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Patient-important outcomes in randomized controlled trials in critically ill
patients: a systematic review
#MMPMID28271450
Gaudry S
; Messika J
; Ricard JD
; Guillo S
; Pasquet B
; Dubief E
; Boukertouta T
; Dreyfuss D
; Tubach F
Ann Intensive Care
2017[Dec]; 7
(1
): 28
PMID28271450
show ga
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. CONCLUSION: 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.
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