Designing and conducting a cluster-randomized trial of ICU admission for the elderly patients: the ICE-CUB 2 study

International audienceBackgroundThe benefit of ICU admission for elderly patients remains controversial. This report highlights the methodology, the feasibility of and the ethical and logistical constraints in designing and conducting a cluster-randomized trial of intensive care unit (ICU) admission for critically ill elderly patients.MethodsWe designed an interventional open-label cluster-randomized controlled trial in 24 centres in France. Clusters were healthcare centres with at least one emergency department (ED) and one ICU. Healthcare centres were randomly assigned either to recommend a systematic ICU admission (intervention group) or to follow standard practices regarding ICU admission (control group). Clusters were stratified by the number of ED annual visits (44,616 visits), the presence or absence of a geriatric ward and the geographical area (Paris area vs other regions in France). All elderly patients (≥75 years of age) who got to the ED were assessed for eligibility. Patients were included if they had one of the pre-established critical conditions, a preserved functional status as assessed by an ADL scale ≥4 (0 = very dependent, 6 = independent), a preserved nutritional status (subjectively assessed by physicians) and without active cancer. Exclusion criteria were an ED stay >24 h, a secondary referral to the ED and refusal to participate. The primary outcome was the mortality at 6 months calculated at the individual patient level. Secondary outcomes were ICU and hospital mortality, as well as ADL scale and quality of life (as assessed by the SF-12 Health Survey) at 6 months.ResultsBetween January 2012 and April 2015, 3036 patients were included in the trial, 1518 patients in 11 clusters allocated to intervention group and 1518 patients in 13 clusters allocated to standard care. There were 51 protocol violations.ConclusionsThe ICE-CUB 2 trial was deemed feasible and ethically acceptable. The ICE-CUB 2 trial will be the first cluster-randomized trial to assess the benefits of ICU admission for selected elderly patients on long-term mortality

Potential for recovery between 4 and 8 years after a severe traumatic brain injury. Data from the PariS-TBI longitudinal study

International audienceBackground: Severe traumatic brain injury (TBI) is a leading cause of complex and persistent disability. Yet, long-term change in global functioning and determinants of this change remain unclear. Objectives: This study aimed to assess change in global functioning in the long-term after severe TBI and factors associated with the change. Methods: This was a prospective observational study of an inception cohort of adults with severe TBI in the Paris area (PariS-TBI). Outcome was assessed at 1, 4 and 8 years post-injury. For the included participants (n = 257), change in global outcome between 4 and 8 years was evaluated with the Glasgow Outcome Scale Extended (GOSE) score, and its association with pre-injury, injury-related and post-injury variables was tested with univariate and multivariable analyses. Results: More than half of the 73 participants evaluated at both 4 and 8 years showed global improvement (of at least one point) in GOSE score and an improvement in mood, executive function, and subjective complaints. On univariate analysis, none of the pre-injury, injury or post-injury variables were associated with GOSE score change between 4 and 8 years, except for GOSE score at 4 years (rho = −0.24, P = 0.04). On multivariable analysis, probability of increased GOSE score was associated with more years of education (odds ratio 1.18 [95% confidence interval 1.02–1.37], P = 0.03). The change in GOSE score was significantly correlated with change in Hospital Anxiety Depression Scale score between 4 and 8 years (rho = −0.42, P < 0.001). Conclusions: Most participants with severe TBI in the present sample showed a late improvement (4 to 8 years post-injury) in global functioning. Of the socio-demographic and injury-related factors, only more years of education was associated with improvement in global functioning. Decreased anxiety and depression symptoms were associated with improved global functioning. Targeting interventions to enhance resilience may be the most effective in the long-term after severe TBI

Disability and health-related quality-of-life 4 years after a severe traumatic brain injury: A structural equation modelling analysis

