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Cochrane Database of Systematic Reviews Protocol - Intervention

Prophylactic corticosteroids for pediatric open heart surgery

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Table 1. Data Extraction Form

Questions

Answers

AUTHORS

PUBLICATION ID

YEAR OF PUBLICATION

LANGUAGE

TYPE OF STUDY

COMMENTS ON STUDY DESIGN
Allocation was concealed and drawn consecutively
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 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 seperately 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

Figures and Tables -
Table 1. Data Extraction Form