Dataset Information

Economic analysis of oral dexamethasone for symptom relief of sore throat: the UK TOAST study.

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.

SUBMITTER: Burns RM

PROVIDER: S-EPMC5931286 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Economic analysis of oral dexamethasone for symptom relief of sore throat: the UK TOAST study.

Burns Richeal M RM Wolstenholme Jane J Jawad Sena S Williams Nicola N Thompson Matthew M Perera Rafael R Hay Alastair D AD Heneghan Carl C Little Paul P Moore Michael M Hayward Gail G

BMJ open 20180428 4

<h4>Objectives</h4>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.<h4>Design</h4>A UK-based, multicentre, two arm, individually randomised, double blind trial.<h4>Setting and population</h4>Adults (≥18 years) with acute sore throat and painful swallowing judged to be infective in origin, recruited and randomised in primary care.<h4>Intervention</h4>a single dose of 10 mg oral dexamethas ...[more]

PMID: 29705751

Similar Datasets

Project description:Management of acute sore throat poses a significant burden on UK general practices, with almost 10% of registered patients attending their GP with sore throat every year. Nearly half of all patients presenting with acute sore throat are treated with antibiotics, despite their limited effect. In a recent systematic review we demonstrated that a single dose of steroids reduced the severity and time to resolution of sore throat. However, all of the trials included looked at the use of steroids alongside antibiotics and only one was in a primary care setting. This trial aims to assess the efficacy and cost-effectiveness of a single oral dose of corticosteroids on symptoms of sore throat in patients receiving either a delayed antibiotic prescription or no antibiotics at all in UK primary care.A double-blind, two arm, randomized, placebo controlled trial in adults (? 18 years of age) presenting to primary care with acute sore throat (<seven days). Participants are recruited on the day of presentation to their GP practice. GPs or nurses assess eligibility, record baseline clinical features and obtain a throat swab for bacterial culture. Participants are being randomized to treatment arms at a ratio of 1:1. Treatment arms will be stratified according to whether patients are being given a delayed antibiotic prescription or no antibiotic prescription and by recruiting centre (Oxford, Bristol or Southampton). Outcome data is being collected at 24 and 48 hours via text message or telephone call, from days 0 to 7 using a patient symptom diary and at one month via a GP notes review.This will be the first randomized controlled trial of oral corticosteroids in adults presenting to primary care with sore throat in the UK, and the first to examine the clinical and cost-effectiveness of oral corticosteroids for the treatment of sore throat in the absence of antibiotics.This trial is registered with Current Controlled Trials on 26 March 2013, registration number: ISRCTN17435450.

Project description:ImportanceAcute sore throat poses a significant burden on primary care and is a source of inappropriate antibiotic prescribing. Corticosteroids could be an alternative symptomatic treatment.ObjectiveTo assess the clinical effectiveness of oral corticosteroids for acute sore throat in the absence of antibiotics.Design, setting, and participantsDouble-blind, placebo-controlled randomized trial (April 2013-February 2015; 28-day follow-up completed April 2015) conducted in 42 family practices in South and West England, enrolled 576 adults recruited on the day of presentation to primary care with acute sore throat not requiring immediate antibiotic therapy.InterventionsSingle oral dose of 10 mg of dexamethasone (n = 293) or identical placebo (n = 283).Main outcomes and measuresPrimary: proportion of participants experiencing complete resolution of symptoms at 24 hours. Secondary: complete resolution at 48 hours, duration of moderately bad symptoms (based on a Likert scale, 0, normal; 6, as bad as it could be), visual analog symptom scales (0-100 mm; 0, no symptom to 100, worst imaginable), health care attendance, days missed from work or education, consumption of delayed antibiotics or other medications, adverse events.ResultsAmong 565 eligible participants who were randomized (median age, 34 years [interquartile range, 26.0-45.5 year]; 75.2% women; 100% completed the intervention), 288 received dexamethasone; 277, placebo. At 24 hours, 65 participants (22.6%) in the dexamethasone group and 49 (17.7%) in the placebo group achieved complete resolution of symptoms, for a risk difference of 4.7% (95% CI, -1.8% to 11.2%) and a relative risk of 1.28 (95% CI; 0.92 to 1.78; P = .14). At 24 hours, participants receiving dexamethasone were not more likely than those receiving placebo to have complete symptom resolution. At 48 hours, 102 participants (35.4%) in the dexamethasone group vs 75 (27.1%) in the placebo group achieved complete resolution of symptoms, for a risk difference of 8.7% (95% CI, 1.2% to 16.2%) and a relative risk of 1.31 (95% CI, 1.02 to 1.68; P = .03). This difference also was observed in participants not offered delayed antibiotic prescription, for a risk difference of 10.3% (95% CI, 0.6% to 20.1%) and a relative risk of 1.37 (95% CI, 1.01 to 1.87; P = .046). There were no significant differences in any other secondary outcomes.Conclusions and relevanceAmong adults presenting to primary care with acute sore throat, a single dose of oral dexamethasone compared with placebo did not increase the proportion of patients with resolution of symptoms at 24 hours. However, there was a significant difference at 48 hours.Trial registrationisrctn.org Identifier: ISRCTN17435450.

