Randomized Evidence for Reduction of Perioperative Mortality: An Updated Consensus Process

Landoni, Giovanni; Pisano, Antonio; Lomivorotov, Vladimir V.; Alvaro, Gabriele; Hajjar, Ludhmila Abrahão; Paternoster, Gianluca; Neto, Caetano Nigro; Latronico, Nicola; Fominskiy, Evgeny; Pasin, Laura; Finco, Gabriele; Lobreglio, Rosetta; Azzolini, Maria Luisa; Buscaglia, Giuseppe; Castella, Alberto; Comis, Marco; Conte, A; Conte, Massimiliano; Corradi, Francesco; Checco, Erika Dal; Vuono, G. De; Ganzaroli, Marco; Garofalo, Eugenio; Gazivoda, Gordana; Lembo, Rosalba; Marianello, Daniele; Redaelli, Martina Baiardo; Monaco, Fabrizio; Tarzia, Valentina; Mucchetti, Marta; Belletti, Alessandro; Mura, Paolo; Musu, Mario; Pala, Giovanni; Paltenghi, Massimiliano; Pasyuga, Vadim; Piras, Desiderio; Riefolo, Claudio; Roasio, Agostino; Ruggeri, Laura; Santini, Francesco; Székely, Andrea; Verniero, Luigi; Vezzani, Antonella; Zangrillo, Alberto; Bellomo, Rinaldo

doi:10.1053/j.jvca.2016.07.017

Cited by 64 publications

(40 citation statements)

References 68 publications

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“…Univariate analyses without seven trials that did not meet the original Fragility Index criteria gave similar results, although the number needed to treat or harm in a trial was also associated with the Fragility Index, R 2 = 0.50, p = 0.039. There was also an association of median (IQR [range]) Fragility Index with whether mortality was the primary outcome (16 RCTs), 3 (2)(3)(4) [0-49]) vs. 2 (0-2 [0-5]), p = 0.017. Without these seven trials the Fragility Index was independently associated with the number of reported deaths on multivariate analyses (see also Supporting Information Table S5b).…”

Section: Index Inclusion Criteria (See Also Supporting Informationmentioning

confidence: 99%

“…Small reductions in perioperative mortality would, therefore, save thousands of lives. Despite its importance, there is little evidence to support peri-operative medical practice, possibly due to the complexity of the clinical setting [2,3]. The use of p values, generated by frequentist analyses, to assess evidence has recently been questioned [4][5][6][7][8]: statistically significant mortality effects are often based on a small number of events, with p values sensitive to single events [9].…”

Section: Introductionmentioning

confidence: 99%

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The Fragility Index in peri‐operative randomised trials that reported significant mortality effects in adults

Bertaggia¹,

Redaelli²,

Lembo³

et al. 2019

Anaesthesia

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More than one million peri-operative patients die each year. Thus, small improvements in peri-operative care may save thousands of lives. However, clinicians need confidence in the robustness of trial findings. The Fragility Index may complement frequentist analysis and provide quantitative assessment of robustness. We searched MEDLINE for peri-operative critical care randomised controlled trials that reported a statistically significant difference in mortality. We identified 46 trials with 37,347 participants. The median (IQR [range]) Fragility Index was 2 (1-3 [0-49]). Eleven trials had a Fragility Index of zero (changing from the Chi-square test to Fisher's exact test removed significance) and seven trials had a Fragility Index of 1. Only 23/46 trials had a Fragility Index greater than the number of patients lost to follow-up. There was a strong positive correlation between the Fragility Index and: the number of participants, R 2 = 0.97, p < 0.0001; the number of centres that recruited participants, R 2 = 0.96, p < 0.0001; the number of nations that recruited participants, R 2 = 0.93, p < 0.0001; and the number of deaths, R 2 = 0.97, p < 0.0001. As measured by the Fragility Index, the effect of perioperative interventions on mortality in individual randomised controlled trials are not robust.

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Section: Index Inclusion Criteria (See Also Supporting Informationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The Fragility Index in peri‐operative randomised trials that reported significant mortality effects in adults

Bertaggia¹,

Redaelli²,

Lembo³

et al. 2019

Anaesthesia

View full text Add to dashboard Cite

show abstract

“…Although the effectiveness of RRSs remains controversial, 6 these systems are being used with increasing frequency. 7 Although considerable efforts have been made to assess the benefit associated with implementation of evidencebased surgical pathways, 8 relatively little information is available regarding the benefits of implementing an RRS for postoperative surgical patients recovering in a general hospital ward. One prospective study suggests that medical emergency teams may improve postoperative mortality and morbidity rates, 9 but it did not consider the incidence of CPA.…”

Section: Hospitalizedmentioning

confidence: 99%

A rapid response system reduces the incidence of in-hospital postoperative cardiopulmonary arrest: a retrospective study

Kim

Lee

et al. 2018

Can J Anesth/J Can Anesth

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“…Despite being a cost‐effective and efficacious method to reduce perioperative bleeding with minimal risk of harm, TXA remains underutilized . Concerns regarding the safety of the drug, particularly fears of thromboembolic events and seizures, are an important barrier preventing an increase in the utilization of TXA in perioperative care .…”

mentioning

confidence: 99%

Exclusion criteria and adverse events in perioperative trials of tranexamic acid: a systematic review and meta‐analysis

et al. 2018

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BACKGROUND: Tranexamic acid (TXA) is an inexpensive therapy effective at minimizing perioperative blood loss and transfusion. However, it remains underutilized due to safety concerns. To date, no evidence-based guidelines exist identifying which patients should not receive TXA therapy. This study determined patient groups for whom safety information regarding TXA is lacking due to common exclusion from perioperative TXA trials. STUDY DESIGN AND METHODS: A systematicreview searching the databases Medline, EMBASE, CENTRAL, and Clinicaltrials.gov was performed. Randomized controlled trials (RCTs) administering systemic TXA perioperatively to elective or emergent surgery patients were eligible. Our primary outcome was to describe exclusion criteria of RCTs, and the secondary outcome was TXA safety. A descriptive synthesis of exclusion criteria was performed, and TXA safety was assessed by meta-analysis.ABBREVIATIONS: CIs = confidence intervals; RCTs = randomized controlled trials; RRs = relative risks; TXA = tranexamic acid; VTEs = venous thromboembolic events.From the

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Randomized Evidence for Reduction of Perioperative Mortality: An Updated Consensus Process

Cited by 64 publications

References 68 publications

The Fragility Index in peri‐operative randomised trials that reported significant mortality effects in adults

The Fragility Index in peri‐operative randomised trials that reported significant mortality effects in adults

A rapid response system reduces the incidence of in-hospital postoperative cardiopulmonary arrest: a retrospective study

Exclusion criteria and adverse events in perioperative trials of tranexamic acid: a systematic review and meta‐analysis

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