160 Chapter 7 To evaluate heterogeneity with regards to population characteristics (population risk stratification) and index test characteristics (contrast media, technology, operator skills). METHODS Criteria for considering studies for this review Types of studies We will include studies on the diagnostic test accuracy of a single index test and studies on the comparative diagnostic test accuracy of two or more index tests. For the diagnostic test accuracy of a single index test, we will include single‐gate studies, in which one of the index tests (defined below) is compared with the reference standard within a timeframe in which the tubal status is unlikely to be changed (within three months). For the comparative diagnostic test accuracy of two or more index tests, we will include the two following types of studies. 1. Studies with fully‐paired direct comparisons. In these studies, the participants receive two or more index tests and the reference standard. 2. Randomized controlled trials that directly compares two or more index tests. In all arms, the index test should be followed by diagnostic laparoscopy as the reference standard. We will exclude two‐gate studies, as these study designs are likely to overestimate sensitivity and specificity. Furthermore, we will exclude studies with the primary endpoint of prognostic capacity for fertility outcomes, as well as diagnostic accuracy studies for sterilization purposes. We will exclude studies with a sample size of fewer than 50 participants, given the relatively low prevalence of bilateral tubal occlusion across all risk groups. Although this threshold may be considered arbitrary, both sensitivity and specificity could be unreliable or biased in studies with smaller sample size. Participants We will include participants with infertility undergoing a visual tubal patency test and a diagnostic laparoscopy. We will include participants who have been trying to conceive for one year or more, both with low and high risk of tubal pathology, as well as unselected
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