Julia D Cartwright, Moshiur Rahman, Blythe Pollack, Stephen M Gorga, Kristen A Smith, Hallie C Prescott, Erin F Carlton
{"title":"Healthcare Encounters in the Week Preceding a Sepsis Hospitalization in Pediatric Patients.","authors":"Julia D Cartwright, Moshiur Rahman, Blythe Pollack, Stephen M Gorga, Kristen A Smith, Hallie C Prescott, Erin F Carlton","doi":"10.1097/CCM.0000000000007336","DOIUrl":"https://doi.org/10.1097/CCM.0000000000007336","url":null,"abstract":"<p><strong>Objectives: </strong>Sepsis is a leading cause of morbidity and mortality for critically ill children, yet the pattern of healthcare use before admission for sepsis remains unknown. We measured the proportion and characteristics of healthcare encounters within 7 days before sepsis hospitalizations.</p><p><strong>Design: </strong>Using the Merative MarketScan administrative claims database, we conducted a retrospective observational cohort study to quantify pre-admission healthcare encounters among children hospitalized with sepsis.</p><p><strong>Setting: </strong>The Merative MarketScan database includes inpatient, outpatient, and emergency medical claims from employer-based insurance plans and Medicaid data from approximately 7 million healthcare consumers across multiple states.</p><p><strong>Patients: </strong>Included patients were 0-18 years old and hospitalized with sepsis between January 1, 2016, and December 31, 2022. Children were required to have 30 days of continuous insurance enrollment before admission.</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>Our primary outcome was the occurrence of any healthcare encounter in the 7 days before sepsis hospitalization, including outpatient, emergency department, or inpatient visits. Of those encounters, we identified the proportion that were related to infection. We compared hospitalization characteristics, including mechanical ventilation, ICU use, and length of stay, among those with vs. without pre-sepsis healthcare utilization. We identified 6928 pediatric sepsis hospitalizations, of whom 64.3% (4452/6928) had a complex chronic condition with a median age of 10 years (interquartile range, 3-15 yr). Overall, 53.5% (3707/928) of sepsis hospitalizations had a healthcare encounter within 7 days of admission, including 33.7% (2338/6928) with an outpatient visit, 28.2% (1956/6928) with an emergency department visit, and 6.2% (431/6928) with an inpatient hospitalization. Among sepsis hospitalizations with any pre-admission encounter, 38.9% (1445/3707) had an infection-related diagnosis documented at the encounter. There was no difference in mechanical ventilation, ICU use, or length of stay between those with vs. without pre-sepsis healthcare encounters.</p><p><strong>Conclusions: </strong>Over half of children hospitalized with sepsis were evaluated in the outpatient or emergency department setting in the week preceding admission, with one in five evaluated for infection. Further understanding of these pre-admission encounters may allow for earlier sepsis identification and possibly intervention in the prehospital setting.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2026-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148890990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Rethinking Where Gender Gaps in Critical Care Authorship Really Lie.","authors":"Fatima Sheikh, Kirsten M Fiest","doi":"10.1097/CCM.0000000000007347","DOIUrl":"https://doi.org/10.1097/CCM.0000000000007347","url":null,"abstract":"","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2026-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148891004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Counting Sepsis: The Epidemiology of a Syndrome.","authors":"Olaf L Cremer","doi":"10.1097/CCM.0000000000007352","DOIUrl":"https://doi.org/10.1097/CCM.0000000000007352","url":null,"abstract":"","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2026-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148890948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Vladyslav Dieiev, Pedro D Salinas, Felipe Teran, Clark G Owyang, Dylan Rupska, Aniruddh Kapoor, Zubair Siddiqui, Daniel Strama, Cindy Ndiaye, Nathaniel A Sands, Aarthi Kaviyarasu, Katharine M Burns
