Citations

OBJECTIVES: This study aimed to establish a set of guiding principles for data sharing and harmonization in critical care, focusing on the use of real-world data (RWD) and real-world evidence (RWE) to improve patient outcomes and research efficacy. The principles were developed through a systematic literature review and a modified Delphi process, with the goal of enhancing data accessibility, standardization, and interoperability across critical care settings. DATA SOURCES: Data sources included a comprehensive search of peer-reviewed literature, specifically studies related to the use of RWD and RWE in healthcare, guidelines, best practices, and recommendations on data sharing and harmonization. A total of 8150 articles were initially identified through databases such as MEDLINE and Web of Science, with 257 studies meeting inclusion criteria. STUDY SELECTION: Inclusion criteria focused on publications discussing health-related informatics, recommendations for RWD/RWE usage, data sharing, and harmonization principles. Exclusion criteria ruled out non-human studies, case studies, conference abstracts, and articles published before 2013, as well as those not available in English. DATA EXTRACTION: From the 257 selected studies, 322 statements were extracted. After removing irrelevant definitions and off-topic content, 232 statements underwent content validation and thematic analysis. These statements were then consolidated into 24 candidate guiding principles after rigorous review and consensus-building among the expert panel. DATA SYNTHESIS: A three-phase modified Delphi process was employed, involving a conceptualization group, a review group, and a Delphi group. In phase 1, experts identified key themes and search terms for the systematic review. Phase 2 involved validating and refining the prospective guiding principles, while phase 3 employed a Delphi panel to rate principles on acceptability, importance, and feasibility. This process resulted in 24 guiding principles, with high consensus achieved in rounds 2 and 3 on their relevance and applicability. CONCLUSIONS: The systematic review and Delphi process resulted in 24 guiding principles to improve data sharing and harmonization in critical care. These principles address challenges across the data lifecycle, including generation, storage, access, and usage of RWD and RWE. This framework is designed to promote more effective and equitable data practices, with relevance for the development of artificial intelligence-based decision support tools and clinical research. The principles are intended to guide the responsible use of data science in critical care, with emphasis on ethics and equity, while acknowledging the variability of resources across settings.

OBJECTIVES: To develop the first core Critical Care Data Dictionary (C2D2) with common data elements (CDEs) to characterize critical illness and injuries. DESIGN: Group consensus process using modified Delphi approach. SETTING: Electronic surveys and in-person meetings. SUBJECTS: A multidisciplinary workgroup of clinicians and researchers with expertise in the care of the critically ill and injured. INTERVENTIONS: The Delphi process was divided into domain and CDE portions with each composed of two item generation rounds and one item reduction/refinement rounds. Two in-person meetings augmented this process to facilitate review and consideration of the domains and by panel members. The final set of domains and CDEs was then reviewed by the group to meet the competing criteria of utility and feasibility, resulting in the core dataset. MEASUREMENTS AND MAIN RESULTS: The 23-member Delphi panel was provided 1833 candidate variables for potential dataset inclusion. The final dataset includes 226 patient-level CDCs in nine domains, which include anthropometrics and demographics (8), chronic comorbid illnesses (18), advanced directives (1), ICU diagnoses (61), diagnostic tests (42), interventions (27), medications (38), objective assessments (26), and hospital course and outcomes (5). Upon final review, 91% of the panel endorsed the CDCs as meeting criteria for a minimum viable data dictionary. Data elements cross the lifespan of neonate through adult patients. CONCLUSIONS: The resulting C2D2 provides a foundation to facilitate rapid collection, analyses, and dissemination of information necessary for research, quality improvement, and clinical practice to optimize critical care outcomes. Further work is needed to validate the effectiveness of the dataset in a variety of critical care settings.

