Authors' objectives:

This report aims to undertake a systematic review and economic evaluation of M2A(R) capsule endoscopy in patients with obscure gastrointestinal (GI) bleeding.

Authors' results and conclusions: Due to the lack of a suitable reference standard for M2A(R) capsule endoscopy, diagnostic yield (the number of patients with a pathological lesion identified / the total number of patients assessed) was used as the measure of diagnostic test performance. This measure does not take into consideration the number of false positive and false negative results that may be associated with the findings of M2A(R) capsule endoscopy. Therefore, the diagnostic yield of M2A(R) capsule endoscopy and the comparator are likely to overestimate the diagnostic capabilities of these two procedures. At present due to the lack of a valid reference standard only level 3 and 4 evidence is available to describe the effectiveness of M2A(R) capsule endoscopy. 16 studies met the criteria for inclusion in the effectiveness review of M2A(R) capsule endoscopy. Only one small (13 patients) head-to-head trial comparing M2A(R) capsule endoscopy to small bowel series radiology (SBS) was identified at the time of this assessment. Therefore, a meta-analysis incorporating evidence from the head-to-head study of M2A(R) capsule endoscopy versus SBS, as well as indirect evidence from studies comparing M2A(R) capsule endoscopy to push enteroscopy (PE), and PE to SBS, was undertaken. The summary point estimates of diagnostic yield for the two tests determined in the main analysis were: 58 per cent (CI, 46.367.7%) for M2A(R) capsule endoscopy and 4 per cent (CI, 0.512.0%) for SBS. These point estimates of diagnostic yield were surrounded by wide credibility intervals due to the limited quantity of SBS data available. Despite this fact, the odds ratio of diagnostic yield of M2A. Capsule Endoscopy versus SBS was statistically significant (37.3 CI, 9.43270.97) and favoured M2A(R) capsule endoscopy. It should be noted that the patients enrolled in these studies are likely to resemble the prevalent obscure GI bleeding patient population currently present in Australia. Thus, the incremental estimates of diagnostic yield derived from these studies are likely to overestimate the apparent benefit of M2A(R) capsule endoscopy in an incident patient population where the M2A(R) capsule endoscopy is used as a third line investigation (ie, after upper GI endoscopy and colonoscopy). M2A(R) capsule endoscopy is a relatively new technology. As yet there are little available data on this technologys effect on patient management and long-term clinical outcomes. There are no head-to-head (ie, SBS versus M2A(R) capsule endoscopy) comparative studies that report changes in clinical outcomes or clinical management associated with M2A(R) capsule endoscopy. In summary, based on the available evidence, M2A(R) capsule endoscopy has a significantly greater diagnostic yield compared to SBS radiology.

Authors' recommendations: The MSAC recommended that, on the strength of evidence pertaining to M2A(R) capsule endoscopy for use in obscure GI bleeding, interim funding should be supported for this procedure for patients with confirmed recurrent obscure gastrointestinal bleeding following previous colonoscopy and endoscopy without identifying bleeding source. The recommendation is to be reviewed no later than three years from the date of this report.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.msac.gov.au/

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Medical Services Advisory Committee

Contact Address: MSAC (MDP 107), GPO Box 9848, Canberra, ACT 2601, Australia. Tel: +61 2 6289 6811; Fax: +61 2 6289 8799.

Contact Name: msac.secretariat@health.gov.au

Contact Email: msac.secretariat@health.gov.au

Copyright: Medicare Services Advisory Committee (MSAC)