined the effect of dance on falls or cognition. This study aims to determine whether participation in social dancing: i) reduces the number of falls; and ii) improves cognitive functions associated with fall risk in older people. A single-blind, cluster randomised controlled trial of 12 months duration will be conducted. Approximately 450 participants will be recruited from 24 self-care retirement villages that house at least 60 residents each in Sydney, Australia. Village residents without cognitive impairment and obtain medical clearance will be eligible. After comprehensive baseline measurements including physiological and cognitive tests and self-completed questionnaires, villages will be randomised to intervention sites (ballroom or folk dance) or to a wait-listed control using a computer randomisation method that minimises imbalances between villages based on two baseline fall risk measures. Main outcome measures are falls, prospectively measured, and the Trail Making cognitive function test. Cost-effectiveness and cost-utility analyses will be performed. This study offers a novel approach to balance training for older people. As a community-based approach to fall prevention, dance offers older people an opportunity for greater social engagement, thereby making a major contribution to healthy ageing. Providing diversity in exercise programs targeting

  20. Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Lazo-Porras, Maria; Bernabe-Ortiz, Antonio; Sacksteder, Katherine A; Gilman, Robert H; Malaga, German; Armstrong, David G; Miranda, J Jaime

    2016-04-19

    Diabetic foot neuropathy (DFN) is one of the most important complications of diabetes mellitus; its early diagnosis and intervention can prevent foot ulcers and the need for amputation. Thermometry, measuring the temperature of the feet, is a promising emerging modality for diabetic foot ulcer prevention. However, patient compliance with at-home monitoring is concerning. Delivering messages to remind patients to perform thermometry and foot care might be helpful to guarantee regular foot monitoring. This trial was designed to compare the incidence of diabetic foot ulcers (DFUs) between participants who receive thermometry alone and those who receive thermometry as well as mHealth (SMS and voice messaging) over a year-long study period. This is an evaluator-blinded, randomized, 12-month trial. Individuals with a diagnosis of type 2 diabetes mellitus, aged between 18-80 years, having a present dorsalis pedis pulse in both feet, are in risk group 2 or 3 using the diabetic foot risk classification system (as specified by the International Working Group on the Diabetic Foot), have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent will be eligible to participate in the study. Recruitment will be performed in diabetes outpatient clinics at two Ministry of Health tertiary hospitals in Lima, Peru. participants in both groups will receive education about foot care at the beginning of the study and they will be provided with a thermometry device (TempStat™). TempStat™ is a tool that captures a thermal image of the feet, which, depending on the temperature of the feet, shows different colors. In this study, if a participant notes a single yellow image or variance between one foot and the contralateral foot, they will be prompted to notify a nurse to evaluate their activity within the previous 2 weeks and make appropriate recommendations. In addition to thermometry, participants in the intervention arm

  1. Preventing anxiety problems in children with Cool Little Kids Online: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Morgan, Amy J; Rapee, Ronald M; Tamir, Elli; Goharpey, Nahal; Salim, Agus; McLellan, Lauren F; Bayer, Jordana K

    2015-11-05

    Anxiety disorders are the most common type of mental health problem and begin early in life. Early intervention to prevent anxiety problems in young children who are at risk has the potential for long-term impact. The 'Cool Little Kids' parenting group program was previously established to prevent anxiety disorders in young children at risk because of inhibited temperament. This group program was efficacious in two randomised controlled trials and has recently been adapted into an online format. 'Cool Little Kids Online' was developed to widen and facilitate access to the group program's preventive content. A pilot evaluation of the online program demonstrated its perceived utility and acceptability among parents. This study aims to evaluate the efficacy of Cool Little Kids Online in a large randomised controlled trial. Parents of young children who are 3-6 years old and who have an inhibited temperament will be recruited (n = 385) and randomly assigned to either immediate access to Cool Little Kids Online or delayed access after a waiting period of 24 weeks. The online program contains eight modules that help parents address key issues in the development of anxiety problems in inhibited children, including children's avoidant coping styles, overprotective parenting behaviours, and parents' own fears and worries. Intervention participants will be offered clinician support when requested. The primary outcome will be change in parent-reported child anxiety symptoms. Secondary outcomes will be child internalising symptoms, child and family life interference due to anxiety, over-involved/protective parenting, plus child anxiety diagnoses assessed by using a new online diagnostic tool. Assessments will take place at baseline and 12 and 24 weeks after baseline. This trial expands upon previous research on the Cool Little Kids parenting group program and will evaluate the efficacy of online delivery. Online delivery of the program could result in an easily accessible

  2. A parenting programme to prevent abuse of adolescents in South Africa: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Cluver, Lucie; Meinck, Franziska; Shenderovich, Yulia; Ward, Catherine L; Romero, Rocio Herrero; Redfern, Alice; Lombard, Carl; Doubt, Jenny; Steinert, Janina; Catanho, Ricardo; Wittesaele, Camille; De Stone, Sachin; Salah, Nasteha; Mpimpilashe, Phelisa; Lachman, Jamie; Loening, Heidi; Gardner, Frances; Blanc, Daphnee; Nocuza, Mzuvekile; Lechowicz, Meryn

    2016-07-19

    An estimated one billion children experience child abuse each year, with the highest rates in low- and middle-income countries. The Sinovuyo Teen programme is part of Parenting for Lifelong Health, a WHO/UNICEF initiative to develop and test violence-prevention programmes for implementation in low-resource contexts. The objectives of this parenting support programme are to prevent the abuse of adolescents, improve parenting and reduce adolescent behavioural problems. This trial aims to evaluate the effectiveness of Sinovuyo Teen compared to an attention-control group of a water hygiene programme. This is a pragmatic cluster randomised controlled trial, with stratified randomisation of 37 settlements (rural and peri-urban) with 40 study clusters in the Eastern Cape of South Africa. Settlements receive either a 14-session parenting support programme or a 1-day water hygiene programme. The primary outcomes are child abuse and parenting practices, and secondary outcomes include adolescent behavioural problems, mental health and social support. Concurrent process evaluation and qualitative research are conducted. Outcomes are reported by both primary caregivers and adolescents. Brief follow-up measures are collected immediately after the intervention, and full follow-up measures collected at 3-8 months post-intervention. A 15-24-month follow-up is planned, but this will depend on the financial and practical feasibility given delays related to high levels of ongoing civil and political violence in the research sites. This is the first known trial of a parenting programme to prevent abuse of adolescents in a low- or middle-income country. The study will also examine potential mediating pathways and moderating factors. Pan-African Clinical Trials Registry PACTR201507001119966. Registered on 27 April 2015. It can be found by searching for the key word 'Sinovuyo' on their website or via the following link: http://www.pactr.org/ATMWeb/appmanager/atm

  3. Outcomes of disease prevention and management interventions in food pantries and food banks: protocol for a scoping review.

    Science.gov (United States)

    Long, Christopher R; Rowland, Brett; Steelman, Susan C; McElfish, Pearl A

    2017-10-05

    Food insecurity is a difficulty faced in many households. During periods of food insecurity, households often seek food supplied by food pantries and food banks. Food insecurity has been associated with increased risk for several health conditions. For this reason, food pantries and food banks may have great promise as intervention sites, and health researchers have begun targeting food pantries and food banks as sites for disease prevention or management interventions. The aim of the scoping review is to examine disease prevention or management interventions implemented in food pantries and food banks. Relevant electronic databases (eg, MEDLINE, Cumulative Index to Nursing and Allied Health Literature-CINAHL Complete, Science Citation Index, Cochrane Database of Systematic Reviews) will be searched for articles with a publication date of 1997 or later using Medical Subject Headings and key terms, including food aid, food banks, food pantries, food shelves, hunger, food insecurity and related concepts. For each de-duplicated study record identified by the search strategy, two reviewers will independently assess whether the study meets eligibility criteria (eg, related to intervention type, context). The reviewers will examine studies' titles, abstracts and full text, comparing eligibility decisions to address any discrepancies. For each eligible study, data extraction will be executed by two reviewers independently, comparing extracted data to address any discrepancies. Extracted data will be synthesised and reported in a narrative review assessing the coverage and gaps in existing literature related to disease prevention and management interventions implemented in food pantries. The review's results will be useful to healthcare practitioners who work with food-insecure populations, healthcare researchers and food pantry or food bank personnel. The results of this scoping review will be submitted for publication to a peer-reviewed journal, and the authors will

  4. Comparison of pharmacological and non-pharmacological interventions to prevent delirium in critically ill patients: a protocol for a systematic review incorporating network meta-analyses.

    Science.gov (United States)

    Burry, L D; Hutton, B; Guenette, M; Williamson, D; Mehta, S; Egerod, I; Kanji, S; Adhikari, N K; Moher, D; Martin, C M; Rose, L

    2016-09-08

    Delirium is characterized by acute changes in mental status including inattention, disorganized thinking, and altered level of consciousness, and is highly prevalent in critically ill adults. Delirium has adverse consequences for both patients and the healthcare system; however, at this time, no effective treatment exists. The identification of effective prevention strategies is therefore a clinical and research imperative. An important limitation of previous reviews of delirium prevention is that interventions were considered in isolation and only direct evidence was used. Our systematic review will synthesize all existing data using network meta-analysis, a powerful statistical approach that enables synthesis of both direct and indirect evidence. We will search Ovid MEDLINE, CINAHL, Embase, PsycINFO, and Web of Science from 1980 to March 2016. We will search the PROSPERO registry for protocols and the Cochrane Library for published systematic reviews. We will examine reference lists of pertinent reviews and search grey literature and the International Clinical Trials Registry Platform for unpublished studies and ongoing trials. We will include randomized and quasi-randomized trials of critically ill adults evaluating any pharmacological, non-pharmacological, or multi-component intervention for delirium prevention, administered in or prior to (i.e., peri-operatively) transfer to the ICU. Two authors will independently screen search results and extract data from eligible studies. Risk of bias assessments will be completed on all included studies. To inform our network meta-analysis, we will first conduct conventional pair-wise meta-analyses for primary and secondary outcomes using random-effects models. We will generate our network meta-analysis using a Bayesian framework, assuming a common heterogeneity parameter across all comparisons, and accounting for correlations in multi-arm studies. We will perform analyses using WinBUGS software. This systematic review

  5. Working With Parents to Prevent Childhood Obesity: Protocol for a Primary Care-Based eHealth Study.

    Science.gov (United States)

    Avis, Jillian Ls; Cave, Andrew L; Donaldson, Stephanie; Ellendt, Carol; Holt, Nicholas L; Jelinski, Susan; Martz, Patricia; Maximova, Katerina; Padwal, Raj; Wild, T Cameron; Ball, Geoff Dc

    2015-03-25

    Parents play a central role in preventing childhood obesity. There is a need for innovative, scalable, and evidence-based interventions designed to enhance parents' motivation to support and sustain healthy lifestyle behaviors in their children, which can facilitate obesity prevention. (1) Develop an online screening, brief intervention, and referral to treatment (SBIRT) eHealth tool to enhance parents' concern for, and motivation to, support children's healthy lifestyle behaviors, (2) refine the SBIRT eHealth tool by assessing end-user acceptability, satisfaction, and usability through focus groups, and (3) determine feasibility and preliminary effectiveness of the refined SBIRT eHealth tool through a randomized controlled trial. This is a three-phase, multi-method study that includes SBIRT eHealth tool development (Phase I), refinement (Phase II), and testing (Phase III). Phase I: Theoretical underpinnings of the SBIRT tool, entitled the Resource Information Program for Parents on Lifestyle and Education (RIPPLE), will be informed by concepts applied within existing interventions, and content will be based on literature regarding healthy lifestyle behaviors in children. The SBIRT platform will be developed in partnership between our research team and a third-party intervention development company. Phase II: Focus groups with parents, as well as health care professionals, researchers, and trainees in pediatrics (n=30), will explore intervention-related perceptions and preferences. Qualitative data from the focus groups will inform refinements to the aesthetics, content, structure, and function of the SBIRT. Phase III: Parents (n=200) of children-boys and girls, 5 to 17 years old-will be recruited from a primary care pediatric clinic while they await their children's clinical appointment. Parents will be randomly assigned to one of five groups-four intervention groups and one control group-as they complete the SBIRT. The randomization function is built into the

  6. The PAV trial: Does lactobacillus prevent post-antibiotic vulvovaginal candidiasis? Protocol of a randomised controlled trial [ISRCTN24141277

    Directory of Open Access Journals (Sweden)

    Hurley Susan

    2004-03-01

    Full Text Available Abstract Background Complementary and alternative medicines are used by many consumers, and increasingly are being incorporated into the general practitioner's armamentarium. Despite widespread usage, the evidence base for most complementary therapies is weak or non-existent. Post-antibiotic vulvovaginitis is a common problem in general practice, for which complementary therapies are often used. A recent study in Melbourne, Australia, found that 40% of women with a past history of vulvovaginitis had used probiotic Lactobacillus species to prevent or treat post-antibiotic vulvovaginitis. There is no evidence that this therapy is effective. This study aims to test whether oral or vaginal lactobacillus is effective in the prevention of post-antibiotic vulvovaginitis. Methods/design A randomised placebo-controlled blinded 2 × 2 factorial design is being used. General practitioners or pharmacists approach non-pregnant women, aged 18–50 years, who present with a non-genital infection requiring a short course of oral antibiotics, to participate in the study. Participants are randomised in a four group factorial design either to oral lactobacillus powder or placebo and either vaginal lactobacillus pessaries or placebo. These interventions are taken while on antibiotics and for four days afterwards or until symptoms of vaginitis develop. Women self collect a vaginal swab for culture of Candida species and complete a survey at baseline and again four days after completing their study medications. The sample size (a total of 496 – 124 in each factorial group is calculated to identify a reduction of half in post-antibiotic vulvovaginitis from 23%, while allowing for a 25% drop-out. An independent Data Monitoring Committee is supervising the trial. Analysis will be intention-to-treat, with two pre-specified main comparisons: (i oral lactobacillus versus placebo and (ii vaginal lactobacillus versus placebo.

  7. A novel six consecutive monthly doses of palivizumab prophylaxis protocol for the prevention of respiratory syncytial virus infection in high-risk preterm infants in Taiwan.

    Directory of Open Access Journals (Sweden)

    Hsin Chi

    Full Text Available Respiratory syncytial virus (RSV circulates year round in Taiwan. A novel six consecutive monthly doses of palivizumab for RSV prevention protocol has been approved for high risk preterm infants since December 2010. This study aimed to determine the clinical effectiveness and safety of this novel protocol for the prevention of RSV infection.From April 2011 to March 2013, we enrolled infants born at ≤28 weeks gestation and infants born at ≤35 weeks gestation with chronic lung disease (CLD who received palivizumab prophylaxis as study group and followed up for 12 months. Historic control, those who were born and followed up between July 2000 and June 2008, were retrieved for propensity score matching. Primary endpoint was RSV-related hospitalization, and secondary endpoints included the length of hospital stay and intensive care unit (ICU care.We enrolled 127 infants (108 infants born at ≤28 weeks and 19 infants born at 29-35 weeks with CLD. They completed 6-dose palivizumab as scheduled. Among the study group, the RSV-related hospitalizations were 2 (1.6% within 6 months and 5 (3.9% within 12 months after discharge. We matched 127 infants in the control group with 127 infants in the study group by propensity score matching. The reduction of RSV-related hospitalization rates were 86% (10.2% vs 1.6%, p = 0.002 within 6 months after discharge and 78% (15.7% vs 3.9%, p = 0.004 within 12 months after discharge. Compared to the control group, the rate of ICU care significantly decreased from 7.1% to 0.8% (p = 0.024 within 6 months after discharge and from 7.9% to 0.8% (p = 0.014 within 12 months after discharge. Adverse events were recorded in 6.4% injections.Six monthly intramuscular administration of palivizumab is effective for prevention of RSV hospitalization in regions with no single seasonal peak of RSV infection such as Taiwan.

  8. High-Yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya (GIRLS Study): Implementation Science Protocol for a Priority Population.

    Science.gov (United States)

    Inwani, Irene; Chhun, Nok; Agot, Kawango; Cleland, Charles M; Buttolph, Jasmine; Thirumurthy, Harsha; Kurth, Ann E

    2017-12-13

    Sub-Saharan Africa is the region with the highest HIV burden. Adolescent girls and young women (AGYW) in the age range of 15 to 24 years are twice as likely as their male peers to be infected, making females in sub-Saharan Africa the most at-risk group for HIV infection. It is therefore critical to prioritize access to HIV testing, prevention, and treatment for this vulnerable population. Using an implementation science framework, the purpose of this research protocol was to describe the approaches we propose to optimize engagement of AGYW in both the HIV prevention and care continuum and to determine the recruitment and testing strategies that identify the highest proportion of previously undiagnosed HIV infections. We will compare two seek recruitment strategies, three test strategies, and pilot adaptive linkage to care interventions (sequential multiple assignment randomized trial [SMART] design) among AGYW in the age range of 15 to 24 years in Homa Bay County, western Kenya. AGYW will be recruited in the home or community-based setting and offered three testing options: oral fluid HIV self-testing, staff-aided rapid HIV testing, or referral to a health care facility for standard HIV testing services. Newly diagnosed AGYW with HIV will be enrolled in the SMART trial pilot to determine the most effective way to support initial linkage to care after a positive diagnosis. They will be randomized to standard referral (counseling and a referral note) or standard referral plus SMS text message (short message service, SMS); those not linked to care within 2 weeks will be rerandomized to receive an additional SMS text message or a one-time financial incentive (approximately US $4). We will also evaluate a primary prevention messaging intervention to support identified high-risk HIV-negative AGYW to reduce their HIV risk and adhere to HIV retesting recommendations. We will also conduct analyses to determine the incremental cost-effectiveness of the seek, testing and

  9. Toward optimal implementation of cancer prevention and control programs in public health: a study protocol on mis-implementation.

    Science.gov (United States)

    Padek, Margaret; Allen, Peg; Erwin, Paul C; Franco, Melissa; Hammond, Ross A; Heuberger, Benjamin; Kasman, Matt; Luke, Doug A; Mazzucca, Stephanie; Moreland-Russell, Sarah; Brownson, Ross C

    2018-03-23

    Much of the cancer burden in the USA is preventable, through application of existing knowledge. State-level funders and public health practitioners are in ideal positions to affect programs and policies related to cancer control. Mis-implementation refers to ending effective programs and policies prematurely or continuing ineffective ones. Greater attention to mis-implementation should lead to use of effective interventions and more efficient expenditure of resources, which in the long term, will lead to more positive cancer outcomes. This is a three-phase study that takes a comprehensive approach, leading to the elucidation of tactics for addressing mis-implementation. Phase 1: We assess the extent to which mis-implementation is occurring among state cancer control programs in public health. This initial phase will involve a survey of 800 practitioners representing all states. The programs represented will span the full continuum of cancer control, from primary prevention to survivorship. Phase 2: Using data from phase 1 to identify organizations in which mis-implementation is particularly high or low, the team will conduct eight comparative case studies to get a richer understanding of mis-implementation and to understand contextual differences. These case studies will highlight lessons learned about mis-implementation and identify hypothesized drivers. Phase 3: Agent-based modeling will be used to identify dynamic interactions between individual capacity, organizational capacity, use of evidence, funding, and external factors driving mis-implementation. The team will then translate and disseminate findings from phases 1 to 3 to practitioners and practice-related stakeholders to support the reduction of mis-implementation. This study is innovative and significant because it will (1) be the first to refine and further develop reliable and valid measures of mis-implementation of public health programs; (2) bring together a strong, transdisciplinary team with

  10. Prevention of ICU delirium and delirium-related outcome with haloperidol: a study protocol for a multicenter randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Delirium is a frequent disorder in intensive care unit (ICU) patients with serious consequences. Therefore, preventive treatment for delirium may be beneficial. Worldwide, haloperidol is the first choice for pharmacological treatment of delirious patients. In daily clinical practice, a lower dose is sometimes used as prophylaxis. Some studies have shown the beneficial effects of prophylactic haloperidol on delirium incidence as well as on mortality, but evidence for effectiveness in ICU patients is limited. The primary objective of our study is to determine the effect of haloperidol prophylaxis on 28-day survival. Secondary objectives include the incidence of delirium and delirium-related outcome and the side effects of haloperidol prophylaxis. Methods This will be a multicenter three-armed randomized, double-blind, placebo-controlled, prophylactic intervention study in critically ill patients. We will include consecutive non-neurological ICU patients, aged ≥18 years with an expected ICU length of stay >1 day. To be able to demonstrate a 15% increase in 28-day survival time with a power of 80% and alpha of 0.05 in both intervention groups, a total of 2,145 patients will be randomized; 715 in each group. The anticipated mortality rate in the placebo group is 12%. The intervention groups will receive prophylactic treatment with intravenous haloperidol 1 mg/q8h or 2 mg/q8h, and patients in the control group will receive placebo (sodium chloride 0.9%), both for a maximum period of 28-days. In patients who develop delirium, study medication will be stopped and patients will subsequently receive open label treatment with a higher (therapeutic) dose of haloperidol. We will use descriptive summary statistics as well as Cox proportional hazard regression analyses, adjusted for covariates. Discussion This will be the first large-scale multicenter randomized controlled prevention study with haloperidol in ICU patients with a high risk of delirium, adequately

  11. Art therapy and music reminiscence activity in the prevention of cognitive decline: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mahendran, Rathi; Rawtaer, Iris; Fam, Johnson; Wong, Jonathan; Kumar, Alan Prem; Gandhi, Mihir; Jing, Kenny Xu; Feng, Lei; Kua, Ee Heok

    2017-07-12

    Attention has shifted to the use of non-pharmacological interventions to prevent cognitive decline as a preventive strategy, as well as for those at risk and those with mild cognitive impairment. Early introduction of psycho-social interventions can address cognitive decline and significantly impact quality of life and the wellbeing of elderly individuals. This pilot study explores the feasibility of using art therapy and music reminiscence activity to improve the cognition of community living elderly with mild cognitive impairment. This open-label, interventional study involves a parallel randomized controlled trial design with three arms (two intervention arms and a control group) over a nine-month period. Participants will be community-living elderly individuals aged 60-85 years, both genders, who meet predefined inclusion and exclusion criteria. In the initial three months, interventions will be provided weekly and for the remaining six months fortnightly. A sample size of 90 participants is targeted based on expected neuropsychological test performance, a primary outcome measure, and drop-out rates. The randomization procedure will be carried out via a web-based randomization system. Interventions will be provided by trained staff with a control group not receiving any intervention but continuing life as usual. Assessments will be done at baseline, three months, and nine months, and include neuroimaging to measure cerebral changes and neuropsychological tests to measure for changes in cognition. Secondary outcome measures will include mood changes in anxiety and depression and telomere lengths. Statistical analysis will be undertaken by statisticians; all efficacy analysis will be carried out on an intention-to-treat basis. Primary and secondary outcomes will be modeled using the linear mixed model for repeated measurements and further analysis may be undertaken to adjust for potential confounders. This will be the first study to compare the effectiveness of

  12. Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dregan Alex

    2012-10-01

    Full Text Available Abstract Background The purpose of this research is to develop and evaluate methods for conducting pragmatic cluster randomized trials in a primary care electronic database. The proposal describes one application, in a less frequent chronic condition of public health importance, secondary prevention of stroke. A related protocol in antibiotic prescribing was reported previously. Methods/Design The study aims to implement a cluster randomized trial (CRT using the electronic patient records of the General Practice Research Database (GPRD as a sampling frame and data source. The specific objective of the trial is to evaluate the effectiveness of a computer-delivered intervention at enhancing the delivery of stroke secondary prevention in primary care. GPRD family practices will be allocated to the intervention or usual care. The intervention promotes the use of electronic prompts to support adherence with the recommendations of the UK Intercollegiate Stroke Working Party and NICE guidelines for the secondary prevention of stroke in primary care. Primary outcome measure will be the difference in systolic blood pressure between intervention and control trial arms at 12-month follow-up. Secondary outcomes will be differences in serum cholesterol, prescribing of antihypertensive drugs, statins, and antiplatelet therapy. The intervention will continue for 12 months. Information on the utilization of the decision-support tools will also be analyzed. Discussion The CRT will investigate the effectiveness of using a computer-delivered intervention to reduce the risk of stroke recurrence following a first stroke event. The study will provide methodological guidance on the implementation of CRTs in electronic databases in primary care. Trial registration Current Controlled Trials ISRCTN35701810

  13. Prevention of Alcohol-Related Crime and Trauma (PACT: brief interventions in routine care pathway – a study protocol

    Directory of Open Access Journals (Sweden)

    Jayaraj Rama

    2013-01-01

    Full Text Available Abstract Background Globally, alcohol-related injuries cause millions of deaths and huge economic loss each year . The incidence of facial (jawbone fractures in the Northern Territory of Australia is second only to Greenland, due to a strong involvement of alcohol in its aetiology, and high levels of alcohol consumption. The highest incidences of alcohol-related trauma in the Territory are observed amongst patients in the Maxillofacial Surgery Unit of the Royal Darwin Hospital. Accordingly, this project aims to introduce screening and brief interventions into this unit, with the aims of changing health service provider practice, improving access to care, and improving patient outcomes. Methods Establishment of Project Governance: The project governance team includes a project manager, project leader, an Indigenous Reference Group (IRG and an Expert Reference Group (ERG. Development of a best practice pathway: PACT project researchers collaborate with clinical staff to develop a best practice pathway suited to the setting of the surgical unit. The pathway provides clear guidelines for screening, assessment, intervention and referral. Implementation: The developed pathway is introduced to the unit through staff training workshops and associate resources and adapted in response to staff feedback. Evaluation: File audits, post workshop questionnaires and semi-structured interviews are administered. Discussion This project allows direct transfer of research findings into clinical practice and can inform future hospital-based injury prevention strategies.

  14. Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Qian, Yang-Yang; Chen, Hui; Tang, Xin-Ying; Jiang, Xi; Qian, Wei; Zou, Wen-Bin; Xin, Lei; Li, Bo; Qi, Yan-Fen; Hu, Liang-Hao; Zou, Duo-Wu; Jin, Zhen-Dong; Wang, Dong; Du, Yi-Qi; Wang, Luo-Wei; Liu, Feng; Li, Zhao-Shen; Liao, Zhuan

    2017-11-02

    Pancreatic extracorporeal shock wave lithotripsy (P-ESWL) is the first-line therapy for large pancreatic duct stones. Although it is a highly effective and safe procedure for the fragmentation of pancreatic stones, it is still not complication-free. Just like endoscopic retrograde cholangiopancreatography (ERCP), pancreatitis is the most common complication. To date, nonsteroidal anti-inflammatory drugs (NSAIDs) have proven to be the only effective prophylactic medication for post-ERCP pancreatitis and the European, American and Japanese Society for Gastrointestinal Endoscopy guidelines have recommended prophylactic rectally administered indomethacin for all patients undergoing ERCP. Given the little research about effective prevention for post P-ESWL pancreatitis, we aim to determine whether rectally administered indomethacin can reduce post-ESWL-pancreatitis. The RIPEP study is a prospective, randomized, double-blinded, placebo-controlled trial. One thousand three hundred and seventy patients with chronic pancreatitis and pancreatic stones (>5 mm in diameter) treated with P-ESWL at Changhai Hospital will be randomly allocated to rectally administered indomethacin or placebo therapy before the procedure. The primary endpoint is the incidence of post-ESWL pancreatitis. Secondary endpoints include the severity of pancreatitis, occurrence rate of asymptomatic hyperamylasemia and other complications. The RIPEP trial is designed to show that rectally administered indomethacin reduces the development and severity of post-ESWL pancreatitis and benefits patients treated with P-ESWL. ClinicalTrials.gov, ID: NCT02797067 . Registered on 17 November 2016.

  15. Healthy School, Happy School: Design and Protocol for a Randomized Clinical Trial Designed to Prevent Weight Gain in Children.

    Science.gov (United States)

    Schuh, Daniela Schneid; Goulart, Maíra Ribas; Barbiero, Sandra Mari; Sica, Caroline D'Azevedo; Borges, Raphael; Moraes, David William; Pellanda, Lucia Campos

    2017-06-01

    Schools have become a key figure for the promotion of health and obesity interventions, bringing the development of critical awareness to the construction and promotion of a healthy diet, physical activity, and the monitoring of the nutritional status in childhood and adolescence. To describe a study protocol to evaluate the effectiveness of an intervention designed to improve knowledge of food choices in the school environment. This is a cluster-randomized, parallel, two-arm study conducted in public elementary and middle schools in Brazil. Participants will be children and adolescents between the ages of 5 and 15 years, from both genders. The interventions will be focusing on changes in lifestyle, physical activities and nutritional education. Intervention activities will occur monthly in the school's multimedia room or sports court. The control group arm will receive usual recommendations by the school. The primary outcome variable will be anthropometric measures, such as body mass index percentiles and levels of physical activity by the International Physical Activity Questionnaire. We expect that after the study children will increase the ingestion of fresh food, reduce excessive consumption of sugary and processed foods, and reduce the hours of sedentary activities. The purpose of starting the dietary intervention at this stage of life is to develop a knowledge that will enable for healthy choices, providing opportunities for a better future for this population. As escolas tornaram-se essenciais para a promoção de saúde e de intervenções para obesidade, propiciando o desenvolvimento de consciência crítica para a construção e promoção de dieta saudável, atividade física e monitoramento do status nutricional na infância e adolescência. Descrever um protocolo de estudo para avaliar a eficiência de uma intervenção projetada para aprimorar o conhecimento sobre escolhas alimentares no ambiente escolar. Estudo clínico randomizado em cluster

  16. Pre-exposure and postexposure prophylaxes and the combination HIV prevention methods (The Combine! Study): protocol for a pragmatic clinical trial at public healthcare clinics in Brazil.

    Science.gov (United States)

    Grangeiro, Alexandre; Couto, Márcia Thereza; Peres, Maria Fernanda; Luiz, Olinda; Zucchi, Eliana Miura; de Castilho, Euclides Ayres; Estevam, Denize Lotufo; Alencar, Rosa; Wolffenbüttel, Karina; Escuder, Maria Mercedes; Calazans, Gabriela; Ferraz, Dulce; Arruda, Érico; Corrêa, Maria da Gloria; Amaral, Fabiana Rezende; Santos, Juliane Cardoso Villela; Alvarez, Vivian Salles; Kietzmann, Tiago

    2015-08-25

    Few results from programmes based on combination prevention methods are available. We propose to analyse the degree of protection provided by postexposure prophylaxis (PEP) for consensual sexual activity at healthcare clinics, its compensatory effects on sexual behaviour; and the effectiveness of combination prevention methods and pre-exposure prophylaxis (PrEP), compared with exclusively using traditional methods. A total of 3200 individuals aged 16 years or older presenting for PEP at 5 sexually transmitted disease (STD)/HIV clinics in 3 regions of Brazil will be allocated to one of two groups: the PEP group-individuals who come to the clinic within 72 h after a sexual exposure and start PEP; and the non-PEP group-individuals who come after 72 h but within 30 days of exposure and do not start PEP. Clinical follow-up will be conducted initially for 6 months and comprise educational interventions based on information and counselling for using prevention methods, including PrEP. In the second study phase, individuals who remain HIV negative will be regrouped according to the reported use of prevention methods and observed for 18 months: only traditional methods; combined methods; and PrEP. Effectiveness will be analysed according to the incidence of HIV, syphilis and hepatitis B and C and protected sexual behaviour. A structured questionnaire will be administered to participants at baseline and every 6 months thereafter. Qualitative methods will be employed to provide a comprehensive understanding of PEP-seeking behaviour, preventive choices and exposure to HIV. This study will be conducted in accordance with the resolution of the School of Medicine Research Ethics Commission of Universidade de São Paulo (protocol no. 251/14). The databases will be available for specific studies, after management committee approval. Findings will be presented to researchers, health managers and civil society members by means of newspapers, electronic media and scientific journals

  17. Curative treatment for central nervous system medulloepithelioma despite residual disease after resection. Report of two cases treated according to the GPHO protocol HIT 2000 and review of the literature

    Energy Technology Data Exchange (ETDEWEB)

    Mueller, Klaus [Leipzig Univ. (Germany). Dept. of Radiotherapy and Radiooncology; Zwiener, Isabella [University Medical Center Univ. Mainz (Germany). Inst. for Medical Biostatistics, Epidemiology and Informatics; Welker, Helmut [Katharinenhospital, Stuttgart (Germany). Dept. of Radiotherapy and Radiooncology; Maass, Eberhard [Klinikum Stuttgart - Olgahospital (DE). Pediatrics 5 (Oncology, Hematology, Immunology); Bongartz, Rudolf [Koeln Univ. (Germany). Dept. of Radiotherapy and Radiooncology; Berthold, Frank [Koeln Univ. (Germany). Dept. of Pediatric Oncology; Pietsch, Torsten [Bonn Univ. Medical Center (Germany). Dept. of Neuropathology; Warmuth-Metz, Monika [Wuerzburg Univ. (Germany). Dept. of Neuroradiology; Bueren, Andre von; Rutkowski, Stefan [University Medical Center Hamburg-Eppendorf, Hamburg (Germany). Dept. of Pediatric Hematology and Oncology

    2011-11-15

    Medulloepithelioma of the central nervous system (CNS) is an uncommon primitive neuroectodermal tumor (PNET) usually occurring in early childhood. It is characterized by highly malignant behavior with a propensity for progression, recurrence, and dissemination despite intensive therapy. Due to its rarity, the optimal management is still unknown. However, gross total resection (GTR) has been considered crucial to achieve cure. In this article, the authors report on 2 cases of CNS medulloepithelioma in which long-term survival (more than 6 years) could be achieved despite evidence of, or suspected postoperative residual disease with an otherwise dismal prognosis. The patients were treated according to different strata of the protocol for primitive neuroectodermal tumors (PNET) of the German-Austrian multicenter trial of the German Society for Pediatric Oncology and Hematology (GPOH) for childhood brain tumors (HIT 2000). Treatment included postoperative hyperfractionated radiotherapy of the craniospinal axis followed by a boost to the tumor site in combination with chemotherapy. A review of the 2 reported and 37 previously published cases confirmed GTR and older age as positive prognostic factors. (orig.)

  18. Tranexamic Acid versus Placebo to Prevent Blood Transfusion during Radical Cystectomy for Bladder Cancer (TACT): Study Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Breau, Rodney H; Lavallée, Luke T; Cnossen, Sonya; Witiuk, Kelsey; Cagiannos, Ilias; Momoli, Franco; Bryson, Gregory; Kanji, Salmaan; Morash, Christopher; Turgeon, Alexis; Zarychanski, Ryan; Mallick, Ranjeeta; Knoll, Greg; Fergusson, Dean A

    2018-05-02

    Radical cystectomy for bladder cancer is associated with a high risk of needing red blood cell transfusion. Tranexamic acid reduces blood loss during cardiac and orthopedic surgery, but no study has yet evaluated tranexamic acid use during cystectomy. A randomized, double-blind (surgeon-, anesthesiologist-, patient-, data-monitor-blinded), placebo-controlled trial of tranexamic acid during cystectomy was initiated in June 2013. Prior to incision, the intervention arm participants receive a 10 mg/kg loading dose of intravenously administered tranexamic acid, followed by a 5 mg/kg/h maintenance infusion. In the control arm, the patient receives an identical volume of normal saline that is indistinguishable from the intervention. The primary outcome is any blood transfusion from the start of surgery up to 30 days post operative. There are no strict criteria to mandate the transfusion of blood products. The decision to transfuse is entirely at the discretion of the treating physicians who are blinded to patient allocation. Physicians are allowed to utilize all resources to make transfusion decisions, including serum hemoglobin concentration and vital signs. To date, 147 patients of a planned 354 have been randomized to the study. This protocol reviews pertinent data relating to blood transfusion during radical cystectomy, highlighting the need to identify methods for reducing blood loss and preventing transfusion in patients receiving radical cystectomy. It explains the clinical rationale for using tranexamic acid to reduce blood loss during cystectomy, and outlines the study methods of our ongoing randomized controlled trial. Canadian Institute for Health Research (CIHR) Protocol: MOP-342559; ClinicalTrials.gov, ID: NCT01869413. Registered on 5 June 2013.

  19. A Community-Engaged Approach to Developing a Mobile Cancer Prevention App: The mCPA Study Protocol

    Science.gov (United States)

    2016-01-01

    Background Rapid growth of mobile technologies has resulted in a proliferation of lifestyle-oriented mobile phone apps. However, most do not have a theoretical framework and few have been developed using a community-based participatory research approach. A community academic team will develop a theory-based, culturally tailored, mobile-enabled, Web-based app—the Mobile Cancer Prevention App (mCPA)—to promote adherence to dietary and physical activity guidelines. Objective The aim of this study is to develop mCPA content with input from breast cancer survivors. Methods Members of SISTAAH (Survivors Involving Supporters to Take Action in Advancing Health) Talk (N=12), treated for Stages I-IIIc breast cancer for less than 1 year, 75 years of age or younger, and English-speaking and writing, will be recruited to participate in the study. To develop the app content, breast cancer survivors will engage with researchers in videotaped and audiotaped sessions, including (1) didactic instructions with goals for, benefits of, and strategies to enhance dietary intake and physical activity, (2) guided discussions for setting individualized goals, monitoring progress, and providing or receiving feedback, (3) experiential nutrition education through cooking demonstrations, and (4) interactive physical activity focused on walking, yoga, and strength training. Qualitative (focus group discussions and key informant interviews) and quantitative (sensory evaluation) methods will be used to evaluate the participatory process and outcomes. Results Investigators and participants anticipate development of an acceptable (frequency and duration of usage) feasible (structure, ease of use, features), and accessible mobile app available for intervention testing in early 2017. Conclusions Depending on the availability of research funding, mCPA testing, which will be initiated in Miami, will be extended to Chicago, Houston, Philadelphia, and Los Angeles. PMID:26935995

  20. A Community-Engaged Approach to Developing a Mobile Cancer Prevention App: The mCPA Study Protocol.

    Science.gov (United States)

    Smith, Selina Ann; Whitehead, Mary Smith; Sheats, Joyce; Mastromonico, Jeff; Yoo, Wonsuk; Coughlin, Steven Scott

    2016-03-02

    Rapid growth of mobile technologies has resulted in a proliferation of lifestyle-oriented mobile phone apps. However, most do not have a theoretical framework and few have been developed using a community-based participatory research approach. A community academic team will develop a theory-based, culturally tailored, mobile-enabled, Web-based app-the Mobile Cancer Prevention App (mCPA)-to promote adherence to dietary and physical activity guidelines. The aim of this study is to develop mCPA content with input from breast cancer survivors. Members of SISTAAH (Survivors Involving Supporters to Take Action in Advancing Health) Talk (N=12), treated for Stages I-IIIc breast cancer for less than 1 year, 75 years of age or younger, and English-speaking and writing, will be recruited to participate in the study. To develop the app content, breast cancer survivors will engage with researchers in videotaped and audiotaped sessions, including (1) didactic instructions with goals for, benefits of, and strategies to enhance dietary intake and physical activity, (2) guided discussions for setting individualized goals, monitoring progress, and providing or receiving feedback, (3) experiential nutrition education through cooking demonstrations, and (4) interactive physical activity focused on walking, yoga, and strength training. Qualitative (focus group discussions and key informant interviews) and quantitative (sensory evaluation) methods will be used to evaluate the participatory process and outcomes. Investigators and participants anticipate development of an acceptable (frequency and duration of usage) feasible (structure, ease of use, features), and accessible mobile app available for intervention testing in early 2017. Depending on the availability of research funding, mCPA testing, which will be initiated in Miami, will be extended to Chicago, Houston, Philadelphia, and Los Angeles.

  1. Vitamin D supplementation for the prevention of type 2 diabetes in overweight adults: study protocol for a randomized controlled trial.

    Science.gov (United States)

    de Courten, Barbora; Mousa, Aya; Naderpoor, Negar; Teede, Helena; de Courten, Maximilian P J; Scragg, Robert

    2015-08-07

    Despite Australia's sunny climate, low vitamin D levels are increasingly prevalent. Sun exposure is limited by long working hours, an increase in time spent indoors, and sun protection practices, and there is limited dietary vitamin D fortification. While the importance of vitamin D for bone mineralization is well known, its role as a protective agent against chronic diseases, such as type 2 diabetes and cardiovascular disease, is less understood. Observational and limited intervention studies suggest that vitamin D might improve insulin sensitivity and secretion, mainly via its anti-inflammatory properties, thereby decreasing the risk of development and progression of type 2 diabetes. The primary aim of this trial is to investigate whether improved plasma concentrations of 25-hydroxyvitamin D (25(OH)D), obtained through vitamin D supplementation, will increase insulin sensitivity and insulin secretion. A secondary aim is to determine whether these relationships are mediated by a reduction in underlying subclinical inflammation associated with obesity. Fifty overweight but otherwise healthy nondiabetic adults between 18 and 60 years old, with low vitamin D levels (25(OH)D daily, while the placebo group will receive apparently identical capsules, both for a period of 16 weeks. All measurements will be repeated at follow-up, with the primary outcome measure expressed as a change from baseline in insulin sensitivity and secretion for the intervention group compared with the placebo group. Secondary outcome measures will compare changes in anthropometry, cardiovascular risk factors, and inflammatory markers. The trial will provide much needed clinical evidence on the impact of vitamin D supplementation on insulin resistance and secretion and its underlying mechanisms, which are relevant for the prevention and management of type 2 diabetes. Clinicaltrials.gov ID: NCT02112721 .

  2. Study protocol for the Flooring for Injury Prevention (FLIP) Study: a randomised controlled trial in long-term care.

    Science.gov (United States)

    Lachance, Chantelle C; Feldman, Fabio; Laing, Andrew C; Leung, Pet Ming; Robinovitch, Stephen N; Mackey, Dawn C

    2016-12-01

    A promising strategy for reducing the incidence and severity of fall-related injuries in long-term care (LTC) is to decrease the ground surface stiffness, and the subsequent forces applied to the body parts at impact, through installation of compliant flooring that does not substantially affect balance or mobility. Definitive evidence of the effects of compliant flooring on fall-related injuries in LTC is lacking. The Flooring for Injury Prevention (FLIP) Study is designed to address this gap. The FLIP Study is a 4-year, parallel-group, 2-arm, randomised controlled superiority trial of flooring in 150 resident rooms at a LTC site. The primary objective is to determine whether compliant flooring reduces serious fall-related injuries relative to control flooring. Intervention (2.54 cm SmartCells compliant; 74 rooms) and control (2.54 cm plywood; 76 rooms) floorings were installed over the top of existing concrete floors and covered with identical 2.00 mm vinyl. The primary outcome is serious fall-related injury, defined as any impact-related injury due to a fall in a study room that results in Emergency Department visit or hospital admission. Secondary outcomes include minor fall-related injury, any fall-related injury, falls, number of fallers, fractures, and healthcare utilisation and costs for serious fall-related injuries. Randomisation of study rooms, and residents in rooms, was stratified by residential unit, and flooring assignments were concealed. Outcome ascertainment began September 2013. Results from the FLIP Study will provide evidence about the effects of compliant flooring on fall-related injuries in LTC and will guide development of safer environments for vulnerable older adults. NCT01618786. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  3. Stress Prevention@Work : A study protocol for the evaluation of a multifaceted integral stress prevention strategy to prevent employee stress in a healthcare organization: a cluster controlled trial

    NARCIS (Netherlands)

    Hoek, R.J.A.; Havermans, B.M.; Houtman, I.L.D.; Brouwers, E.P.M.; Heerkens, Y.F.; Zijlstra-vlasveld, M.C.; Anema, J.R.; van der Beek, A.J.; Boot, C.R.L.

    2018-01-01

    Adequate implementation of work-related stress management interventions can reduce or prevent work-related stress and sick leave in organizations. We developed a multifaceted integral stress-prevention strategy for organizations from several sectors that includes a digital platform and collaborative

  4. Stress Prevention@Work: a study protocol for the evaluation of a multifaceted integral stress prevention strategy to prevent employee stress in a healthcare organization: a cluster controlled trial

    NARCIS (Netherlands)

    Hoek, R.J.A.; Havermans, B.M.; Houtman, I.L.D.; Brouwers, E.P.M.; Heerkens, Y.F.; Zijlstra-Vlasveld, M.C.; Anema, J.R.; Beek, A.J. van der; Boot, C.R.L.

