What Is the Potential Value of a Randomized Trial of Different Thresholds to Initiate Invasive Ventilation? A Health Economic Analysis.


Journal

Critical care explorations
ISSN: 2639-8028
Titre abrégé: Crit Care Explor
Pays: United States
ID NLM: 101746347

Informations de publication

Date de publication:
01 Jun 2024
Historique:
medline: 5 6 2024
pubmed: 5 6 2024
entrez: 5 6 2024
Statut: epublish

Résumé

To estimate the expected value of undertaking a future randomized controlled trial of thresholds used to initiate invasive ventilation compared with usual care in hypoxemic respiratory failure. Publicly funded healthcare payer. Critical care units capable of providing invasive ventilation and unconstrained by resource limitations during usual (nonpandemic) practice. We performed a model-based cost-utility estimation with individual-level simulation and value-of-information analysis focused on adults, admitted to critical care, receiving noninvasive oxygen. In the primary scenario, we compared hypothetical threshold A to usual care, where threshold A resulted in increased use of invasive ventilation and improved survival compared with usual care. In the secondary scenario, we compared hypothetical threshold B to usual care, where threshold B resulted in decreased use of invasive ventilation and similar survival compared with usual care. We assumed a willingness-to-pay of 100,000 Canadian dollars (CADs) per quality-adjusted life year. In the primary scenario, threshold A was cost-effective compared with usual care due to improved hospital survival (78.1% vs. 75.1%), despite more use of invasive ventilation (62% vs. 30%) and higher lifetime costs (86,900 vs. 75,500 CAD). In the secondary scenario, threshold B was cost-effective compared with usual care due to similar survival (74.5% vs. 74.6%) with less use of invasive ventilation (20.2% vs. 27.6%) and lower lifetime costs (71,700 vs. 74,700 CAD). Value-of-information analysis showed that the expected value to Canadian society over 10 years of a 400-person randomized trial comparing a threshold for invasive ventilation to usual care in hypoxemic respiratory failure was 1.35 billion CAD or more in both scenarios. It would be highly valuable to society to identify thresholds that, in comparison to usual care, either increase survival or reduce invasive ventilation without reducing survival.

Identifiants

pubmed: 38836575
doi: 10.1097/CCE.0000000000001098
pii: 02107256-202406000-00005
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e1098

Subventions

Organisme : CIHR
ID : Vanier Scholar

Informations de copyright

Copyright © 2024 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine.

Déclaration de conflit d'intérêts

Dr. Yarnell was funded by the Canadian Institutes for Health Research Vanier Scholar program, the Eliot Phillipson Clinician Scientist Training Program, and the Clinician Investigator Program of the University of Toronto. Dr. Heath is supported by a Canada Research Chair in Statistical Trial Design and funded by the Discovery Grant Program of the Natural Sciences and Engineering Research Council of Canada (RGPIN-2021-03366). Dr. Sung is supported by the Canada Research Chair in Pediatric Oncology Supportive Care. Dr. Fowler is the H. Barrie Fairley Professor of Critical Care at the University Health Network, Interdepartmental Division of Critical Care Medicine, and University of Toronto. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Références

