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 |
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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 |
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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 |
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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 |
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Flow and timing |
Timing of CEA vs reference standard (days) per protocol |
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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 |