Carlsson 1983.
Study characteristics | |||
Patient sampling |
Country Sweden Study design Prospective study Setting Hospital Dates of data collection N/R Population (n) 163 Inclusion Criteria Curative operation for colorectal cancer Exclusion Criteria Advanced age, moving away, death 3 months postop Participants Included (n) 139 |
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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? No Recurrences (n) 50 Site of recurrences N/R |
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Index tests |
CEA timing Blood tests 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 60 months post‐1977‐ blood tests 3, 6, 12, 18, 24, 30, 36, 42, 48, 60 months CEA technique Direct radio immunoassay method developed at the Department of Nuclear Medicine, Malmo General Hospital CEA threshold 3 µg/L Definition of positive 1 elevated value Which CEA value (s) used? At time of recurrence |
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Target condition and reference standard(s) |
Follow‐up schedule Until 1977: Follow‐up exam and rectoscopy 3, 6, 9, 12, 15, 18 ,21, 24, 26, 42, 48, 60 months. Double contrast enema 3, 12, 24, 36, 48, 60 months. CXR and blood tests 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 60 months. From 1977: Physical exam and rectoscopy 3, 12, 24, 36, 48, 60 months. Double contrast enema 3, 12, 24, 36, 48, 60 months. CXR and blood tests 3, 6, 12, 18, 24, 30, 36, 42, 48, 60 months |
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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? | 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? | No | ||
Was the the timing between index test(s) and reference standard ascertainable? | Yes | ||
Did all patients receive a reference standard? | Yes | ||
Low |