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

Banaszkiewicz 2011.

Study characteristics
Patient sampling Country
Poland
Study design
Retrospective casenote review
Setting
Hospital
Dates of data collection
N/R
Population (n)
965
Inclusion criteria
Patients after radical surgery in whom prognosis following a possible second operation was good
Exclusion criteria
Non‐radical surgery or concomitant disease making survival of a second operation unlikely
Participants included (n)
340
Patient characteristics and setting Age range
N/R
Smoking status
N/R
Site of primary tumour
Colorectal
Stage of primary tumour
Dukes A ‐ D
Perioperative Investigations done to ensure no residual disease
Endoscopic polypectomy
Chemotherapy/radiotherapy?
Radical
Recurrences (n)
112
Site of recurrences
Liver 44, Local 32, Lung 7, Disseminated 12, other 6, 2 sites 11
Index tests CEA timing
CEA 3, 6, 12 months, then once a year up to 5 years
CEA technique
N/R
CEA threshold
5 µg/L
Definition of positive
N/R
Which CEA value (s) used?
N/R
Target condition and reference standard(s) Follow‐up schedule
Follow‐up visits at 3, 6, 12 months, then once a year up to 5 years. Follow‐up schedule included patient’s history and physical examination, measurement of CEA serum concentration and classic colonoscopy
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? No    
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? Unclear    
Is the same method and instrument used for all CEA measurements? Unclear    
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    
    Unclear 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? Unclear    
Did all patients receive a reference standard? Yes    
    Low