    2017-01-01

    Background. Adequate implementation of work-related stress management interventions can reduce or prevent work-related stress and sick leave in organizations. We developed a multifaceted integral stress-prevention strategy for organizations from several sectors that includes a digital platform and

  5. Understanding how pain education causes changes in pain and disability: protocol for a causal mediation analysis of the PREVENT trial.

    Science.gov (United States)

    Lee, Hopin; Moseley, G Lorimer; Hübscher, Markus; Kamper, Steven J; Traeger, Adrian C; Skinner, Ian W; McAuley, James H

    2015-07-01

    Pain education is a complex intervention developed to help clinicians manage low back pain. Although complex interventions are usually evaluated by their effects on outcomes, such as pain or disability, most do not directly target these outcomes; instead, they target intermediate factors that are presumed to be associated with the outcomes. The mechanisms underlying treatment effects, or the effect of an intervention on an intermediate factor and its subsequent effect on outcome, are rarely investigated in clinical trials. This leaves a gap in the evidence for understanding how treatments exert their effects on outcomes. Mediation analysis provides a method for identifying and quantifying the mechanisms that underlie interventions. To determine whether the effect of pain education on pain and disability is mediated by changes in self-efficacy, catastrophisation and back pain beliefs. Causal mediation analysis of the PREVENT randomised controlled trial. Two hundred and two participants with acute low back pain from primary care clinics in the Sydney metropolitan area. Participants will be randomised to receive either 'pain education' (intervention group) or 'sham education' (control group). All outcome measures (including patient characteristics), primary outcome measures (pain and disability), and putative mediating variables (self-efficacy, catastrophisation and back pain beliefs) will be measured prior to randomisation. Putative mediators and primary outcome measures will be measured 1 week after the intervention, and primary outcome measures will be measured 3 months after the onset of low back pain. Causal mediation analysis under the potential outcomes framework will be used to test single and multiple mediator models. A sensitivity analysis will be conducted to evaluate the robustness of the estimated mediation effects on the influence of violating sequential ignorability--a critical assumption for causal inference. Mediation analysis of clinical trials can

  6. Protocol for the CHORD project (community health outreach to reduce diabetes): a cluster-randomized community health worker trial to prevent diabetes.

    Science.gov (United States)

    Islam, Nadia; Gepts, Thomas; Lief, Isaac; Gore, Radhika; Levy, Natalie; Tanner, Michael; Fang, Yixin; Sherman, Scott E; Schwartz, Mark D

    2018-04-19

    Type 2 diabetes mellitus (DM) affects 9.4% of US adults and children, while another 33.9% of Americans are at risk of DM. Health care institutions face many barriers to systematically delivering the preventive care needed to decrease DM incidence. Community health workers (CHWs) may, as frontline public health workers bridging clinic and community, help overcome these challenges. This paper presents the protocol for a pragmatic, cluster-randomized trial integrating CHWs into two primary care clinics to support DM prevention for at-risk patients. The trial will randomize 15 care teams, stratified by practice site (Bellevue Hospital and Manhattan VA), totaling 56 primary care physicians. The study cohort will consist of ~ 2000 patients who are 18-75 years of age, actively enrolled in a primary care team, able to speak English or Spanish, and have at least one glycosylated hemoglobin (HbA1c) result in the prediabetic range (5.7-6.4%) since 2012. Those with a current DM diagnosis or DM medication prescription (other than metformin) are ineligible. The intervention consists of four core activities - setting health goals, health education, activation for doctor's appointments, and referrals to DM prevention programs - adjustable according to the patient's needs and readiness. The primary outcome is DM incidence. Secondary outcomes include weight loss, HbA1C, and self-reported health behaviors. Clinical variables and health behaviors will be obtained through electronic medical records and surveys, respectively. Implementation outcomes, namely implementation fidelity and physicians' perspectives about CHW integration into the clinic, will be assessed using interviews and CHW activity logs and analyzed for the influence of moderating organizational factors. This is the first rigorous, pragmatic trial to test the effectiveness of integrating CHWs into primary care for DM prevention reaching a population-based sample. Our study's limitations include language

  7. Using the intervention mapping protocol to develop a community-based intervention for the prevention of childhood obesity in a multi-centre European project: the IDEFICS intervention.

    Science.gov (United States)

    Verbestel, Vera; De Henauw, Stefaan; Maes, Lea; Haerens, Leen; Mårild, Staffan; Eiben, Gabriele; Lissner, Lauren; Moreno, Luis A; Frauca, Natalia Lascorz; Barba, Gianvincenzo; Kovács, Eva; Konstabel, Kenn; Tornaritis, Michael; Gallois, Katharina; Hassel, Holger; De Bourdeaudhuij, Ilse

    2011-08-01

    The prevalence of childhood obesity has increased during the past decades and is now considered an urgent public health problem. Although stabilizing trends in obesity prevalence have been identified in parts of Europe, preventive efforts in children are still needed. Using the socio-ecological approach as the underlying theoretical perspective, the IDEFICS project aimed to develop, implement and evaluate a community-based intervention for the prevention of childhood obesity in eight European countries. The aim of the present manuscript was to describe the content and developmental process of the IDEFICS intervention. The intervention mapping protocol (IMP) was used to develop the community-based intervention for the prevention of childhood obesity in 3 to 10 years old children. It is a theory- and evidence-based tool for the structured planning and development of health promotion programs that requires the completion of six different steps. These steps were elaborated by two coordinating centers and discussed with the other participating centers until agreement was reached. Focus group research was performed in all participating centers to provide an informed basis for intervention development. The application of the IMP resulted in an overall intervention framework with ten intervention modules targeting environmental and personal factors through the family, the school and the community. The summary results of the focus group research were used to inform the development of the overall intervention. The cultural adaptation of the overall intervention was realised by using country specific focus group results. The need for cultural adaptation was considered during the entire process to improve program adoption and implementation. A plan was developed to evaluate program effectiveness and quality of implementation. The IDEFICS project developed a community-based intervention for the prevention of childhood obesity by using to the intervention mapping heuristic. The

  8. 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)

  9. Follow-up care, surveillance protocol, and secondary prevention measures for survivors of colorectal cancer: American Society of Clinical Oncology clinical practice guideline endorsement.

    Science.gov (United States)

    Meyerhardt, Jeffrey A; Mangu, Pamela B; Flynn, Patrick J; Korde, Larissa; Loprinzi, Charles L; Minsky, Bruce D; Petrelli, Nicholas J; Ryan, Kim; Schrag, Deborah H; Wong, Sandra L; Benson, Al B

    2013-12-10

    The American Society of Clinical Oncology (ASCO) has a policy and set of procedures for endorsing recent clinical practice guidelines that have been developed by other professional organizations. The Cancer Care Ontario (CCO) Guideline on Follow-up Care, Surveillance Protocol, and Secondary Prevention Measures for Survivors of Colorectal Cancer was reviewed by ASCO for methodologic rigor and considered for endorsement. The ASCO Panel concurred with the CCO recommendations and recommended endorsement, with the addition of several qualifying statements. Surveillance should be guided by presumed risk of recurrence and functional status of the patient (important within the first 2 to 4 years). Medical history, physical examination, and carcinoembryonic antigen testing should be performed every 3 to 6 months for 5 years. Patients at higher risk of recurrence should be considered for testing in the more frequent end of the range. A computed tomography scan (abdominal and chest) is recommended annually for 3 years, in most cases. Positron emission tomography scans should not be used for surveillance outside of a clinical trial. A surveillance colonoscopy should be performed 1 year after the initial surgery and then every 5 years, dictated by the findings of the previous one. If a colonoscopy was not preformed before diagnosis, it should be done after completion of adjuvant therapy (before 1 year). Secondary prevention (maintaining a healthy body weight and active lifestyle) is recommended. If a patient is not a candidate for surgery or systemic therapy because of severe comorbid conditions, surveillance tests should not be performed. A treatment plan from the specialist should have clear directions on appropriate follow-up by a nonspecialist.

  10. Implications of bio-efficacy and persistence of insecticides when indoor residual spraying and long-lasting insecticide nets are combined for malaria prevention

    Directory of Open Access Journals (Sweden)

    Okumu Fredros O

    2012-11-01

    Full Text Available Abstract Background Bio-efficacy and residual activity of insecticides used for indoor residual spraying (IRS and long-lasting insecticide nets (LLINs were assessed against laboratory-reared and wild populations of the malaria vector, Anopheles arabiensis in south eastern Tanzania. Implications of the findings are examined in the context of potential synergies and redundancies where IRS and LLINs are combined. Methods Bioassays were conducted monthly for six months on three LLIN types (Olyset® PermaNet 2.0®,and Icon Life® and three IRS treatments (2 g/m2 pirimiphos-methyl, 2 g/m2 DDT and 0.03 g/m2 lambda-cyhalothrin, sprayed on mud walls and palm ceilings of experimental huts. Tests used susceptible laboratory-reared An. arabiensis exposed in cones (nets and IRS or wire balls (nets only. Susceptibility of wild populations was assessed using WHO diagnostic concentrations and PCR for knock-down resistance (kdr genes. Results IRS treatments killed ≥ 85% of mosquitoes exposed on palm ceilings and ≥ 90% of those exposed on mud walls, but up to 50% of this toxicity decayed within 1–3 months, except for DDT. By 6th month, only 7.5%, 42.5% and 30.0% of mosquitoes died when exposed to ceilings sprayed with pirimiphos-methyl, DDT or lambda-cyhalothrin respectively, while 12.5%, 36.0% and 27.5% died after exposure to mud walls sprayed with the same insecticides. In wire-ball assays, mortality decreased from 98.1% in 1st month to 92.6% in 6th month in tests on PermaNet 2.0®, from 100% to 61.1% on Icon Life® and from 93.2% to 33.3% on Olyset® nets. In cone bioassays, mortality reduced from 92.8% in 1st month to 83.3% in 6th month on PermaNet 2.0®, from 96.9% to 43.80% on Icon Life® and from 85.6% to 14.6% on Olyset®. Wild An. arabiensis were 100% susceptible to DDT, 95.8% to deltamethrin, 90.2% to lambda cyhalothrin and 95.2% susceptible to permethrin. No kdr gene mutations were detected. Conclusions In bioassays where sufficient contact with

  11. Implications of bio-efficacy and persistence of insecticides when indoor residual spraying and long-lasting insecticide nets are combined for malaria prevention.

    Science.gov (United States)

    Okumu, Fredros O; Chipwaza, Beatrice; Madumla, Edith P; Mbeyela, Edgar; Lingamba, Geoffrey; Moore, Jason; Ntamatungro, Alex J; Kavishe, Deo R; Moore, Sarah J

    2012-11-19

    Bio-efficacy and residual activity of insecticides used for indoor residual spraying (IRS) and long-lasting insecticide nets (LLINs) were assessed against laboratory-reared and wild populations of the malaria vector, Anopheles arabiensis in south eastern Tanzania. Implications of the findings are examined in the context of potential synergies and redundancies where IRS and LLINs are combined. Bioassays were conducted monthly for six months on three LLIN types (Olyset® PermaNet 2.0®,and Icon Life®) and three IRS treatments (2 g/m2 pirimiphos-methyl, 2 g/m2 DDT and 0.03 g/m2 lambda-cyhalothrin, sprayed on mud walls and palm ceilings of experimental huts). Tests used susceptible laboratory-reared An. arabiensis exposed in cones (nets and IRS) or wire balls (nets only). Susceptibility of wild populations was assessed using WHO diagnostic concentrations and PCR for knock-down resistance (kdr) genes. IRS treatments killed ≥ 85% of mosquitoes exposed on palm ceilings and ≥ 90% of those exposed on mud walls, but up to 50% of this toxicity decayed within 1-3 months, except for DDT. By 6th month, only 7.5%, 42.5% and 30.0% of mosquitoes died when exposed to ceilings sprayed with pirimiphos-methyl, DDT or lambda-cyhalothrin respectively, while 12.5%, 36.0% and 27.5% died after exposure to mud walls sprayed with the same insecticides. In wire-ball assays, mortality decreased from 98.1% in 1st month to 92.6% in 6th month in tests on PermaNet 2.0®, from 100% to 61.1% on Icon Life® and from 93.2% to 33.3% on Olyset® nets. In cone bioassays, mortality reduced from 92.8% in 1st month to 83.3% in 6th month on PermaNet 2.0®, from 96.9% to 43.80% on Icon Life® and from 85.6% to 14.6% on Olyset®. Wild An. arabiensis were 100% susceptible to DDT, 95.8% to deltamethrin, 90.2% to lambda cyhalothrin and 95.2% susceptible to permethrin. No kdr gene mutations were detected. In bioassays where sufficient contact with treated surfaces is assured, LLINs and IRS kill high

  12. Relapse prevention and residual symptoms: a closer analysis of placebo-controlled continuation studies with escitalopram in major depressive disorder, generalized anxiety disorder, social anxiety disorder, and obsessive-compulsive disorder.

    Science.gov (United States)

    Bech, Per; Lönn, Sara L; Overø, Kerstin F

    2010-02-01

    Analyses of data from 4 relapse-prevention studies with escitalopram were conducted in order to compare patients with and without residual symptoms with regard to relapse rates and global illness during double-blind, 24-week continuation periods. Clinical Global Impressions-Severity of Illness scores and relapse status in 4 studies published from 2005 to 2007, 1 each in major depressive disorder (MDD), generalized anxiety disorder, social anxiety disorder, and obsessive-compulsive disorder (OCD), were analyzed using mixed-effects model repeated measures as a function of Montgomery-Asberg Depression Rating Scale (MADRS) scores on items 1, 3, and 7 at randomization. All studies showed a statistically significant (P 0) and without residual symptoms (MADRS score = 0) at the start of continuation treatment were defined by how patients scored on 3 core items of the MADRS: depressed mood (observed), inner or psychic tension, and lassitude. At randomization, patients with a residual symptom were globally more ill than patients without such a symptom. Patients who did not continue active treatment worsened, even if they were initially free of a residual symptom. In contrast, patients who continued receiving escitalopram remained stable or further improved, regardless of residual symptoms or diagnosis. No clear picture emerged regarding whether patients with residual symptoms had a higher relapse rate. The presence of residual symptoms is associated with significantly worse overall illness severity in all 4 diagnostic groups and with a higher (although not significantly) risk of relapse for patients with MDD or OCD. The greatest difference in all of the studies was between patients treated with escitalopram (relapse rates ~ 20%) and placebo (relapse rates of about 50%). Copyright 2010 Physicians Postgraduate Press, Inc.

  13. PRALIMAP: study protocol for a high school-based, factorial cluster randomised interventional trial of three overweight and obesity prevention strategies

    Directory of Open Access Journals (Sweden)

    Agrinier Nelly

    2010-12-01

    Full Text Available Abstract Background Given the increase in overweight and obesity prevalence in adolescents in the last decade, effective prevention strategies for these conditions in adolescents are urgently needed. The PRALIMAP (Promotion de l'ALImentation et de l'Activité Physique trial aims to evaluate the effectiveness for these conditions of 3 health promotion strategies -- educational, screening and environmental -- applied singly or in combination in high schools over a 2-year intervention period. Methods PRALIMAP is a stratified 2 × 2 × 2 factorial cluster randomised controlled trial including 24 state high schools in Lorraine, northeastern France, in 2 waves: 8 schools in 2006 (wave 1 and 16 in 2007 (wave 2. Students entering the selected high schools in the 4 academic years from 2006 to 2009 are eligible for data collection. Interventional strategies are organized over 2 academic years. The follow-up consists of 3 visits: at the entry of grade 10 (T0, grade 11 (T1 and grade 12 (T2. At T0, 5,458 (85.7% adolescents participated. The educational strategy consists of nutritional lessons, working groups and a final party. The screening strategy consists in detecting overweight/obesity and eating disorders in adolescents and proposing, if necessary, an adapted care management program of 7 group educational sessions. The environmental strategy consists in improving dietary and physical activity offerings in high schools and facilities, especially catering. The main outcomes are body size evolution over time, nutritional behaviour and knowledge, health and quality of life. An evaluation process documents how each intervention strategy is implemented in the schools and estimates the dose of the intervention, allowing for a per protocol analysis after the main intention-to-treat analysis. Discussion PRALIMAP aims at improving the prevention and management of overweight and obesity in adolescents by translating current evidence into public health practice

  14. Implementation of preventive strength training in residential geriatric care: a multi-centre study protocol with one year of interventions on multiple levels.

    Science.gov (United States)

    Brach, Michael; Nieder, Frank; Nieder, Ulrike; Mechling, Heinz

    2009-11-24

    There is scientific evidence that preventive physical exercise is effective even in high age. In contrast, there are few opportunities of preventive exercise for highly aged people endangered by or actually in need of care. For example, they would not be able to easily go to training facilities; standard exercises may be too intensive and therefore be harmful to them; orientation disorders like dementia would exacerbate individuals and groups in following instructions and keeping exercises going. In order to develop appropriate interventions, these and other issues were assigned to different levels: the individual-social level (ISL), the organisational-institutional level (OIL) and the political-cultural level (PCL). Consequently, this conceptional framework was utilised for development, implementation and evaluation of a new strength and balance exercise programme for old people endangered by or actually in need of daily care. The present paper contains the development of this programme labeled "fit for 100", and a study protocol of an interventional single-arm multi-centre trial. The intervention consisted of (a) two group training sessions every week over one year, mainly resistance exercises, accompanied by sensorimotor and communicative group exercises and games (ISL), (b) a sustainable implementation concept, starting new groups by instructors belonging to the project, followed by training and supervision of local staff, who stepwise take over the group (OIL), (c) informing and convincing activities in professional, administrative and governmental contexts, public relation activities, and establishing an advisory council with renowned experts and public figures (PCL). Participating institutions of geriatric care were selected through several steps of quality criteria assessment. Primary outcome measures were continuous documentation of individual participation (ISL), number of groups continued without external financial support (at the end of the project, and

  15. Early screening for Chlamydia trachomatis in young women for primary prevention of pelvic inflammatory disease (i-Predict): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Tamarelle, Jeanne; Thiébaut, Anne C M; Sabin, Bénédicte; Bébéar, Cécile; Judlin, Philippe; Fauconnier, Arnaud; Rahib, Delphine; Méaude-Roufai, Layidé; Ravel, Jacques; Morré, Servaas A; de Barbeyrac, Bertille; Delarocque-Astagneau, Elisabeth

    2017-11-13

    Genital infection with Chlamydia trachomatis (Ct) is the most common bacterial sexually transmitted infection, especially among young women. Mostly asymptomatic, it can lead, if untreated, to pelvic inflammatory disease (PID), tubal factor infertility and ectopic pregnancy. Recent data suggest that Ct infections are not controlled in France and in Europe. The effectiveness of a systematic strategy for Ct screening in under-25 women remains controversial. The main objective of the i-Predict trial (Prevention of Diseases Induced by Chlamydia trachomatis) is to determine whether early screening and treatment of 18- to-24-year-old women for genital Ct infection reduces the incidence of PID over 24 months. This is a randomised prevention trial including 4000 eighteen- to twenty-four-year-old sexually active female students enrolled at five universities. The participants will provide a self-collected vaginal swab sample and fill in an electronic questionnaire at baseline and at 6, 12 and 18 months after recruitment. Vaginal swabs in the intervention arm will be analysed immediately for Ct positivity, and participants will be referred for treatment if they have a positive test result. Vaginal swabs from the control arm will be analysed at the end of the study. All visits to general practitioners, gynaecologists or gynaecology emergency departments for pelvic pain or other gynaecological symptoms will be recorded to evaluate the incidence of PID, and all participants will attend a final visit in a hospital gynaecology department. The primary endpoint measure will be the incidence of PID over 24 months. The outcome status (confirmed, probable or no PID) will be assessed by two independent experts blinded to group assignment and Ct status. This trial is expected to largely contribute to the development of recommendations for Ct screening in young women in France to prevent PID and related complications. It is part of a comprehensive approach to gathering data to

  16. Continuous versus intermittent endotracheal cuff pressure control for the prevention of ventilator-associated respiratory infections in Vietnam: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Dat, Vu Quoc; Geskus, Ronald B; Wolbers, Marcel; Loan, Huynh Thi; Yen, Lam Minh; Binh, Nguyen Thien; Chien, Le Thanh; Mai, Nguyen Thi Hoang; Phu, Nguyen Hoan; Lan, Nguyen Phu Huong; Hao, Nguyen Van; Long, Hoang Bao; Thuy, Tran Phuong; Kinh, Nguyen Van; Trung, Nguyen Vu; Phu, Vu Dinh; Cap, Nguyen Trung; Trinh, Dao Tuyet; Campbell, James; Kestelyn, Evelyne; Wertheim, Heiman F L; Wyncoll, Duncan; Thwaites, Guy Edward; van Doorn, H Rogier; Thwaites, C Louise; Nadjm, Behzad

    2018-04-04

    Ventilator-associated respiratory infection (VARI) comprises ventilator-associated pneumonia (VAP) and ventilator-associated tracheobronchitis (VAT). Although their diagnostic criteria vary, together these are the most common hospital-acquired infections in intensive care units (ICUs) worldwide, responsible for a large proportion of antibiotic use within ICUs. Evidence-based strategies for the prevention of VARI in resource-limited settings are lacking. Preventing the leakage of oropharyngeal secretions into the lung using continuous endotracheal cuff pressure control is a promising strategy. The aim of this study is to investigate the efficacy of automated, continuous endotracheal cuff pressure control in preventing the development of VARI and reducing antibiotic use in ICUs in Vietnam. This is an open-label randomised controlled multicentre trial. We will enrol 600 adult patients intubated for ≤ 24 h at the time of enrolment. Eligible patients will be stratified according to admission diagnosis (180 tetanus, 420 non-tetanus) and site and will be randomised in a 1:1 ratio to receive either (1) automated, continuous control of endotracheal cuff pressure or (2) intermittent measurement and control of endotracheal cuff pressure using a manual cuff pressure meter. The primary outcome is the occurrence of VARI, defined as either VAP or VAT during the ICU admission up to a maximum of 90 days after randomisation. Patients in both groups who are at risk for VARI will receive a standardised battery of investigations if their treating physician feels a new infection has occurred, the results of which will be used by an endpoint review committee, blinded to the allocated arm and independent of patient care, to determine the primary outcome. All enrolled patients will be followed for mortality and endotracheal tube cuff-related complications at 28 days and 90 days after randomisation. Other secondary outcomes include antibiotic use; days ventilated, in ICU and in hospital

  17. A cluster-randomised, controlled trial to assess the impact of a workplace osteoporosis prevention intervention on the dietary and physical activity behaviours of working women: study protocol.

    Science.gov (United States)

    Tan, Ai May; Lamontagne, Anthony D; Sarmugam, Rani; Howard, Peter

    2013-04-29

    Osteoporosis is a debilitating disease and its risk can be reduced through adequate calcium consumption and physical activity. This protocol paper describes a workplace-based intervention targeting behaviour change in premenopausal women working in sedentary occupations. A cluster-randomised design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the clusters and units of randomisation and intervention. Sample size calculations incorporated the cluster design. Final number of clusters was determined to be 16, based on a cluster size of 20 and calcium intake parameters (effect size 250 mg, ICC 0.5 and standard deviation 290 mg) as it required the highest number of clusters.Sixteen workplaces were recruited from a pool of 97 workplaces and randomly assigned to intervention and control arms (eight in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organisation wide educational activities. Workplaces in the control/standard care arm received print resources. Intervention workshops were guided by self-efficacy theory and included participatory activities such as goal setting, problem solving, local food sampling, exercise trials, group discussion and behaviour feedback.Outcomes measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, four weeks and six months post intervention. This study addresses the current lack of evidence for behaviour change interventions focussing on osteoporosis prevention. It addresses missed opportunities of using workplaces as a platform to target high-risk individuals with sedentary occupations. The intervention was designed to modify behaviour levels to bring about risk reduction. It is the first to address dietary and physical activity components each with unique intervention strategies in the context of osteoporosis

  18. Implementation of preventive strength training in residential geriatric care: a multi-centre study protocol with one year of interventions on multiple levels

    Directory of Open Access Journals (Sweden)

    Nieder Ulrike

    2009-11-01

    Full Text Available Abstract Background There is scientific evidence that preventive physical exercise is effective even in high age. In contrast, there are few opportunities of preventive exercise for highly aged people endangered by or actually in need of care. For example, they would not be able to easily go to training facilities; standard exercises may be too intensive and therefore be harmful to them; orientation disorders like dementia would exacerbate individuals and groups in following instructions and keeping exercises going. In order to develop appropriate interventions, these and other issues were assigned to different levels: the individual-social level (ISL, the organisational-institutional level (OIL and the political-cultural level (PCL. Consequently, this conceptional framework was utilised for development, implementation and evaluation of a new strength and balance exercise programme for old people endangered by or actually in need of daily care. The present paper contains the development of this programme labeled "fit for 100", and a study protocol of an interventional single-arm multi-centre trial. Methods The intervention consisted of (a two group training sessions every week over one year, mainly resistance exercises, accompanied by sensorimotor and communicative group exercises and games (ISL, (b a sustainable implementation concept, starting new groups by instructors belonging to the project, followed by training and supervision of local staff, who stepwise take over the group (OIL, (c informing and convincing activities in professional, administrative and governmental contexts, public relation activities, and establishing an advisory council with renowned experts and public figures (PCL. Participating institutions of geriatric care were selected through several steps of quality criteria assessment. Primary outcome measures were continuous documentation of individual participation (ISL, number of groups continued without external financial

  19. Residual stresses

    International Nuclear Information System (INIS)

    Sahotra, I.M.

    2006-01-01

    The principal effect of unloading a material strained into the plastic range is to create a permanent set (plastic deformation), which if restricted somehow, gives rise to a system of self-balancing within the same member or reaction balanced by other members of the structure., known as residual stresses. These stresses stay there as locked-in stresses, in the body or a part of it in the absence of any external loading. Residual stresses are induced during hot-rolling and welding differential cooling, cold-forming and extruding: cold straightening and spot heating, fabrication and forced fitting of components constraining the structure to a particular geometry. The areas which cool more quickly develop residual compressive stresses, while the slower cooling areas develop residual tensile stresses, and a self-balancing or reaction balanced system of residual stresses is formed. The phenomenon of residual stresses is the most challenging in its application in surface modification techniques determining endurance mechanism against fracture and fatigue failures. This paper discusses the mechanism of residual stresses, that how the residual stresses are fanned and what their behavior is under the action of external forces. Such as in the case of a circular bar under limit torque, rectangular beam under limt moment, reclaiming of shafts welds and peening etc. (author)

  20. Protocol for the systematic review of the prevention, treatment and public health management of impetigo, scabies and fungal skin infections in resource-limited settings.

    Science.gov (United States)

    May, Philippa; Bowen, Asha; Tong, Steven; Steer, Andrew; Prince, Sam; Andrews, Ross; Currie, Bart; Carapetis, Jonathan

    2016-09-23

    Impetigo, scabies, and fungal skin infections disproportionately affect populations in resource-limited settings. Evidence for standard treatment of skin infections predominantly stem from hospital-based studies in high-income countries. The evidence for treatment in resource-limited settings is less clear, as studies in these populations may lack randomisation and control groups for cultural, ethical or economic reasons. Likewise, a synthesis of the evidence for public health control within endemic populations is also lacking. We propose a systematic review of the evidence for the prevention, treatment and public health management of skin infections in resource-limited settings, to inform the development of guidelines for the standardised and streamlined clinical and public health management of skin infections in endemic populations. The protocol has been designed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols statement. All trial designs and analytical observational study designs will be eligible for inclusion. A systematic search of the peer-reviewed literature will include PubMed, Excertpa Medica and Global Health. Grey literature databases will also be systematically searched, and clinical trials registries scanned for future relevant studies. The primary outcome of interest will be the clinical cure or decrease in prevalence of impetigo, scabies, crusted scabies, tinea capitis, tinea corporis or tinea unguium. Two independent reviewers will perform eligibility assessment and data extraction using standardised electronic forms. Risk of bias assessment will be undertaken by two independent reviewers according to the Cochrane Risk of Bias tool. Data will be tabulated and narratively synthesised. We expect there will be insufficient data to conduct meta-analysis. The final body of evidence will be reported against the Grades of Recommendation, Assessment, Development and Evaluation grading system. The evidence

  1. Residual stresses

    International Nuclear Information System (INIS)

    Macherauch, E.

    1978-01-01

    Residual stresses are stresses which exist in a material without the influence of external powers and moments. They come into existence when the volume of a material constantly changes its form as a consequence of mechanical, thermal, and/or chemical processes and is hindered by neighbouring volumes. Bodies with residual stress are in mechanical balance. These residual stresses can be manifested by means of all mechanical interventions disturbing this balance. Acoustical, optical, radiological, and magnetical methods involving material changes caused by residual stress can also serve for determining residual stress. Residual stresses have an ambivalent character. In technical practice, they are feared and liked at the same time. They cause trouble because they can be the cause for unexpected behaviour of construction elements. They are feared since they can cause failure, in the worst case with catastrophical consequences. They are appreciated, on the other hand, because, in many cases, they can contribute to improvements of the material behaviour under certain circumstances. But they are especially liked for their giving convenient and (this is most important) mostly uncontrollable explanations. For only in very few cases we have enough knowledge and possibilities for the objective evaluation of residual stresses. (orig.) [de

  2. A best practice fall prevention exercise program to improve balance, strength / power, and psychosocial health in older adults: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Gschwind, Yves J; Kressig, Reto W; Lacroix, Andre; Muehlbauer, Thomas; Pfenninger, Barbara; Granacher, Urs

    2013-10-09

    With increasing age neuromuscular deficits (e.g., sarcopenia) may result in impaired physical performance and an increased risk for falls. Prominent intrinsic fall-risk factors are age-related decreases in balance and strength / power performance as well as cognitive decline. Additional studies are needed to develop specifically tailored exercise programs for older adults that can easily be implemented into clinical practice. Thus, the objective of the present trial is to assess the effects of a fall prevention program that was developed by an interdisciplinary expert panel on measures of balance, strength / power, body composition, cognition, psychosocial well-being, and falls self-efficacy in healthy older adults. Additionally, the time-related effects of detraining are tested. Healthy old people (n = 54) between the age of 65 to 80 years will participate in this trial. The testing protocol comprises tests for the assessment of static / dynamic steady-state balance (i.e., Sharpened Romberg Test, instrumented gait analysis), proactive balance (i.e., Functional Reach Test; Timed Up and Go Test), reactive balance (i.e., perturbation test during bipedal stance; Push and Release Test), strength (i.e., hand grip strength test; Chair Stand Test), and power (i.e., Stair Climb Power Test; countermovement jump). Further, body composition will be analysed using a bioelectrical impedance analysis system. In addition, questionnaires for the assessment of psychosocial (i.e., World Health Organisation Quality of Life Assessment-Bref), cognitive (i.e., Mini Mental State Examination), and fall risk determinants (i.e., Fall Efficacy Scale - International) will be included in the study protocol. Participants will be randomized into two intervention groups or the control / waiting group. After baseline measures, participants in the intervention groups will conduct a 12-week balance and strength / power exercise intervention 3 times per week, with each training session lasting 30 min

  3. ATTIRE: Albumin To prevenT Infection in chronic liveR failurE: study protocol for a single-arm feasibility trial.

    Science.gov (United States)

    China, Louise; Muirhead, Nicola; Skene, Simon S; Shabir, Zainib; De Maeyer, Roel P H; Maini, Alexander A N; Gilroy, Derek W; O'Brien, Alastair J

    2016-01-25

    Circulating prostaglandin E2 levels are elevated in acutely decompensated cirrhosis and have been shown to contribute to immune suppression. Albumin binds and inactivates this hormone. Human albumin solution could thus be repurposed as an immune restorative drug in these patients.This feasibility study aims to determine whether it is possible and safe to restore serum albumin to >30 g/L and maintain it at this level in patients admitted with acute decompensated cirrhosis using repeated 20% human albumin infusions according to daily serum albumin levels. Albumin To prevenT Infection in chronic liveR failurE (ATTIRE) stage 1 is a multicentre, open label dose feasibility trial. Patients with acutely decompensated cirrhosis admitted to hospital with a serum albumin of albumin solution will be infused, according to serum albumin levels, for up to 14 days or discharge in all patients. The primary end point is daily serum albumin levels for the duration of the treatment period and the secondary end point is plasma-induced macrophage dysfunction. The trial will recruit 80 patients. Outcomes will be used to assist with study design for an 866 patient randomised controlled trial at more than 30 sites across the UK. Research ethics approval was given by the London-Brent research ethics committee (ref: 15/LO/0104). The clinical trials authorisation was issued by the medicines and healthcare products regulatory agency (ref: 20363/0350/001-0001). Will be disseminated through peer reviewed journals and international conferences. Recruitment of the first participant occurred on 26/05/2015. The trial is registered with the European Medicines Agency (EudraCT 2014-002300-24) and has been adopted by the NIHR (ISRCTN 14174793). This manuscript refers to V.4.0 of the protocol; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  4. Preventing disease through opportunistic, rapid engagement by primary care teams using behaviour change counselling (PRE-EMPT): protocol for a general practice-based cluster randomised trial.

    Science.gov (United States)

    Spanou, Clio; Simpson, Sharon A; Hood, Kerry; Edwards, Adrian; Cohen, David; Rollnick, Stephen; Carter, Ben; McCambridge, Jim; Moore, Laurence; Randell, Elizabeth; Pickles, Timothy; Smith, Christine; Lane, Claire; Wood, Fiona; Thornton, Hazel; Butler, Chris C

    2010-09-21

    Smoking, excessive alcohol consumption, lack of exercise and an unhealthy diet are the key modifiable factors contributing to premature morbidity and mortality in the developed world. Brief interventions in health care consultations can be effective in changing single health behaviours. General Practice holds considerable potential for primary prevention through modifying patients' multiple risk behaviours, but feasible, acceptable and effective interventions are poorly developed, and uptake by practitioners is low. Through a process of theoretical development, modeling and exploratory trials, we have developed an intervention called Behaviour Change Counselling (BCC) derived from Motivational Interviewing (MI). This paper describes the protocol for an evaluation of a training intervention (the Talking Lifestyles Programme) which will enable practitioners to routinely use BCC during consultations for the above four risk behaviours. This cluster randomised controlled efficacy trial (RCT) will evaluate the outcomes and costs of this training intervention for General Practitioners (GPs) and nurses. Training methods will include: a practice-based seminar, online self-directed learning, and reflecting on video recorded and simulated consultations. The intervention will be evaluated in 29 practices in Wales, UK; two clinicians will take part (one GP and one nurse) from each practice. In intervention practices both clinicians will receive training. The aim is to recruit 2000 patients into the study with an expected 30% drop out. The primary outcome will be the proportion of patients making changes in one or more of the four behaviours at three months. Results will be compared for patients seeing clinicians trained in BCC with patients seeing non-BCC trained clinicians. Economic and process evaluations will also be conducted. Opportunistic engagement by health professionals potentially represents a cost effective medical intervention. This study integrates an existing

  5. Curcumin and long-chain Omega-3 polyunsaturated fatty acids for Prevention of type 2 Diabetes (COP-D): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Thota, Rohith N; Acharya, Shamasunder H; Abbott, Kylie A; Garg, Manohar L

    2016-11-29

    have been made to the clinical protocol post recruitment. If successful, this trial will provide considerable evidence for performing a larger trial to investigate whether this combination can be administered for preventing or delaying the onset of T2D in high-risk individuals. ACTRN12615000559516 , registered on 29 May 2015).

  6. Disrupting the rhythm of depression: design and protocol of a randomized controlled trial on preventing relapse using brief cognitive therapy with or without antidepressants

    Directory of Open Access Journals (Sweden)

    Huibers Marcus JH

    2011-01-01

    Full Text Available Abstract Background Maintenance treatment with antidepressants is the leading strategy to prevent relapse and recurrence in patients with recurrent major depressive disorder (MDD who have responded to acute treatment with antidepressants (AD. However, in clinical practice most patients (up to 70-80% are not willing to take this medication after remission or take too low dosages. Moreover, as patients need to take medication for several years, it may not be the most cost-effective strategy. The best established effective and available alternative is brief cognitive therapy (CT. However, it is unclear whether brief CT while tapering antidepressants (AD is an effective alternative for long term use of AD in recurrent depression. In addition, it is unclear whether the combination of AD to brief CT is beneficial. Methods/design Therefore, we will compare the effectiveness and cost-effectiveness of brief CT while tapering AD to maintenance AD and the combination of CT with maintenance AD. In addition, we examine whether the prophylactic effect of CT was due to CT tackling illness related risk factors for recurrence such as residual symptoms or to its efficacy to modify presumed vulnerability factors of recurrence (e.g. rigid explicit and/or implicit dysfunctional attitudes. This is a multicenter RCT comparing the above treatment scenarios. Remitted patients on AD with at least two previous depressive episodes in the past five years (n = 276 will be recruited. The primary outcome is time related proportion of depression relapse/recurrence during minimal 15 months using DSM-IV-R criteria as assessed by the Structural Clinical Interview for Depression. Secondary outcome: economic evaluation (using a societal perspective and number, duration and severity of relapses/recurrences. Discussion This will be the first trial to investigate whether CT is effective in preventing relapse to depression in recurrent depression while tapering antidepressant treatment

  7. Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of depressive relapse/recurrence: the PREVENT trial

    Directory of Open Access Journals (Sweden)

    Hayes Rachel

    2010-10-01

    Full Text Available Abstract Background Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating depression and maintenance anti-depressants (m-ADM can prevent relapse. However, individuals with depression often express a wish for psychological help that can help them recover from depression in the long-term. We need to develop psychological therapies that prevent depressive relapse/recurrence. A recently developed treatment, Mindfulness-based Cognitive Therapy (MBCT, see http://www.mbct.co.uk shows potential as a brief group programme for people with recurring depression. In two studies it has been shown to halve the rates of depression recurring compared to usual care. This trial asks the policy research question, is MBCT superior to m-ADM in terms of: a primary outcome of preventing depressive relapse/recurrence over 24 months; and, secondary outcomes of (a depression free days, (b residual depressive symptoms, (c antidepressant (ADM usage, (d psychiatric and medical co-morbidity, (e quality of life, and (f cost effectiveness? An explanatory research question asks is an increase in mindfulness skills the key mechanism of change? Methods/Design The design is a single blind, parallel RCT examining MBCT vs. m-ADM with an embedded process study. To answer the main policy research question the proposed trial compares MBCT plus ADM-tapering with m-ADM for patients with recurrent depression. Four hundred and twenty patients with recurrent major depressive disorder in full or partial remission will be recruited through primary care. Depressive relapse/recurrence over two years is the primary outcome variable. The explanatory question will be addressed in two mutually informative ways: quantitative measurement of potential mediating variables pre/post-treatment and a qualitative study of service users' views and experiences

  8. 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...

  9. Solid residues

    International Nuclear Information System (INIS)

    Mulder, E.; Duin, P.J. van; Grootenboer, G.J.

    1995-01-01

    A summary is presented of the many investigations that have been done on solid residues of atmospheric fluid bed combustion (AFBC). These residues are bed ash, cyclone ash and bag filter ash. Physical and chemical properties are discussed and then the various uses of residues (in fillers, bricks, gravel, and for recovery of aluminium) are summarised. Toxicological properties of fly ash and stack ash are discussed as are risks of pneumoconiosis for workers handling fly ash, and contamination of water by ashes. On the basis of present information it is concluded that risks to public health from exposure to emissions of coal fly ash from AFBC appear small or negligible as are health risk to workers in the coal fly ash processing industry. 35 refs., 5 figs., 12 tabs

  10. Education Against Tobacco (EAT): a quasi-experimental prospective evaluation of a programme for preventing smoking in secondary schools delivered by medical students: a study protocol.

    Science.gov (United States)

    Brinker, Titus J; Stamm-Balderjahn, Sabine; Seeger, Werner; Groneberg, David A

    2014-07-24

    A survey conducted by the German Federal Centre for Health Education in 2012 showed that 35.2% of all young adults (18-25 years) and 12.0% of all adolescents (12-17 years) in Germany are regular cigarette smokers. Most smoked their first cigarette in early adolescence. We recently reported a significantly positive short-term effect of a physician-delivered school-based smoking prevention programme on the smoking behaviour of schoolchildren in Germany. However, physician-based programmes are usually very expensive. Therefore, we will evaluate and optimise Education against Tobacco (EAT), a widespread, low-cost programme delivered by about 400 medical students from 16 universities in Germany. A prospective quasi-experimental study design with two measurements at baseline (t1) and 6 months post-intervention (t2) to investigate an intervention in 10-15-year-olds in grades 6-8 at German secondary schools. The intervention programme consists of two 60-min school-based medical-student-delivered modules with (module 1) and without the involvement of patients with tobacco-related diseases and control groups (no intervention). The study questionnaire measuring smoking status (water pipe and cigarette smoking), smoking-related cognitions, and gender, social and cultural aspects was designed and pre-tested in advance. The primary end point is the prevalence of smokers and non-smokers in the two study arms at 6 months after the intervention. The percentage of former smokers and new smokers in the two groups and the measures of smoking behaviour will be studied as secondary outcome measures. In accordance with Good Epidemiologic Practice (GEP) guidelines, the study protocol was submitted for approval by the responsible ethics committee, which decided that the study does not need ethical approval (Goethe University, Frankfurt-Main, Germany). Findings will be disseminated in peer-reviewed journals, at conferences, within our scientific advisory board and through medical

  11. Cost-benefit and extended cost-effectiveness analysis of a comprehensive adolescent pregnancy prevention program in Zambia: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Mori, Amani Thomas; Kampata, Linda; Musonda, Patrick; Johansson, Kjell Arne; Robberstad, Bjarne; Sandøy, Ingvild

    2017-12-19

    Early marriages, pregnancies and births are the major cause of school drop-out among adolescent girls in sub-Saharan Africa. Birth complications are also one of the leading causes of death among adolescent girls. This paper outlines a protocol for a cost-benefit analysis (CBA) and an extended cost-effectiveness analysis (ECEA) of a comprehensive adolescent pregnancy prevention program in Zambia. It aims to estimate the expected costs, monetary and non-monetary benefits associated with health-related and non-health outcomes, as well as their distribution across populations with different standards of living. The study will be conducted alongside a cluster-randomized controlled trial, which is testing the hypothesis that economic support with or without community dialogue is an effective strategy for reducing adolescent childbearing rates. The CBA will estimate net benefits by comparing total costs with monetary benefits of health-related and non-health outcomes for each intervention package. The ECEA will estimate the costs of the intervention packages per unit health and non-health gain stratified by the standards of living. Cost data include program implementation costs, healthcare costs (i.e. costs associated with adolescent pregnancy and birth complications such as low birth weight, pre-term birth, eclampsia, medical abortion procedures and post-abortion complications) and costs of education and participation in community and youth club meetings. Monetary benefits are returns to education and averted healthcare costs. For the ECEA, health gains include reduced rate of adolescent childbirths and non-health gains include averted out-of-pocket expenditure and financial risk protection. The economic evaluations will be conducted from program and societal perspectives. While the planned intervention is both comprehensive and expensive, it has the potential to produce substantial short-term and long-term health and non-health benefits. These benefits should be

  12. Exercise therapy for prevention of falls in people with Parkinson's disease: A protocol for a randomised controlled trial and economic evaluation

    Directory of Open Access Journals (Sweden)

    Allen Natalie E

    2009-01-01

    Full Text Available Abstract Background People with Parkinson's disease are twice as likely to be recurrent fallers compared to other older people. As these falls have devastating consequences, there is an urgent need to identify and test innovative interventions with the potential to reduce falls in people with Parkinson's disease. The main objective of this randomised controlled trial is to determine whether fall rates can be reduced in people with Parkinson's disease using exercise targeting three potentially remediable risk factors for falls (reduced balance, reduced leg muscle strength and freezing of gait. In addition we will establish the cost effectiveness of the exercise program from the health provider's perspective. Methods/Design 230 community-dwelling participants with idiopathic Parkinson's disease will be recruited. Eligible participants will also have a history of falls or be identified as being at risk of falls on assessment. Participants will be randomly allocated to a usual-care control group or an intervention group which will undertake weight-bearing balance and strengthening exercises and use cueing strategies to address freezing of gait. The intervention group will choose between the home-based or support group-based mode of the program. Participants in both groups will receive standardized falls prevention advice. The primary outcome measure will be fall rates. Participants will record falls and medical interventions in a diary for the duration of the 6-month intervention period. Secondary measures include the Parkinson's Disease Falls Risk Score, maximal leg muscle strength, standing balance, the Short Physical Performance Battery, freezing of gait, health and well being, habitual physical activity and positive and negative affect schedule. Discussion No adequately powered studies have investigated exercise interventions aimed at reducing falls in people with Parkinson's disease. This trial will determine the effectiveness of the exercise

  13. Early coordinated multidisciplinary intervention to prevent sickness absence and labour market exclusion in patients with low back pain: study protocol of a randomized controlled trial.

