Disparities between randomized clinical trial participants and sepsis patients in real-world

• Published in: Journal of critical care 2023-10, Vol.77, p.154362-154362, Article 154362
• Main Authors: Bai, Xue, Zeng, Peng, Wang, Bo, Zhang, Zhongwei, Jin, Xiaodong, Kang, Yan, Cheng, Yisong, Wu, Qin
• Format: Article
• Language: English
• Subjects: Age; Chronic illnesses; Chronic obstructive pulmonary disease; Clinical medicine; Comorbidity; Epidemiology; External validity; Infections; Intensive care; Kidney diseases; Mortality; Patient admissions; Physiology; Renal replacement therapy; Sepsis
• ISSN: 0883-9441; 1557-8615
• DOI: 10.1016/j.jcrc.2023.154362

The external validity or “generalizability” of randomized controlled trials (RCTs) often needs be considered when making treatment decisions. We evaluate whether participants in large multicenter RCTs investigating sepsis were similar in age, disease severity, comorbidities, and mortality to the general population of sepsis patients. Using MEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials, RCTs that enrolled 100 or more adult sepsis patients from two or more sites published from 01 January 2000 to 04 August 2019 were identified. The weighted mean age of trial participants was calculated as the main variable, and it was compared with the mean ages of the overall populations derived from the MIMIC database and the EICU database. Two researchers independently screened all abstracts and performed data extraction, then aggregated the data using a random effects model. Multiple linear regression was used to determine whether any factors were significantly associated with age disparities. The mean age of the 60,577 participants in the 94 trials included in the analysis was significantly lower than those of the patients in the MIMIC and EICU databases (weighted mean age 62.28 years vs. 64.47 years for MIMIC and 65.20 years for EICU; both p