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 |
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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? 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 |
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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 |
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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. |
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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? | 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 |