Input required

Support Services for the Management and Utilization of
Monitoring and Assessment of the EIP - MAFEIP Tool
Data Collection
Codebook
Overview of Questions and Input required
http://mafeip.eu
[email protected]
MAFEIP Tool Overview of Questions and Input required
Questions
Input required
Name/acronym of the intervention
<free text input>
Please select one of the following:
Action group under which the
intervention is registered
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A1
A2
A3
B3
C2
D4
Demographic characteristics of your
target group (e.g. age, gender)
<free text input>
Geographic characteristics of your target
group (e.g. country, region)
<free text input>
What is the condition that your
intervention aims to prevent, improve or
cure?
<free text input>
What are the typical disease
characteristics of your target group (e.g.
comorbidities)?
<free text input>
Your intervention relates to a:
o
o
o
Device
Protocol/treatment method
Other, please specify
 <free text input>
2
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Brief description of the clinical
implementation of your intervention (e.g.
who uses it, when, in which setting, how
often etc.)
<free text input>
Brief description of the current care
situation without the intervention (e.g.
current treatments provided, whether the
intervention replaces or complements
the current therapy, etc.)
<free text input>
Does your intervention have an impact
on health and resource use compared to
current care? (please describe briefly).
<free text input>
Stage of development of your
intervention
Do you collect empirical evidence on
the effectiveness of your intervention?
If effectiveness = Yes:
1) What is the study design with which
evidence
on
effectiveness
is
gathered?
2) Was there a control group against
which
the
effectiveness
was
assessed?
If control group = Yes:
o
o
o
o
o
Pre-trial (e.g. proof of concept)
Clinical trials ongoing
Pilot implementation
Routine use
Other, please specify
 <free text input>
o
o
Yes
No
o
o
o
o
o
Randomized Controlled Trial
Longitudinal observational
Cross-sectional observational
Case-control
Other, please specify
 <free text input>
o
o
Yes
No
<free text input>
3
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1) Number
of
patients
intervention arm of study
in
2) Number of patients in control
<free text input>
arm of study
If control group = No:
<free text input>
Number of patients in the study
Do you collect empirical evidence on the
impact of your intervention on resource
use?
If resource use = Yes:
o
o
Yes
No
o
o
o
o
Piggyback study with clinical trial
Micro-costing study
Patient records based study
Other, please specify
o
o
Yes
No
1) What is the study design with which
evidence on resource use is
<free text input>
gathered?
2) Was there a control group against
which
the
effectiveness
was
assessed?
If control group = Yes:
1) Number
of
patients
intervention arm of study
in <free text input>
2) Number of patients in control
<free text input>
arm of study
If control group = No:
Number of patients in the study
If resource use = No:
<free text input>
o
Yes
4
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[email protected]
o
Do you have alternative sources of
resource use evidence to populate the
model?
No
If alternative sources = Yes:
Please specify your alternative sources
for effectiveness evidence (literature,
expert opinion, other)
<free text input>
Do you collect empirical evidence on the
impact of your intervention on Health
Related Quality of Life (HRQoL)?
If HRQoL = Yes:
1) What is the study design with
which evidence on HRQoL is
gathered?
2) Was there a control group against
which the effectiveness was
assessed?
