Objectives: To critically evaluate the comparative effects of open or flexible family presence policies vs. restricted or traditional family presence policies on the occurrence of delirium and other major outcomes among adult patients admitted to ICUs. Data Sources: We conducted a comprehensive electronic search of MEDLINE, Embase, Scopus, Web of Science, CINAHL, and the Cochrane Central Register of Controlled Trials from inception to November 21, 2025. Study Selection: We included randomized controlled trials (RCTs) comparing open or flexible vs. restricted ICU visiting policies in adult patients. Data Extraction: The primary outcome extracted was delirium occurrence. Secondary outcomes included the duration of invasive mechanical ventilation (IMV), ICU length of stay, hospital-acquired infections, and ICU mortality. Data Synthesis: Thirteen RCTs comprising 3861 patients were included. Random-effects models showed that compared with restricted policies, open/flexible family presence reduced delirium occurrence (risk ratio [RR], 0.48; 95% CI, 0.29–0.81; low certainty) and IMV duration (mean difference [MD], –0.36 d; 95% CI, –0.46 to –0.26 d; low certainty). The intervention did not affect the ICU length of stay (MD, 4.21 d; 95% CI, –4.65 to 13.07 d; very low certainty), the rates of hospital-acquired infections (RR, 1.00; 95% CI, 0.81–1.23; low certainty), or ICU mortality (RR, 0.88; 95% CI, 0.72–1.08; very low certainty). Conclusions: Open/flexible ICU family presence may reduce delirium and shorten the duration of IMV slightly, without increasing infections or ICU mortality, although the certainty of evidence is low and heterogeneity remains substantial.
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