Banaszkiewicz 2011.
Study characteristics | |||
Patient sampling |
Country Poland Study design Retrospective casenote review Setting Hospital Dates of data collection N/R Population (n) 965 Inclusion criteria Patients after radical surgery in whom prognosis following a possible second operation was good Exclusion criteria Non‐radical surgery or concomitant disease making survival of a second operation unlikely Participants included (n) 340 |
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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 Dukes A ‐ D Perioperative Investigations done to ensure no residual disease Endoscopic polypectomy Chemotherapy/radiotherapy? Radical Recurrences (n) 112 Site of recurrences Liver 44, Local 32, Lung 7, Disseminated 12, other 6, 2 sites 11 |
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Index tests |
CEA timing CEA 3, 6, 12 months, then once a year up to 5 years CEA technique N/R CEA threshold 5 µg/L Definition of positive N/R Which CEA value (s) used? N/R |
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Target condition and reference standard(s) |
Follow‐up schedule Follow‐up visits at 3, 6, 12 months, then once a year up to 5 years. Follow‐up schedule included patient’s history and physical examination, measurement of CEA serum concentration and classic 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? | No | ||
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? | 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? | 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? | Unclear | ||
Did all patients receive a reference standard? | Yes | ||
Low |