The The SCOOPSCOOP Study Study

Lee ShepstoneLee Shepstone

A Brief History of A Brief History of SCOOPSCOOP

22002 Local Modelling002 Local Modelling

22002 Outline application to the 002 Outline application to the arcarc ((££580 000580 000))

22003 Invitation to submit full application003 Invitation to submit full application

22004 Full application submitted with Sheffield 004 Full application submitted with Sheffield (£(£1 200 0001 200 000))

22004 Yes.. but no… here’s £200 000004 Yes.. but no… here’s £200 000

22005 Start the Pilot005 Start the Pilot

22006 Full application to MRC006 Full application to MRC (£(£4 280 2834 280 283))

22007 Start of Full Scale Study 007 Start of Full Scale Study February – Funding startsFebruary – Funding startsJune – First Trial Steering Committee MeetingJune – First Trial Steering Committee MeetingSeptember – Ethical Approval ReceivedSeptember – Ethical Approval Received

A Brief Future of A Brief Future of SCOOPSCOOP

22008 Start the Recruitment008 Start the Recruitment

22009 Screening Complete009 Screening Complete

22009 – 2014 Watch and wait009 – 2014 Watch and wait

22014 014 SCOOPSCOOP ends – analyze and write up. ends – analyze and write up.

AA change in NHS policy ? change in NHS policy ?

The The SCOOPSCOOP Study Study

What are we doing?What are we doing?

““Does a community based screening program Does a community based screening program reduce the incidence of fractures, and is it cost-reduce the incidence of fractures, and is it cost-

effective, in older women?”effective, in older women?”

The The SCOOPSCOOP Study Study

What are we doing?What are we doing?

A pragmatic, 7 centre, 7 year, randomised A pragmatic, 7 centre, 7 year, randomised controlled trial controlled trial

FundingFunding

££££££

MMedical Research Council :edical Research Council : 3 754 7033 754 703

AArthritis Research Campaign :rthritis Research Campaign : 380 000380 000

NNHS Transitional Funds :HS Transitional Funds : 96 72096 720

DDepartment of Health epartment of Health Ad HocAd Hoc Levy : Levy : 72 54072 540

DDepartment of Health Excess Treatment Costs:epartment of Health Excess Treatment Costs: 994 488994 488

UUK Comprehensive Research Network :K Comprehensive Research Network : 1 815 5171 815 517

ManagementManagement

Trial Steering Committee

Data Monitoring Committee

Joint Trial Management Group

Local Trial Management Groups

Local PI Local Trial Co-ordinator

Chief Investigator (LS)Trial Manager (EL)

RecruitmentRecruitment

AAiming for 11 580 recruitediming for 11 580 recruitedInvitation to 50 350 over 3 recruitment phasesInvitation to 50 350 over 3 recruitment phases

SStart January 2008 finish June 2009.tart January 2008 finish June 2009.

RecruitmentRecruitment

IIdentified through primary caredentified through primary careFemaleFemaleAged 70 to 85Aged 70 to 85Not currently on prescription medication for osteoporosisNot currently on prescription medication for osteoporosisNot deemed inappropriate for research Not deemed inappropriate for research

RecruitmentRecruitment

IInvited to join by letter (with reminder)nvited to join by letter (with reminder)Invite questionnaire with decline and consent formsInvite questionnaire with decline and consent forms(Uptake ~20%-30%)(Uptake ~20%-30%)Baseline questionnairesBaseline questionnaires

VValid respondents to be randomised to Screening or Controlalid respondents to be randomised to Screening or Control

ScreeningScreening

BBased upon the WHO risk toolased upon the WHO risk toolAll subjects to complete the risk questionnaire at baselineAll subjects to complete the risk questionnaire at baselineAround 60% of Screening arm to DXAAround 60% of Screening arm to DXAUpdate 10 year fracture riskUpdate 10 year fracture riskRecommend treatment as appropriateRecommend treatment as appropriate

Follow-UpFollow-Up

A A minimum of 5 years follow-upminimum of 5 years follow-up

PPrimary End-point:rimary End-point:All fracturesAll fractures(18% reduction, around 1000 fractures in total)(18% reduction, around 1000 fractures in total)

SSecondary End-points:econdary End-points:Hip fracturesHip fracturesQuality of LifeQuality of LifeMortality (Anticipating 20% mortality overall)Mortality (Anticipating 20% mortality overall)

Follow-UpFollow-Up

AAt what Cost?t what Cost?

IImplementation of screening, including DXA scansmplementation of screening, including DXA scans

Cost of treatmentCost of treatment

Cost of fracturesCost of fractures

PPsychological Distresssychological Distress

Add-on StudiesAdd-on Studies

TTreatment Adherence (reatment Adherence (Amanda HoweAmanda Howe))

CCollection of Blood (ollection of Blood (Sue Fairweather-TaitSue Fairweather-Tait))

What next?What next?