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A Systematic Review and International Web-Based Survey of Randomized Controlled Trials in the Perioperative and
Chiara Sartini1, Vladimir Lomivorotov2, Antonio Pisano3
1Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Objective:
Reducing mortality is a key target in critical care and perioperative medicine. The authors aimed to identify all nonsurgical interventions (drugs, techniques, strategies) shown by randomized trials to increase mortality in these clinical settings.
Design:
A systematic review of the literature followed by a consensus-based voting process.
Setting:
A web-based international consensus conference.
Participants:
Two hundred fifty-one physicians from 46 countries.
Interventions:
The authors performed a systematic literature search and identified all randomized controlled trials (RCTs) showing a significant increase in unadjusted landmark mortality among surgical or critically ill patients. The authors reviewed such studies during a meeting by a core group of experts. Studies selected after such review advanced to web-based voting by clinicians in relation to agreement, clinical practice, and willingness to include each intervention in international guidelines.
Measurements And Main Results:
The authors selected 12 RCTs dealing with 12 interventions increasing mortality: diaspirin-crosslinked hemoglobin (92% of agreement among web voters), overfeeding, nitric oxide synthase inhibitor in septic shock, human growth hormone, thyroxin in acute kidney injury, intravenous salbutamol in acute respiratory distress syndrome, plasma-derived protein C concentrate, aprotinin in high-risk cardiac surgery, cysteine prodrug, hypothermia in meningitis, methylprednisolone in traumatic brain injury, and albumin in traumatic brain injury (72% of agreement). Overall, a high consistency (ranging from 80% to 90%) between agreement and clinical practice was observed.
Conclusion:
The authors identified 12 clinical interventions showing increased mortality supported by randomized controlled trials with nonconflicting evidence, and wide agreement upon clinicians on a global scale.
Insights
This study identified 12 nonsurgical interventions that increase mortality in critical care and perioperative settings, confirmed by randomized trials and global clinician agreement. These findings highlight critical areas for improving patient safety and outcomes.
Area of Science:
- Critical care medicine
- Perioperative medicine
- Clinical interventions
Background:
- Reducing patient mortality is a primary goal in critical care and perioperative medicine.
- Nonsurgical interventions can inadvertently increase mortality.
- Identifying such interventions is crucial for patient safety.
Purpose of the Study:
- To identify nonsurgical interventions (drugs, techniques, strategies) that increase mortality.
- To base identification on evidence from randomized controlled trials (RCTs).
- To assess global clinician agreement on these interventions.
Main Methods:
- Systematic literature review of RCTs showing increased mortality.
- Web-based international consensus conference with 251 physicians from 46 countries.
- Consensus-based voting on identified interventions regarding agreement and clinical practice.
Main Results:
- Twelve RCTs identified 12 interventions associated with increased mortality.
- Examples include diaspirin-crosslinked hemoglobin, overfeeding, and specific drug therapies.
- High clinician agreement (80-90%) was observed between agreement and clinical practice.
Conclusions:
- Twelve clinical interventions demonstrably increase mortality, supported by robust RCT evidence.
- There is broad international consensus among clinicians regarding these harmful interventions.
- Findings underscore the need to re-evaluate and potentially revise guidelines for these interventions.
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