Intravascular device administration sets: Replacement after standard versus prolonged use in hospitalised patients--a study protocol for a randomised controlled trial (The RSVP Trial)

Introduction Vascular access devices (VADs), such as peripheral or central venous catheters, are vital across all medical and surgical specialties. To allow therapy or haemodynamic monitoring, VADs frequently require administration sets (AS) composed of infusion tubing, fluid containers, pressure-monitoring transducers and/or burettes. While VADs are replaced only when necessary, AS are routinely replaced every 3–4 days in the belief that this reduces infectious complications. Strong evidence supports AS use up to 4 days, but there is less evidence for AS use beyond 4 days. AS replacement twice weekly increases hospital costs and workload. Methods and analysis This is a pragmatic, multicentre, randomised controlled trial (RCT) of equivalence design comparing AS replacement at 4 (control) versus 7 (experimental) days. Randomisation is stratified by site and device, centrally allocated and concealed until enrolment. 6554 adult/paediatric patients with a central venous catheter, peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4 years. The primary outcome is VAD-related bloodstream infection (BSI) and secondary outcomes are VAD colonisation, AS colonisation, all-cause BSI, all-cause mortality, number of AS per patient, VAD time in situ and costs. Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days (95% CIs) will summarise the impact of 7-day relative to 4-day AS use and test equivalence. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare VAD-BSI over time. Appropriate parametric or non-parametric techniques will be used to compare secondary end points. p Values of <0.05 will be considered significant.

On food security and alternative food networks: Understanding and performing food security in the context of urban bias

This paper offers one explanation for the institutional basis of food insecurity in Australia, and argues that while alternative food networks and the food sovereignty movement perform a valuable function in building forms of social solidarity between urban consumers and rural producers, they currently make only a minor contribution to Australia’s food and nutrition security. The paper begins by identifying two key drivers of food security: household incomes (on the demand side) and nutrition-sensitive, ‘fair food’ agriculture (on the supply side). We focus on this second driver and argue that healthy populations require an agricultural sector that delivers dietary diversity via a fair and sustainable food system. In order to understand why nutrition-sensitive, fair food agriculture is not flourishing in Australia we introduce the development economics theory of urban bias. According to this theory, governments support capital intensive rather than labour intensive agriculture in order to deliver cheap food alongside the transfer of public revenues gained from rural agriculture to urban infrastructure, where the majority of the voting public resides. We chart the unfolding of the Urban Bias across the twentieth century and its consolidation through neo-liberal orthodoxy, and argue that agricultural policies do little to sustain, let alone revitalize, rural and regional Australia. We conclude that by observing food system dynamics through a re-spatialized lens, Urban Bias Theory is valuable in highlighting rural–urban socio-economic and political economy tensions, particularly regarding food system sustainability. It also sheds light on the cultural economy tensions for alternative food networks as they move beyond niche markets to simultaneously support urban food security and sustainable rural livelihoods.

Child protection training for professionals to improve reporting of child abuse and neglect (Protocol)

Child abuse and neglect results in significant costs for children and communities. As a core public health strategy, diverse professional groups are required by law and policy in many jurisdictions to report suspected cases. Numerous different training initiatives appear to have been developed and implemented for professionals but there is little evidence regarding the precise training components and mechanisms that improve reporting of child abuse and neglect both generally, for specific professions, and for distinct types of child abuse and neglect. To enhance reporting practice, designers of training programmes require detailed information about what programme features will offer greatest benefit. A systematic review which identifies the effectiveness of different training approaches will advance the evidence base and develop a clearer understanding of optimal training content and methods. In addition, it will provide policymakers with a means by which to assess whether current training interventions are congruent with what is demonstrated to be effective. It will also inform future research, public policy, and professional practice in this field.

pH testing for detecting the position of nasogastric tubes in adults and children (Intervention Protocol)

This is the protocol for a review and there is no abstract. The objectives are as follows: Our objective is to determine if there is sufficient evidence to recommend the use of pH testing (the intervention under scrutiny) for verification of correct placement of nasogastric tubes in adults and children. To this end, we will attempt to answer the following questions: 1. In adults and children, is pH testing an effective and safe method for determining whether nasogastric tubes are correctly positioned in the stomach before feeding (or delivery of any fluid) begins? 2. What evidence is there about the risk of adverse events in the case of incorrect placement? For this review, pH testing is defined as: litmus paper, pH indicator test strips, pH meters. These will be tested against other methods used for detecting placement of nasogastric tubes, including visual examination of aspirate, auscultation with insufflation of air, detection of air bubbles in a bowl of water, X-ray, ultrasonography, endoscopy, enzyme analysis of aspirate, capnography, and other methods that do not rely on measurement of pH.

