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

Handke 2020.

Study characteristics
General information Objective 

  • Added biomarkers, biomarkers compared


Journal

  • European Journal of Anaesthesiology


Country

  • Germany


Study design

  • Prospective cohort study
Participants Number of included patients

  • 233


Surgical specialty

  • Noncardiac surgery


Age

  • Median 69 years (IQR = 65 to 75 years)


Male sex

  • 80%


High‐risk surgery

  • Not reported  


Insulin‐dependent diabetes mellitus

  • 15%


History of ischaemic heart disease

  • Not reported 


History of congestive heart failure

  • 2%


History of cerebrovascular events

  • Not reported


Elevated creatinine

  • Not reported


0 RCRI factors

  • 22%


1 RCRI factor

  • 54%


2 RCRI factors

  • 19%


3 or more RCRI factors

  • 5%
Predictors Predictor 1:
High‐sensitivity troponin T

  • Objective: added biomarker

  • Category: blood

  • Scale: not reported

  • Threshold: not applicable

  • Assay/device: Cobas E4111, Roche Diagnostics, Mannheim, Germany


 
Predictor 2:
NT‐proBNP

  • Objective: added biomarker

  • Category: blood

  • Scale: continuous

  • Threshold: not applicable

  • Assay/device: Immulite, Siemens Health care Diagnostics, Erlangen, Germany


 
Predictor 3:
Presepsin

  • Objective: added biomarker, biomarker compared

  • Category: blood

  • Scale: dichotomous

  • Threshold: 184 pg/ml

  • Assay/device: noncompetitive immunoassay on the PATHFAST analyser (LSI Medience, Tokyo, Japan)


 
Predictor 4:
High‐sensitivity troponin T + NT‐proBNP

  • Objective: added biomarker

  • Category: blood

  • Scale: continuous

  • Threshold: not applicable

  • Assay/device: Cobas E4111, Roche Diagnostics, Mannheim, Germany and Immulite, Siemens Health care Diagnostics, Erlangen, Germany


 
Predictor 5:
High‐sensitivity troponin T + presepsin

  • Objective: added biomarker

  • Category: blood

  • Scale: continuous

  • Threshold: not applicable

  • Assay/device: Cobas E4111, Roche Diagnostics, Mannheim, Germany and noncompetitive immunoassay on the PATHFAST analyser (LSI Medience, Tokyo, Japan)


 
Predictor 6:
NT‐proBNP + presepsin

  • Objective: added biomarker

  • Category: blood

  • Scale: continuous

  • Threshold: not applicable

  • Assay/device: Immulite, Siemens Health care Diagnostics, Erlangen, Germany and noncompetitive immunoassay on the PATHFAST analyser (LSI Medience, Tokyo, Japan)


 
Predictor 7:
NT‐proBNP + high‐sensitivity troponin T + presepsin

  • Objective: added biomarker

  • Category: blood

  • Scale: continuous

  • Threshold: not applicable


Assay/device: Immulite, Siemens Health care Diagnostics, Erlangen, Germany and Cobas E4111, Roche Diagnostics, Mannheim, Germany and noncompetitive immunoassay on the PATHFAST analyser (LSI Medience, Tokyo, Japan)
Outcome Outcome category

  • MACE


Full outcome definition

  • Cardiovascular death, myocardial infarction, myocardial ischaemia or stroke


Prediction horizon

  • 30‐day events
Analysis Number of outcomes

  • 23        


Handling missing data

  • No information on handling missing data


Discrimination reported?

  • Yes


Calibration reported?

  • No  


Reclassification reported?

  • No
PROBAST: Applicability Domain 1: Participant selection

  • High


Justification: only included participants with coronary artery disease
Domain 2: Predictors

  • Unclear


Justification: no information on how the RCRI predictors were defined
Domain 3: Outcome

  • High


Justification: outcome definition of MACE is different from the outcome in the development study
Overall judgement

  • High


Justification: only a selected group of patients was included, 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 Appropriate participant selection in which patients were selected in whom the RCRI model can be applied.
Domain 2: Predictors Unclear No information on how the RCRI predictors were defined.
Domain 3: Outcome Yes Clearly defined outcome definitions and appropriate adjudication of outcomes.
Domain 4:  Analysis No Low number of events and dichotomisation of continuous predictors.
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 and dichotomisation of continuous variables.