CRITICAL

APPRAISAL
Sunil J. Bhat
18.06.2020
W H A T I S A J O U R NAL C L U B?
 An educational meeting in which a group of
individuals read, evaluate and discuss
current articles from the biomedical
literature.

Successful Journal Clubs include:

 A well constructed clinical question
 Searching for evidence
 A critical appraisal
C R I T I C A L A P P R A I S A L:
DEFINITION
A systematic process used to identify the
strengths and weaknesses of a research
article to assess the usefulness and
validity of research findings.

Why is it
important?
Despite the plethora of documents
available to guide the process,
no 'gold-standard' instrument
for critical appraisal exists
RE LE VANCE & VALI DITY?
1) Is the study question relevant?
2) Does the study add anything new?
3) What type of research question is being asked?
4) Was the study design appropriate for the research
question?
5) Did the methods address the most important
sources of bias?
6) Was the study performed according to the original
protocol?
7) Does the study test a stated hypothesis?
8) Were the statistical analyses performed correctly?
9) Do the data justify the conclusions?
TOOLS AVAILABLE
- CASP ([Link]

- CONSORT ([Link])

- PRISMA ([Link])

- STROBE ([Link])

- Equator network ([Link])

- CEBM ([Link])

-
CONS O
RT

• Consolidated Standards of Reporting Trials

• Comprehensive tool to assess the standard of

reporting in randomized trials.

• 25 item checklist*

* [Link]
T
Item Checklist item Analyses Page I
No. no. 1 T
L
Title and Abstract E

1. 1a. Identification as a randomized &

trial in the title. √
A
1b. Structured summary of trial B
design, methods, results, and √ S
conclusions T
R
A
C
T
Item Checklist item Analyses Page
No. no. 1
I
Background and objectives N
T
2. 2a. Scientific background and R
explanation of rationale √ O
D
2b. Specific objectives or U
hypotheses √ C
T
I
O
N
Item Checklist item Analyses Page
No. no. 2

Trial Design M
E
3. 3a. Description of trial design T
(such as parallel, factorial) × H
including allocation ratio O
D
3b. Important changes to methods S
after trial commencement
(such as eligibility criteria), ×
with reasons
Item Checklist item Analyses Page
No. no. 2

Participants M
E
4. 4a. Eligibility criteria for participants √ T
H
4b. Settings and locations where the O
data were collected √ D
S
Item Checklist item Analyses Page
No. no. 2 , 3

Interventions M
E
5. The interventions for each group T
with sufficient details to allow
√ H
replication, including how and O
when they were actually administered D
S
1. Lavage output <80% ,
≥70%
2. Minimum Target volume
2.5-3 l/24 h- Frequency
not mentioned,
Maximum not mentioned
Item Checklist item Analyses Page
No. no. 3

Outcomes M
E
6. 6a. Completely defined pre-specified T
primary and secondary outcome H
measures, including how and when √ O
they were assessed D
S

6b. Any changes to trial outcomes

after the trial commenced, with ×
reasons
Item Checklist item Analyses Page
No. no.

Sample size M
E
7. 7a. How sample size was determined × T
H
7b. When applicable, explanation of O
any interim analyses and stopping × D
guidelines S
Item Checklist item Analyses Page
No. no. 2
Randomisation
Sequence generation
8a. Method used to generate the random allocation M
sequence √ E
8b. Type of randomisation; details of any restriction T
(such as blocking and block size)
Allocation concealment mechanism
H
9. Mechanism used to implement the random O
allocation sequence (such as sequentially D
numbered containers), describing any steps S
taken
to conceal the sequence until interventions were
assigned
Implementation
10. Who generated the random allocation sequence,
who enrolled participants, and who assigned
Item Checklist item Analyses Page
No. no.

Blinding M
E
11. 11a. If done, who was blinded T
after assignment to interventions
×
H
(for example, participants, care O
providers, those assessing D
outcomes) and how S
11b. If relevant, description of the
×
similarity of interventions
Item Checklist item Analyses Page
No. no. 3

Statistical methods M
E
12. 12a. Statistical methods used to T
compare groups for primary √ H
and secondary outcomes O
D
12b. Methods for additional analyses, S
such as subgroup analyses ×
and adjusted analyses
Item Checklist item Analyses Page
No. no. 2

Participants flow (CONSORT diagram)

R
13. 13a. For each group, the numbers E
of participants who were S
randomly assigned, received U
√ L
intended treatment, and
were analysed for the primary T
outcome S

13b. For each group, losses and

exclusions after randomisation,√
together with reasons
Item Checklist item Analyses Page
No. no. 2

Recruitment R
E
14. 14a. Dates defining the periods of S
√
recruitment and follow-up U
L
14b. Why the trial ended or was T
stopped ×
S
Item Checklist item Analyses Page
No. no. 4

Baseline data R
E
15. A table showing baseline demographic S
and clinical characteristics for each group √ U
L
T
S
Item Checklist item Analyses Page
No. no. 4 , 5

Numbers analysed R
E
16. For each group, number of S
participants (denominator) U
included in each analysis and √ L
whether the analysis was by T
original assigned groups S
Item Checklist item Analyses Page
No. no. 5

Outcomes and estimation R

E
17. 17a. For each primary and S
secondary outcome, results for each U
group, and the estimated effect size and √
L
its precision (such as 95% confidence T
interval) S
17b. For binary outcomes,
presentation of both absolute and
relative effect sizes is recommended
Item Checklist item Analyses Page
No. no. 5

R
Ancillary analyses E
S
18. Results of any other analyses U
performed, including subgroup analyses L
and adjusted analyses, distinguishing √
T
pre-specified from exploratory S
Item Checklist item Analyses Page
No. no. 3

Harms R
E
19. All important harms or unintended S
effects in each group √ U
L
T
S
Item Checklist item Analyses Page
No. no.

Limitations D
I
20. Trial limitations, addressing S
sources of potential bias, imprecision,
× C
and, if relevant, multiplicity of analyses U
-Small sample size S
-Longer period and multiple PCD in LT S
I
arm
O
N
Item Checklist item Analyses Page
No. no.

Generalisability D
I
21. Generalisability (external validity, S
applicability) of the trial findings ×
C
U
-1st study of this kind – needs validation S
S
I
O
N
Item Checklist item Analyses Page
No. no. 6

Interpretation D
I
22. Interpretation consistent S
with results, balancing benefits √ C
and harms, and considering other U
relevant evidence S
S
I
O
N
O
Item Checklist item Analyses Page T
No. no. 6 H
E
Registration R

I
23. Registration number and name of √ N
trial registry F
O
R
M
A
T
I
O
N
O
Item Checklist item Analyses Page T
No. no. 6 H
E
Protocol R

I
24. Where the full trial protocol can be
accessed, if available
√ N
F
O
R
[Link] M
A
T
I
O
N
O
Item Checklist item Analyses Page T
No. no. 6 H
E
Funding R

I
25. Sources of funding and other
N
support (such as supply of drugs), role of √ F
funders O
R
M
A
T
I
O
N
RE LE VANCE & VALI DITY?
1) Is the study question relevant? Yes
Yes
2) Does the study add anything new?
3) What type of research question is being Comparative
asked?
4) Was the study design appropriate for the Yes
research question?
No
5) Did the methods address the most important
sources of bias? Yes
6) Was the study performed according to the
original protocol? Yes
Yes
7) Does the study test a stated hypothesis?
8) Were the statistical analyses performed Yes
correctly? No
9) Do the data justify the conclusions?
LESSONS LEARNT

 Critical appraisal of RCT

 Consort diagram

 ITT and PP analyses

THANK YOU