{"title":"Feasibility and Operator-Reported Utility of Transesophageal Lung Ultrasound As an Adjunct to Resuscitative Transesophageal Echocardiography in the Evaluation of Shock: A Multicenter Observational Study.","authors":"Vladyslav Dieiev, Pedro D Salinas, Felipe Teran, Clark G Owyang, Dylan Rupska, Aniruddh Kapoor, Zubair Siddiqui, Daniel Strama, Cindy Ndiaye, Nathaniel A Sands, Aarthi Kaviyarasu, Katharine M Burns","doi":"10.1097/CCM.0000000000007337","DOIUrl":"https://doi.org/10.1097/CCM.0000000000007337","url":null,"abstract":"<p><strong>Objectives: </strong>To describe the utilization, feasibility, and operator-reported diagnostic and management impact of transesophageal lung ultrasound (TELUS) integrated into resuscitative transesophageal echocardiography (TEE) for the assessment of mechanically ventilated adults with shock.</p><p><strong>Design: </strong>Multicenter observational cohort study using prospectively collected data.</p><p><strong>Setting: </strong>Twenty-three hospitals from the Resuscitative Transesophageal Echocardiography Collaborative Registry (rTEECoRe) network.</p><p><strong>Patients: </strong>From 1213 registry TEE examinations, 379 met the inclusion criteria for shock evaluation or hemodynamic monitoring in mechanically ventilated adults; 96 (25.3%) of these included TELUS.</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>TELUS integration was associated with significantly higher operator-reported identification of shock etiology compared with resuscitative TEE alone (86.5% vs. 75.3%; odds ratio [OR], 1.95; 95% CI, 1.02-3.72; p = 0.04). Although overall clinical management changes were more frequently reported in the TELUS group, this difference did not reach statistical significance (78.1% vs. 71.7%; OR, 1.40; 95% CI, 0.82-2.41; p = 0.22). TELUS examinations were associated with longer procedure duration (median 21.5 vs.19.0 min; p = 0.01) and were predominantly performed by intensivists. Pulmonary findings, including B-lines, pleural effusions, consolidations, and A-line patterns, varied in frequency and were occasionally associated with specific respiratory or antimicrobial interventions. Procedure-related complications were rare and similar between groups.</p><p><strong>Conclusions: </strong>In this multicenter cohort of mechanically ventilated adults with shock, adding TELUS to resuscitative TEE was associated with a higher rate of operator-reported identification of shock etiology and was feasible with minimal additional procedure time. Prospective studies with standardized TELUS acquisition and interpretation, independent adjudication, and evaluation of patient-centered outcomes are needed to define clinical scenarios of incremental value.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2026-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148890972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kaylee T Stebbins, Chun Yee Yap, Lois Segun-Beloved, Alexandra M Hodgson, Anais Charles-Nelson, Ary Serpa Neto, Jayatee Banerjee, Lane Meredith, Lorena Romero, Vicki Papanikolaou, Zhomart Orman, Carol L Hodgson, Alisa M Higgins
{"title":"Long-Term Mortality and Functional Outcomes After Extracorporeal Membrane Oxygenation in Critically Ill Adults: A Systematic Review and Meta-Analysis.","authors":"Kaylee T Stebbins, Chun Yee Yap, Lois Segun-Beloved, Alexandra M Hodgson, Anais Charles-Nelson, Ary Serpa Neto, Jayatee Banerjee, Lane Meredith, Lorena Romero, Vicki Papanikolaou, Zhomart Orman, Carol L Hodgson, Alisa M Higgins","doi":"10.1097/CCM.0000000000007318","DOIUrl":"https://doi.org/10.1097/CCM.0000000000007318","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate long-term all-cause mortality and functional outcomes among critically ill adults treated with extracorporeal membrane oxygenation (ECMO), including differences by ECMO modality and clinical indication.</p><p><strong>Data sources: </strong>Ovid MEDLINE, Embase, Emcare, Central Register of Controlled Trials, and Scopus were searched to March 2025.</p><p><strong>Study selection: </strong>Randomized controlled trials and observational studies reporting mortality or functional outcomes at or beyond 6 months in adults receiving ECMO were eligible for inclusion.</p><p><strong>Data extraction: </strong>A systematic review and meta-analysis were conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines and prospectively registered with PROSPERO (CRD420251002639). Two reviewers independently extracted data. Mortality was pooled using random-effects meta-analysis with 95% CIs. Prespecified subgroup analyses examined ECMO modality and clinical indication. Sensitivity analyses assessed the impact of missing outcome data. Functional outcomes were narratively synthesized due to heterogeneity.</p><p><strong>Data synthesis: </strong>A total of 163 studies including 78,053 adults met inclusion criteria, with 59,454 adults in 156 of 163 studies (95.7%) contributing to mortality meta-analyses. At 1 year, pooled mortality was 37.2% (95% CI, 30.0-45.1%) in 13 of 33 venovenous ECMO studies (39.4%), 55.2% (95% CI, 50.2-60.1%) in 42 of 55 venoarterial ECMO studies (76.4%), and 74.4% (95% CI, 71.4-77.2%) in 14 of 24 (58.3%) extracorporeal cardiopulmonary resuscitation (ECPR) studies. Functional outcomes were reported in 38 of 163 studies (23.3%) in 7,876 survivors and were assessed using various instruments, most commonly the Cerebral Performance Category in 20 of 38 studies (52.6%), the World Health Organization Disability Assessment Schedule 2.0 in five of 38 studies (13.2%), and the modified Rankin Scale in five of 38 studies (13.2%).