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
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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