Electronic Patient‐Reported Health‐Related Quality of Life Trajectories in ICU Survivors: A Multicentre Pilot Study‐Within‐a‐Trial Protocol

ABSTRACT Background Patient‐important outcomes beyond mortality, particularly health‐related quality of life (HRQoL), are frequently used in intensive care unit (ICU) trials. However, HRQoL assessment remains challenging due to methodological complexities, including poorly defined recovery trajectories, lack of consensus on measurement instruments, complexity of statistical analysis, and missing data. Electronic patient‐reported outcomes (ePROs) may improve data collection and efficiency, though their feasibility in ICU survivors is uncertain. Methods This protocol outlines a longitudinal, multicentre pilot study‐within‐a‐trial aimed at evaluating the feasibility of ePRO‐based HRQoL follow‐up and exploring a trajectory‐based approach to HRQoL characterisation after critical illness. We plan to enrol 100 participants already undergoing 180‐day HRQoL follow‐up in the Intensive Care Platform Trial (INCEPT) to complete monthly EQ‐5D‐5L surveys delivered by text messages from 6 to 12 months after randomisation. Feasibility outcomes include enrolment and response rate, time to completion, reminder‐dependency, attrition pattern, agreement between modes of collection, and accessibility. Agreement between telephone‐ and ePRO‐based assessments at 180 days will be evaluated at the group and at the individual level. Longitudinal EQ‐5D‐5L index values and visual analogue scale trajectories will be analysed using area‐under‐the‐curve methods based on linear interpolation. Scenario‐based sensitivity analyses will assess the potential impact of unobserved mortality among dropouts. Discussion We hypothesise that ePRO‐based repeated assessments of HRQoL will support the goal of optimised data collection methods, while ensuring resources control. Moreover, identification of a candidate approach to HRQoL characterisation may shed light into the full recovery trajectory of ICU survivors and improve the interpretation and clinical relevance of HRQoL outcome assessments.