Risk of bias

Applicability

Quality indicator

Notes

Quality indicator

Notes

Domain 1

Patient Selection

Could the selection of patients have introduced bias? (High/low/unclear)

Are there concerns that the included patients and settings do not match the review question? (High/low/unclear)

1. Was a consecutive or random sample of patients enrolled?

'Yes' if a consecutive or random

sample of patients was enrolled.

'No' if a selected group of patients

was enrolled.

'Unclear' if there was insufficient information on enrolment.

1. Were the patients diagnosed by conventional diagnostic work‐up for advanced stage ovarian cancer?

'Yes' if patients were diagnosed by conventional

diagnostic work‐up with advanced stage‐ovarian cancer.

'No' if patients included in the trial were diagnosed with low stage‐disease (FIGO I or II) only. No high stage‐disease patients in the trial.

'Unclear' if there was insufficient information on recruitment method, criteria for diagnosis of ovarian cancer.

2. Did the study avoid inappropriate exclusions?

'Yes' if there were no inappropriate exclusions.

'No' if there were inappropriate exclusions.

'Unclear' if there was insufficient information on exclusions.

2. Were the patients scheduled for primary debulking surgery after conventional diagnostic work‐up?

'Yes' if the patients were scheduled for primary debulking surgery after conventional diagnostic work‐up.

'No' if none of the patients were scheduled for primary debulking surgery.

'Unclear' if there was insufficient information.

Domain 2

Index Test

Could the interpretation of the Index test have introduced bias? (High/low/unclear)

Were there concerns that the index test, its conduct, or the interpretation differed from the review question? (High/low/unclear)

1. Were the index test results interpreted without the knowledge of the results of the reference standard?

This will always be rated as 'yes', because the index test is performed before the reference standard.

1. Were the same clinical data available when test results were interpreted as would be available when the test is used in clinical practice?

'Yes' if all usual clinical data (except laparotomy results) were available when the index test was interpreted, including details of physical examination, serum tumour markers, ultrasound, and CT/MRI imaging.

Also answer 'yes' if one of the items was missing.

'No' if clinical information (as mentioned by 'yes') was not available to the gynaecologist.

'Unclear' if insufficient information was reported.

2.Was the threshold used prespecified?

'Yes' if a clear description of the threshold was given which was specified before start of the study.

'No' if no clear description was given beforehand.

'Unclear' if there was insufficient information within the paper to determine whether or not a prespecified threshold was used.

2. Did the study provide a clear definition of what was considered to be a ’positive’ result for the index test?

'Yes' if a clear description was given about when the index test was positive or negative (e.g. what the cut‐off for too extensive abdominal disease was).

'No' if there was no clear description given about what was classified as too extensive disease or not.

'Unclear' if there was insufficient information within the paper to determine whether or not a defined threshold was used for a positive test result.

3. Did the whole sample, or a random selection of the sample, receive verification using a reference

standard of diagnosis?

'Yes' if all patients underwent the reference standard (laparotomy).

'No' if not all patients underwent reference standard.

'Unclear' if insufficient information was provided.

4. Did patients receive the same reference standard regardless of the index test result?

'Yes' if patients who underwent the reference standard had laparotomy.

'No' if patients did not undergo laparotomy.

'Unclear' if insufficient information was provided.

Domain 3

Reference Standard

Could the interpretation of the reference standard have introduced bias? (High/low/unclear)

Were there concerns that the target condition as defined by the reference standard did not match the question? (High/low/unclear)

1. Was the reference standard likely to correctly classify the target condition?

'Yes' if the reference standard was laparotomy.

'No' if the reference standard used was not the one defined in the protocol.

'Unclear' if the information was insufficient.

1. Did the study provide a clear definition of what was considered to be a ’positive’ result for the reference standard?

'Yes' if a clear description was given about when the reference standard was positive or negative (e.g. if description was given about the size of the tumour deposits left after surgery).

'No' if there was no clear description of tumour deposit size after surgery.

'Unclear' if there was insufficient information within the paper that described tumour size after surgery.

2. Were the reference standard results interpreted without the knowledge of the results of the index test?

'Yes' if the report stated that the reference test was performed by individuals who did not perform the

index test.

'No' if the reference test was done by the same person performing the index test.

'Unclear' if not reported.

3. Was the surgeon's expertise adequate to perform the reference standard?

'Yes' if the reference test was performed by a gynaecological oncologist.

'No' if the reference test was not performed by a gynaecological oncologist.

'Unclear' if not reported.

Domain 4

Flow and Timing

Could the patient flow have introduced bias? (High/low/unclear)

1. Was the time period between reference standard and index test short enough to be reasonably sure that the target condition did not change between the two tests?

'Yes' if the time period between the index test and reference standard did not extend 6 weeks.

'No' if the time period was more than 6 weeks for an unacceptably high proportion of patients.

'Unclear' if the information on the timing of tests was not provided.

2. Did all patients receive the same reference standard?

'Yes' if all patients underwent the reference standard (laparotomy, diagnostic laparoscopy or image‐guided biopsy of distant metastases).

'No' if not all patients underwent the reference standard.

'Unclear' if insufficient information was provided.

3. Were all patients included in the analysis?

'Yes' if for all patients entered in the study were included in the analysis.

'No' if not all the patients in the study were included in the analysis.

'Unclear' if it was not clear whether all patients were accounted for.

4.Were withdrawals from the study reported?

'Yes' if, for all patients entered in the study,it was reported what happened

during the study, also those who withdrew or answered 'Yes' if no withdrawals were reported, and results were reported for all patients who entered in the study.

'No' if not all the patients in the study completed the study and these patients were not accounted for.

'Unclear' if it was not clear whether all patients were accounted for.