Is there a link between poverty and food security?

This paper addresses the gap in economic theory underlying the multidimensional concept of food security and observed data by deriving a composite food security index using the latent class model. The link between poverty and food security is then examined using the new food security index and the robustness of the link is compared with two unidimensional measures often used in the literature. Using Vietnam as a case study, it was found that a weak link exists for the rural but not for the urban composite food security index. The unidimensional measures on the other hand show a strong link in both the rural and urban regions. The results on the link are also different and mixed when two poverty types given by persistent and transient poverty are considered. These findings have important policy implications for a targeted approach to addressing food security.

Overcoming language barriers in healthcare: A protocol for investigating safe and effective communication when patients or clinicians use a second language

Background Miscommunication in the healthcare sector can be life-threatening. The rising number of migrant patients and foreign-trained staff means that communication errors between a healthcare practitioner and patient when one or both are speaking a second language are increasingly likely. However, there is limited research that addresses this issue systematically. This protocol outlines a hospital-based study examining interactions between healthcare practitioners and their patients who either share or do not share a first language. Of particular interest are the nature and efficacy of communication in language-discordant conversations, and the degree to which risk is communicated. Our aim is to understand language barriers and miscommunication that may occur in healthcare settings between patients and healthcare practitioners, especially where at least one of the speakers is using a second (weaker) language. Methods/Design Eighty individual interactions between patients and practitioners who speak either English or Chinese (Mandarin or Cantonese) as their first language will be video recorded in a range of in- and out-patient departments at three hospitals in the Metro South area of Brisbane, Australia. All participants will complete a language background questionnaire. Patients will also complete a short survey rating the effectiveness of the interaction. Recordings will be transcribed and submitted to both quantitative and qualitative analyses to determine elements of the language used that might be particularly problematic and the extent to which language concordance and discordance impacts on the quality of the patient-practitioner consultation. Discussion Understanding the role that language plays in creating barriers to healthcare is critical for healthcare systems that are experiencing an increasing range of culturally and linguistically diverse populations both amongst patients and practitioners. The data resulting from this study will inform policy and practical solutions for communication training, provide an agenda for future research, and extend theory in health communication.

Medical Data Access Accountability in EHR Systems, A Practical Perspective

The world has experienced a large increase in the amount of available data. Therefore, it requires better and more specialized tools for data storage and retrieval and information privacy. Recently Electronic Health Record (EHR) Systems have emerged to fulfill this need in health systems. They play an important role in medicine by granting access to information that can be used in medical diagnosis. Traditional systems have a focus on the storage and retrieval of this information, usually leaving issues related to privacy in the background. Doctors and patients may have different objectives when using an EHR system: patients try to restrict sensible information in their medical records to avoid misuse information while doctors want to see as much information as possible to ensure a correct diagnosis. One solution to this dilemma is the Accountable e-Health model, an access protocol model based in the Information Accountability Protocol. In this model patients are warned when doctors access their restricted data. They also enable a non-restrictive access for authenticated doctors. In this work we use FluxMED, an EHR system, and augment it with aspects of the Information Accountability Protocol to address these issues. The Implementation of the Information Accountability Framework (IAF) in FluxMED provides ways for both patients and physicians to have their privacy and access needs achieved. Issues related to storage and data security are secured by FluxMED, which contains mechanisms to ensure security and data integrity. The effort required to develop a platform for the management of medical information is mitigated by the FluxMED's workflow-based architecture: the system is flexible enough to allow the type and amount of information being altered without the need to change in your source code.

