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

Johnson 1985.

Study characteristics
Patient sampling Country
Norway
Study design
Propsective
Setting
Hosptial + primary care
Dates of data collection
N/R
Population (n)
93
Inclusion criteria
Radical treatment for colorectal cancer
Exclusion criteria
Palliative, new cancers, no CEA monitoring
Participants included (n)
51
Patient characteristics and setting Age range
N/R
Smoking status
N/R
Site of primary tumour
Colon 49, rectal 44
Stage of primary tumour
Dukes A 28, B 27, C 21, palliative 17
Perioperative investigations done to ensure no residual disease
N/R
Chemotherapy/radiotherapy?
N/R
Recurrences (n)
15
Site of recurrences
N/R
Index tests CEA timing
Postoperatively, then at 3 ‐ 4‐monthly intervals
CEA technique
N/R
CEA threshold
5 µg/L
Definition of positive
N/R
Which CEA value (s) used?
N/R
More data available?
N/R
Target condition and reference standard(s) Follow‐up schedule
Postoperatively, then at 3 ‐ 4 monthly intervals, rising CEA resulted in further investigation, general clinical investigations, angiography of the liver, resection. No fixed schedule
Flow and timing Timing of CEA vs reference standard (days)
CEA triggered investigation
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? Unclear    
    Unclear 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? 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? Unclear    
Were the reference standard results interpreted without knowledge of the results of the index tests? No    
    Unclear Unclear
DOMAIN 4: Flow and Timing
Did all patients receive the same reference standard? No    
Were all patients included in the analysis? Unclear    
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? Unclear    
    Unclear