    Science.gov (United States)

    Fisker, Annette; Langberg, Henning; Petersen, Tom; Mortensen, Ole Steen

    2013-03-13

    Musculoskeletal disorders account for one third of the long-term absenteeism in Denmark and the number of individuals sick listed for more than four weeks is increasing. Compared to other diagnoses, patients with musculoskeletal diseases, including low back pain, are less likely to return to work after a period of sick leave. It seems that a multidisciplinary intervention, including cooperation between the health sector, the social sector and in the work place, has a positive effect on days off work due to musculoskeletal disorders and particularly low back pain. It is a challenge to coordinate this type of intervention, and the implementation of a return-to-work (RTW)-coordinator is suggested as an effective strategy in this process. The purpose of this paper is to describe the study protocol and present a new type of intervention, where the physiotherapist both has the role as RTW-coordinator and treating the patient. A randomized controlled trial (RCT) is currently on-going. The RCT includes 770 patients with low back pain of minimum four weeks who are referred to an outpatient back centre. The study population consists of patients, who are sick-listed or at risk of sick-leave due to LBP. The control group is treated with usual care in a team of a physiotherapist, a chiropractor, a rheumatologist and a social worker employed at the centre. The Intervention group is treated with usual care and in addition intervention of a psychologist, an occupational physician, an ergonomist, a case manager from the municipal sickness benefit office, who has the authority in the actual case concerning sickness benefit payment and contact to the patients employer/work place. The treating physiotherapist is the RTW-coordinator. Outcome will be reported at the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of days off work. Secondary outcomes are disability, pain, and quality of life. The study will follow the recommendations in CONSORT

  14. Residual basins

    International Nuclear Information System (INIS)

    D'Elboux, C.V.; Paiva, I.B.

    1980-01-01

    Exploration for uranium carried out over a major portion of the Rio Grande do Sul Shield has revealed a number of small residual basins developed along glacially eroded channels of pre-Permian age. Mineralization of uranium occurs in two distinct sedimentary units. The lower unit consists of rhythmites overlain by a sequence of black shales, siltstones and coal seams, while the upper one is dominated by sandstones of probable fluvial origin. (Author) [pt

  15. Prevention and assessment of infectious diseases among children and adult migrants arriving to the European Union/European Economic Association: a protocol for a suite of systematic reviews for public health and health systems.

    Science.gov (United States)

    Pottie, Kevin; Mayhew, Alain D; Morton, Rachael L; Greenaway, Christina; Akl, Elie A; Rahman, Prinon; Zenner, Dominik; Pareek, Manish; Tugwell, Peter; Welch, Vivian; Meerpohl, Joerg; Alonso-Coello, Pablo; Hui, Charles; Biggs, Beverley-Ann; Requena-Méndez, Ana; Agbata, Eric; Noori, Teymur; Schünemann, Holger J

    2017-09-11

    The European Centre for Disease Prevention and Control is developing evidence-based guidance for voluntary screening, treatment and vaccine prevention of infectious diseases for newly arriving migrants to the European Union/European Economic Area. The objective of this systematic review protocol is to guide the identification, appraisal and synthesis of the best available evidence on prevention and assessment of the following priority infectious diseases: tuberculosis, HIV, hepatitis B, hepatitis C, measles, mumps, rubella, diphtheria, tetanus, pertussis, poliomyelitis (polio), Haemophilus influenza disease, strongyloidiasis and schistosomiasis. The search strategy will identify evidence from existing systematic reviews and then update the effectiveness and cost-effectiveness evidence using prospective trials, economic evaluations and/or recently published systematic reviews. Interdisciplinary teams have designed logic models to help define study inclusion and exclusion criteria, guiding the search strategy and identifying relevant outcomes. We will assess the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. There are no ethical or safety issues. We anticipate disseminating the findings through open-access publications, conference abstracts and presentations. We plan to publish technical syntheses as GRADEpro evidence summaries and the systematic reviews as part of a special edition open-access publication on refugee health. We are following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols reporting guideline. This protocol is registered in PROSPERO: CRD42016045798. © 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.

  16. Antibiotic protocol for the prevention of osteoradionecrosis following dental extractions in irradiated head and neck cancer patients: A 10 years prospective study

    Directory of Open Access Journals (Sweden)

    Saleh A Al-Bazie

    2016-01-01

    Conclusion: Based on the results of this study, perioperative oral antibiotics in combination with antibacterial mouthwashes are effective in preventing ORN following dental extractions in irradiated patients.

  17. Vision for utilization of livestock residue as bioenergy resource in Japan

    International Nuclear Information System (INIS)

    Fujino, Junichi; Morita, Akihiro; Matsuoka, Yasunari; Sawayama, Shigeki

    2005-01-01

    Utilization of livestock residue is important not only for energy recovery and material recycling but also for preventing environmental pollution. This paper focuses on the following options from the viewpoint of the Law on Promoting Proper Management and Use of Livestock Excreta and the Kyoto protocol: energy use from livestock residue, reductions in CO 2 emissions resulting from substitution of fossil fuels, and reduction of other greenhouse gas emissions through appropriate treatment of livestock residue. Bioenergy potential of livestock residue in Japan was estimated to be 167 PJ in the year 2000. This is equivalent to about 0.7% of total primary energy supply. Biogas production with methane fermentation and burning poultry residue at power plants can produce 4.1 TWh of electricity and 46 PJ of heat. The amount of CO 2 substitution for fossil fuels is 6.9 Mt-CO 2 . This corresponds to about 0.6% of total CO 2 emissions in 1990. This also has an additional effect of reducing other greenhouse gas (CH 4 and N 2 O) emissions from conventional treatment of livestock residue. Development of biogas plants, promotion of biogas utilization, and effective use of fertilizer components extracted from livestock residue are expected to gain importance in the future

  18. Avaliação da utilização de protocolos na prevenção de úlceras por pressão Evaluation of the use of protocols in the prevention of pressure ulcers

    Directory of Open Access Journals (Sweden)

    Rosilene Alves de Almeida

    2012-08-01

    Full Text Available Introdução: A úlcera por pressão é um problema de saúde que repercute com elevados custos e consequências biopsicossociais sobre os portadores. Para reduzir sua incidência, protocolos de prevenção são utilizados, sendo importante enfatizar o impacto desta estratégia sobre as práticas de saúde e na qualidade de vida do paciente. Objetivo: Este artigo objetiva revisar o impacto da utilização de protocolos de prevenção de úlcera por pressão sobre sua incidência e na assistência. Materiais e Métodos: O estudo é de revisão sistemática fundamentado em publicações disponíveis em meio eletrônico. Foram selecionados 07 trabalhos, do período de 2002 a 2010, encontrados nas bases de dados Medline, Lilacs, IBECS e Cochrane, utilizando os descritores “úlcera por pressão ou úlcera de pressão ou escara de decúbito e protocolo”. Resultados: Três estudos mostraram redução da incidência de úlcera por pressão de 23 para 5%, 60 para 15%, 43 para 28%, com relato de eficácia do protocolo em 79% dos pacientes. Outros revelaram incidências de 0,2 e 2,77% após aplicação do protocolo. Incidências de 23,5 e 25,8% foram verificadas em unidades intensivas após o uso de protocolos. Ademais, a adoção de protocolos para prevenção de úlcera por pressão é uma decisão estratégica eficaz, que além de diminuir a incidência, otimiza recursos, melhora a qualidade da assistência, fortalece as práticas assistenciais. Conclusão: Os protocolos promovem impactos positivos sobre a prevenção das úlceras por pressão e a qualidade de vida das pessoas, sendo um recurso essencial para um cuidado humanizado pautado nas necessidades de saúde.Introduction: Pressure ulcer is a medical condition that involves high costs and biopsychosocial consequences for the patients. Prevention protocols have been used to reduce pressure ulcers incidence, and it is important to emphasize the impact of this strategy on the health care

  19. Marine Pollution Prevention Act

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The Marine Pollution Prevention Act of 2008 implements the International Convention for the Prevention of Pollution from Ships, including related Protocols (MARPOL)...

  20. A cluster-randomised, controlled trial to assess the impact of a workplace osteoporosis prevention intervention on the dietary and physical activity behaviours of working women: study protocol

    OpenAIRE

    Tan, Ai May; LaMontagne, Anthony D; Sarmugam, Rani; Howard, Peter

    2013-01-01

    Background Osteoporosis is a debilitating disease and its risk can be reduced through adequate calcium consumption and physical activity. This protocol paper describes a workplace-based intervention targeting behaviour change in premenopausal women working in sedentary occupations. Method/Design A cluster-randomised design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the clusters and units of randomisation and intervention. Sample size calculat...

  1. Preventive nebulization of mucolytic agents and bronchodilating drugs in invasively ventilated intensive care unit patients (NEBULAE): study protocol for a randomized controlled trial.

    Science.gov (United States)

    van der Hoeven, Sophia M; Binnekade, Jan M; de Borgie, Corianne A J M; Bosch, Frank H; Endeman, Henrik; Horn, Janneke; Juffermans, Nicole P; van der Meer, Nardo J M; Merkus, Maruschka P; Moeniralam, Hazra S; van Silfhout, Bart; Slabbekoorn, Mathilde; Stilma, Willemke; Wijnhoven, Jan Willem; Schultz, Marcus J; Paulus, Frederique

    2015-09-02

    Preventive nebulization of mucolytic agents and bronchodilating drugs is a strategy aimed at the prevention of sputum plugging, and therefore atelectasis and pneumonia, in intubated and ventilated intensive care unit (ICU) patients. The present trial aims to compare a strategy using the preventive nebulization of acetylcysteine and salbutamol with nebulization on indication in intubated and ventilated ICU patients. The preventive nebulization of mucolytic agents and bronchodilating drugs in invasively ventilated intensive care unit patients (NEBULAE) trial is a national multicenter open-label, two-armed, randomized controlled non-inferiority trial in the Netherlands. Nine hundred and fifty intubated and ventilated ICU patients with an anticipated duration of invasive ventilation of more than 24 hours will be randomly assigned to receive either a strategy consisting of preventive nebulization of acetylcysteine and salbutamol or a strategy consisting of nebulization of acetylcysteine and/or salbutamol on indication. The primary endpoint is the number of ventilator-free days and surviving on day 28. Secondary endpoints include ICU and hospital length of stay, ICU and hospital mortality, the occurrence of predefined pulmonary complications (acute respiratory distress syndrome, pneumonia, large atelectasis and pneumothorax), and the occurrence of predefined side effects of the intervention. Related healthcare costs will be estimated in a cost-benefit and budget-impact analysis. The NEBULAE trial is the first randomized controlled trial powered to investigate whether preventive nebulization of acetylcysteine and salbutamol shortens the duration of ventilation in critically ill patients. NCT02159196, registered on 6 June 2014.

  2. Preventing acute rejection, Epstein-Barr virus infection, and posttransplant lymphoproliferative disorders after kidney transplantation: Use of aciclovir and mycophenolate mofetil in a steroid-free immunosuppressive protocol

    DEFF Research Database (Denmark)

    Birkeland, S.A.; Andersen, H.K.; Hamilton-Dutoit, Stephen Jacques

    1999-01-01

    Background: A widely held view is that any increase in the potency of an immunosuppressive agent will lead to an increase in infection and malignancy, such as life-threatening Epstein-Barr virus (EBV) induced posttransplant lymphoproliferative disorders (PTLD), We tested this paradigm by studying......; the effect of adding mofetil to a steroid-free protocol under cover of high-dose aciclovir prophylaxis on the number of acute rejections, EBV infections and PTLDs after kidney transplantation. Methods: EBV serology was performed in 267 consecutive renal transplantations (1990-1997), All were treated...

  3. Value-based cognitive-behavioural therapy for the prevention of chronic whiplash associated disorders: protocol of a randomized controlled trial.

    Science.gov (United States)

    Andersen, Tonny Elmose; Ravn, Sophie Lykkegaard; Roessler, Kirsten Kaya

    2015-09-01

    Whiplash injury is the most common traffic-related injury affecting thousands of people every year. Conservative treatments have not proven effective in preventing persistent symptoms and disability after whiplash injury. Early established maladaptive pain behaviours within the first weeks after the injury may explain part of the transition from acute to chronic whiplash associated disorder (WAD). Hence, early targeting of psychological risk factors such as pain catastrophizing, fear-avoidance-beliefs, depression, and symptoms of posttraumatic stress disorder (PTSD) may be important in preventing the development of chronic WAD. Some evidence exists that targeting fear-avoidance beliefs and PTSD with exposure strategies and value-based actions may prevent development of persistent disability after whiplash injury. Yet, the results have to be tested in a randomized controlled trial (RCT). The primary objective of the present study is to test whether a specifically tailored value-based cognitive-behavioural therapy program (V-CBT) is able to prevent the development of persistent disability, pain, and psychological distress if delivered within the first three months after a whiplash injury. The current study is a two-armed randomized controlled study with a crossover design. Group A is scheduled for V-CBT within one week of randomization and group B with a delayed onset 3 months after randomization. If the study detects significant effects of V-CBT as a preventive intervention, the study will provide new insights of preventive treatment for patients with WAD and thereby serve as an important step towards preventing the chronic condition. Current Controlled Trials Registration September 19, 2014: NCT02251028.

  4. Residual nilpotence and residual solubility of groups

    International Nuclear Information System (INIS)

    Mikhailov, R V

    2005-01-01

    The properties of the residual nilpotence and the residual solubility of groups are studied. The main objects under investigation are the class of residually nilpotent groups such that each central extension of these groups is also residually nilpotent and the class of residually soluble groups such that each Abelian extension of these groups is residually soluble. Various examples of groups not belonging to these classes are constructed by homological methods and methods of the theory of modules over group rings. Several applications of the theory under consideration are presented and problems concerning the residual nilpotence of one-relator groups are considered.

  5. Measures for radiation prevention and remediation of islightly radioactive contaminated sites by phytoremediation and subsequent utilization of the loaded plant residues (PHYTOREST). Final report

    International Nuclear Information System (INIS)

    Willscher, Sabine; Werner, Peter; Jablonski, Lukasz; Wittig, Juliane

    2013-01-01

    contaminated geosubstrates now can be carried out within the radiation protection regulations. Hence, the project provides a substantial contribution to the radiation protection of HM/R contaminated soils. Within the research project, ways for the utilization of HM/R- contaminated plant residuals were highlighted; this gives a substantial contribution for minimization of wastes, the winning of sustainable bioenergy and the recycling of materials. Here, different ways of solutions were investigated. The research project was carried out within the scientific funding program ''Closedown and decommissioning of nuclear facilities''. The results of the project will contribute to the development of a biologically benign, sustainable technique for the remediation of large contaminated areas that originate mostly from the legacy of the former U mining. As a general result of this comprehensive research project, a phytostabilization/ phytoextraction of such SM/R contaminated sites is feasible with a protection of ground water, and the plant crop from phytoremediation of the HM/R contaminated field site can be utilized for the winning of bioenergy (gaseous/ liquid products or thermal utilization). The beneficial combination of phytoremediation and subsequent utilization of the biomass can be further developed to an innovative and sustainable remediation technology with national and international application potential.

  6. A Three-Year Follow-Up Study of Antibiotic and Metal Residues, Antibiotic Resistance and Resistance Genes, Focusing on Kshipra—A River Associated with Holy Religious Mass-Bathing in India: Protocol Paper

    Directory of Open Access Journals (Sweden)

    Vishal Diwan

    2017-05-01

    Full Text Available Background: Antibiotic resistance (ABR is one of the major health emergencies for global society. Little is known about the ABR of environmental bacteria and therefore it is important to understand ABR reservoirs in the environment and their potential impact on health. Method/Design: Quantitative and qualitative data will be collected during a 3-year follow-up study of a river associated with religious mass-bathing in Central India. Surface-water and sediment samples will be collected from seven locations at regular intervals for 3 years during religious mass-bathing and in absence of it to monitor water-quality, antibiotic residues, resistant bacteria, antibiotic resistance genes and metals. Approval has been obtained from the Ethics Committee of R.D. Gardi Medical College, Ujjain, India (No. 2013/07/17-311. Results: The results will address the issue of antibiotic residues and antibiotic resistance with a focus on a river environment in India within a typical socio-behavioural context of religious mass-bathing. It will enhance our understanding about the relationship between antibiotic residue levels, water-quality, heavy metals and antibiotic resistance patterns in Escherichia coli isolated from river-water and sediment, and seasonal differences that are associated with religious mass-bathing. We will also document, identify and clarify the genetic differences/similarities relating to phenotypic antibiotic resistance in bacteria in rivers during religious mass-bathing or during periods when there is no mass-bathing.

  7. A Three-Year Follow-Up Study of Antibiotic and Metal Residues, Antibiotic Resistance and Resistance Genes, Focusing on Kshipra-A River Associated with Holy Religious Mass-Bathing in India: Protocol Paper.

    Science.gov (United States)

    Diwan, Vishal; Purohit, Manju; Chandran, Salesh; Parashar, Vivek; Shah, Harshada; Mahadik, Vijay K; Stålsby Lundborg, Cecilia; Tamhankar, Ashok J

    2017-05-29

    Antibiotic resistance (ABR) is one of the major health emergencies for global society. Little is known about the ABR of environmental bacteria and therefore it is important to understand ABR reservoirs in the environment and their potential impact on health. Quantitative and qualitative data will be collected during a 3-year follow-up study of a river associated with religious mass-bathing in Central India. Surface-water and sediment samples will be collected from seven locations at regular intervals for 3 years during religious mass-bathing and in absence of it to monitor water-quality, antibiotic residues, resistant bacteria, antibiotic resistance genes and metals. Approval has been obtained from the Ethics Committee of R.D. Gardi Medical College, Ujjain, India (No. 2013/07/17-311). The results will address the issue of antibiotic residues and antibiotic resistance with a focus on a river environment in India within a typical socio-behavioural context of religious mass-bathing. It will enhance our understanding about the relationship between antibiotic residue levels, water-quality, heavy metals and antibiotic resistance patterns in Escherichia coli isolated from river-water and sediment, and seasonal differences that are associated with religious mass-bathing. We will also document, identify and clarify the genetic differences/similarities relating to phenotypic antibiotic resistance in bacteria in rivers during religious mass-bathing or during periods when there is no mass-bathing.

  8. Smartphone-based safety planning and self-monitoring for suicidal patients : Rationale and study protocol of the CASPAR (Continuous Assessment for Suicide Prevention And Research) study

    NARCIS (Netherlands)

    Nuij, Chani; van Ballegooijen, Wouter; Ruwaard, Jeroen; de Beurs, Derek; Mokkenstorm, Jan; van Duijn, Erik; de Winter, Remco F.P.; O'Connor, Rory C.; Smit, Jan H.; Riper, Heleen; Kerkhof, Ad

    2018-01-01

    Background: It remains difficult to predict and prevent suicidal behaviour, despite growing understanding of the aetiology of suicidality. Clinical guidelines recommend that health care professionals develop a safety plan in collaboration with their high-risk patients, to lower the imminent risk of

  9. Trial for the Prevention of Depression (TriPoD) in final-year secondary students : Study protocol for a cluster randomised controlled trial

    NARCIS (Netherlands)

    Perry, Yael; Calear, Alison L.; Mackinnon, Andrew; Batterham, Philip J.; Licinio, Julio; King, Catherine; Thomsen, Noel; Scott, Jan; Donker, Tara; Merry, Sally; Fleming, Theresa; Stasiak, Karolina; Werner-Seidler, Aliza; Christensen, Helen

    2015-01-01

    Background: Evidence suggests that current treatments cannot fully alleviate the burden of disease associated with depression but that prevention approaches offer a promising opportunity to further reduce this burden. Adolescence is a critical period in the development of mental illness, and final

  10. Effectiveness of adolescent suicide prevention e-learning modules that aim to improve knowledge and self-confidence of gatekeepers: Study protocol of a randomized controlled trial

    NARCIS (Netherlands)

    Ghoncheh, R.; Kerkhof, A.J.F.M.; Koot, H.M.

    2014-01-01

    Background: Providing e-learning modules can be an effective strategy for enhancing gatekeepers' knowledge, self-confidence and skills in adolescent suicide prevention. The aim of this study was to test the effectiveness of an online training program called Mental Health Online which consists of

  11. In Preparation of the Nationwide Dissemination of the School-Based Obesity Prevention Program DOiT: Stepwise Development Applying the Intervention Mapping Protocol

    NARCIS (Netherlands)

    van Nassau, F.; Singh, A.S.; van Mechelen, W.; Brug, J.; Chin A Paw, M.J.M.

    2014-01-01

    BACKGROUND: The school-based Dutch Obesity Intervention in Teenagers (DOiT) program is an evidence-based obesity prevention program. In preparation for dissemination throughout the Netherlands, this study aimed to adapt the initial program and to develop an implementation strategy and materials.

  12. The effectiveness of a trauma-focused psycho-educational secondary prevention program for children exposed to interparental violence: study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Overbeek, M.M.; de Schipper, J.C.; Lamers-Winkelman, F.; Schuengel, C.

    2012-01-01

    Background: Children who witness interparental violence are at a heightened risk for developing psychosocial, behavioral and cognitive problems, as well as posttraumatic stress symptoms. For these children the psycho-educational secondary prevention program 'En nu ik...!' ('It's my turn now!') has

  13. Evaluation of a Dutch school-based depression prevention program for youths in highrisk neighborhoods: study protocol of a two-armed randomized controlled trial

    NARCIS (Netherlands)

    Kindt, K.C.M.; Zundert, R.M.P. van; Engels, R.C.M.E.

    2012-01-01

    Background Research has indicated that depression prevention programs attenuate the development of symptoms of depression in adolescents. To implement these programs on a large scale, implementation in a school setting with teachers providing the programs is needed. In the present study, the

  14. In Preparation of the Nationwide Dissemination of the School-Based Obesity Prevention Program DOiT: Stepwise Development Applying the Intervention Mapping Protocol

    Science.gov (United States)

    van Nassau, Femke; Singh, Amika S.; van Mechelen, Willem; Brug, Johannes; Chin A. Paw, Mai J. M.

    2014-01-01

    Background: The school-based Dutch Obesity Intervention in Teenagers (DOiT) program is an evidence-based obesity prevention program. In preparation for dissemination throughout the Netherlands, this study aimed to adapt the initial program and to develop an implementation strategy and materials. Methods: We revisited the Intervention Mapping (IM)…

  15. INTroducing A Care bundle To prevent pressure injury (INTACT) in at-risk patients: A protocol for a cluster randomised trial.

    Science.gov (United States)

    Chaboyer, Wendy; Bucknall, Tracey; Webster, Joan; McInnes, Elizabeth; Banks, Merrilyn; Wallis, Marianne; Gillespie, Brigid M; Whitty, Jennifer A; Thalib, Lukman; Roberts, Shelley; Cullum, Nicky

    2015-11-01

    Pressure injuries are a significant clinical and economic issue, affecting both patients and the health care system. Many pressure injuries in hospitals are facility acquired, and are largely preventable. Despite growing evidence and directives for pressure injury prevention, implementation of preventative strategies is suboptimal, and pressure injuries remain a serious problem in hospitals. This study will test the effectiveness and cost-effectiveness of a patient-centred pressure injury prevention care bundle on the development of hospital acquired pressure injury in at-risk patients. This is a multi-site, parallel group cluster randomised trial. The hospital is the unit of randomisation. Adult medical and surgical patients admitted to the study wards of eight hospitals who are (a) deemed to be at risk of pressure injury (i.e. have reduced mobility), (b) expected to stay in hospital for ≥48h, (c) admitted to hospital in the past 36h; and (d) able to provide informed consent will be eligible to participate. Consenting patients will receive either the pressure injury prevention care bundle or standard care. The care bundle contains three main messages: (1) keep moving; (2) look after your skin; and (3) eat a healthy diet. Nurses will receive education about the intervention. Patients will exit the study upon development of a pressure injury, hospital discharge or 28 days, whichever comes first; transfer to another hospital or transfer to critical care and mechanically ventilated. The primary outcome is incidence of hospital acquired pressure injury. Secondary outcomes are pressure injury stage, patient participation in care and health care costs. A health economic sub-study and a process evaluation will be undertaken alongside the trial. Data will be analysed at the cluster (hospital) and patient level. Estimates of hospital acquired pressure injury incidence in each group, group differences and 95% confidence interval and p values will be reported. To our

  16. An entanglement concentration protocol for cluster states using ...

    Indian Academy of Sciences (India)

    Permanent link: http://www.ias.ac.in/article/fulltext/pram/086/05/0973-0983 ... The purpose of this paper is a proposal on entanglement concentration protocol forcluster states. The protocol ... We also make a comparative numerical study of the residual entanglement left out after the execution of each step of the protocol.

  17. An interdisciplinary intervention to prevent falls in community-dwelling elderly persons: protocol of a cluster-randomized trial [PreFalls

    Directory of Open Access Journals (Sweden)

    Schuster Tibor

    2011-02-01

    Full Text Available Abstract Background Prevention of falls in the elderly is a public health target in many countries around the world. While a large number of trials have investigated the effectiveness of fall prevention programs, few focussed on interventions embedded in the general practice setting and its related network. In the Prevent Falls (PreFalls trial we aim to investigate the effectiveness of a pre-tested multi-modal intervention compared to usual care in this setting. Methods/Design PreFalls is a controlled multicenter prospective study with cluster-randomized allocation of about 40 general practices to an experimental or a control group. We aim to include 382 community dwelling persons aged 65 and older with an increased risk of falling. All participating general practitioners are trained to systematically assess the risk of falls using a set of validated tests. Patients from intervention practices are invited to participate in a 16-weeks exercise program with focus on fall prevention delivered by specifically trained local physiotherapists. Patients from practices allocated to the control group receive usual care. Main outcome measure is the number of falls per individual in the first 12 months (analysis by negative binomial regression. Secondary outcomes include falls in the second year, the proportion of participants falling in the first and the second year, falls associated with injury, risk of falls, fear of falling, physical activity and quality of life. Discussion Reducing falls in the elderly remains a major challenge. We believe that with its strong focus on a both systematic and realistic fall prevention strategy adapted to primary care setting PreFalls will be a valuable addition to the scientific literature in the field. Trial registration NCT01032252

  18. Cost effectiveness of preventing falls and improving mobility in people with Parkinson disease: protocol for an economic evaluation alongside a clinical trial

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2008-09-01

    Full Text Available Abstract Background Cost of illness studies show that Parkinson disease (PD is costly for individuals, the healthcare system and society. The costs of PD include both direct and indirect costs associated with falls and related injuries. Methods This protocol describes a prospective economic analysis conducted alongside a randomised controlled trial (RCT. It evaluates whether physical therapy is more cost effective than usual care from the perspective of the health care system. Cost effectiveness will be evaluated using a three-way comparison of the cost per fall averted and the cost per quality adjusted life year saved across two physical therapy interventions and a control group. Conclusion This study has the potential to determine whether targetted physical therapy as an adjunct to standard care can be cost effective in reducing falls in people with PD. Trial Registration No: ACTRN12606000344594

  19. A Healthy School Start Plus for prevention of childhood overweight and obesity in disadvantaged areas through parental support in the school setting - study protocol for a parallel group cluster randomised trial.

    Science.gov (United States)

    Elinder, Liselotte Schäfer; Patterson, Emma; Nyberg, Gisela; Norman, Åsa

    2018-04-06

    Systematic reviews conclude that interventions to prevent overweight and obesity in children obtain stronger effects when parents are involved. Parenting practices and parent-child interactions shape children's health-related behaviours. The Healthy School Start Plus intervention aims to promote healthy dietary habits and physical activity and prevent obesity in children through parental support in disadvantaged areas with increased health needs, delivered by teachers and school nurses. This protocol describes the design, outcome and process evaluation of the study. Effectiveness of the intervention is compared to standard care within school health services. The 6-month programme, based on Social Cognitive Theory, consists of four components: 1) Health information to parents regarding the child; 2) Motivational Interviewing with the parents by the school nurse concerning the child; 3) classroom activities for the children by teachers; and 4) a web-based self-test of type-2 diabetes risk by parents. Effects will be studied in a cluster randomised trial including 17 schools and 352 six-year old children. The primary outcome is dietary intake of indicator foods, and secondary outcomes are physical activity, sedentary behaviour and BMI. Outcomes will be measured at baseline, at 6 months directly after the intervention, and at follow-up 18 months post baseline. Statistical analysis will be by mixed-effect regression analysis according to intention to treat and per protocol. Mediation analysis will be performed with parental self-efficacy and parenting practices. Quantitative and qualitative methods will be used to study implementation in terms of dose, fidelity, feasibility and acceptability. The hypothesis is that the programme will be more effective than standard care and feasible to perform in the school context. The programme is in line with the cumulated evidence regarding the prevention of childhood obesity: That schools should be a focal point of prevention

  20. 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...

  1. Facilitators and barriers to the delivery of school-based smoking prevention interventions for children and young people: a protocol for a systematic review of qualitative studies.

    Science.gov (United States)

    Dobbie, Fiona; Angus, Kathryn; Littlecott, Hannah; Allum, Karen; Wells, Valerie; Amos, Amanda; Haw, Sally; Bauld, Linda

    2018-04-06

    Despite a decline in child and adult smoking prevalence, young people who smoke (even occasionally) can rapidly become addicted to nicotine, with most adult smokers initiating smoking before they are 18. Schools have long been a popular setting to deliver youth smoking prevention interventions, but evidence of the effectiveness of school-based prevention programmes is mixed, and outcomes vary by the type of programme delivered. Existing systematic reviews that explore the factors contributing to the success or failure of school-based smoking prevention programmes often exclude qualitative studies, due to a focus on intervention effectiveness which qualitative research cannot answer. Instead, qualitative research is focussed on the experiences and perceptions of those involved in the programmes. This systematic review will address this gap by updating a 2009 review to examine qualitative studies. The aim is to generate deeper insight to help target resources which have the potential to save lives by preventing smoking initiation among children and young people. This systematic review will be searching the following databases: the Cochrane Library, MEDLINE, EMBASE, PsycINFO, HMIC, ERIC, ASSIA, Web of Science and CINAHL. In order to identify additional references, we will consult the reference lists of a sample of systematic reviews and search relevant organizational websites in order to identify appropriate grey literature. The search strategy will include key words and database-specific subject headings relating to smoking, children and young people, health promotion and school. Authors will independently screen, assess data quality and extract data for synthesis. Study findings will be synthesised thematically using 'best-fit framework syntheses'. This allows for an existing set of themes to be used as a starting point to map or code included studies. These themes are then adapted as coding takes place to accommodate new emerging themes. This review will focus on

  2. The effectiveness of an intervention in increasing community health clinician provision of preventive care: a study protocol of a non-randomised, multiple-baseline trial

    Directory of Open Access Journals (Sweden)

    McElwaine Kathleen M

    2011-12-01

    Full Text Available Abstract Background The primary behavioural risks for the most common causes of mortality and morbidity in developed countries are tobacco smoking, poor nutrition, risky alcohol use, and physical inactivity. Evidence, guidelines and policies support routine clinician delivery of care to prevent these risks within primary care settings. Despite the potential afforded by community health services for the delivery of such preventive care, the limited evidence available suggests it is provided at suboptimal levels. This study aims to assess the effectiveness of a multi-strategic practice change intervention in increasing clinician's routine provision of preventive care across a network of community health services. Methods/Design A multiple baseline study will be conducted involving all 56 community health facilities in a single health district in New South Wales, Australia. The facilities will be allocated to one of three administratively-defined groups. A 12 month practice change intervention will be implemented in all facilities in each group to facilitate clinician risk assessment of eligible clients, and clinician provision of brief advice and referral to those identified as being 'at risk'. The intervention will be implemented in a non-random sequence across the three facility groups. Repeated, cross-sectional measurement of clinician provision of preventive care for four individual risks (smoking, poor nutrition, risky alcohol use, and physical inactivity will occur continuously for all three facility groups for 54 months via telephone interviews. The interviews will be conducted with randomly selected clients who have visited a community health facility in the last two weeks. Data collection will commence 12 months prior to the implementation of the intervention in the first group, and continue for six months following the completion of the intervention in the last group. As a secondary source of data, telephone interviews will be undertaken

  3. The effectiveness of a trauma-focused psycho-educational secondary prevention program for children exposed to interparental violence: study protocol for a randomized controlled trial

    OpenAIRE

    Overbeek, M.M.; de Schipper, J.C.; Lamers-Winkelman, F.; Schuengel, C.

    2012-01-01

    Abstract Background Children who witness interparental violence are at a heightened risk for developing psychosocial, behavioral and cognitive problems, as well as posttraumatic stress symptoms. For these children the psycho-educational secondary prevention program 'En nu ik...!' ('It's my turn now!') has been developed. This program includes specific therapeutic factors focused on emotion awareness and expression, increasing feelings of emotional security, teaching specific coping strategies...

  4. The First-aid Advice and Safety Training (FAST) parents programme for the prevention of unintentional injuries in preschool children: a protocol.

    Science.gov (United States)

    Mytton, Julie A; Towner, Elizabeth Ml; Kendrick, Denise; Stewart-Brown, Sarah; Emond, Alan; Ingram, Jenny; Blair, Peter S; Powell, Jane; Mulvaney, Caroline; Thomas, James; Deave, Toity; Potter, Barbara

    2014-02-01

    Unintentional injury is the leading cause of preventable death in children in the UK, and 0-4-year-olds frequently attend emergency departments following injuries in the home. Parenting programmes designed to support parents, promote behaviour change and enhance parent-child relationships have been shown to improve health outcomes in children. It is not known whether group-based parenting programmes have the potential to prevent unintentional injuries in preschool children. A study to develop a group-based parenting programme to prevent unintentional home injuries in preschool children, and assess the feasibility of evaluation through a cluster-randomised controlled trial. The intervention, designed for parents of children who have sustained a medically attended injury, will be developed with two voluntary sector organisations. The feasibility study will assess ability to recruit parents, deliver the programme and follow-up participants. Participants will complete questionnaires at baseline, 3 months and 6 months, and report injuries in their preschool children using a tool designed and validated for this study. Qualitative methods will assess user and deliverer perceptions of the programme. This study will develop the first group-based parenting programme to prevent injuries in preschool children, and design tools for parent-reported injury outcomes. A key challenge will be to recruit parents to participate in a manner that is non-stigmatising, and does not result in feelings of guilt or belief that they are perceived to be a bad parent. The findings will be used to prepare a trial to assess the effectiveness and cost-effectiveness of the intervention.

  5. Effectiveness of adolescent suicide prevention e-learning modules that aim to improve knowledge and self-confidence of gatekeepers: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ghoncheh, Rezvan; Kerkhof, Ad J F M; Koot, Hans M

    2014-02-08

    Providing e-learning modules can be an effective strategy for enhancing gatekeepers' knowledge, self-confidence and skills in adolescent suicide prevention. The aim of this study was to test the effectiveness of an online training program called Mental Health Online which consists of eight short e-learning modules, each capturing an important aspect of the process of recognition, guidance and referral of suicidal adolescents (12-20 years). The primary outcomes of this study are participant's ratings on perceived knowledge, perceived self-confidence, and actual knowledge regarding adolescent suicidality. A randomized controlled trial will be carried out among 154 gatekeepers. After completing the first assessment (pre-test), participants will be randomly assigned to either the experimental group or the waitlist control group. One week after completing the first assessment the experimental group will have access to the website Mental Health Online containing the eight e-learning modules and additional information on adolescent suicide prevention. Participants in both conditions will be assessed 4 weeks after completing the first assessment (post-test), and 12 weeks after completing the post-test (follow-up). At post-test, participants from the experimental group are asked to complete an evaluation questionnaire on the modules. The waitlist control group will have access to the modules and additional information on the website after completing the follow-up assessment. Gatekeepers can benefit from e-learning modules on adolescent suicide prevention. This approach allows them to learn about this sensitive subject at their own pace and from any given location, as long as they have access to the Internet. Given the flexible nature of the program, each participant can compose his/her own training creating an instant customized course with the required steps in adolescent suicide prevention. Netherlands Trial Register NTR3625.

  6. Effectiveness of adolescent suicide prevention e-learning modules that aim to improve knowledge and self-confidence of gatekeepers: study protocol for a randomized controlled trial

    OpenAIRE

    Ghoncheh, Rezvan; Kerkhof, Ad JFM; Koot, Hans M

    2014-01-01

    Background Providing e-learning modules can be an effective strategy for enhancing gatekeepers’ knowledge, self-confidence and skills in adolescent suicide prevention. The aim of this study was to test the effectiveness of an online training program called Mental Health Online which consists of eight short e-learning modules, each capturing an important aspect of the process of recognition, guidance and referral of suicidal adolescents (12–20 years). The primary outcomes of this study are par...

  7. Effectiveness of adolescent suicide prevention e-learning modules that aim to improve knowledge and self-confidence of gatekeepers: Study protocol of a randomized controlled trial

    OpenAIRE

    Ghoncheh, R.; Kerkhof, A.J.F.M.; Koot, H.M.

    2014-01-01

    Background: Providing e-learning modules can be an effective strategy for enhancing gatekeepers' knowledge, self-confidence and skills in adolescent suicide prevention. The aim of this study was to test the effectiveness of an online training program called Mental Health Online which consists of eight short e-learning modules, each capturing an important aspect of the process of recognition, guidance and referral of suicidal adolescents (12-20 years). The primary outcomes of this study are pa...

  8. ICT-based system to predict and prevent falls (iStoppFalls): study protocol for an international multicenter randomized controlled trial

    OpenAIRE

    Gschwind, Yves J.; Eichberg, Sabine; Marston, Hannah R.; Ejupi, Andreas; De Rosario Martínez, Helios; Kroll, Michael; Drobics, Mario; Annegarn, Janneke; Wieching, Rainer; Lord, Stephen R.; Aal, Konstantin; Delbaere, Kim

    2014-01-01

    Background: Falls are very common, especially in adults aged 65 years and older. Within the current international European Commission's Seventh Framework Program (FP7) project 'iStoppFalls' an Information and Communication Technology (ICT) based system has been developed to regularly assess a person's risk of falling in their own home and to deliver an individual and tailored home-based exercise and education program for fall prevention. The primary aims of iStoppFalls are to assess the feasi...

  9. Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS: a protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Leistner Stefanie

    2013-01-01

    Full Text Available Abstract Background Patients with recent stroke or TIA are at high risk for new vascular events. Several evidence based strategies in secondary prevention of stroke are available but frequently underused. Support programs with multifactorial risk factor modifications after stroke or TIA have not been investigated in large-scale prospective controlled trials so far. INSPiRE-TMS is a prospective, multi-center, randomized open intervention trial for intensified secondary prevention after minor stroke and TIA. Methods/design Patients with acute TIA or minor stroke admitted to the participating stroke centers are screened and recruited during in-hospital stay. Patients are randomised in a 1:1 ratio to intervention (support program and control (usual care arms. Inclusion of 2.082 patients is planned. The support program includes cardiovascular risk factor measurement and feedback, monitoring of medication adherence, coaching in lifestyle modifications, and active involvement of relatives. Standardized motivational interviewing is used to assess and enhance patients’ motivation. Primary objective is a reduction of new major vascular events defined as nonfatal stroke and myocardial infarction or vascular death. Recruitment time is planned for 3.5 years, follow up time is at least 2 years for every patient resulting in a total study time of 5 years (first patient in to last patient out. Discussion Given the high risk for vascular re-events in acute stroke and the available effective strategies in secondary prevention, the INSPIRE-TMS support program has the potential to lead to a relevant reduction of recurrent events and a prolongation of the event-free survival time. The trial will provide the basis for the decision whether an intensified secondary prevention program after stroke should be implemented into regular care. A cost-effectiveness evaluation will be performed. Trial registration clinicaltrials.gov: 01586702

  10. Effectiveness of a multifactorial falls prevention program in community-dwelling older people when compared to usual care: study protocol for a randomised controlled trial (Prevquedas Brazil).

    Science.gov (United States)

    de Negreiros Cabral, Kelem; Perracini, Monica Rodrigues; Soares, Aline Thomaz; de Cristo Stein, Francine; Sera, Celisa Tiemi Nakagawa; Tiedemann, Anne; Sherrington, Cathie; Filho, Wilson Jacob; Paschoal, Sérgio Márcio Pacheco

    2013-03-15

    Falling in older age is a major public health concern due to its costly and disabling consequences. However very few randomised controlled trials (RCTs) have been conducted in developing countries, in which population ageing is expected to be particularly substantial in coming years. This article describes the design of an RCT to evaluate the effectiveness of a multifactorial falls prevention program in reducing the rate of falls in community-dwelling older people. Multicentre parallel-group RCT involving 612 community-dwelling men and women aged 60 years and over, who have fallen at least once in the previous year. Participants will be recruited in multiple settings in Sao Paulo, Brazil and will be randomly allocated to a control group or an intervention group. The usual care control group will undergo a fall risk factor assessment and be referred to their clinicians with the risk assessment report so that individual modifiable risk factors can be managed without any specific guidance. The intervention group will receive a 12-week Multifactorial Falls Prevention Program consisting of: an individualised medical management of modifiable risk factors, a group-based, supervised balance training exercise program plus an unsupervised home-based exercise program, an educational/behavioral intervention. Both groups will receive a leaflet containing general information about fall prevention strategies. Primary outcome measures will be the rate of falls and the proportion of fallers recorded by monthly falls diaries and telephone calls over a 12 month period. Secondary outcomes measures will include risk of falling, fall-related self-efficacy score, measures of balance, mobility and strength, fall-related health services use and independence with daily tasks. Data will be analysed using the intention-to-treat principle.The incidence of falls in the intervention and control groups will be calculated and compared using negative binomial regression analysis. This study is the

  11. A falls prevention programme to improve quality of life, physical function and falls efficacy in older people receiving home help services: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Bjerk, Maria; Brovold, Therese; Skelton, Dawn A; Bergland, Astrid

    2017-08-14

    Falls and fall-related injuries in older adults are associated with great burdens, both for the individuals, the health care system and the society. Previous research has shown evidence for the efficiency of exercise as falls prevention. An understudied group are older adults receiving home help services, and the effect of a falls prevention programme on health-related quality of life is unclear. The primary aim of this randomised controlled trial is to examine the effect of a falls prevention programme on quality of life, physical function and falls efficacy in older adults receiving home help services. A secondary aim is to explore the mediating factors between falls prevention and health-related quality of life. The study is a single-blinded randomised controlled trial. Participants are older adults, aged 67 or older, receiving home help services, who are able to walk with or without walking aids, who have experienced at least one fall during the last 12 months and who have a Mini Mental State Examination of 23 or above. The intervention group receives a programme, based on the Otago Exercise Programme, lasting 12 weeks including home visits and motivational telephone calls. The control group receives usual care. The primary outcome is health-related quality of life (SF-36). Secondary outcomes are leg strength, balance, walking speed, walking habits, activities of daily living, nutritional status and falls efficacy. All measurements are performed at baseline, following intervention at 3 months and at 6 months' follow-up. Sample size, based on the primary outcome, is set to 150 participants randomised into the two arms, including an estimated 15-20% drop out. Participants are recruited from six municipalities in Norway. This trial will generate new knowledge on the effects of an exercise falls prevention programme among older fallers receiving home help services. This knowledge will be useful for clinicians, for health managers in the primary health care service

  12. 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...

