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Economic analysis of oral dexamethasone for symptom relief of sore throat: the UK TOAST study
  1. Richeal M Burns1,
  2. Jane Wolstenholme1,
  3. Sena Jawad2,
  4. Nicola Williams3,
  5. Matthew Thompson4,
  6. Rafael Perera5,
  7. Alastair D Hay6,
  8. Carl Heneghan7,
  9. Paul Little8,
  10. Michael Moore9,
  11. Gail Hayward10
  12. The TOAST Trial Investigators
    1. 1 Nuffield Department of Population Health, University of Oxford, Oxford, UK
    2. 2 Department of Medicine, Imperial College London, Neonatal Data Analysis Unit, London, UK
    3. 3 Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
    4. 4 Department of Family Medicine, University of Washington, Seattle, Washington, USA
    5. 5 Primary Health Care, University of Oxford, Oxford, UK
    6. 6 School of Social and Community Medicine, University of Bristol, Bristol, Bristol, UK
    7. 7 Primary Health Care, Oxford University, Oxford, UK
    8. 8 Southampton Medical School, University of Southampton, Southampton, UK
    9. 9 Three Swans Surgery, NHS, Salisbury, UK
    10. 10 Department of Primary Care Health Sciences, Oxford University, Oxford, UK
    1. Correspondence to Dr Richeal M Burns; rburns{at}stangelas.nuigalway.ie

    Abstract

    Objectives To undertake an economic analysis assessing the cost-effectiveness of a single dose of oral dexamethasone compared with placebo for the relief of sore throat.

    Design A UK-based, multicentre, two arm, individually randomised, double blind trial.

    Setting and population Adults (≥18 years) with acute sore throat and painful swallowing judged to be infective in origin, recruited and randomised in primary care. Intervention: a single dose of 10 mg oral dexamethasone compared with placebo given at primary care visit.

    Main outcome Incremental cost-effectiveness ratios (ICERs), cost per quality-adjusted symptom resolution using the EuroQol-five dimensions-five levels instrument, were estimated as part of a cost–utility analysis performed on an intention-to-treat cohort adopting a health payers perspective.

    Results Differences in health-related quality of life (HRQoL) over 7 days from baseline and at 24 hours in the dexamethasone compared with the placebo group (2.9% and 2.5% higher, respectively) were observed. After controlling for the baseline HRQoL imbalances, the economic impact of the intervention was not statistically significant: the quality-adjusted life year difference was −0.00005 (95% CI −0.0002 to 0.00011) equivalent to a loss in HRQoL of a half hour in the dexamethasone group. The average cost per patient associated in the dexamethasone and placebo groups in the basecase analysis was £73 and £69, respectively. In the basecase probabilistic analysis, the mean ICER was −£6440 (95% CI −£132 151 to £126 335) and the median ICER was −£304 (IQR-£5816 to £3877); suggesting considerable uncertainty.

    Conclusions and relevance The economic burden associated with sore throat is substantial and was estimated at £2.35 billion to the healthcare services payer based on reported resource use and 2015 UK unit costs. There is considerable uncertainty regarding the cost-effectiveness of a single dose of oral dexamethasone as a treatment strategy and therefore insufficient evidence to support its use in clinical practice.

    Trial registration number ISRCTN17435450; Post-results.

    • cost-utility analysis
    • primary care
    • sore throat

    This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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    Footnotes

    • RMB and JW are joint first authors.

    • Contributors All authors contributed to: the conception and design of the TOAST trial analysis including guidance on the health economic evaluation; the drafting and revising of this manuscript; approval of the final version of the manuscript and are accountable for all aspects of the work presented. Each author has particular areas of expertise as follows: applied economic evaluation leads–RMB and JW (joint first authors), statistical analysis: SJ, NW and RP, project management, project conception, design and clinical lead:GH, clinical leadership and guidance, interpretation and policy interpretation: ADH, MT, CH, PL and MM. His research presents an honest, accurate and transparent account of the economic evaluation of the TOAST UK study; no relevant aspects of the study have been omitted and the wide range of scenario analyses addresses both the clinical heterogeneity and variability in structural assumptions.

    • Funding This paper presents independent research funded by the National Institute for Health Research School for Primary Care Research (Project number 172).

    • Disclaimer The views expressed are those of the authors and not necessarily those of the NIHR, the NHS or the Department of Health.

    • Competing interests None decalred.

    • Patient consent Not required.

    • Ethics approval The research protocol was approved by the National Research Ethics Committee South Central (12/SC/0684).

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

    • Data sharing statement There is no additional data available for this study.

    • Collaborators Voysey M, Cook J, Allen J, Harman K

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