</p><p><strong>Conclusions: </strong>Long-term mortality following ECMO differed substantially by ECMO modality, ranging from 37.2% among adults receiving venovenous ECMO to 74.4% among adults receiving ECPR. Functional outcomes were inconsistently reported, limiting the understanding of functional recovery among survivors. Standardized reporting and benchmarking are required to better inform long-term prognosis, patient selection, and factors that may improve functional recovery after ECMO.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148863827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nathan J Klingensmith, Jennifer M Leonard, Patricia Martinez-Quinones, Cherylee W J Chang, Ravinder Nagpal, Philip A Efron, Marlies Ostermann, Gail A M Cresci, Robert C Keskey, John C Alverdy, Craig M Coopersmith, Lewis J Kaplan
{"title":"The Microbiome in Critical Illness.","authors":"Nathan J Klingensmith, Jennifer M Leonard, Patricia Martinez-Quinones, Cherylee W J Chang, Ravinder Nagpal, Philip A Efron, Marlies Ostermann, Gail A M Cresci, Robert C Keskey, John C Alverdy, Craig M Coopersmith, Lewis J Kaplan","doi":"10.1097/CCM.0000000000007327","DOIUrl":"https://doi.org/10.1097/CCM.0000000000007327","url":null,"abstract":"<p><strong>Objectives: </strong>To review how the human microbiome impacts management of the critically ill or injured patient.</p><p><strong>Data sources: </strong>English-language manuscripts were sourced from PubMed and OVID from inception to August 2025.</p><p><strong>Study selection: </strong>Manuscripts addressing the mammalian microbiome, microbiome characterization, microbiome derangement, microbiome restoration, critical care interventions, the ICU, and organ system outcomes related to the human microbiome. Gray literature was excluded.</p><p><strong>Data extraction: </strong>Data that informed microbiome characterization, derangement, support, manipulation, as well as the impact of the microbiome on critical care medicine interventions or outcomes were abstracted.</p><p><strong>Data synthesis: </strong>Humans demonstrate a variety of unique microbiomes spanning eyes, skin, oropharynx, lung, bladder, and gastrointestinal tract. The most identifiable active outside of the lifecycles of resident microbiota is the gastrointestinal microbiome. The gastrointestinal microbiome plays a critical role in health maintenance as well as the physiologic recovery-or failure-of the critically ill or injured. Microbial balance disruption is common in ICU patients due to index admission disease processes as well as rescue or management therapeutics. Understanding how disease-modulated and therapy-driven microbiome changes occur-as well as their impact-may reveal strategies to improve critical care outcomes. The gastrointestinal microbiome serves as a lens through which microbial actions and host-microbe-regulated functions may be understood.</p><p><strong>Conclusions: </strong>Based on the impact of the human microbiome on critical care-relevant interventions and outcomes, the ICU clinician will benefit from understanding: 1) microbiome evaluation fundamentals, 2) microbiome adaptive or maladaptive alteration by disease process as well as therapeutic agents, and 3) current and emerging interventions to mitigate pathobiome induction and restore homeostasis to improve outcomes.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2026-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148817641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joanne Jegou, Ioana Manolescu, Stéphane Ruckly, Jean-François Timsit, Michael Thy
{"title":"ICU Open-Access Databases for Artificial Intelligence in Sepsis: Balancing Innovation With Data Quality Challenges.","authors":"Joanne Jegou, Ioana Manolescu, Stéphane Ruckly, Jean-François Timsit, Michael Thy","doi":"10.1097/CCM.0000000000007319","DOIUrl":"https://doi.org/10.1097/CCM.0000000000007319","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the suitability of three major open-access ICU databases (Medical Information Mart for Intensive Care IV [MIMIC-IV], eICU Collaborative Research Database [eICU-CRD], and Amsterdam University Medical Center Database [AmsterdamUMCdb]) for artificial intelligence (AI)-based sepsis research, with a focus on data completeness, internal consistency, terminological standardization, and structural redundancy affecting clinical interpretability and reproducibility.