Research interrupted: applying the CONSERVE 2021 Statement to a randomized trial of rehabilitation during critical illness affected by the COVID-19 pandemic

Table 2 Attempted versus completed tasks by intervention delivery in the ICU, primary outcome, and 90-day follow-up

	Patients (n)	Attempted (n/total, %)	Reasons not attempted	Completed (n/total, %)	Reasons not completed
Randomized ICU intervention
Routine PR	5	15/15 (100%) days	N/A	12/15 (80%) days	Patient D/C from ICU before noon^b (n = 2) Therapist workload (n = 1)
Cycling	2	3/5 (60%) days	Research personnel not permitted on site^a (n = 2 days)	2/3 (67%) days	Patient D/C from ICU before noon^b (n = 1)
Outcomes
3-days post-ICU physical function Ax*	6	5/6 (83%) Ax	Research personnel not permitted on site^a (n = 1)	3/5 (60%) Ax	Patient refusal (n = 1) Assessor perceived patient unable^c (n = 1)
90-day Ax	17	17/17 (100%) Ax	N/A	15/17 (88%) Ax	Unable to reach patient or SDM within timeframe (n = 2)

In this table, we summarize the attempted versus completed research activities and associated reasons. We highlight both pandemic and non-pandemic reasons for unsuccessful protocol delivery and outcomes assessments
Abbreviations: PR physical rehabilitation, D/C discharge, ICU intensive care unit, Ax assessment, SDM substitute decision maker
*Primary outcome for the trial
^aUnable to attempt due to COVID reasons
^bThese reasons are within protocol and are not considered to be deviations
^cAssessor perceives the patient is unable to complete an assessment due to safety concerns

ISSN: 1745-6215