Table 18 Diagnostic yield (% of subjects) May 2010 Takano 2011 Domagk 2011 Efthymiou 2012 Lenz 2013 DBE 52.0% 50.0% 43.1% 53.0% 48.2% SBE 42.0% 61.1% 36.9% 56.6% 61.7% p-value ns 0.53 0.59 0.70 <0.001 In the four randomised controlled studies there was no significant difference in diagnostic yield between DBE and SBE. In the non-randomised study by Lenz et al (2013), a significant difference in diagnostic yield in favour of SBE was found. However in this study DBE was performed over the period 2004 to 2011, whereas SBE was performed from 2008 to 2011. The authors suggest that a change over time in the reasons for referral for enteroscopy may explain the higher yield with SBE. Therapeutic intervention yield This endpoint refers the percentage of patients in whom a therapeutic intervention (e.g. argon plasma coagulation, endoscopic haemostasis, polypectomy, dilatation) can be undertaken during enteroscopy. It was measured in four studies: Table 19 Therapeutic yield using oral approach only or anal approach only % of subjects Lenz 2013 Oral approach Anal approach DBE 11.1% 3.5% SBE 14.4% 10.4% p-value ns <0.001 ns = not significant Table 20 Therapeutic yield using oral AND anal approaches % of subjects May 2010 Takano 2011 Domagk 2011 Efthymiou 2012 Lenz 2013 DBE - 15.0% 9.2% 25.7% - SBE - 11.1% 4.6% 30.0% - p-value - ns 0.49 0.592 - Takano 2011 reported results for “endoscopic haemostasis” and “endoscopic polypectomy”. ns = not significant These findings do not suggest that SBE is associated with inferior ability to perform therapeutic interventions compared with DBE. Biopsy yield. One study (Efthymiou et al 2012) reported on the proportion of patients who had targeted biopsies collected during enteroscopy using oral and anal approaches. Table 21 Therapeutic yield of targeted biopsies using oral AND anal approaches % of subjects Efthymiou 2012
Table 36 Method used to identify the type of analysis Comparative effectiveness versus comparator Superior Non-inferior Inferior Comparative safety versus comparator Superior CEA/CUA CEA/CUA Net clinical benefit CEA/CUA Neutral benefit CEA/CUA* Net harms None^ CEA/CUA CEA/CUA* None^ Inferior Net clinical benefit CEA/CUA None^ None^ Neutral benefit CEA/CUA* Net harms None^ Abbreviations: CEA = cost-effectiveness analysis; CUA = cost-utility analysis * May be reduced to cost-minimisation analysis. Cost-minimisation analysis should only be presented when the proposed service has been indisputably demonstrated to be no worse than its main comparator(s) in terms of both effectiveness and safety, so the difference between the service and the appropriate comparator can be reduced to a comparison of costs. In most cases, there will be some uncertainty around such a conclusion (i.e., the conclusion is often not indisputable). Therefore, when an assessment concludes that an intervention was no worse than a comparator, an assessment of the uncertainty around this conclusion should be provided by presentation of and/or cost-utility analyses. ^ No economic evaluation needs to be presented; MSAC is unlikely to recommend government subsidy of this intervention Population The current assessment is for SBE for obscure GI bleeding. The assessment has not been restricted by age group for either the proposed intervention or the comparator of DBE. This is consistent with MSAC Assessment 1102 (2006) which assessed the safety, effectiveness and cost-effectiveness of DBE for obscure GI bleeding or suspected small bowel disease relative to laparotomy with or without intra-operative enteroscopy. MSAC Assessment 1102 did not restrict by the age of the patient. Current literature indicates that there are limited studies on DBE in children which describe the procedure as safe and clinically useful, but these are mostly retrospective and include relatively small numbers. In 2012-13, Medicare statistics for items 30680 to 30684 show nil services for the 0 to 4 age group with only one claim under item 30682 for the 5-14 year age group. Figure 2 andFigure 3 show the age breakdown of services for item 30680 (DBE oral approach) and item 30682 (DBE anal approach) in 2012-13.