SEDENTEXCT Consortium Meeting

Radisson Blu Hotel

Malmö, Sweden

8 January 2010

Present: / Keith Horner (KH) / Project coordinator (UNIMAN)
Roberto Passalacqua (EC PO) / EC Project Officer
Gillian Armitt (GMA) / (UNIMAN) (secretary)
Hugh Devlin (HD) / (UNIMAN)
Chrysoula Theodorakou (CT) / (UNIMAN)
Kostas Tsiklakis (KT) / (NKUA)
Kety Karayianni (KK) / (NKUA)
Harry Stamatakis (HS) / (NKUA)
Anastasia Mitsea (AM) / (NKUA)
Sophia Gavala (SG) / (NKUA)
Mihaela Hedesiu (MH) / (CLUJ)
Mihaela Baciut (MB) / (CLUJ)
Reinhilde Jacobs (RJ) / (KUL)
Ria Bogaerts (RB) / (KUL)
Olivia Nackaerts (ON) / (KUL)
Ruben Pauwels (RP) / (KUL)
Guozhi Zhang (GZ) / (KUL)
Christina Lindh (CL) / (MAHOD)
Madeleine Rohlin (MR) / (MAHOD)
Helena Christell (HC) / (MAHOD)
Deimante Ivanauskaite (DI) / (VU)
Ausra Urboniene (AU) / (VU)
Apologies / Vivian Rushton / (UNIMAN)
Anne-Marie Glenny / (UNIMAN)
Gareth Hughes / (UNIMAN)
Ian Jacob / (UNIMAN)
Anne Walker / (UNIMAN)
Adrian Walker / (LTO)
Mats Nilsson / (MAHOD)

1. Welcome and apologies

KH welcomed meeting attendees and introduced the new EC Project Officer, Roberto Passalacqua, to the group. Apologies were presented as above.

2. Minutes of Amsterdam meeting 27 June 2009

2i Matters arising

The minutes were accepted.

Proposed external workshop at the end of the project: KH reported that funding was necessary but he had not been able to progress this. The EC PO suggested that the event be funded through participation/registration fees from attendees. However, he reminded the group that the project is non-profit-making therefore any profit from the workshop must be deducted from the last payment. KH proposes to approach EADMFR with a view to a joint workshop.

ACTION: KH

Public deliverables:

GMA asked for the EC Project Officer’s advice on public deliverables, where some material should be confidential until published in academic journals / conferences. It was agreed that in these cases, the main part of the deliverable should be public and any work deemed confidential should be provided to the Commission separately as an appendix.

ACTION: Partners to note

3. Information from the European Commission

The EC PO commented that the project is well-balanced in terms of partners and that the principle of justification in WP1 is important to the EC. His own role is to monitor and assess the results of the project. He read a paragraph from the proceedings of an EC Parliament Committee, which stressed the importance of efficiency with regard to costs in Framework projects. He also commented that the Anti-Fraud Office of the EC is concerned about the genuineness of work within projects. He asked the Consortium to pay attention to any possible risk of double funding of the same work for different projects.

ACTION: Partners to note

The EC PO drew the Consortium’s attention to a call to be released in April, concerning Euratom cooperation with China. This is important to the EC as China in exchange will provide data on individuals exposed to ionising radiation.

ACTION: Partners to note

4. WP0 project management report

4.1 Progress

GMA gave a report on Workpackage 0, which can be found on the project intranet. Workpackage 0 is on schedule. The Consortium noted that matters related to dissemination and impact (also WP0) would be covered under agenda item 11.

It was noted that person-months to Month 18 were lower than originally planned in WPs 0, 2, 5 and 6, owing to the late appointment of staff reported in the Year 1 Annual Report. Staff are now in place and the gap (planned – actual) will narrow during the rest of the project.

Partners were asked to note that the next quarterly progress monitoring report, covering the period 1 January – 31 March 2010, is due on 30 April.

ACTION: Partners to note

DI explained the difficulties achieving ethical approval in Vilnius. Ethical approval has now been granted.

It was noted that a further review of the Communication Action Plan will take place in Q1 2010, to incorporate planning for dissemination of the website and SEDENTEXCT training.

ACTION: GMA

4.2 Issues resolved and outstanding – project overview

The project is now on target with minor deviations, following the completion of staffing appointments. An issue concerning the source of developer expertise in WP3 was referred to the Project Coordinator and resolved.

