3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 6 sources, which was discussed by the committee. The evidence included 2 non-randomised clinical trials, 1 randomised clinical trial (including a dose evaluation study and an open-label confirmation study), 1 randomised controlled clinical trial and 2 additional papers that reported longer-term outcomes from the 2 randomised clinical trials. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: improvement in quality of life and functional measures of activity, and a reduction in exacerbations and hospital admissions.
3.3 The professional experts and the committee considered the key safety outcomes to be: periprocedural adverse events, bronchial damage and gastrointestinal effects.
3.4 Patient commentary was sought but none was received.
3.5 The committee noted that there were a few well conducted but small trials, which primarily focused on safety. The committee noted that larger, suitably powered trials are needed to provide more evidence on efficacy.
3.6 The committee was told that the procedure is evolving, including different power levels and a change from rigid to flexible bronchoscopic delivery. These changes may affect the safety of the procedure.
3.7 The committee noted that pulmonary rehabilitation plays an important role in optimising outcomes for patients with chronic obstructive pulmonary disease.
3.8 The committee was told that measures of pulmonary function do not necessarily correlate with quality of life.