Heterogeneity of treatment effect by baseline risk of mortality in critically ill patients: re-analysis of three recent sepsis and ARDS randomised controlled trials.
Shalini SanthakumaranAnthony GordonA Toby PrevostCecilia O'KaneDaniel F McAuleyManu Shankar-HariPublished in: Critical care (London, England) (2019)
We assessed HTE in three recent ICU RCTs, using multivariable baseline risk of death models. There was considerable within-trial variation in the baseline risk of death. We observed potential HTE for simvastatin in ARDS, but no evidence of HTE for vasopressin, hydrocortisone or levosimendan in the two sepsis trials. Our findings could be explained either by true lack of HTE (no benefit of vasopressin, hydrocortisone or levosimendan vs comparator for any patient subgroups) or by lack of power to detect HTE. Our results require validation using similar trial databases.
Keyphrases
- septic shock
- intensive care unit
- mechanical ventilation
- acute respiratory distress syndrome
- cardiac surgery
- acute kidney injury
- phase iii
- study protocol
- extracorporeal membrane oxygenation
- clinical trial
- phase ii
- single cell
- cardiovascular events
- case report
- randomized controlled trial
- open label
- risk assessment
- cardiovascular disease
- climate change
- artificial intelligence
- human health