An improved protocol for the isolation of total genomic DNA from Labyrinthulomycetes

Many protocols have been used for extraction of DNA from Thraustochytrids. These generally involve the use of CTAB, phenol/chloroform and ethanol. They also feature mechanical grinding, sonication, N2 freezing or bead beating. However, the resulting chemical and physical damage to extracted DNA reduces its quality. The methods are also unsuitable for large numbers of samples. Commercially-available DNA extraction kits give better quality and yields but are expensive. Therefore, an optimized DNA extraction protocol was developed which is suitable for Thraustochytrids to both minimise expensive and time-consuming steps prior to DNA extraction and also to improve the yield. The most effective method is a combination of single bead in TissueLyser (Qiagen) and Proteinase K. Results were conclusive: both the quality and the yield of extracted DNA were higher than with any other method giving an average yield of 8.5 µg/100 mg biomass.

A 2-hour diagnostic protocol for possible cardiac chest pain in the emergency department: A randomized clinical trial

IMPORTANCE Patients with chest pain represent a high health care burden, but it may be possible to identify a patient group with a low short-term risk of adverse cardiac events who are suitable for early discharge. OBJECTIVE To compare the effectiveness of a rapid diagnostic pathway with a standard-care diagnostic pathway for the assessment of patients with possible cardiac chest pain in a usual clinical practice setting. DESIGN, SETTING, AND PARTICIPANTS A single-center, randomized parallel-group trial with blinded outcome assessments was conducted in an academic general and tertiary hospital. Participants included adults with acute chest pain consistent with acute coronary syndrome for whom the attending physician planned further observation and troponin testing. Patient recruitment occurred from October 11, 2010, to July 4, 2012, with a 30-day follow-up. INTERVENTIONS An experimental pathway using an accelerated diagnostic protocol (Thrombolysis in Myocardial Infarction score, 0; electrocardiography; and 0- and 2-hour troponin tests) or a standard-care pathway (troponin test on arrival at hospital, prolonged observation, and a second troponin test 6-12 hours after onset of pain) serving as the control. MAIN OUTCOMES AND MEASURES Discharge from the hospital within 6 hours without a major adverse cardiac event occurring within 30 days. RESULTS Fifty-two of 270 patients in the experimental group were successfully discharged within 6 hours compared with 30 of 272 patients in the control group (19.3% vs 11.0%; odds ratio, 1.92; 95% CI, 1.18-3.13; P = .008). It required 20 hours to discharge the same proportion of patients from the control group as achieved in the experimental group within 6 hours. In the experimental group, 35 additional patients (12.9%) were classified as low risk but admitted to an inpatient ward for cardiac investigation. None of the 35 patients received a diagnosis of acute coronary syndrome after inpatient evaluation. CONCLUSIONS AND RELEVANCE Using the accelerated diagnostic protocol in the experimental pathway almost doubled the proportion of patients with chest pain discharged early. Clinicians could discharge approximately 1 of 5 patients with chest pain to outpatient follow-up monitoring in less than 6 hours. This diagnostic strategy could be easily replicated in other centers because no extra resources are required.

Manufacturing and use of human placenta-derived mesenchymal stromal cells for phase I clinical trials: Establishment and evaluation of a protocol

Background/Aim. Mesenchymal stromal cells (MSCs) have been utilised in many clinical trials as an experimental treatment in numerous clinical settings. Bone marrow remains the traditional source tissue for MSCs but is relatively hard to access in large volumes. Alternatively, MSCs may be derived from other tissues including the placenta and adipose tissue. In an initial study no obvious differences in parameters such as cell surface phenotype, chemokine receptor display, mesodermal differentiation capacity or immunosuppressive ability, were detected when we compared human marrow derived- MSCs to human placenta-derived MSCs. The aim of this study was to establish and evaluate a protocol and related processes for preparation placenta-derived MSCs for early phase clinical trials. Methods. A full-term placenta was taken after delivery of the baby as a source of MSCs. Isolation, seeding, incubation, cryopreservation of human placentaderived MSCs and used production release criteria were in accordance with the complex regulatory requirements applicable to Code of Good Manufacturing Practice manufacturing of ex vivo expanded cells. Results. We established and evaluated instructions for MSCs preparation protocol and gave an overview of the three clinical areas application. In the first trial, MSCs were co-transplanted iv to patient receiving an allogeneic cord blood transplant as therapy for treatmentrefractory acute myeloid leukemia. In the second trial, MSCs were administered iv in the treatment of idiopathic pulmonary fibrosis and without serious adverse effects. In the third trial, MSCs were injected directly into the site of tendon damage using ultrasound guidance in the treatment of chronic refractory tendinopathy. Conclusion. Clinical trials using both allogeneic and autologous cells demonstrated MSCs to be safe. A described protocol for human placenta-derived MSCs is appropriate for use in a clinical setting, relatively inexpensive and can be relatively easily adjusted to a different set of regulatory requirements, as applicable to early phase clinical trials.

