Background Obesity hypoventilation syndrome (OHS) is treated with either non-invasive ventilation (NIV) or CPAP, but there are no long-term cost-effectiveness studies comparing the two treatment modalities.
Objectives We performed a large, multicentre, randomised, open-label controlled study to determine the comparative long-term cost and effectiveness of NIV versus CPAP in patients with OHS with severe obstructive sleep apnoea (OSA) using hospitalisation days as the primary outcome measure.
Methods Hospital resource utilisation and within trial costs were evaluated against the difference in effectiveness based on the primary outcome (hospitalisation days/year, transformed and non-transformed in monetary term). Costs and effectiveness were estimated from a log-normal distribution using a Bayesian approach. A secondary analysis by adherence subgroups was performed.
Results In total, 363 patients were selected, 215 were randomised and 202 were available for the analysis. The median (IQR) follow-up was 3.01 (2.91–3.14) years for NIV group and 3.00 (2.92–3.17) years for CPAP. The mean (SD) Bayesian estimated hospital days was 2.13 (0.73) for CPAP and 1.89 (0.78) for NIV. The mean (SD) Bayesian estimated cost per patient/year in the NIV arm, excluding hospitalisation costs, was €2075.98 (91.6), which was higher than the cost in the CPAP arm of €1219.06 (52.3); mean difference €857.6 (105.5). CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs. Similar findings were observed in the high and low adherence subgroups.
Conclusion CPAP is more cost-effective than NIV; therefore, CPAP should be the preferred treatment for patients with OHS with severe OSA.
Trial registration number NCT01405976
- sleep apnoea
- non invasive ventilation
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Contributors Substantial contributions to study conception and design, acquisition of data, or analysis and interpretation of data: JFM, M-ÁS-Q, FJGdT, IB, F-JV-P, MAN, MM-E, FB, AR, CC-E, EO-C, MLA-Á, TG-G, MG, SL-M, JMM, OR, TD-C, EC, CE, BM, JC, IU, JB, EO, NG-M, MFT, M-ÁM-M, EO-C, DLP, SJC, BG, MP, OR, SM, MAR, EA, JM-M, CS, JNS-C, NBNS, JS-G, RG, AS-R and MB. Drafting the article or revising the article critically for important intellectual content: JFM, BM, IB, FJGdT, MÁS-Q, AR, CC-E, EO, MLA-Á, MFT, MG, SL-M, JMM, SM, TD-C, EC, CE, F-JV-P, MAN, MM-E, FB and JC. Performing of the version to be published: JFM, BM, IB, F-JV-P, MAN and JC. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved: JFM. JFM has full access to all data from the study and takes responsibility for the integrity of the data, the accuracy of the data analysis and for the decision to submit for publication.
Funding Instituto de Salud Carlos III (Fondo de Investigaciones Sanitarias, Ministerio de Sanidad y Consumo) PI050402, Spanish Respiratory Foundation 2005 (FEPAR) and Air Liquide Spain.
Disclaimer The sponsors and funders of the study had no involvement or any influence in study design; in the collection, analysis and interpretation of data; in the writing of the manuscript; and in the decision to submit the manuscript for publication.
Competing interests None declared.
Patient consent for publication Obtained.
Ethics approval The study was approved by the ethics committees of the 16 centres.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as online supplementary information.
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