Yu 1992.
| Study characteristics | |||
| Patient sampling |
Country China Study design Retrospective observational study Setting Teaching hospital in Shanghai Dates of data collection May 1988 ‐ March 1990 Population (n) 216 Inclusion criteria Primary colorectal cancer having curative surgery in the teaching hospital or other hospitals Exclusion Criteria N/R Participants Included (n) 182 |
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| Patient characteristics and setting |
Age
range N/R Smoking status N/R Site of primary tumour Colorectal cancer 121, colon cancer 95 Stage of primary tumour Only reported Dukes stage data for the 28 before‐ surgery cases (Table 1) Perioperative investigations done to ensure no residual disease N/R Chemotherapy/ radiotherapy? N/R Recurrences (n) 66 Site of recurrences N/R |
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| Index tests |
CEA
timing N/R CEA technique RIA CEA threshold 15 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 first measured at 6 weeks after curative surgery; then every 3 months, plus liver ultrasound test and basic health check. Reference standard Positive CEA and CA‐19‐9 triggers ultrasound and CT or colonoscopy |
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| Flow and timing |
Timing of CEA vs reference standard (days) N/R |
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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? | Yes | ||
| 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 | |||
ACBE= air contrast barium enema ALP: alkaline phosphatase APCT: abdominopelvic computed tomography BE: barium enema CT: computed tomography CXR: chest xray DCBE: double contrast barium enema DM: diabetes mellitus ESR: erythrocyte sedimentation rate FOBT: faecal occult blood test LDH: lactate dehydrogenase LFT: latex fixation test MRI: magnetic resonance imaging N/R: not reported RIA: radioimmunoassay SCC: squamous cell carcinoma. SGOT: serum glutamic oxaloacetic transaminase SGPT: serum glutamate pyruvate transaminase TNM: primary tumour, regional nodes, metastasis TPA: tissue plasminogen activator µg/L = micrograms per litre USS = ultrasound scan