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Critical appraisal.docx IMPORTAN TO HEALTH SCIENCE STUDENTS
1. Critical appraisal
• Critical appraisal is the process of systematically examining evidence to assess its validity,
results, and relevance before using it to inform a decision.
• The aim is to identify potential threats to the validity of the research findings from the literature
and to ensure that the review is credible and useful for informing healthcare policy, clinical
practice, and future research. Critical appraisal were involved(rapid critical appraisal,
evaluation and synthesis of the evidence)
The critical appraisal process hinges on three overarching questions that apply to any
Study
1. Are the results of the study valid? (Validity)
2. What are the results? (Reliability)
3. Will the results help me in caring for my patients? (Applicability)
After searching best available evidence based on burning clinical question we have got around 22 external
evidence strategies which will support the EBP to improve the patient outcome, as described in the
searching.
That external evidence obtained from searching engine does not used directly for clinical decision making
rather we should critically appraise each evidences based on specific check list for final synthesis.
Critical appraisal tools were used to appraise the evidence which are:
AMSTAR 1 (11 Criteria)
• A critical appraisal tool for all types of systematic reviews (systematic reviews from
experimental, observational or qualitative studies)
AMSTAR 2 (16 Criteria)
• A critical appraisal tool for systematic reviews that include randomized or non-randomized
studies of healthcare interventions, or both
FOR GUIDELINES
• Agree II
FOR PRIMARY STUDIES
• JBI Critical Appraisal tools
2. Critical appraisal of Systematic Reviews
AMSTAR 1
Critical appraisal of Systematic Reviews
AMSTAR 1
3. Fatal flaws (Score below 6 out of 11 criteria)
Limitations those are sufficiently important to render the results of the review unreliable. As such, the
results should not be used for synthesizing evidence for decision
Important limitations (Score 6-9 out of 11 criteria)
Limitations important enough to make searching for another systematic review worthwhile. The results
of this review should be interpreted cautiously if a better review cannot be found (however, the
information provided in the review could potentially be supplemented with additional searches, or
information from included studies may be included for synthesizing evidence for decision)
Reliable (Score 10-11 out of 11 criteria)
Only minor limitations and the review can be used as a reliable summary of the best available evidence
JBI critical appraisal checklist for randomized controlled trials
1. Was true randomization used for assignment of participants to treatment? groups? Yes/ No /Unclear
/NA
2. Was allocation to treatment groups concealed? Yes/ No /Unclear /NA
3. Were treatment groups similar at the baseline? Yes/ No /Unclear /NA
4. Were participants blind to treatment assignment? Yes/ No /Unclear /NA
5. Were those delivering treatment blind to treatment assignment? Yes/ No /Unclear /NA
6. Were outcomes assessors blind to treatment assignment? Yes/ No /Unclear /NA
7. Were treatment groups treated identically other than the intervention of interest? Yes/ No /Unclear /NA
8. Was follow up complete and if not, were differences between groups in terms of their follow up
adequately described and analyzed? Yes/ No /Unclear /NA
9. Were participants analyzed in the groups to which they were randomized? Yes/ No /Unclear /NA
10. Were outcomes measured in the same way for treatment groups? Yes/ No /Unclear /NA
11. Were outcomes measured in a reliable way? Yes/ No /Unclear /NA
12. Was appropriate statistical analysis used? Yes/ No /Unclear /NA
4. 13. Were the trial design appropriate and any deviations from the standard RCT?
Design (individual randomization, parallel groups) accounted for in the conduct and analysis of the trial?
Yes/ No /Unclear /NA
Overall appraisal: Include □ Exclude □ Seek further info □
After appraising the evidence with respective check list we have extract 6 literatures out of 22 and
translated for final synthesis.
The final synthesized studies were critically appraised of validity, reliability and applicability as
an interventional study we give spatial attention to inclusion criteria
i. Randomization and design (validity)
ii. followed up and double blinded (validity)
iii. sample size (validity
iv. Effect size and level of significant (reliability)
v. demographic characteristic and prognostic factor (validity)
I. Feasibility and risk beneficence (applicability)
II. double study were excluded
From screened literatures
one systematic review conducted on Interventions to prevent hypothermia at birth in preterm
and/or low birth weight infants were showed that: Plastic wraps improved core body temperature
on admission to the neonatal intensive care unit (NICU) or up to two hours after birth (mean
difference (MD) 0.58°C, 95% confidence interval (CI) 0.50 to 0.66; 13 studies; 1633 infants), and
fewer infants had hypothermia on admission to the NICU or up to two hours after birth (typical
risk ratio (RR) 0.67, 95% CI 0.62 to 0.72; typical risk reduction (RD) -0.25, 95% CI -0.29 to-
0.20; number needed to treat for an additional beneficial outcome (NNTB) 4, 95% CI 4 to 5; 10
studies; 1417 infants).
Another study presented with systematic and meta- analysis showed that compared with
unwrapped infants, plastic wrap was associated with a significantly higher baseline temperature
and post-stabilization temperature both in infants < 28 weeks of gestation (mean difference [MD]
= 0.62,95% CI 0.38 to 0.85; MD = 0.41, 95% CI 0.33 to 0.50, respectively), and in infants
between 28 to 34 weeks of gestation (MD = 0.54, 95% CI 0.21 to 0.87; MD = 0.64, 95% CI 0.45
to 0.82, respectively).
