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

Scrutinio 2014.

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


Journal
  • Annals of Vascular Surgery


Country
  • Italy


Study design
  • Prospective cohort study

Participants Number of included patients
  • 411


Surgical specialty
  • Vascular surgery


Age
  • Mean 70.2 years (SD 9.4 years)


Male sex
  • 78.8%


High‐risk surgery
  • Not reported  


Insulin‐dependent diabetes mellitus
  • 16.8%


History of ischaemic heart disease
  • 27.7%


History of congestive heart failure
  • 4.4%


History of cerebrovascular events
  • 17.8%


Elevated creatinine
  • 9.5%


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:
NT‐proBNP 
  • Objective: added biomarker 

  • Category: blood

  • Scale: continuous

  • Threshold: not applicable

  • Assay/device: not reported


 
Predictor 2:
High‐sensitivity CRP 
  • Objective: added biomarker 

  • Category: blood

  • Scale: continuous

  • Threshold: not applicable

  • Assay/device: Dimension RxL immunoassay (Siemens Healthcare Diagnostics, Glasgow, DE)


 
Predictor 3:
NT‐proBNP+ high‐sensitivity CRP 
  • Objective: added biomarker 

  • Category: blood

  • Scale: continuous

  • Threshold: not applicable

  • Assay/device: Dimension RxL immunoassay (Siemens Healthcare Diagnostics, Glasgow, DE)


 
Predictor 4:
New developed prediction model including insulin therapy for diabetes, open surgery and the highest tertiles of fibrinogen (> 377 mg/dL), hs‐CRP (> 3.2 mg/L) and NT‐proBNP (> 221 ng/L)
  • Objective: prediction model compared

  • Category: prediction model

  • Scale: not applicable

  • Threshold: not applicable

  • Assay/device: not applicable

Outcome Outcome category
  • All‐cause mortality and MACE


Full outcome definition
  • Composite of death, acute coronary syndromes, acute pulmonary oedema within 30 days of surgery and postoperative myocardial damage


Prediction horizon
  • 30‐day events

Analysis Number of outcomes
  • 74


Handling missing data
  • No information on handling missing data


Discrimination reported?
  • Yes


Calibration reported?
  • Yes


Reclassification reported?
  • Yes

PROBAST: Applicability Domain 1: Participant selection
  • Low


Justification: patient selection was appropriate and generalisable to the population used in the RCRI development study
Domain 2: Predictors
  • Low


Justification: predictor definitions were clearly defined and comparable to the definitions used in the development study
Domain 3: Outcome
  • Low


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


Patient selected were generalisable to the patient population used in the RCRI development study. Predictor and outcome definitions were clearly defined/assessed and comparable to the definitions used in the RCRI 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 Yes Clear (RCRI) predictor definitions were described.
Domain 3: Outcome Yes Clearly defined outcome definitions and appropriate adjudication of outcomes.
Domain 4:  Analysis No Low number of outcomes and no information on handling missing data.
Overall judgement No Patient selection was appropriate. Predictors and outcomes were clearly defined and assessed. However, the number of outcomes was low and there was no information on missing data.