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

Triboulet 1983.

Study characteristics
Patient sampling Country
France
Study design
Prospective cohort study
Setting
Hospital
Dates of data collection
1976 ‐ 1979
Population (n)
91
Inclusion criteria
Operated on with curative intent for colorectal cancer
Exclusion criteria
Conditions which could affect B2 microglobulin level: altered renal function (creatinine > 88.4 umol/l); liver disease: chronic active cirrhosis, primary biliary cirrhosis, acute hepatitis. Metastasis or Dukes D cancers. Patients whose CEA had not returned to normal within 3 months of the operation.
Patient characteristics and setting Participants included (n)
91
Age range
33 ‐ 80
Smoking status
N/R
Site of primary tumour
Colon 65, rectum 26
Stage of primary tumour
Dukes A&B = 50; C = 41
Perioperative investigations done to ensure no residual disease
N/R
Chemotherapy/radiotherapy?
No
Recurrences (n)
43
Site of recurrences
12 rectum, 31 colon
Index tests CEA timing
Every 3 months
CEA technique
Radioimmunoassay (sorin)
CEA threshold
20 µg/L
Definition of positive
N/R
Which CEA value (s) used?
N/R
Target condition and reference standard(s) Follow‐up schedule
CEA & B2m every 3 months for at least 2 years. Clinical and laboratory monitoring was ensured by the same physician during the first two years post‐op in a pre‐established protocol with a barium enema and / or an endoscopy during the first two years enema. CXR and Liver USS annually. Further investigations if indicated (CT chest, bone scan)
Flow and timing Timing of CEA vs reference standard (days)
Yearly CXR and liver USS; enema and/or endoscopy done at least once in the 2 year follow‐up
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? Unclear    
Was the the timing between index test(s) and reference standard ascertainable? Unclear    
Did all patients receive a reference standard? No    
    High