Study characteristics |
Patient sampling |
Design: Prospective diagnostic test accuracy
Setting: UK
Accrual dates: Jan 2000 to Dec 2010
No participants: 1445
No assessed: 1439
Inclusion criteria: Women with possible ovarian malignancy were included. Women with obvious disseminated malignancy (FIGO stage III/IV) were excluded.
Included previous histological diagnosis: yes, 6 cases |
Patient characteristics and setting |
Women with possible ovarian malignancy were included. Women with obvious disseminated malignancy (FIGO stage III/IV) were excluded.Tertiary centre, UK. |
Index tests |
Two pieces of tissue taken for FS staining and reporting by consultant pathologist. Report was then phoned through to surgeon who used the info to determine the extent of surgery. |
Target condition and reference standard(s) |
Malignant or borderline on PS. |
Flow and timing |
FS before PS. |
Comparative |
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Notes |
Women with borderline and malignant diagnosis underwent surgical staging. |
Methodological quality |
Item |
Authors' judgement |
Risk of bias |
Applicability concerns |
DOMAIN 1: Patient Selection |
Was a consecutive or random sample of patients enrolled? |
Yes |
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Was a case‐control design avoided? |
Yes |
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Did the study avoid inappropriate exclusions? |
Yes |
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Was the sample representative of patients in practice (90% stage I/II with RMI>200)? |
Yes |
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Low |
Low |
DOMAIN 2: Index Test All tests |
Were the index tests interpreted without knowledge of the reference standard? |
Yes |
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Were the index tests Interpreted by consultant or specialist gyn‐onc pathologist? |
Yes |
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Low |
Low |
DOMAIN 3: Reference Standard |
Is the reference standards likely to correctly classify the target condition? |
Yes |
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Were the reference standard results interpreted without knowledge of the results of the index tests? |
Unclear |
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Unclear |
Low |
DOMAIN 4: Flow and Timing |
Did all patients receive a reference standard? |
Yes |
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Did all patients receive the same reference standard? |
Yes |
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Were un‐interpretable/intermediate test results reported? |
Yes |
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Were withdrawals from the study explained? |
Yes |
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Low |
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