Template Critical Appraisal
Template Critical Appraisal
Template Critical Appraisal
JUDUL…..
citation
1. Topic
2. Reviewer
3. Cititation
4. Study Design
(A=RCT, B=cohort study, C=non randomized trial with concurrent or
historicalcontrols / case control study of sensistivity and specificity
5. Class
of a diagnostic test/ time series, D=cross sectional study/trend
study/case series/case report/before and after study)
6. Quality Rating + (Positive) - (Negative) Ø (Neutral)
7. Research Purpose
8. Inclusion Criteria
9. Exclusion Criteria
10. Recruitment or
Description of sampling
Study
Blinding used
Protocol
Description of
10.
study design
Description of
Intervention
Study
Statistical
Protocol
analysis
Timing and
method of
measurements
Dependent
Variables
Data (outcomes)
Collection Independent
Summary: variables
(intervention or
procedure)
Other variables
(control
variables)
Description of Initial n
Actual Data Final n (attrition)
Sample Age
Ethnicity
Other relevant
setting
characteristics
Anthropometrics
or other relevant
subject
characteristics
Symbols Used
+ Positive: Indicates that the report has clearly addressed issues of inclusion/exclusion,
bias, generalizability, and data collection and analysis.
-- Negative: Indicates that these issues have not been adequately addressed.
∅ Neutral: Indicates that the report is neither exceptionally strong nor exceptionally weak
Screening Questions
Consider
a. Why this is a randomised
controlled trial (RCT)
and was it appropriately
so?
………
Detailed Questions
Consider
a. how participants were
allocated to intervention
and control groups. Was
the process trully random?
b. Whether the method of
allocation was described.
Was a method used to
balance the randomization,
e.g stratification?
c. How the randomization
schedule was generated and
how a participant was
allocated to a study group
d. If the groups were well
balanced. Are any
differences between the
groups at entry to trial
reported
Consider
a. the fact that blinding is
not always possible
b. if every effort was made to
achieve blinding
c. if you think it matters in
this study
d. the fact that we are
looking for ‘observer
bias’
Consider
a. if any intervention-group
participants got a control
group option or vice versa
b. if all participants were
followed up in each study
group (was there loss to
follow up?)
c. if all the participants
outcomes were analysed
by the groupd towhich
they were originally
allocated (intention to
treat analysis)
d. What additional
information would you
liked to have seen to make
you feel better about this
Consider
a. if for example, they were
reviewed at the same time
intervals and if they
received the same amount
of attention from
researchers and health
worker. Any differences
may introduce
performance bias
Consider
a. if there is a power
calcualtion. This will
estimate how many
participants are neededd
to be reasonably sure of
finding something
important (if it really exits
and for a given level of
uncertainity about the
final result)
Consider
a. if for example, the
results are presented as
a proportion of people
experiencing an
outcome, such as risks
or as a measurment,
such as mean or
median differences or
as survival curves and
hazards
b. How large this size of
the result is and how
meaningful it
c. How you would sum up
the bottom line result of
the trial in one sentence
Consider
a. If the result is precise
enough to make a decision
b. If a confidence interval
were reported. Would
your decision about
whether or not to use the
same at the upper
confidence limit as at the
lower confidence limit?
c. If a p-value is reported
where confidence
intervals are unavailable
Consider whether
a. The people included in
the trail could be
different from your
population in ways that
would produce different
results
b. Your local setting
differs much from that
of the trial
c. You can provide the
same treatment in your
setting
RELEVANCE QUESTIONS
Would implementing the studied intervention or procedure (if found successful) result in Yes No Unclear N/A
improved outcomes for the patients/clients/population group? (NA for some Epi studies)
Did the authors study an outcome (dependent variable) or topic that the Yes No Unclear N/A
patients/clients/population group would care about?
. Is the focus of the intervention or procedure (independent variable) or topic of study a Yes No Unclear N/A
common issue of concern to dietetics practice?
Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes No Unclear N/A
If the answers to all of the above relevance questions are “Yes,” the report is eligible for designation with a plus (+) on the
Evidence Quality Worksheet, depending on answers to the following validity questions
VALIDITY QUESTIONS
Was the research question clearly stated? Yes No Unclear N/A
1.1 Was the specific intervention(s) or procedure (independent variable(s)) identified?
1.2 Was the outcome(s) (dependent variable(s)) clearly indicated?
1.3 Were the target population and setting specified?
Was the selection of study subjects/patients free from bias? Yes No Unclear N/A
2.1 Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression,
diagnostic or prognosis criteria), and with sufficient detail and without omitting
criteria critical to the study?
2.2 Were criteria applied equally to all study groups?
2.3 Were health, demographics, and other characteristics of subjects described?
2.4 Were the subjects/patients a representative sample of the relevant population?
VALIDITY QUESTIONS
Was method of handling withdrawals described? Yes No Unclear N/A
4.1 Were follow up methods described and the same for all groups?
4.2 Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up,
attrition rate) and/or response rate (cross-sectional studies) described for each
group? (Follow up goal for a strong study is 80%.)
4.3 Were all enrolled subjects/patients (in the original sample) accounted for?
4.4 Were reasons for withdrawals similar across groups?
4.5 If diagnostic test, was decision to perform reference test not dependent on results of
test under study?
MINUS/NEGATIVE (-)
If most (six or more) of the answers to the above validity questions are “No,” the report should be
designated with a minus (-) symbol on the Evidence Worksheet.
NEUTRAL (∅)
If the answers to validity criteria questions 2, 3, 6, and 7 do not indicate that the study is
exceptionally strong, the report should be designated with a neutral (∅) symbol on the
Evidence Worksheet.
PLUS/POSITIVE (+)
If most of the answers to the above validity questions are “Yes” (including criteria 2, 3, 6, 7
and at least one additional “Yes”), the report should be designated with a plus symbol (+) on
the Evidence Worksheet