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The SCOOP Study

The SCOOP Study. Lee Shepstone. A Brief History of SCOOP. 2 002 Local Modelling 2 002 Outline application to the arc ( £ 580 000 ) 2 003 Invitation to submit full application 2 004 Full application submitted with Sheffield (£ 1 200 000 ) 2 004 Yes.. but no… here’s £200 000

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The SCOOP Study

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  1. The SCOOP Study Lee Shepstone

  2. A Brief History of SCOOP 2002 Local Modelling 2002 Outline application to the arc (£580 000) 2003 Invitation to submit full application 2004 Full application submitted with Sheffield (£1 200 000) 2004 Yes.. but no… here’s £200 000 2005 Start the Pilot 2006 Full application to MRC (£4 280 283) 2007 Start of Full Scale Study February – Funding starts June – First Trial Steering Committee Meeting September – Ethical Approval Received

  3. A Brief Future of SCOOP 2008 Start the Recruitment 2009 Screening Complete 2009 – 2014 Watch and wait 2014 SCOOP ends – analyze and write up. A change in NHS policy ?

  4. The SCOOP Study What are we doing? “Does a community based screening program reduce the incidence of fractures, and is it cost-effective, in older women?”

  5. The SCOOP Study What are we doing? A pragmatic, 7 centre, 7 year, randomised controlled trial

  6. Funding £££ Medical Research Council : 3 754 703Arthritis Research Campaign : 380 000NHS Transitional Funds : 96 720Department of Health Ad Hoc Levy : 72 540Department of Health Excess Treatment Costs: 994 488UK Comprehensive Research Network : 1 815 517

  7. Management Trial Steering Committee Data Monitoring Committee Chief Investigator (LS)Trial Manager (EL) Joint Trial Management Group Local PI Local Trial Co-ordinator Local Trial Management Groups

  8. Recruitment Aiming for 11 580 recruitedInvitation to 50 350 over 3 recruitment phases Start January 2008 finish June 2009.

  9. Recruitment Identified through primary careFemaleAged 70 to 85Not currently on prescription medication for osteoporosisNot deemed inappropriate for research

  10. Recruitment Invited to join by letter (with reminder)Invite questionnaire with decline and consent forms(Uptake ~20%-30%)Baseline questionnaires Valid respondents to be randomised to Screening or Control

  11. Screening Based upon the WHO risk toolAll subjects to complete the risk questionnaire at baselineAround 60% of Screening arm to DXAUpdate 10 year fracture riskRecommend treatment as appropriate

  12. Follow-Up A minimum of 5 years follow-up Primary End-point:All fractures(18% reduction, around 1000 fractures in total) Secondary End-points:Hip fracturesQuality of LifeMortality (Anticipating 20% mortality overall)

  13. Follow-Up At what Cost? Implementation of screening, including DXA scans Cost of treatment Cost of fractures Psychological Distress

  14. Add-on Studies Treatment Adherence (Amanda Howe) Collection of Blood (Sue Fairweather-Tait)

  15. What next?

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