Guideline on the design and conduct of cystic fibrosis clinical trials: The European Cystic Fibrosis Society–Clinical Trials Network (ECFS-CTN)

We describe the rationale for disease specific research networks in general as well as the aims and function of the European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) specifically. The ECFS-CTN was founded in 2009 with the aim of improving the quality and quantity of clinical research in the area of cystic fibrosis (CF) in Europe. A network of 18 clinical trial sites in 8 European countries was established according to uniform state-of-the-art quality criteria. To support the ECFS-CTN in the acquisition, planning and conduct of clinical trials, the network is equipped with a coordinating centre, steering and executive committees, and committees for protocol review, standardization, training and networking as well as a data safety monitoring board. A strong partnership with European CF patient parent organizations aims to increase awareness of the need for efficient clinical research and the participation of patients in clinical trials.

Exploring the impact of institutional and organizational factors on the reaction of MNCs to the global financial crisis

This paper analyses some of the factors that impact multinational companies' (MNCs) reaction to the global financial crisis. This paper reports the results from a large-scale study of its impact on MNCs in Australia, considering occurrences of site closures, offshoring, outsourcing, labour force reductions, reductions in working hours, salary reductions, and reductions in training and travel. Evidence showed that MNC reactions varied according to certain institutional and organizational effects. For example, MNCs originating from liberal-market economies are more likely to have offshored and outsourced production and reduced employment. The implications for understanding of MNC behaviour are discussed. © 2013 Copyright Taylor and Francis Group, LLC.

British Society of Gastroenterology guidelines on the diagnosis and management of Barrett's oesophagus

These guidelines provide a practical and evidence-based resource for the management of patients with Barrett's oesophagus and related early neoplasia. The Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument was followed to provide a methodological strategy for the guideline development. A systematic review of the literature was performed for English language articles published up until December 2012 in order to address controversial issues in Barrett's oesophagus including definition, screening and diagnosis, surveillance, pathological grading for dysplasia, management of dysplasia, and early cancer including training requirements. The rigour and quality of the studies was evaluated using the SIGN checklist system. Recommendations on each topic were scored by each author using a five-tier system (A+, strong agreement, to D+, strongly disagree). Statements that failed to reach substantial agreement among authors, defined as >80% agreement (A or A+), were revisited and modified until substantial agreement (>80%) was reached. In formulating these guidelines, we took into consideration benefits and risks for the population and national health system, as well as patient perspectives. For the first time, we have suggested stratification of patients according to their estimated cancer risk based on clinical and histopathological criteria. In order to improve communication between clinicians, we recommend the use of minimum datasets for reporting endoscopic and pathological findings. We advocate endoscopic therapy for high-grade dysplasia and early cancer, which should be performed in high-volume centres. We hope that these guidelines will standardise and improve management for patients with Barrett's oesophagus and related neoplasia.

The Impact of the Recent Economic Recession on the NEC Contract in Northern Ireland: A Preliminary Study

In comparison to the rest of the United Kingdom (UK) the Northern Irish Construction Industry was disproportionately affected by the recent economic recession. During this period, use of the New Engineering Contract (NEC) has proliferated in the public sector, however no study has been undertaken to examine the impact of the recession on this contract in Northern Ireland. The aim of this paper is to explore NEC contract implementation in Northern Ireland and the impact of the recession on its operation. A qualitative methodology is adopted using a literature review and semi structured interviews with six construction professionals. A qualitative analysis identifies themes and issues arising exploring connections and links between them using thematic coding. The initial findings are that the introduction of the NEC contract in Northern Ireland makes demands of contractors and consultants in terms of additional resources and training. Some consultants show a clear lack of understanding of the contract and its provisions. Whilst there is general agreement that the contract does help to stimulate good project management, the interviewees find the contract time consuming and complicated to administer, describing it as “unforgiving for the architect and unforgiving to the contractor.” Due to the impact of the recession, both contractors and consultants are still reporting a drop in income from pre-recession levels. Project resourcing levels have dropped significantly since the onset of the recession. Adversarial and opportunistic behaviour has increased. Many consultants and contractors are struggling to adequately administer the NEC contract at current income levels. The introduction of the NEC contract and the economic recession have exerted opposing forces on the implementation of the contract, hindering its execution. As the pressures exerted by the economic recession abate and a greater understanding of the contract develops, these opposing forces will ease leading to a more consistent implementation of the contract.

The effect of altering a single component of a rehabilitation programme on the functional recovery of stroke patients: a systematic review and meta-analysis

OBJECTIVE: To evaluate the effect of altering a single component of a rehabilitation programme (e.g. adding bilateral practice alone) on functional recovery after stroke, defined using a measure of activity.