  13. Trial Protocol: Home-based exercise programs to prevent falls and upper limb dysfunction among community-dwelling older people: study protocol for the BEST (Balance Exercise Strength Training at Home randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Amanda Bates

    2018-04-01

    Full Text Available Introduction: Falling when older is a major public health issue. There is compelling evidence to show that specific exercise programs can reduce the risk and rate of falls in community-dwelling older people. Another major health issue for older people living in the community is upper limb dysfunction, including shoulder pain. Home-based exercise programs appeal to some older people, due to their convenience. Research questions: This trial aims to determine the effectiveness and cost-effectiveness of a home-based lower limb exercise program compared with a home-based upper limb exercise program to prevent falls and upper limb dysfunction among community-dwelling people aged 65+ years. Design: Randomised, controlled trial. Participants and setting: A total of 576 community-dwelling people will be recruited from the Illawarra and Shoalhaven regions of New South Wales, Australia. Intervention: Participants will be randomised to either a home-based lower limb exercise intervention or a home-based upper limb exercise intervention. The lower limb program is designed to improve balance and strength in the lower limbs. The upper limb program is designed to improve upper limb strength and mobility. Participants will attend three group-based instruction sessions to learn and progress the exercises, and will be instructed to perform the exercises three times per week at home for 12 months. Outcome measures: The two primary outcomes will be fall rates, recorded with monthly calendars for a 12-month period, and upper limb dysfunction, measured with the Disability of the Arm, Shoulder and Hand questionnaire. Secondary outcomes will include: lower limb strength and balance; shoulder strength and mobility; physical activity; quality of life; attitudes to exercise; proportion of fallers; fear of falling; and health and community service use. The cost-effectiveness of both exercise programs from a health and community service provider perspective will be evaluated

  14. Trial Protocol: Home-based exercise programs to prevent falls and upper limb dysfunction among community-dwelling older people: study protocol for the BEST (Balance Exercise Strength Training) at Home randomised, controlled trial.

    Science.gov (United States)

    Bates, Amanda; Furber, Susan; Tiedemann, Anne; Ginn, Karen; van den Dolder, Paul; Howard, Kirsten; Bauman, Adrian; Chittenden, Catherine; Franco, Lisa; Kershaw, Michelle; Sherrington, Catherine

    2018-04-01

    Falling when older is a major public health issue. There is compelling evidence to show that specific exercise programs can reduce the risk and rate of falls in community-dwelling older people. Another major health issue for older people living in the community is upper limb dysfunction, including shoulder pain. Home-based exercise programs appeal to some older people, due to their convenience. This trial aims to determine the effectiveness and cost-effectiveness of a home-based lower limb exercise program compared with a home-based upper limb exercise program to prevent falls and upper limb dysfunction among community-dwelling people aged 65+ years. Randomised, controlled trial. A total of 576 community-dwelling people will be recruited from the Illawarra and Shoalhaven regions of New South Wales, Australia. Participants will be randomised to either a home-based lower limb exercise intervention or a home-based upper limb exercise intervention. The lower limb program is designed to improve balance and strength in the lower limbs. The upper limb program is designed to improve upper limb strength and mobility. Participants will attend three group-based instruction sessions to learn and progress the exercises, and will be instructed to perform the exercises three times per week at home for 12 months. The two primary outcomes will be fall rates, recorded with monthly calendars for a 12-month period, and upper limb dysfunction, measured with the Disability of the Arm, Shoulder and Hand questionnaire. Secondary outcomes will include: lower limb strength and balance; shoulder strength and mobility; physical activity; quality of life; attitudes to exercise; proportion of fallers; fear of falling; and health and community service use. The cost-effectiveness of both exercise programs from a health and community service provider perspective will be evaluated. Negative binomial regression models will be used to estimate the between-group difference in fall rates. Modified

  15. Mindfulness-based relapse prevention combined with virtual reality cue exposure for methamphetamine addiction: Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Chen, XiJing; Wang, Dongmei; Zhou, Lidan; Winkler, Markus; Pauli, Paul; Sui, Nan; Li, Yonghui

    2018-04-18

    Mindfulness-based relapse prevention (MBRP) is a method that combines cognitive behavioral relapse prevention with mindfulness practice. Research shows that MBRP can effectively reduce negative emotions and craving in people with substance use disorders (SUDs). An important part of MBRP is to practice mindfulness meditation to cope with high-risk situations for relapse, such as stimuli and situations associated with drug taking. Virtual reality cue exposure (VRCE) may be a complementary approach to MBRP as it allows for controlled and graded presentations of various high-risk situations with distal and proximal drug cues. The aim of the study is to investigate the effects of MBRP combined with VRCE, in comparison to MBRP alone or treatment as usual, on craving and emotional responses in people with methamphetamine use disorders. The study is a parallel randomized controlled study including 180 participants with methamphetamine use disorders. Three parallel groups will receive 8 weeks of MBRP combined with VRCE, MBRP alone, or treatment as usual, respectively. Craving, virtual cue reactivity, anxiety, depression, emotion regulation, mindfulness and drug-related attention bias will be assessed at pre-treatment, post-treatment, and 3 and 6 months of follow-up. This innovative study aims at investigating the effects of MBRP combined with VRCE in people with SUDs. The combined intervention may have important clinical implications for relapse prevention due to its ease of application and high cost-effectiveness. This study may also stimulate research on the neuronal and psychological mechanisms of MBRP in drug addiction. ChiCTR-INR-17013041. Copyright © 2018. Published by Elsevier Inc.

  16. Effects of complex interventions in 'skin cancer prevention and treatment': protocol for a mixed-method systematic review with qualitative comparative analysis.

    Science.gov (United States)

    Beifus, Karolina; Breitbart, Eckhard; Köberlein-Neu, Juliane

    2017-09-05

    Occurring from ultraviolet radiation combined with impairing ozone levels, uncritical sun exposure and use of tanning beds an increasing number of people are affected by different types of skin cancer. But preventive interventions like skin cancer screening are still missing the evidence for effectiveness and therefore are criticised. Fundamental for an appropriate course of action is to approach the defined parameters as measures for effectiveness critically. A prerequisite should be the critical application of used parameter that are defined as measures for effectiveness. This research seeks to establish, through the available literature, the effects and conditions that prove the effectiveness of prevention strategies in skin cancer. A mixed-method approach is employed to combine quantitative to qualitative methods and answer what effects can display effectiveness considering time horizon, perspective and organisational level and what are essential and sufficient conditions to prove effectiveness and cost-effectiveness in skin cancer prevention strategies. A systematic review will be performed to spot studies from any design and assess the data quantitatively and qualitatively. Included studies from each key question will be summarised by characteristics like population, intervention, comparison, outcomes, study design, endpoints, effect estimator and so on. Beside statistical relevancies for a systematic review the qualitative method of qualitative comparative analysis (QCA) will be performed. The estimated outcomes from this review and QCA are the accomplishment and absence of effects that are appropriate for application in effectiveness assessments and further cost-effectiveness assessment. Formal ethical approval is not required as primary data will not be collected. International Prospective Register for Systematic Reviews number CRD42017053859. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights

  17. Room temperature stable carbetocin for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Widmer, Mariana; Piaggio, Gilda; Abdel-Aleem, Hany; Carroli, Guillermo; Chong, Yap-Seng; Coomarasamy, Arri; Fawole, Bukola; Goudar, Shivaprasad; Hofmeyr, G Justus; Lumbiganon, Pisake; Mugerwa, Kidza; Nguyen, Thi My Huong; Qureshi, Zahida; Souza, Joao Paulo; Gülmezoglu, A Metin

    2016-03-17

    Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and contributes to nearly a quarter of maternal deaths globally. The current available interventions for prevention of postpartum haemorrhage, oxytocin and carbetocin, are limited by their need for refrigeration to maintain potency, as the ability to maintain a cold chain across the drug distribution and storage network is inconsistent, thus restricting their use in countries with the highest burden of maternal mortality. We describe a randomized, double-blind non-inferiority trial comparing a newly developed room temperature stable formulation of carbetocin to the standard intervention (oxytocin) for the prevention of PPH after vaginal birth. Approximately 30,000 women delivering vaginally will be recruited across 22 centres in 10 countries. The primary objectives are to evaluate the non-inferiority of room temperature stable carbetocin (100 μg intramuscular) versus oxytocin (10 IU intramuscular) in the prevention of PPH and severe PPH after vaginal birth. The primary endpoints are blood loss ≥500 mL or the use of additional uterotonics (composite endpoint required by drug regulatory authorities) and blood loss ≥1,000 mL (WHO requirement). Non-inferiority will be assessed using a two-sided 95 % confidence interval for the relative risk of the above endpoints for room temperature stable carbetocin versus oxytocin. The upper limit of the two-sided 95 % confidence interval for the relative risk for the composite endpoint of blood loss ≥500 mL or the use of additional uterotonics, and for the endpoint of blood loss ≥1,000 mL, will be compared to a non-inferiority margin of 1.16 and 1.23, respectively. If the upper limit is below the corresponding margin, non-inferiority will have been demonstrated. The safety analysis will include all women receiving treatment. Safety and tolerability will be assessed by a review of adverse events, by conducting inferential testing

  18. Evaluation of a Dutch school-based depression prevention program for youths in highrisk neighborhoods: study protocol of a two-armed randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kindt Karlijn CM

    2012-03-01

    Full Text Available Abstract Background Research has indicated that depression prevention programs attenuate the development of symptoms of depression in adolescents. To implement these programs on a large scale, implementation in a school setting with teachers providing the programs is needed. In the present study, the effectiveness of the Dutch depression prevention program Op Volle Kracht (OVK provided by school teachers during school hours with adolescents from high risk neighborhoods will be tested. The mediating effects of cognitive distortions and alexithymia will be evaluated as well. We hypothesize that the OVK program will prevent or decrease reported depressive symptoms, and that this association will be mediated by cognitive distortions and alexithymia. Methods/Design Schools with at least 30% of their pupils living in low income areas in the Netherlands are invited to participate in the study. Classes from vocational training up to pre-university level are eligible and 1324 adolescents (11-14 years will be participating in the study. Randomisation will be done at class level, randomly assigning participants to an intervention group (OVK and a control group (care as usual, stratifying by school level (high versus low. Trained school teachers will be delivering the program, which covers cognitive-behavioral and social problem-solving skills. Longitudinal data will be collected with self-report measurements administered in the school setting at baseline, post intervention and at two follow ups (at 6 and 12 months. Primary outcome is the level of depressive symptoms, and secondary outcomes include: cognitive errors, response style, attributional style, alexithymia, stressful life events, substance use, happiness, and school grades. Discussion If the OVK program proves to be effective when it is provided by school teachers, a structural implementation of the program in the school curriculum will enhance the quality of the lives of adolescents and their

  19. Protocol for the "Michigan Awareness Control Study": A prospective, randomized, controlled trial comparing electronic alerts based on bispectral index monitoring or minimum alveolar concentration for the prevention of intraoperative awareness

    Directory of Open Access Journals (Sweden)

    Avidan Michael S

    2009-11-01

    Full Text Available Abstract Background The incidence of intraoperative awareness with explicit recall is 1-2/1000 cases in the United States. The Bispectral Index monitor is an electroencephalographic method of assessing anesthetic depth that has been shown in one prospective study to reduce the incidence of awareness in the high-risk population. In the B-Aware trial, the number needed to treat in order to prevent one case of awareness in the high-risk population was 138. Since the number needed to treat and the associated cost of treatment would be much higher in the general population, the efficacy of the Bispectral Index monitor in preventing awareness in all anesthetized patients needs to be clearly established. This is especially true given the findings of the B-Unaware trial, which demonstrated no significant difference between protocols based on the Bispectral Index monitor or minimum alveolar concentration for the reduction of awareness in high risk patients. Methods/Design To evaluate efficacy in the general population, we are conducting a prospective, randomized, controlled trial comparing the Bispectral Index monitor to a non-electroencephalographic gauge of anesthetic depth. The total recruitment for the study is targeted for 30,000 patients at both low and high risk for awareness. We have developed a novel algorithm that is capable of real-time analysis of our electronic perioperative information system. In one arm of the study, anesthesia providers will receive an electronic page if the Bispectral Index value is >60. In the other arm of the study, anesthesia providers will receive a page if the age-adjusted minimum alveolar concentration is Discussion Awareness during general anesthesia is a persistent problem and the role of the Bispectral Index monitor in its prevention is still unclear. The Michigan Awareness Control Study is the largest prospective trial of awareness prevention ever conducted. Trial Registration Clinical Trial NCT00689091

  20. Protocol for a randomised controlled trial of a school based cognitive behaviour therapy (CBT intervention to prevent depression in high risk adolescents (PROMISE

    Directory of Open Access Journals (Sweden)

    Sayal Kapil

    2010-11-01

    Full Text Available Abstract Background Depression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood. Relatively few adolescents with depression are identified and referred for treatment indicating the need to investigate alternative preventive approaches. Study Design A pragmatic cluster randomised controlled trial evaluating the effectiveness of a school based prevention programme on symptoms of depression in "high risk" adolescents (aged 12-16. The unit of allocation is year groups (n = 28 which are assigned to one of three conditions: an active intervention based upon cognitive behaviour therapy, attention control or treatment as usual. Assessments will be undertaken at screening, baseline, 6 months and 12 months. The primary outcome measure is change on the Short Mood and Feeling Questionnaire at 12 months. Secondary outcome measures will assess changes in negative thoughts, self esteem, anxiety, school connectedness, peer attachment, alcohol and substance misuse, bullying and self harm. Discussion As of August 2010, all 28 year groups (n = 5023 had been recruited and the assigned interventions delivered. Final 12 month assessments are scheduled to be completed by March 2011. Trial Registration ISRCTN19083628

  1. A Multi-Center Randomized Controlled Trial of Adding Brief Skill-Based Psychoeducation to Primary Needle and Syringe Programs to prevent Human Immunodeficiency Virus: Study Protocol.

    Directory of Open Access Journals (Sweden)

    Morteza Naserbakht

    2014-09-01

    Full Text Available Our objective was to design an RCT in order to assess the effects of adding a brief skill-based psychoeducation (PE to routine Needle and Syringe Programs to reduce injection and high risk sexual behaviors associated with Human Immunodeficiency Virus (HIV infection among referrals of Drop-in Centers (DICs.This was a randomized control trial with the primary hypothesis that adding skill-based PE to the routine needle syringe program (NSP provided in the DICs would be more effective in reducing injection and high risk sexual behaviors associated with HIV infection compared to the routine programs. We intended to randomly allocate 60 patients per group after obtaining informed written consent,. The intervention group receive a combination of brief psychoeducation consisting two individual sessions of skill-based education concerning blood borne viral infection, specifically HIV. The control group received the routine primary NSP services provided in DIC. Study assessments were undertaken by a psychologist at baseline, 1 and 3 months after recruitment. The primary outcome measure was the comparison of the trend of alterations in high risk sexual and injection behaviors associated with HIV infection during 3 months after the initiation of the intervention between the two groups. Secondary outcome measures included the comparison of HIV/AIDS related knowledge and client satisfaction in the participants.This paper presents a protocol for an RCT of brief skill-based PE by a trained psychologist to reduce the sexual and injection related high risk behaviors among drug users who received primary NSP services in DIC. This trial tried to investigate the efficacy of the intervention on increasing HIV/AIDS related knowledge and client satisfaction. The results of different indicators of high risk behaviors will be discussed.

  2. Effects of an internet-based cognitive behavioural therapy intervention on preventing major depressive episodes among workers: a protocol for a randomised controlled trial.

    Science.gov (United States)

    Imamura, Kotaro; Kawakami, Norito; Furukawa, Toshi A; Matsuyama, Yutaka; Shimazu, Akihito; Kasai, Kiyoto

    2015-05-12

    The aim of this study is to examine the effects of an internet-based cognitive behavioural therapy (iCBT) program on decreasing the risk of major depressive episodes (MDEs) among workers employed in a private corporate group in Japan, using a randomised controlled trial design. All of the workers in a corporate group (n=20,000) will be recruited through an invitation email. Participants who fulfil the inclusion criteria will be randomly allocated to intervention or control groups (planned N=4050 for each group). They will be allowed to complete the six lessons of the iCBT program within 10 weeks after the baseline survey. Those in the control group will receive the same iCBT after 12 months. The program includes several CBT skills: self-monitoring, cognitive restructuring, assertiveness, problem-solving and relaxation. The primary outcome measure is no new onset of MDE (using Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)/DSM-5 criteria) during the 12-month follow-up. Assessment will use the web version of the WHO Composite International Diagnostic Interview V.3.0 depression section. The Research Ethics Review Board of Graduate School of Medicine, the University of Tokyo (No. 3083-(2)), approved the study procedures. The study protocol is registered at the UMIN Clinical Trials Registry (UMIN-CTR; ID=UMIN000014146). 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.

  3. Eye movement desensitization and reprocessing therapy versus supportive therapy in affective relapse prevention in bipolar patients with a history of trauma: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Moreno-Alcázar, Ana; Radua, Joaquim; Landín-Romero, Ramon; Blanco, Laura; Madre, Mercè; Reinares, Maria; Comes, Mercè; Jiménez, Esther; Crespo, Jose Manuel; Vieta, Eduard; Pérez, Victor; Novo, Patricia; Doñate, Marta; Cortizo, Romina; Valiente-Gómez, Alicia; Lupo, Walter; McKenna, Peter J; Pomarol-Clotet, Edith; Amann, Benedikt L

    2017-04-04

    Up to 60% of patients with bipolar disorder (BD) have a history of traumatic events, which is associated with greater episode severity, higher risk of comorbidity and higher relapse rates. Trauma-focused treatment strategies for BD are thus necessary but studies are currently scarce. The aim of this study is to examine whether Eye Movement Desensitization and Reprocessing (EMDR) therapy focusing on adherence, insight, de-idealisation of manic symptoms, prodromal symptoms and mood stabilization can reduce episode severity and relapse rates and increase cognitive performance and functioning in patients with BD. This is a single-blind, randomized controlled, multicentre trial in which 82 patients with BD and a history of traumatic events will be recruited and randomly allocated to one of two treatment arms: EMDR therapy or supportive therapy. Patients in both groups will receive 20 psychotherapeutic sessions, 60 min each, during 6 months. The primary outcome is a reduction of affective episodes after 12 and 24 months in favour of the EMDR group. As secondary outcome we postulate a greater reduction in affective symptoms in the EMDR group (as measured by the Bipolar Depression Rating Scale, the Young Mania Rating Scale and the Clinical Global Impression Scale modified for BD), and a better performance in cognitive state, social cognition and functioning (as measured by the Screen for Cognitive Impairment in Psychiatry, The Mayer-Salovey-Caruso Emotional Intelligence Test and the Functioning Assessment Short Test, respectively). Traumatic events will be evaluated by The Holmes-Rahe Life Stress Inventory, the Clinician-administered PTSD Scale and the Impact of Event Scale. The results of this study will provide evidence whether a specific EMDR protocol for patients with BD is effective in reducing affective episodes, affective symptoms and functional, cognitive and trauma symptoms. The trial is registered at ClinicalTrials.gov, identifier: NCT02634372 . Registered on

  4. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services.

    Science.gov (United States)

    Tickle, Martin; Milsom, Keith M; Donaldson, Michael; Killough, Seamus; O'Neill, Ciaran; Crealey, Grainne; Sutton, Matthew; Noble, Solveig; Greer, Margaret; Worthington, Helen V

    2011-10-10

    Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education) with dental health education alone in young children. A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years), fluoride toothpaste (1,450 ppm F) (supplied twice per year), a toothbrush (supplied twice a year) or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit). 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group.The primary end-point is whether the child develops caries (cavitation into dentine) or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs which will be obtained from parental

  5. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

    Directory of Open Access Journals (Sweden)

    Noble Solveig

    2011-10-01

    Full Text Available Abstract Background Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education with dental health education alone in young children. Methods/Design A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years, fluoride toothpaste (1,450 ppm F (supplied twice per year, a toothbrush (supplied twice a year or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit. 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group. The primary end-point is whether the child develops caries (cavitation into dentine or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs

  6. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

    LENUS (Irish Health Repository)

    Tickle, Martin

    2011-10-10

    Abstract Background Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education) with dental health education alone in young children. Methods\\/Design A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years), fluoride toothpaste (1,450 ppm F) (supplied twice per year), a toothbrush (supplied twice a year) or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit). 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group. The primary end-point is whether the child develops caries (cavitation into dentine) or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs which will

  7. The effectiveness of a trauma-focused psycho-educational secondary prevention program for children exposed to interparental violence: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Overbeek Mathilde M

    2012-02-01

    Full Text Available Abstract Background Children who witness interparental violence are at a heightened risk for developing psychosocial, behavioral and cognitive problems, as well as posttraumatic stress symptoms. For these children the psycho-educational secondary prevention program 'En nu ik...!' ('It's my turn now!' has been developed. This program includes specific therapeutic factors focused on emotion awareness and expression, increasing feelings of emotional security, teaching specific coping strategies, developing a trauma narrative, improving parent-child interaction and psycho-education. The main study aim is to evaluate the effectiveness of the specific therapeutic factors in the program. A secondary objective is to study mediating and moderating factors. Methods/design This study is a prospective multicenter randomized controlled trial across cities in the Netherlands. Participants (N = 140 are referred to the secondary preventive intervention program by police, social work, women shelters and youth (mental health care. Children, aged 6-12 years, and their parents, who experienced interparental violence are randomly assigned to either the intervention program or the control program. The control program is comparable on nonspecific factors by offering positive attention, positive expectations, recreation, distraction, warmth and empathy of the therapist, and social support among group participants, in ways that are similar to the intervention program. Primary outcome measures are posttraumatic stress symptoms and emotional and behavioral problems of the child. Mediators tested are the ability to differentiate and express emotions, emotional security, coping strategies, feelings of guilt and parent-child interaction. Mental health of the parent, parenting stress, disturbances in parent-child attachment, duration and severity of the domestic violence and demographics are examined for their moderating effect. Data are collected one week before the program

  8. Standardised high dose versus low dose cranberry Proanthocyanidin extracts for the prevention of recurrent urinary tract infection in healthy women [PACCANN]: a double blind randomised controlled trial protocol.

    Science.gov (United States)

    Asma, Babar; Vicky, Leblanc; Stephanie, Dudonne; Yves, Desjardins; Amy, Howell; Sylvie, Dodin

    2018-05-02

    Urinary tract infections (UTIs) are amongst the most common bacterial infections affecting women. Although antibiotics are the treatment of choice for UTI, cranberry derived products have been used for many years to prevent UTIs, with limited evidence as to their efficacy. Our objective is to assess the efficacy of a cranberry extract capsule standardized in A-type linkage proanthocyanidins (PACs) for the prevention of recurrent urinary tract infection. We will perform a 1:1 randomized, controlled, double blind clinical trial in women aged 18 years or more who present ≥2 UTIs in 6 months or ≥ 3 UTIs in 12 months. One hundred and forty-eight women will be recruited and randomized in two groups to either receive an optimal dose of cranberry extract quantified and standardized in PACs (2 × 18.5 mg PACs per day) or a control dose (2 × 1 mg PACs per day). The primary outcome for the trial is the mean number of new symptomatic UTIs in women during a 6-month intervention period. Secondary outcomes are: (1) To evaluate the mean number of new symptomatic UTIs with pyuria as demonstrated by a positive leucocyte esterase test; (2) To detect the mean number of new symptomatic culture-confirmed UTIs; (3) To quantify urinary PACs metabolites in women who take a daily dose of 37 mg PACs per day compared to women who take a daily dose of 2 mg per day for 6 months; (4) To characterize women who present recurrent UTI based on known risk factors for recurrent UTI; (5) To describe the side effects of daily intake of cranberry extract containing 37 mg PACs compared to 2 mg PACs. This report provides comprehensive methodological data for this randomized controlled trial. The results of this trial will inform urologists, gynaecologists, family physicians and other healthcare professionals caring for healthy women with recurrent UTI, as to the benefits of daily use of an optimal dose of cranberry extract for the prevention of recurrent UTI. Clinicaltrials

  9. Stop or go? Preventive cognitive therapy with guided tapering of antidepressants during pregnancy: study protocol of a pragmatic multicentre non-inferiority randomized controlled trial.

    Science.gov (United States)

    Molenaar, Nina M; Brouwer, Marlies E; Bockting, Claudi L H; Bonsel, Gouke J; van der Veere, Christine N; Torij, Hanneke W; Hoogendijk, Witte J G; Duvekot, Johannes J; Burger, Huibert; Lambregtse-van den Berg, Mijke P

    2016-03-18

    Approximately 6.2 % of women in the USA and 3.7 % of women in the UK, use Selective Serotonin Reuptake Inhibitors (SSRIs) during their pregnancies because of depression and/or anxiety. In the Netherlands, this prevalence is around 2 %. Nonetheless, SSRI use during pregnancy is still controversial. On the one hand SSRIs may be toxic to the intrauterine developing child, while on the other hand relapse or recurrence of depression during pregnancy poses risks for both mother and child. Among patients and professionals there is an urgent need for evidence from randomized studies to make rational decisions regarding continuation or tapering of SSRIs during pregnancy. At present, no such studies exist. 'Stop or Go' is a pragmatic multicentre randomized non-inferiority trial among 200 pregnant women with a gestational age of less than 16 weeks who use SSRIs without clinically relevant depressive symptoms. Women allocated to the intervention group will receive preventive cognitive therapy with gradual, guided discontinuation of SSRIs under medical management (STOP). Women in the control group will continue the use of SSRIs (GO). Primary outcome will be the (cumulative) incidence of relapse or recurrence of maternal depressive disorder (as assessed by the Structured Clinical Interview for DSM disorders) during pregnancy and up to three months postpartum. Secondary outcomes will be child outcome (neonatal outcomes and psychomotor and behavioural outcomes up to 24 months postpartum), and health-care costs. Total study duration for participants will be therefore be 30 months. We specified a non-inferiority margin of 15 % difference in relapse risk. This study is the first to investigate the effect of guided tapering of SSRIs with preventive cognitive therapy from early pregnancy onwards as compared to continuation of SSRIs during pregnancy. We will study the effects on both mother and child with a pragmatic approach. Additionally, the study examines cost effectiveness. If non

  10. Community based intervention to prevent domestic violence against women in the reproductive age in Northwestern Ethiopia: a protocol for quasi-experimental study.

    Science.gov (United States)

    Semahegn, Agumasie; Torpey, Kwasi; Manu, Abubakar; Assefa, Nega; Ankomah, Augustine

    2017-11-21

    Violence against women is a well understood devastating global pandemic, and human right violation. One in three women experienced intimate partner violence worldwide. In Ethiopia, the level of domestic violence against women is one of the highest in the world. However, Ethiopia is signatory for various conventions and incorporated in legal frameworks. Nevertheless, effective implementation of the existing policy documents, and engaging different stakeholders is very limited. Therefore, we aimed to pilot feasibility of implementing available research evidence and policy documents at community level to prevent domestic violence against women in Awi zone, northwestern Ethiopia. A community-based quasi-experimental study design will be employed using mixed method. Multistage stratified systematic sampling and purposive sampling will be used to recruit quantitative and qualitative study participants, respectively. A total of 1,269 women will be participated in the intervention, active comparator and control groups. Pre and post-test quantitative data will be collected using face-to-face interview. Qualitative data will be collected through in-depth, key informant interview and focus group discussions. advocacy meeting will be held to persuade local politicians and sustain the implementation of community based intervention to prevent domestic violence against women. Community representatives will be trained to enhance peer education to promote community awareness and engage stakeholders to transform the traditional gender norm within local context. Awareness creation and husband involvement will be made through integrating the intervention with community health extension program. Only husband involvement will not be promoted in the active comparator to test the role of husband involvement on the domestic violence prevention activities. Intervention progress will be monitored regularly. Gathered data will be entered in Epidata and exported to SPSS (23.0) software for

  11. ICT-based system to predict and prevent falls (iStoppFalls): study protocol for an international multicenter randomized controlled trial.

    Science.gov (United States)

    Gschwind, Yves J; Eichberg, Sabine; Marston, Hannah R; Ejupi, Andreas; Rosario, Helios de; Kroll, Michael; Drobics, Mario; Annegarn, Janneke; Wieching, Rainer; Lord, Stephen R; Aal, Konstantin; Delbaere, Kim

    2014-08-20

    Falls are very common, especially in adults aged 65 years and older. Within the current international European Commission's Seventh Framework Program (FP7) project 'iStoppFalls' an Information and Communication Technology (ICT) based system has been developed to regularly assess a person's risk of falling in their own home and to deliver an individual and tailored home-based exercise and education program for fall prevention. The primary aims of iStoppFalls are to assess the feasibility and acceptability of the intervention program, and its effectiveness to improve balance, muscle strength and quality of life in older people. This international, multicenter study is designed as a single-blinded, two-group randomized controlled trial. A total of 160 community-dwelling older people aged 65 years and older will be recruited in Germany (n = 60), Spain (n = 40), and Australia (n = 60) between November 2013 and May 2014. Participants in the intervention group will conduct a 16-week exercise program using the iStoppFalls system through their television set at home. Participants are encouraged to exercise for a total duration of 180 minutes per week. The training program consists of a variety of balance and strength exercises in the form of video games using exergame technology. Educational material about a healthy lifestyle will be provided to each participant. Final reassessments will be conducted after 16 weeks. The assessments include physical and cognitive tests as well as questionnaires assessing health, fear of falling, quality of life and psychosocial determinants. Falls will be followed up for six months by monthly falls calendars. We hypothesize that the regular use of this newly developed ICT-based system for fall prevention at home is feasible for older people. By using the iStoppFalls sensor-based exercise program, older people are expected to improve in balance and strength outcomes. In addition, the exercise training may have a positive impact on quality of

  12. Effect of Tai Chi for the prevention or treatment of osteoporosis in elderly adults: protocol for a systematic review and meta-analysis.

    Science.gov (United States)

    Mu, Wei-Qiang; Huang, Xia-Yu; Zhang, Jiang; Liu, Xiao-Cong; Huang, Mao-Mao

    2018-04-09

    Osteoporosis (OP) has been defined as a degenerative bone disease characterised by low bone mass and microstructural deterioration of bone tissue, leading to fragility and an increased risk of fractures, especially of the hip, spine and wrist. Exercise has been shown to benefit the maintenance of bone health and improvement of muscle strength, balance and coordination, thereby reducing the risk of falls and fractures. However, prior findings regarding the optimal types and regimens of exercise for treating low bone mineral density (BMD) in elderly people are not consistent. As an important component of traditional Chinese Qigong exercises, Tai Chi (TC) is an ancient art and science of healthcare derived from the martial arts. The objective of this study is to attempt to conduct a systematic review and meta-analysis of the existing studies on TC exercise as an intervention for the prevention or treatment of OP in elderly adults and to draw more useful conclusions regarding the safety and the effectiveness of TC in preventing or treating OP. Eight electronic databases (Science Citation Index, PubMed Database, Embase (Ovid) Database, the Cochrane Central Register of Controlled Trials, and Chinese databases, including Chinese BioMedical Database, China National Knowledge Infrastructure, Wanfang database and the Chongqing VIP Chinese Science and Technology Periodical Database) will be searched from the beginning of each database to 1 April 2018. Potential outcomes of interest will include rates of fractures or falls, BMD at the total hip and the total spine, bone formation biomarkers, bone resorption biomarkers, bone biomarkers, health-related quality of life and adverse events. Only randomised controlled trials comparing TC exercise against each other or non-intervention will be included. The Cochrane risk of bias assessment tool will be used for quality assessment. Ethical approval is not required as the study will be a review of existing studies. This review may help

  13. Toward onset prevention of cognitive decline in adults with Down syndrome (the TOP-COG study): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cooper, Sally-Ann; Caslake, Muriel; Evans, Jonathan; Hassiotis, Angela; Jahoda, Andrew; McConnachie, Alex; Morrison, Jill; Ring, Howard; Starr, John; Stiles, Ciara; Sullivan, Frank

    2014-06-03

    Early-onset dementia is common in Down syndrome adults, who have trisomy 21. The amyloid precursor protein gene is on chromosome 21, and so is over-expressed in Down syndrome, leading to amyloid β (Aβ) over-production, a major upstream pathway leading to Alzheimer disease (AD). Statins (microsomal 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors), have pleiotropic effects including potentially increasing brain amyloid clearance, making them plausible agents to reduce AD risk. Animal models, human observational studies, and small scale trials support this rationale, however, there are no AD primary prevention trials in Down syndrome adults. In this study we study aim to inform the design of a full-scale primary prevention trial. TOP-COG is a feasibility and pilot double-blind randomized controlled trial (RCT), with a nested qualitative study, conducted in the general community. About 60 Down syndrome adults, aged ≥50 will be included. The intervention is oral simvastatin 40 mg at night for 12 months, versus placebo. The primary endpoint is recruitment and retention rates. Secondary endpoints are (1) tolerability and safety; (2) detection of the most sensitive neurocognitive instruments; (3) perceptions of Down syndrome adults and caregivers on whether to participate, and assessment experiences; (4) distributions of cognitive decline, adaptive behavior, general health/quality of life, service use, caregiver strain, and sample size implications; (5) whether Aβ42/Aβ40 is a cognitive decline biomarker. We will describe percentages recruited from each source, the number of contacts to achieve this, plus recruitment rate by general population size. We will calculate summary statistics with 90% confidence limits where appropriate, for each study outcome as a whole, by treatment group and in relation to baseline age, cognitive function, cholesterol and other characteristics. Changes over time will be summarized graphically. The sample size for a definitive

  14. Ahead of the game protocol: a multi-component, community sport-based program targeting prevention, promotion and early intervention for mental health among adolescent males.

    Science.gov (United States)

    Vella, Stewart A; Swann, Christian; Batterham, Marijka; Boydell, Katherine M; Eckermann, Simon; Fogarty, Andrea; Hurley, Diarmuid; Liddle, Sarah K; Lonsdale, Chris; Miller, Andrew; Noetel, Michael; Okely, Anthony D; Sanders, Taren; Telenta, Joanne; Deane, Frank P

    2018-03-21

    There is a recognised need for targeted community-wide mental health strategies and interventions aimed specifically at prevention and early intervention in promoting mental health. Young males are a high need group who hold particularly negative attitudes towards mental health services, and these views are detrimental for early intervention and help-seeking. Organised sports provide a promising context to deliver community-wide mental health strategies and interventions to adolescent males. The aim of the Ahead of the Game program is to test the effectiveness of a multi-component, community-sport based program targeting prevention, promotion and early intervention for mental health among adolescent males. The Ahead of the Game program will be implemented within a sample drawn from community sporting clubs and evaluated using a sample drawn from a matched control community. Four programs are proposed, including two targeting adolescents, one for parents, and one for sports coaches. One adolescent program aims to increase mental health literacy, intentions to seek and/or provide help for mental health, and to decrease stigmatising attitudes. The second adolescent program aims to increase resilience. The goal of the parent program is to increase parental mental health literacy and confidence to provide help. The coach program is intended to increase coaches' supportive behaviours (e.g., autonomy supportive behaviours), and in turn facilitate high-quality motivation and wellbeing among adolescents. Programs will be complemented by a messaging campaign aimed at adolescents to enhance mental health literacy. The effects of the program on adolescent males' psychological distress and wellbeing will also be explored. Organised sports represent a potentially engaging avenue to promote mental health and prevent the onset of mental health problems among adolescent males. The community-based design, with samples drawn from an intervention and a matched control community

  15. Comparison of tai chi vs. strength training for fall prevention among female cancer survivors: study protocol for the GET FIT trial

    International Nuclear Information System (INIS)

    Winters-Stone, Kerri M; Li, Fuzhong; Horak, Fay; Luoh, Shiuh-Wen; Bennett, Jill A; Nail, Lillian; Dieckmann, Nathan

    2012-01-01

    Women with cancer are significantly more likely to fall than women without cancer placing them at higher risk of fall-related fractures, other injuries and disability. Currently, no evidence-based fall prevention strategies exist that specifically target female cancer survivors. The purpose of the GET FIT (Group Exercise Training for Functional Improvement after Treatment) trial is to compare the efficacy of two distinct types of exercise, tai chi versus strength training, to prevent falls in women who have completed treatment for cancer. The specific aims of this study are to: 1) Determine and compare the efficacy of both tai chi training and strength training to reduce falls in older female cancer survivors, 2) Determine the mechanism(s) by which tai chi and strength training each reduces falls and, 3) Determine whether or not the benefits of each intervention last after structured training stops. We will conduct a three-group, single-blind, parallel design, randomized controlled trial in women, aged 50–75 years old, who have completed chemotherapy for cancer comparing 1) tai chi 2) strength training and 3) a placebo control group of seated stretching exercise. Women will participate in supervised study programs twice per week for six months and will be followed for an additional six months after formal training stops. The primary outcome in this study is falls, which will be prospectively tracked by monthly self-report. Secondary outcomes are maximal leg strength measured by isokinetic dynamometry, postural stability measured by computerized dynamic posturography and physical function measured by the Physical Performance Battery, all measured at baseline, 3, 6 and 12 months. The sample for this trial (N=429, assuming 25% attrition) will provide adequate statistical power to detect at least a 47% reduction in the fall rate over 1 year by being in either of the 2 exercise groups versus the control group. The GET FIT trial will provide important new knowledge

  16. Efficacy of a multifaceted podiatry intervention to improve balance and prevent falls in older people: study protocol for a randomised trial.

    Science.gov (United States)

    Spink, Martin J; Menz, Hylton B; Lord, Stephen R

    2008-11-25

    Falls in older people are a major public health problem, with at least one in three people aged over 65 years falling each year. There is increasing evidence that foot problems and inappropriate footwear increase the risk of falls, however no studies have been undertaken to determine whether modifying these risk factors decreases the risk of falling. This article describes the design of a randomised trial to evaluate the efficacy of a multifaceted podiatry intervention to reduce foot pain, improve balance, and reduce falls in older people. Three hundred community-dwelling men and women aged 65 years and over with current foot pain and an increased risk of falling will be randomly allocated to a control or intervention group. The "usual cae" control group will receive routine podiatry (i.e. nail care and callus debridement). The intervention group will receive usual care plus a multifaceted podiatry intervention consisting of: (i) prefabricated insoles customised to accommodate plantar lesions; (ii) footwear advice and assistance with the purchase of new footwear if current footwear is inappropriate; (iii) a home-based exercise program to strengthen foot and ankle muscles; and (iv) a falls prevention education booklet. Primary outcome measures will be the number of fallers, number of multiple fallers and the falls rate recorded by a falls diary over a 12 month period. Secondary outcome measures assessed six months after baseline will include the Medical Outcomes Study Short Form 12 (SF-12), the Manchester Foot Pain and Disability Index, the Falls Efficacy Scale International, and a series of balance and functional tests. Data will be analysed using the intention to treat principle. This study is the first randomised trial to evaluate the efficacy of podiatry in improving balance and preventing falls. The trial has been pragmatically designed to ensure that the findings can be generalised to clinical practice. If found to be effective, the multifaceted podiatry

  17. Irie Classroom Toolbox: a study protocol for a cluster-randomised trial of a universal violence prevention programme in Jamaican preschools.

    Science.gov (United States)

    Baker-Henningham, Helen; Vera-Hernández, Marcos; Alderman, Harold; Walker, Susan

    2016-05-10

    We aim to determine the effectiveness of a school-based violence prevention programme implemented in Jamaican preschools, on reducing the levels of aggression among children at school, and violence against children by teachers. This is a 2-arm, single-blind, cluster-randomised controlled trial with parallel assignment. Clusters are 76 preschools in Kingston, and all teachers and classrooms in the selected schools are included in the study. In addition, a random sample of up to 12 children in the 4-year-old classes have been selected for evaluation of child-level outcomes. The intervention involves training teachers in classroom behaviour management and in strategies to promote children's social-emotional competence. Training is delivered through five full-day workshops, monthly in-class coaching over 2 school terms, and weekly text messages. The primary outcome measures are: (1) observed levels of child aggression and (2) observed violence against children by teachers. Secondary outcomes include observations of the levels of children's prosocial behaviour and the quality of the classroom environment, teachers' reports of their mental health, teacher-reported child mental health, direct tests of children's self-regulation and child attendance. If this intervention were effective at improving the caregiving environment of young children in school, this would have significant implications for the prevention of child mental health problems, and prevention of violence against children in low and middle-income countries where services are often limited. The intervention is integrated into the school system and involves training existing staff, and thus, represents an appropriate strategy for large-scale implementation and benefits at the population level. Ethical consent for the study was given by the School of Psychology Ethics and Research Committee, Bangor University (ref: 2014-14167), and by the University of the West Indies Ethics Committee (ref: ECP 50

  18. Exercise and the Prevention of Oesophageal Cancer (EPOC study protocol: a randomized controlled trial of exercise versus stretching in males with Barrett's oesophagus

    Directory of Open Access Journals (Sweden)

    Reeves Marina M

    2010-06-01

    Full Text Available Abstract Background Chronic gastro-oesophageal reflux disease and excessive body fat are considered principal causes of Barrett's oesophagus (a metaplastic change in the cells lining the oesophagus and its neoplastic progression, oesophageal adenocarcinoma. Metabolic disturbances including altered levels of obesity-related cytokines, chronic inflammation and insulin resistance have also been associated with oesophageal cancer development, especially in males. Physical activity may have the potential to abrogate metabolic disturbances in males with Barrett's oesophagus and elicit beneficial reductions in body fat and gastro-oesophageal reflux symptoms. Thus, exercise may be an effective intervention in reducing oesophageal adenocarcinoma risk. However, to date this hypothesis remains untested. The 'Exercise and the Prevention of Oesophageal Cancer Study' will determine whether 24 weeks of exercise training will lead to alterations in risk factors or biomarkers for oesophageal adenocarcinoma in males with Barrett's oesophagus. Our primary outcomes are serum concentrations of leptin, adiponectin, tumour necrosis factor-alpha, C-reactive protein and interleukin-6 as well as insulin resistance. Body composition, gastro-oesophageal reflux disease symptoms, cardiovascular fitness and muscular strength will also be assessed as secondary outcomes. Methods/Design A randomized controlled trial of 80 overweight or obese, inactive males with Barrett's oesophagus will be conducted in Brisbane, Australia. Participants will be randomized to an intervention arm (60 minutes of moderate-intensity aerobic and resistance training, five days per week or a control arm (45 minutes of stretching, five days per week for 24 weeks. Primary and secondary endpoints will be measured at baseline (week 0, midpoint (week 12 and at the end of the intervention (week 24. Discussion Due to the increasing incidence and very high mortality associated with oesophageal adenocarcinoma

  19. Exercise and the Prevention of Oesophageal Cancer (EPOC) study protocol: a randomized controlled trial of exercise versus stretching in males with Barrett's oesophagus

    International Nuclear Information System (INIS)

    Winzer, Brooke M; Paratz, Jennifer D; Reeves, Marina M; Whiteman, David C

    2010-01-01

    Chronic gastro-oesophageal reflux disease and excessive body fat are considered principal causes of Barrett's oesophagus (a metaplastic change in the cells lining the oesophagus) and its neoplastic progression, oesophageal adenocarcinoma. Metabolic disturbances including altered levels of obesity-related cytokines, chronic inflammation and insulin resistance have also been associated with oesophageal cancer development, especially in males. Physical activity may have the potential to abrogate metabolic disturbances in males with Barrett's oesophagus and elicit beneficial reductions in body fat and gastro-oesophageal reflux symptoms. Thus, exercise may be an effective intervention in reducing oesophageal adenocarcinoma risk. However, to date this hypothesis remains untested. The 'Exercise and the Prevention of Oesophageal Cancer Study' will determine whether 24 weeks of exercise training will lead to alterations in risk factors or biomarkers for oesophageal adenocarcinoma in males with Barrett's oesophagus. Our primary outcomes are serum concentrations of leptin, adiponectin, tumour necrosis factor-alpha, C-reactive protein and interleukin-6 as well as insulin resistance. Body composition, gastro-oesophageal reflux disease symptoms, cardiovascular fitness and muscular strength will also be assessed as secondary outcomes. A randomized controlled trial of 80 overweight or obese, inactive males with Barrett's oesophagus will be conducted in Brisbane, Australia. Participants will be randomized to an intervention arm (60 minutes of moderate-intensity aerobic and resistance training, five days per week) or a control arm (45 minutes of stretching, five days per week) for 24 weeks. Primary and secondary endpoints will be measured at baseline (week 0), midpoint (week 12) and at the end of the intervention (week 24). Due to the increasing incidence and very high mortality associated with oesophageal adenocarcinoma, interventions effective in

  20. Efficacy of a multifaceted podiatry intervention to improve balance and prevent falls in older people: study protocol for a randomised trial

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2008-11-01

    Full Text Available Abstract Background Falls in older people are a major public health problem, with at least one in three people aged over 65 years falling each year. There is increasing evidence that foot problems and inappropriate footwear increase the risk of falls, however no studies have been undertaken to determine whether modifying these risk factors decreases the risk of falling. This article describes the design of a randomised trial to evaluate the efficacy of a multifaceted podiatry intervention to reduce foot pain, improve balance, and reduce falls in older people. Methods Three hundred community-dwelling men and women aged 65 years and over with current foot pain and an increased risk of falling will be randomly allocated to a control or intervention group. The "usual cae" control group will receive routine podiatry (i.e. nail care and callus debridement. The intervention group will receive usual care plus a multifaceted podiatry intervention consisting of: (i prefabricated insoles customised to accommodate plantar lesions; (ii footwear advice and assistance with the purchase of new footwear if current footwear is inappropriate; (iii a home-based exercise program to strengthen foot and ankle muscles; and (iv a falls prevention education booklet. Primary outcome measures will be the number of fallers, number of multiple fallers and the falls rate recorded by a falls diary over a 12 month period. Secondary outcome measures assessed six months after baseline will include the Medical Outcomes Study Short Form 12 (SF-12, the Manchester Foot Pain and Disability Index, the Falls Efficacy Scale International, and a series of balance and functional tests. Data will be analysed using the intention to treat principle. Discussion This study is the first randomised trial to evaluate the efficacy of podiatry in improving balance and preventing falls. The trial has been pragmatically designed to ensure that the findings can be generalised to clinical practice. If

  1. Trial for the Prevention of Depression (TriPoD) in final-year secondary students: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Perry, Yael; Calear, Alison L; Mackinnon, Andrew; Batterham, Philip J; Licinio, Julio; King, Catherine; Thomsen, Noel; Scott, Jan; Donker, Tara; Merry, Sally; Fleming, Theresa; Stasiak, Karolina; Werner-Seidler, Aliza; Christensen, Helen

    2015-10-12

    Evidence suggests that current treatments cannot fully alleviate the burden of disease associated with depression but that prevention approaches offer a promising opportunity to further reduce this burden. Adolescence is a critical period in the development of mental illness, and final school examinations are a significant and nearly universal stressor that may act as a trigger for mental health difficulties such as depression. The aim of the present trial is to investigate the impact of SPARX-R, an online, gamified intervention based on cognitive behavioural principles, on the prevention of depression in secondary school students before their final examinations. Government, independent and Catholic secondary schools in New South Wales, Australia, will be recruited to participate in the trial. All students enrolled in their final year of high school (year 12) in participating schools will be invited to participate. To account for possible attrition, the target sample size was set at 1600 participants across 30 schools. Participating schools will be cluster randomised at the school level to receive either SPARX-R or lifeSTYLE, an attention-controlled placebo comparator. The control intervention is an online program aimed at maintaining a healthy lifestyle. The primary outcome will be symptoms of depression, and secondary outcomes will include symptoms of anxiety, suicidal ideation and behaviours, stigma and academic performance. Additional measures of cost-effectiveness, as well as process variables (e.g., adherence, acceptability) and potential predictors of response to treatment, will be collected. Consenting parents will be invited to complete measures regarding their own mental health and expectations for their child. Assessments will be conducted pre- and post-intervention and at 6- and 18-month follow-up. Primary analyses will compare changes in levels of depressive symptomatology for the intervention group relative to the attention control condition using

  2. Cluster randomised controlled trial of 'whole school' child maltreatment prevention programme in primary schools in Northern Ireland: study protocol for Keeping Safe.

