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

Carlsson 1983.

Study characteristics
Patient sampling Country
Sweden
Study design
Prospective study
Setting
Hospital
Dates of data collection
N/R
Population (n)
163
Inclusion Criteria
Curative operation for colorectal cancer
Exclusion Criteria
Advanced age, moving away, death 3 months postop
Participants Included (n)
139
Patient characteristics and setting Age range
N/R
Smoking status
N/R
Site of primary tumour
Colorectal
Stage of primary tumour
N/R
Perioperative Investigations done to ensure no residual disease
N/R
Chemotherapy/radiotherapy?
No
Recurrences (n)
50
Site of recurrences
N/R
Index tests CEA timing
Blood tests 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 60 months post‐1977‐ blood tests 3, 6, 12, 18, 24, 30, 36, 42, 48, 60 months
CEA technique
Direct radio immunoassay method developed at the Department of Nuclear Medicine, Malmo General Hospital
CEA threshold
3 µg/L
Definition of positive
1 elevated value
Which CEA value (s) used?
At time of recurrence
Target condition and reference standard(s) Follow‐up schedule
Until 1977: Follow‐up exam and rectoscopy 3, 6, 9, 12, 15, 18 ,21, 24, 26, 42, 48, 60 months. Double contrast enema 3, 12, 24, 36, 48, 60 months. CXR and blood tests 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 60 months. From 1977: Physical exam and rectoscopy 3, 12, 24, 36, 48, 60 months. Double contrast enema 3, 12, 24, 36, 48, 60 months. CXR and blood tests 3, 6, 12, 18, 24, 30, 36, 42, 48, 60 months
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? Yes    
Did all patients receive a reference standard? Yes    
    Low