DATA SOURCES: A search was conducted of Medline/Pubmed, CINAHL and Web of Science.

REVIEW METHODS: Two reviewers independently assessed eligibility. Randomized controlled trials were included if all participants received the same base intervention, and the experimental group experienced alteration of a single component of the training programme. This could be manipulation of an intrinsic component of training (e.g. intensity) or the addition of a discretionary component (e.g. augmented feedback). One reviewer extracted the data and another independently checked a subsample (20%). Quality was appraised according to the PEDro scale.

RESULTS: Thirty-six studies (n = 1724 participants) were included. These evaluated nine training components: mechanical degrees of freedom, intensity of practice, load, practice schedule, augmented feedback, bilateral movements, constraint of the unimpaired limb, mental practice and mirrored-visual feedback. Manipulation of the mechanical degrees of freedom of the trunk during reaching and the addition of mental practice during upper limb training were the only single components found to independently enhance recovery of function after stroke.

CONCLUSION: This review provides limited evidence to support the supposition that altering a single component of a rehabilitation programme realises greater functional recovery for stroke survivors. Further investigations are required to determine the most effective single components of rehabilitation programmes, and the combinations that may enhance functional recovery.

Factors that impact on the use of mechanical ventilation weaning protocols in critically ill adults and children: a qualitative-evidence synthesis

Background:
Prolonged mechanical ventilation is associated with a longer intensive care unit (ICU) length of stay and higher mortality. Consequently, methods to improve ventilator weaning processes have been sought. Two recent Cochrane systematic reviews in ICU adult and paediatric populations concluded that protocols can be effective in reducing the duration of mechanical ventilation, but there was significant heterogeneity in study findings. Growing awareness of the benefits of understanding the contextual factors impacting on effectiveness has encouraged the integration of qualitative evidence syntheses with effectiveness reviews, which has delivered important insights into the reasons underpinning (differential) effectiveness of healthcare interventions.

Objectives:
1. To locate, appraise and synthesize qualitative evidence concerning the barriers and facilitators of the use of protocols for weaning critically-ill adults and children from mechanical ventilation;

2. To integrate this synthesis with two Cochrane effectiveness reviews of protocolized weaning to help explain observed heterogeneity by identifying contextual factors that impact on the use of protocols for weaning critically-ill adults and children from mechanical ventilation;

3. To use the integrated body of evidence to suggest the circumstances in which weaning protocols are most likely to be used.

Search methods:
We used a range of search terms identified with the help of the SPICE (Setting, Perspective, Intervention, Comparison, Evaluation) mnemonic. Where available, we used appropriate methodological filters for specific databases. We searched the following databases: Ovid MEDLINE, Embase, OVID, PsycINFO, CINAHL Plus, EBSCOHost, Web of Science Core Collection, ASSIA, IBSS, Sociological Abstracts, ProQuest and LILACS on the 26th February 2015. In addition, we searched: the grey literature; the websites of professional associations for relevant publications; and the reference lists of all publications reviewed. We also contacted authors of the trials included in the effectiveness reviews as well as of studies (potentially) included in the qualitative synthesis, conducted citation searches of the publications reporting these studies, and contacted content experts.

We reran the search on 3rd July 2016 and found three studies, which are awaiting classification.

Selection criteria:
We included qualitative studies that described: the circumstances in which protocols are designed, implemented or used, or both, and the views and experiences of healthcare professionals either involved in the design, implementation or use of weaning protocols or involved in the weaning of critically-ill adults and children from mechanical ventilation not using protocols. We included studies that: reflected on any aspect of the use of protocols, explored contextual factors relevant to the development, implementation or use of weaning protocols, and reported contextual phenomena and outcomes identified as relevant to the effectiveness of protocolized weaning from mechanical ventilation.

Data collection and analysis:
At each stage, two review authors undertook designated tasks, with the results shared amongst the wider team for discussion and final development. We independently reviewed all retrieved titles, abstracts and full papers for inclusion, and independently extracted selected data from included studies. We used the findings of the included studies to develop a new set of analytic themes focused on the barriers and facilitators to the use of protocols, and further refined them to produce a set of summary statements. We used the Confidence in the Evidence from Reviews of Qualitative Research (CERQual) framework to arrive at a final assessment of the overall confidence of the evidence used in the synthesis. We included all studies but undertook two sensitivity analyses to determine how the removal of certain bodies of evidence impacted on the content and confidence of the synthesis. We deployed a logic model to integrate the findings of the qualitative evidence synthesis with those of the Cochrane effectiveness reviews.

