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. 2014 Feb 21;2014(2):CD009786. doi: 10.1002/14651858.CD009786.pub2
  Risk of Bias Applicabillity
  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 is insufficient information on enrollement,
  
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 are diagnosed with low‐stage disease (FIGO I or IIA) only. No high stage disease patients in the trial.
“Unclear” if there is 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 is insufficient information on exclusions
 
2. Were the patients planned for primary cytoreductive surgery after conventional diagnostic work‐up?
 
 
“Yes” if the patients were planned for primary cytoreductive surgery after conventional diagnostic work‐up?
“No” if none of the patients were planned for primary cytoreductive surgery
“Unclear” if there is insufficient information
 
Domain 2
 
Index Test
Could the interpretation of the Index test have introduced bias? (High/low/unclear) Are there concerns that the index test, its conduct or the interpretation differ 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 practice?
 
“Yes” if all usual clinical data (except laparotomy results) are available when the index test is interpreted, including details of physical examination, serum tumor markers, and ultrasound and CT/MRI imaging. Also answer “yes” if one of the items is missing.
“No” if clinical information (as mentioned by “yes”) was not available to the gynaecologist
“Unclear” if insufficient information is reported.
 
2. Was the threshold used prespecified?
 
“Yes” if a clear description of the threshold is given which was specified before start of the study.
“No” if no clear description is given before hand
“Unclear” if there is 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 is given about when the index test is positive or negative. (e.g. what the cut‐off for too extensive abdominal disease was)
“No” if there is no clear description of what is classified as too extensive disease or not.
“Unclear” if there is insufficient information within the paper to determine whether or not a defined threshold was used to 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, also those who were tested negative by indextest didn't undergo reference test.  
“Unclear” if insufficient information is provided.
 
   
4. Did patients receive the same reference standard regardless of the index test result? “Yes” if patients who underwent reference standard had laparotomy.
“No” if patients did not undergo laparotomy.
“Unclear” if insufficient information is provided. 
 
   
 
Domain 3
 
 
Reference Standard
Could the interpretation of the reference standard have introduced bias? (High/low/unclear)
 
Are there concerns that the target condition as defined by the reference standard does not match the question?
(High/low/unclear)
 
1. Is the reference standard likely to correctly classify the target condition?
 
“Yes” if the reference standard is laparotomy.
 “No” if the reference standard used is not the one defined in the protocol.
“Unclear” if the information is 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 is given about when the reference standard is positive or negative. (e.g. what the cut‐off at laparotomy is for too extensive abdominal disease was)
“No” if there is no clear description of what is classified as too extensive disease or not.
“Unclear” if there is insufficient information within the paper to determine whether or not a defined threshold was used to a positive test result
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 is performed by individuals who did not perform the index test.
“No” if the reference test were done by the same person performing the index test.
“Unclear” if not reported.
 
   
 
Domain 4
 
Flow and Timing
Could the patient flow have introduced bias?  (High/low/unclear)    
1. Is 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 is not longer than 3 weeks.
“No” if the time period is more than 3 weeks for an unacceptable high proportion of patients.
“Unclear” if the information on the timing of tests is not provided
   
 
2. Did all patients receive the same reference standard?
 
“Yes” if all patients underwent the reference standard (laparotomy)
“No” if not all patients underwent reference standard, also those who were tested negative by indextest didn’t undergo reference test.  
“Unclear” if insufficient information is provided.
 
   
 
3. Were all patients included in the analysis?
 
“Yes” if for all patients entered in the study are included in the analysis.
“No” if not all the patients in the study are included in the analysis
“Unclear” if it is not clear whether all patients were accounted for.
   
 
4. Were withdrawals from the study reported?
 
“Yes” if for all patients entered in the study is reported what happened during the study, also those who withdraw or answer “yes” if no withdrawals where reported and all patients who entered in the study results were reported.
“No” if not all the patients in the study complete the study and these patients were not accounted for.
“Unclear” if it is not clear whether all patients were accounted for.