1 exp Cardiac Surgical Procedures/
2 Cardiopulmonary Bypass/
3 cardiac surger$.tw.
4 heart surger$.tw.
5 cardiosurgery.tw.
6 cardiopulmonary bypass$.tw.
7 or/1‐6
8 exp Anti‐Inflammatory Agents/
9 exp Adrenal Cortex Hormones/
10 Mineralocorticoids/
11 steroid$.tw.
12 corticosteroid$.tw.
13 immunosuppress$.tw.
14 predniso$.tw.
15 dexamethason$.tw.
16 methylprednison$.tw.
17 hydrocortiso$.tw.
18 budesonide$.tw.
19 cortiso$.tw.
20 fludrocortiso$.tw.
21 or/8‐20
22 7 and 21
23 limit 22 to "all child (0 to 18 years)"
24 randomized controlled trial.pt.
25 controlled clinical trial.pt.
26 Randomized controlled trials/
27 random allocation.sh.
28 double blind method.sh.
29 single‐blind method.sh.
30 or/24‐29
31 exp animals/ not human/
32 30 not 31
33 clinical trial.pt.
34 exp Clinical trials/
35 (clin$ adj25 trial$).ti,ab.
36 ((singl$ or doubl$ or trebl$ or tripl$) adj (blind$ or mask$)).ti,ab.
37 placebos.sh.
38 placebo$.ti,ab.
39 random$.ti,ab.
40 research design.sh.
41 or/33‐40
42 41 not 31
43 32 or 42
44 43 and 23

1 exp heart surgery/
2 Cardiopulmonary Bypass/
3 cardiac surger$.tw.
4 heart surger$.tw.
5 cardiosurgery.tw.
6 cardiopulmonary bypass$.tw.
7 or/1‐6
8 exp Antiinflammatory Agent/
9 exp Corticosteroid/
10 steroid$.tw.
11 corticosteroid$.tw.
12 immunosuppress$.tw.
13 predniso$.tw.
14 dexamethason$.tw.
15 methylprednison$.tw.
16 hydrocortiso$.tw.
17 budesonide$.tw.
18 cortiso$.tw.
19 fludrocortiso$.tw.
20 or/8‐19
21 7 and 20
22 clinical trial/
23 random$.tw.
24 randomized controlled trial/
25 trial$.tw.
26 follow‐up.tw.
27 double blind procedure/
28 placebo$.tw.
29 placebo/
30 factorial$.ti,ab.
31 (crossover$ or cross‐over$).ti,ab.
32 (double$ adj blind$).ti,ab.
33 (singl$ adj blind$).ti,ab.
34 assign$.ti,ab.
35 allocat$.ti,ab.
36 volunteer$.ti,ab.
37 Crossover Procedure/
38 Single Blind Procedure/
39 or/22‐38
40 (exp animal/ or exp animal experiment/ or exp nonhuman/) not exp human/
41 39 not 40
42 21 and 41
43 limit 42 to (infant <to one year> or child <unspecified age> or preschool child <1 to 6 years> or school child <7 to 12 years> or adolescent <13 to 17 years>)

19 #7 and #18
#18 #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17
#17 budesonide*
#16 fludrocortiso*
#15 hydrocortison*
#14 betamethasone
#13 cortiso*
#12 methylprednison*
#11 predniso*
#10 dexamethason*
#9 corticosteroid*
#8 steroid*
#7 #1 or #2 or #3 or #4 or #5 or #6
#6 septal defect*
#5 congenital heart
#4 cardiopulmonary bypass
#3 cardiac surgery
#2 heart surgery
#1 cardiosurgery

Questions

Answers

AUTHORS

PUBLICATION ID

YEAR OF PUBLICATION

LANGUAGE

TYPE OF STUDY

COMMENTS ON STUDY DESIGN
Allocation was concealed and drawn consequetively
Disclosure of Allocation was Possible
Allocation concealment was not stated or was unclear
Allocation was not concealed (e.g quasi ‐randomisation)

Inclusion and exclusion criteria were clearly defined in the text?
Inclusion and exclusion criteria were not clearly defined in the text?

Outcomes of patients who withdrew or were excluded from after allocation
were either detailed seperately or included in an intention to treat analysis
or the text stated that there were no withdrawals.

Outcome of patients who withdrew or were excluded after allocation were
NEITHER detailed sperately nor included in an intention to treat analysis

Treatment and control groups were adequately described at entry (a minimum of 4 admission details were described (age,sex,weight,allergies)

Treatment and control groups were NOT adequately described at entry

The text stated that the care programmes other than the trial options were identical
The text stated that the care programmes other than the trial options were NOT identical

Outcome measures were clearly defined in the text
Outcome measures were NOT clearly defined in the text

Outcome assessors were blind to the allocation of patients
Outcome assessors were NOT blind to the allocation of patients

The timing of outcome measures was appropriate
The timing of outcome measures was NOT appropriate

Yes No Unclear
Yes No Unclear

METHODS:
Physician‐ Blinded
Outcome assessor blinded

Yes No Unclear
Yes No Unclear

PARTICIPANTS:
Number of eligible participants
Number enrolled in study
Number Males : Females
Age range
Type of surgery

Were groups similar at entry

Yes No Unclear

INTERVENTION
Steroid type
Dose
Withdrawals : total number
Drop outs: total number
Included in analysis:

Yes No Unclear
Yes No Unclear

Yes No Unclear

COMMENT ON TREATMENT

OUTCOMES: (mean values for continuous data)

Reported treatment group SD
Reported control group SD
Mortality %
Duration of ventilation (hours:mins)
Need for renal dysfunction %
Length of Stay ICU (days)
Capillary Leak %
Temperature %
Inotrope therapy (> 3 agents ) %

Authors contacted regarding unreported outcome data
Date contacted
Response received

Yes No Unclear

COMMENTS ON OUTCOMES