Main results:
We included 11 studies in our synthesis, involving 267 participants (one study did not report the number of participants). Five more studies are awaiting classification and will be dealt with when we update the review.

The quality of the evidence was mixed; of the 35 summary statements, we assessed 17 as ‘low’, 13 as ‘moderate’ and five as ‘high’ confidence. Our synthesis produced nine analytical themes, which report potential barriers and facilitators to the use of protocols. The themes are: the need for continual staff training and development; clinical experience as this promotes felt and perceived competence and confidence to wean; the vulnerability of weaning to disparate interprofessional working; an understanding of protocols as militating against a necessary proactivity in clinical practice; perceived nursing scope of practice and professional risk; ICU structure and processes of care; the ability of protocols to act as a prompt for shared care and consistency in weaning practice; maximizing the use of protocols through visibility and ease of implementation; and the ability of protocols to act as a framework for communication with parents.

Authors' conclusions:
There is a clear need for weaning protocols to take account of the social and cultural environment in which they are to be implemented. Irrespective of its inherent strengths, a protocol will not be used if it does not accommodate these complexities. In terms of protocol development, comprehensive interprofessional input will help to ensure broad-based understanding and a sense of ‘ownership’. In terms of implementation, all relevant ICU staff will benefit from general weaning as well as protocol-specific training; not only will this help secure a relevant clinical knowledge base and operational understanding, but will also demonstrate to others that this knowledge and understanding is in place. In order to maximize relevance and acceptability, protocols should be designed with the patient profile and requirements of the target ICU in mind. Predictably, an under-resourced ICU will impact adversely on protocol implementation, as staff will prioritize management of acutely deteriorating and critically-ill patients.

Assessment of Intervention Fidelity and Recommendations for Researchers Conducting Studies on the Diagnosis and Treatment of Chronic Cough in the Adult: CHEST Guideline and Expert Panel Report

BACKGROUND: Successful management of chronic cough has varied in the primary research studies in the reported literature. One of the potential reasons relates to a lack of intervention fidelity to the core elements of the diagnostic and/or therapeutic interventions that were meant to be used by the investigators.

METHODS: We conducted a systematic review to summarize the evidence supporting intervention fidelity as an important methodologic consideration in assessing the effectiveness of clinical practice guidelines used for the diagnosis and management of chronic cough. We developed and used a tool to assess for five areas of intervention fidelity. Medline (PubMed), Scopus, and the Cochrane Database of Systematic Reviews were searched from January 1998 to May 2014. Guideline recommendations and suggestions for those conducting research using guidelines or protocols to diagnose and manage chronic cough in the adult were developed and voted upon using CHEST Organization methodology.

RESULTS: A total of 23 studies (17 uncontrolled prospective observational, two randomized controlled, and four retrospective observational) met our inclusion criteria. These articles included 3,636 patients. Data could not be pooled for meta-analysis because of heterogeneity. Findings related to the five areas of intervention fidelity included three areas primarily related to the provider and two primarily related to the patients. In the area of study design, 11 of 23 studies appeared to be underpinned by a single guideline/protocol; for training of providers, two of 23 studies reported training, and zero of 23 reported the use of an intervention manual; and for the area of delivery of treatment, when assessing the treatment of gastroesophageal reflux disease, three of 23 studies appeared consistent with the most recent guideline/protocol referenced by the authors. For receipt of treatment, zero of 23 studies mentioned measuring concordance of patient-interventionist understanding of the treatment recommended, and zero of 23 mentioned measuring enactment of treatment, with three of 23 measuring side effects and two of 23 measuring adherence. The overall average intervention fidelity score for all 23 studies was poor (20.74 out of 48).

CONCLUSIONS: Only low-quality evidence supports that intervention fidelity strategies were used when conducting primary research in diagnosing and managing chronic cough in adults. This supports the contention that some of the variability in the reporting of patients with unexplained or unresolved chronic cough may be due to lack of intervention fidelity. By following the recommendations and suggestions in this article, researchers will likely be better able to incorporate strategies to address intervention fidelity, thereby strengthening the validity and generalizability of their results that provide the basis for the development of trustworthy guidelines.

On the Privacy of Encrypted Skype Communications

The privacy of voice over IP (VoIP) systems is achieved by compressing and encrypting the sampled data. This paper investigates in detail the leakage of information from Skype, a widely used VoIP application. In this research, it has been demonstrated by using the dynamic time warping (DTW) algorithm, that sentences can be identified with an accuracy of 60%. The results can be further improved by choosing specific training data. An approach involving the Kalman filter is proposed to extract the kernel of all training signals.