Bellani G, Laffey JG, Pham T, et al.; LUNG SAFE Investigators: Epidemiology, patterns of care, and mortality for patients with acute respiratory distress syndrome in intensive care units in 50 countries. JAMA 2016; 315:788–800
Ranieri VM, Rubenfeld GD, Thompson BT, et al.; ARDS Definition Task Force: Acute respiratory distress syndrome. JAMA 2012; 307:2526–2533
Herridge MS, Tansey CM, Matté A, et al.; Canadian Critical Care Trials Group: Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med 2011; 364:1293–1304
Cuthbertson BH, Roughton S, Jenkinson D, et al.: Quality of life in the five years after intensive care: A cohort study. Crit Care 2010; 14:R6
Cook T, Woodall N, Frerk C: The NAP4 Report: Major Complications of Airway Management in the UK. London, United Kingdom, Royal College of Anaesthetists, 2011. Available at: https://www.rcoa.ac.uk/research/research-projects/national-audit-projects-naps/nap4-major-complications-airway-management. Accessed May 22, 2024
Russotto V, Myatra SN, Laffey JG, et al.; INTUBE Study Investigators: Intubation practices and adverse peri-intubation events in critically ill patients from 29 countries. JAMA 2021; 325:1164–1172
Devlin JW, Skrobik Y, Gélinas C, et al.: Clinical practice guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU. Crit Care Med 2018; 46:e825–e873
Papazian L, Klompas M, Luyt CE: Ventilator-associated pneumonia in adults: A narrative review. Intensive Care Med 2020; 46:888–906
Vanhorebeek I, Latronico N, Van den Berghe G: ICU-acquired weakness. Intensive Care Med 2020; 46:637–653
Hakim R, Watanabe-Tejada L, Sukhal S, et al.: Acute respiratory failure in randomized trials of noninvasive respiratory support: A systematic review of definitions, patient characteristics, and criteria for intubation. J Crit Care 2020; 57:141–147
Bellani G, Laffey JG, Pham T, et al.; LUNG SAFE Investigators: Noninvasive ventilation of patients with acute respiratory distress syndrome: Insights from the LUNG SAFE Study. Am J Respir Crit Care Med 2017; 195:67–77
Yarnell CJ, Angriman F, Ferreyro BL, et al.: Oxygenation thresholds for invasive ventilation in hypoxemic respiratory failure: A target trial emulation in two cohorts. Crit Care 2023; 27:67
Noseworthy TW, Konopad E, Shustack A, et al.: Cost accounting of adult intensive care: Methods and human and capital inputs. Crit Care Med 1996; 24:1168–1172
Understanding costs and cost-effectiveness in critical care: Report from the second American Thoracic Society workshop on outcomes research. Am J Respir Crit Care Med 2002; 165:540–550
Byrick RJ, Mindorff C, McKEE L, et al.: Cost-effectiveness of intensive care for respiratory failure patients. Crit Care Med 1980; 8:332–337
Soares MO, Welton NJ, Harrison DA, et al.: An evaluation of the feasibility, cost and value of information of a multicentre randomised controlled trial of intravenous immunoglobulin for sepsis (severe sepsis and septic shock): Incorporating a systematic review, meta-analysis and value of information analysis. Health Technol Assess 2012; 16:1–186
Guideline Working Group. Guidelines for the Economic Evaluation of Health Technologies: Canada. Fourth Edition. Ottawa, ON, Canada, Canadian Agency for Drugs and Technologies in Health, 2017. Available at: https://www.cadth.ca/guidelines-economic-evaluation-health-technologies-canada-4th-edition. Accessed May 22, 2024
Husereau D, Drummond M, Augustovski F, et al.; CHEERS 2022 ISPOR Good Research Practices Task Force: Consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) statement: Updated reporting guidance for health economic evaluations. BMC Med 2022; 20:23
Sanders GD, Neumann PJ, Basu A, et al.: Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: Second panel on cost-effectiveness in health and medicine. JAMA 2016; 316:1093–1103
Goldberger AL, Amaral LA, Glass L, et al.: PhysioBank, PhysioToolkit, PhysioNet: Components of a new research resource for complex physiologic signals. Circulation 2000; 101:E215–E220
Johnson AEW, Bulgarelli L, Shen L, et al.: MIMIC-IV, a freely accessible electronic health record dataset. Sci Data 2023; 10:1
Grasselli G, Zangrillo A, Zanella A, et al.; COVID-19 Lombardy ICU Network: Baseline characteristics and outcomes of 1591 patients infected with SARS-CoV-2 admitted to ICUs of the Lombardy Region, Italy. JAMA 2020; 323:1574–1581
Richardson S, Hirsch JS, Narasimhan M, et al.; the Northwell COVID-19 Research Consortium: Presenting characteristics, comorbidities, and outcomes among 5700 patients hospitalized with COVID-19 in the New York City Area. JAMA 2020; 323:2052–2059
Huang C, Wang Y, Li X, et al.: Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020; 395:497–506
Bertram MY, Lauer JA, Stenberg K, et al.: Methods for the economic evaluation of health care interventions for priority setting in the health system: An update from WHO CHOICE. Int J Health Policy Manage 2021; 10:673–677
Evans J, Kobewka D, Thavorn K, et al.: The impact of reducing intensive care unit length of stay on hospital costs: Evidence from a tertiary care hospital in Canada. Can J Anaesth 2018; 65:627–635
Kaier K, Heister T, Wolff J, et al.: Mechanical ventilation and the daily cost of ICU care. BMC Health Serv Res 2020; 20:267
Tan SS, Hakkaart-van Roijen L, Al MJ, et al.: A microcosting study of intensive care unit stay in the Netherlands. J Intensive Care Med 2008; 23:250–257
Canadian Institute for Health Information: Care in Canadian ICUs. 2016. Available at: https://secure.cihi.ca/estore/productSeries.htm?pc=PCC1475. Accessed May 22, 2024
Dasta JF, McLaughlin TP, Mody SH, et al.: Daily cost of an intensive care unit day: The contribution of mechanical ventilation. Crit Care Med 2005; 33:1266–1271
Kristinsdottir EA, Long TE, Sigvaldason K, et al.: Long-term survival after intensive care: A retrospective cohort study. Acta Anaesthesiol Scand 2020; 64:75–84
Hill AD, Fowler RA, Burns KEA, et al.: Long-term outcomes and health care utilization after prolonged mechanical ventilation. Ann Am Thorac Soc 2017; 14:355–362
Khandelwal N, Hough CL, Bansal A, et al.: Long-term survival in patients with severe acute respiratory distress syndrome and rescue therapies for refractory hypoxemia. Crit Care Med 2014; 42:1610–1618
Thompson K, Taylor C, Jan S, et al.: Health-related outcomes of critically ill patients with and without sepsis. Intensive Care Med 2018; 44:1249–1257
Steenbergen S, Rijkenberg S, Adonis T, et al.: Long-term treated intensive care patients outcomes: The one-year mortality rate, quality of life, health care use and long-term complications as reported by general practitioners. BMC Anesthesiol 2015; 15:142–142
Williams TA, Dobb GJ, Finn JC, et al.: Determinants of long-term survival after intensive care. Crit Care Med 2008; 36:1523–1530
Sprooten RTM, Rohde GGU, Janssen MTHF, et al.: Predictors for long-term mortality in COPD patients requiring non-invasive positive pressure ventilation for the treatment of acute respiratory failure. Clin Respir J 2020; 14:1144–1152
Meynaar IA, Van Den Boogaard M, Tangkau PL, et al.: Long-term survival after ICU treatment. Minerva Anestesiol 2012; 78:1324–1332
Herridge MS, Chu LM, Matte A, et al.; RECOVER Program Investigators (Phase 1: towards RECOVER): The RECOVER program: Disability risk groups and 1-year outcome after 7 or more days of mechanical ventilation. Am J Respir Crit Care Med 2016; 194:831–844
Wodchis WP, Austin PC, Henry DA: A 3-year study of high-cost users of health care. CMAJ 2016; 188:182–188
R Core Team: R: A Language and Environment for Statistical Computing. Vienna, Austria, R Foundation for Statistical Computing, 2020. Available at: https://www.r-project.org. Accessed May 22, 2024
TreeAge Software: TreeAge Pro. Williamstown MA, TreeAge Software, 2021. Available at: http://www.treeage.com. Accessed May 22, 2024
Fenwick E, Steuten L, Knies S, et al.: Value of information analysis for research decisions—an introduction: Report 1 of the ISPOR value of information analysis emerging good practices task force. Value Health 2020; 23:139–150
Krishnan JK, Rajan M, Baer BR, et al.: Assessing mortality differences across acute respiratory failure management strategies in Covid-19. J Crit Care 2022; 70:154045
Moore TJ, Heyward J, Anderson G, et al.: Variation in the estimated costs of pivotal clinical benefit trials supporting the US approval of new therapeutic agents, 2015–2017: A cross-sectional study. BMJ Open 2020; 10:e038863
Baston CM, Coe NB, Guerin C, et al.: The cost-effectiveness of interventions to increase utilization of prone positioning for severe acute respiratory distress syndrome. Crit Care Med 2019; 47:e198–e205
Koffijberg H, Rothery C, Chalkidou K, et al.: Value of information choices that influence estimates: A systematic review of prevailing considerations. Med Decis Making 2018; 38:888–900
Jackson CH, Baio G, Heath A, et al.: Value of information analysis in models to inform health policy. Annu Rev Stat Appl 2022; 9:95–118
Heath A, Myriam Hunink MG, Krijkamp E, et al.: Prioritisation and design of clinical trials. Eur J Epidemiol 2021; 36:1111–1121
Silberzahn R, Uhlmann EL, Martin DP, et al.: Many analysts, one data set: Making transparent how variations in analytic choices affect results. Adv Methods Pract Psychol Sci 2018; 1:337–356
Eaton Turner E, Jenks M: Cost-effectiveness analysis of the use of high-flow oxygen through nasal cannula in intensive care units in NHS England. Expert Rev Pharmacoecon Outcomes Res 2018; 18:331–337

