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. 2021 Dec 21;2021(12):CD013139. doi: 10.1002/14651858.CD013139.pub2

Gualandro 2018.

Study characteristics
General information Objective 
  • Added biomarkers, biomarkers compared


Journal
  • American Heart Journal


Country
  • Switzerland and Brazil


Study design
  • Prospective cohort study

Participants Number of included patients
  • 243


Surgical specialty
  • Vascular surgery


Age
  • Median 68 years (IQR = 62 to 74)


Male sex
  • 73%


High‐risk surgery
  • Not reported


Insulin‐dependent diabetes mellitus
  • Not reported


History of ischaemic heart disease
  • 39%


History of congestive heart failure
  • 16%


History of cerebrovascular events
  • 25%


Elevated creatinine
  • Not reported


0 RCRI factors
  • 10%


1 RCRI factor
  • 35%


2 RCRI factors
  • 35%


3 or more RCRI factors
  • 20%

Predictors Predictor 1:
High‐sensitivity troponin T
  • Objective: added biomarker, biomarker compared

  • Category: blood

  • Scale: continuous, dichotomous

  • Threshold: > 14 ng/L

  • Assay/device: Elecsys, Roche diagnostics, Mannheim, Germany


 
Predictor 2:
High‐sensitivity troponin I
  • Objective: added biomarker, biomarker compared

  • Category: blood

  • Scale: continuous, dichotomous

  • Threshold: > 13 ng/L

  • Assay/device: ARCHITECT high‐sensitivity STAT Troponin I assay, Abbott Laboratories


 
Predictor 3:
Sensitive cardiac troponin I
  • Objective: biomarker compared

  • Category: blood

  • Scale: continuous, dichotomous

  • Threshold: > 13 ng/L

  • Assay/device: s‐cTnI, Siemens Ultra, Advia Centaur immunoassay system

Outcome Outcome category
  • MACE


Full outcome definition
  • Cardiac arrest, perioperative myocardial infarction, clinically relevant arrhythmia and acute heart failure (AHF)


Prediction horizon
30‐day events
Analysis Number of outcomes
  • 58        


Handling missing data
  • Complete case analysis


Discrimination reported?
  • Yes


Calibration reported?
  • No  


Reclassification reported?
  • No

PROBAST: Applicability Domain 1: Participant selection
  • Low


Justification: patient selected were generalisable to the patient population used in the RCRI development study
Domain 2: Predictors
  • Unclear


Justification: unclear what definitions for the RCRI has been used
Domain 3: Outcome
  • Low


Justification: outcome definitions were clearly defined and comparable to the definitions used in the development study
Overall judgement
  • Unclear


Patient selected were generalisable to the patient population used in the RCRI development study. Outcomes definitions were clearly defined and comparable to definitions used in the RCRI development study. However, there was no information on the definition of predictors and their assessment.
Notes
 
Item Authors' judgement Support for judgement
Domain 1: Participant selection Yes Although only patients undergoing vascular surgery were included, participant selection was appropriate and the RCRI model can be applied in these patients. 
Domain 2: Predictors Unclear Unclear what definitions for the RCRI has been used.
Domain 3: Outcome Yes Clearly defined outcome definitions and appropriate adjudication of outcomes.
Domain 4:  Analysis No Low number of outcomes; exclusion of patients (> 50%) without preoperative troponin; no measures of calibration or reclassification reported.
Overall judgement No Patient selection was appropriate. Outcomes were clearly defined and assessed. However, predictors definitions were not clear/reported. Furthermore, the number of outcomes was low, inappropriate exclusion of patients with missing data and no calibration/reclassification measures were reported.