    Science.gov (United States)

    McElearney, Aisling; Brennan-Wilson, Aoibheann; Murphy, Christina; Stephenson, Phyllis; Bunting, Brendan

    2018-05-03

    Child maltreatment has a pervasive, detrimental impact on children's wellbeing. Despite a growing focus on prevention through school based education, few programmes adopt a whole- school approach, are multi-component, seek to address all forms of maltreatment, or indeed have been robustly evaluated. This paper describes a cluster randomised controlled trial designed to evaluate a school based child maltreatment prevention programme: 'Keeping Safe' in primary schools in Northern Ireland. The intervention has been designed by a non-profit agency. Programme resources include 63 lessons taught incrementally to children between four and 11 years old, and is premised on three core themes: healthy relationships, my body, and being safe. There are programme resources to engage parents and to build the capacity and skills of school staff. A cluster Randomised Controlled Trial (RCT) will be conducted with children in 80 schools over a two-year period. The unit of randomisation is the school. Schools will be allocated to intervention or wait-list control groups using a computer-generated list. Data will be collected at three time points: baseline, end of year one, and end of year two of programme implementation. Primary outcomes will include: children's understanding of key programme concepts, self-efficacy to keep safe in situations of maltreatment, anxiety arising from programme participation, and disclosure of maltreatment. Secondary outcomes include teachers' comfort and confidence in teaching the programme and parents' confidence in talking to their children about programme concepts. This RCT will address gaps in current practice and evidence regarding school based child maltreatment prevention programmes. This includes the use of a whole- school approach and multi-component programme that addresses all maltreatment concepts, a two-year period of programme implementation, and the tracking of outcomes for children, parents, and teachers. Methodologically, it will extend

  3. The Good Schools Toolkit to prevent violence against children in Ugandan primary schools: study protocol for a cluster randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background We aim to evaluate the effectiveness of the Good School Toolkit, developed by Raising Voices, in preventing violence against children attending school and in improving child mental health and educational outcomes. Methods/design We are conducting a two-arm cluster randomised controlled trial with parallel assignment in Luwero District, Uganda. We will also conduct a qualitative study, a process evaluation and an economic evaluation. A total of 42 schools, representative of Luwero District, Uganda, were allocated to receive the Toolkit plus implementation support, or were allocated to a wait-list control condition. Our main analysis will involve a cross-sectional comparison of the prevalence of past-week violence from school staff as reported by children in intervention and control primary schools at follow-up. At least 60 children per school and all school staff members will be interviewed at follow-up. Data collection involves a combination of mobile phone-based, interviewer-completed questionnaires and paper-and-pen educational tests. Survey instruments include the ISPCAN Child Abuse Screening Tools to assess experiences of violence; the Strengths and Difficulties Questionnaire to measure symptoms of common childhood mental disorders; and word recognition, reading comprehension, spelling, arithmetic and sustained attention tests adapted from an intervention trial in Kenya. Discussion To our knowledge, this is the first study to rigorously investigate the effects of any intervention to prevent violence from school staff to children in primary school in a low-income setting. We hope the results will be informative across the African region and in other settings. Trial registration clinicaltrials.gov NCT01678846 PMID:23883138

  4. The Healthy Heart-Mind trial: melatonin for prevention of delirium following cardiac surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ford, Andrew H; Flicker, Leon; Passage, Jurgen; Wibrow, Bradley; Anstey, Matthew; Edwards, Mark; Almeida, Osvaldo P

    2016-01-28

    Delirium is a common occurrence in patients undergoing major cardiac surgery and is associated with a number of adverse consequences for the individual, their family and the health system. Current approaches to the prevention of delirium include identifying those at risk together with various non-pharmacological and pharmacological strategies, although the efficacy of these is often modest. Emerging evidence suggests that melatonin may be biologically implicated in the development of delirium and that melatonin supplementation may be beneficial in reducing the incidence of delirium in medical and surgical patients. We designed this trial to determine whether melatonin reduces the incidence of delirium following cardiac surgery compared with placebo. The Healthy Heart-Mind trial is a randomized, double-blind, placebo-controlled clinical trial of 3 mg melatonin or matching placebo administered on seven consecutive days for the prevention of delirium following cardiac surgery. We will recruit 210 adult participants, aged 50 and older, undergoing elective or semi-elective cardiac surgery with the primary outcome of interest for this study being the difference in the incidence of delirium between the groups within 7 days of surgery. Secondary outcomes of interest include the difference between groups in the severity and duration of delirious episodes, hospital length of stay and referrals to mental health services during admission. In addition, we will assess differences in depressive and anxiety symptoms, as well as cognitive performance, at discharge and 3 months after surgery. The results of this trial will clarify whether melatonin reduces the incidence of delirium following cardiac surgery. The trial is registered with the Australian Clinical Trials Registry, trial number ACTRN12615000819527 (10 August 2015).

  5. The Good Schools Toolkit to prevent violence against children in Ugandan primary schools: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Devries, Karen M; Allen, Elizabeth; Child, Jennifer C; Walakira, Eddy; Parkes, Jenny; Elbourne, Diana; Watts, Charlotte; Naker, Dipak

    2013-07-24

    We aim to evaluate the effectiveness of the Good School Toolkit, developed by Raising Voices, in preventing violence against children attending school and in improving child mental health and educational outcomes. We are conducting a two-arm cluster randomised controlled trial with parallel assignment in Luwero District, Uganda. We will also conduct a qualitative study, a process evaluation and an economic evaluation. A total of 42 schools, representative of Luwero District, Uganda, were allocated to receive the Toolkit plus implementation support, or were allocated to a wait-list control condition. Our main analysis will involve a cross-sectional comparison of the prevalence of past-week violence from school staff as reported by children in intervention and control primary schools at follow-up.At least 60 children per school and all school staff members will be interviewed at follow-up. Data collection involves a combination of mobile phone-based, interviewer-completed questionnaires and paper-and-pen educational tests. Survey instruments include the ISPCAN Child Abuse Screening Tools to assess experiences of violence; the Strengths and Difficulties Questionnaire to measure symptoms of common childhood mental disorders; and word recognition, reading comprehension, spelling, arithmetic and sustained attention tests adapted from an intervention trial in Kenya. To our knowledge, this is the first study to rigorously investigate the effects of any intervention to prevent violence from school staff to children in primary school in a low-income setting. We hope the results will be informative across the African region and in other settings. clinicaltrials.gov NCT01678846.

  6. Enoxaparin for the prevention of preeclampsia and intrauterine growth restriction in women with a prior history - an open-label randomised trial (the EPPI trial): study protocol.

    Science.gov (United States)

    Groom, K M; McCowan, L M; Stone, P R; Chamley, L C; McLintock, C

    2016-11-22

    Preeclampsia and intrauterine fetal growth restriction (IUGR) are two of the most common causes of maternal and perinatal morbidity and mortality. Current methods of predicting those at most risk of these conditions remain relatively poor, and in clinical practice past obstetric history remains the most commonly used tool. Aspirin and, in women at risk of preeclampsia only, calcium have been demonstrated to have a modest effect on risk reduction. Several observational studies and randomised trials suggest that low molecular weight heparin (LMWH) therapy may confer some benefit. This is a multicentre open label randomised controlled trial to determine the effect of the LMWH, enoxaparin, on the prevention of recurrence of preeclampsia and/or IUGR in women at high risk due to their past obstetric history in addition to standard high risk care for all participants. A singleton pregnancy >6 +0 and 12 weeks having; (1) preeclampsia delivered women are randomly assigned to 'standard high risk care' or 'standard high risk care' plus enoxaparin 40 mg from recruitment until 36 +0 weeks or delivery, whichever occurs sooner. Standard high risk care includes the use of aspirin 100 mg daily and calcium 1000-1500 mg daily (unless only had previous SGA with no preeclampsia). The primary outcome is preeclampsia and/or SGA restricted composite primary outcome. The inclusion of standard use of aspirin (and calcium) for all participants will help to ensure that any differences observed in outcome are likely to be related to enoxaparin use. These data will make a significant contribution to future meta-analyses and systematic reviews on the use of LMWH for the prevention of placental mediated conditions. ACTRN12609000699268 Australian New Zealand Clinical Trials Registry. Date registered 13/Aug/2009 (prospective registration).

  7. Comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination to prevent functional decline in community-dwelling older persons: protocol of a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Suijker Jacqueline J

    2012-04-01

    Full Text Available Abstract Background Functional decline in community-dwelling older persons is associated with the loss of independence, the need for hospital and nursing-home care and premature death. The effectiveness of multifactorial interventions in preventing functional decline remains controversial. The aim of this study is to investigate whether functional decline in community-dwelling older persons can be delayed or prevented by a comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination. Methods/Design In a cluster randomized controlled trial, with the general practice as the unit of randomization, 1281 participants from 25 general practices will be enrolled in each condition to compare the intervention with usual care. The intervention will focus on older persons who are at increased risk for functional decline, identified by an Identification of Seniors at Risk Primary Care (ISAR-PC score (≥ 2. These older persons will receive a comprehensive geriatric assessment, an individually tailored care and treatment plan, consisting of multifactorial, evidence-based interventions and subsequent nurse-led care coordination. The control group will receive 'care as usual' by the general practitioner (GP. The main outcome after 12 months is the level of physical functioning on the modified Katz-15 index score. The secondary outcomes are health-related quality of life, psychological and social functioning, healthcare utilization and institutionalization. Furthermore, a process evaluation and cost-effectiveness analysis will be performed. Discussion This study will provide new knowledge regarding the effectiveness and feasibility of a comprehensive geriatric assessment, multifactorial interventions and nurse-led elderly care in general practice. Trial registration NTR2653 Grant Unrestricted grant 'The Netherlands Organisation for Health Research and development' no 313020201

  8. Nonblocking and orphan free message logging protocols

    Science.gov (United States)

    Alvisi, Lorenzo; Hoppe, Bruce; Marzullo, Keith

    1992-12-01

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

  9. Establishing the effectiveness, cost-effectiveness and student experience of a Simulation-based education Training program On the Prevention of Falls (STOP-Falls) among hospitalised inpatients: a protocol for a randomised controlled trial.

    Science.gov (United States)

    Williams, Cylie; Bowles, Kelly-Ann; Kiegaldie, Debra; Maloney, Stephen; Nestel, Debra; Kaplonyi, Jessica; Haines, Terry

    2016-06-02

    Simulation-based education (SBE) is now commonly used across health professional disciplines to teach a range of skills. The evidence base supporting the effectiveness of this approach for improving patient health outcomes is relatively narrow, focused mainly on the development of procedural skills. However, there are other simulation approaches used to support non-procedure specific skills that are in need of further investigation. This cluster, cross-over randomised controlled trial with a concurrent economic evaluation (cost per fall prevented) trial will evaluate the effectiveness, cost-effectiveness and student experience of health professional students undertaking simulation training for the prevention of falls among hospitalised inpatients. This research will target the students within the established undergraduate student placements of Monash University medicine, nursing and allied health across Peninsula Health acute and subacute inpatient wards. The intervention will train the students in how to provide the Safe Recovery program, the only single intervention approach demonstrated to reduce falls in hospitals. This will involve redevelopment of the Safe Recovery program into a one-to-many participant SBE program, so that groups of students learn the communication skills and falls prevention knowledge necessary for delivery of the program. The primary outcome of this research will be patient falls across participating inpatient wards, with secondary outcomes including student satisfaction with the SBE and knowledge gain, ward-level practice change and cost of acute/rehabilitation care for each patient measured using clinical costing data. The Human Research Ethics Committees of Peninsula Health (LRR/15/PH/11) and Monash University (CF15/3523-2015001384) have approved this research. The participant information and consent forms provide information on privacy, storage of results and dissemination. Registration of this trial has been completed with the

  10. Intramuscular oxytocin versus intravenous oxytocin to prevent postpartum haemorrhage at vaginal delivery (LabOR trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Adnan, Nita; Boland, Fiona; Murphy, Deirdre J

    2017-11-15

    .12.2015; trial commenced 04.01.2016. The protocol (Ref 012012) was approved by the National Maternity Hospital Research Ethics Committee on 10.06.2015 and the Research Ethics Committee of the Coombe Women & Infants University Hospital (Ref 26-2015) on 09.12.2015.

  11. Prevention of: self harm in British South Asian women: study protocol of an exploratory RCT of culturally adapted manual assisted Problem Solving Training (C- MAP

    Directory of Open Access Journals (Sweden)

    Nagaraj Diwaker

    2011-06-01

    Full Text Available Abstract Background Suicide is a major public health problem worldwide. In the UK suicide is the second most common cause of death in people aged 15-24 years. Self harm is one of the commonest reasons for medical admission in the UK. In the year following a suicide attempt the risk of a repeat attempt or death by suicide may be up to 100 times greater than in people who have never attempted suicide. Research evidence shows increased risk of suicide and attempted suicide among British South Asian women. There are concerns about the current service provision and its appropriateness for this community due to the low numbers that get involved with the services. Both problem solving and interpersonal forms of psychotherapy are beneficial in the treatment of patients who self harm and could potentially be helpful in this ethnic group. The paper describes the trial protocol of adapting and evaluating a culturally appropriate psychological treatment for the adult British South Asian women who self harm. Methods We plan to test a culturally adapted Problem Solving Therapy (C- MAP in British South Asian women who self harm. Eight sessions of problem solving each lasting approximately 50 minutes will be delivered over 3 months. The intervention will be assessed using a prospective rater blind randomized controlled design comparing with treatment as usual (TAU. Outcome assessments will be carried out at 3 and 6 months. A sub group of the participants will be invited for qualitative interviews. Discussion This study will test the feasibility and acceptability of the C- MAP in British South Asian women. We will be informed on whether a culturally adapted brief psychological intervention compared with treatment as usual for self-harm results in decreased hopelessness and suicidal ideation. This will also enable us to collect necessary information on recruitment, effect size, the optimal delivery method and acceptability of the intervention in preparation for a

  12. Prevention of: self harm in British South Asian women: study protocol of an exploratory RCT of culturally adapted manual assisted Problem Solving Training (C- MAP).

    Science.gov (United States)

    Husain, Nusrat; Chaudhry, Nasim; Durairaj, Steevart V; Chaudhry, Imran; Khan, Sarah; Husain, Meher; Nagaraj, Diwaker; Naeem, Farooq; Waheed, Waquas

    2011-06-21

    Suicide is a major public health problem worldwide. In the UK suicide is the second most common cause of death in people aged 15-24 years. Self harm is one of the commonest reasons for medical admission in the UK. In the year following a suicide attempt the risk of a repeat attempt or death by suicide may be up to 100 times greater than in people who have never attempted suicide. Research evidence shows increased risk of suicide and attempted suicide among British South Asian women. There are concerns about the current service provision and its appropriateness for this community due to the low numbers that get involved with the services. Both problem solving and interpersonal forms of psychotherapy are beneficial in the treatment of patients who self harm and could potentially be helpful in this ethnic group.The paper describes the trial protocol of adapting and evaluating a culturally appropriate psychological treatment for the adult British South Asian women who self harm. We plan to test a culturally adapted Problem Solving Therapy (C- MAP) in British South Asian women who self harm. Eight sessions of problem solving each lasting approximately 50 minutes will be delivered over 3 months. The intervention will be assessed using a prospective rater blind randomized controlled design comparing with treatment as usual (TAU). Outcome assessments will be carried out at 3 and 6 months. A sub group of the participants will be invited for qualitative interviews. This study will test the feasibility and acceptability of the C- MAP in British South Asian women. We will be informed on whether a culturally adapted brief psychological intervention compared with treatment as usual for self-harm results in decreased hopelessness and suicidal ideation. This will also enable us to collect necessary information on recruitment, effect size, the optimal delivery method and acceptability of the intervention in preparation for a definitive RCT using repetition of self harm and cost

  13. "CAN Stop"--implementation and evaluation of a secondary group prevention for adolescent and young adult cannabis users in various contexts--study protocol.

    Science.gov (United States)

    Baldus, Christiane; Miranda, Alejandra; Weymann, Nina; Reis, Olaf; Moré, Kerstin; Thomasius, Rainer

    2011-04-18

    gain knowledge about the programme's utility within different settings of the German help system for young cannabis users and information about the settings' specific clientele. The study protocol is discussed with regard to potential difficulties within the different settings. ISRCTN: ISRCTN57036983.

  14. "CAN Stop" - Implementation and evaluation of a secondary group prevention for adolescent and young adult cannabis users in various contexts - study protocol

    Directory of Open Access Journals (Sweden)

    Moré Kerstin

    2011-04-01

    seeking to reduce or quit their cannabis use. Moreover, we seek to gain knowledge about the programme's utility within different settings of the German help system for young cannabis users and information about the settings' specific clientele. The study protocol is discussed with regard to potential difficulties within the different settings. Trial registration ISRCTN: ISRCTN57036983

  15. Effectiveness of olive oil for the prevention of pressure ulcers caused in immobilized patients within the scope of primary health care: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Lupiáñez-Pérez, Inmaculada; Morilla-Herrera, Juan Carlos; Ginel-Mendoza, Leovigildo; Martín-Santos, Francisco Javier; Navarro-Moya, Francisco Javier; Sepúlveda-Guerra, Rafaela Pilar; Vázquez-Cerdeiros, Rosa; Cuevas-Fernández-Gallego, Magdalena; Benítez-Serrano, Isabel María; Lupiáñez-Pérez, Yolanda; Morales-Asencio, José Miguel

    2013-10-23

    Pressure ulcers are considered an important issue, mainly affecting immobilized older patients. These pressure ulcers increase the care burden for the professional health service staff as well as pharmaceutical expenditure. There are a number of studies on the effectiveness of different products used for the prevention of pressure ulcers; however, most of these studies were carried out at a hospital level, basically using hyperoxygenated fatty acids (HOFA). There are no studies focused specifically on the use of olive-oil-based products and therefore this research is intended to find the most cost-effective treatment and achieve an alternative treatment. The main objective is to assess the effectiveness of olive oil, comparing it with HOFA, to treat immobilized patients at home who are at risk of pressure ulcers. As a secondary objective, the cost-effectiveness balance of this new application with regard to the HOFA will be assessed. The study is designed as a noninferiority, triple-blinded, parallel, multi-center, randomized clinical trial. The scope of the study is the population attending primary health centers in Andalucía (Spain) in the regional areas of Malaga, Granada, Seville, and Cadiz. Immobilized patients at risk of pressure ulcers will be targeted. The target group will be treated by application of an olive-oil-based formula whereas the control group will be treated by application of HOFA to the control group. The follow-up period will be 16 weeks. The main variable will be the presence of pressure ulcers in the patient. Secondary variables include sociodemographic and clinical information, caregiver information, and whether technical support exists. Statistical analysis will include the Kolmogorov-Smirnov test, symmetry and kurtosis analysis, bivariate analysis using the Student's t and chi-squared tests as well as the Wilcoxon and the Man-Whitney U tests, ANOVA and multivariate logistic regression analysis. The regular use of olive-oil-based formulas

  16. The REFORM study protocol: a cohort randomised controlled trial of a multifaceted podiatry intervention for the prevention of falls in older people.

    Science.gov (United States)

    Cockayne, Sarah; Adamson, Joy; Corbacho Martin, Belen; Fairhurst, Caroline; Hewitt, Catherine; Hicks, Kate; Hull, Robin; Keenan, Anne Maree; Lamb, Sarah E; Loughrey, Lorraine; McIntosh, Caroline; Menz, Hylton B; Redmond, Anthony C; Rodgers, Sara; Vernon, Wesley; Watson, Judith; Torgerson, David

    2014-12-17

    Falls and fall-related injuries are a serious cause of morbidity and cost to society. Foot problems and inappropriate footwear may increase the risk of falls; therefore podiatric interventions may play a role in reducing falls. Two Cochrane systematic reviews identified only one study of a podiatry intervention aimed to reduce falls, which was undertaken in Australia. The REFORM trial aims to evaluate the clinical and cost-effectiveness of a multifaceted podiatry intervention in reducing falls in people aged 65 years and over in a UK and Irish setting. This multicentre, cohort randomised controlled trial will recruit 2600 participants from routine podiatry clinics in the UK and Ireland to the REFORM cohort. In order to detect a 10% point reduction in falls from 50% to 40%, with 80% power 890 participants will be randomised to receive routine podiatry care and a falls prevention leaflet or routine podiatry care, a falls prevention leaflet and a multifaceted podiatry intervention. The primary outcome is rate of falls (falls/person/time) over 12 months assessed by patient self-report falls diary. Secondary self-report outcome measures include: the proportion of single and multiple fallers and time to first fall over a 12-month period; Short Falls Efficacy Scale-International; fear of falling in the past 4 weeks; Frenchay Activities Index; fracture rate; Geriatric Depression Scale; EuroQoL-five dimensional scale 3-L; health service utilisation at 6 and 12 months. A qualitative study will examine the acceptability of the package of care to participants and podiatrists. The trial has received a favourable opinion from the East of England-Cambridge East Research Ethics Committee and Galway Research Ethics Committee. The trial results will be published in peer-reviewed journals and at conference presentations. Current Controlled Trials ISRCTN68240461 assigned 01/07/2011. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

  17. Physical activity as a preventive measure against overweight, obesity, infections, allergies and cardiovascular disease risk factors in adolescents: AFINOS Study protocol.

    Science.gov (United States)

    Veiga, Oscar L; Gómez-Martínez, Sonia; Martínez-Gómez, David; Villagra, Ariel; Calle, María E; Marcos, Ascensión

    2009-12-19

    Prior studies addressing the impacts of regular physical activity or sedentary habits on the immune system have been conducted in adults and laboratory settings. Thus, it is practically unknown how a healthy active lifestyle could affect low-grade inflammation processes, infections or allergies in young persons. The AFINOS Study was designed to determine the relationship between the regular physical activity levels of adolescents and overweight, infection, and allergies along with the presence of metabolic and immunological biomarkers of a deteriorated health status. A further objective of the AFINOS Study is to assess the health status and lifestyle habits of an adolescent population in an effort to identify any protective factors that could be used as preventive measures, since many chronic diseases and their associated co-morbidities often persist from adolescence into adulthood. This study was conducted as three separate sub-studies in three different populations as follows: (a) Study 1 was performed on a population sample of adolescents; (b) Study 2 on the adolescents' parents; and (c) Study 3 on a subset of the adolescents from Study 1. Study 1 assessed health and lifestyle indicators through a questionnaire administered to a representative sample of adolescents from the Madrid Region (n = 2400) aged 13 to 16 years. In Study 2, the parents of the teenagers participating in Study 1 were required to fill out a questionnaire. Finally in Study 3, body composition, physical activity, health-related physical fitness, and blood measurements were determined in a subset (n = 200) of the individuals included in Study 1. This paper describes the rationale, design, and methodologies used in the AFINOS Study. This multidisciplinary, multicenter study seeks to evaluate several aspects of existing relationships between routine physical activity/sedentary behaviour and several health status markers, specifically those related to the immune system. The results of this cross

  18. A behavioural change package to prevent hand dermatitis in nurses working in the national health service (the SCIN trial): study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Madan, Ira; Parsons, Vaughan; Cookson, Barry; English, John; Lavender, Tina; McCrone, Paul; Murphy, Caroline; Ntani, Georgia; Rushton, Lesley; Smedley, Julia; Williams, Hywel; Wright, Alison; Coggon, David

    2016-03-17

    Hand dermatitis can be a serious health problem in healthcare workers. While a range of skin care strategies and policy directives have been developed in recent years to minimise the risk, their effectiveness and cost-effectiveness remain unclear. Evidence now suggests that psychological theory can facilitate behaviour change with respect to improved hand care practices. Therefore, we will test the hypothesis that a behavioural change intervention to improve hand care, based on the Theory of Planned Behaviour and implementation intentions, coupled with provision of hand moisturisers, can produce a clinically useful reduction in the occurrence of hand dermatitis, when compared to standard care, among nurses working in the UK National Health Service (NHS) who are particularly at risk. Secondary aims will be to assess impacts on participants' beliefs and behaviour regarding hand care. In addition, we will assess the cost-effectiveness of the intervention in comparison with normal care. We will conduct a cluster randomised controlled trial at 35 NHS hospital trusts/health boards/universities, focussing on student nurses with a previous history of atopic disease or hand eczema and on nurses in intensive care units. Nurses at 'intervention-light' sites will be managed according to what would currently be regarded as best practice, with provision of an advice leaflet about optimal hand care to prevent hand dermatitis and encouragement to contact their occupational health (OH) department early if hand dermatitis occurs. Nurses at 'intervention-plus' sites will additionally receive a behavioural change programme (BCP) with on-going active reinforcement of its messages, and enhanced provision of moisturising cream. The impact of the interventions will be compared using information collected by questionnaires and through standardised photographs of the hands and wrists, collected at baseline and after 12 months follow-up. In addition, we will assemble relevant economic data

  19. To assess whether indoor residual spraying can provide additional protection against clinical malaria over current best practice of long-lasting insecticidal mosquito nets in The Gambia: study protocol for a two-armed cluster-randomised trial

    Directory of Open Access Journals (Sweden)

    Parker David

    2011-06-01

    Full Text Available Abstract Background Recently, there has been mounting interest in scaling-up vector control against malaria in Africa. It needs to be determined if indoor residual spraying (IRS with DDT will provide significant marginal protection against malaria over current best practice of long-lasting insecticidal nets (LLINs and prompt treatment in a controlled trial, given that DDT is currently the most persistent insecticide for IRS. Methods A 2 armed cluster-randomised controlled trial will be conducted to assess whether DDT IRS and LLINs combined provide better protection against clinical malaria in children than LLINs alone in rural Gambia. Each cluster will be a village, or a group of small adjacent villages; all clusters will receive LLINs and half will receive IRS in addition. Study children, aged 6 months to 13 years, will be enrolled from all clusters and followed for clinical malaria using passive case detection to estimate malaria incidence for 2 malaria transmission seasons in 2010 and 2011. This will be the primary endpoint. Exposure to malaria parasites will be assessed using light and exit traps followed by detection of Anopheles gambiae species and sporozoite infection. Study children will be surveyed at the end of each transmission season to estimate the prevalence of Plasmodium falciparum infection and the prevalence of anaemia. Discussion Practical issues concerning intervention implementation, as well as the potential benefits and risks of the study, are discussed. Trial Registration ISRCTN01738840 - Spraying And Nets Towards malaria Elimination (SANTE

  20. Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home patients: study protocol for a prospective multi-centre randomised controlled trial (ISRCTN17553857

    Directory of Open Access Journals (Sweden)

    Montgomery Ken

    2008-01-01

    Full Text Available Abstract Background Pressure ulcers are a major problem, especially in nursing home patients, although they are regarded as preventable and there are many pressure relieving methods and materials. One such pressure relieving material is the recently developed Australian Medical Sheepskin, which has been shown in two randomized controlled trials 12 to be an effective intervention in the prevention of sacral pressure ulcers in hospital patients. However, the use of sheepskins has been debated and in general discouraged by most pressure ulcer working groups and pressure ulcer guidelines, but these debates were based on old forms of sheepskins. Furthermore, nothing is yet known about the (cost-effectiveness of the Australian Medical sheepskin in nursing home patients. The objective of this study is to assess the effects and costs of the use of the Australian Medical Sheepskin combined with usual care with regard to the prevention of sacral pressure ulcers in somatic nursing home patients, versus usual care only. Methods/Design In a multi-centre randomised controlled trial 750 patients admitted for a primarily somatic reason to one of the five participating nursing homes, and not having pressure ulcers on the sacrum at admission, will be randomized to either usual care only or usual care plus the use of the Australian Medical Sheepskin as an overlay on the mattress. Outcome measures are: incidence of sacral pressure ulcers in the first month after admission; sacrum pressure ulcer free days; costs; patient comfort; and ease of use. The skin of all the patients will be observed once a day from admission on for 30 days. Patient characteristics and pressure risk scores are assessed at admission and at day 30 after it. Additional to the empirical phase, systematic reviews will be performed in order to obtain data for economic weighting and modelling. The protocol is registered in the Controlled Trial Register as ISRCTN17553857.

  1. Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home patients: study protocol for a prospective multi-centre randomised controlled trial (ISRCTN17553857).

    Science.gov (United States)

    Mistiaen, Patriek; Achterberg, Wilco; Ament, Andre; Halfens, Ruud; Huizinga, Janneke; Montgomery, Ken; Post, Henri; Francke, Anneke L

    2008-01-07

    Pressure ulcers are a major problem, especially in nursing home patients, although they are regarded as preventable and there are many pressure relieving methods and materials. One such pressure relieving material is the recently developed Australian Medical Sheepskin, which has been shown in two randomized controlled trials 12 to be an effective intervention in the prevention of sacral pressure ulcers in hospital patients. However, the use of sheepskins has been debated and in general discouraged by most pressure ulcer working groups and pressure ulcer guidelines, but these debates were based on old forms of sheepskins. Furthermore, nothing is yet known about the (cost-)effectiveness of the Australian Medical sheepskin in nursing home patients. The objective of this study is to assess the effects and costs of the use of the Australian Medical Sheepskin combined with usual care with regard to the prevention of sacral pressure ulcers in somatic nursing home patients, versus usual care only. In a multi-centre randomised controlled trial 750 patients admitted for a primarily somatic reason to one of the five participating nursing homes, and not having pressure ulcers on the sacrum at admission, will be randomized to either usual care only or usual care plus the use of the Australian Medical Sheepskin as an overlay on the mattress. Outcome measures are: incidence of sacral pressure ulcers in the first month after admission; sacrum pressure ulcer free days; costs; patient comfort; and ease of use. The skin of all the patients will be observed once a day from admission on for 30 days. Patient characteristics and pressure risk scores are assessed at admission and at day 30 after it. Additional to the empirical phase, systematic reviews will be performed in order to obtain data for economic weighting and modelling. The protocol is registered in the Controlled Trial Register as ISRCTN17553857.

  2. The Norwegian healthy body image programme: study protocol for a randomized controlled school-based intervention to promote positive body image and prevent disordered eating among Norwegian high school students.

    Science.gov (United States)

    Sundgot-Borgen, Christine; Bratland-Sanda, Solfrid; Engen, Kethe M E; Pettersen, Gunn; Friborg, Oddgeir; Torstveit, Monica Klungland; Kolle, Elin; Piran, Niva; Sundgot-Borgen, Jorunn; Rosenvinge, Jan H

    2018-03-06

    Body dissatisfaction and disordered eating raise the risk for eating disorders. In the prevention of eating disorders, many programmes have proved partly successful in using cognitive techniques to combat such risk factors. However, specific strategies to actively promote a positive body image are rarely used. The present paper outlines a protocol for a programme integrating the promotion of a positive body image and the prevention of disordered eating. Using a cluster randomized controlled mixed methods design, 30 high schools and 2481 12th grade students were allocated to the Healthy Body Image programme or to a control condition. The intervention comprised three workshops, each of 90 min with the main themes body image, media literacy, and lifestyle. The intervention was interactive in nature, and were led by trained scientists. The outcome measures include standardized instruments administered pre-post intervention, and at 3 and 12 months follow-ups, respectively. Survey data cover feasibility and implementation issues. Qualitative interviews covers experiential data about students' benefits and satisfaction with the programme. The present study is one of the first in the body image and disordered eating literature that integrates a health promotion and a disease prevention approach, as well as integrating standardized outcome measures and experiential findings. Along with mediator and moderator analyses it is expected that the Healthy Body Image programme may prove its efficacy. If so, plans are made with respect to further dissemination as well as communicating the findings to regional and national decision makers in the education and health care services. The study was registered and released at ClinicalTrials.gov 21th August 2016 with the Clinical Trial.gov ID: PRSNCT02901457 . In addition, the study is approved by the Regional Committee for Medical and Health Research Ethics.

  3. The effectiveness of a skin care program for the prevention of contact dermatitis in health care workers (the Healthy Hands Project): study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Soltanipoor, Maryam; Kezic, Sanja; Sluiter, Judith K; Rustemeyer, Thomas

    2017-02-28

    Health care workers (HCW) are at high risk for developing occupational hand dermatitis (HD) due to frequent exposure to 'wet work'. Amongst HCWs, nurses are at highest risk, with an estimated point prevalence of HD ranging between 12 and 30%. The burden of disease is high with chronicity, sick leave, risk of unemployment and impaired quality of life. Despite evidence from the medical literature on the risk factors and the importance of skin care in the prevention of HD, in practice, compliance to skin care protocols are below 30%. New preventive strategies are obviously needed. This is a cluster randomized controlled trial, focusing on nurses performing wet work. In total, 20 wards are recruited to include 504 participating nurses in the study at baseline. The wards will be randomized to an intervention or a control group and followed up for 18 months. The intervention consists of the facilitation of creams being available at the wards combined with the continuous electronic monitoring of their consumption with regular feedback on skin care performance in teams of HCWs. Both the intervention and the control group receive basic education on skin protection (as 'care as usual'). Every 6 months, participants of both groups will fill in the questionnaires regarding exposure to wet work and skin protective behavior. Furthermore, skin condition will be assessed and samples of the stratum corneum collected. The effect of the intervention will be measured by comparing the change in Hand Eczema Severity Index (HECSI score) from baseline to 12 months. The Natural Moisturizing Factor (NMF) levels, measured in the stratum corneum as an early biomarker of skin barrier damage, and the total consumption of creams per ward will be assessed as a secondary outcome. This trial will assess the clinical effectiveness of an intervention program to prevent hand dermatitis among health care workers TRIAL REGISTRATION: Netherlands Trial Register (NTR), identification number NTR5564

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

    Science.gov (United States)

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

    2015-03-08

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

  5. Effectiveness of the Strengthening Families Programme 10–14 in Poland for the prevention of alcohol and drug misuse: protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Okulicz-Kozaryn Katarzyna

    2012-06-01

    Full Text Available Abstract Background Alcohol and other drug use and misuse is a significant problem amongst Polish youth. The SFP10-14 is a family-based prevention intervention that has positive results in US trials, but questions remain about the generalizability of these results to other countries and settings. Methods/Design A cluster randomized controlled trial in community settings across Poland. Communities will be randomized to a SFP10-14 trial arm or to a control arm. Recruitment and consent of families, and delivery of the SFP10-14, will be undertaken by community workers. The primary outcomes are alcohol and other drug use and misuse. Secondary (or intermediate outcomes include parenting practices, parent–child relations, and child problem behaviour. Interview-based questionnaires will be administered at baseline, 12 and 24 months. Discussion The trial will provide information about the effectiveness of the SFP10-14 in Poland. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN89673828

  6. Health coaching and pedometers to enhance physical activity and prevent falls in community-dwelling people aged 60 years and over: study protocol for the Coaching for Healthy AGEing (CHAnGE) cluster randomised controlled trial.

    Science.gov (United States)

    Tiedemann, Anne; Rissel, Chris; Howard, Kirsten; Tong, Allison; Merom, Dafna; Smith, Stuart; Wickham, James; Bauman, Adrian; Lord, Stephen R; Vogler, Constance; Lindley, Richard I; Simpson, Judy M; Allman-Farinelli, Margaret; Sherrington, Catherine

    2016-05-10

    Prevention of falls and promotion of physical activity are essential for maximising well-being in older age. However, there is evidence that promoting physical activity among older people without providing fall prevention advice may increase fall rates. This trial aims to establish the impact of a physical activity and fall prevention programme compared with a healthy eating programme on physical activity and falls among people aged 60+ years. This cluster randomised controlled trial will involve 60 groups of community-dwelling people aged 60+ years. Participating groups will be randomised to: (1) a physical activity and fall prevention intervention (30 groups), involving written information, fall risk assessment and prevention advice, a pedometer-based physical activity tracker and telephone-based health coaching; or (2) a healthy eating intervention (30 groups) involving written information and telephone-based dietary coaching. Primary outcomes will be objectively measured physical activity at 12 months post-randomisation and self-reported falls throughout the 12-month trial period. Secondary outcomes include: the proportion of fallers, the proportion of people meeting the Australian physical activity guidelines, body mass index, eating habits, mobility goal attainment, mobility-related confidence, quality of life, fear of falling, risk-taking behaviour, mood, well-being, self-reported physical activity, disability, and health and community service use. The between-group difference in the number of falls per person-year will be analysed using negative binomial regression models. For the continuously scored primary and secondary outcome measures, linear regression adjusted for corresponding baseline scores will assess the effect of group allocation. Analyses will be preplanned, conducted while masked to group allocation, will take into account cluster randomisation, and will use an intention-to-treat approach. Protocol has been approved by the Human Research

  7. Web-based cognitive behavioral relapse prevention program with tailored feedback for people with methamphetamine and other drug use problems: protocol for a multicenter randomized controlled trial in Japan.

    Science.gov (United States)

    Takano, Ayumi; Miyamoto, Yuki; Kawakami, Norito; Matsumoto, Toshihiko; Shinozaki, Tomohiro; Sugimoto, Takashi

    2016-04-04

    Despite the effectiveness of psychosocial programs for recovery from drug use problems, there have been challenges in implementation of treatment. Internet-based and computerized approaches have been known to be effective in treatment dissemination. The study purpose is to assess the effects of a web-based psychosocial relapse prevention program with a multicenter randomized controlled trial. Recruitment began in January 2015 for outpatient participants diagnosed with drug abuse or dependence who have used a primary abused drug in the past year at psychiatric hospitals and a clinic. Participants are randomized either to a web-based relapse prevention program or a self-monitoring group. The intervention is a web-based relapse prevention program named "e-SMARPP" that consists of six relapse prevention program modules with tailored feedback from health care professionals and 8 weeks of self-monitoring. The content is adapted from a face-to-face relapse prevention program which is based on cognitive behavioral therapy and motivational enhancement. The primary outcomes are relapse risk assessed by the Stimulant Relapse Risk Scale (baseline, 2-, 5- and 8-month) and the longest duration of consecutive abstinent days from primary abused drug during the intervention. Secondary outcomes will include motivation to change, self-efficacy for drug use and craving, abstinent days in the past 28 or 56 days, quality of life, sense of coherence, cost of substance use, medical cost, retention of treatment and use of self-help group. Completion, usability and satisfaction of the program will be also assessed to explore feasibility. This study protocol was approved by the Ethics Committee of The University of Tokyo and each recruiting hospital and clinic. To our knowledge, this study is the first clinical trial to assess the effects of a web-based therapeutic program for drug users in Japan. If successful, this program is a promising approach for drug user treatment in Japan, where the

  8. Study protocol for a group randomized controlled trial of a classroom-based intervention aimed at preventing early risk factors for drug abuse: integrating effectiveness and implementation research.

    Science.gov (United States)

    Poduska, Jeanne; Kellam, Sheppard; Brown, C Hendricks; Ford, Carla; Windham, Amy; Keegan, Natalie; Wang, Wei

    2009-09-02

    While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program (WD), aimed at two early antecedents to drug abuse and other problem behaviors, namely, aggressive, disruptive behavior and poor academic achievement. The second purpose--the focus of this paper--was to examine the utility of a multilevel structure to support high levels of implementation during the effectiveness trial, to sustain WD practices across additional years, and to train additional teachers in WD practices. The WD intervention integrated three components, each previously tested separately: classroom behavior management; instruction, specifically reading; and family-classroom partnerships around behavior and learning. Teachers and students in 12 schools were randomly assigned to receive either the WD intervention or the standard first-grade program of the school system (SC). Three consecutive cohorts of first graders were randomized within schools to WD or SC classrooms and followed through the end of third grade to test the effectiveness of the WD intervention. Teacher practices were assessed over three years to examine the utility of the multilevel structure to support sustainability and scaling-up. The design employed in this trial appears to have considerable utility to provide data on WD effectiveness and to inform the field with regard to structures required to move evidence-based programs into practice. NCT00257088.

  9. The Brain Games study: protocol for a randomised controlled trial of computerised cognitive training for preventing mental illness in adolescents with high-risk personality styles.

    Science.gov (United States)

    Mewton, Louise; Hodge, Antoinette; Gates, Nicola; Visontay, Rachel; Teesson, Maree

    2017-09-25

    A broad range of mental disorders are now understood as aberrations of normal adolescent brain development. In both adolescents and adults, executive dysfunction has been implicated across a range of mental illnesses, and enhancing executive functioning may prove to be a useful prevention strategy for adolescents at risk for a range of psychopathology. This study will consist of a double-blind, randomised controlled trial with a 12-month follow-up period. Participants will consist of 200 people aged 16-24 years who are at risk for a range of mental disorders based on personality risk factors, but have not experienced a lifetime mental illness as determined by a structured diagnostic interview. Participants will be randomly allocated to either an intervention group who complete an online cognitive training programme specifically targeting executive functioning ability or a control group who complete an online cognitive training programme that has limited executive functioning training potential. Superiority of the executive functioning training programme compared with the control training programme will be assessed at baseline, post-training and at 3-month, 6-month and 12-month follow-up. All assessments will be conducted online. The primary outcome of the study will be general psychopathology as measured by the Strengths and Difficulties Questionnaire. Secondary outcomes will include executive functioning ability, day-to-day functioning and alcohol consumption. All analyses will be undertaken using mixed-model repeated measures analysis of variance with planned contrasts. Ethics approval has been obtained from the University of New South Wales Human Research Ethics Committee (HC15094). Results of the trial immediately post-treatment and at 12 months follow-up will be submitted for publication in peer-reviewed journals. ACTRN12616000127404; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All

  10. Monitoring of clinical strains and environmental fungal aerocontamination to prevent invasive aspergillosis infections in hospital during large deconstruction work: a protocol study.

