Assessment of drug-induced sleep endoscopy (DISE) in adults with obstructive sleep apnoea (OSA) - INAHTA Brief

Aim

To evaluate the validity of funding of this procedure by the French National Health Insurance system:

• Assess the clinical utility, diagnostic performance and safety of drug-induced sleep endoscopy (DISE) to locate sites of upper airway obstruction in adults with obstructive sleep apnoea (OSA), via comparison with the usual strategy (including clinical assessment and awake endoscopy).
• In the event of a demonstrated clinical benefit, describe the conditions for optimum performance of this procedure.

Conclusions and results

In total, the following studies were analysed: two randomised controlled trials and six prospective studies (for the different questions relative to clinical utility, diagnostic performance and safety), along with four randomised controlled trials for the question relative to the choice of anaesthetic (the only question relating to the conditions for optimum performance covered).

Based on all the information gathered and analysed in the report, including two recent randomised controlled trials, it has not been possible to formally conclude that performing DISE in addition to the usual strategy in the management of OSA improves patient outcomes or reduces the number of patients wrongly operated on.

The analysis of the diagnostic studies revealed a very poor level of agreement between the obstructions observed with DISE and with the comparator in more than half of the patients (one study), as well as a higher number of multisite obstructions with DISE than with the comparator (one study), but both studies have limitations that weaken the conclusions that can be drawn from them.

The studies presenting safety data did not note any particular complications with this technique, and this finding was shared by the experts consulted.

Finally, the analysis of the randomised controlled trials comparing different anaesthetics did not enable any definite conclusion to be reached in favour of one anaesthetic over another.

Recommendations

In view of all the data collected and analysed, the French National Authority for Health (HAS) issues an unfavourable opinion for the funding of this procedure in the indications covered by the report. It should be noted that the indication relating to the performance of DISE before the implantation of a hypoglossal nerve stimulation device has been the subject of a separate assessment document.

Methods

• a critical analysis of the literature identified after a systematic literature search and selected on the basis of explicit criteria. The methodological validity of the studies selected for the analysis was assessed using the RoB 2 tool for the RCTs and the Quadas 2 grid for the diagnostic studies.

The data collected were summarised in the form of a narrative analysis or a meta-analysis (when at least three studies presented data on the outcome in question).

• consultation of healthcare professionals and users, questioned first individually and then collectively (as stakeholders);
• compilation of these different elements in the health technology assessment report, examined by the HAS committee for the assessment of diagnostic, prognostic and predictive health technologies (CEDiag), and then validated by the HAS Board.

Further research/reviews required

The HAS recognises the need for an additional diagnostic tool to better characterise obstructions occurring during sleep, in order to ensure optimal adaptation of OSA treatment(s). To this end, the HAS encourages the performance of studies to demonstrate the clinical utility of DISE, taking into account the specificities of interpretation and comparison of results, which are recalled in the conclusions of the report.