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  • Cost-effectiveness of outpatient versus inpatient non-invasive ventilation setup in obesity hypoventilation syndrome: the OPIP trial

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Non-invasive ventilation
Original research
Cost-effectiveness of outpatient versus inpatient non-invasive ventilation setup in obesity hypoventilation syndrome: the OPIP trial
  1. Patrick Brian Murphy1,2,
  2. Maxime Patout3,4,
  3. Gill Arbane1,
  4. Swapna Mandal5,
  5. Georgios Kaltsakas1,2,
  6. Michael I Polkey6,
  7. Mark Elliott7,
  8. Jean-François Muir8,9,
  9. Abdel Douiri10,
  10. David Parkin11,
  11. Jean-Paul Janssens12,
  12. Jean Louis Pépin13,14,
  13. Antoine Cuvelier15,
  14. Clare Flach10,
  15. Nicholas Hart1,2
  1. 1 Lane Fox Respiratory Service, Guy's and St Thomas' Hospitals NHS Trust, London, UK
  2. 2 Centre for Human & Applied Physiological Sciences (CHAPS), King’s College London, London, UK
  3. 3 Service des Pathologies du Sommeil (Département R3S), Groupe Hospitalier Universitaire APHP-Sorbonne Université, Site Pitié-Salpêtrière, Paris, France
  4. 4 UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, INSERM, Paris, France
  5. 5 Thoracic Medicine, Royal Free London NHS Foundation Trust, London, UK
  6. 6 NIHR Respiratory BRU, Royal Brompton Hospital and National Heart and Lung Institute, London, UK
  7. 7 Respiratory Medicine, St James' University Hospital, Leeds, UK
  8. 8 Institute for Research and Innovation in Biomedicine (IRIB), Normandie Univ, UNIRouen, Rouen, France
  9. 9 ADIR Assistance, Fédération ANTADIR, Paris, France
  10. 10 School of Population Health & Environmental Sciences, King’s College London, London, UK
  11. 11 OHE, Office of Health Economics, London, UK
  12. 12 Division of Pulmonary Diseases, Geneva University Hospital, Geneva, Switzerland
  13. 13 HP2 laboratory, INSERM U1042, Universite Grenoble Alpes, Saint-Martin-d'Heres, France
  14. 14 Pôle Locomoteur, Rééducation et Physiologie, CHU de Grenoble, Grenoble, France
  15. 15 Service de Pneumologie, CHU Rouen Normandie, Rouen, France
  1. Correspondence to Dr Patrick Brian Murphy, Guy's and St Thomas' Hospitals NHS Trust, London, London, UK; patrick.murphy{at}gstt.nhs.uk

Abstract

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 (PaCO2) 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/m2 and PaCO2 6.8±0.6 kPa. Safety analysis demonstrated no difference in ∆PaCO2 (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.

  • Non invasive ventilation

Data availability statement

Data are available on reasonable request. Requests for deidentified individual participant data for individual patient data meta-analysis will be considered by the trial steering committee. Applications may be submitted to the corresponding author any time after publication.

https://doi.org/10.1136/thorax-2021-218497

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    Data availability statement

    Data are available on reasonable request. Requests for deidentified individual participant data for individual patient data meta-analysis will be considered by the trial steering committee. Applications may be submitted to the corresponding author any time after publication.

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    Footnotes

    • Twitter @maximepatout, @DrPanik, @NickHartThorax

    • Contributors Conception and design: NH, PBM, GA, MIP, ME, JF-M, AD, J-PJ, JLP, AC and SM. Data collection: PBM, MP, GA, GK and J-PJ. Data interpretation: NH, PBM, AD, CF, DP. Manuscript drafting: NH, PBM and CF. Manuscript review, critical appraisal and final approval: NH, PBM, CF. MP, GK, GA, MIP, ME, JF-M, AD, J-PJ, JLP, AC, SM, DP.

    • Funding 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.

    • Disclaimer 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.

    • Competing interests 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.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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