Montagnana 2011.
| Study characteristics | |||
| Patient Sampling | Country: Italy Centres: single Study design: within‐person comparison Recruitment: unclear Method of patient selection: convenience Inappropriate exclusions: non‐EOC excluded Comments (if applicable): N/A |
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| Patient characteristics and setting | Clinical setting: secondary Study entry criteria: women with pelvic mass scheduled to have radical surgery Sample size: 104 Age range: not reported Mean age: EOC 56.9 (SD 14.4) years, benign 42 (SD 15.5) years Median age: not reported Percentage postmenopausal (n): 51% (53) Comments: only women undergoing radical surgery were included |
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| Index tests | Combination ROMA Prior test: unclear Threshold for test positivity predefined: yes Threshold for test positivity: premenopausal ≥ 12.5, postmenopausal ≥ 14.4 Interval between index test and reference standard: 1 day Type of ultrasound (TAS, TVS or both): N/A Operator experience of sonographer (generalist, specialist or trainee): N/A Type of technology or manufacturer of biomarker test: CA125 (ECLIA), HE4 (RIA) |
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| Target condition and reference standard(s) | Only surgical patients included Follow‐up: none Duration of follow‐up: N/A Histology (n): benign 49, borderline – ? excluded, malignant 55, metastatic and others? excluded Staging: early 15, late 40, unstaged 0 |
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| Flow and timing | |||
| Comparative | N/A | ||
| Notes | |||
| Methodological quality | |||
| Item | Authors' judgement | Risk of bias | Applicability concerns |
| DOMAIN 1: Patient Selection | |||
| Was a consecutive or random sample of patients enrolled? | Unclear | ||
| Was a case‐control design avoided? | Yes | ||
| Did the study avoid inappropriate exclusions? | Unclear | ||
| A) Includes all ages regardless of menopausal status or justify restrictions | Unclear | ||
| B) Includes all stages and types of ovarian cancer | Unclear | ||
| C) Includes comorbidities such as infertility and endometriosis | Unclear | ||
| Could the selection of patients have introduced bias? | Unclear risk | ||
| A) All patients are symptomatic or symptomatic and asymptomatic can be disaggregated | |||
| B) Prior test in primary care: self‐reported symptoms | |||
| C) Prior test secondary care: self‐reported symptoms or self‐reported symptoms plus one or more biochemical markers and ultrasound | |||
| Are there concerns that the included patients and setting do not match the review question? | Unclear | ||
| DOMAIN 2: Index Test (ADNEX) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | |||
| If a threshold was used, was it pre‐specified? | |||
| Were all components and thresholds of composite index test (including multivariable model) prespecified before their application? | |||
| If a composite index test was used, were components of a composite index test/model defined and assessed in a similar way (e.g. in the same healthcare setting) for all participants? | |||
| Could the conduct or interpretation of the index test have introduced bias? | |||
| A) Was ultrasound performed in all patients by non‐specialised sonographers | |||
| B) i. Were symptoms interpreted without the knowledge of ultrasound and biomarkers; ii: was ultrasound interpreted without the knowledge of biomarkers | |||
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? | |||
| DOMAIN 2: Index Test (RMI) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | |||
| If a threshold was used, was it pre‐specified? | |||
| Were all components and thresholds of composite index test (including multivariable model) prespecified before their application? | |||
| If a composite index test was used, were components of a composite index test/model defined and assessed in a similar way (e.g. in the same healthcare setting) for all participants? | |||
| Could the conduct or interpretation of the index test have introduced bias? | |||
| A) Was ultrasound performed in all patients by non‐specialised sonographers | |||
| B) i. Were symptoms interpreted without the knowledge of ultrasound and biomarkers; ii: was ultrasound interpreted without the knowledge of biomarkers | |||
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? | |||
| DOMAIN 2: Index Test (ACOG) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | |||
| If a threshold was used, was it pre‐specified? | |||
| Were all components and thresholds of composite index test (including multivariable model) prespecified before their application? | |||
| If a composite index test was used, were components of a composite index test/model defined and assessed in a similar way (e.g. in the same healthcare setting) for all participants? | |||
| Could the conduct or interpretation of the index test have introduced bias? | |||
| A) Was ultrasound performed in all patients by non‐specialised sonographers | |||
| B) i. Were symptoms interpreted without the knowledge of ultrasound and biomarkers; ii: was ultrasound interpreted without the knowledge of biomarkers | |||
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? | |||
| DOMAIN 2: Index Test (ROMA) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
| If a threshold was used, was it pre‐specified? | Yes | ||
| Were all components and thresholds of composite index test (including multivariable model) prespecified before their application? | Yes | ||
| If a composite index test was used, were components of a composite index test/model defined and assessed in a similar way (e.g. in the same healthcare setting) for all participants? | Yes | ||
| Could the conduct or interpretation of the index test have introduced bias? | Low risk | ||
| A) Was ultrasound performed in all patients by non‐specialised sonographers | |||
| B) i. Were symptoms interpreted without the knowledge of ultrasound and biomarkers; ii: was ultrasound interpreted without the knowledge of biomarkers | |||
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
| DOMAIN 2: Index Test (LR2) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | |||
| If a threshold was used, was it pre‐specified? | |||
| Were all components and thresholds of composite index test (including multivariable model) prespecified before their application? | |||
| If a composite index test was used, were components of a composite index test/model defined and assessed in a similar way (e.g. in the same healthcare setting) for all participants? | |||
| Could the conduct or interpretation of the index test have introduced bias? | |||
| A) Was ultrasound performed in all patients by non‐specialised sonographers | |||
| B) i. Were symptoms interpreted without the knowledge of ultrasound and biomarkers; ii: was ultrasound interpreted without the knowledge of biomarkers | |||
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? | |||
| 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? | |||
| Could the reference standard, its conduct, or its interpretation have introduced bias? | Low risk | ||
| Can borderline tumours be grouped with primary ovarian cancer for the purposes of analysis? | |||
| Are there concerns that the target condition as defined by the reference standard does not match the question? | Unclear | ||
| DOMAIN 4: Flow and Timing | |||
| Was there an appropriate interval between index test and reference standard? | Yes | ||
| Did all patients receive the same reference standard? | Yes | ||
| Were all patients included in the analysis? | Unclear | ||
| Could the patient flow have introduced bias? | Unclear risk | ||
| DOMAIN 5: Comparative | |||
| For studies comparing two or more index tests or testing strategies in different populations, were the selection criteria for participants receiving one or other index test or testing strategy the same? | |||
| For within‐study comparisons of index tests: was the interval between application of index test less than 3 months? | |||
| For within‐study comparison of individual index tests: were index tests interpreted blind to the results of other index test results? | |||
| Could the conduct of the comparative studies have introduced bias? | |||
| Is there concern that included patients have been selected in a different way to participants in non‐comparative studies? | |||