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Clinical relevance The Keratoconus International Consortium (KIC) will allow better understanding of keratoconus. Background Keratoconus is a disorder characterised by corneal elevation and thinning, leading to reduced vision. The current gaps in understanding of this disease will be discussed and the need for a multi-pronged and multi-centre engagement to enhance our understanding of keratoconus will be highlighted. Design KIC has been established to address the gaps in our understanding of keratoconus with the aim of collecting baseline as well as longitudinal data on several fields. Participants Keratoconus and control (no corneal condition) subjects from different sites globally will be recruited in the study. Methods KIC collects data using an online, secure database, which enables standardised data collection at member sites. Data fields collected include medical history, clinical features, quality of life and economic burden questionnaires and possible genetic sample collection from patients of different ethnicities across different geographical locations. Results There are currently 40 Australian and international clinics or hospital departments who have joined the KIC. Baseline data has so far been collected on 1130 keratoconus patients and indicates a median age of 29.70 years with 61% being male. A total of 15.3% report a positive family history of keratoconus and 57.7% self-report a history of frequent eye rubbing. Conclusion The strength of this consortium is its international, collaborative design and use of a common data collection tool. Inclusion and analyses of cross-sectional and longitudinal data will help answer many questions that remain in keratoconus, including factors affecting progression and treatment outcomes.

A multi-centre clinical trial involves the implementation of the same clinical protocol at several independent investigational centres. Multi-centre clinical trials may be preferable to single-centre trials, but their implementation and management is more complex. EU-funded collaborative projects involve several participating organizations and countries and their consortia are typically multidisciplinary. Their coordination requires a joint effort from several actors, and an appropriate managerial structure and procedures need to be defined and established. The management of the Framework Programme 7 (FP7) PREVIEW project, whose core consisted of a clinical trial with 8 intervention centres/sites is presented as case study. PREVIEW was coordinated by the University of Copenhagen. The project management was implemented by a combination of decentralised project management, at the department level, jointly by the Project Coordinator (PC) and Project Manager (PM), and centralised, by a dedicated EU Liaison Officer from the Project Management Office (PMO). The Quality Manager role was undertaken by the PC, with support from selected consortium members. The Exploitation Manager role was assumed by the leader of the dissemination and exploitation work package. The Data Manager (DM) at the University of Copenhagen established and maintained a datahub for all data from the clinical trial. The General Assembly and Steering Committee were key decision bodies with regard to taking and implementing decisions. The Scientific Advisory Board (SAB) was formed by reputed external experts providing guidance and advice. The project website was the main channel to reach the general public. A password protected private section was used as internal repository for the project. Regular meetings at all levels were key to ensure good communication and collaboration among the project team. Appropriate attention to data management was given from the start. The privacy of personal data was ensured in accordance with national and EU regulations. The PC was also the Sponsor of the multicentre clinical trial, and the PM served as the overall Clinical Trial Administrator. Each centre was led by a Principal Investigator (PI), running the trial together with the local daily responsible. The tasks and responsibilities for the clinical trial of the Coordinating Centre were shared between Copenhagen and Helsinki centres. The trial was overall led by the Clinical Trial Manager (CTM), who was the PI at the Helsinki centre. The local Independent Ethical Committees approved the protocol prior to the start of the intervention. One member of the SAB acted as Ethical Officer. The trial/study had an overall statistician. The Analyst role was shared among different people from the Copenhagen and Helsinki centres. The DM created and maintained database for the intervention and the Clinical Report Forms by using OpenClinica open source software. The staff in the intervention received training in Good Clinical Practices, the protocol and its procedures. The monitoring tasks were jointly undertaken by the Sponsor and the CTM. The documents from the Trial Master File were saved in the Internal Repository. A set of Standard Operation Procedures was defined. Meetings among all Pis, and within the Instructors' Network were key in the success of the intervention. This case study aims at serving as guidance to coordinating researchers, both duringthe proposal preparation and project implementation phases, as well as to provide visibility and insight into the multi-faceted role of the project managers and administrators of such projects.

Background Parents of children with cancer experience a demanding situation and often suffer from psychological problems such as stress. Trying to coping with the complex body of information about their child’s disease is one factor that contributes to this stress. The aim of this study is to evaluate an intervention for person-centred information to parents of children with cancer that consists of four sessions with children’s nurses trained in the intervention method. Methods/Design This is a multi-centre RCT with two parallel arms and a 1:1 allocation ratio. The primary outcome is illness-related parental stress. Secondary outcomes are post-traumatic stress symptoms, anxiety, depression, satisfaction with information, expected and received knowledge, and experiences with health care providers. A process evaluation is performed to describe experiences and contextual factors. Data are collected using web questionnaires or paper forms according to the parents’ preference, audio recording of the intervention sessions, and qualitative interviews with parents and the intervention nurses. Discussion Few studies have evaluated information interventions for parents of children with cancer using large multi-centre RCTs. This intervention is designed to be performed by regular staff children’s nurses, which will facilitate implementation if the intervention proves to be effective. Trial registration Clinical trials NCT02332226 (December 11, 2014).

