Assessment of health-related quality of life, cognitive, physical and psychological impairments in critically ill adults after status epilepticus (POSEIDON 2): protocol for a multicentre longitudinal study.

Status epilepticus in adults is associated with high morbidity and mortality rates, yet comprehensive evaluations of patient-reported outcomes remain lacking in ICU populations.

• Existing functional outcome assessments rely on general scoring systems
• Limited data on health-related quality of life (HRQoL) specifically in ICU-admitted SE patients are available
• Patient-reported physical, cognitive, mental health, and psychological outcomes have not been comprehensively evaluated in this population
• Caregiver burden has not been adequately quantified in this context

The POSEIDON 2 study is designed as a prospective, multicentre, longitudinal study conducted in 19 French ICUs.

• The study combines data from the SE ICTAL Registry with prospectively recruited ICU survivors following status epilepticus
• Patient-reported outcome (PRO) data are collected at 3 months (M3) and 12 months (M12) after ICU discharge
• Validated instruments are used for all PRO assessments
• The study is conducted in accordance with the Declaration of Helsinki, Good Clinical Practice, and French regulatory requirements
• Ethical approval was received from 'Comité de Protection des Personnes Ouest VI' on 5 October 2023 (#2023-A01223-42)

The primary endpoint of POSEIDON 2 is the prevalence of overall HRQoL impairment at 3 and 12 months post-ICU discharge.

• HRQoL impairment is defined by dichotomous scores on the physical and mental components of the 36-Item Short Form Health Survey (SF-36) compared with those of the general population
• Assessments are conducted at both M3 and M12
• The sample size was calculated based on an estimated prevalence of 75% for HRQoL impairment
• A planned sample size of 140 patients was determined based on this estimated prevalence

Secondary endpoints include domain-specific impairments covering cognitive function, dependence, mental health, and patient experiences.

• The Zarit scale is used to measure caregiver burden at M3 and M12
• Secondary endpoints encompass cognitive function, dependence, mental health, and patient experiences
• The study quantifies caregiver burden as a formal study outcome
• Multiple validated instruments are employed to capture the range of secondary outcomes

The study is registered under ClinicalTrials.gov identifier NCT06100978 and requires written informed consent from all participants.

• Participants are able to decline participation or withdraw from the study at any time
• Written informed consent is obtained from all participants
• The study protocol received ethical approval on 5 October 2023
• Findings will be disseminated through peer-reviewed journal publications and scientific conference presentations