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TABLE 1Quality assessment operational definitions

1. Was the spectrum of patients representative of the patients who will receive the test in practice?Yes: The study included a consecutive series or random sample of adults undergoing staging for known or suspected primary cancer of the colon or rectum who received PET/CT at any point in the pre-operative staging pathway, either as the first imaging investigation or referred following equivocal or suspicious findings on other tests including imaging, clinical exam and carcinoembryonic antigen (CEA) test

No: The study included a non-consecutive or non-random sample, or there is clear evidence of selective sampling, e.g. restriction to patients with particular findings on PET/CT

Unclear: Insufficient information on the method of recruitment and selection criteria
2. Is the reference standard likely to correctly classify the target condition?Yes: Surgical histopathology if surgical resection, or clinical/imaging follow-up of at least 6 months

No: Criteria clearly not met

Unclear: Insufficient information
3. Is the time period between the index test and reference standard short enough to be reasonably sure that the target condition did not change between the two tests?Yes: If the time between PET/CT and the reference standard is less than 6 weeks, the clinical rational being a finding on PET/CT in a patient with colon or rectal cancer should be acted upon within 6 weeks of study, or disease progression may occur. Similarly a negative finding should really be confirmed within the same timescale

No: ‘Yes’ criteria clearly not met

Unclear: The time lapse between tests was not reported
4. Did the whole sample or a random selection of the sample receive verification using a reference standard of diagnosis?Yes: It is reported that all or a random sample of the study participants did receive verification of their disease status using the reference standard defined in 2 above

No: All participants did not receive verification using the reference standard and those who did were not selected randomly

Unclear: Insufficient information
5. Did patients receive the same reference standard regardless of the index test result?Yes: All PET/CT results were verified by the same reference standard

No: Some PET/CT results were verified by a different reference standard

Unclear: Insufficient information
6. Was the reference standard independent of the index test (i.e. the index test did not form part of the reference standard)?Yes: PET/CT was not used in establishing the final diagnosis (i.e. PET/CT was not a component of the reference standard)

No: PET/CT did form part of the reference standard (NB: this does not include the PET/CT index test result being known when the reference standard diagnosis was made, only the specific incorporation of PET/CT as part of the reference standard test)

Unclear: Insufficient information
7. Were the index test results interpreted without knowledge of the results of the reference standard?Yes: It is clearly stated that PET/CT results were interpreted blind to the results of the reference standard; or the PET/CT results were clearly interpreted before the results of the reference standard were available

No: It is clearly stated that PET/CT results were interpreted with knowledge of the results of the reference standard

Unclear: Insufficient information
8. Were the reference standard results interpreted without knowledge of the results of the index test?Yes: It is clearly stated that the results of the reference standard were interpreted blind to the PET/CT results

No: It is clearly stated that the results of the reference standard were interpreted with knowledge of the PET/CT results

Unclear: Insufficient information
9. Were the same clinical data available when the test results were interpreted as would be available when the test is used in practice?Yes: It is stated that the clinical information, including all previous test results, that would normally be available to the assessors when PET/CT images are interpreted in practice was available when the index test was evaluated

No: It is stated that the clinical information that would normally be available when PET/CT images are interpreted in practice was not available to the assessors when the index test was evaluated

Unclear: Insufficient information
10. Were uninterpretable/intermediate test results reported?Yes: It is clear that all test results including those that were uninterpretable, indeterminate or intermediate are reported, or it is clear that there were none

No: It is reported that uninterpretable, indeterminate or intermediate test results were excluded with no further information given, or there is reason to believe that such results occurred but were not reported

Unclear: It is not clear whether there were any uninterpretable, indeterminate or intermediate result
11. Were withdrawals from the study explained?Yes: All participants who were entered in the study either completed the study or were accounted for if they did not complete the study (reasons for withdrawal and loss to follow-up were given)

No: Some participants who entered the study did not complete the study and were not accounted for

Unclear: Insufficient information to judge whether all participants who entered the study were accounted for

From: Appendix 5, Systematic review protocol: FDG PET-CT imaging for pre-operative staging in patients with primary colorectal cancer

Cover of The Value of FDG Positron Emission Tomography/Computerised Tomography (PET/CT) in Pre-Operative Staging of Colorectal Cancer: A Systematic Review and Economic Evaluation
The Value of FDG Positron Emission Tomography/Computerised Tomography (PET/CT) in Pre-Operative Staging of Colorectal Cancer: A Systematic Review and Economic Evaluation.
Health Technology Assessment, No. 15.35.
Brush J, Boyd K, Chappell F, et al.
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