82 chapter 2 Table 2. Overview of modified QUADAS-2 signalling questions Signalling questions, modified to fit our systematic review* More specifically for the topic of our systematic review: Domain 1: Patient selection 1. Was a consecutive or random sample of patients enrolled? In retrospective studies: were patients selected based only on presence of indeterminate cytology, and not on availability of a reference standard (histopathology)? 3. Did the study avoid inappropriate exclusions? Were exclusions avoided of patients with known lower risk of malignancy based on e.g. known absence of suspicious ultrasound features or known absence of a certain oncogenic mutation? Were exclusions avoided of patients with known higher risk of malignancy based on e.g. medical history or clinical symptoms? Exception: ‘presence of suspicious ultrasound features’ is a basic criterion in the routine clinical work-up of thyroid nodules to warrant FNA and is therefore not considered a factor with increased risk of malignancy for the purpose of this signalling question. (The 2015 ATA thyroid guidelines were adhered for detailed definitions of the factors that imply a lower or higher clinical risk of thyroid malignancy [17]) 4. Did the study apply the BSRTC, Thy system or TIR classification or provide a definition for indeterminate cytology? Domain 2: Conduct and interpretation of the index tests 1. Were the results of the index test interpreted without knowledge of the results of the reference standard? If this type of blinding was reported in the article, answer question with ‘yes’. If it is not reported, answer question with ‘unclear’. If it is reported that this type of blinding is not performed, answer question with ‘no’. 2. If a threshold was used, was it pre-specified? If a threshold was used, was it not based on ROC curve analysis performed on the same study population? Regarding applicability for ultrasound studies: were results for separate ultrasound features reported separately? Signalling questions, modified to fit our systematic review* More specifically for the topic of our systematic review:
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