An open collaborative international network has been established which aims to improve inter-centre standards for collection of high-resolution, neurointensive care data on patients with traumatic brain injury. The group is also working towards the creation of an open access, detailed and validated database that will be useful for post-hoc hypothesis testing. In Part A, the underlying concept, the group coordination structure, membership guidelines and database access and publication criteria are described. Secondly, in part B, we describe a set of meetings funded by the EEC that allowed us to define a \"Core Dataset\" and we present the results of a feasibility exercise for collection of this core dataset. Four group meetings funded by the EEC have enabled definition of a \"Core Dataset\" to be collected from all centres regardless of specific project aim. A paper based pilot collection of data was conducted to determine the feasibility for collection of the core dataset. Specially designed forms to collect the core dataset demographic and clinical information as well as sample the time-series data elements were distributed by both email and standard mail to 22 BrainIT centres. A deadline of two months was set to receive completed forms back from centres. A pilot data collection of minute by minute physiological monitoring data was also performed. A core-dataset was defined and can be downloaded from the BrainIT web-site (go to \"Core dataset\" link at: www.brainit.org). Eighteen centres (82%) returned completed forms by the set deadline. Overall the feasibility for collection of the core data elements was high with only 10 of the 64 questions (16%) showing missing data. Of those 10 fields with missing data, the average number of centres not responding was 12% and the median 6%. An SQL database to hold the data has been designed and is being tested. Software tools for collection of the core dataset have been developed. Ethics approval has been granted for collection of multi-centre data as part of a pilot data collection study. The BrainIT network provides a more standardised and higher resolution data collection mechanism for research groups, organisations and the device industry to conduct multi-centre trials of new health care technology in patients with traumatic brain injury.

OBJECTIVES: To compare the practices of local research ethics committees and the time they take to obtain ethical approval for a multi-centre study. DESIGN: A retrospective analysis of outcome of applications for a multi-centre study to local research ethics committees. SETTING: Thirty-six local research ethics committees covering 38 district health authorities in England. MAIN MEASURES: Response of chairmen and women, the time required to obtain approval, and questions asked in application forms. RESULTS: We received replies from all 36 chairmen contacted: four (11%) granted their approval, and 32 (89%) required our proposal to be considered by their local research ethics committee. Three committees asked us to attend their meetings. The application was approved by all 36 local research ethics committees but the time to obtain ethical approval varied between six to 208 days. One third of the committees did not approve the project within three months, and three took longer than six months. There was considerable variation in the issues raised by local research ethics committees and none conformed exactly to the Royal College of Physicians' guidelines. CONCLUSION: Obtaining ethical approval for a multi-centre study is time-consuming. There is much diversity in the practice of local research ethics committees. Our data support the recommendation for a central or regional review body of multi-centre studies which will be acceptable to all local research ethics committees.

IntroductionCatheter use is associated with many complications and is an iatrogenic source of morbidity and mortality in intensive care units (ICU). The catheter being studied (Certofix Protect) was developed to reduce the risk of catheter related infections. This clinical trial will compare the safety and efficiency of Certofix Protect with that of an ordinary Certofix catheter.Methods and analysisIn this multicentre trial, we will randomly assigned dual lumen central venous catheterisation (≥5 ds) in patients in the adult ICU to the antimicrobial central venous catheter (CVC) group or the ordinary CVC group. We plan to recruit 12–16 medical centres in China. Our main objective is to assess the effectiveness of antimicrobial CVCs in reducing catheter related bloodstream infection (CRBSI), all cause mortality, catheter colonisation, catheter related thrombosis and other catheter related complications. The primary outcome is the incidence of CRBSI.Ethics and disseminationThe ethics committee of West China Hospital of Sichuan University has granted ethics approval for this study (27 January 2015). The results will be published in peer reviewed journals and presented at conferences.Trial registration number NCT02645682.

The result of extensive collaboration among leading scholars from across Europe, Conceptual History in the European Space represents a landmark intervention in the historiography of concepts. It brings together ambitious thematic studies that combine the pioneering methods of historian Reinhart Koselleck with contemporary insights and debates, each one illuminating a key feature of the European conceptual landscape. With clarifying overviews of such contested theoretical terrain as translatability, spatiality, and center-periphery dynamics, it also provides indispensable contextualization for an era of widespread disenchantment with and misunderstanding of the European project.

A trend toward decentralisation has meant that sub-national governments increasingly find themselves responsible for providing a host of public goods and services. Rarely, however, can they \"go it alone\". Co-ordination among levels of government is imperative. This book offers a unique analytic framework for assessing multi-level governance arrangements, which is subsequently applied to five case studies of regional development policy: Canada, France, Germany, Italy, and Spain. The book reveals the importance of contractual arrangements for customised management of interdependencies, for clarifying responsibilities among actors, for dialogue, and for learning.

Ralph J. Bunche (1904-1971), winner of the Nobel Peace Prize in 1950, was a key U.S. diplomat in the planning and creation of the United Nations in 1945. In 1947 he was invited to join the permanent UN Secretariat as director of the new Trusteeship Department. In this position, Bunche played a key role in setting up the trusteeship system that provided important impetus for postwar decolonization ending European control of Africa as well as an international framework for the oversight of the decolonization process after the Second World War.Trustee for the Human Communityis the first volume to examine the totality of Bunche's unrivalled role in the struggle for African independence both as a key intellectual and an international diplomat and to illuminate it from the broader African American perspective.These commissioned essays examine the full range of Ralph Bunche's involvement in Africa. The scholars explore sensitive political issues, such as Bunche's role in the Congo and his views on the struggle in South Africa.Trustee for the Human Communitystands as a monument to the profoundly important role of one of the greatest Americans in one of the greatest political movements in the history of the twentieth century.Contributors: David Anthony, Ralph A. Austen, Abena P. A. Busia, Neta C. Crawford, Robert R. Edgar, Charles P. Henry, Robert A. Hill, Edmond J. Keller, Martin Kilson, Georges Nzongola-Ntalaja, Jon Olver, Pearl T. Robinson, Elliott P. Skinner, Crawford Young