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

Handke 2019.

Study characteristics
General information Objective 
  • Biomarkers compared


Journal
  • Anesthesia and Analgesia


Country
  • Germany


Study design
  • Prospective cohort study

Participants Number of included patients
  • 38


Surgical specialty
  • Noncardiac surgery


Age
  • Mean 69 years (SD 8.2 years)


Male sex
  • 82%


High‐risk surgery
  • 42%     


Insulin‐dependent diabetes mellitus
  • Not reported


History of ischaemic heart disease
  • Not reported 


History of congestive heart failure
  • 3%


History of cerebrovascular events
  • Not reported


Elevated creatinine
  • Not reported


0 RCRI factors
  • 0%


1 RCRI factor
  • 11%


2 RCRI factors
  • 45%


3 or more RCRI factors
  • 45%

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

  • Category: blood

  • Scale: dichotomous

  • Threshold: 14 pg/ml

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


 
Predictor 2:
NT‐proBNP
  • Objective: biomarker compared

  • Category: blood

  • Scale: dichotomous

  • Threshold: 300 ng/ml

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


 
Predictor 3:
eGFR (KDIGO stage ≥ 3)
  • Objective: biomarker compared

  • Category: blood

  • Scale: dichotomous

  • Threshold: 60 ml/min

  • Assay/device: not applicable


 
Predictor 4:
Presepsin
  • Objective: biomarker compared

  • Category: blood

  • Scale: dichotomous

  • Threshold: 184 pg/ml

  • Assay/device: noncompetitive immunoassay on the PATHFAST analyzer (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
  • 5          


Handling missing data
  • In case of missing laboratory values, last measurement carried forward


Discrimination reported?
  • No


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 as it includes e.g. stroke and myocardial ischaemia
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 included patients and outcomes, dichotomisation of continuous variables, no predictive performance measures reported that compared the RCRI with 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, dichotomisation of continuous variables and inappropriate reporting of performance measures.