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A new generic approach for scoping HTA. Iris Pasternack.
1. A new generic approach
for scoping HTA
9th HTAi in Bilbao June 2012
Iris Pasternack, Finnish Office for Health Technology Assessment at
THL, Helsinki, Finland
2. The HTA Core Model
METHODOLOGICAL
ONTOLOGY
GUIDANCE
Questions that an HTA
How to answer
should answer
the questions
REPORTING
STRUCTURE
How to present
the answers
2
3. Domains of the HTA Core Model
1. Health problem and current use of technology
2. Description and technical characteristics
3. Safety
4. Clinical effectiveness
5. Costs and economic evaluation
6. Ethical analysis
7. Organisational aspects
8. Social aspects
9. Legal aspects
3
4. Drug eluting stents (DES) vs bare metal
stents (BMS) in coronary artery disease
(CAD)
Multislice computed tomography (MSCT)
coronary angiography vs current practice in
CAD
Three genomic tests (OncotypeDX,
Mammaprint, Femtelle) versus current
grading practice in breast cancer
Pazopanib versus current practice in renal cell
carcinoma: a rapid assessment
Scoping pilot projects first with
PICO
5. Case MSCT
Patients with
diagnosed CAD
SPECT Healthy In screening
PET In triage (ruling people
non-
in, ruling out) MSCT
Suspected MSCT
case: high risk Suspected case:
In monitoring low risk
IVUS
Suspected case: ICA
moderate risk
In diagnosis
Stress MRI
ECHO
6. MSCT (technology)
in ruling out CAD (intended use)
in patients with low risk of having CAD
(population and health condition)
compared to non-MSCT (technology
compared)
for “better outcomes” (outcome)
Structured scope for MSCT project
7. Social domain: What are the
consequences of the technology on daily
living?:
◦ “Should we only look at the differences
between DES and BMS?” > No
◦ “Should we only look at the differences
between pazopanib and sunitinib?” > Yes
Expanding C
8. Safety domain: What are the direct harms
of the technology to the patient?
◦ “Should we only report the results of studies
examining radiation exposure of MSCT in
patient with CAD?” >no
Ethical domain: What are the possible
consequences to patient autonomy?
◦ “Should we consider only the given 3 tests, or
look at all prognostic tests in breast cancer, or
prognostic tests in any cancer?” > probably yes
Expanding P and I
9. All cancer patients All x-ray devices
All breast cancer patients All CTs
Women with early MSCT
breast cancer
Expanding frame around PICO
elements
10. T Use Pop D C O
•Treatment •Gender
•First line •Age
•Second •Low-high risk
line of having D
•Diagnosing •Low-high risk
•Ruling in/out of developing D
•Screening •etc
•Monitoring
•Assessing
prognosis
•Preventing
From PICO to “TUPDCO” (or TICO)
12. „Intended use‟ is missing from PICO
Outcomes are difficult to define for the
whole project but they need to be outlined
Extending frame does not necessarily
imply deviation from scope
Conclusions