Presneill JJ, Bellomo R, Brickell K, et al, for the TEAM Study Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Protocol and statistical analysis plan for the phase 3 randomised controlled Treatment of Invasively Ventilated Adults with Early Activity and Mobilisation (TEAM III) trial. Crit Care Resusc 2021; 23: 262-72; DOI: 10.51893/2021.3.OA3.
The authors wish to correct errors in the recently published protocol and statistical analysis plan for the TEAM III trial which have been identified before completion of trial data entry and before any trial data analyses.
Page 262: In the section of the Abstract titled “Main outcome measures”, ICU-free days, ventilator-free days, delirium- free days are listed to be reported at both day 28 and day 180. These outcomes will only be reported to day 28. The corrected text should read, “Secondary outcomes include ICU-free days, ventilator-free days and delirium-free days at day 28, all-cause mortality at 28 and 180 days, and functional outcome at 180 days after randomisation” as per the originally published clinicaltrials.gov registration.
Page 265: On Table 2, “Primary and secondary outcomes”, the authors with to correct the formatting and time of reporting:
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The title “Primary and secondary outcomes” should read “Primary outcome, secondary outcomes, process of care measures and mobilisation outcomes” to reflect the contents of Table 2.
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“Time from randomisation until death” at day 28 is listed as a secondary outcome. However, this will only be reported across the total study period, up to day 180.
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Both “Process-of-care measures” and “ICU mobilisation outcomes (censored at ICU discharge if before Day 28)” should be formatted as bold and left aligned, as headings equal to the existing bold headings within the table.
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“ICU-free days, defined as days alive and discharged from ICU” at day 180 is listed as a secondary outcomonly be calculated across the shorter time, from randomisation to day 28. only be calculated across the shorter time, from randomisation to day 28.
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“Ventilator-free days from randomisation” is listed as a secondary outcome to be reported at both 28 days and 180 days after randomisation. This outcome will only be reported to day 28.
Page 267: In the paragraph titled “Pre-specified subgroup analyses of the primary outcome”, the full analysis set median dichotomised APACHE II score, not the median dichotomised APACHE III score, will be used to define a prespecified severity of illness subgroup for exploration of heterogeneity of the trial treatment effect.