A possible change to the DoW concerning further validation of the proposed standardised dose indices has been referred to the Project Coordinator. Following discussion with the EC PO, KH will write to the Commission to explain what is intended and why a change to the DoW may not be required.

ACTION: KH

Delays in patient recruitment have affected WPs 2, 4 and 5 (see agenda items 6, 8 & 9).

4.3 Electronic submission of Form C

The Consortium noted that partners will have to submit their own Form Cs electronically using the ECAS system, as well as providing paper copies for the Commission. Further details about what to do are available at ftp://ftp.cordis.europa.eu/pub/fp7/docs/presentation-force_en.pdf (NB underscore before .en.pdf).

Partners should notify GMA of who in their institution will perform the electronic submission, and GMA will then contact them regarding access.

ACTION: Partners

The following deadlines for preparation of Form C will apply:

Excel spreadsheet to GMA for checking: / 20 January 2010
Enter electronic data on ECAS: / 31 January
Final checking (UNIMAN) and amendments to ECAS and paper versions (partners): / Before 15 February
Send paper copies of Form C to GMA: / 15 February

ACTION: GMA, partners

4.4 QUEST system – upload of deliverables

The EC PO requested that deliverables are uploaded into the QUEST system. He will send a link.

ACTION: Roberto Passalacqua

5. WP1 report

5.1 Progress

KH gave a report on Workpackage 1, which can be found on the project intranet. Workpackage 1 is on schedule.

5.2 Forward planning

Partners were asked to note that work on the development of definitive Guidelines may start a little earlier than June 2010 (Milestone 1.6: start of definitive Guideline development). This may lead to a further interim version of the Guidelines. Other key dates can be found in the presentation.

It was agreed that a wider range of professionals be involved in reviewing the Guidelines, e.g. orthodontists. KH will email partners for suggestions.

ACTION: KH, partners

The Definitive Guidelines will be reviewed by EADMFR members (subject to EADMFR approval) using a Delphi process. MR asked whether this was going against the philosophy of “evidence-based” guidelines. KH indicated that the Delphi process consultation would only relate to guidelines for which the evidence base was deficient.

RJ proposed links with the European Association for Osseointegration, who are developing guidelines on implantology. KT will present the SEDENTEXCT Guidelines in Athens in September 2011. KH requested partner proposals for national organisations to whom the Guidelines should be disseminated.

ACTION: Partners

6. Workpackage 2 report

6.1 Progress

RB and CT presented a report on WP2 (RB: tasks 2.1, 2.2 and 2.3; CT: tasks 2.4 and 2.5). The presentation is available on the project intranet.

6.2 Issues resolved and outstanding

The Consortium noted that, while the workpackage is on schedule, there is a small delay of (from Month 24 to M26) in the scatter dose measurements at UNIMAN.

A key decision was made that the plexiglass phantom should be ‘simple’ rather than risk-related, i.e. the phantom will not model different organs such as the thyroid.

Problems with patient recruitment in WP2.3 have been handled by widening the ranges for Body Mass Index (BMI) and age.

The Consortium noted the proposed change in the DoW to extend the validation of the dose indices (see agenda item 4). This will require a new phantom for validation, based on the existing phantom design.

ACTION: LTO to note

6.3 Cancer risk from CBCT

The EC PO commented that the x-ray dose from CBCT, as shown in the presentations, is too low for a linear extrapolation of cancer risk to be made. KH and others responded that the linear model is that advocated by the International Commission on Radiological Protection and that we must follow it. The PO further commented that the LNT hypothesis remains a prudent basis for radiation protection at low doses and low dose rates (i.e. for the definition of measures to reduce the risk of exposure of public and workers to ionizing radiation), but it is not a tool meant to assess the cancer risk in terms of expected casualties. Therefore any use of the LNT model for assessment and comparison of the relative risk associated to a specific application, as for example the CBCT, should mention the lack of experimental evidence of this linear extrapolation to low doses.

7. Workpackage 3 report

7.1 Progress

KT presented the project management/WP3.1 report, and RP presented the WP3.2 report. These can be found on the project intranet. Workpackage 3 is on schedule.

8. WP4 report

8.1 Progress

RJ presented a report on WP4, which is available on the project intranet.

8.2 Issues resolved and outstanding

Milestone M4.3 is delayed from Month 18 to Month 28. The comparison with μCT and the root lesions work is on-going. The delay does not affect other parts of the project.

