Document text
ACIP Evidence to Recommendations Framework
Question: Overarching policy question to be answered by the guideline panel (ACIP) using the Evidence to Recommendations (EtR) frame work.
The quest ion shou ld be precise and ident ify the specific interv ention, compar ison, and outcome, as w ell as the tar get popul ation and t he setting
(specific s ubpopul ations) in PICO format.
Popula tion: Target popul ation for vaccine (e.g., a ge range, se x, immune sta tus, pregnancy )
Intervention: Vaccination (if appl icable, dosag e and sc hedul e)
Compa rison(s): No Vaccination/S tandard of care/An existing vaccine/O ther prevention option
Outcome : Outcome(s) associated with vaccination (e.g., prevention outcomes or adverse effects)
Background: The addressed PICO question should be described in detail, and important background information for understanding the questio n
and why a recommendation or decision is needed should be briefly provided. If a recommendation is preferential or represents off-label use,
this should be indicated.
Include sample language: Additional background information supporting the ACIP recommendations on the use of xxx vaccine can be found in
the relevant publication of the recommendation referenced on the ACIP website .
WORK GROUP JUDGMENTS EVIDENCE ADDITIONAL INFORMATION PROBLEM Is the problem of public health importance?
○ No
○ Probably no
○ Probably yes
○ Yes
○ Varies
○ Don't know Provide available scientific evidence on
burden of disease, preferably within the
target population for the
recommendation.
If no published evidence is available,
provide expert judgment on the public
health priority considerations. Identify any additional public health
priority considerations, including
consideration of disparities.
WORK GROUP JUDGMENTS EVIDENCE ADDITIONAL INFORMATION BENEFITS & HARMS How substantial are the desirable
anticipated effects?
○Minimal
○S
mall
○M
oderate
○L
arge
○Va
ries
○D
on't knowDescribe the magnitude of the beneficial
effects of vaccination on individual
(vaccine effectiveness, duration of
protection) and population (herd
immunity) levels. Take into consideration:
Is the baseline benefit similar across
subgroups (by age, sex, pregnancy or
lactation s tatus, occupation [ i.e., healthcare
workers], immune s tatus, r ace, S ES, and
other gr oups)?
Are there indirect ef fects that should b e
considered ( e.g., herd i mmunity)?
How substantial are the undesirable
anticipated effects?
○Minimal
○S
mall
○M
oderate
○L
arge
○Va
ries
○D
on't knowAre there undesirable effects of the
vaccine, either on the individual (e.g.,
adverse events following immunization) or population (e .g., age -shift of disease,
serotype replacement) levels? Take into consideration:
Is the baseline risk for harm similar across subgroups (see above)?
S
hould there be separate recommendations
for subgroups based on harms?
Do the desirable effects outweigh the
undesirable effects?
○Favors interventionl
○F
avors comparison
○F
avors both
○F
avors neither
○Va
ries
○D
on't knowDescribe the balance of benefits of the
vaccine with possible harms (individual and population level).
WORK GROUP JUDGMENTS EVIDENCE ADDITIONAL INFORMATION
What is the overall certainty of this
evidence for the critical outcomes ?
Effectiveness of the intervention
○ No studies found
○ 4 (very low)
○ 3 (low)
○ 2 (moderate)
○ 1 (high)
Safety of the intervention
○ No studies found
○ 4 (very low)
○ 3 (low)
○ 2 (moderate)
○ 1 (high)
Please refer to GRADE evidence profiles for
detailed assessment of the certainty of the
evidence. For more information, please see the
ACIP Handbook for Developing Evidence -
Based Recommendations. If GRADE was n ot used to evaluate the
certainty of evidence, please provide
justification and the method and outcome of any other tools used to evaluate the body of evidence relevant to the critical outcomes. VALUES Does the target population feel that the
desirable effects are large relative to
undesirable effects?
○ No
○ Probably no
○ Probably yes
○ Yes
○ Varies
○ Don't know Provide any available evidence on target
population values & preferences related to
vaccination and comparative health benefits
and risks. Describe the source of these estimates. Are values and preferences for relevant
outcomes measured? Are the benefits,
harms and costs of vaccination valued
differently by different subgroups?
If the target group doesn’t value the intervention, or attributes little value to the
harms and benefits, consider whether potential education measures are needed.
