From: Challenges in diagnostic accuracy studies in primary care: the fecal calprotectin example
Signaling questions | Answer | Risk of bias/applicability | Planned adjustment |
---|---|---|---|
Domain 1: Patient selection | Â | Â | Â |
Risk of bias | Â | Low risk | Â |
Is a consecutive sample of patients enrolled? | Yes | Â | Â |
Is a case-control design avoided? | Yes | Â | Â |
Does the study avoid inappropriate exclusions? | Yes | Â | Â |
Applicability | Â | High concern | - Magnitude will be evaluated |
Are there concerns that the included patients and setting do not match the topic of our study (patients had symptoms suggestive of inflammatory bowel disease in primary care)? | Â | Â | Â |
Domain 2: Index test | Â | Â | Â |
Risk of bias | Â | Low Risk | Â |
Are the index test results interpreted without knowledge of the results of the reference standard? | Yes | Â | Â |
If a threshold was used, is it pre-specified? | Yes | Â | Â |
Applicability | Â | Low Concern | Â |
Are there concerns that the index test, its conduct, or interpretation differ from the topic of our study (fecal calprotectin was measured with ELISA)? | Â | Â | Â |
Domain 3: Reference standard | Â | Â | Â |
Risk of bias | Â | High risk | Â |
Is the reference standard likely to correctly classify the target condition? | No | Â | - Probably not clinically relevant |
Are the reference standard results interpreted without knowledge of the results of the index test? | Yes | Â | Â |
Domain 4: Flow and timing | Â | Â | Â |
Risk of bias | Â | High risk | Â |
Is there an appropriate interval between index test and reference standard? | No | Â | - Represents care as usual |
- Repeated measurement index test before endoscopy | |||
Do all patients receive a reference standard? | Yes | Â | Â |
Do all patients receive the same reference standard? | No | Â |