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

Jarai 2011.

Study characteristics
General information Objective 
  • Added biomarkers     


Journal
  • American Journal of Cardiology


Country
  • Austria


Study design
  • Prospective cohort study

Participants Number of included patients
  • 198


Surgical specialty
  • Vascular surgery


Age
  • Mean 69 years (SD 9 years)


Male sex
  • 78.8%


High‐risk surgery
  • 82.3%  


Insulin‐dependent diabetes mellitus
  • Not reported


History of ischaemic heart disease
  • Not reported 


History of congestive heart failure
  • 5.1%


History of cerebrovascular events
  • 17.7%


Elevated creatinine
  • 0%


0 RCRI factors
  • 64.1%


1 or more RCRI factors
  • 35.9%

Predictors Predictor 1:
Copeptin
  • Objective: added biomarker

  • Category: blood

  • Scale: dichotomous

  • Threshold: 14 mg/dL

  • Assay/device: chemiluminescence assay (Brahms AG, Hennigsdorf, Germany)


 
Predictor 2:
NT‐proBNP + copeptin
  • Objective: added biomarker

  • Category: blood

  • Scale: dichotomous

  • Threshold: 280 pg/mL and 14 mg/dL, respectively

  • Assay/device: chemiluminescence assay (Brahms AG, Hennigsdorf, Germany)

Outcome Outcome category
  • MACE


Full outcome definition
  • Cardiac death, nonfatal myocardial infarction and emergent coronary artery revascularisation


Prediction horizon
  • 24 to 30 months after surgery

Analysis Number of outcomes
  • 40      


Handling missing data
  • No information on handling missing data


Discrimination reported?
  • No


Calibration reported?
  • No  


Reclassification reported?
  • Yes

PROBAST: Applicability Domain 1: Participant selection
  • Low


Justification: 
Domain 2: Predictors
  • High


Justification: preoperative creatinine was deleted from the model as all patients with creatinines > 1.4 were excluded
Domain 3: Outcome
  • High


Justification: the outcome definition differed from the MACE definition in the development study
Overall judgement
  • High


Justification: patient selected were generalisable to the patient population used in the RCRI development study. There was no/unclear information on predictor definitions and outcome definition was different compared to the RCRI development study.
Notes
 
Item Authors' judgement Support for judgement
Domain 1: Participant selection No Excluded were patients with acute coronary syndromes or evidence of myocardial ischaemia on stress tests (n = 4), decompensated heart failure (n = 2), aortic stenosis (n   2), atrial fibrillation (n = 17), kidney dysfunction (serum creatinine  1.4 mg/dl; n = 26), reduced left ventricular function (left ventricular ejection fraction 40%; n = 10)
Domain 2: Predictors No Preoperative creatinine was deleted from the model as all patients with creatinines > 1.4 were excluded
Domain 3: Outcome No Independent cardiologist had access to all available documents and clinical charts of each patient.
Domain 4:  Analysis No Low number of outcomes, dichotomisation of predictors and no handling of missing data.
Overall judgement No Patient selection and outcome and predictor definitions/assessments were inappropriate. In addition, the number of outcomes was low, there was no information on the handling of missing data and predictors were dichotomised.