    Science.gov (United States)

    Loeffert, Sophie Tiphaine; Melloul, Elise; Dananché, Cédric; Hénaff, Laetitia; Bénet, Thomas; Cassier, Pierre; Dupont, Damien; Guillot, Jacques; Botterel, Françoise; Wallon, Martine; Gustin, Marie-Paule; Vanhems, Philippe

    2017-11-25

    Monitoring fungal aerocontamination is an essential measure to prevent severe invasive aspergillosis (IA) infections in hospitals. One central block among 32 blocks of Edouard Herriot Hospital (EHH) was entirely demolished in 2015, while care activities continued in surrounding blocks. The main objective was to undertake broad environmental monitoring and clinical surveillance of IA cases to document fungal dispersion during major deconstruction work and to assess clinical risk. A daily environmental survey of fungal loads was conducted in eight wards located near the demolition site. Air was collected inside and outside selected wards by agar impact samplers. Daily spore concentrations were monitored continuously by volumetric samplers at a flow rate of 10 L.min -1 . Daily temperature, wind direction and speed as well as relative humidity were recorded by the French meteorological station Meteociel. Aspergillus fumigatus strains stored will be genotyped by multiple-locus, variable-number, tandem-repeat analysis. Antifungal susceptibility will be assessed by E-test strips on Roswell Park Memorial Institute medium supplemented with agar. Ascertaining the adequacy of current environmental monitoring techniques in hospital is of growing importance, considering the rising impact of fungal infections and of curative antifungal costs. The present study could improve the daily management of IA risk during major deconstruction work and generate new data to ameliorate and redefine current guidelines. This study was approved by the clinical research and ethics committees of EHH. © 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.

  11. Evidence of accessibility and utility of point-of-care diagnostics as an integral part of prevention of mother-to-child transmission services: systematic scoping review protocol.

    Science.gov (United States)

    Katoba, Juliet; Hangulu, Lydia; Mashamba-Thompson, Tivani Phosa

    2017-11-04

    Point-of-care (POC) testing has been shown to help improve healthcare access in resource-limited settings. However, there is paucity of evidence on accessibility of POC testing for prevention of mother-to-child transmission (PMTCT) in resource-limited settings. We propose to conduct a systematic scoping review to map the evidence on POC testing services for PMTCT. A scoping review framework, proposed by Arksey and O'Malley, will guide the study. A comprehensive literature search will be performed in the following electronic databases: PubMed, Science Direct, Cochrane Central, Google Scholar and databases within EBSCOhost (Medline and CINAHL). The primary research articles published in peer-reviewed journals and grey articles addressing our question will be included. One reviewer will conduct title screening and the results will be exported to endnote library. Two independent reviewers will perform abstract, then full article screening in parallel. The same process shall be employed to extract data from eligible studies. Data analysis will involve a narrative summary of included studies and thematic content analysis aided by NVIVO software V.11. The mixed methods assessment tool will be used to assess the quality of studies that will be included. Ethical approval is not applicable to this study. The study findings will be disseminated through publication in a peer-reviewed journal and presentations at conferences related to syphilis, HIV, PMTCT, bacterial infections and POC diagnostics. CRD42017056267. © 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.

  12. Prevention of diabetes in overweight/obese children through a family based intervention program including supervised exercise (PREDIKID project): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Arenaza, Lide; Medrano, María; Amasene, María; Rodríguez-Vigil, Beatriz; Díez, Ignacio; Graña, Manuel; Tobalina, Ignacio; Maiz, Edurne; Arteche, Edurne; Larrarte, Eider; Huybrechts, Inge; Davis, Catherine L; Ruiz, Jonatan R; Ortega, Francisco B; Margareto, Javier; Labayen, Idoia

    2017-08-10

    The global pandemic of obesity has led to an increased risk for prediabetes and type-2 diabetes (T2D). The aims of the current project are: (1) to evaluate the effect of a 22-week family based intervention program, including supervised exercise, on insulin resistance syndrome (IRS) risk in children with a high risk of developing T2D and (2) to identify the profile of microRNA in circulating exosomes and in peripheral blood mononuclear cells in children with a high risk of developing T2D and its response to a multidisciplinary intervention program including exercise. A total of 84 children, aged 8-12 years, with a high risk of T2D will be included and randomly assigned to control (N = 42) or intervention (N = 42) groups. The control group will receive a family based lifestyle education and psycho-educational program (2 days/month), while the intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program (3 days/week, 90 min per session including warm-up, moderate to vigorous aerobic activities, and strength exercises). The following measurements will be evaluated at baseline prior to randomization and after the intervention: fasting insulin, glucose and hemoglobin A1c; body composition (dual-energy X-ray absorptiometry); ectopic fat (magnetic resonance imaging); microRNA expression in circulating exosomes and in peripheral blood mononuclear cells (MiSeq; Illumina); cardiorespiratory fitness (cardiopulmonary exercise testing); dietary habits and physical activity (accelerometry). Prevention and identification of children with a high risk of developing T2D could help to improve their cardiovascular health and to reduce the comorbidities associated with obesity. ClinicalTrials.gov, ID: NCT03027726 . Registered on 16 January 2017.

  13. Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Smeets, Xavier J N M; da Costa, David W; Fockens, Paul; Mulder, Chris J J; Timmer, Robin; Kievit, Wietske; Zegers, Marieke; Bruno, Marco J; Besselink, Marc G H; Vleggaar, Frank P; van der Hulst, Rene W M; Poen, Alexander C; Heine, Gerbrand D N; Venneman, Niels G; Kolkman, Jeroen J; Baak, Lubbertus C; Römkens, Tessa E H; van Dijk, Sven M; Hallensleben, Nora D L; van de Vrie, Wim; Seerden, Tom C J; Tan, Adriaan C I T L; Voorburg, Annet M C J; Poley, Jan-Werner; Witteman, Ben J; Bhalla, Abha; Hadithi, Muhammed; Thijs, Willem J; Schwartz, Matthijs P; Vrolijk, Jan Maarten; Verdonk, Robert C; van Delft, Foke; Keulemans, Yolande; van Goor, Harry; Drenth, Joost P H; van Geenen, Erwin J M

    2018-04-02

    Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication of ERCP and may run a severe course. Evidence suggests that vigorous periprocedural hydration can prevent PEP, but studies to date have significant methodological drawbacks. Importantly, evidence for its added value in patients already receiving prophylactic rectal non-steroidal anti-inflammatory drugs (NSAIDs) is lacking and the cost-effectiveness of the approach has not been investigated. We hypothesize that combination therapy of rectal NSAIDs and periprocedural hydration would significantly lower the incidence of post-ERCP pancreatitis compared to rectal NSAIDs alone in moderate- to high-risk patients undergoing ERCP. The FLUYT trial is a multicenter, parallel group, open label, superiority randomized controlled trial. A total of 826 moderate- to high-risk patients undergoing ERCP that receive prophylactic rectal NSAIDs will be randomized to a control group (no fluids or normal saline with a maximum of 1.5 mL/kg/h and 3 L/24 h) or intervention group (lactated Ringer's solution with 20 mL/kg over 60 min at start of ERCP, followed by 3 mL/kg/h for 8 h thereafter). The primary endpoint is the incidence of post-ERCP pancreatitis. Secondary endpoints include PEP severity, hydration-related complications, and cost-effectiveness. The FLUYT trial design, including hydration schedule, fluid type, and sample size, maximize its power of identifying a potential difference in post-ERCP pancreatitis incidence in patients receiving prophylactic rectal NSAIDs. EudraCT: 2015-000829-37 . Registered on 18 February 2015. 13659155 . Registered on 18 May 2015.

  14. Study protocol for a group randomized controlled trial of a classroom-based intervention aimed at preventing early risk factors for drug abuse: integrating effectiveness and implementation research

    Directory of Open Access Journals (Sweden)

    Keegan Natalie

    2009-09-01

    Full Text Available Abstract Background While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program (WD, aimed at two early antecedents to drug abuse and other problem behaviors, namely, aggressive, disruptive behavior and poor academic achievement. The second purpose--the focus of this paper--was to examine the utility of a multilevel structure to support high levels of implementation during the effectiveness trial, to sustain WD practices across additional years, and to train additional teachers in WD practices. Methods The WD intervention integrated three components, each previously tested separately: classroom behavior management; instruction, specifically reading; and family-classroom partnerships around behavior and learning. Teachers and students in 12 schools were randomly assigned to receive either the WD intervention or the standard first-grade program of the school system (SC. Three consecutive cohorts of first graders were randomized within schools to WD or SC classrooms and followed through the end of third grade to test the effectiveness of the WD intervention. Teacher practices were assessed over three years to examine the utility of the multilevel structure to support sustainability and scaling-up. Discussion The design employed in this trial appears to have considerable utility to provide data on WD effectiveness and to inform the field with regard to structures required to move evidence-based programs into practice. Trial Registration Clinical Trials Registration Number: NCT00257088

  15. Prognostic significance of flow-cytometry evaluation of minimal residual disease in children with acute myeloid leukaemia treated according to the AIEOP-AML 2002/01 study protocol.

    Science.gov (United States)

    Buldini, Barbara; Rizzati, Frida; Masetti, Riccardo; Fagioli, Franca; Menna, Giuseppe; Micalizzi, Concetta; Putti, Maria Caterina; Rizzari, Carmelo; Santoro, Nicola; Zecca, Marco; Disarò, Silvia; Rondelli, Roberto; Merli, Pietro; Pigazzi, Martina; Pession, Andrea; Locatelli, Franco; Basso, Giuseppe

    2017-04-01

    In children with acute myeloid leukaemia (AML), assessment of initial treatment response is an essential prognostic factor; methods more sensitive than morphology are still under evaluation. We report on the measurement of minimal residual disease (MRD), by multicolour flow-cytometry in one centralized laboratory, in 142 children with newly diagnosed AML enrolled in the Associazione Italiana di EmatoOncologia Pediatrica-AML 2002/01 trial. At the end of the first induction course, MRD was 1% in 51 patients. The 8-year disease-free survival (DFS) of 125 children in morphological complete remission and with MRD <0·1%, 0·1-1% and ≥1% was 73·1 ± 5·6%, 37·8 ± 12·1% and 34·1 ± 8·8%, respectively (P < 0·01). MRD was also available after the second induction course in 92/142 patients. MRD was ≥0·1% at the end of the first induction course in 36 patients; 13 reached an MRD <0·1% after the second one and their DFS was 45·4 ± 16·7% vs. 22·8 ± 8·9% in patients with persisting MRD ≥0·1% (P = 0·037). Multivariate analysis demonstrated that MRD ≥0·1% after first induction course was, together with a monosomal karyotype, an independent adverse prognostic factor for DFS. Our results show that MRD detected by flow-cytometry after induction therapy predicts outcome in patients with childhood AML and can help stratifying post-remission treatment. © 2017 John Wiley & Sons Ltd.

  16. Using cotton plant residue to produce briquettes

    Energy Technology Data Exchange (ETDEWEB)

    Coates, W. [University of Arizona, Tucson, AZ (United States). Bioresources Research Facility

    2000-07-01

    In Arizona, cotton (Gossypium) plant residue left in the field following harvest must be buried to prevent it from serving as an overwintering site for insects such as the pink bollworm. Most tillage operations employed to incorporate the residue into the soil are energy intensive and often degrade soil structure. Trials showed that cotton plant residue could be incorporated with pecan shells to produce commercially acceptable briquettes. Pecan shell briquettes containing cotton residue rather than waste paper were slightly less durable, when made using equivalent weight mixtures and moisture contents. Proximate and ultimate analyses showed the only difference among briquette samples to be a higher ash content in those made using cotton plant residue. Briquettes made with paper demonstrated longer flame out time, and lower ash percentage, compared to those made with cotton plant residue. (author)

  17. 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....

  18. Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol of a controlled clinical trial developed by consensus of an international study group. Part three: individual patient, complication algorithm and quality manage.

    NARCIS (Netherlands)

    Stinner, B.; Bauhofer, A.; Lorenz, W.; Rothmund, M.; Plaul, U.; Torossian, A.; Celik, I.; Sitter, H.; Koller, M.; Black, A.; Duda, D.; Encke, A.; Greger, B.; Goor, H. van; Hanisch, E.; Hesterberg, R.; Klose, K.J.; Lacaine, F.; Lorijn, R.H.; Margolis, C.; Neugebauer, E.; Nystrom, P.O.; Reemst, P.H.M.; Schein, M.; Solovera, J.

    2001-01-01

    GENERAL DESIGN: Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased

  19. The European Innovation Partnership on Active and Healthy Ageing synergies: protocol for a prospective observational study to measure the Impact of a community-based program on prevention and mitigation of frailty (ICP – PMF) in community-dwelling older adults

    NARCIS (Netherlands)

    Liotta, G.; Orfila, F.; Vollenbroek-Hutten, Miriam Marie Rosé; Roller-Winsberger, R.; Illaria, M.; Musian, D.; Alvino, S.; O'Caoimh, R.; Cano, A.; Molloy, W.; Iaccarino, G.; Marazzi, M.C.; Inzerilli, M.C.; Madaro, O.; Paul, C.; Csonka, P.; Vince, A.C.; Menditto, E.; Maggio, M.; Scarcella, P.; Gilardi, F.; Lucaroni, F.; Abete, P.; Girardi, V.; Barra, R.; Palombi, L.

    2016-01-01

    Aim of this paper is to describe the protocol of the study “Impact of a Community-based Program on Prevention and Mitigation of Frailty in community-dwelling older adults‿ developed in the framework of the European Innovation Partnership on Active and Healthy Ageing. This proposal has been developed

  20. 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

  1. Protocol for a randomized controlled trial testing the impact of feedback on familial risk of chronic diseases on family-level intentions to participate in preventive lifestyle behaviors

    Directory of Open Access Journals (Sweden)

    Carlene J. Wilson

    2016-09-01

    Full Text Available Abstract Background Common disease risk clusters in families due to shared genetics, exposure to environmental risk factors, and because many health behaviours are established and maintained in family environments. This randomised controlled trial will test whether the provision of a family health history (FHH risk assessment tool increases intentions and engagement in health behaviors. Message distribution and collective behavior change within family networks will be mapped using social network analysis. The relative intervention impact will be compared between families from different ethnic backgrounds. Methods One hundred and fifty mothers (50 Anglo-Australian, 50 Italian-Australian, 50 Vietnamese-Australian will be recruited, with four or more other family members across three generations, including a child (aged 10–18 years. Each family is randomly assigned to intervention or control. At baseline and 6-month follow-up, all participants complete surveys to assess dietary and physical activity intentions and behaviors, attitudes towards food, and perceived disease risk. Intervention families receive a visual pedigree detailing their FHH of diabetes, heart disease, breast and bowel cancer, a health education workbook to ascertain members’ disease risk (i.e. average or above average risk, and screening and primary prevention recommendations. After completion of follow-up assessments, controls will receive their pedigree and workbook. The primary hypothesis is that attitudes and lifestyle behaviors will improve more within families exposed to FHH feedback, although the extent of this improvement may vary between families from different ethnic backgrounds. Additionally, the extent of improvement in the treatment group will be moderated by the level of family disease risk, with above-average risk leading to greater improvement. A secondary aim will explore different family members’ roles in message distribution and collective responses to

  2. Evidence-based new service package vs. routine service package for smoking cessation to prevent high risk patients from cardiovascular diseases (CVD): study protocol for randomized controlled trial.

    Science.gov (United States)

    Aung, Myo Nyein; Yuasa, Motoyuki; Lorga, Thaworn; Moolphate, Saiyud; Fukuda, Hiroshi; Kitajima, Tsutomu; Yokokawa, Hirohide; Minematsu, Kazuo; Tanimura, Susumu; Hiratsuka, Yoshimune; Ono, Koichi; Naunboonruang, Prissana; Thinuan, Payom; Kawai, Sachio; Suya, Yaoyanee; Chumvicharana, Somboon; Marui, Eiji

    2013-12-05

    Smoking cessation is a high-priority intervention to prevent CVD events and deaths in developing countries. While several interventions to stop smoking have been proved successful, the question of how to increase their effectiveness and practicality in developing countries remains. In this study, a newly devised evidence-based smoking cessation service package will be compared with the existing service in a randomized controlled trial within the community setting of Thailand. This randomized control trial will recruit 440 current smokers at CVD risk because of being diabetic and/or hypertensive. Informed, consented participants will be randomly allocated into the new service-package arm and the routine service arm. The study will take place in the non-communicable disease clinics of the Maetha District Hospital, Lampang, northern Thailand. The new smoking-cessation service-package comprises (1) regular patient motivation and coaching from the same primary care nurse over a 3-month period; (2) monthly application of piCO + smokerlyzer to sustain motivation of smoker's quitting attempt and provide positive feedback over a 3-month period; (3) assistance by an assigned family member; (4) nicotine replacement chewing gum to relieve withdrawal symptoms. This new service will be compared with the traditional routine service comprising the 5A approach in a 1-year follow-up. Participants who consent to participate in the study but refuse to attempt quitting smoking will be allocated to the non-randomized arm, where they will be just followed up and monitored. Primary outcome of the study is smoking cessation rate at 1-year follow-up proven by breath analysis measuring carbomonoxide in parts per million in expired air. Secondary outcomes are smoking cessation rate at the 6-month follow-up, blood pressure and heart rate, CVD risk according to the Framingham general cardiovascular risk score, CVD events and deaths at the 12-month follow-up, and the cost-effectiveness of the

  3. Innovative interventions to promote positive dental health behaviors and prevent dental caries in preschool children: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Gao, Xiaoli; Lo, Edward Chin Man; McGrath, Colman; Ho, Samuel Mun Yin

    2013-04-30

    Dental caries (tooth decay) is highly prevalent and is largely attributable to unhealthy self-care behaviors (diet and oral hygiene). The conventional (health) education (CE), focusing on disseminating information and giving normative advice, often fails to achieve sustained behavioral changes. This study incorporates two innovative elements into CE: (i) motivational interviewing (MI), a client-centered counseling for changing behaviors, and (ii) an interactive caries risk assessment (RA) tool, which is devised to facilitate dental counseling and may enhance MI in several ways. Through a randomized, controlled, evaluator-blinded trial, three intervention schemes (CE, CE+MI, and CE+MI+RA) will be compared for their effectiveness in eliciting dentally healthy behaviors and preventing caries in preschool children. This study targets 3-year-old children who are at a critical stage for embedding health habits. Children with unfavorable dental behaviors (insufficient toothbrushing and/or frequent snacking) and their parents will be recruited from 12 participating kindergartens. Parent-child dyads (n=690) will be randomly assigned into three groups. In the first group (CE), oral health information and advice will be delivered to parents through pamphlets. In the second group (CE+MI), in addition to the pamphlets, individual MI counseling with each parent will be performed by one of two trained dental hygienists. In the third group (CE+MI+RA), besides pamphlets and MI, interactive RA will be integrated into MI to motivate parents and facilitate their informed decision making and goal planning. At baseline and after 12 and 24 months, parents will complete a questionnaire and children will undergo a dental examination. The effectiveness of the intervention schemes will be compared over 12 and 24 months. The primary outcome will be caries increment in children and proportion of caries-free children. Secondary outcomes will be changes in parental efficacy for protecting

  4. The BBaRTS Healthy Teeth Behaviour Change Programme for preventing dental caries in primary school children: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Pine, Cynthia; Adair, Pauline; Robinson, Louise; Burnside, Girvan; Moynihan, Paula; Wade, William; Kistler, James; Curnow, Morag; Henderson, Mary

    2016-02-20

    Oral health behaviours such as establishing twice-daily toothbrushing and sugar control intake need parental self-efficacy (PSE) to prevent the development of childhood dental caries. A previous study has shown that behaviour change techniques (BCTs) delivered via a storybook can improve parental self-efficacy to undertake twice-daily toothbrushing. to determine whether an intervention (BBaRTS, Bedtime Brush and Read Together to Sleep), designed to increase PSE; delivered through storybooks with embedded BCTs, parenting skills and oral health messages, can improve child oral health compared to (1) an exactly similar intervention containing no behaviour change techniques, and (2) the BBaRTS intervention supplemented with home supply of fluoride toothpaste and supervised toothbrushing on schooldays. A 2-year, three-arm, multicentre, cluster randomised controlled trial. children (estimated 2000-2600) aged 5-7 years and their families from 60 UK primary schools. Test group 1: a series of eight children's storybooks developed by a psychologist, public health dentist, science educator, children's author and illustrators, with guidance from the Department for Education (England). The books feature animal characters and contain embedded dental health messages, parenting skills and BCTs to promote good oral health routines focused on controlling sugar intake and toothbrushing, as well as reading at bedtime. Books are given out over 2 years. Test group 2: as Test group 1 plus home supplies of fluoride toothpaste (1000 ppmF), and daily supervised toothbrushing in school on schooldays. Active Control group: series of eight books with exactly the same stories, characters and illustrations, but without BCTs, dental health messages or parenting skills. Annual child dental examinations and parental questionnaires will be undertaken. A sub-set of participants will be invited to join an embedded study of the child's diet and salivary microbiota composition. dental caries experience

  5. Effectiveness, relapse prevention and mechanisms of change of cognitive therapy vs. interpersonal therapy for depression: Study protocol for a randomised controlled trial.

    Science.gov (United States)

    Lemmens, Lotte H J M; Arntz, Arnoud; Peeters, Frenk P M L; Hollon, Steven D; Roefs, Anne; Huibers, Marcus J H

    2011-06-14

    Major depression is a common mental disorder that substantially impairs quality of life and has high societal costs. Although psychotherapies have proven to be effective antidepressant treatments, initial response rates are insufficient and the risk of relapse and recurrence is high. Improvement of treatments is badly needed. Studying the mechanisms of change in treatment might be a good investment for improving everyday mental health care. However, the mechanisms underlying therapeutic change remain largely unknown. The objective of the current study is to assess both the effectiveness of two commonly used psychotherapies for depression in terms of reduction of symptoms and prevention of relapse on short and long term, as well as identifying underlying mechanisms of change. In a randomised trial we will compare (a) Cognitive Therapy (CT) with (b) Interpersonal therapy (IPT), and (c) an 8-week waiting list condition followed by treatment of choice. One hundred eighty depressed patients (aged 18-65) will be recruited in a mental health care centre in Maastricht (the Netherlands). Eligible patients will be randomly allocated to one of the three intervention groups. The primary outcome measure of the clinical evaluation is depression severity measured by the Beck Depression Intenvory-II (BDI-II). Other outcomes include process variables such as dysfunctional beliefs, negative attributions, and interpersonal problems. All self-report outcome assessments will take place on the internet at baseline, three, seven, eight, nine, ten, eleven, twelve and twenty-four months. At 24 months a retrospective telephone interview will be administered. Furthermore, a rudimentary analysis of the cost-effectiveness will be embedded. The study has been ethically approved and registered. By comparing CT and IPT head-to-head and by investigating multiple potential mediators and outcomes at multiple time points during and after therapy, we hope to provide new insights in the effectiveness

  6. Effectiveness, relapse prevention and mechanisms of change of cognitive therapy vs. interpersonal therapy for depression: Study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Roefs Anne

    2011-06-01

    Full Text Available Abstract Background Major depression is a common mental disorder that substantially impairs quality of life and has high societal costs. Although psychotherapies have proven to be effective antidepressant treatments, initial response rates are insufficient and the risk of relapse and recurrence is high. Improvement of treatments is badly needed. Studying the mechanisms of change in treatment might be a good investment for improving everyday mental health care. However, the mechanisms underlying therapeutic change remain largely unknown. The objective of the current study is to assess both the effectiveness of two commonly used psychotherapies for depression in terms of reduction of symptoms and prevention of relapse on short and long term, as well as identifying underlying mechanisms of change. Methods In a randomised trial we will compare (a Cognitive Therapy (CT with (b Interpersonal therapy (IPT, and (c an 8-week waiting list condition followed by treatment of choice. One hundred eighty depressed patients (aged 18-65 will be recruited in a mental health care centre in Maastricht (the Netherlands. Eligible patients will be randomly allocated to one of the three intervention groups. The primary outcome measure of the clinical evaluation is depression severity measured by the Beck Depression Intenvory-II (BDI-II. Other outcomes include process variables such as dysfunctional beliefs, negative attributions, and interpersonal problems. All self-report outcome assessments will take place on the internet at baseline, three, seven, eight, nine, ten, eleven, twelve and twenty-four months. At 24 months a retrospective telephone interview will be administered. Furthermore, a rudimentary analysis of the cost-effectiveness will be embedded. The study has been ethically approved and registered. Discussion By comparing CT and IPT head-to-head and by investigating multiple potential mediators and outcomes at multiple time points during and after therapy, we

  7. Protocol for a randomized controlled trial testing the impact of feedback on familial risk of chronic diseases on family-level intentions to participate in preventive lifestyle behaviors.

    Science.gov (United States)

    Wilson, Carlene J; de la Haye, Kayla; Coveney, John; Hughes, Donna L; Hutchinson, Amanda; Miller, Caroline; Prichard, Ivanka; Ward, Paul; Koehly, Laura M

    2016-09-13

    Common disease risk clusters in families due to shared genetics, exposure to environmental risk factors, and because many health behaviours are established and maintained in family environments. This randomised controlled trial will test whether the provision of a family health history (FHH) risk assessment tool increases intentions and engagement in health behaviors. Message distribution and collective behavior change within family networks will be mapped using social network analysis. The relative intervention impact will be compared between families from different ethnic backgrounds. One hundred and fifty mothers (50 Anglo-Australian, 50 Italian-Australian, 50 Vietnamese-Australian) will be recruited, with four or more other family members across three generations, including a child (aged 10-18 years). Each family is randomly assigned to intervention or control. At baseline and 6-month follow-up, all participants complete surveys to assess dietary and physical activity intentions and behaviors, attitudes towards food, and perceived disease risk. Intervention families receive a visual pedigree detailing their FHH of diabetes, heart disease, breast and bowel cancer, a health education workbook to ascertain members' disease risk (i.e. average or above average risk), and screening and primary prevention recommendations. After completion of follow-up assessments, controls will receive their pedigree and workbook. The primary hypothesis is that attitudes and lifestyle behaviors will improve more within families exposed to FHH feedback, although the extent of this improvement may vary between families from different ethnic backgrounds. Additionally, the extent of improvement in the treatment group will be moderated by the level of family disease risk, with above-average risk leading to greater improvement. A secondary aim will explore different family members' roles in message distribution and collective responses to risk using social network approaches and to compare

  8. Efficacy and safety of the C-Qur™ Film Adhesion Barrier for the prevention of surgical adhesions (CLIPEUS Trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Stommel, Martijn W J; Strik, Chema; ten Broek, Richard P G; van Goor, Harry

    2014-09-26

    complications are considered multifactorial and difficult to interpret. Incidence of adhesions at repeat surgery is believed to be the most valuable surrogate endpoint for clinically relevant adhesion prevention, since small bowel obstruction and adhesiolysis at repeat surgery are not likely to occur when complete adhesion reduction in a patient is accomplished. ClinicalTrials.gov Identifier NCT01872650, registration date 6 June 2013.

  9. The prevention and reduction of weight loss in an acute tertiary care setting: protocol for a pragmatic stepped wedge randomised cluster trial (the PRoWL project)

    Science.gov (United States)

    2013-01-01

    Background Malnutrition, with accompanying weight loss, is an unnecessary risk in hospitalised persons and often remains poorly recognised and managed. The study aims to evaluate a hospital-wide multifaceted intervention co-facilitated by clinical nurses and dietitians addressing the nutritional care of patients, particularly those at risk of malnutrition. Using the best available evidence on reducing and preventing unplanned weight loss, the intervention (introducing universal nutritional screening; the provision of oral nutritional supplements; and providing red trays and additional support for patients in need of feeding) will be introduced by local ward teams in a phased way in a large tertiary acute care hospital. Methods/Design A pragmatic stepped wedge randomised cluster trial with repeated cross section design will be conducted. The unit of randomisation is the ward, with allocation by a random numbers table. Four groups of wards (n = 6 for three groups, n = 7 for one group) will be randomly allocated to each intervention time point over the trial. Two trained local facilitators (a nurse and dietitian for each group) will introduce the intervention. The primary outcome measure is change in patient’s body weight, secondary patient outcomes are: length of stay, all-cause mortality, discharge destinations, readmission rates and ED presentations. Patient outcomes will be measured on one ward per group, with 20 patients measured per ward per time period by an unblinded researcher. Including baseline, measurements will be conducted at five time periods. Staff perspectives on the context of care will be measured with the Alberta Context Tool. Discussion Unplanned and unwanted weight loss in hospital is common. Despite the evidence and growing concern about hospital nutrition there are very few evaluations of system-wide nutritional implementation programs. This project will test the implementation of a nutritional intervention across one hospital system using a

  10. A longitudinal cohort study of HIV 'treatment as prevention' in gay, bisexual and other men who have sex with men: the Treatment with Antiretrovirals and their Impact on Positive And Negative men (TAIPAN) study protocol.

    Science.gov (United States)

    Callander, D; Stoové, M; Carr, A; Hoy, J F; Petoumenos, K; Hellard, M; Elliot, J; Templeton, D J; Liaw, S; Wilson, D P; Grulich, A; Cooper, D A; Pedrana, A; Donovan, B; McMahon, J; Prestage, G; Holt, M; Fairley, C K; McKellar-Stewart, N; Ruth, S; Asselin, J; Keen, P; Cooper, C; Allan, B; Kaldor, J M; Guy, R

    2016-12-12

    Australia has increased coverage of antiretroviral treatment (ART) over the past decade, reaching 73% uptake in 2014. While ART reduces AIDS-related deaths, accumulating evidence suggests that it could also bolster prevention efforts by reducing the risk of HIV transmission ('treatment as prevention'). While promising, evidence of community-level impact of treatment as prevention on reducing HIV incidence among gay and bisexual men is limited. We describe a study protocol that aims to determine if scale up of testing and treatment for HIV leads to a reduction in community viraemia and, in turn, if this reduction is temporally associated with a reduction in HIV incidence among gay and bisexual men in Australia's two most populous states. Over the period 2009 to 2017, we will establish two cohorts making use of clinical and laboratory data electronically extracted retrospectively and prospectively from 73 health services and laboratories in the states of New South Wales and Victoria. The 'positive cohort' will consist of approximately 13,000 gay and bisexual men (>90% of all people living with HIV). The 'negative cohort' will consist of at least 40,000 HIV-negative gay and bisexual men (approximately half of the total population). Within the negative cohort we will use standard repeat-testing methods to calculate annual HIV incidence. Community prevalence of viraemia will be defined as the proportion of men with a viral load ≥200RNA copies/mm 3 , which will combine viral load data from the positive cohort and viraemia estimates among those with an undiagnosed HIV infection. Using regression analyses and adjusting for behavioural and demographic factors associated with infection, we will assess the temporal association between the community prevalence of viraemia and the incidence of HIV infection. Further analyses will make use of these cohorts to assess incidence and predictors of treatment initiation, repeat HIV testing, and viral suppression. This study will

  11. Surgical treatment for residual or recurrent strabismus

    Directory of Open Access Journals (Sweden)

    Tao Wang

    2014-12-01

    Full Text Available Although the surgical treatment is a relatively effective and predictable method for correcting residual or recurrent strabismus, such as posterior fixation sutures, medial rectus marginal myotomy, unilateral or bilateral rectus re-recession and resection, unilateral lateral rectus recession and adjustable suture, no standard protocol is established for the surgical style. Different surgical approaches have been recommended for correcting residual or recurrent strabismus. The choice of the surgical procedure depends on the former operation pattern and the surgical dosages applied on the patients, residual or recurrent angle of deviation and the operator''s preference and experience. This review attempts to outline recent publications and current opinion in the management of residual or recurrent esotropia and exotropia.

  12. 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...

  13. Establishing treatment protocols for clinical mastitis.

    Science.gov (United States)

    Roberson, Jerry R

    2003-03-01

    Each farm has a unique mix of mastitis pathogens and management procedures that have evolved over time. The herd veterinarian should work with the manager/owner to systematically develop treatment protocols that meet the needs and management of the farm. To establish a mastitis treatment protocol, it is necessary to develop a system to routinely identify clinical mastitis cases, develop a herd-specific severity level assessment system, manage the clinical mastitis cases based on severity level and culture result (when available), avoid antibiotic residues, and monitor the success of the system and alter the protocol as necessary.

  14. Avaliação de protocolo de prevenção e tratamento de úlceras de pressão Evaluation of a prevention protocol of pressure ulcers

    Directory of Open Access Journals (Sweden)

    Marisol Louro

    2007-09-01

    during one year. Seventy patients were excluded for insufficient data. The prevention protocol (Norton scale; positioning according the risk grade and therapeutic protocol (hydrocolloid dressings; hydrogel dressings if tissue necrosis and/or devitalized and alginate dressings if ulcer bleeds was applied to all patients. RESULTS: One hundred and fifty five patients were studied. Eighteen patients were admitted already with PU. During ICU stay, 40 patients developed a total of 125 PU. The prevalence of PU was 37.41% and incidence was 25.8%. The development of new PU occurred on average by the 7th day. Patients with PU presented 2.6 PU on the average. Seventy nine percent of the patients admitted in the ICU remained stable or improved. Patients admitted with PU had a SAPS 2 significantly higher than those without, 54 ± 8.7 and 44 ± 17, respectively (p = 0.015. At the day of discharge, patients classified as high risk had significantly more PU (p = 0.039. Non-survivors had significantly more PU than survivors (p < 0.001. Patients with longer ICU stay had more PU (p < 0.001 CONCLUSIONS: In our patient population we found 37.41% prevalence and 25.8% incidence of PU. The present prevention protocol of PU was effective in 79% of the patients; severely ill patients developed PU more frequently.

  15. Protocol for “Seal or Varnish?” (SoV trial: a randomised controlled trial to measure the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental decay

    Directory of Open Access Journals (Sweden)

    Chestnutt Ivor Gordon

    2012-11-01

    Full Text Available Abstract Background Dental caries remains a significant public health problem, prevalence being linked to social and economic deprivation. Occlusal surfaces of first permanent molars are the most susceptible site in the developing permanent dentition. Cochrane reviews have shown pit and fissure sealants (PFS and fluoride varnish (FV to be effective over no intervention in preventing caries. However, the comparative cost and effectiveness of these treatments is uncertain. The primary aim of the trial described in this protocol is to compare the clinical effectiveness of PFS and FV in preventing dental caries in first permanent molars in 6-7 year-olds. Secondary aims include: establishing the costs and the relative cost-effectiveness of PFS and FV delivered in a community/school setting; examining the impact of PFS and FV on children and their parents/carers in terms of quality of life/treatment acceptability measures; and examining the implementation of treatment in a community setting. Methods/design The trial design comprises a randomised, assessor-blinded, two-arm, parallel group trial in 6–7 year old schoolchildren. Clinical procedures and assessments will be performed at 66 primary schools, in deprived areas in South Wales. Treatments will be delivered via a mobile dental clinic. In total, 920 children will be recruited (460 per trial arm. At baseline and annually for 36 months dental caries will be recorded using the International Caries Detection and Assessment System (ICDAS by trained and calibrated dentists. PFS and FV will be applied by trained dental hygienists. The FV will be applied at baseline, 6, 12, 18, 24 and 30 months. The PFS will be applied at baseline and re-examined at 6, 12, 18, 24, and 30 months, and will be re-applied if the existing sealant has become detached/is insufficient. The economic analysis will estimate the costs of providing the PFS versus FV. The process evaluation will assess implementation and

  16. A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study): study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Abramsky, Tanya; Devries, Karen; Kiss, Ligia; Francisco, Leilani; Nakuti, Janet; Musuya, Tina; Kyegombe, Nambusi; Starmann, Elizabeth; Kaye, Dan; Michau, Lori; Watts, Charlotte

    2012-06-29

    Gender based violence, including violence by an intimate partner, is a major global human rights and public health problem, with important connections with HIV risk. Indeed, the elimination of sexual and gender based violence is a core pillar of HIV prevention for UNAIDS. Integrated strategies to address the gender norms, relations and inequities that underlie both violence against women and HIV/AIDS are needed. However there is limited evidence about the potential impact of different intervention models. This protocol describes the SASA! an evaluation of a community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda. The SASA! STUDY is a pair-matched cluster randomised controlled trial being conducted in eight communities in Kampala. It is designed to assess the community-level impact of the SASA! intervention on the following six primary outcomes: attitudes towards the acceptability of violence against women and the acceptability of a woman refusing sex (among male and female community members); past year experience of physical intimate partner violence and sexual intimate partner violence (among females); community responses to women experiencing violence (among women reporting past year physical/sexual partner violence); and past year concurrency of sexual partners (among males). 1583 women and men (aged 18-49 years) were surveyed in intervention and control communities prior to intervention implementation in 2007/8. A follow-up cross-sectional survey of community members will take place in 2012. The primary analysis will be an adjusted cluster-level intention to treat analysis, comparing outcomes in intervention and control communities at follow-up. Complementary monitoring and evaluation and qualitative research will be used to explore and describe the process of intervention implementation and the pathways through which change is achieved. This is one of few cluster randomised trials globally to assess

  17. A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study: study protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Abramsky Tanya

    2012-06-01

    Full Text Available Abstract Background Gender based violence, including violence by an intimate partner, is a major global human rights and public health problem, with important connections with HIV risk. Indeed, the elimination of sexual and gender based violence is a core pillar of HIV prevention for UNAIDS. Integrated strategies to address the gender norms, relations and inequities that underlie both violence against women and HIV/AIDS are needed. However there is limited evidence about the potential impact of different intervention models. This protocol describes the SASA! Study: an evaluation of a community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda. Methods/Design The SASA! Study is a pair-matched cluster randomised controlled trial being conducted in eight communities in Kampala. It is designed to assess the community-level impact of the SASA! intervention on the following six primary outcomes: attitudes towards the acceptability of violence against women and the acceptability of a woman refusing sex (among male and female community members; past year experience of physical intimate partner violence and sexual intimate partner violence (among females; community responses to women experiencing violence (among women reporting past year physical/sexual partner violence; and past year concurrency of sexual partners (among males. 1583 women and men (aged 18–49 years were surveyed in intervention and control communities prior to intervention implementation in 2007/8. A follow-up cross-sectional survey of community members will take place in 2012. The primary analysis will be an adjusted cluster-level intention to treat analysis, comparing outcomes in intervention and control communities at follow-up. Complementary monitoring and evaluation and qualitative research will be used to explore and describe the process of intervention implementation and the pathways through which change is achieved

  18. A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study): study protocol for a cluster randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background Gender based violence, including violence by an intimate partner, is a major global human rights and public health problem, with important connections with HIV risk. Indeed, the elimination of sexual and gender based violence is a core pillar of HIV prevention for UNAIDS. Integrated strategies to address the gender norms, relations and inequities that underlie both violence against women and HIV/AIDS are needed. However there is limited evidence about the potential impact of different intervention models. This protocol describes the SASA! Study: an evaluation of a community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda. Methods/Design The SASA! Study is a pair-matched cluster randomised controlled trial being conducted in eight communities in Kampala. It is designed to assess the community-level impact of the SASA! intervention on the following six primary outcomes: attitudes towards the acceptability of violence against women and the acceptability of a woman refusing sex (among male and female community members); past year experience of physical intimate partner violence and sexual intimate partner violence (among females); community responses to women experiencing violence (among women reporting past year physical/sexual partner violence); and past year concurrency of sexual partners (among males). 1583 women and men (aged 18–49 years) were surveyed in intervention and control communities prior to intervention implementation in 2007/8. A follow-up cross-sectional survey of community members will take place in 2012. The primary analysis will be an adjusted cluster-level intention to treat analysis, comparing outcomes in intervention and control communities at follow-up. Complementary monitoring and evaluation and qualitative research will be used to explore and describe the process of intervention implementation and the pathways through which change is achieved. Discussion This is one of few

  19. Can a combined screening/treatment programme prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies: study protocol for the multicentre randomised controlled OuTSMART trial

    Science.gov (United States)

    2014-01-01

    Background Renal transplantation is the best treatment for kidney failure, in terms of length and quality of life and cost-effectiveness. However, most transplants fail after 10 to 12 years, consigning patients back onto dialysis. Damage by the immune system accounts for approximately 50% of failing transplants and it is possible to identify patients at risk by screening for the presence of antibodies against human leukocyte antigens. However, it is not clear how best to treat patients with antibodies. This trial will test a combined screening and treatment protocol in renal transplant recipients. Methods/Design Recipients >1 year post-transplantation, aged 18 to 70 with an estimated glomerular filtration rate >30 mL/min will be randomly allocated to blinded or unblinded screening arms, before being screened for the presence of antibodies. In the unblinded arm, test results will be revealed. Those with antibodies will have biomarker-led care, consisting of a change in their anti-rejection drugs to prednisone, tacrolimus and mycophenolate mofetil. In the blinded arm, screening results will be double blinded and all recruits will remain on current therapy (standard care). In both arms, those without antibodies will be retested every 8 months for 3 years. The primary outcome is the 3-year kidney failure rate for the antibody-positive recruits, as measured by initiation of long-term dialysis or re-transplantation, predicted to be approximately 20% in the standard care group but transplant dysfunction, incidence of infection, cancer and diabetes mellitus, an analysis of adherence with medication and a health economic analysis of the combined screening and treatment protocol. Blood samples will be collected and stored every 4 months and will form the basis of separately funded studies to identify new biomarkers associated with the outcomes. Discussion We have evidence that the biomarker-led care regime will be effective at preventing graft dysfunction and expect this to

  20. Diagnosis, Prevalence, Awareness, Treatment, Prevention, and Control of Hypertension in Cameroon: Protocol for a Systematic Review and Meta-Analysis of Clinic-Based and Community-Based Studies.

    Science.gov (United States)

    Kuate Defo, Barthelemy; Mbanya, Jean Claude; Tardif, Jean-Claude; Ekundayo, Olugbemiga; Perreault, Sylvie; Potvin, Louise; Cote, Robert; Kengne, Andre Pascal; Choukem, Simeon Pierre; Assah, Felix; Kingue, Samuel; Richard, Lucie; Pongou, Roland; Frohlich, Katherine; Saji, Jude; Fournier, Pierre; Sobngwi, Eugene; Ridde, Valery; Dubé, Marie-Pierre; De Denus, Simon; Mbacham, Wilfred; Lafrance, Jean-Philippe; Nsagha, Dickson Shey; Mampuya, Warner; Dzudie, Anastase; Cloutier, Lyne; Zarowsky, Christina; Tanya, Agatha; Ndom, Paul; Hatem, Marie; Rey, Evelyne; Roy, Louise; Borgès Da Silva, Roxane; Dagenais, Christian; Todem, David; Weladji, Robert; Mbanya, Dora; Emami, Elham; Njoumemi, Zakariaou; Monnais, Laurence; Dubois, Carl-Ardy

    2017-05-29

    independently search, screen, extract data, and assess the quality of selected studies using suitable tools. Selected studies will be analyzed by narrative synthesis, meta-analysis, or both, depending on the nature of the data retrieved in line with the review objectives. This review is part of an ongoing research program on disease prevention and control in the context of the dual burden of communicable and noncommunicable diseases in Africa. The first results are expected in 2017. This review will provide a comprehensive assessment of the burden of hypertension and control measures that have been designed and implemented in Cameroon. Findings will form the knowledge base relevant to stakeholders across the health system and researchers who are involved in hypertension prevention and control in the community and clinic settings in Cameroon, as a yardstick for similar African countries. PROSPERO registration number: CRD42017054950; http://www.crd.york.ac.uk/PROSPERO/ display_record.asp?ID=CRD42017054950 (Archived by WebCite at http://www.webcitation.org/6qYSjt9Jc). ©Barthelemy Kuate Defo, Jean Claude Mbanya, Jean-Claude Tardif, Olugbemiga Ekundayo, Sylvie Perreault, Louise Potvin, Robert Cote, Andre Pascal Kengne, Simeon Pierre Choukem, Felix Assah, Samuel Kingue, Lucie Richard, Roland Pongou, Katherine Frohlich, Jude Saji, Pierre Fournier, Eugene Sobngwi, Valery Ridde, Marie-Pierre Dubé, Simon De Denus, Wilfred Mbacham, Jean-Philippe Lafrance, Dickson Shey Nsagha, Warner Mampuya, Anastase Dzudie, Lyne Cloutier, Christina Zarowsky, Agatha Tanya, Paul Ndom, Marie Hatem, Evelyne Rey, Louise Roy, Roxane Borgès Da Silva, Christian Dagenais, David Todem, Robert Weladji, Dora Mbanya, Elham Emami, Zakariaou Njoumemi, Laurence Monnais, Carl-Ardy Dubois. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.05.2017.

