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

Golubovic 2018.

Study characteristics
General information Objective 
  • Added biomarkers, biomarkers compared, prediction model compared


Journal
  • BioMed Research International; Medical Principles and Practice


Country
  • Serbia


Study design
  • Prospective cohort study

Participants Number of included patients
  • 122


Surgical specialty
  • Vascular surgery


Age
  • Mean 67 years (SD 4.5)


Male sex
  • 77%


High‐risk surgery
  • Not reported


Insulin‐dependent diabetes mellitus
  • 15.6%


History of ischaemic heart disease
  • 21.3%


History of congestive heart failure
  • Not reported


History of cerebrovascular events
  • 26.2%


Elevated creatinine
  • Not reported


0 RCRI factors
  • Not reported


1 RCRI factor
  • Not reported


2 RCRI factors
  • Not reported


3 or more RCRI factors
  • Not reported

Predictors Predictor 1:
V‐POSSUM
  • Objective: added biomarker, biomarker compared

  • Category: prediction model

  • Scale: not applicable

  • Threshold: not applicable

  • Assay/device: not applicable


 
Predictor 2:
NT‐proBNP
  • Objective: added biomarkers, biomarker compared

  • Category: blood

  • Scale: continuous

  • Threshold: not applicable

  • Assay/device: chemiluminescence enzyme immunoassay technology (CLEIA) (Mitsubishi Chemical Europe GmbH, Düsseldorf, Germany)


 
Predictor 3:
High‐sensitivity troponin I
  • Objective: added biomarkers

  • Category: blood

  • Scale: continuous

  • Threshold: not applicable

  • Assay/device: Magtration5 technology on a PATHFAST Immunoanalyser (Mitsubishi Chemical Europe GmbH, Düsseldorf, Germany)


 
Predictor 4:
V‐POSSUM + NT‐proBNP
  • Objective: added biomarker

  • Category: prediction model

  • Scale: not applicable

  • Threshold: not applicable

  • Assay/device: chemiluminescence enzyme immunoassay technology (CLEIA) (Mitsubishi Chemical Europe GmbH, Düsseldorf, Germany)


 
Predictor 5:
NT‐proBNP + high‐sensitivity troponin I
  • Objective: added biomarkers, biomarker compared

  • Category: blood

  • Scale: continuous

  • Threshold: not applicable

  • Assay/device: chemiluminescence enzyme immunoassay technology (CLEIA) and Magtration5 technology on a PATHFAST Immunoanalyser (Mitsubishi Chemical Europe GmbH, Düsseldorf, Germany)


 
Predictor 6:
V‐POSSUM + high‐sensitivity troponin I
  • Objective: added biomarker, biomarker compared

  • Category: prediction model

  • Scale: not applicable

  • Threshold: not applicable

  • Assay/device: Magtration5 technology on a PATHFAST Immunoanalyser (Mitsubishi Chemical Europe GmbH, Düsseldorf, Germany)


 
Predictor 7:
V‐POSSUM + NT‐proBNP + high‐sensitivity troponin I
  • Objective: added biomarker, biomarker compared

  • Category: prediction model

  • Scale: not applicable

  • Threshold: not applicable

  • Assay/device: chemiluminescence enzyme immunoassay technology (CLEIA) and Magtration5 technology on a PATHFAST Immunoanalyser (Mitsubishi Chemical Europe GmbH, Düsseldorf, Germany)


 
Predictor 8:
High‐sensitivity troponin I + high‐sensitivity CRP
  • Objective: biomarker compared

  • Category: blood

  • Scale: continuous

  • Threshold: not applicable

  • Assay/device: Magtration5 technology on a PATHFAST Immunoanalyser (Mitsubishi Chemical Europe GmbH, Düsseldorf, Germany) and immunoturbidimetry method on a Beckman Coulter AU 680 analyser (Beckman Coulter Inc., Brea, CA, USA)


 
Predictor 9:
High‐sensitivity troponin I + CK‐MB
  • Objective: biomarker compared

  • Category: blood

  • Scale: continuous

  • Threshold: not applicable

  • Assay/device: Magtration5 technology on a PATHFAST Immunoanalyser (Mitsubishi Chemical Europe GmbH, Düsseldorf, Germany) and immunoturbidimetry method on a Beckman Coulter AU 680 analyser (Beckman Coulter Inc., Brea, CA, USA)


 
Predictor 10:
NT‐proBNP + high‐sensitivity troponin I + high‐sensitivity CRP
  • Objective: biomarker compared

  • Category: blood

  • Scale: continuous

  • Threshold: not applicable

  • Assay/device: chemiluminescence enzyme immunoassay technology (CLEIA) and Magtration5 technology on a PATHFAST Immunoanalyser (Mitsubishi Chemical Europe GmbH, Düsseldorf, Germany) and immunoturbidimetry method on a Beckman Coulter AU 680 analyser (Beckman Coulter Inc., Brea, CA, USA)

Outcome Outcome category
  • MACE


Full outcome definition
  • Acute myocardial infarction, cardiac arrhythmia, pulmonary oedema, acutely decompensated heart failure and cardiac arrest


Prediction horizon
  • 30‐day events and 90‐day events

Analysis Number of outcomes
  • 13 within 30 days and 29 within 90 days      


Handling missing data
  • Assumption of normal value if missing


Discrimination reported?
  • Yes


Calibration reported?
  • No  


Reclassification reported?
  • Yes

PROBAST: Applicability Domain 1: Participant selection
  • Low


Justification: 
Domain 2: Predictors
  • Unclear


Justification: no information on RCRI predictor definitions
Domain 3: Outcome
  • High


Justification: definition of MACE varies from the development cohort (includes cardiac arrhythmias)
Overall judgement
  • High


Justification: patients selected were generalisable to the patient population used in the RCRI development study. However, there was no/unclear information on predictor definitions and outcome definition was different compared to the development study.
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 No information on RCRI predictor definitions.
Domain 3: Outcome Unclear No information how the individual items of the composite outcome were defined and whether blinding occurred.
Domain 4:  Analysis No Low number of events, dichotomisation of continuous variable and no information on handling missing data.
Overall judgement No Patient selection was appropriate. There was no/unclear information on how predictors were defined/assessed. However, the number of outcomes was low and there was no information on missing data and no calibration was reported.