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Critically

Appraised
Topics:
An Overview
Marishiel Mejia-Samonte, MD, DFM
Evidence-Based Medicine
Systematic approach
Acquisition
Appraisal
Application
Evidence-Based Medicine
more than 12,000 new articles, including
papers, are added to the MEDLINE
database each week

'information overload

develop efficient skills in critical appraisal
Young, JM & Solomon, MJ. How to Critically Appraise an Article
Nat Clin Pract Gastroenterol Hepatol. 2009;6(2):82-91.

Evidence-Based Medicine
focus only on the highest-quality studies
that will guide their clinical practice

extrapolate information when necessary
from studies of less rigorous design if high-
quality trials are unavailable

Young, JM & Solomon, MJ. How to Critically Appraise an Article
Nat Clin Pract Gastroenterol Hepatol. 2009;6(2):82-91.

Critical Appraisal
Systematic process used to identify the
strengths and weaknesses of a research
article in order to assess the usefulness
and validity of research findings

The rules of evidence vary with
circumstances
Critical Appraisal
NO 'gold-standard' instrument for critical
appraisal exists
criteria used are not static
evolve with improvements in
understanding of the important sources of
bias inherent in different study designs
and increased awareness of the potential
influence of other nonmethodological
factors, such as conflicts of interest
Most Important Components
of a Critical Appraisal
Evaluation of the appropriateness of the study
design for the research question
Careful assessment of the key
methodological features of this design
Other factors that also should be considered:
Suitability of the statistical methods used and
their subsequent interpretation
Potential conflicts of interest
Relevance of the research to one's own
practice
Young, J.M. and Solomon, M.J., 2008
10 Basic Questions Asked
1. Is the research question relevant?
Always the first question asked
Subjective opinion
What might be crucial to some will be
irrelevant to others

10 Basic Questions Asked
2. Does it add something new?
New ideas or knowledge are usually
based on previous work
Breakthrough researches are rare
Researches that make incremental
advances are also valuable
Repeating a study can increase its validity
Extending the original article to a new
population
10 Basic Questions Asked
3. What type of research question does the
study pose?
Components of a well-developed
research question:
P = the group or population of patients
I/C = the studied parameter (e.g. a therapy
or clinical intervention)
O = the outcomes of interest
10 Basic Questions Asked
4. Was the Study Design Appropriate for the
Research Question?
Heirarchy of study designs


10 Basic Questions Asked
4. Was the Study Design Appropriate for the
Research Question?

However, in some circumstances, RCTs are
either not feasible or considered ethically
inappropriate. These issues are more
common in nonpharmaceutical trials, such as
those of surgical procedures.
When specific design is not feasible, the
reasons that preclude its use will determine
the type of alternate study design that can
be used

10 Basic Questions Asked
5. Did the Study Methods Address the Key
Potential Sources of Bias?
Presence of bias means that the results of a
study have deviated from the truth

chance (e.g. a random error) = Random error
does not influence the results in any particular
direction, but it will affect the precision of the
study
study methods (systematic bias) = Systematic
bias has a direction and results in the
overestimation or underestimation of the
'truth'.

10 Basic Questions Asked
6. Was the Study Performed in Line with the Original
Protocol?
Deviations affect the validity or relevance of a study
Failure to recruit the planned number of participants
potentially reduces the extent to which the results of
the study can be generalized
reduces the power of the study
Changes to the inclusion and exclusion criteria
Variation in the provided treatments or interventions
Changes to the employed techniques or technologies,
and changes to the duration of follow-up.

10 Basic Questions Asked
7. Does the Study Test a Stated Hypothesis?
A hypothesis is a clear statement of what
the investigators expect the study to find
Hypothesis states the research question in
a form that can be tested and refuted
Null hypothesis states that the findings of a
study are no different to those that would
have been expected to occur by
chance.

10 Basic Questions Asked
8. Were the Statistical Analyses Performed
Correctly?
Difficult for nonstatisticians
All quantitative research articles should
include a segment within their 'Method'
section that explains the tools used in the
statistical analysis and the rationale for this
approach
Original data should be presented in such a
way that readers can check the statistical
accuracy of the paper.

10 Basic Questions Asked
9. Do the Data Justify the Conclusions?
Are conclusions reasonable on the basis of
the accumulated data
Issues to be wary of are whether the authors
generalized their findings to broader groups of
patients or contexts than was reasonable
given their study sample, and whether
statistically significant associations have been
misinterpreted to imply a cause and effect

10 Basic Questions Asked
10. Are There any Conflicts of Interest?
Researchers are in a position to decide which
studies will be conducted in their unit, which
patients will be invited to participate in a
study and whether certain clinical
occurrences should be reported as adverse
events
Decisions require researchers to act with
integrity and not for personal or institutional
gain

Parts of a Critical Appraisal
Internal Validity

What are the Results?

External Validity / Applicability
Therapy
Was the assignment of patients to
treatment randomised?
Were the groups similar at the start of the
trial?
Aside from the allocated treatment, were
groups treated equally?
Were all patients who entered the trial
accounted for? And were they analysed
in the groups to which they were
randomised
Internal Validity
How large was the
treatment effect?
RR
ARR
RRR
NNT
How precise was
the estimate of the
treatment effect?
Will the results help
me in caring for my
patients?
Results
Therapy
External
Validity
Or
Applicability
Internal Validity
Was the diagnostic test evaluated in a
representative spectrum of patients (like
those in whom it would be used in
practice)?
Was the reference standard applied
regardless of the index test result?
Was there an independent, blind
comparison between the index test and
on appropriate reference (gold)
standard of diagnosis?
Diagnostics
Are test
characteristics
presented?
Sensitivity
Specificity
Positive Predictive
Value
Negative
Predictive Value
Diagnostics
Were the methods
for performing the
test described in
sufficient detail to
permit replication?
Results
External
Validity
Or
Applicability
Internal Validity
Was the defined representative sample of
patients assembled at a common (usually
early) point in the course of their disease?
Was patient follow-up sufficiently long and
complete?
Were outcome criteria either objective or
applied in a blind fashion?
If subgroups with different prognoses were
identified, did adjustment for important
factors take place?
Prognosis
How likely are the
outcomes over
time?
How precise are
the prognostic
estimates?

Prognosis
Can I apply this
valid, important
evidence about
prognosis to my
patient?
Results
External
Validity
Or
Applicability
Internal Validity
What question (PICO) did the systematic
review address?
Is it unlikely that important, relevant studies
were missed?
Were the criteria used to select articles for
inclusion appropriate?
Were the included studies sufficiently valid
for the type of question asked?
Were the results similar from study to study?
Systematic Review
How are the results
presented?
Will the results help
me in caring for my
patients?

Systematic Review
Results
External Validity
Or
Applicability
What do we do with the
appraised articles?
discuss the published information
gathered from these appraised articles
regarding a particular subject matter

APPLY IT TO YOUR PATIENTS


WORKSHOP
1. Divide yourselves into 8 groups composed of
10 to 11 members per group (this will be your
permanent grouping for Research 1).
2. Articles will be provided to the different
groups.
3. Determine if the appraisal questions can be
answered or not using the abstract alone,
using full text, not at all

Therapy
Diagnostics

Prognosis


Systematic Review

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