</p><p><strong>Design: </strong>A descriptive comparative design was employed to evaluate data completeness, terminological consistency, structural integrity, and clinical usability, with emphasis on sepsis-related variables such as antimicrobial administration, hemodynamic support, and mortality indicators.</p><p><strong>Setting: </strong>Open-access ICU electronic health record databases including MIMIC-IV (2008-2019), eICU-CRD (2014-2015), and AmsterdamUMCdb (2003-2016), accessed under credentialed use agreements. Documentation, schema, and metadata were reviewed in parallel to primary datasets.</p><p><strong>Interventions: </strong>Structured queries and descriptive analyses were performed to quantify missing values, distinct diagnosis strings, medication administration completeness, and redundancy of mortality markers. Manual semantic inspection of terminology, units, and coding (International Classification of Diseases, 9th revision/10th revision) was applied to evaluate inconsistency and typographical variability. Comparisons were made across key clinical dimensions including diagnosis, mortality, microbiology, and antibiotic administration.</p><p><strong>Measurements and main results: </strong>Marked heterogeneity and data quality limitations were identified. MIMIC-IV demonstrated extensive missingness in medication route (49%) and dose (58%), 99.9% missing fields in microbiology quantity, and diagnosis redundancy with 17,557 unique strings and 174 near-duplicate variants. eICU-CRD exhibited 1.9% admissions lacking diagnosis and discordance between ICU and hospital mortality in 7,319 stays. AmsterdamUMCdb showed fewer structural inconsistencies but limited demographics and the highest proportion of admissions without diagnosis (61.4%), complicated by mixed English-Dutch terminology. All three databases lacked reliable sepsis diagnosis timestamps, constraining analysis of early intervention.</p><p><strong>Conclusions: </strong>Although widely used and valuable for sepsis research, open-access ICU databases exhibit substantial missingness, redundancy, semantic variability, and demographic imbalance. These limitations require rigorous preprocessing and highlight the need for standardized data collection to improve the validity and generalizability of AI-driven sepsis studies.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2026-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148808285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rebecca A Aslakson, Christopher E Cox, Douglas B White
{"title":"Family Support Interventions in the ICU: Reckoning With the Past and Planning for the Future.","authors":"Rebecca A Aslakson, Christopher E Cox, Douglas B White","doi":"10.1097/CCM.0000000000007322","DOIUrl":"https://doi.org/10.1097/CCM.0000000000007322","url":null,"abstract":"","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2026-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148808222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laura I O Santos, Renato D Oliveira, Amanda Quintairos, Filipe Amado, Sangeeta Mehta, Jorge I F Salluh, Antonio P Nassar, Roberta M L Roepke
{"title":"Gender Disparity in Authorship of Critical Care Scientific Publications From Low-, Middle-, and High-Income Countries.","authors":"Laura I O Santos, Renato D Oliveira, Amanda Quintairos, Filipe Amado, Sangeeta Mehta, Jorge I F Salluh, Antonio P Nassar, Roberta M L Roepke","doi":"10.1097/CCM.0000000000007309","DOIUrl":"https://doi.org/10.1097/CCM.0000000000007309","url":null,"abstract":"<p><strong>Objectives: </strong>To investigate whether gender disparity in authorship of critical care scientific publications is greater in studies originating from low- and middle-income countries (L/MICs) compared with those from high-income countries (HICs).</p><p><strong>Design: </strong>Cross-sectional bibliometric analysis.</p><p><strong>Setting: </strong>Original research publications, including observational studies and randomized controlled trials, published from 2018 to 2022 in the ten critical care journals with the highest 2022 impact factors as reported by Clarivate Analytics Journal Citation Reports.</p><p><strong>Patients: </strong>A total of 4,982 publications, 4,479 from HICs, and 503 from L/MICs, comprising 50,357 authors.</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>We evaluated the proportion of women authors overall, and in first and senior positions; proportions of coauthors; differences by country income classification; temporal trends; and subgroup analyses stratified by funding type. Women accounted for 31.3% of all authors, 35.4% of first authors, and 21.4% of senior authors. Women's representation was higher in L/MICs than in HICs (38.2% vs. 30.6%; p < 0.01). The proportion of women in first (40.7% vs. 34.7%; p < 0.01) and senior (27.6% vs. 20.7%; p < 0.01) positions was also higher in publications from L/MICs. Coauthorships (i.e., the dyad of first and senior authors) involving at least one woman accounted for less than 30% across all publications. There were temporal increases in overall and senior woman authorship in HICs (p < 0.01 for both) and in overall authorship in L/MICs (p = 0.02). Women authors were more frequently represented among funded publications from L/MICs.