<p><i>Objectives</i>: To assess predictors and indicators of disability and quality-of-life 4 years after severe traumatic brain injury (TBI), using structural equation modelling (SEM).</p> <p><i>Methods</i>: The PariS-TBI study is a longitudinal multi-centre inception cohort study of 504 patients with severe TBI. Among 245 survivors, 147 patients were evaluated upon 4-year follow-up, and 85 completed the full assessment. Two outcome measures were analysed separately using SEM: the Glasgow Outcome Scale-extended (GOS-E), to measure disability, and the QOLIBRI, to assess quality-of-life. Four groups of variables were entered in the model: demographics; injury severity; mood and cognitive impairments; somatic impairments.</p> <p><i>Results</i>: The GOS-E was directly significantly related to mood and cognition, injury severity, and somatic impairments. Age and education had an indirect effect, mediated by mood/cognition or somatic deficiencies. In contrast, the only direct predictor of QOLIBRI was mood and cognition. Age and somatic impairments had an indirect influence on the QOLIBRI.</p> <p><i>Conclusion</i>: Although this study should be considered as explorative, it suggests that disability and quality-of-life were directly influenced by different factors. While disability appeared to result from an interaction of a wide range of factors, quality-of-life was solely directly related to psycho-cognitive factors.</p

Effect of Systematic Intensive Care Unit Triage on Long-term Mortality Among Critically Ill Elderly Patients in France: A Randomized Clinical Trial

International audienceImportance:The high mortality rate in critically ill elderly patients has led to questioning of the beneficial effect of intensive care unit (ICU) admission and to a variable ICU use among this population.Objective:To determine whether a recommendation for systematic ICU admission in critically ill elderly patients reduces 6-month mortality compared with usual practice.Design, Setting, and Participants:Multicenter, cluster-randomized clinical trial of 3037 critically ill patients aged 75 years or older, free of cancer, with preserved functional status (Index of Independence in Activities of Daily Living ≥4) and nutritional status (absence of cachexia) who arrived at the emergency department of one of 24 hospitals in France between January 2012 and April 2015 and were followed up until November 2015.Interventions:Centers were randomly assigned either to use a program to promote systematic ICU admission of patients (n=1519 participants) or to follow standard practice (n=1518 participants).Main Outcomes and Measures:The primary outcome was death at 6 months. Secondary outcomes included ICU admission rate, in-hospital death, functional status, and quality of life (12-Item Short Form Health Survey, ranging from 0 to 100, with higher score representing better self-reported health) at 6 months.Results:One patient withdrew consent, leaving 3036 patients included in the trial (median age, 85 [interquartile range, 81-89] years; 1361 [45%] men). Patients in the systematic strategy group had an increased risk of death at 6 months (45% vs 39%; relative risk [RR], 1.16; 95% CI, 1.07-1.26) despite an increased ICU admission rate (61% vs 34%; RR, 1.80; 95% CI, 1.66-1.95). After adjustments for baseline characteristics, patients in the systematic strategy group were more likely to be admitted to an ICU (RR, 1.68; 95% CI, 1.54-1.82) and had a higher risk of in-hospital death (RR, 1.18; 95% CI, 1.03-1.33) but had no significant increase in risk of death at 6 months (RR, 1.05; 95% CI, 0.96-1.14). Functional status and physical quality of life at 6 months were not significantly different between groups.Conclusions and Relevance:Among critically ill elderly patients in France, a program to promote systematic ICU admission increased ICU use but did not reduce 6-month mortality. Additional research is needed to understand the decision to admit elderly patients to the ICU.Trial Registration: clinical trials.gov Identifier: NCT01508819

Espace privé/Espace public, in Théâtre/Public, n°179, Gennevilliers, 4e trimestre 2005

Direction d'un dossier de revue en collaboration avec Bénédicte Boisson

Espace privé/Espace public, in Théâtre/Public, n°179, Gennevilliers, 4e trimestre 2005

Direction d'un dossier de revue en collaboration avec Bénédicte Boisson

MOESM1 of Designing and conducting a cluster-randomized trial of ICU admission for the elderly patients: the ICE-CUB 2 study

Additional file 1. Members of the ICE-CUB 2 study network