Interventions affecting mortality in critically ill and perioperative patients: A systematic review of contemporary trials

Martina Baiardo Redaelli, Giovanni Landoni, Stefania Di Sanzo, Samuele Frassoni, Chiara Sartini, Luca Cabrini, Giacomo Monti, Mara Scandroglio, Alberto Zangrillo, Rinaldo Bellomo

Research output: Contribution to journalReview ArticleResearchpeer-review

8 Citations (Scopus)

Abstract

Purpose Confounders in randomized controlled trials (RCTs) reporting significant effects on mortality in critically ill patients using non-surgical techniques have not been systematically explored. We aimed to identify factors unrelated to the reported intervention that might have affected the findings and robustness of such trials. Methods We searched Pubmed/MEDLINE for all RCTs on any non-surgical interventions reporting an effect on unadjusted mortality in critically ill patients between 1/1/2000 and 1/12/2015. We assessed: the number needed to treat/harm (NNT or NNH), sample size, trial design (blinded/unblinded, single or multinational, single or multicenter (sRCT or mRCT)), intention to treat (ITT) analysis, and countries of origin. Results Almost half of RCTs were sRCTs. Median sample size was small, and 1/3 were not analyzed according to ITT principle. Lack of ITT analysis was associated with greater effect size (p = 0.0028). Harm was more likely in mRCTs (p = 0.002) and/or in blinded RCTs (p = 0.003). Blinded RCTs had double sample size (p = 0.007) and an increased NNT/NNH (p = 0.002). Finally, mRCTs had higher NNT (p = 0.005) and NNH (p = 0.02), and harm was only detected in studies from Western countries (p = 0.007). Conclusions These observations imply that major systematic biases exist and affect trial findings irrespective of the intervention being studied.

Original languageEnglish
Pages (from-to)107-111
Number of pages5
JournalJournal of Critical Care
Volume41
DOIs
Publication statusPublished - Oct 2017
Externally publishedYes

Keywords

  • Anesthesia
  • Critically ill
  • Intensive care
  • Mortality
  • Perioperative
  • Randomized clinical trials
  • RCT
  • Review
  • Trials

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