Patient Reported Outcomes and Experience Measures in Clinical Trials of Critically Ill Adults with Sepsis: A Scoping Review

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 Randomised 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 18 November 2024. Studies were included if they were: 1) conducted in adult patients admitted to the Intensive Care Unit (ICU) with sepsis; 2) RCTs (or a follow-up study of an RCT); 3) included at least one PROM or PREM; 4) published since 1 January 2000, in English, and available in full text. 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 one 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 one 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 one PREM was identified. HRQoL captured the most survivor-centricity domains.

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Journal
Annals of the American Thoracic Society
Published
2026-04-16
DOI
https://doi.org/10.1093/annalsats/aaoag102
Primary Topic
Sepsis Diagnosis and Treatment
Type
article
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article

Patient Reported Outcomes and Experience Measures in Clinical Trials of Critically Ill Adults with Sepsis: A Scoping Review

Simon R. Finfer, Sheraya De Silva, Kiran Shekar, Jacob Dye et al.
Annals of the American Thoracic Society
Sepsis Diagnosis and Treatment
article

Patient Reported Outcomes and Experience Measures in Clinical Trials of Critically Ill Adults with Sepsis: A Scoping Review

Simon R. Finfer, Sheraya De Silva, Kiran Shekar, Jacob Dye, Kimberley Haines, Elizabeth Hibbert, Andrew Alexander Udy, Hallie C. Prescott, David Pilcher, Carol Lynette Hodgson, Nina Leggett, Glenn M. Eastwood, Alisa M. Higgins, Edward Litton, Lewis Campbell, Evelyn Hutcheon, AM Deane, Alexis Poole, Brett Abbenbroek, Dasom Kim, Rose Messiha, Korina Valentine, Manoj Saxena, Mick O’Dowd
article en

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 Randomised 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 18 November 2024. Studies were included if they were: 1) conducted in adult patients admitted to the Intensive Care Unit (ICU) with sepsis; 2) RCTs (or a follow-up study of an RCT); 3) included at least one PROM or PREM; 4) published since 1 January 2000, in English, and available in full text. 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 one 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 one 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 one PREM was identified. HRQoL captured the most survivor-centricity domains.

Annals of the American Thoracic Society
The Royal Melbourne Hospital (AU), Federation University (AU), The University of Queensland (AU), The University of Melbourne (AU), The University of Western Australia (AU), The George Institute for Global Health (GB), University of Michigan (US), Austin Hospital (AU), Fiona Stanley Hospital (AU), The Alfred Hospital (AU), UNSW Sydney (AU), Menzies School of Health Research (AU), Australian and New Zealand Intensive Care Society (AU), The George Institute for Global Health (AU), VA Center for Clinical Management Research (US), Western Health (AU), Monash Health (AU), St George Hospital (AU), Prince Charles Hospital (AU), Royal Darwin Hospital (AU), St. George Hospital (IN), Imperial College London (GB), Monash University (AU), The University of Adelaide (AU)
Openalex Percentile: Top 15%
Sepsis Diagnosis and Treatment
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