VPDT Cohort Study Update

1
VPDT Cohort Study Update

• Jon Gibson

3rd Investigator Meeting, Birmingham 2006
2

• History of PDT in the UK
• VPDT Cohort Study
• design
• current progress
• difficulties with implementation

3
Introduction of PDT in the UK

• 1996 Verteporfin therapy TAP/VIP trials start
• 1999 Year 1 data published , efficacy and safety
  shown
• 2000 Visudyne licensed in EU launched in the UK

4
Introduction of PDT in the UK

• NICE appraisal process,

2003 final guidance, mandatory implementation
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NICE guidance to NHS Sept 2003

• 1.1 recommended treatment of wet AMD
  confirmed diagnosis of classic with no occult
  subfoveal CNV, and best-corrected visual acuity
  6/60 or better. carried out only by retinal
  specialists with expertise in its use
• 1.2 recommended that for predominantly
  classic CNV with some occult present used
  only as part of ongoing or new clinical studies
  generate robust and relevant outcome data,
  including data on optimum treatment regimens,
  long-term outcomes, quality of life and costs.
• 1.3 . no recommendation .. for occult CNV .

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• History of PDT in the UK
• VPDT Cohort Study
• design
• current progress
• difficulties with implementation

7
What is a cohort study?

• Observational study (no change to planned
  management cf. a randomised clinical trial)
• Measures translation of research findings into
  clinical practice
• Advantages for NHS
• sets standard of care
• model of managed introduction of new
  interventions
• crucial to future planning

8
Stakeholders and funding

• Commissioned by NCCHTA (NHS RD) on behalf of
  Dept of Health and NICE
• Sponsored by NCCHTA
• Run by RCOphth steering committee

Partnership funding PCTs treatment, all data
collection SHAs reading centres NCCHTA
central study management Novartis training,
database development
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Study objectives

• To inform NICE re-appraisal of VPDT planned for
  2007
• To describe
• changes over time in main outcomes
• clinical management of patients referred for PDT
• relationship between clinical outcomes,
  self-reported visual function and health-related
  QoL
• To estimate
• incidence of patients with CNV referred for PDT
• cost-effectiveness, cost-utility and cost impact
  on the NHS of implementing PDT for patients who
  are eligible for treatment.

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Key features

• Treating Centres (Designated Providers) nominated
  by commissioners
• Requirements for DPs
• contracts negotiated with PCTs / SHA
• dedicated PDT clinics achieving service
  specification standards
• competence in stereo FFA classification of CNV
• inclusion of all screened cases for duration of
  study
• Decision to treat is made by clinician with
  patient
• Reading centre classification of CNV used for
• analysis of cohort study outcomes
• summary statistics to help monitor resource use
  and allocation
• Central data management and analysis by LSHTM

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Data set

• Baseline visit (all screened patients)
• ID, age, sex, medical and AMD history, symptom
  duration and referral details
• All visits
• Binocular presenting and monocular best corrected
  VA (logMAR ETDRS charts at 2 or 4 M
• refraction at 0, 12 and 24 months
• stereo FFA (submit for grading by reading centre)
• lesion characteristics (aetiology, GLD)
• treatment data
• adverse events (during visit) and reactions
  (between visits

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Extended data set

• 24 designated providers nominated to collect
• Contrast sensitivity
• Pelli Robson
• Questionnaires
• NEIVFQ-25
• SF-36
• Additional questions about social circumstances,
  etc.
• Custom-designed resource use questionnaire

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Benefits of VPDT cohort study

• Unique opportunities
• network of specialised treating centres
  capacity building and improved skills base
  other new technology new clinical studies and
  trials
• Acquisition of nationwide statistics for planning
  of services
• Data on cost of AMD using a bottom up approach
• Improved clinical governance
• Improved clinical practice through education and
  feedback

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• History of PDT in the UK
• VPDT Cohort Study
• design
• current progress
• difficulties with implementation

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Delays in implementation
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Review of implementation

• 01 Jul 2005 Project review initiated by Steering
  Committee to document challenges experienced
  and lessons learnt
• 28 Jul 2005 Site monitoring visit by NCCHTA
  concluded that timetable has slipped by about one
  year recommended applying for one year
  extension to data collectionsextension
  approved but confirmation of funding awaited

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Implementation of PDT

• Not responsibility of VPDT study. Evidence from
  Novartis (treatment penetration rates)
• November 2004
• 48 penetration
• 3 DPs not providing
• 2 DPs withdrawn
• March 2005
• 59 penetration
• 1 DP not providing
• 2 DPs withdrawn

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Recruitment of providers

• Responsibility of DMC

DESIGNATED
PROVIDERS


54
I
NVITATION NOT RETURNED

3


-
Funding Problems





1

-
Proposal problems





1

-
Recently sent invitation





1
LREC NOT SUBMITTED YET

4

-

Funding problems



2

-
Slow to comply

1
-
Other problem

1
AWAITING APPROVAL

2

LREC APPROVED
45
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Data collection at providers

• Responsibility of DMC

LREC APPROVED
45

AWAITING RD APPROVAL

3
FUNDING PROBLEMS


1
AWAITING
EQUIPMENT
/ STAFF

2

WILL SEND DATA SHORTLY

3

TRANSMITTING DATA
36

-

Data going to Strategen and LSHTM
17

-
Data going to LSHTM only



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Recruitment to 31 Jan 06

• Providers collecting data 39
• Providers sending data 36
• Total patients recruited 2828 20/12/2005
• Patients treated 80
• Total visits 5983 20/12/2005

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Patient recruitment
Centres 3 4 5 9 13 14
16 18 20 22 24 26 27 27 28
28 31 33
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• History of PDT in the UK
• VPDT Cohort Study
• design
• current progress
• difficulties with implementation

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Difficulties with implementation

• NICE FAD not clearly worded
• No mandate for study from DH / commissioners
• Some stakeholders not consulted about study
• Considered as research study but mandatory!
• Designation of providers
• Problems with procurement and contracting
• Problems with internal flow of funding to PDT
  service in designated providers
• Problems with data collection