  1. Evaluating the effectiveness of selected community-level interventions on key maternal, child health, and prevention of mother-to-child transmission of HIV outcomes in three countries (the ACCLAIM Project): a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Woelk, Godfrey B; Kieffer, Mary Pat; Walker, Damilola; Mpofu, Daphne; Machekano, Rhoderick

    2016-02-16

    Efforts to scale up and improve programs for prevention of mother-to-child transmission of HIV (PMTCT) have focused primarily at the health facility level, and limited attention has been paid to defining an effective set of community interventions to improve demand and uptake of services and retention. Many barriers to PMTCT are also barriers to pregnancy, childbirth, and postnatal care faced by mothers regardless of HIV status. Demand for maternal and child health (MCH) and PMTCT services can be limited by critical social, cultural, and structural barriers. Yet, rigorous evaluation has shown limited evidence of effectiveness of multilevel community-wide interventions aimed at improving MCH and HIV outcomes for pregnant women living with HIV. We propose to assess the effect of a package of multilevel community interventions: a social learning and action component, community dialogues, and peer-led discussion groups, on the demand for, uptake of, and retention of HIV positive pregnant/postpartum women in MCH/PMTCT services. This study will undertake a three-arm randomized trial in Swaziland, Uganda, and Zimbabwe. Districts/regions (n = 9) with 45 PMTCT-implementing health facilities and their catchment areas (populations 7,300-27,500) will be randomly allocated to three intervention arms: 1) community leader engagement, 2) community leader engagement with community days, or 3) community leader engagement with community days and male and female community peer groups. The primary study outcome is HIV exposed infants (HEIs) returning to the health facility within 2 months for early infant diagnosis (EID) of HIV. Secondary study outcomes include gestational age of women attending for first antenatal care, male partners tested for HIV, and HEIs receiving nevirapine prophylaxis at birth. Changes in community knowledge, attitudes, practices, and beliefs on MCH/PMTCT will be assessed through household surveys. Implementation of the protocol necessitated changes in the

  2. Rationale and study protocol for the 'active teen leaders avoiding screen-time' (ATLAS) group randomized controlled trial: an obesity prevention intervention for adolescent boys from schools in low-income communities.

    Science.gov (United States)

    Smith, Jordan J; Morgan, Philip J; Plotnikoff, Ronald C; Dally, Kerry A; Salmon, Jo; Okely, Anthony D; Finn, Tara L; Babic, Mark J; Skinner, Geoff; Lubans, David R

    2014-01-01

    The negative consequences of unhealthy weight gain and the high likelihood of pediatric obesity tracking into adulthood highlight the importance of targeting youth who are 'at risk' of obesity. The aim of this paper is to report the rationale and study protocol for the 'Active Teen Leaders Avoiding Screen-time' (ATLAS) obesity prevention intervention for adolescent boys living in low-income communities. The ATLAS intervention will be evaluated using a cluster randomized controlled trial in 14 secondary schools in the state of New South Wales (NSW), Australia (2012 to 2014). ATLAS is an 8-month multi-component, school-based program informed by self-determination theory and social cognitive theory. The intervention consists of teacher professional development, enhanced school-sport sessions, researcher-led seminars, lunch-time physical activity mentoring sessions, pedometers for self-monitoring, provision of equipment to schools, parental newsletters, and a smartphone application and website. Assessments were conducted at baseline and will be completed again at 9- and 18-months from baseline. Primary outcomes are body mass index (BMI) and waist circumference. Secondary outcomes include BMI z-scores, body fat (bioelectrical impedance analysis), physical activity (accelerometers), muscular fitness (grip strength and push-ups), screen-time, sugar-sweetened beverage consumption, resistance training skill competency, daytime sleepiness, subjective well-being, physical self-perception, pathological video gaming, and aggression. Hypothesized mediators of behavior change will also be explored. ATLAS is an innovative school-based intervention designed to improve the health behaviors and related outcomes of adolescent males in low-income communities. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Can commonly prescribed drugs be repurposed for the prevention or treatment of Alzheimer's and other neurodegenerative diseases? Protocol for an observational cohort study in the UK Clinical Practice Research Datalink.

    Science.gov (United States)

    Walker, Venexia M; Davies, Neil M; Jones, Tim; Kehoe, Patrick G; Martin, Richard M

    2016-12-13

    Current treatments for Alzheimer's and other neurodegenerative diseases have only limited effectiveness meaning that there is an urgent need for new medications that could influence disease incidence and progression. We will investigate the potential of a selection of commonly prescribed drugs, as a more efficient and cost-effective method of identifying new drugs for the prevention or treatment of Alzheimer's disease, non-Alzheimer's disease dementias, Parkinson's disease and amyotrophic lateral sclerosis. Our research will focus on drugs used for the treatment of hypertension, hypercholesterolaemia and type 2 diabetes, all of which have previously been identified as potentially cerebroprotective and have variable levels of preclinical evidence that suggest they may have beneficial effects for various aspects of dementia pathology. We will conduct a hypothesis testing observational cohort study using data from the Clinical Practice Research Datalink (CPRD). Our analysis will consider four statistical methods, which have different approaches for modelling confounding. These are multivariable adjusted Cox regression; propensity matched regression; instrumental variable analysis and marginal structural models. We will also use an intention-to-treat analysis, whereby we will define all exposures based on the first prescription observed in the database so that the target parameter is comparable to that estimated by a randomised controlled trial. This protocol has been approved by the CPRD's Independent Scientific Advisory Committee (ISAC). We will publish the results of the study as open-access peer-reviewed publications and disseminate findings through national and international conferences as are appropriate. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  4. The efficacy of hypotonic and near-isotonic saline for parenteral fluid therapy given at low maintenance rate in preventing significant change in plasma sodium in post-operative pediatric patients: protocol for a prospective randomized non-blinded study

    Directory of Open Access Journals (Sweden)

    Stigzelius Shayarina

    2011-07-01

    Full Text Available Abstract Background Hyponatremia is the most frequent electrolyte abnormality observed in post-operative pediatric patients receiving intravenous maintenance fluid therapy. If plasma sodium concentration (p-Na+ declines to levels below 125 mmol/L in vs. restricted rate of infusion and the composition of solutions used for parenteral maintenance fluid therapy (hypotonic vs. isotonic solutions contribute to the development of hyponatremia. So far, there is no definitive pediatric data to support a particular choice of parenteral fluid for maintenance therapy in post-surgical patients. Methods/Design Our prospective randomized non-blinded study will be conducted in healthy children and adolescents aged 1 to 14 years who have been operated for acute appendicitis. Patients will be randomized either to intravenous hypotonic (0.23% or 0.40% sodium chloride in glucose, respectively or near-isotonic (0.81% sodium chloride in glucose solution given at approximately three-fourths of the average maintenance rate. The main outcome of interest from this study is to evaluate 24 h post-operatively whether differences in p-Na+ between treatment groups are large enough to be of clinical relevance. In addition, water and electrolyte balance as well as regulatory hormones will be measured. Discussion This study will provide valuable information on the efficacy of hypotonic and near-isotonic fluid therapy in preventing a significant decrease in p-Na+. Finally, by means of careful electrolyte and water balance and by measuring regulatory hormones our results will also contribute to a better understanding of the physiopathology of post-operative changes in p-Na+ in a population at risk for hyponatremia. Trial registration The protocol for this study is registered with the current controlled trials registry; registry number: ISRCTN43896775.

  5. Detecting organic gunpowder residues from handgun use

    Science.gov (United States)

    MacCrehan, William A.; Ricketts, K. Michelle; Baltzersen, Richard A.; Rowe, Walter F.

    1999-02-01

    The gunpowder residues that remain after the use of handguns or improvised explosive devices pose a challenge for the forensic investigator. Can these residues be reliably linked to a specific gunpowder or ammunition? We investigated the possibility by recovering and measuring the composition of organic additives in smokeless powder and its post-firing residues. By determining gunpowder additives such as nitroglycerin, dinitrotoluene, ethyl- and methylcentralite, and diphenylamine, we hope to identify the type of gunpowder in the residues and perhaps to provide evidence of a match to a sample of unfired powder. The gunpowder additives were extracted using an automated technique, pressurized fluid extraction (PFE). The conditions for the quantitative extraction of the additives using neat and solvent-modified supercritical carbon dioxide were investigated. All of the major gunpowder additives can be determined with baseline resolution using capillary electrophoresis (CE) with a micellar agent and UV absorbance detection. A study of candidate internal standards for use in the CE method is also presented. The PFE/CE technique is used to evaluate a new residue sampling protocol--asking shooters to blow their noses. In addition, an initial investigation of the compositional differences among unfired and post-fired .22 handgun residues is presented.

  6. Residual gas analysis

    International Nuclear Information System (INIS)

    Berecz, I.

    1982-01-01

    Determination of the residual gas composition in vacuum systems by a special mass spectrometric method was presented. The quadrupole mass spectrometer (QMS) and its application in thin film technology was discussed. Results, partial pressure versus time curves as well as the line spectra of the residual gases in case of the vaporization of a Ti-Pd-Au alloy were demonstrated together with the possible construction schemes of QMS residual gas analysers. (Sz.J.)

  7. Local administration of enriched mononuclear cells, platelets and zoledronic acid for preventing collapse of the femoral head in the early stage of osteonecrosis: study protocol for a prospective randomized parallel-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Ning Ma

    2016-01-01

    Trial registration: ClinicalTrial.gov identifier: NCT02721940. Written approval for this protocol was obtained from the ethics committee of the Chinese PLA General Hospital in China (approval No. S2015-082-01.

  8. Study protocol to assess the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units: a cluster-randomised, crossover trial (The ICU Visits Study).

    Science.gov (United States)

    Rosa, Regis Goulart; Falavigna, Maicon; Robinson, Caroline Cabral; da Silva, Daiana Barbosa; Kochhann, Renata; de Moura, Rafaela Moraes; Santos, Mariana Martins Siqueira; Sganzerla, Daniel; Giordani, Natalia Elis; Eugênio, Cláudia; Ribeiro, Tarissa; Cavalcanti, Alexandre Biasi; Bozza, Fernando; Azevedo, Luciano Cesar Pontes; Machado, Flávia Ribeiro; Salluh, Jorge Ibrain Figueira; Pellegrini, José Augusto Santos; Moraes, Rafael Barberena; Hochegger, Taís; Amaral, Alexandre; Teles, José Mario Meira; da Luz, Lucas Gobetti; Barbosa, Mirceli Goulart; Birriel, Daniella Cunha; Ferraz, Iris de Lima; Nobre, Vandack; Valentim, Helen Martins; Corrêa E Castro, Livia; Duarte, Péricles Almeida Delfino; Tregnago, Rogério; Barilli, Sofia Louise Santin; Brandão, Nilton; Giannini, Alberto; Teixeira, Cassiano

    2018-04-13

    Flexible intensive care unit (ICU) visiting hours have been proposed as a means to improve patient-centred and family-centred care. However, randomised trials evaluating the effects of flexible family visitation models (FFVMs) are scarce. This study aims to compare the effectiveness and safety of an FFVM versus a restrictive family visitation model (RFVM) on delirium prevention among ICU patients, as well as to analyse its potential effects on family members and ICU professionals. A cluster-randomised crossover trial involving adult ICU patients, family members and ICU professionals will be conducted. Forty medical-surgical Brazilian ICUs with RFVMs (<4.5 hours/day) will be randomly assigned to either an RFVM (visits according to local policies) or an FFVM (visitation during 12 consecutive hours per day) group at a 1:1 ratio. After enrolment and follow-up of 25 patients, each ICU will be switched over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome will be the cumulative incidence of delirium among ICU patients, measured twice a day using the Confusion Assessment Method for the ICU. Secondary outcome measures will include daily hazard of delirium, ventilator-free days, any ICU-acquired infections, ICU length of stay and hospital mortality among the patients; symptoms of anxiety and depression and satisfaction among the family members; and prevalence of burnout symptoms among the ICU professionals. Tertiary outcomes will include need for antipsychotic agents and/or mechanical restraints, coma-free days, unplanned loss of invasive devices and ICU-acquired pneumonia, urinary tract infection or bloodstream infection among the patients; self-perception of involvement in patient care among the family members; and satisfaction among the ICU professionals. The study protocol has been approved by the research ethics committee of all participant institutions. We aim to disseminate the findings through

  9. Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery.

    Science.gov (United States)

    Warner, Matthew A; Welsby, Ian J; Norris, Phillip J; Silliman, Christopher C; Armour, Sarah; Wittwer, Erica D; Santrach, Paula J; Meade, Laurie A; Liedl, Lavonne M; Nieuwenkamp, Chelsea M; Douthit, Brian; van Buskirk, Camille M; Schulte, Phillip J; Carter, Rickey E; Kor, Daryl J

    2017-08-18

    The transfusion-related respiratory complications, transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO), are leading causes of transfusion-related morbidity and mortality. At present, there are no effective preventive strategies with red blood cell (RBC) transfusion. Although mechanisms remain incompletely defined, soluble biological response modifiers (BRMs) within the RBC storage solution may play an important role. Point-of-care (POC) washing of allogeneic RBCs may remove these BRMs, thereby mitigating their impact on post-transfusion respiratory complications. This is a multicenter randomised clinical trial of standard allogeneic versus washed allogeneic RBC transfusion for adult patients undergoing cardiac surgery testing the hypothesis that POC RBC washing is feasible, safe, and efficacious and will reduce recipient immune and physiologic responses associated with transfusion-related respiratory complications. Relevant clinical outcomes will also be assessed. This investigation will enrol 170 patients at two hospitals in the USA. Simon's two-stage design will be used to assess the feasibility of POC RBC washing. The primary safety outcomes will be assessed using Wilcoxon Rank-Sum tests for continuous variables and Pearson chi-square test for categorical variables. Standard mixed modelling practices will be employed to test for changes in biomarkers of lung injury following transfusion. Linear regression will assess relationships between randomised group and post-transfusion physiologic measures. Safety oversight will be conducted under the direction of an independent Data and Safety Monitoring Board (DSMB). Approval of the protocol was obtained by the DSMB as well as the institutional review boards at each institution prior to enrolling the first study participant. This study aims to provide important information regarding the feasibility of POC washing of allogeneic RBCs and its potential impact on ameliorating

  10. The prevention access and risk taking in young people (PARTY) project protocol: a cluster randomised controlled trial of health risk screening and motivational interviewing for young people presenting to general practice.

    Science.gov (United States)

    Sanci, Lena; Grabsch, Brenda; Chondros, Patty; Shiell, Alan; Pirkis, Jane; Sawyer, Susan; Hegarty, Kelsey; Patterson, Elizabeth; Cahill, Helen; Ozer, Elizabeth; Seymour, Janelle; Patton, George

    2012-06-06

    There are growing worldwide concerns about the ability of primary health care systems to manage the major burden of illness in young people. Over two thirds of premature adult deaths result from risks that manifest in adolescence, including injury, neuropsychiatric problems and consequences of risky behaviours. One policy response is to better reorientate primary health services towards prevention and early intervention. Currently, however, there is insufficient evidence to support this recommendation for young people. This paper describes the design and implementation of a trial testing an intervention to promote psychosocial risk screening of all young people attending general practice and to respond to identified risks using motivational interviewing. clinicians' detection of risk-taking and emotional distress, young people's intention to change and reduction of risk taking. pathways to care, trust in the clinician and likelihood of returning for future visits. The design of the economic and process evaluation are not detailed in this protocol. PARTY is a cluster randomised trial recruiting 42 general practices in Victoria, Australia. Baseline measures include: youth friendly practice characteristics; practice staff's self-perceived competency in young people's care and clinicians' detection and response to risk taking behaviours and emotional distress in 14-24 year olds, attending the practice. Practices are then stratified by a social disadvantage index and billing methods and randomised. Intervention practices receive: nine hours of training and tools; feedback of their baseline data and two practice visits over six weeks. Comparison practices receive a three hour seminar in youth friendly practice only. Six weeks post-intervention, 30 consecutive young people are interviewed post-consultation from each practice and followed-up for self-reported risk taking behaviour and emotional distress three and 12 months post consultation. The PARTY trial is the

  11. The prevention access and risk taking in young people (PARTY project protocol: A cluster randomised controlled trial of health risk screening and motivational interviewing for young people presenting to general practice

    Directory of Open Access Journals (Sweden)

    Sanci Lena

    2012-06-01

    Full Text Available Abstract Background There are growing worldwide concerns about the ability of primary health care systems to manage the major burden of illness in young people. Over two thirds of premature adult deaths result from risks that manifest in adolescence, including injury, neuropsychiatric problems and consequences of risky behaviours. One policy response is to better reorientate primary health services towards prevention and early intervention. Currently, however, there is insufficient evidence to support this recommendation for young people. This paper describes the design and implementation of a trial testing an intervention to promote psychosocial risk screening of all young people attending general practice and to respond to identified risks using motivational interviewing. Main outcomes: clinicians’ detection of risk-taking and emotional distress, young people’s intention to change and reduction of risk taking. Secondary outcomes: pathways to care, trust in the clinician and likelihood of returning for future visits. The design of the economic and process evaluation are not detailed in this protocol. Methods PARTY is a cluster randomised trial recruiting 42 general practices in Victoria, Australia. Baseline measures include: youth friendly practice characteristics; practice staff’s self-perceived competency in young people’s care and clinicians’ detection and response to risk taking behaviours and emotional distress in 14–24 year olds, attending the practice. Practices are then stratified by a social disadvantage index and billing methods and randomised. Intervention practices receive: nine hours of training and tools; feedback of their baseline data and two practice visits over six weeks. Comparison practices receive a three hour seminar in youth friendly practice only. Six weeks post-intervention, 30 consecutive young people are interviewed post-consultation from each practice and followed-up for self-reported risk taking

  12. Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery

    Science.gov (United States)

    Warner, Matthew A; Welsby, Ian J; Norris, Phillip J; Silliman, Christopher C; Armour, Sarah; Wittwer, Erica D; Santrach, Paula J; Meade, Laurie A; Liedl, Lavonne M; Nieuwenkamp, Chelsea M; Douthit, Brian; van Buskirk, Camille M; Schulte, Phillip J; Kor, Daryl J

    2017-01-01

    Introduction The transfusion-related respiratory complications, transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO), are leading causes of transfusion-related morbidity and mortality. At present, there are no effective preventive strategies with red blood cell (RBC) transfusion. Although mechanisms remain incompletely defined, soluble biological response modifiers (BRMs) within the RBC storage solution may play an important role. Point-of-care (POC) washing of allogeneic RBCs may remove these BRMs, thereby mitigating their impact on post-transfusion respiratory complications. Methods and analysis This is a multicenter randomised clinical trial of standard allogeneic versus washed allogeneic RBC transfusion for adult patients undergoing cardiac surgery testing the hypothesis that POC RBC washing is feasible, safe, and efficacious and will reduce recipient immune and physiologic responses associated with transfusion-related respiratory complications. Relevant clinical outcomes will also be assessed. This investigation will enrol 170 patients at two hospitals in the USA. Simon’s two-stage design will be used to assess the feasibility of POC RBC washing. The primary safety outcomes will be assessed using Wilcoxon Rank-Sum tests for continuous variables and Pearson chi-square test for categorical variables. Standard mixed modelling practices will be employed to test for changes in biomarkers of lung injury following transfusion. Linear regression will assess relationships between randomised group and post-transfusion physiologic measures. Ethics and dissemination Safety oversight will be conducted under the direction of an independent Data and Safety Monitoring Board (DSMB). Approval of the protocol was obtained by the DSMB as well as the institutional review boards at each institution prior to enrolling the first study participant. This study aims to provide important information regarding the feasibility of POC

  13. Relapse prevention and residual symptoms: a closer analysis of placebo-controlled continuation studies with escitalopram in major depressive disorder, generalized anxiety disorder, social anxiety disorder, and obsessive-compulsive disorder

    DEFF Research Database (Denmark)

    Bech, Per; Lönn, Sara L; Overø, Kerstin F

    2010-01-01

    -Asberg Depression Rating Scale (MADRS) scores on items 1, 3, and 7 at randomization. RESULTS: All studies showed a statistically significant (P ...-Severity of Illness scores and relapse status in 4 studies published from 2005 to 2007, 1 each in major depressive disorder (MDD), generalized anxiety disorder, social anxiety disorder, and obsessive-compulsive disorder (OCD), were analyzed using mixed-effects model repeated measures as a function of Montgomery...... > 0) and without residual symptoms (MADRS score = 0) at the start of continuation treatment were defined by how patients scored on 3 core items of the MADRS: depressed mood (observed), inner or psychic tension, and lassitude. At randomization, patients with a residual symptom were globally more ill...

  14. Relapse prevention and residual symptoms: a closer analysis of placebo-controlled continuation studies with escitalopram in major depressive disorder, generalized anxiety disorder, social anxiety disorder, and obsessive-compulsive disorder

    DEFF Research Database (Denmark)

    Bech, Per; Lönn, Sara L; Overø, Kerstin F

    2010-01-01

    -Severity of Illness scores and relapse status in 4 studies published from 2005 to 2007, 1 each in major depressive disorder (MDD), generalized anxiety disorder, social anxiety disorder, and obsessive-compulsive disorder (OCD), were analyzed using mixed-effects model repeated measures as a function of Montgomery......-Asberg Depression Rating Scale (MADRS) scores on items 1, 3, and 7 at randomization. RESULTS: All studies showed a statistically significant (P ... > 0) and without residual symptoms (MADRS score = 0) at the start of continuation treatment were defined by how patients scored on 3 core items of the MADRS: depressed mood (observed), inner or psychic tension, and lassitude. At randomization, patients with a residual symptom were globally more ill...

  15. 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...

  16. Handling of Solid Residues

    International Nuclear Information System (INIS)

    Medina Bermudez, Clara Ines

    1999-01-01

    The topic of solid residues is specifically of great interest and concern for the authorities, institutions and community that identify in them a true threat against the human health and the atmosphere in the related with the aesthetic deterioration of the urban centers and of the natural landscape; in the proliferation of vectorial transmitters of illnesses and the effect on the biodiversity. Inside the wide spectrum of topics that they keep relationship with the environmental protection, the inadequate handling of solid residues and residues dangerous squatter an important line in the definition of political and practical environmentally sustainable. The industrial development and the population's growth have originated a continuous increase in the production of solid residues; of equal it forms, their composition day after day is more heterogeneous. The base for the good handling includes the appropriate intervention of the different stages of an integral administration of residues, which include the separation in the source, the gathering, the handling, the use, treatment, final disposition and the institutional organization of the administration. The topic of the dangerous residues generates more expectation. These residues understand from those of pathogen type that are generated in the establishments of health that of hospital attention, until those of combustible, inflammable type, explosive, radio-active, volatile, corrosive, reagent or toxic, associated to numerous industrial processes, common in our countries in development

  17. Characterization of Hospital Residuals

    International Nuclear Information System (INIS)

    Blanco Meza, A.; Bonilla Jimenez, S.

    1997-01-01

    The main objective of this investigation is the characterization of the solid residuals. A description of the handling of the liquid and gassy waste generated in hospitals is also given, identifying the source where they originate. To achieve the proposed objective the work was divided in three stages: The first one was the planning and the coordination with each hospital center, in this way, to determine the schedule of gathering of the waste can be possible. In the second stage a fieldwork was made; it consisted in gathering the quantitative and qualitative information of the general state of the handling of residuals. In the third and last stage, the information previously obtained was organized to express the results as the production rate per day by bed, generation of solid residuals for sampled services, type of solid residuals and density of the same ones. With the obtained results, approaches are settled down to either determine design parameters for final disposition whether for incineration, trituration, sanitary filler or recycling of some materials, and storage politics of the solid residuals that allow to determine the gathering frequency. The study concludes that it is necessary to improve the conditions of the residuals handling in some aspects, to provide the cleaning personnel of the equipment for gathering disposition and of security, minimum to carry out this work efficiently, and to maintain a control of all the dangerous waste, like sharp or polluted materials. In this way, an appreciable reduction is guaranteed in the impact on the atmosphere. (Author) [es

  18. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded

  19. 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.)

  20. 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...

  1. Management of NORM Residues

    International Nuclear Information System (INIS)

    2013-06-01

    The IAEA attaches great importance to the dissemination of information that can assist Member States in the development, implementation, maintenance and continuous improvement of systems, programmes and activities that support the nuclear fuel cycle and nuclear applications, and that address the legacy of past practices and accidents. However, radioactive residues are found not only in nuclear fuel cycle activities, but also in a range of other industrial activities, including: - Mining and milling of metalliferous and non-metallic ores; - Production of non-nuclear fuels, including coal, oil and gas; - Extraction and purification of water (e.g. in the generation of geothermal energy, as drinking and industrial process water; in paper and pulp manufacturing processes); - Production of industrial minerals, including phosphate, clay and building materials; - Use of radionuclides, such as thorium, for properties other than their radioactivity. Naturally occurring radioactive material (NORM) may lead to exposures at some stage of these processes and in the use or reuse of products, residues or wastes. Several IAEA publications address NORM issues with a special focus on some of the more relevant industrial operations. This publication attempts to provide guidance on managing residues arising from different NORM type industries, and on pertinent residue management strategies and technologies, to help Member States gain perspectives on the management of NORM residues

  2. The effect of an active on-ward participation of hospital pharmacists in Internal Medicine teams on preventable Adverse Drug Events in elderly inpatients: protocol of the WINGS study (Ward-oriented pharmacy in newly admitted geriatric seniors)

    NARCIS (Netherlands)

    Klopotowska, J.E.; Wierenga, P.C.; de Rooij, S.E.; Stuijt, C.C.; Arisz, L.; Kuks, P.F.; Dijkgraaf, M.G.; Lie-A-Huen, L.; Smorenburg, S.M.

    2011-01-01

    The potential of clinical interventions, aiming at reduction of preventable Adverse Drug Events (preventable ADEs) during hospital stay, have been studied extensively. Clinical Pharmacy is a well-established and effective service, usually consisting of full-time on-ward participation of clinical

  3. Management of municipal solid waste incineration residues

    International Nuclear Information System (INIS)

    Sabbas, T.; Polettini, A.; Pomi, R.; Astrup, T.; Hjelmar, O.; Mostbauer, P.; Cappai, G.; Magel, G.; Salhofer, S.; Speiser, C.; Heuss-Assbichler, S.; Klein, R.; Lechner, P.

    2003-01-01

    The management of residues from thermal waste treatment is an integral part of waste management systems. The primary goal of managing incineration residues is to prevent any impact on our health or environment caused by unacceptable particulate, gaseous and/or solute emissions. This paper provides insight into the most important measures for putting this requirement into practice. It also offers an overview of the factors and processes affecting these mitigating measures as well as the short- and long-term behavior of residues from thermal waste treatment under different scenarios. General conditions affecting the emission rate of salts and metals are shown as well as factors relevant to mitigating measures or sources of gaseous emissions

  4. Residual stress measurement in 304 stainless steel weld overlay pipes

    International Nuclear Information System (INIS)

    Yen, H.J.; Lin, M.C.C.; Chen, L.J.

    1996-01-01

    Welding overlay repair (WOR) is commonly employed to rebuild piping systems suffering from intergranular stress corrosion cracking (IGSCC). To understand the effects of this repair, it is necessary to investigate the distribution of residual stresses in the welding pipe. The overlay welding technique must induce compressive residual stress at the inner surface of the welded pipe to prevent IGSCC. To understand the bulk residual stress distribution, the stress profile as a function of location within wall is examined. In this study the full destructive residual stress measurement technique -- a cutting and sectioning method -- is used to determine the residual stress distribution. The sample is type 304 stainless steel weld overlay pipe with an outside diameter of 267 mm. A pipe segment is cut from the circular pipe; then a thin layer is removed axially from the inner to the outer surfaces until further sectioning is impractical. The total residual stress is calculated by adding the stress relieved by cutting the section away to the stress relieved by axially sectioning. The axial and hoop residual stresses are compressive at the inner surface of the weld overlay pipe. Compressive stress exists not only at the surface but is also distributed over most of the pipe's cross section. On the one hand, the maximum compressive hoop residual stress appears at the pipe's inner surface. The thermal-mechanical induced crack closure from significant compressive residual stress is discussed. This crack closure can thus prevent IGSCC very effectively

  5. Single-cell qPCR on dispersed primary pituitary cells -an optimized protocol

    Directory of Open Access Journals (Sweden)

    Haug Trude M

    2010-11-01

    Full Text Available Abstract Background The incidence of false positives is a potential problem in single-cell PCR experiments. This paper describes an optimized protocol for single-cell qPCR measurements in primary pituitary cell cultures following patch-clamp recordings. Two different cell harvesting methods were assessed using both the GH4 prolactin producing cell line from rat, and primary cell culture from fish pituitaries. Results Harvesting whole cells followed by cell lysis and qPCR performed satisfactory on the GH4 cell line. However, harvesting of whole cells from primary pituitary cultures regularly produced false positives, probably due to RNA leakage from cells ruptured during the dispersion of the pituitary cells. To reduce RNA contamination affecting the results, we optimized the conditions by harvesting only the cytosol through a patch pipette, subsequent to electrophysiological experiments. Two important factors proved crucial for reliable harvesting. First, silanizing the patch pipette glass prevented foreign extracellular RNA from attaching to charged residues on the glass surface. Second, substituting the commonly used perforating antibiotic amphotericin B with β-escin allowed efficient cytosol harvest without loosing the giga seal. Importantly, the two harvesting protocols revealed no difference in RNA isolation efficiency. Conclusion Depending on the cell type and preparation, validation of the harvesting technique is extremely important as contaminations may give false positives. Here we present an optimized protocol allowing secure harvesting of RNA from single cells in primary pituitary cell culture following perforated whole cell patch clamp experiments.

  6. Residual-stress measurements

    Energy Technology Data Exchange (ETDEWEB)

    Ezeilo, A N; Webster, G A [Imperial College, London (United Kingdom); Webster, P J [Salford Univ. (United Kingdom)

    1997-04-01

    Because neutrons can penetrate distances of up to 50 mm in most engineering materials, this makes them unique for establishing residual-stress distributions non-destructively. D1A is particularly suited for through-surface measurements as it does not suffer from instrumental surface aberrations commonly found on multidetector instruments, while D20 is best for fast internal-strain scanning. Two examples for residual-stress measurements in a shot-peened material, and in a weld are presented to demonstrate the attractive features of both instruments. (author).

  7. Designing with residual materials

    NARCIS (Netherlands)

    Walhout, W.; Wever, R.; Blom, E.; Addink-Dölle, L.; Tempelman, E.

    2013-01-01

    Many entrepreneurial businesses have attempted to create value based on the residual material streams of third parties. Based on ‘waste’ materials they designed products, around which they built their company. Such activities have the potential to yield sustainable products. Many of such companies

  8. Evaluating the effectiveness of a clinical practice change intervention in increasing clinician provision of preventive care in a network of community-based mental health services: a study protocol of a non-randomized, multiple baseline trial.

    Science.gov (United States)

    Bartlem, Kate; Bowman, Jennifer; Freund, Megan; Wye, Paula; McElwaine, Kathleen; Knight, Jenny; McElduff, Patrick; Gillham, Karen; Wiggers, John

    2013-08-06

    People with a mental illness experience substantial disparities in health, including increased rates of morbidity and mortality caused by potentially preventable chronic diseases. One contributing factor to such disparity is a higher prevalence of modifiable health risk behaviors, such as smoking, inadequate fruit and vegetable intake, harmful alcohol consumption, and inadequate physical activity. Evidence supports the effectiveness of preventive care in reducing such risks, and guidelines recommend that preventive care addressing such risks be incorporated into routine clinical care. Although community-based mental health services represent an important potential setting for ensuring that people with a mental illness receive such care, research suggests its delivery is currently sub-optimal. A study will be undertaken to evaluate the effectiveness of a clinical practice change intervention in increasing the routine provision of preventive care by clinicians in community mental health settings. A two-group multiple baseline design will be utilized to assess the effectiveness of a multi-strategic intervention implemented over 12 months in increasing clinician provision of preventive care. The intervention will be implemented sequentially across the two groups of community mental health services to increase provision of client assessment, brief advice, and referral for four health risk behaviors (smoking, inadequate fruit and vegetable consumption, harmful alcohol consumption, and inadequate physical activity). Outcome measures of interest will be collected via repeated cross-sectional computer-assisted telephone interviews undertaken on a weekly basis for 36 months with community mental health clients. This study is the first to assess the effectiveness of a multi-strategic clinical practice change intervention in increasing routine clinician provision of preventive care for chronic disease behavioral risk factors within a network of community mental health services

  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. Evaluation of residue-residue contact predictions in CASP9

    KAUST Repository

    Monastyrskyy, Bohdan; Fidelis, Krzysztof; Tramontano, Anna; Kryshtafovych, Andriy

    2011-01-01

    This work presents the results of the assessment of the intramolecular residue-residue contact predictions submitted to CASP9. The methodology for the assessment does not differ from that used in previous CASPs, with two basic evaluation measures

  11. Sharing Residual Liability

    DEFF Research Database (Denmark)

    Carbonara, Emanuela; Guerra, Alice; Parisi, Francesco

    2016-01-01

    Economic models of tort law evaluate the efficiency of liability rules in terms of care and activity levels. A liability regime is optimal when it creates incentives to maximize the value of risky activities net of accident and precaution costs. The allocation of primary and residual liability...... for policy makers and courts in awarding damages in a large number of real-world accident cases....

  12. Can primary care nurse administered pelvic floor muscle training (PFMT be implemented for the prevention and treatment of urinary incontinence? A study protocol [v1; ref status: indexed, http://f1000r.es/wo

    Directory of Open Access Journals (Sweden)

    Sue Child

    2013-02-01

    Full Text Available Background: We aim to evaluate if Pelvic Floor Muscle Training (PFMT delivered in primary care results in fewer referrals to secondary care for urinary incontinence (UI, thereby reducing the number and associated costs of surgical procedures for UI. Methods / design: The study will consist of two populations – a prevention group and a treatment group who will both be offered PFMT in primary care. The prevention group will consist of parous women aged 25-64 attending for a routine cervical smear. Their pelvic floor will be assessed using the Modified Oxford Scale (MOS and a baseline data form will be completed that asks about the frequency and associated bother of urine leakage. From the answers given, the group will be subdivided into two groups. The first (prevention group will be subdivided into a primary prevention arm (no symptoms of urinary incontinence and pelvic floor strength ≤2 on MOS and a secondary prevention arm (women reporting symptoms of urine leakage irrespective of MOS. The second (treatment group will be women of any age who may or may not have had a vaginal birth presenting to their GP with UI. Semi-structured, in-depth interviews will be conducted with a subset of patients and staff with the aim of identifying barriers and facilitators in delivering PFMT in primary care. Discussion: A recently completed community study showed good outcomes with practice nurse delivery of PFMT. We suggest if this were to be implemented more widely it would reduce the need for referral to secondary care. We believe that this study will show whether implementing a package of PFMT delivered in primary care can treat as well as prevent UI and will also be helpful in exploring the benefits / drawbacks of such implementation, thus providing lessons for implementation in other Primary Care Trusts (PCTs.

  13. Manual of Standard Operating Procedures for Veterinary Drug Residue Analysis

    International Nuclear Information System (INIS)

    2016-01-01

    Laboratories are crucial to national veterinary drug residue monitoring programmes. However, one of the main challenges laboratories encounter is obtaining access to relevant methods of analysis. Thus, in addition to training, providing technical advice and transferring technology, the Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture has resolved to develop clear and practical manuals to support Member State laboratories. The Coordinated Research Project (CRP) on Development of Radiometric and Allied Analytical Methods to Strengthen Residue Control Programs for Antibiotic and Anthelmintic Veterinary Drug Residues has developed a number of analytical methods as standard operating procedures (SOPs), which are now compiled here. This publication contains SOPs on chromatographic and spectrometric techniques, as well as radioimmunoassay and associated screening techniques, for various anthelmintic and antimicrobial veterinary drug residue analysis. Some analytical method validation protocols are also included. The publication is primarily aimed at food and environmental safety laboratories involved in testing veterinary drug residues, including under organized national residue monitoring programmes. It is expected to enhance laboratory capacity building and competence through the use of radiometric and complementary tools and techniques. The publication is also relevant for applied research on residues of veterinary drugs in food and environmental samples

  14. The effectiveness of a web-based Dutch parenting program to prevent overweight in children 9-13 years of age: study protocol for a two-armed cluster randomized controlled trial

    NARCIS (Netherlands)

    Ruiter, E.L.M.; Fransen, G.A.J.; Molleman, G.R.M.; Velden, K. van der; Engels, R.C.M.E.

    2015-01-01

    BACKGROUND: Although parental support is an important component in overweight prevention programs for children, current programs pay remarkably little attention to the role of parenting. To close this gap, we developed a web-based parenting program for parents entitled "Making a healthy deal with

  15. Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home patients: study protocol for a prospective multi-centre randomised controlled trial (ISRCTN17553857).

    NARCIS (Netherlands)

    Mistiaen, P.; Achterberg, W.P.; Ament, A.; Halfen, R.; Huizinga, J.; Montgomery, K.; Post, H.; Francke, A.

    2008-01-01

    BACKGROUND: Pressure ulcers are a major problem, especially in nursing home patients, although they are regarded as preventable and there are many pressure relieving methods and materials. One such pressure relieving material is the recently developed Australian Medical Sheepskin, which has been

  16. A community-based intervention for primary prevention of cardiovascular diseases in the slums of Nairobi: the SCALE UP study protocol for a prospective quasi-experimental community-based trial

    NARCIS (Netherlands)

    Oti, Samuel O.; van de Vijver, Steven J. M.; Kyobutungi, Catherine; Gomez, Gabriela B.; Agyemang, Charles; Moll van Charante, Eric P.; Brewster, Lizzy M.; Hendriks, Marleen E.; Schultsz, Constance; Ettarh, Remare; Ezeh, Alex; Lange, Joep

    2013-01-01

    The burden of cardiovascular disease is rising in sub-Saharan Africa with hypertension being the main risk factor. However, context-specific evidence on effective interventions for primary prevention of cardiovascular diseases in resource-poor settings is limited. This study aims to evaluate the

  17. Bright light therapy versus physical exercise to prevent co-morbid depression and obesity in adolescents and young adults with attention-deficit / hyperactivity disorder: study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Mayer, J.S.; Hees, K.; Medda, J.; Grimm, O.; Asherson, P.; Bellina, M.; Colla, M.; Ibanez, P.; Koch, E.; Martinez-Nicolas, A.; Muntaner-Mas, A.; Rommel, A.; Rommelse, N.N.J.; Ruiter, S.W. de; Ebner-Priemer, U.W.; Kieser, M.; Ortega, F.B.; Thome, J.; Buitelaar, J.K.; Kuntsi, J.; Ramos-Quiroga, J.A.; Reif, A.; Freitag, C.M.

    2018-01-01

    BACKGROUND: The risk for major depression and obesity is increased in adolescents and adults with attention-deficit / hyperactivity disorder (ADHD) and adolescent ADHD predicts adult depression and obesity. Non-pharmacological interventions to treat and prevent these co-morbidities are urgently

  18. Impact of Corn Residue Removal on Crop and Soil Productivity

    Science.gov (United States)

    Johnson, J. M.; Wilhelm, W. W.; Hatfield, J. L.; Voorhees, W. B.; Linden, D.

    2003-12-01

    Over-reliance on imported fuels, increasing atmospheric levels of greenhouses and sustaining food production for a growing population are three of the most important problems facing society in the mid-term. The US Department of Energy and private enterprise are developing technology necessary to use high cellulose feedstock, such as crop residues, for ethanol production. Based on production levels, corn (Zea mays L.) residue has potential as a biofuel feedstock. Crop residues are a renewable and domestic fuel source, which can reduce the rate of fossil fuel use (both imported and domestic) and provide an additional farm commodity. Crop residues protect the soil from wind and water erosion, provide inputs to form soil organic matter (a critical component determining soil quality) and play a role in nutrient cycling. Crop residues impact radiation balance and energy fluxes and reduce evaporation. Therefore, the benefits of using crop residues as fuel, which removes crop residues from the field, must be balanced against negative environmental impacts (e.g. soil erosion), maintaining soil organic matter levels, and preserving or enhancing productivity. All ramifications of new management practices and crop uses must be explored and evaluated fully before an industry is established. There are limited numbers of long-term studies with soil and crop responses to residue removal that range from negative to negligible. The range of crop and soil responses to crop residue removal was attributed to interactions with climate, management and soil type. Within limits, corn residue can be harvested for ethanol production to provide a renewable, domestic source of energy feedstock that reduces greenhouse gases. Removal rates must vary based on regional yield, climatic conditions and cultural practices. Agronomists are challenged to develop a protocol (tool) for recommending maximum permissible removal rates that ensure sustained soil productivity.

  19. The SPHERE Study. Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411].

    LENUS (Irish Health Repository)

    Murphy, Andrew W

    2005-07-29

    BACKGROUND: The aim of the SPHERE study is to design, implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease (CHD) in general practice across two different health systems on the island of Ireland. CHD is a common cause of death and a significant cause of morbidity in Ireland. Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives. Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the island of Ireland. The review literature recommends structured programmes with continued support and follow-up of patients; the provision of training, tailored to practice needs of access to evidence of effectiveness of secondary prevention; structured recall programmes that also take account of individual practice needs; and patient-centred consultations accompanied by attention to disease management guidelines. METHODS: SPHERE is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups, recruiting 960 patients from 48 practices in three study centres (Belfast, Dublin and Galway). Primary outcomes are blood pressure, total cholesterol, physical and mental health status (SF-12) and hospital re-admissions. The intervention takes place over two years and data is collected at baseline, one-year and two-year follow-up. Data is obtained from medical charts, consultations with practitioners, and patient postal questionnaires. The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice. It is a multi-faceted intervention that has been developed to respond to barriers and solutions to

  20. Effectiveness and cost-effectiveness of a guided Internet- and mobile-based intervention for the indicated prevention of major depression in patients with chronic back pain-study protocol of the PROD-BP multicenter pragmatic RCT.