Another study conducted by RCT trial methodology at the University Teaching Hospital in
Lusaka, Zambia Placement of preterm/low birth weight infants inside a plastic bag at birth
compared with standard thermoregulation care reduced hypothermia without resulting in
hyperthermia, and is a low cost. At 1 hour after birth, infants randomized to plastic bag (n = 49)
were more likely to have a temperature in the normal range as compared with infants in the
standard thermoregulation care group (n = 55; 59.2% vs 32.7%; relative risk 1.81; 95%
confidence interval 1.16–2.81; P = .007).
5. Another study presented with RCT design showed that at japan university pediatrics. The mean
admission temperature was significantly higher in the wrap group (35.8 vs 34.8°C, P < 0.01).
Admission hypothermia (axillary temperature <36.5°C) was present in 38 (78%) and 58 (98%)
infants in the wrap and control groups, respectively
Generally, from the above evidence of view we conclude that plastic wraps were prevent hypothermia
which compared with standard care, while during transporting to NICU or immediately after delivery
within two hours. However, when sustainable practice changes are required, careful evaluation and
synthesis of evidence are necessary
Evaluation table
Citation
of a
Single
Study
Theoretical
or
Conceptual
Framework
Study
Design
and
Method
Sample
Characteri
stics
and
Setting
Names
and
Definitions
of Major
Variables
Outcome
s
Measures
Data
Analysis
Finding
s
Level
and
Quality
of
Evidenc
e
McCallEM,
AlderdiceF,
HallidayHL,
JenkinsJG,
VohraS., 2010
None SR
/RCT/
QUACI
RCT
4 trials
n=264
NICU
DV=reduce
hypothermi
a
IV=wrap
with plastic
and
standard
care
Mean
differenc
e(MD),95
% CI
0.57
[0.37,
0.77]
Met
analysis
Chi-
square
SD Level 1
McCall EM,
Alderdice F,
Halliday HL,
Vohra S,
Johnston
L2018
None SR 25 trial
T=3004
I=1480
C=1524
ON NICU
DV=reduce
hypothermi
a
IV=wrap
with plastic
and
standard
care
MD)
0.58°C,
95%
confidenc
e interval
(CI) 0.50
to 0.66
Meta-
analysis
Chi-
square
SD Level 1
Shaojun Li1,
Pengfei Guo,
Qing Zou2,
Fuxiang He,
Feng Xu,
Liping Tan
2016
None SR and
MA
11 trial
T=1503
I=741
C=762
NICU
DV=reduce
hypothermi
a
IV=wrap
with plastic
and
standard
care
MD =
0.57,
95% CI
(0.4 to
0.73)
Meta-
analysis
Chi-
square
SD Level 1
6. Alicia E.
Leadford,
MD,a Jamie B.
Warren, MD,
MPH,b Albert
2013
None RCT T=231
I=119
C=112
NICU
DV=reduce
hypothermi
a
IV=wrap
with plastic
and
standard
care
RR 1.81;
95%
confidenc
e interval
(1.16–
2.81); P =
.007
Chi-
square
test
SD Level 2
Jaafar Rohana,
Wan Khairina,
Nem Yun
Booand Ishak
Shareena2011
None RTC T=110
I=50
C=60
NICU
‘’ (35.8 vs
34.8°C, P
< 0.01).
χ2
Student’s
t-test
SD Level 2
Xiao-jing Hu, Li
Wang, Ru-yi
Zheng1, Tian-
chan Lv. Yu-xia
Zhang, Yun Cao
Guo-ying Huang
2017
None RCT T=108
I=54
C=54
“ RR 0.10;
CL 95%
(0.02–
0.46); P <
0.001)
SD Level 2
DV=dependent variable,
IV independent variable, SD =no significant difference, NICU =neonatal intensive care unit, MA=Meta-
analysis, SD=significant difference, CT=random control group, =necrotizing enter colitis, T=Total, I=
Intervention, C=control
Synthesis table
In preterm/low birth weight neonates (P), how plastic wrap (I) in comparison with standard
thermoregulation (C) to prevent hypothermia within 2 hours immediately after delivery/on
admission to NICU (T).
Study
Author
Year Number of
Participants
Mean
GA(Wks.)
Study
Design
Intervention Major
Finding
That
Addresses
Your
Question
McCall_EM, Alderdice_F,
Halliday_HL, Jenkins_JG,
Vohra_S.
2010 264 29 SR Plastic wrap Reduce
hypothermia
McCall EM, Alderdice F,
Halliday HL, Vohra S,
Johnston L
2018 3004 31 SR Plastic wrap Reduce
hypothermia
John P. Thomas Shaojun
Li1, Pengfei Guo, Qing
2016 1502 30 MA and
SR
Polyethylene
cap or wrap,
Reduced
hypothermia
7. Zou2, Fuxiang He, Feng Xu,
Liping Tan
Polyethylene
plastic sheets
Alicia E. Leadford, MD,a
Jamie B. Warren, MD,
MPH,b Albert 2013
2013 104 26-36 RCT Plastic bag Reduced
hypothermia
Jaafar Rohana, Wan
Khairina, Nem Yun Booand
Ishak Shareena2011
201 110 24-34 RCT polyethylene wrap Reduced
hypothermia
Xiao-jing Hu, Li Wang, Ru-
yi Zheng1, Tian-chan Lv.
Yu-xia Zhang, Yun Cao
Guo-ying Huang
2017
2017 108 24-34 RCT polyethylene
plastic bag
Reduced
hypothermia
Evaluation and synthesis table were used to discussion and comparison multiple studies across the table
for final clinical decision to improve patient outcome. Indeed, the final synthesis evidence should be
implement with clinician experience and patient value with context.