Research on ICU criteria and related data

Position du problème et objectif(s) de l’étude

Mortality has traditionally served as a robust endpoint and a standard benchmark in clinical trials, particularly within intensive care settings. However, with ongoing improvements in treatment, mortality rates have decreased significantly. Consequently, detecting differences in mortality between interventions has become more challenging and often requires larger sample sizes. Therefore, alternative endpoints have been proposed, such as Ventilator-Free Days (the number of days alive without ventilation) (VFDs), which are considered more patient-centered outcomes (PROMs). Nevertheless, there is variability in how this criterion is applied and interpreted. Additionally, other patient-centered measures—such as quality of life or survival without sequelae—may be valuable, although these have been less extensively studied, especially in patients with acute respiratory distress syndrome. Our objective was to review the various assessment criteria used in clinical research studies involving French intensive care physicians. A secondary aim was to assess whether current responses align with established criteria and to explore the development of new evaluation measures.

Matériel et méthodes

An anonymous survey was distributed through the SFAR and the SRLF. The survey was hosted on the LimeSurvey platform provided by Clermont Auvergne University. Participants included any physicians, including residents, practicing in intensive care, as well as researchers working in the field of intensive care. The primary outcome measure was the prevalence of various outcome measures used in clinical research studies on resuscitation. The secondary outcome assessed the appropriateness of these outcome measures in relation to their actual definitions.

Résultats & Discussion

A total of 265 physicians responded to the survey. The respondent pool included a diverse group of French intensive care physicians, primarily from university hospital settings, with a higher proportion of male practitioners compared to females. Responses varied regarding the continued relevance of mortality as an outcome measure. Regarding the definition of VFDs, there was significant heterogeneity among respondents. Some expressed difficulty in interpreting newer criteria such as the win ratio. Additionally, there was consensus that more PROMs—such as the ability to communicate or discharge without sequelae—should be incorporated. The choice to use composite criteria instead of mortality alone has implications. Over-summarizing data or combining criteria of differing importance can be problematic. While the win ratio offers a potential solution, it remains complex to interpret. We recommend developing standardized core outcome sets that encompass these various criteria and ensure consistent definitions. Furthermore, providing clear explanations—particularly for physicians who are not engaged in research—would be beneficial.

Conclusion

Shifting focus beyond mortality as the sole primary outcome appears to be important in the development of PROMs. However, we advise careful consideration in the selection of outcomes, especially with regard to their clinical interpretation.

Auteurs

Laurent RENARD TRICHÉ (1) , Matthieu JABAUDON (2), Alexandre LAUTRETTE (3), Sylvie CHEVRET (4) - (1)Department Of Perioperative Medicine, Chu Clermont-Ferrand, Clermont-Ferrand, France ; Igred, Inserm, Cnrs, Université Clermont Auvergne, Clermont-Ferrand, France ; Ecstrra Team, Irsl, Inserm Umr1342, Université Paris Cité, Paris, France., Clermont-Ferrand, France, (2)Department Of Perioperative Medicine, Chu Clermont-Ferrand, Clermont-Ferrand, France ; Igred, Inserm, Cnrs, Université Clermont Auvergne, Clermont-Ferrand, France., Clermont-Ferrand, France, (3)Medical Intensive Care Unit, Jean Perrin Oncology Institut And Montpied Teaching Hospital, Clermont-Ferrand, France., Clermont-Ferrand, France, (4)Ecstrra Team, Irsl, Inserm Umr1342, Université Paris Cité, Paris, France ; Department Of Biostatistics, Hôpital Saint-Louis, Ap-Hp, Paris, France., Paris, France

Orateur(s)

Laurent RENARD TRICHÉ (Clermont-Ferrand)