Jubert 1978.
Study characteristics | |||
Patient sampling |
Country USA Study design Retrospective Setting Hospital Dates of data collection N/R Population (n) 97 Inclusion criteria Colorectal cancer Exclusion criteria N/R Participants Included (n) 97 |
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Patient characteristics and setting |
Age range 65 mean (39 ‐ 89) Smoking status Unknown Site of primary tumour Colon 56, rectum 41 Stage of primary tumour Dukes A 10, B 42, C 34, D 6 Perioperative investigations done to ensure no residual disease N/R Chemotherapy/radiotherapy? 5 chemo, 5 immuno Recurrences (n) 20 Site of recurrences 7 liver, 13 non‐liver |
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Index tests |
CEA timing At 6‐week intervals postoperatively CEA technique N/R CEA threshold 2.5 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 CEA is done preoperatively and at six week intervals postoperatively. In addition, patients are evaluated postoperatively at 6 to 8 week intervals by physical examination and the usual laboratory and radiological tests, and where indicated, suspicions of recurrence and/or metastasis are documented histologically for the most part. Reference standard "suspicions of recurrence and/or metastasis are documented histologically for the most part". |
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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? | Unclear | ||
Unclear | Low | ||
DOMAIN 2: Index Test All CEA thresholds | |||
If a threshold was used, was it pre‐specified? | Unclear | ||
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? | Unclear | ||
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? | Unclear | ||
Unclear |