飯塚 悠祐

IMPORTANCE: The optimal intensity of care for older patients (age ≥80 years) in intensive care units (ICUs) remains uncertain. Although institutional variation in critical care practice has been described, less is known about case-mix-adjusted variation in life-sustaining treatment use among older patients admitted to ICUs and whether greater institutional treatment intensity is associated with improved survival. OBJECTIVE: To quantify institutional variation in the use of life-sustaining treatments for older patients among ICUs and examine the association of treatment intensity with in-hospital mortality. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used nationwide data from the Japanese Intensive Care Patient Database (JIPAD) for patients aged 80 years or older admitted to 127 ICUs at JIPAD-participating institutions in Japan between April 1, 2015, and March 31, 2023. EXPOSURES: Intensive care unit admission and age 80 years or older. MAIN OUTCOMES AND MEASURES: Institutional treatment intensity was quantified using standardized treatment ratio (STR), defined as the ratio of observed-to-expected life-sustaining treatment use after adjustment for patient-level characteristics. The association between STR category and in-hospital mortality was evaluated using both logistic regression and hierarchical bayesian multilevel logistic regression models. RESULTS: Among 60 713 patients (median age, 84 years [IQR, 82-87 years]; 32 302 male [53.2%]), the crude institutional rate of life-sustaining treatment use ranged from 4.8% (8 of 167 patients) to 38.0% (322 of 847 patients). After adjustment for patient case mix, the STR ranged from 0.24 (95% CI, 0.11-0.48) to 2.34 (95% CI, 1.91-2.85) across participating ICUs. In multilevel analyses adjusted for patient- and institution-level factors, higher institutional treatment intensity was not associated with in-hospital survival compared with intermediate treatment intensity (high STR category: odds ratio, 1.17; 95% credible interval, 0.91-1.39). CONCLUSIONS AND RELEVANCE: In this cohort study of older patients admitted to ICUs, institutional use of life-sustaining treatments varied substantially even after case-mix adjustment and higher institutional treatment intensity was not associated with better in-hospital survival. These findings suggest that increasing treatment intensity alone may not be associated with improved outcomes in this population and support the need for better approaches to identify patients most likely to benefit from intensive treatment.

INTRODUCTION: With the rapid increase in the ageing population, the use of procedural sedation and analgesia (PSA) for diagnostic procedures such as prostate biopsy in older adults is increasing. However, elderly patients are particularly susceptible to respiratory depression during PSA testing and have a significantly higher risk of hypoxaemia during procedures requiring deep sedation. Although propofol combined with fentanyl is commonly used, it frequently causes hypoxaemia and apnoea. Remimazolam, a novel ultrashort-acting benzodiazepine, may be a safer alternative with less respiratory compromise; however, the supporting evidence remains limited. This study aims to assess whether remimazolam combined with fentanyl reduces the incidence of respiratory depression compared with propofol combined with fentanyl in elderly patients undergoing prostate biopsy under deep sedation requiring immobility. METHODS AND ANALYSIS: This is a single-centre, participant and assessor-blinded (with pragmatic blinding of participants), parallel-group, superiority randomised controlled trial conducted at the Jichi Medical University Saitama Medical Centre, Japan. Eligible participants are men aged ≥70 years who are scheduled to undergo prostate biopsy under intravenous sedation. Participants will be randomised in a 1:1 ratio to receive either remimazolam or propofol, each administered in combination with fentanyl at a fixed effect-site concentration. The primary outcome is the incidence of severe apnoea (≥1 min). The primary analysis will follow the intention-to-treat principle, implemented practically as a full analysis set analysed using a complete case approach. Sensitivity analyses will include a per-protocol analysis and multiple imputations of missing data. A subgroup analysis of patients aged ≥75 years was performed. ETHICS AND DISSEMINATION: This study was approved by the Jichi Medical University Central Clinical Research Ethics Committee (approval number: 24JMU001S-2) and was registered with the Japan Registry of Clinical Trials on 11 November 2024. Written informed consent was obtained from all participants before enrolment. These findings will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBER: jRCTs031240478.