Kim 2013.
Study characteristics | |||
Patient sampling |
Country Korea Study design Retrospective Setting Hospital Dates of data collection 2005 ‐ 2009 Population (n) N/R Inclusion criteria Radical resection Exclusion criteria Patients with stage 0, I or IV cancer, insufficient follow‐up (less than 3 years), abnormal CEA in the first measurement after surgery (checked within three months after surgery), history of other cancers and/or history of preoperative concurrent chemoradiation therapy were excluded Participants Included (n) 336 |
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Patient characteristics and setting |
Age range Stage 111: 29 ‐ 81, Stage 11: 33 ‐ 83 Smoking status N/R Site of primary tumour Colorectal Stage of primary tumour Stage II 189, Stage III 147 Perioperative investigations done to ensure no residual disease N/R Chemotherapy/radiotherapy? N/R Recurrences (n) 79 Site of recurrences |
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Index tests |
CEA timing CEA levels were assayed with a 3‐month interval for the first 2 years and every 6 months thereafter CEA technique Immunoassay method (ADIVA Centaur XP immunoassay system, Siemen AG, Erlangen, Germany) 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 CEA levels were assayed with a 3‐month interval for the first 2 years and every 6 months thereafter. Chest CT and abdomino‐pelvic CT were performed with a 6‐month interval for the first 2 years and every year thereafter Reference standard The diagnosis of a tumour recurrence was confirmed by biopsy and radiologic evidence |
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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? | No | ||
Did all patients receive a reference standard? | Yes | ||
Low |