WORK GROUP JUDGMENTS EVIDENCE ADDITIONAL INFORMATION
Is there important uncertainty about or
variability in how much people value the
main outcomes?
○ Important uncertainty or variability
○ Probably important uncertainty or variability
○ Probabl not important uncertainty or variability
○ No important uncertainty or variability
○ No known undesireable outcomes
Please provide available data used to
determine the relative importance that the
target population attributes to the desirable
and the undesirable outcomes related to the
intervention as well as the comparison. Describe the source of variability, if any.
Are there methods for determining values
satisfactory for this recommendation?
If not, systematic assessment of values and
preferences of target group may be
considered. ACCEPTABILITY Is the intervention acceptable to key
stakeholders?
○ No
○ Probably no
○ Probably yes
○ Yes
○ Varies
○ Don't know
Provide assessment of whether intervention
would be acceptable to stakeholders
(ethically, programmatically, financially, etc.) RESOURCE USE Is the intervention a reasonable and
efficient allocation of resources?
○ No
○ Probably no
○ Probably yes
○ Yes
○ Varies
○ Don't know
Provide summary of cost -effectiveness
analyses (CEAs) of the vaccine in the target
population. Include base case results and a
sensitivity range. Include any other notable
findings, for example, specific policy -
relevant scenario s. Overall findings: Summarize the findings
from available CEAs, including major
differences in baseline assumptions.
Uncertainty: Does the analysis capture the
full range of uncertainty? For example, are
the findings from the uncertainty of
evidence ana lysis, identified earlier in this
document (the EtR Framework),
appropriately represented in the methods of
the CEAs?
Multiple assessments: Are there multiple
CEAs? If so, what are the major differences
in methods and results?
WORK GROUP JUDGMENTS EVIDENCE ADDITIONAL INFORMATION EQUITY What would be the impact on health
equity?
○ Reduced
○ Probably reduced
○ Probably no impact
○ Probably increased
○ Increased
○ Varies
○ Don't know
Summarize the findings from a review of the
literature addressing issues of health inequities or groups who may be disadvantaged. Consider from the evidence or guideline
panel:
• Are there any groups or settings that might be disadvantaged in relation to
the problem or options that are
considered?
• Are there plausible reasons for
anticipating differences in the relative effectiveness of the option for disadvantaged groups or settings?
• Are there different baseline conditions across groups or settings that affect the
absolute effectiveness of the option o r
the importance of the problem for
disadvantaged groups or settings?
• Are there important considerations
that should be made when implementing the intervention (option) in order to ensure that
inequities are reduced, if possible,
and that they are not incr eased? FEASIBILITY Is the intervention feasible to implement?
○ No
○ Probably no
○ Probably yes
○ Yes
○ Varies
○ Don't know
Are there any barriers to implementation?
Please refer to the Implementation
Considerations checklist.
Balance of
consequences Undesirable
consequences
clearly outweigh
desirable
consequences
in most settings Undesirable
consequences
probably outweigh
desirable
consequences
in most settings The balance
between
desirable and
undesirable
consequences
is closely balanced
or uncertain
Desirable
consequences
probably outweigh
undesirable
consequences
in most settings Desirable
consequences
clearly outweigh
undesirable
consequences
in most settings There is
insufficient
evidence to
determine the
balance of
consequences
○ ○ ○ ○ ○ ○
Is there sufficient information to move forward with a recommendation?
Yes ○ No ○
Policy options for
ACIP consideration
ACIP does not recommend the
intervention*
*Intervention may be used within
FDA licensed indications
ACIP recommends the intervention
for individuals based on shared
clinical decision -making
ACIP recommends the intervention
○ ○ ○
Draft
recommendation
(text) Please provide the draft recommendations proposed to ACIP.
Additional
considerations
(optional) Please outline any significant additional considerations (e.g., aspects related to implementation, monitoring and
evaluation, research priorities, etc.).
Final deliberation and decision by the ACIP
Final ACIP
recommendation
ACIP does not recommend the
intervention*
*Intervention may be used within FDA
licensed indications
ACIP recommends the intervention for
individuals based on shared clinical
decision -making
ACIP recommends the intervention
○ ○ ○
Additional ACIP
considerations
Wording as accepted in the guide