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

Objective Risk scores and accelerated diagnostic protocols can identify chest pain patients with low risk of major adverse cardiac event who could be discharged early from the ED, saving time and costs. We aimed to derive and validate a chest pain score and accelerated diagnostic protocol (ADP) that could safely increase the proportion of patients suitable for early discharge. Methods Logistic regression identified statistical predictors for major adverse cardiac events in a derivation cohort. Statistical coefficients were converted to whole numbers to create a score. Clinician feedback was used to improve the clinical plausibility and the usability of the final score (Emergency Department Assessment of Chest pain Score [EDACS]). EDACS was combined with electrocardiogram results and troponin results at 0 and 2 h to develop an ADP (EDACS-ADP). The score and EDACS-ADP were validated and tested for reproducibility in separate cohorts of patients. Results In the derivation (n = 1974) and validation (n = 608) cohorts, the EDACS-ADP classified 42.2% (sensitivity 99.0%, specificity 49.9%) and 51.3% (sensitivity 100.0%, specificity 59.0%) as low risk of major adverse cardiac events, respectively. The intra-class correlation coefficient for categorisation of patients as low risk was 0.87. Conclusion The EDACS-ADP identified approximately half of the patients presenting to the ED with possible cardiac chest pain as having low risk of short-term major adverse cardiac events, with high sensitivity. This is a significant improvement on similar, previously reported protocols. The EDACS-ADP is reproducible and has the potential to make considerable cost reductions to health systems.

Performance analysis of secure unified communications in the VMware-based cloud

Unified communications as a service (UCaaS) can be regarded as a cost-effective model for on-demand delivery of unified communications services in the cloud. However, addressing security concerns has been seen as the biggest challenge to the adoption of IT services in the cloud. This study set up a cloud system via VMware suite to emulate hosting unified communications (UC), the integration of two or more real time communication systems, services in the cloud in a laboratory environment. An Internet Protocol Security (IPSec) gateway was also set up to support network-level security for UCaaS against possible security exposures. This study was aimed at analysis of an implementation of UCaaS over IPSec and evaluation of the latency of encrypted UC traffic while protecting that traffic. Our test results show no latency while IPSec is implemented with a G.711 audio codec. However, the performance of the G.722 audio codec with an IPSec implementation affects the overall performance of the UC server. These results give technical advice and guidance to those involved in security controls in UC security on premises as well as in the cloud.

An information accountability perspective to eHealth security and privacy

Rigid security boundaries hinder the proliferation of eHealth. Through active audit logs, accountable-eHealth systems alleviate privacy concerns and enhance information availability.

The short-term impact of curative colorectal cancer treatment on physical activity, functional status and quality of life: A systematic review protocol

REVIEW QUESTION/OBJECTIVE The quantitative objectives are to identify the impact of curative colorectal cancer treatment (surgery or adjuvant therapy) on physical activity, functional status and quality of life within one year of treatment or diagnosis. INCLUSION CRITERIA Types of participants: This review will consider studies that include individuals aged 18 years and over who have been diagnosed with colorectal cancer. Types of intervention(s)/phenomena of interest: This review will consider studies that evaluate the impact of curative colorectal cancer treatment: surgery and/or adjuvant therapy. Types of outcomes: This review will consider studies that include the following outcome measures assessed within one year of diagnosis or treatment: Physical activity - any bodily movement produced by skeletal muscles resulting in energy expenditure. Physical activity is not exclusive to exercise; activities can also be walking, housework, occupational or leisure. Physical activity can be measured objectively using pedometers or accelerometers, or subjectively using self-reported measures. Functional status – measured as the capacity to perform all activities of daily living such as walking, showering, and eating; and instrumental activities of daily living such as (but not limited to) grocery shopping, housekeeping and laundry. Quality of life – defined as the individual meaning of mental, physical and psychosocial wellbeing, as measured by validated tools such as SF-36, EORTC-QLQ-C30, or FACT-C.