o
o
Yes
No
o
o
o
o
o
Randomized Controlled Trial
Longitudinal observational
Cross-sectional observational
Case-control
Other, please specify
 <free text input>
o
o
Yes
No
If control group = Yes:
1) Number
of
patients
intervention arm of study
in <free text input>
2) Number of patients in control
<free text input>
arm of study
If control group = No:
<free text input>
Number of patients in the study
Discount factor for costs
<free percentage input>
5
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Discount factor for utilities
<free percentage input>
Target population Minimum age
<free number input>
Target population Maximum age
<free number input>
Please select one of the following:
Target population Gender
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Both males and females
Males only
Females only
Please select one of the following:
Target population Country
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Austria
Belgium
Bulgaria
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
6
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[email protected]

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Sweden
United Kingdom
Please select one of the following:
Target Population Currency
Patient Flow through Model States
Gender
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Euro
Bulgarian lev
British pound sterling
Croatian kuna
Czech koruna
Danish krone
Hungarian forint
Polish zloty
Romanian leu
Swedish krona
Swiss franc
o
o
Male
Female
Patient Flow through Model States
<free number input>
Age
Incidence Rate
Control Group
<free percentage input>
Intervention Group
<free percentage input>
Recovery Rate
Control Group
<free percentage input>
Intervention Group
<free percentage input>
Relative risk of mortality in baseline
health
<free number input>
7
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[email protected]
Control Group
<free number input>
Intervention Group
Relative risk of mortality in deteriorated
health
Control Group
Intervention Group
<free number input>
<free number input>
One-off intervention costs
<free number input>
Intervention costs per person per year
<free number input>
Healthcare costs baseline health
Control Group
<free number input>
Intervention Group
<free number input>
Societal costs baseline health
Control Group
<free number input>
Intervention Group
<free number input>
Healthcare costs deteriorated health
Control Group
<free number input>
Intervention Group
<free number input>
Societal costs deteriorated health
Control Group
<free number input>
Intervention Group
<free number input>
8
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[email protected]
Utility of baseline health
Control Group
<input between 0 to 1>
Intervention Group
<input between 0 to 1>
Utility of deteriorated health
Control Group
<input between 0 to 1>
Intervention Group
<input between 0 to 1>
Sensitivity Analysis (optional)
The following fields are filled in only after the assessment has been made and the
user wishes to perform a sensitivity analysis.
Discount Factor for costs
Base value
<free percentage input>
Min
<free percentage input>
Max
<free percentage input>
Discount Factor for utilities
Base value
<free percentage input>
Min
<free percentage input>
Max
<free percentage input>
Incidence (control group)
Base value
<free percentage input>
Min
<free percentage input>
Max
<free percentage input>
Recovery (control group)
9
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[email protected]
Base value
<free percentage input>
Min
<free percentage input>
Max
<free percentage input>
Incidence (intervention group)
Base value
<free percentage input>
Min
<free percentage input>
Max
<free percentage input>
Recovery (intervention group)
Base value
<free percentage input>
Min
<free percentage input>
Max
<free percentage input>
Relative risk of mortality in baseline
health (control group)
Base value
Min
Max
<free number input>
<free number input>
<free number input>
Relative risk of mortality in deteriorated
health (control group)
Base value
Min
Max
Relative risk of mortality in baseline
health (intervention group)
Base value
<free number input>
<free number input>
<free number input>
<free number input>
<free number input>
10
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[email protected]
Min
<free number input>
Max
Relative risk of mortality in deteriorated
health (intervention group)
Base value
Min
Max
<free number input>
<free number input>
<free number input>
One-off intervention costs
Base value
<free number input>
Min
<free number input>
Max
<free number input>
Intervention costs per person per year
Base value
<free number input>
Min
<free number input>
Max
<free number input>
Healthcare costs baseline health (control
group)
Base value
Min
Max
Societal costs baseline health (control
group)
<free number input>
<free number input>
<free number input>
<free number input>
Base value
<free number input>
Min
<free number input>
11
http://mafeip.eu
[email protected]
Max
Healthcare costs deteriorated health
(control group)
Base value
Min
Max
<free number input>
<free number input>
<free number input>
Societal costs deteriorated health
(control group)
Base value
Min
Max
<free number input>
<free number input>
<free number input>
Healthcare costs baseline health
(intervention group)
Base value
Min
Max
<free number input>
<free number input>
<free number input>
Societal costs baseline health
(intervention group)
Base value
Min
Max
Healthcare costs deteriorated health
(intervention group)
<free number input>
<free number input>
<free number input>
<free number input>
Base value
<free number input>
Min
<free number input>
12
http://mafeip.eu
[email protected]
Max
Societal costs deteriorated health
(intervention group)
Base value
Min
Max
<free number input>
<free number input>
<free number input>
Utility of baseline health (control group)
Base value
<free number input>
Min
<free number input>
Max
<free number input>
Utility of deteriorated health (control
group)
Base value
Min
Max
<free number input>
<free number input>
<free number input>
Utility of baseline health (intervention
group)
Base value
Min
Max
<free number input>
<free number input>
<free number input>
Utility of deteriorated health (intervention
group)
Base value
Min
Max
<free number input>
<free number input>
<free number input>
13
http://mafeip.eu
[email protected]
14