title: Patient-important outcomes in randomized controlled trials in critically ill patients: a systematic review.
abstract: BACKGROUND
  Intensivists' clinical decision making pursues two main goals for patients: to decrease mortality and to improve quality of life and functional status in survivors. Patient-important outcomes are gaining wide acceptance in most fields of clinical research. We sought to systematically review how well patient-important outcomes are reported in published randomized controlled trials (RCTs) in critically ill patients.
  
  
  METHODS
  Literature search was conducted to identify eligible trials indexed from January to December 2013. Articles were eligible if they reported an RCT involving critically ill adult patients. We excluded phase II, pilot and physiological crossover studies. We assessed study characteristics. All primary and secondary outcomes were collected, described and classified using six categories of outcomes including patient-important outcomes (involving mortality at any time on the one hand and quality of life, functional/cognitive/neurological outcomes assessed after ICU discharge on the other).
  
  
  RESULTS
  Of the 716 articles retrieved in 2013, 112 RCTs met the inclusion criteria. Most common topics were mechanical ventilation (27%), sepsis (19%) and nutrition (17%). Among the 112 primary outcomes, 27 (24%) were patient-important outcomes (mainly mortality, 21/27) but only six (5%) were patient-important outcomes besides mortality assessed after ICU discharge (functional disability = 4; quality of life = 2). Among the 598 secondary outcomes, 133 (22%) were patient-important outcomes (mainly mortality, 92/133) but only 41 (7%) were patient-important outcomes besides mortality assessed after ICU discharge (quality of life = 20, functional disability = 14; neurological/cognitive performance = 5; handicap = 1; post-traumatic stress = 1). Seventy-three RCTs (65%) reported at least one patient-important outcome but only 11 (10%) reported at least one patient-important outcome besides mortality assessed after ICU discharge.
  
  
  CONCLUSIONS
  Patient-important outcomes are rarely primary outcomes in RCTs in critically ill patients published in 2013. Among them, mortality accounted for the majority. We promote the use of patient-important outcomes in critical care trials.
authors.affiliation: Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, AP-HP, 178 rue des Renouillers, 92700, Colombes, France. stephanegaudry@gmail.com.|ECEVE, UMRS 1123, Sorbonne Paris Cité, Univ Paris Diderot, Paris, France. stephanegaudry@gmail.com.|ECEVE, U1123, CIC 1421, INSERM, Paris, France. stephanegaudry@gmail.com.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Gaudry
authors.affiliation: Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, AP-HP, 178 rue des Renouillers, 92700, Colombes, France.|IAME, UMR 1137, INSERM, 75018, Paris, France.|IAME, UMR 1137, Sorbonne Paris Cité, Univ Paris Diderot, 75018, Paris, France.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Messika
authors.affiliation: Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, AP-HP, 178 rue des Renouillers, 92700, Colombes, France.|IAME, UMR 1137, INSERM, 75018, Paris, France.|IAME, UMR 1137, Sorbonne Paris Cité, Univ Paris Diderot, 75018, Paris, France.
authors.forename: Jean-Damien
authors.initials: JD
authors.lastname: Ricard
authors.affiliation: ECEVE, UMRS 1123, Sorbonne Paris Cité, Univ Paris Diderot, Paris, France.|ECEVE, U1123, CIC 1421, INSERM, Paris, France.|Département de Biostatistiques, Santé Publique et Informatique Médicale, CIC 1421, Hôpital Pitié Salpétrière, AP-HP, Paris, France.|Unité de Recherche Clinique Paris Nord, Hôpital Bichat, AP-HP, Paris, France.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Guillo
authors.affiliation: Département de Biostatistiques, Santé Publique et Informatique Médicale, CIC 1421, Hôpital Pitié Salpétrière, AP-HP, Paris, France.|Unité de Recherche Clinique Paris Nord, Hôpital Bichat, AP-HP, Paris, France.
authors.forename: Blandine
authors.initials: B
authors.lastname: Pasquet
authors.affiliation: Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, AP-HP, 178 rue des Renouillers, 92700, Colombes, France.
authors.forename: Emeline
authors.initials: E
authors.lastname: Dubief
authors.affiliation: Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, AP-HP, 178 rue des Renouillers, 92700, Colombes, France.
authors.forename: Tanissia
authors.initials: T
authors.lastname: Boukertouta
authors.affiliation: Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, AP-HP, 178 rue des Renouillers, 92700, Colombes, France.|IAME, UMR 1137, INSERM, 75018, Paris, France.|IAME, UMR 1137, Sorbonne Paris Cité, Univ Paris Diderot, 75018, Paris, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Dreyfuss
authors.affiliation: ECEVE, UMRS 1123, Sorbonne Paris Cité, Univ Paris Diderot, Paris, France.|ECEVE, U1123, CIC 1421, INSERM, Paris, France.|Département de Biostatistiques, Santé Publique et Informatique Médicale, CIC 1421, Hôpital Pitié Salpétrière, AP-HP, Paris, France.|Unité de Recherche Clinique Paris Nord, Hôpital Bichat, AP-HP, Paris, France.|Université Pierre et Marie Curie, Sorbonne Universités, Paris, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Tubach
keywords: Critical care; Patient-important outcome; Quality of life