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

Deveney 1984.

Study characteristics
Patient sampling Country
USA
Study design
Prospective
Setting
Hospital
Dates of data collection
starting in 1978
Population (n)
N/R
Inclusion criteria
Resection for curable adenocarcinoma of the colon or rectum
Exclusion criteria
Dukes D
Participants included (n)
65
Patient characteristics and setting Age range
67 yrs mean
Smoking status
N/R
Site of primary tumour
Colorectal
Stage of primary tumour
8 Dukes A tumours, 34 had Dukes B tumours, and 20 had Dukes C tumours
Perioperative investigations done to ensure no residual disease
N/R
Chemotherapy/radiotherapy?
Some got radio/chemotherapy
Recurrences (n)
23
Site of recurrences
N/R
Index tests CEA timing
3‐monthly in yr 1, then 6‐monthly to year 5
CEA technique
N/R
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
3‐monthly in year 1, then 6‐monthly to year 5: clinical history, examination, FOBT, LFT, CEA. 6‐monthly CXR, CT abdomen, total colonoscopy. BE at 6 and 12 months then annually
Reference standard
A positive finding on any test prompted additional confirmatory tests, including laparotomy, thoracotomy,or percutaneous CT‐directed biopsy
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? Yes    
Did the study avoid inappropriate exclusions? Yes    
    Low 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? 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? No    
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