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. 2015 Dec 10;2015(12):CD011134. doi: 10.1002/14651858.CD011134.pub2

Kim 2013.

Study characteristics
Patient sampling Country
Korea
Study design
Retrospective
Setting
Hospital
Dates of data collection
2005 ‐ 2009
Population (n)
N/R
Inclusion criteria
Radical resection
Exclusion criteria
Patients with stage 0, I or IV cancer, insufficient follow‐up (less than 3 years), abnormal CEA in the first measurement after surgery (checked within three months after surgery), history of other cancers and/or history of preoperative concurrent chemoradiation therapy were excluded
Participants Included (n)
336
Patient characteristics and setting Age range
Stage 111: 29 ‐ 81, Stage 11: 33 ‐ 83
Smoking status
N/R
Site of primary tumour
Colorectal
Stage of primary tumour
Stage II 189, Stage III 147
Perioperative investigations done to ensure no residual disease
N/R
Chemotherapy/radiotherapy?
N/R
Recurrences (n)
79
Site of recurrences
Index tests CEA timing
CEA levels were assayed with a 3‐month interval for the first 2 years and every 6 months thereafter
CEA technique
Immunoassay method (ADIVA Centaur XP immunoassay system, Siemen AG, Erlangen, Germany)
CEA threshold
5 µg/L
Definition of positive
1 elevated value
Which CEA value (s) used?
All
Target condition and reference standard(s) Follow‐up schedule
CEA levels were assayed with a 3‐month interval for the first 2 years and every 6 months thereafter. Chest CT and abdomino‐pelvic CT were performed with a 6‐month interval for the first 2 years and every year thereafter
Reference standard
The diagnosis of a tumour recurrence was confirmed by biopsy and radiologic evidence
Flow and timing Timing of CEA vs reference standard (days)
per protocol
Comparative  
Notes  
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Unclear    
Did the study avoid inappropriate exclusions? No    
    High Low
DOMAIN 2: Index Test All CEA thresholds
If a threshold was used, was it pre‐specified? Yes    
Is the same method and instrument used for all CEA measurements? Yes    
Is there an estimation of reproducibility of the method, for example the % coefficient of variation at specific concentrations? No    
Is there an indication of method accuracy, for example, is there evidence of participation in an external quality assessment and proficiency testing scheme? No    
    Low Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes    
Were the reference standard results interpreted without knowledge of the results of the index tests? No    
    Low Low
DOMAIN 4: Flow and Timing
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? Yes    
Was the index test repeated prior to the reference standard? No    
Was the the timing between index test(s) and reference standard ascertainable? No    
Did all patients receive a reference standard? Yes    
    Low