Communication strategy
(s’ouvre dans une nouvelle fenêtre)
A plan will be delivered as to how communication with the public, e.g. with a web-site, press releases and newsletters will be put into effect. Policy makers and regulators are also a target audience and particular strategies for communication with them will also be described.
Project Data Management Plan
(s’ouvre dans une nouvelle fenêtre)
A project management handbook will be prepared which sets out the internal communication plan, meeting schedules and expectations of partners to support the described project management processes.
A report on the economic evaluation and social impact of the two-stage procedure for aortic aneurysm repair
(s’ouvre dans une nouvelle fenêtre)
If available, the publication resulting from the economic evaluation and social impact of the staged coiling procedure will be delivered. If it is not yet available, a sketch of the economic model to be used will be provided along with a discussion of planned sensitivity analyses and a basic description of the data to be used.
Ethical guidance document
(s’ouvre dans une nouvelle fenêtre)
A discussion of ethical questions ranging from the risk/benefit considerations of the coiling and waiting period after staging to dealing with incidental findings in CT/MRI scans will be presented in this report. The standpoint of the Trial Steering Committee, the ethics boards and the competent authorities will be presented.
Screening, Recruitment and Randomisation (1st 25 patients)
(s’ouvre dans une nouvelle fenêtre)
A report documenting the Screening, Recruitment and Randomisation will be submitted after the first 25 patients have been enroled in the trial
End of Project Conference Material
(s’ouvre dans une nouvelle fenêtre)
The scientific programme will be delivered along with lists of members of the organizing/scientific committees.
A report on the economic framework for the assessment of the two-stage procedure for aortic aneurysm repair
(s’ouvre dans une nouvelle fenêtre)
A list of the papers reviewed for developing the economic framework will be provided. The variables considered most relevant for the economic models will be listed and the questionnaires devloped here will be submitted. If a publication from this WP has already been accepted, it will be provided and may replace some of the aforementioned items.
Statistical Analysis Plan
(s’ouvre dans une nouvelle fenêtre)
A first draft of the Statistical Analysis Plan will be delivered. This document provides detailed information about the statistical analyses and models to be used for drawing inferences from the data.
PAPA-ARTiS Project Management Handbook
(s’ouvre dans une nouvelle fenêtre)
PAPA-ARTiS Project Management Handbook ‐ including programme of meetings, communication processes and roles and responsibilities of partners
Patient involvement
(s’ouvre dans une nouvelle fenêtre)
Interest groups including patients of different levels of risk and socio-demographic characteristics and their relatives will be located and described. A report detailing the size and frequency of physical and/or online meetings with these groups will be provided. A description of how their input will be incorporated into broader (economic) analyses will be given. Cross-pollination between this WP and communication/dissemination work will be discussed.
Links with existing projects/professional bodies
(s’ouvre dans une nouvelle fenêtre)
A list of existing, planned and potential links with existing projects/professional bodies will be provided.
Clinical Trial Data Management plan
(s’ouvre dans une nouvelle fenêtre)
The Clinical Data Management Plan is a document that describes which clinical data will be acquired and how it will be handled, stored, checked for consistency and plausibility, cleaned, and made available for the final analysis. The document will also describe how the data will be preserved after end of the project, and possibly made available for further research.