    Science.gov (United States)

    Sander, L; Paganini, S; Lin, J; Schlicker, S; Ebert, D D; Buntrock, C; Baumeister, H

    2017-01-21

    Reducing the disease burden of major depressive disorder (MDD) is of major public health relevance. The prevention of depression is regarded as one possible approach to reach this goal. People with multiple risk factors for MDD such as chronic back pain and subthreshold depressive symptoms may benefit most from preventive measures. The Internet as intervention setting allows for scaling up preventive interventions on a public mental health level. This study is a multicenter pragmatic randomized controlled trial (RCT) of parallel design aiming to investigate the (cost-) effectiveness of an Internet- and mobile-based intervention (IMI) for the prevention of depression in chronic back pain patients (PROD-BP) with subthreshold depressive symptoms. eSano BackCare-DP is a guided, chronic back pain-specific depression prevention intervention based on cognitive behavioral therapy (CBT) principles comprising six weekly plus three optional modules and two booster sessions after completion of the intervention. Trained psychologists provide guidance by sending feedback messages after each module. A total of 406 patients with chronic back pain and without a depressive disorder at baseline will be recruited following orthopedic rehabilitation care and allocated to either intervention or treatment-as-usual (TAU). Primary patient-relevant endpoint of the trial is the time to onset of MDD measured by the telephone-administered Structured Clinical Interview for DSM (SCID) at baseline and 1-year post-randomization. Key secondary outcomes are health-related quality of life, depression severity, pain intensity, pain-related disability, ability to work, intervention satisfaction and adherence as well as side effects of the intervention. Online assessments take place at baseline and 9 weeks as well as 6 and 12 months post-randomization. Cox regression survival analysis will be conducted to estimate hazard ratio at 12-month follow-up. Moreover, an economic analysis will be conducted

  1. Effectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Bryant, Maria; Burton, Wendy; Cundill, Bonnie; Farrin, Amanda J; Nixon, Jane; Stevens, June; Roberts, Kim; Foy, Robbie; Rutter, Harry; Hartley, Suzanne; Tubeuf, Sandy; Collinson, Michelle; Brown, Julia

    2017-01-24

    Family-based interventions to prevent childhood obesity depend upon parents' taking action to improve diet and other lifestyle behaviours in their families. Programmes that attract and retain high numbers of parents provide an enhanced opportunity to improve public health and are also likely to be more cost-effective than those that do not. We have developed a theory-informed optimisation intervention to promote parent engagement within an existing childhood obesity prevention group programme, HENRY (Health Exercise Nutrition for the Really Young). Here, we describe a proposal to evaluate the effectiveness of this optimisation intervention in regard to the engagement of parents and cost-effectiveness. The Optimising Family Engagement in HENRY (OFTEN) trial is a cluster randomised controlled trial being conducted across 24 local authorities (approximately 144 children's centres) which currently deliver HENRY programmes. The primary outcome will be parental enrolment and attendance at the HENRY programme, assessed using routinely collected process data. Cost-effectiveness will be presented in terms of primary outcomes using acceptability curves and through eliciting the willingness to pay for the optimisation from HENRY commissioners. Secondary outcomes include the longitudinal impact of the optimisation, parent-reported infant intake of fruits and vegetables (as a proxy to compliance) and other parent-reported family habits and lifestyle. This innovative trial will provide evidence on the implementation of a theory-informed optimisation intervention to promote parent engagement in HENRY, a community-based childhood obesity prevention programme. The findings will be generalisable to other interventions delivered to parents in other community-based environments. This research meets the expressed needs of commissioners, children's centres and parents to optimise the potential impact that HENRY has on obesity prevention. A subsequent cluster randomised controlled pilot

  2. Machine for compacting solid residues

    International Nuclear Information System (INIS)

    Herzog, J.

    1981-11-01

    Machine for compacting solid residues, particularly bulky radioactive residues, constituted of a horizontally actuated punch and a fixed compression anvil, in which the residues are first compacted horizontally and then vertically. Its salient characteristic is that the punch and the compression anvil have embossments on the compression side and interpenetrating plates in the compression position [fr

  3. 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

  4. 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...

  5. 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.

  6. 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

  7. Quadratic residues and non-residues selected topics

    CERN Document Server

    Wright, Steve

    2016-01-01

    This book offers an account of the classical theory of quadratic residues and non-residues with the goal of using that theory as a lens through which to view the development of some of the fundamental methods employed in modern elementary, algebraic, and analytic number theory. The first three chapters present some basic facts and the history of quadratic residues and non-residues and discuss various proofs of the Law of Quadratic Reciprosity in depth, with an emphasis on the six proofs that Gauss published. The remaining seven chapters explore some interesting applications of the Law of Quadratic Reciprocity, prove some results concerning the distribution and arithmetic structure of quadratic residues and non-residues, provide a detailed proof of Dirichlet’s Class-Number Formula, and discuss the question of whether quadratic residues are randomly distributed. The text is a valuable resource for graduate and advanced undergraduate students as well as for mathematicians interested in number theory.

  8. Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery

    OpenAIRE

    Warner, Matthew A; Welsby, Ian J; Norris, Phillip J; Silliman, Christopher C; Armour, Sarah; Wittwer, Erica D; Santrach, Paula J; Meade, Laurie A; Liedl, Lavonne M; Nieuwenkamp, Chelsea M; Douthit, Brian; van Buskirk, Camille M; Schulte, Phillip J; Carter, Rickey E; Kor, Daryl J

    2017-01-01

    Introduction The transfusion-related respiratory complications, transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO), are leading causes of transfusion-related morbidity and mortality. At present, there are no effective preventive strategies with red blood cell (RBC) transfusion. Although mechanisms remain incompletely defined, soluble biological response modifiers (BRMs) within the RBC storage solution may play an important role. Point-of-care ...

  9. Developing implementation strategies for firearm safety promotion in paediatric primary care for suicide prevention in two large US health systems: a study protocol for a mixed-methods implementation study.

    Science.gov (United States)

    Wolk, Courtney Benjamin; Jager-Hyman, Shari; Marcus, Steven C; Ahmedani, Brian K; Zeber, John E; Fein, Joel A; Brown, Gregory K; Lieberman, Adina; Beidas, Rinad S

    2017-06-24

    The promotion of safe firearm practices, or firearms means restriction, is a promising but infrequently used suicide prevention strategy in the USA. Safety Check is an evidence-based practice for improving parental firearm safety behaviour in paediatric primary care. However, providers rarely discuss firearm safety during visits, suggesting the need to better understand barriers and facilitators to promoting this approach. This study, Adolescent Suicide Prevention In Routine clinical Encounters, aims to engender a better understanding of how to implement the three firearm components of Safety Check as a suicide prevention strategy in paediatric primary care. The National Institute of Mental Health-funded Mental Health Research Network (MHRN), a consortium of 13 healthcare systems across the USA, affords a unique opportunity to better understand how to implement a firearm safety intervention in paediatric primary care from a system-level perspective. We will collaboratively develop implementation strategies in partnership with MHRN stakeholders. First, we will survey leadership of 82 primary care practices (ie, practices serving children, adolescents and young adults) within two MHRN systems to understand acceptability and use of the three firearm components of Safety Check (ie, screening, brief counselling around firearm safety and provision of firearm locks). Then, in collaboration with MHRN stakeholders, we will use intervention mapping and the Consolidated Framework for Implementation Research to systematically develop and evaluate a multilevel menu of implementation strategies for promoting firearm safety as a suicide prevention strategy in paediatric primary care. Study procedures have been approved by the University of Pennsylvania. Henry Ford Health System and Baylor Scott & White institutional review boards (IRBs) have ceded IRB review to the University of Pennsylvania IRB. Results will be submitted for publication in peer-reviewed journals. © Article

  10. The efficacy of fall-risk-increasing drug (FRID) withdrawal for the prevention of falls and fall-related complications: protocol for a systematic review and meta-analysis.

    Science.gov (United States)

    Lee, Justin Yusen; Holbrook, Anne

    2017-02-20

    Despite limited evidence of effectiveness, withdrawal (discontinuation or dose reduction) of high risk medications known as "fall-risk increasing drugs" (FRIDs) is typically conducted as a fall prevention strategy based on presumptive benefit. Our objective is to determine the efficacy of fall-risk increasing drugs (FRIDs) withdrawal on the prevention of falls and fall-related complications. We will search for all published and unpublished randomized controlled trials evaluating the effect of FRID withdrawal compared to usual care on the rate of falls, incidence of falls, fall-related injuries, fall-related fractures, fall-related hospitalizations, or adverse effects related to the intervention in adults aged 65 years or older. Electronic database searches will be conducted in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and CINAHL. A grey literature search will be conducted including clinical trial registries and conference proceedings and abstracts. Two reviewers will independently perform in duplicate citation screening, full-text review, data abstraction, and risk of bias assessment. Conflicts will be resolved through team discussion or by a third reviewer if no consensus can be reached. The Grades of Recommendation, Assessment, Development and Evaluation (GRADE) criteria will be used to independently rate overall confidence in effect estimates for each outcome. Results will be synthesized descriptively, and a random effects meta-analysis will be conducted for each outcome if studies are deemed similar methodologically, clinically, and statistically. We will attempt to determine whether a FRID withdrawal strategy alone is effective at preventing falls in older adults. Our results will be used to optimize and focus fall prevention strategies and initiatives internationally with a goal of improving the health of older adults. PROSPERO CRD42016040203.

  11. A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study): study protocol for a cluster randomised controlled trial

    OpenAIRE

    Abramsky, Tanya; Devries, Karen; Kiss, Ligia; Francisco, Leilani; Nakuti, Janet; Musuya, Tina; Kyegombe, Nambusi; Starmann, Elizabeth; Kaye, Dan; Michau, Lori; Watts, Charlotte

    2012-01-01

    Abstract Background Gender based violence, including violence by an intimate partner, is a major global human rights and public health problem, with important connections with HIV risk. Indeed, the elimination of sexual and gender based violence is a core pillar of HIV prevention for UNAIDS. Integrated strategies to address the gender norms, relations and inequities that underlie both violence against women and HIV/AIDS are needed. However there is limited evidence about the potential impact ...

  12. Growing old at home – A randomized controlled trial to investigate the effectiveness and cost-effectiveness of preventive home visits to reduce nursing home admissions: study protocol [NCT00644826

    Directory of Open Access Journals (Sweden)

    Riedel-Heller Steffi G

    2008-05-01

    Full Text Available Abstract Background Regarding demographic changes in Germany it can be assumed that the number of elderly and the resulting need for long term care is increasing in the near future. It is not only an individual's interest but also of public concern to avoid a nursing home admission. Current evidence indicates that preventive home visits can be an effective way to reduce the admission rate in this way making it possible for elderly people to stay longer at home than without home visits. As the effectiveness and cost-effectiveness of preventive home visits strongly depends on existing services in the social and health system existing international results cannot be merely transferred to Germany. Therefore it is necessary to investigate the effectiveness and cost-effectiveness of such an intervention in Germany by a randomized controlled trial. Methods The trial is designed as a prospective multi-center randomized controlled trial in the cities of Halle and Leipzig. The trial includes an intervention and a control group. The control group receives usual care. The intervention group receives three additional home visits by non-physician health professionals (1 geriatric assessment, (2 consultation, (3 booster session. The nursing home admission rate after 18 months will be defined as the primary outcome. An absolute risk reduction from a 20% in the control-group to a 7% admission rate in the intervention group including an assumed drop out rate of 30% resulted in a required sample size of N = 320 (n = 160 vs. n = 160. Parallel to the clinical outcome measurement the intervention will be evaluated economically. The economic evaluation will be performed from a society perspective. Discussion To the authors' knowledge for the first time a trial will investigate the effectiveness and cost-effectiveness of preventive home visits for people aged 80 and over in Germany using the design of a randomized controlled trial. Thus, the trial will contribute to

  13. The efficacy of fall-risk-increasing drug (FRID withdrawal for the prevention of falls and fall-related complications: protocol for a systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Justin Yusen Lee

    2017-02-01

    Full Text Available Abstract Background Despite limited evidence of effectiveness, withdrawal (discontinuation or dose reduction of high risk medications known as “fall-risk increasing drugs” (FRIDs is typically conducted as a fall prevention strategy based on presumptive benefit. Our objective is to determine the efficacy of fall-risk increasing drugs (FRIDs withdrawal on the prevention of falls and fall-related complications. Methods/design We will search for all published and unpublished randomized controlled trials evaluating the effect of FRID withdrawal compared to usual care on the rate of falls, incidence of falls, fall-related injuries, fall-related fractures, fall-related hospitalizations, or adverse effects related to the intervention in adults aged 65 years or older. Electronic database searches will be conducted in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL, and CINAHL. A grey literature search will be conducted including clinical trial registries and conference proceedings and abstracts. Two reviewers will independently perform in duplicate citation screening, full-text review, data abstraction, and risk of bias assessment. Conflicts will be resolved through team discussion or by a third reviewer if no consensus can be reached. The Grades of Recommendation, Assessment, Development and Evaluation (GRADE criteria will be used to independently rate overall confidence in effect estimates for each outcome. Results will be synthesized descriptively, and a random effects meta-analysis will be conducted for each outcome if studies are deemed similar methodologically, clinically, and statistically. Discussion We will attempt to determine whether a FRID withdrawal strategy alone is effective at preventing falls in older adults. Our results will be used to optimize and focus fall prevention strategies and initiatives internationally with a goal of improving the health of older adults. Systematic review registration PROSPERO CRD

  14. An integrated general practice and pharmacy-based intervention to promote the use of appropriate preventive medications among individuals at high cardiovascular disease risk: protocol for a cluster randomized controlled trial

    OpenAIRE

    Hayek, Adina; Joshi, Rohina; Usherwood, Tim; Webster, Ruth; Kaur, Baldeep; Saini, Bandana; Armour, Carol; Krass, Ines; Laba, Tracey-Lea; Reid, Christopher; Shiel, Louise; Hespe, Charlotte; Hersch, Fred; Jan, Stephen; Lo, Serigne

    2016-01-01

    Background Cardiovascular diseases (CVD) are responsible for significant morbidity, premature mortality, and economic burden. Despite established evidence that supports the use of preventive medications among patients at high CVD risk, treatment gaps remain. Building on prior evidence and a theoretical framework, a complex intervention has been designed to address these gaps among high-risk, under-treated patients in the Australian primary care setting. This intervention comprises a general p...

  15. 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...

  16. 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.

  17. Effectiveness of the population-based Check your health preventive programme conducted in primary care with 4 years follow-up [the CORE trial]: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Maindal, Helle Terkildsen; Støvring, Henrik; Sandbaek, Annelli

    2014-08-29

    The periodic health check-up has been a fundamental part of routine medical practice for decades, despite a lack of consensus regarding its value in health promotion and disease prevention. A large-scale Danish population-based preventive programme 'Check your health' was developed based on available evidence of screening and successive accepted treatment, prevention for diseases and health promotion, and is closely aligned with the current health care system.The objective of the 'Check your health' [CORE] trial is to investigate effectiveness on health outcomes of a preventive health check offered at a population-level to all individuals aged 30-49 years, and to establish the cost-effectiveness. The trial will be conducted as a pragmatic household-cluster randomised controlled trial involving 10,505 individuals. All individuals within a well-defined geographical area in the Central Denmark Region, Denmark (DK) were randomised to be offered a preventive health check (Intervention group, n = 5250) or to maintain routine access to healthcare until a delayed intervention (Comparison group, n = 5255). The programme consists of a health examination which yields an individual risk profile, and according to this participants are assigned to one of the following interventions: (a) referral to a health promoting consultation in general practice, (b) behavioural programmes at the local Health Centre, or (c) no need for follow-up.The primary outcomes at 4 years follow-up are: ten-year-risk of fatal cardiovascular event (Heart-SCORE model), physical activity level (self-report and cardiorespiratory fitness), quality of life (SF12), sick leave and labour market attachment. Cost-effectiveness will be evaluated according to life years gained, direct costs and total health costs. Intention to treat analysis will be performed. Results from the largest Danish health check programme conducted within the current healthcare system, spanning the sectors which share responsibility for

  18. Parenting Resilient Kids (PaRK), an online parenting program to prevent anxiety and depression problems in primary school-aged children: Study protocol for a randomised controlled trial.

    Science.gov (United States)

    Fernando, Luwishennadige Madhawee N; Sim, Wan Hua; Jorm, Anthony F; Rapee, Ron; Lawrence, Katherine A; Yap, Marie B H

    2018-04-19

    Preventive efforts targeting childhood anxiety and depression symptoms have the potential to alter the developmental trajectory of depression and anxiety disorders across the lifespan. Substantial previous research suggests that modifiable parenting factors such as parental aversiveness and over-involvement are associated with childhood anxiety, depressive and internalising symptoms, indicating that parents can play a critical role in prevention. The Parenting Resilient Kids study is a new evidence-based online parenting program designed to prevent anxiety and depression problems in primary school-aged children by reducing family-based risk factors and enhancing protective factors through increased positive interactions between parent and child. The current study is a parallel group superiority randomised controlled trial with parent-child dyads randomised to the intervention or active-control group in a 1:1 ratio. The intervention group will receive the Parenting Resilient Kids program consisting of a feedback report on parenting behaviours and up to 12 interactive online modules personalised based on responses to the parent survey. The active-control group will receive a standardised package of online educational materials about child development and wellbeing. The trial website is programmed to run a stratified random allocation sequence (based on parent gender) to determine group membership. We aim to recruit 340 parent-child dyads (170 dyads per group). We hypothesise that the intervention group will show greater improvement in parenting risk and protective factors from baseline to 3-month follow-up (primary outcome), which will in turn mediate changes in child depressive and anxiety symptoms from baseline to 12 and 24 months (co-primary outcomes). We also hypothesise that the intervention group will show greater benefits from baseline to 3-, 12- and 24-month follow-up, with regard to: child depressive and anxiety symptoms (co-primary outcomes); and child and

  19. The incidence of pressure ulcers after the implementation of a prevention protocol Incidencia de las úlceras por presión tras la implementación de un protocolo de prevención Incidência de úlceras por pressão após a implementação de um protocolo de prevenção

    Directory of Open Access Journals (Sweden)

    Noemi Marisa Brunet Rogenski

    2012-04-01

    Full Text Available Even in the present, pressure ulcers still represent a severe health problem, particularly in Intensive Care Units (ICU. This study assesses the implementation of a protocol to prevent pressure ulcers in ICU inpatients. This prospective, descriptive and exploratory study verifies the incidence of pressure ulcers following the implementation of a prevention protocol. Data were collected from April 17th to July 15th 2009. The incidence observed in this study (23.1% was below that reported in a similar study developed in the same institution (41.02% before the implementation of the protocols to assess risk and prevent pressure ulcers. The prevention protocols are essential tools that have an impact on controlling the incidence of pressure ulcers, when used consistently.Las úlceras por presión todavía representan un problema de salud grave, especialmente en unidades de cuidados intensivos. El objetivo de este estudio fue evaluar la aplicación de un protocolo para la prevención de úlceras por presión en pacientes de la Unidad de Cuidados Intensivos. Métodos: Estudio prospectivo, descriptivo y exploratorio, en los que la incidencia de úlceras por presión tras la aplicación de un protocolo de prevención. Los datos fueron recolectados durante el período comprendido entre el 17 abril a 15 julio 2009. Resultados: La incidencia encontrada en este estudio, el 23,1%, fue inferior a la indicada en un estudio similar elaborado en la misma institución (41,02% antes de la aplicación de protocolos para la evaluación de riesgos y la prevención de úlceras por presión. Conclusiones: protocolos de prevención son herramientas fundamentales y el impacto en el control de la incidencia de úlceras por presión, cuando se usan de manera habitual.As úlceras por pressão, ainda hoje, representam sério problema de saúde, em particular nas unidades de terapia intensiva. O objetivo deste trabalho foi o de avaliar a implementação de um protocolo de

  20. Performance of a commercial assay for the diagnosis of influenza A (H1N1 infection in comparison to the Centers for Disease Control and Prevention protocol of real time RT-PCR

    Directory of Open Access Journals (Sweden)

    María G Barbás

    2012-03-01

    Full Text Available At the time of influenza A (H1N1 emergency, the WHO responded with remarkable speed by releasing guidelines and a protocol for a real-time RT-PCR assay (rRT-PCR. The aim of the present study was to evalúate the performance of the "Real Time Ready Influenza A/H1N1 Detection Set" (June 2009-Roche kit in comparison to the CDC reference rRT-PCR protocol. The overall sensitivity of the Roche assay for detection of the Inf A gene in the presence or absence of the H1 gene was 74.5 %. The sensitivity for detecting samples that were only positive for the Inf A gene (absence of the H1 gene was 53.3 % whereas the sensitivity for H1N1-positive samples (presence of the Inf A gene and any other swine gene was 76.4 %. The specificity of the assay was 97.1 %. A new version of the kit (November 2009 is now available, and a recent evaluation of its performance showed good sensitivity to detect pandemic H1N1 compared to other molecular assays.Durante la pandemia de influenza A (H1N1, la OMS recomendó algoritmos y protocolos de detección del virus mediante RT-PCR en tiempo real. El objetivo del presente estudio fue evaluar el desempeño del equipo que comercializa la empresa Roche, Real Time Ready Influenza A/H1N1 Detection Set (junio de 2009, en comparación con el protocolo de RT-PCR en tiempo real de los CDC. La sensibilidad global del ensayo de Roche para la detección del gen Inf A en presencia o ausencia del gen H1 fue 74,5 %. La sensibilidad para la detección de muestras positivas solo para el gen Inf A (ausencia del gen H1 fue 53,3 % y la sensibilidad para la detección de muestras positivas para H1N1 (presencia del gen Inf A y cualquier otro gen porcino fue 76,4 %. La especificidad fue 97,1 %. Existe una nueva versión del equipo (noviembre 2009 que, según se ha descrito, presenta buena sensibilidad en comparación con otros ensayos moleculares para detectar H1N1 pandémica.

  1. Bioenergy from sisal residues

    Energy Technology Data Exchange (ETDEWEB)

    Jungersen, G. [Dansk Teknologisk Inst. (Denmark); Kivaisi, A.; Rubindamayugi, M. [Univ. of Dar es Salaam (Tanzania, United Republic of)

    1998-05-01

    The main objectives of this report are: To analyse the bioenergy potential of the Tanzanian agro-industries, with special emphasis on the Sisal industry, the largest producer of agro-industrial residues in Tanzania; and to upgrade the human capacity and research potential of the Applied Microbiology Unit at the University of Dar es Salaam, in order to ensure a scientific and technological support for future operation and implementation of biogas facilities and anaerobic water treatment systems. The experimental work on sisal residues contains the following issues: Optimal reactor set-up and performance; Pre-treatment methods for treatment of fibre fraction in order to increase the methane yield; Evaluation of the requirement for nutrient addition; Evaluation of the potential for bioethanol production from sisal bulbs. The processing of sisal leaves into dry fibres (decortication) has traditionally been done by the wet processing method, which consumes considerable quantities of water and produces large quantities of waste water. The Tanzania Sisal Authority (TSA) is now developing a dry decortication method, which consumes less water and produces a waste product with 12-15% TS, which is feasible for treatment in CSTR systems (Continously Stirred Tank Reactors). (EG)

  2. Preventing Errors in Laterality

    OpenAIRE

    Landau, Elliot; Hirschorn, David; Koutras, Iakovos; Malek, Alexander; Demissie, Seleshie

    2014-01-01

    An error in laterality is the reporting of a finding that is present on the right side as on the left or vice versa. While different medical and surgical specialties have implemented protocols to help prevent such errors, very few studies have been published that describe these errors in radiology reports and ways to prevent them. We devised a system that allows the radiologist to view reports in a separate window, displayed in a simple font and with all terms of laterality highlighted in sep...

  3. Alcohol handrubbing and chlorhexidine handwashing protocols for routine hospital practice: A randomized clinical trial of protocol efficacy and time effectiveness

    NARCIS (Netherlands)

    Chow, Angela; Arah, Onyebuchi A.; Chan, Siew-Pang; Poh, Bee-Fong; Krishnan, Prabha; Ng, Woei-Kian; Choudhury, Saugata; Chan, Joey; Ang, Brenda

    2012-01-01

    Background: The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) recommend the use of alcohol handrubs to prevent health care-associated infections. However, the efficacy and time effectiveness of different alcohol handrubbing protocols have yet to be

  4. Effectiveness of McKenzie Method-Based Self-Management Approach for the Secondary Prevention of a Recurrence of Low Back Pain (SAFE Trial): Protocol for a Pragmatic Randomized Controlled Trial.

    Science.gov (United States)

    de Campos, Tarcisio F; Maher, Chris G; Clare, Helen A; da Silva, Tatiane M; Hancock, Mark J

    2017-08-01

    Although many people recover quickly from an episode of low back pain (LBP), recurrence is very common. There is limited evidence on effective prevention strategies for recurrences of LBP. The purpose of this study was to determine the effectiveness of a McKenzie method-based self-management approach in the secondary prevention of LBP. This will be a pragmatic randomized controlled trial. Participants will be recruited from the community and primary care, with the intervention delivered in a number of physical therapist practices in Sydney, Australia. The study will have 396 participants, all of whom are at least 18 years old. Participants will be randomly assigned to either the McKenzie method-based self-management approach group or a minimal intervention control group. The primary outcome will be days to first self-reported recurrence of an episode of activity-limiting LBP. The secondary outcomes will include: days to first self-reported recurrence of an episode of LBP, days to first self-reported recurrence of an episode of LBP leading to care seeking, and the impact of LBP over a 12-month period. All participants will be followed up monthly for a minimum of 12 months or until they have a recurrence of activity-limiting LBP. All participants will also be followed-up at 3, 6, 9, and 12 months to assess the impact of back pain, physical activity levels, study program adherence, credibility, and adverse events. Participants and therapists will not be masked to the interventions. To our knowledge, this will be the first large, high-quality randomized controlled trial investigating the effectiveness of a McKenzie method-based self-management approach for preventing recurrences of LBP. If this approach is found to be effective, it will offer a low-cost, simple method for reducing the personal and societal burdens of LBP. © 2017 American Physical Therapy Association

  5. The effectiveness of a web-based Dutch parenting program to prevent overweight in children 9-13 years of age: study protocol for a two-armed cluster randomized controlled trial.

    Science.gov (United States)

    Ruiter, Emilie L M; Fransen, Gerdine A J; Molleman, Gerard R M; van der Velden, Koos; Engels, Rutger C M E

    2015-02-14

    Although parental support is an important component in overweight prevention programs for children, current programs pay remarkably little attention to the role of parenting. To close this gap, we developed a web-based parenting program for parents entitled "Making a healthy deal with your child". This e-learning program can be incorporated into existing prevention programs, thereby improving these interventions by reinforcing the role of parenting and providing parents with practical tools for use in everyday situations in order to stimulate a healthy lifestyle. Here, we report the research design of a study to determine the effectiveness of our e-learning program. The effectiveness of an e-learning program was studied in a two-armed cluster randomized controlled trial. Parents of children 9-13 years of age who live in the Nijmegen region, the Netherlands, and who participated in the existing school-based overweight prevention program "Scoring for Health" were invited to participate in this study. Our goal was to recruit 322 parent-child dyads. At the school grade level, parents were randomly assigned to either the intervention group (which received e-learning and a brochure) or the control group (which received only the brochure); the participants were stratified by ethnicity. Measurements were taken from both the parents and the children at baseline, and then 5 and 12 months after baseline. Primary outcomes included the child's dietary and sedentary behavior, and level of physical activity. Secondary outcomes included general parenting style, specific parenting practices (e.g., set of rules, modeling, and monitoring), and parental self-efficacy. We hypothesize that children of parents who follow the e-learning program will have a healthier diet, will be less sedentary, and will have a higher level of physical activity compared to the children in the control group. If the e-learning program is found to be effective, it can be incorporated into existing

  6. Randomised controlled trial of the clinical and cost-effectiveness of a peer-delivered self-management intervention to prevent relapse in crisis resolution team users: study protocol.

    Science.gov (United States)

    Johnson, Sonia; Mason, Oliver; Osborn, David; Milton, Alyssa; Henderson, Claire; Marston, Louise; Ambler, Gareth; Hunter, Rachael; Pilling, Stephen; Morant, Nicola; Gray, Richard; Weaver, Tim; Nolan, Fiona; Lloyd-Evans, Brynmor

    2017-10-27

    Crisis resolution teams (CRTs) provide assessment and intensive home treatment in a crisis, aiming to offer an alternative for people who would otherwise require a psychiatric inpatient admission. They are available in most areas in England. Despite some evidence for their clinical and cost-effectiveness, recurrent concerns are expressed regarding discontinuity with other services and lack of focus on preventing future relapse and readmission to acute care. Currently evidence on how to prevent readmissions to acute care is limited. Self-management interventions, involving supporting service users in recognising and managing signs of their own illness and in actively planning their recovery, have some supporting evidence, but have not been tested as a means of preventing readmission to acute care in people leaving community crisis care. We thus proposed the current study to test the effectiveness of such an intervention. We selected peer support workers as the preferred staff to deliver such an intervention, as they are well-placed to model and encourage active and autonomous recovery from mental health problems. The CORE (CRT Optimisation and Relapse Prevention) self-management trial compares the effectiveness of a peer-provided self-management intervention for people leaving CRT care, with treatment as usual supplemented by a booklet on self-management. The planned sample is 440 participants, including 40 participants in an internal pilot. The primary outcome measure is whether participants are readmitted to acute care over 1 year of follow-up following entry to the trial. Secondary outcomes include self-rated recovery at 4 and at 18 months following trial entry, measured using the Questionnaire on the Process of Recovery. Analysis will follow an intention to treatment principle. Random effects logistic regression modelling with adjustment for clustering by peer support worker will be used to test the primary hypothesis. The CORE self-management trial was approved

  7. What is the effect of a combined physical activity and fall prevention intervention enhanced with health coaching and pedometers on older adults' physical activity levels and mobility-related goals? Study protocol for a randomised controlled trial.

    Science.gov (United States)

    Tiedemann, Anne; Paul, Serene; Ramsay, Elisabeth; O'Rourke, Sandra D; Chamberlain, Kathryn; Kirkham, Catherine; Merom, Dafna; Fairhall, Nicola; Oliveira, Juliana S; Hassett, Leanne; Sherrington, Catherine

    2015-05-09

    Physical inactivity and falls in older people are important public health problems. Health conditions that could be ameliorated with physical activity are particularly common in older people. One in three people aged 65 years and over fall at least once annually, often resulting in significant injuries and ongoing disability. These problems need to be urgently addressed as the population proportion of older people is rapidly rising. This trial aims to establish the impact of a combined physical activity and fall prevention intervention compared to an advice brochure on objectively measured physical activity participation and mobility-related goal attainment among people aged 60+. A randomised controlled trial involving 130 consenting community-dwelling older people will be conducted. Participants will be individually randomised to a control group (n = 65) and receive a fall prevention brochure, or to an intervention group (n = 65) and receive the brochure plus physical activity promotion and fall prevention intervention enhanced with health coaching and a pedometer. Primary outcomes will be objectively measured physical activity and mobility-related goal attainment, measured at both six and 12 months post randomisation. Secondary outcomes will include: falls, the proportion of people meeting the physical activity guidelines, quality of life, fear of falling, mood, and mobility limitation. Barriers and enablers to physical activity participation will be measured 6 months after randomisation. General linear models will be used to assess the effect of group allocation on the continuously-scored primary and secondary outcome measures, after adjusting for baseline scores. Between-group differences in goal attainment (primary outcome) will be analysed with ordinal regression. The number of falls per person-year will be analysed using negative binomial regression models to estimate the between-group difference in fall rates after one year (secondary outcome). Modified

  8. Bright light therapy versus physical exercise to prevent co-morbid depression and obesity in adolescents and young adults with attention-deficit / hyperactivity disorder: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mayer, Jutta S; Hees, Katharina; Medda, Juliane; Grimm, Oliver; Asherson, Philip; Bellina, Mariano; Colla, Michael; Ibáñez, Pol; Koch, Elena; Martinez-Nicolas, Antonio; Muntaner-Mas, Adrià; Rommel, Anna; Rommelse, Nanda; de Ruiter, Saskia; Ebner-Priemer, Ulrich W; Kieser, Meinhard; Ortega, Francisco B; Thome, Johannes; Buitelaar, Jan K; Kuntsi, Jonna; Ramos-Quiroga, J Antoni; Reif, Andreas; Freitag, Christine M

    2018-02-26

    The risk for major depression and obesity is increased in adolescents and adults with attention-deficit / hyperactivity disorder (ADHD) and adolescent ADHD predicts adult depression and obesity. Non-pharmacological interventions to treat and prevent these co-morbidities are urgently needed. Bright light therapy (BLT) improves day-night rhythm and is an emerging therapy for major depression. Exercise intervention (EI) reduces obesity and improves depressive symptoms. To date, no randomized controlled trial (RCT) has been performed to establish feasibility and efficacy of these interventions targeting the prevention of co-morbid depression and obesity in ADHD. We hypothesize that the two manualized interventions in combination with mobile health-based monitoring and reinforcement will result in less depressive symptoms and obesity compared to treatment as usual in adolescents and young adults with ADHD. This trial is a prospective, pilot phase-IIa, parallel-group RCT with three arms (two add-on treatment groups [BLT, EI] and one treatment as usual [TAU] control group). The primary outcome variable is change in the Inventory of Depressive Symptomatology total score (observer-blinded assessment) between baseline and ten weeks of intervention. This variable is analyzed with a mixed model for repeated measures approach investigating the treatment effect with respect to all three groups. A total of 330 participants with ADHD, aged 14 - obesity, ADHD symptoms, general psychopathology, health-related quality of life, neurocognitive function, chronotype, and physical fitness are explored after the end of the intervention and at the 12-week follow-up. This is the first pilot RCT on the use of BLT and EI in combination with mobile health-based monitoring and reinforcement targeting the prevention of co-morbid depression and obesity in adolescents and young adults with ADHD. If at least medium effects can be established with regard to the prevention of depressive symptoms and

  9. Dynamics behind the scale up of evidence-based obesity prevention: protocol for a multi-site case study of an electronic implementation monitoring system in health promotion practice.

    Science.gov (United States)

    Conte, Kathleen P; Groen, Sisse; Loblay, Victoria; Green, Amanda; Milat, Andrew; Persson, Lina; Innes-Hughes, Christine; Mitchell, Jo; Thackway, Sarah; Williams, Mandy; Hawe, Penelope

    2017-12-06

    The effectiveness of many interventions to promote health and prevent disease has been well established. The imperative has therefore shifted from amassing evidence about efficacy to scale-up to maximise population-level health gains. Electronic implementation monitoring, or 'e-monitoring', systems have been designed to assist and track the delivery of preventive policies and programs. However, there is little evidence on whether e-monitoring systems improve the dissemination, adoption, and ongoing delivery of evidence-based preventive programs. Also, given considerable difficulties with e-monitoring systems in the clinical sector, scholars have called for a more sophisticated re-examination of e-monitoring's role in enhancing implementation. In the state of New South Wales (NSW), Australia, the Population Health Information Management System (PHIMS) was created to support the dissemination of obesity prevention programs to 6000 childcare centres and elementary schools across all 15 local health districts. We have established a three-way university-policymaker-practice research partnership to investigate the impact of PHIMS on practice, how PHIMS is used, and how achievement of key performance indicators of program adoption may be associated with local contextual factors. Our methods encompass ethnographic observation, key informant interviews and participatory workshops for data interpretation at a state and local level. We use an on-line social network analysis of the collaborative relationships across local health district health promotion teams to explore the relationship between PHIMS use and the organisational structure of practice. Insights will be sensitised by institutional theory, practice theory and complex adaptive system thinking, among other theories which make sense of socio-technical action. Our working hypothesis is that the science of getting evidence-based programs into practice rests on an in-depth understanding of the role they play in the on

  10. Preferences for ARV-based HIV prevention methods among men and women, adolescent girls and female sex workers in Gauteng Province, South Africa: a protocol for a discrete choice experiment.

    Science.gov (United States)

    Quaife, Matthew; Eakle, Robyn; Cabrera, Maria; Vickerman, Peter; Tsepe, Motlalepule; Cianci, Fiona; Delany-Moretlwe, Sinead; Terris-Prestholt, Fern

    2016-06-27

    For the past few decades, condoms have been the main method of HIV prevention. Recent advances in antiretroviral (ARV)-based prevention products have substantially changed the prevention landscape, yet little is known about how popular these products will be among potential users, or whether new methods might be used in conjunction with, or instead of, condoms. This study will use a discrete choice experiment (DCE) to (1) explore potential users' preferences regarding HIV prevention products, (2) quantify the importance of product attributes and (3) predict the uptake of products to inform estimates of their potential impact on the HIV epidemic in South Africa. We consider preferences for oral pre-exposure prophylaxis; a vaginal microbicide gel; a long-acting vaginal ring; a SILCS diaphragm used in concert with gel; and a long-acting ARV-based injectable. This study will gather data from 4 populations: 200 women, 200 men, 200 adolescent girls (aged 16-17 years) and 200 female sex workers. The DCE attributes and design will be developed through a literature review, supplemented by a thematic analysis of qualitative focus group discussions. Extensive piloting will be carried out in each population through semistructured interviews. The final survey will be conducted using computer tablets via a household sample (for women, men and adolescents) and respondent-driven sampling (for female sex workers), and DCE data analysed using a range of multinomial logit models. This study has been approved by the University of the Witwatersrand Human Research Ethics Committee and the Research Ethics Committee at the London School of Hygiene and Tropical Medicine. Findings will be presented to international conferences and peer-reviewed journals. Meetings will be held with opinion leaders in South Africa, while results will be disseminated to participants in Ekurhuleni through a public meeting or newsletter. Published by the BMJ Publishing Group Limited. For permission to use (where

  11. Controlled Delegation Protocol in Mobile RFID Networks

    Directory of Open Access Journals (Sweden)

    Yang MingHour

    2010-01-01

    Full Text Available To achieve off-line delegation for mobile readers, we propose a delegation protocol for mobile RFID allowing its readers access to specific tags through back-end server. That is to say, reader-tag mutual authentication can be performed without readers being connected to back-end server. Readers are also allowed off-line access to tags' data. Compared with other delegation protocols, our scheme uniquely enables back-end server to limit each reader's reading times during delegation. Even in a multireader situation, our protocol can limit reading times and reading time periods for each of them and therefore makes back-end server's delegation more flexible. Besides, our protocol can prevent authorized readers from transferring their authority to the unauthorized, declining invalid access to tags. Our scheme is proved viable and secure with GNY logic; it is against certain security threats, such as replay attacks, denial of service (DoS attacks, Man-in-the-Middle attacks, counterfeit tags, and breaches of location and data privacy. Also, the performance analysis of our protocol proves that current tags can afford the computation load required in this scheme.

  12. A Lightweight Buyer-Seller Watermarking Protocol

    Directory of Open Access Journals (Sweden)

    Yongdong Wu

    2008-01-01

    Full Text Available The buyer-seller watermarking protocol enables a seller to successfully identify a traitor from a pirated copy, while preventing the seller from framing an innocent buyer. Based on finite field theory and the homomorphic property of public key cryptosystems such as RSA, several buyer-seller watermarking protocols (N. Memon and P. W. Wong (2001 and C.-L. Lei et al. (2004 have been proposed previously. However, those protocols require not only large computational power but also substantial network bandwidth. In this paper, we introduce a new buyer-seller protocol that overcomes those weaknesses by managing the watermarks. Compared with the earlier protocols, ours is n times faster in terms of computation, where n is the number of watermark elements, while incurring only O(1/lN times communication overhead given the finite field parameter lN. In addition, the quality of the watermarked image generated with our method is better, using the same watermark strength.

  13. 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.

  14. LEACH-A: An Adaptive Method for Improving LEACH Protocol

    Directory of Open Access Journals (Sweden)

    Jianli ZHAO

    2014-01-01

    Full Text Available Energy has become one of the most important constraints on wireless sensor networks. Hence, many researchers in this field focus on how to design a routing protocol to prolong the lifetime of the network. The classical hierarchical protocols such as LEACH and LEACH-C have better performance in saving the energy consumption. However, the choosing strategy only based on the largest residue energy or shortest distance will still consume more energy. In this paper an adaptive routing protocol named “LEACH-A” which has an energy threshold E0 is proposed. If there are cluster nodes whose residual energy are greater than E0, the node of largest residual energy is selected to communicated with the base station; When all the cluster nodes energy are less than E0, the node nearest to the base station is select to communication with the base station. Simulations show that our improved protocol LEACH-A performs better than the LEACH and the LEACH-C.

  15. Antibiotic Residues - A Global Health Hazard

    Directory of Open Access Journals (Sweden)

    Nisha A.R.

    Full Text Available Use of Antibiotic that might result in deposition of residues in meat, milk and eggs must not be permitted in food intended for human consumption. If use of antibiotics is necessary as in prevention and treatment of animal diseases, a withholding period must be observed until the residues are negligible or no longer detected. The use of antibiotics to bring about improved performance in growth and feed efficiency, to synchronize or control of reproductive cycle and breeding performance also often lead to harmful residual effects. Concern over antibiotic residues in food of animal origin occurs in two times; one which produces potential threat to direct toxicity in human, second is whether the low levels of antibiotic exposure would result in alteration of microflora, cause disease and the possible development of resistant strains which cause failure of antibiotic therapy in clinical situations. A withdrawal period is established to safeguard human from exposure of antibiotic added food. The withdrawal time is the time required for the residue of toxicological concern to reach safe concentration as defined by tolerance. It is the interval from the time an animal is removed from medication until permitted time of slaughter. Heavy responsibility is placed on the veterinarian and livestock producer to observe the period for a withdrawal of a drug prior to slaughter to assure that illegal concentration of drug residue in meat, milk and egg do not occur. Use of food additives may improve feed efficiency 17% in beef cattle, 10% in lambs, 15% in poultry and 15% in swine. But their indiscriminate use will produce toxicity in consumers. WHO and FAO establish tolerances for a drug, pesticide or other chemical in the relevant tissues of food producing animals. The tolerance is the tissue concentration below, which a marker residue for the drug or chemical must fall in the target tissue before that animal edible tissues are considered safe for human

  16. 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...

  17. A mixed methods study to assess the effectiveness of food-based interventions to prevent stunting among children under-five years in Districts Thatta and Sujawal, Sindh Province, Pakistan: study protocol

    Directory of Open Access Journals (Sweden)

    Sumra Kureishy

    2017-01-01

    Full Text Available Abstract Background Maternal and child malnutrition is widely prevalent in low and middle income countries. In Pakistan, widespread food insecurity and malnutrition are the main contributors to poor health, low survival rates and the loss of human capital development. The nutritional status trends among children exhibit a continuous deteriorating with rates of malnutrition exceeding the WHO critical threshold. With the high prevalence of maternal and child malnutrition, it is important to identify effective preventative approaches, especially for reducing stunting in children under-five years of age. The primary aim of this study is to assess the effectiveness of food-based interventions to prevent stunting in children under-five years. Methods A mixed methods study design will be conducted to evaluate the effectiveness of food-based interventions to prevent stunting among children under-five years in districts Thatta and Sujawal, Sindh Province, Pakistan. The study will include cross sectional surveys, a community-based cluster randomized controlled trial and a process evaluation. The study participants will be pregnant women, lactating mothers and children under-five years. The cross-sectional surveys will be conducted with 7360 study participants at baseline and endline. For the randomized control trial, 5000 participants will be recruited and followed monthly for compliance of food-based supplements, dietary diversity, pregnancy outcomes, and maternal and child morbidity and mortality. Anthropometric measurements and hemoglobin levels will be measured at baseline, quarterly and at endline. The interventions will consist of locally produced lipid-based nutrient supplement (Wawamum for children 6–23 months, micronutrient powders for children 24–59 months, and wheat soya blends for pregnant and lactating mothers. Government lady health workers will deliver interventions to participants. The effectiveness of the project will be measured in

  18. 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...

  19. 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...

  20. Protocol for economic evaluation alongside a cluster-randomised controlled trial of a psychoeducational intervention for the primary prevention of postnatal mental health problems in first-time mothers.

    Science.gov (United States)

    Ride, Jemimah; Rowe, Heather; Wynter, Karen; Fisher, Jane; Lorgelly, Paula

    2014-10-03

    Postnatal mental health problems, which are an international public health priority, are a suitable target for preventive approaches. The financial burden of these disorders is borne across sectors in society, including health, early childhood, education, justice and the workforce. This paper describes the planned economic evaluation of What Were We Thinking, a psychoeducational intervention for the prevention of postnatal mental health problems in first-time mothers. The evaluation will be conducted alongside a cluster-randomised controlled trial of its clinical effectiveness. Cost-effectiveness and costs-utility analyses will be conducted, resulting in estimates of cost per percentage point reduction in combined 30-day prevalence of depression, anxiety and adjustment disorders and cost per quality-adjusted life year gained. Uncertainty surrounding these estimates will be addressed using non-parametric bootstrapping and represented using cost-effectiveness acceptability curves. Additional cost analyses relevant for implementation will also be conducted. Modelling will be employed to estimate longer term cost-effectiveness if the intervention is found to be clinically effective during the period of the trial. Approval to conduct the study was granted by the Southern Health (now Monash Health) Human Research Ethics Committee (24 April 2013; 11388B). The study was registered with the Monash University Human Research Ethics Committee (30 April 2013; CF12/1022-2012000474). The Education and Policy Research Committee, Victorian Government Department of Education and Early Childhood Development approved the study (22 March 2012; 2012_001472). Use of the EuroQol was registered with the EuroQol Group; 16 August 2012. The trial was registered with the Australian New Zealand Clinical Trials Registry on 7 May 2012 (registration number ACTRN12613000506796). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please