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GRACE WP9/10 Inclusion & data gathering last season

GRACE WP9/10 Inclusion & data gathering last season. GRACE Meeting, Cambridge, September 18, 2008. GRACE WP9-10 Recruitment. Observed vs Target Recruitment Overall. Status after season 1: 1692 inclusions (56% of target). GRACE WP9-10 Recruitment.

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GRACE WP9/10 Inclusion & data gathering last season

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  1. GRACE WP9/10Inclusion & data gatheringlast season GRACE Meeting, Cambridge, September 18, 2008

  2. GRACE WP9-10Recruitment Observed vs Target Recruitment Overall Status after season 1: 1692 inclusions (56% of target)

  3. GRACE WP9-10Recruitment Observed vs Target Recruitment per Network

  4. GRACE WP9-10 Inclusion status after season 1

  5. GRACE WP9-10Overall inclusion rates per week Best week: 101 inclusions (target+17%)

  6. GRACE WP9-10Original plan Planned start date WP9-10: 2 October 2007 Planned inclusion period: 2 winter seasons (October-April) Sites: 13 GP Networks Target: 3000 patients & 3000 controls > 2 Oct: 1st GRACE inclusion in Antwerp

  7. GRACE WP9-10 Start-up First inclusion per network Network WP9 WP10 A: Cardiff 10 Oct 07 15 Nov 07 B: Southampton 10 Dec 07 02 Jan 08 C: Utrecht 26 Nov 07 03 Dec 07 D: Barcelona 26 Nov 07 Week 14 ’08 (Apr) E: Mataro 08 Oct 07 14 Jan 08 F: Rotenburg 11 Oct 07 Not started G: Balatonfured Not started Not started H: Antwerp 02 Oct 07 07 Dec 07 I: Lodz 04 Feb 08 04 Feb 08 J: Milan 21 Nov 07 Not started K: Jonkoping 10 Dec 07 07 Feb 08 Not started N: Bratislava Not started O: Ghent 14 Jan 08 14 Jan 08

  8. Active networks (max 13)

  9. Start GRACE season 2 • Hungary cannot participate (no approval) • Germany & Milano can also start WP10 • Slovakia can start WP9 & 10 & NEW NETWORKS

  10. New networks season 2 1. Nice (France) NNC: Dr. Pia Touboul 2. Szczecin (Poland) NNC: Dr. Arthur Mierzecki 3. Bialystok (Poland) NNC: Prof. Slawomir Chlabicz 4. Jesenice (Slovenia) NNC: Prof. Janko Kersnik

  11. New network capacity Slovenia will aim to recruit 300 patients & 300 controls France & the new Polish networks will aim to recruit 150 patients & 150 controls each Final result: 13-1(Hungary)+2.5=14.5 netw Network capacity: + 11%

  12. Months inclusion corrected for active networks Season: Oct – April (7 months) Planned for season 1: 13 (networks) x 7 = 91 Realisation for season 1: 63 (wp9) 34 (wp10) Planned for season 2: 14.5 (networks) x 7 = 101 (+ 50%!)

  13. % of patients included in WP10 Actual overall status: 52% (450 wp10 vs 412 wp9)

  14. Elderly Target: 50%

  15. Results questionnaire: How to improve our inclusion rates? **Target: 10 incl. per week for 30 weeks *Additional results based on combined questions

  16. In conclusion - We already did better in de 2nd part of season 1 • Network capacity: + 11% (13 14.5) • Ready to go (active months +50%) • Not only for WP9, but also for WP10 • More & more dedicated GPs Requirement: Focus on WP10 pts & elderly!

  17. GRACE WP9-10 Actual Data Entry Status V0 Status Controls (V0) > 15 days in study Data Entry relevant forms completed if 3 Surveys Per Subject are entered.

  18. GRACE WP9-10 Actual Data Entry Status V1 Status Patient (V1) > 15 days in study Data Entry relevant forms completed if 5 Surveys Per Subject are entered.

  19. GRACE WP9-10 Actual Data Entry Status V2 Status Patient (V2) > 50 days in study Data Entry relevant forms completed if 9 Surveys Per Subject are entered.

  20. GRACE WP9-10% X-rays for Patients Visit 1 (28-8-08) Network Total Number of V1 Patients % Chest X-ray A: Cardiff 75 ~96% B: Southampton 55 ~73% C: Utrecht 94 ~84% D: Barcelona 101 ~44%* E: Mataro 95 ~99% F: Rotenburg 96 ~80% G: Balatonfured 0 - H: Antwerp 118 ~97% I: Lodz 146 ~85% J: Milan 25 0%* K: Jönköping 30 ~90% N: Bratislava 0 - O: Ghent 27 ~93% Total 862 * No representative values due to data-entry backlog

  21. GRACE WP9-10% Diaries/tests for Patients Visit 2 (28-8-08) Network Number of V2 % Lung Function % Diary A: Cardiff 75 81 89 B: Southampton 55 85 89 C: Utrecht 94 85 81 D: Barcelona 101 51* 45* E: Mataro 95 91 99 F: Rotenburg 96 88 88 G: Balatonfured - - - H: Antwerp 118 86 91 I: Lodz 146 82 41? J: Milan 25 4* 0* K: Jönköping 30 77* 87* N: Bratislava - - - O: Ghent 27 59* 52* Total 862 * No representative values due to data-entry backlog

  22. GRACE WP10Number of Cases Unblinded Actual status: 12 out of 450 WP10 cases are unblinded (2.7%)

  23. GRACE WP9-10Serious Adverse Events Actual status: 862 WP9 &10 cases, 8 SAEs reported (0.93%)

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