ERAC Data Extraction Form

Supplementary Digital Content - Appendix 2: Data Extraction Form

Study Eligibility

Factors / Assessment / Comments
Is the study described as randomised? / Yes / Unclear / No →EXCLUDE
Were participants patients with critical illness? / Yes / Unclear / No →EXCLUDE
Were comparison groups treated with a pharmacological intervention in one group and control in another? / Yes / Unclear / No →EXCLUDE / Subgroups?
Did the study report on pre-specified outcomes? / Yes / Unclear / No →EXCLUDE
Final Decision / INCLUDE / EXCLUDE

Organisational Aspects

Reference ID
Reviewed By
Checked By
Author, Year
Journal or Source
Study ID / Not reported /
Publication Type / Full Text ☐ / Abstract ☐ / Book Chapter ☐ / Internal Paper ☐ / Other ☐
Current Status
Which Reviewer?
Question to clinician?
Question to author? / Status verified with study investigators or sponsor: Yes☐/ No☐
Name of source:
Contact Address:

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Pharmacological Interventions in Critical Illness

Study Intervention Basics

Disease(s) or stage(s) studied
Inclusion criteria
Exclusion criteria / Specials:
Experimental Intervention(s)
Control Intervention(s)
Type of control / Active ☐ / Placebo ☐ / Active + Placebo ☐ / No therapy ☐
Additional treatment / Balanced between treatment arms? Yes ☐ / No ☐
Compliance evaluated? / Yes ☐ / No ☐
Outcomes assessed?
Treatment arms comparable? / Significant differences between arms?
Subgroups evaluated?
Confounders
Sample size / Randomised ☐ / Recruited ☐
Number excluded
Recruitment method
Setting / Intensive Care ☐ / Rehabilitation Unit ☐ / Outpatient ☐ / Unclear ☐ / NR ☐
Location of trial
Recruitment dates
Trial design / Phase: ______
Single centre ☐ / Multi centre ☐ / Equivalence? ☐
International ☐ / National ☐
Multi-arm? Yes ☐ / No ☐ If yes, now many? ______
Length of follow up / From ______to ______
Median: Mean:
Funding / Industry ☐ / Public ☐
Mixed, i.e. supported ☐ [ Drug ☐ / Data ☐ / Travel ☐ / Salary ☐ / Other ☐ ]
Unclear ☐ / NR ☐
Conflict of interest statement / Yes ☐ / No ☐ / NR ☐
Number of groups
Flow diagram / Yes ☐ / No ☐
Method of randomisation / Central ☐/ Public ☐
Methods NR ☐Minimisation ☐/ Inadequate, e.g. DOB, visit ☐
Stratified by: ______BIAS RISK: Low / High / Unclear
Method of concealment of allocation / Adequate ☐Specify: ______
Done + Unclear ☐Not done ☐/ Inadequate, e.g. coloured envelopes
BIAS RISK: Low / High / Unclear
Blinding / Single (patient) ☐/ Double (+physician) ☐/ Triple (+assessor) ☐/ Not poss ☐
BIAS RISK: Low / High / Unclear
Dataset / Complete ☐/ Incomplete ☐Exclusions from analysis: ______
BIAS RISK: Low / High / Unclear
Selective Reporting / Definitely analysed as per protocol ☐/ Protocol unavail but clear published from pre-specified reports ☐/ Not all reported ☐
BIAS RISK: Low / High / Unclear
Primary study aims / NR ☐
Secondary study aims / NR ☐
Outcomes / Statistically significant for primary end point? Yes ☐/ No ☐ p: ______
Statistically significant for secondary end point? Yes ☐/ No ☐ p: ______
If not significant, due to:
☐ Absent evidence of treatment effect (true negative study)
☐ No evidence for absence of treatment, i.e. inconclusive or low-powered
☐ Unclear
Power calculation / Yes ☐ Expected effect: ______/ No ☐
Alpha pre-specified? Yes ☐ / No ☐ Value: ______
Beta pre-specified? Yes ☐ / No ☐ Value: ______
Calculated sample size? Yes ☐ / No ☐ Value: ______
Sample size achieved? Yes ☐ / No ☐
Statistical methods
Analysis / ITT ☐ / As treated ☐ / Per protocol ☐ / Unclear ☐
Definition: Available and acceptable ☐ / Unavailable ☐
Different endpoints with different analysis? Specify?
Stopping rules
Drop outs stated / Yes ☐ / No ☐

Trial Characteristics

Baseline Characteristics

Experimental Arm / Control Arm / Other Arm / Notes or p values
Overall comment / No significant difference ☐
Number of patients
Age / - / - / -
Mean / ± / ± / ±
Median / ± / ± / ±
Ethnicity / NR ☐ / NR ☐ / NR ☐
Male: Female (%) / : / : / :
APACHE-II

Treatment Details according to Study Protocol

Experimental Arm / Control Arm / Other Arm / Notes or p values
Primary intervention
(including dosage, administration)
Timing of Rx
Duration
Important information
Supportive Tx

Treatment Details according to Publication

Experimental Arm / Control Arm / Other Arm / Notes or p values
No. patients screened
No. patients recruited
No. patients allocated
No. patients evaluated
No. patients receiving planned treatment
Reasons for not receiving treatment
No. drop outs
Reasons for drop out
No. protocol violations

Outcome __ of __

Outcome / Primary ☐ / Secondary ☐ / Not defined ☐
Definition of outcome
Timing of assessment
Statistics
Length of follow up
Number of patients evaluated for outcome / All randomised ☐ / Less ☐ ______& / Unclear ☐
Reasons for drop out
Reasons for exclusion
Source of information

Dichotomous data

Outcome / Time / Experimental Arm / Control Arm
Observed events / Sample size / Observed / Sample size
Source / Text, p _____ ☐ / Figure No ______☐ / Table No ______

Continuous data

Outcome / Time / Experimental Arm / Control Arm
Sample size / Mean / S.D. / Sample size / Mean / S.D.
Source / Text, p _____ ☐ / Figure No ______☐ / Table No ______

Methodological Quality

Yes / No / Unclear / Comments
Randomisation
Treatment allocation
Similarity of groups
Concealment
Implementation of blinding
Transparent patient flow
Completeness of dataset
Selective reporting
ITT ( < 15% loss) / Symmetrical loss to f/u ☐
Different drop-out rates for different end points
Treatment preference / ☐ Standard treatment highly preferred
☐ Standard preferred to new therapy
☐ About equal, new therapy a disappointment
☐ About equal, new therapy a success
☐ New therapy preferred to standard
☐ New therapy highly preferred
Type of end-point / Hard, e.g. functional recovery ☐ / Soft, e.g. muscle mass ☐
Summarised validity / ☐ Low risk of bias
☐ Moderate risk of bias
☐ High risk of bias
Comments

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Pharmacological Interventions in Critical Illness

Outcome __ of __