In WP4.3, there are difficulties in recruiting enough patients with impacted canines, so a decision has been taken to recruit non-surgical as well as surgical cases. There are also difficulties in recruiting enough patients with sinus grafts. This is being handled by widening the protocol for recruitment.

9. WP5 report

9.1 Progress

CL presented the project management/WP5 report, and HC presented a report on the results of the cost analysis. Both reports can be found on the project intranet.

9.2 Issues resolved and outstanding

There is a small delay in Milestone M5.2, due Month 24.

There are delays in Milestone M5.3 due to slow recruitment of patients and difficulties in transferring images to MAHOD for analysis. Patient recruitment is continuing and UNIMAN will start to contribute patients shortly (now that UNIMAN has a CBCT). Target numbers will be reached for three of the four proposed clinical situations. Recruitment for the fourth clinical use of CBCT (TMJ imaging) will be discontinued. The remaining three (impacted canine, impacted third molar and implant assessment) are excellent representative clinical uses as the span the age groups of use of CBCT (child, young adult and older adults, respectively). This is entirely consistent with the WP deliverables. The issue with image transfer is being addressed, with two viable options being considered. The delay does not affect other parts of the project.

There is a delay in the observer work in Milestone M5.4 (due Month 21), two out of five radiologists have assessed the radiographs. Completion is now scheduled for Month 27. The delay does not affect other parts of the project.

Milestone M5.5 is also delayed, with regard to the follow-up work on the diagnosis and treatment of the patients with retained canines, wisdom teeth and implants. Work on retained canines will now be completed at Month 30, and work on wisdom teeth and implants at Month 32. The delay does not affect other parts of the project.

To note: Milestone M5.6 concerns the use of WP2 dosimetry data in WP5, but this is no longer required as the cancer risk is so low.

10. WP6 report

10.1 Progress

HD and GMA gave a presentation on WP6, which may be found on the project intranet.

10.2 Issues resolved and outstanding

The appointment in March 2009 of Gareth Hughes as developer has enabled us to catch up time on the delays reported at the end of Year 1.

The launch of pre-definitive website (Deliverable D6.2/Milestone 6.5) was rescheduled by agreement with the previous EC Project Officer to Month 27. Although the website is technically ready, it requires more scientific content (wiki, training materials, active discussion forum). This deliverable / milestone is now scheduled for completion at Month 30. An action plan leading to the formal launch of the website at Month 30 was drawn up at the WP6 meeting in Malmo on 7th January and the work will be overseen by the WP6 core team meeting monthly under the direction of the Project Coordinator.

There is also an issue with interpretation of DICOM software to generate 3D images, the extent of which is currently unclear.

10.3 Website content – CBCT machines

It was agreed that SEDENTEXCT should provide comparative details on CBCT machines and act as a portal to manufacturers’ websites.

ACTION: WP core team

11. Dissemination and Impact

11.1 Progress

KH gave a presentation on dissemination, impact and KPIs, which may be found on the project intranet. There are no issues or delays.

11.2 SEDENTEXCT newsletter

KH will develop the next newsletter during January. The following actions were noted:

·  WP reports of 100 – 150 words are required, describing what has happened in the last six months. Please send images for the newsletter, if ethical to do so. Staff new to the project (GZ, AU, SG and Ian Jacob) were requested to send a personal profile describing why the project is important to them, plus a photo.

·  All partners were requested to send abstracts from scientific meetings where SEDENTEXCT work had been presented,, where one had been required for the conference or journal.

·  Partners were requested to send photos of meetings

ACTION: Partners

The EC PO agreed to provide a photo and around 50 words on his background.

ACTION: Roberto Passalacqua

11.3 Languages on website

KH expressed concerns that not all the targeted website users would be able to read English, though resources do not allow a multi-language site. The EC PO suggested that a short summary could be produced each month in different languages (“language of the month”).

ACTION: WP6 core team

11.4 EADMFR 2010

The deadline for abstracts for EADMFR in Istanbul is 22 January.

ACTION: Partners to note

12. AOB

12.1 Expert Group 31 consultation

KH reported that Expert Group 31 has released a document for consultation (Radiation Criteria for Acceptability of Medical Radiological Equipment Used in Diagnostic Radiology, Nuclear Medicine and Radiotherapy, update of European Commission publication Radiation Protection 91, 1997.), but it contains nothing on CBCT. KH has contacted the Group and made an offer for SEDENTEXCT to contribute. This will be good for project impact. A response will be needed before 30 June. He particularly needs inputs from the physicists – CT, RB, Hilde Bosmans etc.