163 Cochrane study protocol: Accuracy of tubal patency tests 7 Data collection and analysis Selection of studies Two authors (RT and KR) will independently screen retrieved studies for eligibility on the basis of their titles and abstracts. If the study is potentially eligible, the same two authors will independently evaluate the full text for eligibility. A third author (CK or RW) will be involved to solve any disagreement at both stages. Where studies have multiple publications, we will collate multiple reports of the same study under a single study ID with multiple references. We will perform the study selection process in Covidence 2021 or other similar online platforms. Data extraction and management Two review authors (RT and KR) will perform the data extraction independently. When there is a disagreement between the two authors, a third author (CK or RW) will be consulted in the discussion. We will design a data extraction form for this review and pilot‐test the form on three studies. We will collect the following data from the included studies: general information (first author, year of publication, country), participant characteristics (age, inclusion/exclusion criteria, numbers of participants, risk stratification (high/low risk for tubal pathology or unselected population), index test/reference standard details, two‐by‐two table for each outcome (true positives, true negatives, false positives, and false negatives), inconclusive tests and adverse events. When data for two‐by‐two tables are not available, we will calculate these data from the test accuracy results (sensitivity, specificity, positive predictive value and negative predictive value). Next, we will collect data on test‐specific related conditions found. We will contact study investigators for information when needed. Handling of inconclusive results We will consider both valid inconclusive (intermediate or borderline) results and invalid inconclusive (indeterminate or uninterpretable) results in the analysis, as suggested by Shinkins (34). Participants with valid inconclusive results may receive further fertility treatment in clinical practice, but may also have another test in other settings. Therefore, we will treat all valid inconclusive results as positive (i.e. occluded) in the main analysis and as negative in a sensitivity analysis. Participants with invalid inconclusive results or procedure failures are more likely to have another test or a different index test in clinical practice, and some of these women may have conditions relevant to tubal pathology. Therefore, we will exclude invalid inconclusive results from the main analysis and treat them as positive (i.e. occluded) in a sensitivity analysis. We will evaluate the robustness of the findings by using different methods to handle the inconclusive results. Please refer to Sensitivity analyses.
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