Outpatient follow-up of COPD patients undergoing long-term non-invasive ventilation (OCONIV): a randomised-controlled multicentre trial

Background Long-term non-invasive ventilation (NIV) has emerged as the standard treatment for patients with chronic hypercapnic COPD. Although regular follow-up visits are recommended to maintain treatment success, the favourable setting for such visits have not yet been investigated. Hypothesis Outpatient follow-up of long-term NIV in stable hypercapnic COPD provides comparable patient benefits. Methods A predefined protocol was used to randomise 113 patients with stable hypercapnic COPD to standard (i) inpatient or (ii) outpatient NIV follow-up (1:1). The primary outcome was the mean difference in health-related quality of life (HRQL) after 12 months, as assessed by the Severe Respiratory Insufficiency Questionnaire (SRI). Patient preference, capillary blood gases, exacerbation rates and mortality, total costs and cost-effectiveness served as secondary outcomes. Results Outpatient NIV follow-up was associated with a non-significant improvement in the SRI Summary Score (SRI-SS) after 12 months (adjusted mean difference 3.7±2.6; p=0.164). PaCO 2 (47.6±10.1 versus 46.5±6.2 mmHg, p=0.906) and NIV adherence (8.3±3.5 versus 8.5±2.3 h; p=0.243) were similar, as were mortality and exacerbations rates. Total annual costs reached € 681 (outpatient) and € 3621 (inpatient). The resulting mean cost difference of –€2940 corresponded to a cost-effectiveness ratio of –€794/SRI point, favouring outpatient care. Outpatient treatment was preferred by most patients (84.3%). Discussion Outpatient NIV follow-up achieved comparable clinical patient outcomes to inpatient care, with a tendency towards better HRQL in the outpatient group. Outpatient follow-up is a safe, more cost-effective approach that is preferred by most patients in a selected population of clinically stable long-term NIV users managed at specialised centres.