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

Wood 1980.

Study characteristics
Patient sampling Country
UK
Study design
Retrospective
Setting
Hospital
Dates of data collection
1974 ‐ 1976
Population (n)
148
Inclusion criteria
Apparently curative surgery for adenocarcinoma of the colon and rectum without evidence of metastatic disease
Exclusion criteria
N/R
Participants Included (n)
148
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?
N/R
Recurrences (n)
36
Site of recurrences
Local 17, local + liver 2, local + bone 2, local + metachronous primary 1, liver 8, bone 5, lung 2
Index tests CEA timing
Each follow‐up visit, 2 consecutive raised CEA triggered investigation for recurrence
CEA technique
CEA levels were assayed by a double antibody radioimmunoassay on unextracted serum
CEA threshold
25 µg/L
Definition of positive
2 consecutively elevated values
Which CEA value (s) used?
All
Target condition and reference standard(s) Follow‐up schedule
CEA at 3 ‐ 6 months intervals post‐operative for up to 56 months or until death.
Reference standard
If CEA positive then CXR, Liver scan, and bone scan. If these are negative, additional BE and/or 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? 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? 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? No    
Did all patients receive a reference standard? No    
    High