Introduction: Data on outcomes between unfractionated heparin and bivalirudin anticoagulation during percutaneous coronary intervention (PCI) in acute coronary syndromes remain inconclusive. We aimed to systematically analyze PCI outcomes by comparing unfractionated heparin and bivalirudin. Methods: We systematically searched Ovid MEDLINE, Ovid Embase, Ovid Cochrane Database of Systematic Reviews, Scopus, and Web of Science from database inception in 1966 through January 2024 for studies evaluating PCI outcomes comparing unfractionated heparin and bivalirudin. Two investigators independently reviewed the data. Conflicts were resolved through consensus. Random-effects meta-analyses were used. Results: A total of 10 prospective trials were identified that enrolled 42,253 individuals who presented with an acute coronary syndrome. Our analysis found that heparin when compared to bivalirudin was associated with an increased risk of trial-based definition of major bleeding [relative risk (RR): 1.68, 95% confidence interval (CI): 1.29–2.20], nonaccess site complications (RR: 4.6, 95% CI: 1.75–12.09), thrombolysis in myocardial infarction major bleeding (RR: 1.70, 95% CI: 1.20–2.41), major bleeding risks (RR: 1.87, 95% CI: 1.49–2.36), cardiovascular disease death (RR: 1.26, 95% CI: 1.02–1.57), and thrombocytopenia (RR: 1.67, 95% CI: 1.07–2.62). There were no statistically significant differences between heparin and bivalirudin for all-cause mortality, major adverse cardiovascular event, stroke, reinfarction, target vessel revascularization, and acute or stent thrombosis. Conclusions: The present meta-analysis demonstrates bivalirudin reduces major bleeding when used for anticoagulation during PCI in patients with acute coronary syndromes and is not associated with an increased risk of stent thrombosis or major adverse cardiovascular event.

Purpose: To report a rare case of multifocal chorioretinitis subsequent to intravesical Bacillus Calmette-Guerin therapy for bladder cancer. Methods: Case report. Results: A 74-year-old man presented with ill-defined visual changes in his right eye, along with constitutional symptoms such as low-grade fever, chills with rigors, night sweats, headache, dry cough, memory problems, and unintentional weight loss. These symptoms occurred 11 months after receiving intravesical Bacillus Calmette-Guerin treatment for bladder cancer. His visual acuity in the right eye was 20/30. Examination of his right eye revealed multiple yellow white chorioretinal lesions, and optical coherence tomography imaging showed focal involvement of the choroid and overlying neurosensory retina. Blood-based testing using next-generation sequencing for detection of microbial cell free DNA (Karius test) was positive for Mycobacterium tuberculosis complex. The patient was treated with 12 months of triple therapy consisting of isoniazid, rifampin, and ethambutol. The chorioretinal lesions showed complete regression to flat scars, with no evidence of recurrence 15 months after discontinuation of systemic treatment. Conclusion: Despite being rare, the possibility of mycobacterial chorioretinitis should be considered in patients with new-onset visual symptoms after intravesical Bacillus Calmette-Guerin treatment for bladder cancer.

RATIONALE: Critically ill adults are at risk for a variety of distressing and consequential symptoms both during and after an ICU stay. Management of these symptoms can directly influence outcomes. OBJECTIVES: The objective was to update and expand the Society of Critical Care Medicine’s 2018 Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. PANEL DESIGN: The interprofessional inclusive guidelines task force was composed of 24 individuals including nurses, physicians, pharmacists, physiotherapists, psychologists, and ICU survivors. The task force developed evidence-based recommendations using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. Conflict-of-interest policies were strictly followed in all phases of the guidelines, including task force selection and voting. METHODS: The task force focused on five main content areas as they pertain to adult ICU patients: anxiety (new topic), agitation/sedation, delirium, immobility, and sleep disruption. Using the GRADE approach, we conducted a rigorous systematic review for each population, intervention, control, and outcome question to identify the best available evidence, statistically summarized the evidence, assessed the quality of evidence, and then performed the evidence-to-decision framework to formulate recommendations. RESULTS: The task force issued five statements related to the management of anxiety, agitation/sedation, delirium, immobility, and sleep disruption in adults admitted to the ICU. In adult patients admitted to the ICU, the task force issued conditional recommendations to use dexmedetomidine over propofol for sedation, provide enhanced mobilization/rehabilitation over usual mobilization/rehabilitation, and administer melatonin. The task force was unable to issue recommendations on the administration of benzodiazepines to treat anxiety, and the use of antipsychotics to treat delirium. CONCLUSIONS: The guidelines task force provided recommendations for pharmacologic management of agitation/sedation and sleep, and nonpharmacologic management of immobility in critically ill adults. These recommendations are intended for consideration along with the patient’s clinical status.