Patient-reported Outcome and Patient-reported Experience After Status Epilepticus

Официальное название

Patient-reported Outcomes in Status Epilepticus Requiring Intensive Care Unit Management. A Multicenter Longitudinal Cohort Study

Обзор

Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. The proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory SE. Morbidity is more difficult to evaluate, as adverse effects of SE are often difficult to differentiate from those attributed to the cause of SE. Our experience suggests that nearly 50% of patients may experience long-term functional impairments. The precise description of the consequences of these functional impairments and their impact on quality of life after SE requiring intensive care management has been little studied. Indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term postresuscitation syndrome (PICS), neuronal lesions consecutive to the SE itselfor to its cause could be responsible for these different functional alterations. Thus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress. Assessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. The POSEIDON study was a cross-sectional collection of PROs and HR-QOL components, and associated with patient functional outcomes, in those who required ICU management for status epilepticus. We propose here to continue the description of potential alterations after a subsequent ME, namely a longitudinal study (POSEIDON 2) which will also include the evaluation of patient-reported experience (PREMS) and the measurement of family burden.

Первичные конечные точки

• percentage of global impairment of HRQoL [Срок оценки: at 3 month and 12 month]

Вторичные конечные точки (9)

• percentage of cognitive impairment in patients managed in the ICU for or with SE [Срок оценки: at 3 month and 12 month]
• percentage of disability in patients managed in the ICU for or with SE [Срок оценки: at 3 month and 12 month]
• percentage of physical dependency in patients managed in the ICU for or with SE [Срок оценки: at 3 month and 12 month]
• percentage of anxiety and depression in patients managed in the ICU for or with SE [Срок оценки: at 3 month and 12 month]
• percentage of post traumatic syndrome disorder in patients managed in the ICU for or with SE [Срок оценки: at 3 month and 12 month]
• score of perceived social support by the SSQ6 scale in its 2 dimensions, satisfaction and availability. [Срок оценки: at 3 month and 12 month]
• Presence or absence Post-ICU factors associated of return to work ability in patients managed in the ICU for or with SE. [Срок оценки: at 3 month and 12 month]
• patient's experience of the care system. [Срок оценки: at 3 month and 12 month]
• experience of the patient's relative at M3 and M12 of discharge from intensive care following management with or for a patient's ME. [Срок оценки: at 3 month and 12 month]

Критерии участия

Критерии включения

• Adults 18 years old or older
• Patients previously included in the ICTAL registry (Status Epilepticus cohort NCT03457831)
• Survivors after ICU management for Status Epilepticus More than 3 months and less than 5 years after ICU discharge

Критерии исключения

• Legal guardianship
• Opposition to participate
• Unread and unwritten French language
• Patient not affiliated to a Social Security system

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 19 центров

• CH d'Angoulême — Angoulême
• CH d'Arras — Arras
• CHU de Besançon — Besançon
• CH de Béthune — Béthune
• CHU de Brest — Brest
• CH de Cannes — Cannes
• Hôpital Beaujon — Clichy
• Hôpital Henri Mondor — Créteil
• … и ещё 11 центров

Публикации

• Legriel S, Bernard C, Sboui G, Sigaud F, Lascarrou JB, Mayenco-Cardenal N, Chelly J, Bruel C, Mongardon N, Marzouk M, Quenot JP, Hugues R, Schnell D, Beuret P, Bailly P, Lesieur O, Argaud L, Chambon R, Jacq G. 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 lon PMID 41775483

Идентификаторы

NCT: NCT06100978 · P22/08 - POSEIDON 2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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