Project description:Background/Aims:An updated systematic review and meta-analysis was conducted to assess the effect of prophylactic dexamethasone for tracheal intubation of general anesthesia on postoperative sore throat (POST). Methods:Comprehensive literature search of databases for randomized controlled trials (RCTs), including Embase, PubMed, and Cochrane Library, which evaluate the effect of prophylactic dexamethasone on POST was conducted. RevMan 5.0 and STATA 12.0 software were used to perform meta-analyses. Results:Fourteen RCTs totaling 1,837 patients were included for analysis. Compared with placebo, a significant reduction in the incidence of POST (OR 0.44, 95% CI 0.33-0.58, P<0.00001), hoarseness (OR 0.42, 95% CI 0.31-0.58, P<0.00001), and postoperative nausea and vomiting (PONV) (OR 0.06, 95% CI 0.03-0.14, P<0.00001) and a comparable incidence of cough (OR 0.59, 95% CI 0.19-1.89, P=0.38) was described in patients receiving dexamethasone, with or without concomitant drugs. Dexamethasone ?0.2 mg/kg had a statistically greater impact on reducing the incidence of POST than dexamethasone 0.1-0.2 mg/kg, while dexamethasone ?0.1 mg/kg did not. Dexamethasone was as effective as other drugs such as ondansetron, magnesium sulfate, ketamine gargle, betamethasone gel, and ketorolac for reducing POST (OR 0.70, 95% CI 0.46-1.07, P=0.10). Dexamethasone plus a different drug was more effective than dexamethasone alone for reducing the incidence of POST at 24 hours (OR 0.40, 95% CI 0.21-0.77, P=0.006). Compared with controls, a statistically higher blood glucose level was the only adverse event during the immediate postoperative period in patients receiving dexamethasone. Conclusions:Intravenous dexamethasone ?0.2 mg/kg within 30 minutes before or after induction of general anesthesia should be recommended as grade 1A evidence with safety and efficacy in reducing the incidence of POST, hoarseness, and PONV in patients without pregnancy, diabetes mellitus, or contraindications for corticosteroids.

Project description:Objective To estimate the benefits and harms of using corticosteroids as an adjunct treatment for sore throat.Design Systematic review and meta-analysis of randomised control trials.Data sources Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), trial registries up to May 2017, reference lists of eligible trials, related reviews.Study selection Randomised controlled trials of the addition of corticosteroids to standard clinical care for patients aged 5 or older in emergency department and primary care settings with clinical signs of acute tonsillitis, pharyngitis, or the clinical syndrome of sore throat. Trials were included irrespective of language or publication status.Review methods Reviewers identified studies, extracted data, and assessed the quality of the evidence, independently and in duplicate. A parallel guideline committee (BMJ Rapid Recommendation) provided input on the design and interpretation of the systematic review, including the selection of outcomes important to patients. Random effects model was used for meta-analyses. Quality of evidence was assessed with the GRADE approach.Results 10 eligible trials enrolled 1426 individuals. Patients who received single low dose corticosteroids (the most common intervention was oral dexamethasone with a maximum dose of 10 mg) were twice as likely to experience pain relief after 24 hours (relative risk 2.2, 95% confidence interval 1.2 to 4.3; risk difference 12.4%; moderate quality evidence) and 1.5 times more likely to have no pain at 48 hours (1.5, 1.3 to 1.8; risk difference 18.3%; high quality). The mean time to onset of pain relief in patients treated with corticosteroids was 4.8 hours earlier (95% confidence interval -1.9 to -7.8; moderate quality) and the mean time to complete resolution of pain was 11.1 hours earlier (-0.4 to -21.8; low quality) than in those treated with placebo. The absolute pain reduction at 24 hours (visual analogue scale 0-10) was greater in patients treated with corticosteroids (mean difference 1.3, 95% confidence interval 0.7 to 1.9; moderate quality). Nine of the 10 trials sought information regarding adverse events. Six studies reported no adverse effects, and three studies reported few adverse events, which were mostly complications related to disease, with a similar incidence in both groups.Conclusion Single low dose corticosteroids can provide pain relief in patients with sore throat, with no increase in serious adverse effects. Included trials did not assess the potential risks of larger cumulative doses in patients with recurrent episodes of acute sore throat.Systematic review registration PROSPERO CRD42017067808.

Dataset Information

Economic analysis of oral dexamethasone for symptom relief of sore throat: the UK TOAST study.

Objectives

Design

Setting and population

Intervention

Main outcome

Results

Conclusions and relevance

Trial registration number

Publications

Economic analysis of oral dexamethasone for symptom relief of sore throat: the UK TOAST study.

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