</p><p><strong>Conclusions: </strong>Among high-impact critical care journals, substantial gender disparities persisted in authorship of publications. Women are better represented in publications from L/MICs, and there was an increase in women's authorship over time in both HICs and L/MICs from 2018 to 2022.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148789293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sangeeta Mehta, Karen E A Burns, Nicole Zytaruk, Diane Heels-Ansdell, Lori Hand, France Clarke, Miranda Hardie, Vinayak Lad, Anna Geagea, Alexandra Binnie, François Lauzier, Jennifer L Y Tsang, Simon Finfer, Gabrielle Hanlon, Rebecca Gresham, John C Marshall, Shane W English, Bram Rochwerg, Neill K J Adhikari, Abdulrahman Al-Fares, Draga Jichici, Paul Engels, Sunjay Sharma, Neeraj Bhadange, Wayne Stevens, Gilmar Reis, Patrick M Archambault, Emmanuel Charbonney, Ryan Zarychanski, Gloria Vazquez-Grande, Daniel Ovakim, Tim Karachi, Joanna C Dionne, Daniel J Niven, Charles St-Arnaud, Mir Waheed, DeborahJ Cook
{"title":"Informed Consent in an International Trial of Stress Ulcer Prophylaxis: Patterns and Predictors.","authors":"Sangeeta Mehta, Karen E A Burns, Nicole Zytaruk, Diane Heels-Ansdell, Lori Hand, France Clarke, Miranda Hardie, Vinayak Lad, Anna Geagea, Alexandra Binnie, François Lauzier, Jennifer L Y Tsang, Simon Finfer, Gabrielle Hanlon, Rebecca Gresham, John C Marshall, Shane W English, Bram Rochwerg, Neill K J Adhikari, Abdulrahman Al-Fares, Draga Jichici, Paul Engels, Sunjay Sharma, Neeraj Bhadange, Wayne Stevens, Gilmar Reis, Patrick M Archambault, Emmanuel Charbonney, Ryan Zarychanski, Gloria Vazquez-Grande, Daniel Ovakim, Tim Karachi, Joanna C Dionne, Daniel J Niven, Charles St-Arnaud, Mir Waheed, DeborahJ Cook","doi":"10.1097/CCM.0000000000007314","DOIUrl":"https://doi.org/10.1097/CCM.0000000000007314","url":null,"abstract":"<p><strong>Objectives: </strong>Research examining informed consent in critical care studies is limited. The objective of this study was to describe the patterns and predictors of consent.</p><p><strong>Design: </strong>Research coordinators prospectively documented each consent encounter including consent model (a priori or deferred, also known as consent to continue), who requested consent (research coordinator, site investigator, and ICU physician), who provided or declined consent (patient, substitute decision-maker [SDM], and other), the method to obtain consent (in-person or via telephone), and reasons for consent decline, if applicable. Research coordinators retrospectively reported center characteristics. Using multilevel logistic regression, we evaluated the association of consent provision with characteristics of the consent encounter and participating center.</p><p><strong>Setting: </strong>International randomized trial of stress ulcer prophylaxis for invasively ventilated patients.</p><p><strong>Intervention: </strong>None.</p><p><strong>Measurements and main results: </strong>Among 5024 patients or SDMs approached for consent, the consent rate was 85.0% (ranging from 27.3% to 100%). In 2638 patients (52.5%), an a priori approach was used, and of these, 696 patients (26.4%) declined. The remaining 2386 participants (47.5%) were enrolled by deferred consent, of whom 58 participants (2.4%) ultimately declined. Among first consent encounters, 80.2% were with SDMs, 19.6% with patients, and 0.2% with others. Higher consent rates were independently associated with the deferred consent model (odds ratio [OR], 16.56; 95% CI, 11.50-23.84), consent encounters involving patients (OR, 2.67; 95% CI, 1.63-4.37), and consent encounters during the COVID-19 pandemic (OR, 2.01; 95% CI, 1.30-3.11) or postpandemic period (OR, 2.26; 95% CI, 1.34-3.80) compared with prepandemic. Consent rates were not associated with center characteristics including ICU size, ICU research experience, or research coordinator experience.</p><p><strong>Conclusions: </strong>Deferred consent was used as often as a priori consent in this trial. The informed consent rate was associated with the deferred model, consent from patients, and consent encounters during or after the pandemic.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148789322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}