Auteurs

Christopher J Yarnell (CJ)

Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
Department of Critical Care Medicine, Scarborough Health Network, Toronto, ON, Canada.
Scarborough Health Network Research Institute, Toronto, ON, Canada.
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.

Kali Barrett (K)

Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
Department of Medicine, Division of Respirology, University Health Network and Sinai Health System, Toronto, ON, Canada.

Anna Heath (A)

Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON, Canada.
Division of Biostatistics, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
Department of Statistical Science, University College London, London, United Kingdom.

Margaret Herridge (M)

Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
Department of Medicine, Division of Respirology, University Health Network and Sinai Health System, Toronto, ON, Canada.
Department of Medicine, University of Toronto, Toronto, ON, Canada.

Robert A Fowler (RA)

Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
Department of Medicine, University of Toronto, Toronto, ON, Canada.
Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.
Sunnybrook Health Sciences Centre, Department of Medicine and Department of Critical Care Medicine, Toronto, ON, Canada.

Lillian Sung (L)

Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, ON, Canada.

David M Naimark (DM)

Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
Department of Medicine, University of Toronto, Toronto, ON, Canada.
Sunnybrook Health Sciences Centre, Department of Medicine, Division of Nephrology, Toronto, ON, Canada.

George Tomlinson (G)

Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
Department of Medicine, University Health Network and Sinai Health System, Toronto, ON, Canada.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH