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Patient-reported outcomes and experience measures in clinical trials of critically ill adults with sepsis: a scoping
Elizabeth Hibbert1, Nina Leggett1,2, Dasom Kim3
1Department of Critical Care, School of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
Abstract:
Sepsis survivors may experience ongoing health challenges after hospitalization for sepsis. Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are important endpoints to assess patient health status and health system performance. This review aimed to (1) identify and describe the PROMs and PREMs used in randomized controlled trials (RCTs) of critically ill adults with sepsis and (2) determine the "survivor-centricity" of these measures. MEDLINE, Embase, CINAHL Plus, and PsycINFO were searched on November 18, 2024. Studies were included if they (1) were conducted in adult patients admitted to the intensive care unit (ICU) with sepsis; (2) were RCTs (or a follow-up study of an RCT); (3) included at least 1 PROM or PREM; and (4) were published since January 1, 2000, in English, and available in full text. A total of 7667 studies were screened for eligibility. Eighteen studies were included (n = 21 439 patients). Nine (50%) studies were RCTs, and 9 (50%) were RCT follow-up studies. A total of 21 PROMs, and 1 PREM were identified in these 18 studies. The most common PROM was health-related quality of life (HRQoL), measured in 17 (94%) studies, via the EuroQol-5D-5L (n = 10, 56%). Most PROMs (n = 13, 62%) were aligned with the survivor-centricity health domain of psychological impairment. Only 1 study reported a PREM that captured the patient experience of chronic care. In RCTs of patients admitted to the ICU with sepsis, HRQoL was the most frequently measured PROM. Only 1 PREM was identified. Health-related QoL captured the most survivor-centricity domains. INPLASY Registration: INPLASY (International Platform of Registered Systematic Reviewsand Meta-Analysis Protocols), INPLASY Protocol 5756 - INPLASY, INPLASY202410064.
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