Triboulet 1983.
Study characteristics | |||
Patient sampling |
Country France Study design Prospective cohort study Setting Hospital Dates of data collection 1976 ‐ 1979 Population (n) 91 Inclusion criteria Operated on with curative intent for colorectal cancer Exclusion criteria Conditions which could affect B2 microglobulin level: altered renal function (creatinine > 88.4 umol/l); liver disease: chronic active cirrhosis, primary biliary cirrhosis, acute hepatitis. Metastasis or Dukes D cancers. Patients whose CEA had not returned to normal within 3 months of the operation. |
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Patient characteristics and setting |
Participants included (n) 91 Age range 33 ‐ 80 Smoking status N/R Site of primary tumour Colon 65, rectum 26 Stage of primary tumour Dukes A&B = 50; C = 41 Perioperative investigations done to ensure no residual disease N/R Chemotherapy/radiotherapy? No Recurrences (n) 43 Site of recurrences 12 rectum, 31 colon |
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Index tests |
CEA timing Every 3 months CEA technique Radioimmunoassay (sorin) CEA threshold 20 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 CEA & B2m every 3 months for at least 2 years. Clinical and laboratory monitoring was ensured by the same physician during the first two years post‐op in a pre‐established protocol with a barium enema and / or an endoscopy during the first two years enema. CXR and Liver USS annually. Further investigations if indicated (CT chest, bone scan) |
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Flow and timing |
Timing of CEA vs reference standard (days) Yearly CXR and liver USS; enema and/or endoscopy done at least once in the 2 year follow‐up |
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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? | Unclear | ||
Was the the timing between index test(s) and reference standard ascertainable? | Unclear | ||
Did all patients receive a reference standard? | No | ||
High |