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Table 3 Feasibility criteria of the study

From: Repetitive vascular occlusion stimulus (RVOS) versus standard care to prevent muscle wasting in critically ill patients (ROSProx):a study protocol for a pilot randomised controlled trial

Trial process

Outcome measure

Feasibility criteria

Screening

Percentage of potentially eligible patients being missed

< 55% of potentially eligible patients being missed

Consent

Percentage of personal consultee/participants agreeing to enrolment

> 75% of personal consultees/participants agreeing to enrolment

Recruitment rate

Number of patients recruited

Recruit 30 patients within 16 months

Randomisation

Demographic and severity of illness in the intervention and control arms

Balanced demographic and severity of illness in intervention and control arm participants

Delivery of intervention

Percentage of RVOS sessions performed out of the total possible sessions

80% of the scheduled RVOS sessions performed

Retention rate

Percentage of patients that remain on the ICU for the full 10 days of study enrolment

> 50% of enrolled patients remain on the ICU for the full 10 days of study enrolment

Outcome measure assessments

Percentage of outcome measure assessments performed within 24 h of the scheduled time

Percentage of quality-of-life questionnaires completed at 90-day follow-up

100% of RFCSA ultrasound measurements performed within 24 h of the scheduled time

> 75% of vascular, strength and functional capacity measures performed within 24 h of the scheduled time

> 75% of surviving patients complete the quality-of-life questionnaires at 90-day follow-up

Electronic case report form data collection

Percentage of missing outcome and clinical data

< 10% missing outcome data including ICU and hospital length of stay and survival

< 10% missing clinical data obtained from clinical medical notes and electronic patient records, such as severity of illness scores and requirement for organ supportive therapies

  1. ICU intensive care unit, RFCSA rectus femoris cross sectional area, RVOS repetitive vascular occlusion stimulus