TY - JOUR
T1 - Cost-effectiveness of outpatient versus inpatient non-invasive ventilation setup in obesity hypoventilation syndrome: the OPIP trial
AU - Murphy, Patrick Brian
AU - Patout, Maxime
AU - Arbane, Gill
AU - Mandal, Swapna
AU - Kaltsakas, Georgios
AU - Polkey, Michael, I
AU - Elliott, Mark
AU - Muir, Jean-Francois
AU - Douiri, Abdel
AU - Parkin, David
AU - Janssens, Jean-Paul
AU - Pepin, Jean Louis
AU - Cuvelier, Antoine
AU - Flach, Clare
AU - Hart, Nicholas
N1 - Funding Information:
Detailed conflicts of interest forms are supplied for each author.Role of funderThe study was supported by an unrestricted educational grant from Philips-Respironics. The funders were not involved in design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Philips-Respironics provided the A40 devices and Actiwatch spectrum devices used in the study. The study was supported by Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, National Institute of Health Research Comprehensive Biomedical Research Centre, London, UK and the NIHR Respiratory Disease Biomedical Research Unit at the Royal Brompton and Harefield NHS Foundation Trust and Imperial College London.
Funding Information:
The study was supported by an unrestricted educational grant from Philips-Respironics. The study was supported by Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, National Institute of Health Research Comprehensive Biomedical Research Centre, London, UK and the NIHR Respiratory Disease Biomedical Research Unit at the Royal Brompton and Harefield NHS Foundation Trust and Imperial College London.
Publisher Copyright:
©
PY - 2022/9/2
Y1 - 2022/9/2
N2 - Background Current guidelines recommend that patients with obesity hypoventilation syndrome (OHS) are electively admitted for inpatient initiation of home non-invasive ventilation (NIV). We hypothesised that outpatient NIV setup would be more cost-effective. Methods Patients with stable OHS referred to six participating European centres for home NIV setup were recruited to an open-labelled clinical trial. Patients were randomised via web-based system using stratification to inpatient setup, with standard fixed level NIV and titrated during an attended overnight respiratory study or outpatient setup using an autotitrating NIV device and a set protocol, including home oximetry. The primary outcome was cost-effectiveness at 3 months with daytime carbon dioxide (PaCO 2) as a non-inferiority safety outcome; non-inferiority margin 0.5 kPa. Data were analysed on an intention-to-treat basis. Health-related quality of life (HRQL) was measured using EQ-5D-5L (5 level EQ-5D tool) and costs were converted using purchasing power parities to £(GBP). Results Between May 2015 and March 2018, 82 patients were randomised. Age 59±14 years, body mass index 47±10 kg/m 2 and PaCO 2 6.8±0.6 kPa. Safety analysis demonstrated no difference in â †PaCO 2 (difference -0.27 kPa, 95% CI -0.70 to 0.17 kPa). Efficacy analysis showed similar total per-patient costs (inpatient £2962±£580, outpatient £3169±£525; difference £188.20, 95% CI -£61.61 to £438.01) and similar improvement in HRQL (EQ-5D-5L difference -0.006, 95% CI -0.05 to 0.04). There were no differences in secondary outcomes. Discussion There was no difference in medium-term cost-effectiveness, with similar clinical effectiveness, between outpatient and inpatient NIV setup. The home NIV setup strategy can be led by local resource demand and patient and clinician preference. Trial registration numbers NCT02342899 and ISRCTN51420481.
AB - Background Current guidelines recommend that patients with obesity hypoventilation syndrome (OHS) are electively admitted for inpatient initiation of home non-invasive ventilation (NIV). We hypothesised that outpatient NIV setup would be more cost-effective. Methods Patients with stable OHS referred to six participating European centres for home NIV setup were recruited to an open-labelled clinical trial. Patients were randomised via web-based system using stratification to inpatient setup, with standard fixed level NIV and titrated during an attended overnight respiratory study or outpatient setup using an autotitrating NIV device and a set protocol, including home oximetry. The primary outcome was cost-effectiveness at 3 months with daytime carbon dioxide (PaCO 2) as a non-inferiority safety outcome; non-inferiority margin 0.5 kPa. Data were analysed on an intention-to-treat basis. Health-related quality of life (HRQL) was measured using EQ-5D-5L (5 level EQ-5D tool) and costs were converted using purchasing power parities to £(GBP). Results Between May 2015 and March 2018, 82 patients were randomised. Age 59±14 years, body mass index 47±10 kg/m 2 and PaCO 2 6.8±0.6 kPa. Safety analysis demonstrated no difference in â †PaCO 2 (difference -0.27 kPa, 95% CI -0.70 to 0.17 kPa). Efficacy analysis showed similar total per-patient costs (inpatient £2962±£580, outpatient £3169±£525; difference £188.20, 95% CI -£61.61 to £438.01) and similar improvement in HRQL (EQ-5D-5L difference -0.006, 95% CI -0.05 to 0.04). There were no differences in secondary outcomes. Discussion There was no difference in medium-term cost-effectiveness, with similar clinical effectiveness, between outpatient and inpatient NIV setup. The home NIV setup strategy can be led by local resource demand and patient and clinician preference. Trial registration numbers NCT02342899 and ISRCTN51420481.
UR - http://www.scopus.com/inward/record.url?scp=85137826882&partnerID=8YFLogxK
U2 - 10.1136/thorax-2021-218497
DO - 10.1136/thorax-2021-218497
M3 - Article
SN - 0040-6376
VL - 78
SP - 24
EP - 31
JO - Thorax
JF - Thorax
IS - 1
M1 - thorax-2021-218497
ER -
