Wireless capsule endoscopy in Italy: adding context-specific data to the review of the evidence from literature.

Objectives: The aim of this study was to assess the evidence of diagnostic accuracy of the wireless capsule for endoscopy (WCE) for the diagnosis of obscure gastrointestinal bleeding (OGIB) and small bowel disease in adults and translate it to the context of the Italian National Health Service.

Methods: We performed a systematic review of secondary and primary literature. We reviewed WCE diagnostic accuracy, safety, economic evaluations for OGIB. Context-specific data about WCE diffusion, costs, appropriateness of WCE use were collected by means of a national survey involving all Italian gastroenterological departments.

Results: We updated the systematic review of the most recent health technology assessment report (2006). Our review shows lack of robust comparative evidence of diagnostic accuracy of WCE. The studies' design do not allow collection of reliable evidence due to the uncertainty surrounding morphological variability of bleeding vascular gut lesions. The national survey reported widespread WCE use and data on appropriateness and costs.

Conclusions: Evidence of WCE diagnostic accuracy is of low quality, and there is a requirement for randomized comparisons. Our findings raise the issue of technology governance and show the importance of an assessment before the technology being widely commercialized.