Minimising the Execution of Unknown Bag-of-Task Jobs with Deadlines on the Cloud

Scheduling jobs with deadlines, each of which defines the latest time that a job must be completed, can be challenging on the cloud due to incurred costs and unpredictable performance. This problem is further complicated when there is not enough information to effectively schedule a job such that its deadline is satisfied, and the cost is minimised. In this paper, we present an approach to schedule jobs, whose performance are unknown before execution, with deadlines on the cloud. By performing a sampling phase to collect the necessary information about those jobs, our approach delivers the scheduling decision within 10% cost and 16% violation rate when compared to the ideal setting, which has complete knowledge about each of the jobs from the beginning. It is noted that our proposed algorithm outperforms existing approaches, which use a fixed amount of resources by reducing the violation cost by at least two times.

The U.N. convention on the rights of the child: Relevance and application to pediatric clinical bioethics

This article provides an overview of the relevance and import of the U.N. Convention on the Rights of the Child (CRC) to child health practice and pediatric bioethics. We discuss the four general principles of the CRC that apply to the implementation of all rights contained in the document, the right to health articulated in Article 24, and the important position ascribed to parents in fulfilling the rights of their children. We then examine how the CRC is implemented and monitored in law and practice. The CRC and associated principles of child rights provide strategies for rights-based approaches to clinical practice and health systems, as well as to policy design, professional training, and health services research. In light of the relevance of the CRC and principles of child rights to children’s health and child health practice, it follows that there is an intersection between child rights and pediatric bioethics. Pediatric bioethicists and child rights advocates should work together to define this intersection in all domains of pediatric practice.

Investigating high-achieving sixth grade students' erroneous answers on the angle concept in Yozgat

The angle concept is a multifaceted concept having static and dynamic definitions. The static definition of the angle refers to “the space between two rays” or “the intersection of two rays at the same end point” (Mitchelmore & White, 1998), whereas the dynamic definition of the angle concept highlights that the size of angle is the amount of rotation in direction (Fyhn, 2006). Since both definitions represent two diverse situations and have unique limitations (Henderson & Taimina, 2005), students may hold misconceptions about the angle concept. In this regard, the aim of this research was to explore high achievers’ knowledge regarding the definition of the angle concept as well as to investigate their erroneous answers on the angle concept.

104 grade 6 students drawn from four well-established elementary schools of Yozgat, Turkey were participated in this research. All participants were selected via a purposive sampling method and their mathematics grades were 4 or 5 out of 5, and. Data were collected through four questions prepared by considering the learning competencies set out in the grade 6 curriculum in Turkey and the findings of previous studies whose purposes were to identify students’ misconceptions of the angle concept. The findings were analyzed by two researchers, and their inter-rater agreement was calculated as 0.91, or almost perfect. Thereafter, coding discrepancies were resolved, and consensus was established.

The angle concept is a multifaceted concept having static and dynamic definitions.The static definition of the angle refers to “the space between two rays” or“the intersection of two rays at the same end point” (Mitchelmore & White, 1998), whereas the dynamicdefinition of the angle concept highlights that the size of angle is the amountof rotation in direction (Fyhn, 2006). Since both definitionsrepresent two diverse situations and have unique limitations (Henderson & Taimina, 2005), students may holdmisconceptions about the angle concept. In this regard, the aim of thisresearch was to explore high achievers’ knowledge regarding the definition ofthe angle concept as well as to investigate their erroneous answers on theangle concept.

New Method Based on the UNIFAC–VISCO Model for the Estimation of Ionic Liquids Viscosity Using the Experimental Data Recommended by Mathematical Gnostics

The viscosity of ionic liquids (ILs) has been modeled as a function of temperature and at atmospheric pressure using a new method based on the UNIFAC–VISCO method. This model extends the calculations previously reported by our group (see Zhao et al. J. Chem. Eng. Data 2016, 61, 2160–2169) which used 154 experimental viscosity data points of 25 ionic liquids for regression of a set of binary interaction parameters and ion Vogel–Fulcher–Tammann (VFT) parameters. Discrepancies in the experimental data of the same IL affect the quality of the correlation and thus the development of the predictive method. In this work, mathematical gnostics was used to analyze the experimental data from different sources and recommend one set of reliable data for each IL. These recommended data (totally 819 data points) for 70 ILs were correlated using this model to obtain an extended set of binary interaction parameters and ion VFT parameters, with a regression accuracy of 1.4%. In addition, 966 experimental viscosity data points for 11 binary mixtures of ILs were collected from literature to establish this model. All the binary data consist of 128 training data points used for the optimization of binary interaction parameters and 838 test data points used for the comparison of the pure evaluated values. The relative average absolute deviation (RAAD) for training and test is 2.9% and 3.9%, respectively.