Table 1.
TOAST trial patient characteristics
| Placebo group |
Dexamethasone group |
|
| All eligible participants (ITT) | 277 (49%) | 288 (51%) |
| Male | 73 (13%) | 67 (12%) |
| Female | 204 (36%) | 221 (39%) |
| Mean age* | 37.3 (SD: 14.30) | 37.2 (SD: 14.36) |
| Current smoker | 51 (9%) | 52 (9%) |
| Antibiotic details† | ||
| Given delayed prescription | 108 (19%) | 115 (20%) |
| Reported taking antibiotics | 42 (7%) | 34 (6%) |
| Not given delayed prescription | 169 (30%) | 173 (31%) |
| Reported taking antibiotics | 16 (3%) | 16 (3%) |
| Total reported antibiotics usage | 58 (10%) | 50 (9%) |
| Resource use | ||
| Reported using OTC medicines (days 1–7) | 178 (32%) | 173 (31%) |
| Reported resource use (days 1–7) | 69 (12%) | 67 (12%) |
| Reported resource use in follow-up (days 8–28) | 20 (4%) | 30 (5%) |
| SAE‡ | 1 (<1%) | 1 (<1%) |
| Other AE | 1 (<1%) | 0 (0%) |
| Employment status/sick days | ||
| Reported working FT (22 years and over) | 149 (26%) | 145 (26%) |
| Reported working PT (22 years and over) | 40 (7%) | 39 (7%) |
| Assumed in FT/PT education§ (18–21 years) | 28 (5%) | 33 (6%) |
| Unemployed | 60 (11%) | 71 (13%) |
| Sick days—proportion reporting >1 hour missing (days 0–7) | 104 (18%) | 89 (16%) |
| Sick days—proportion reporting >1 hour missing (days 1–7) | 72 (13%) | 60 (11%) |
| Usual activities—proportion reporting >1 hour missing (days 0–7) | 137 (24%) | 127 (22%) |
| Usual activities—proportion reporting >1 hour missing (days 1–7) | 98 (17%) | 104 (18%) |
Percentages in brackets represent proportion of full trial cohort (n=565).
*Mean age was estimated using the ITT population previous to the amendment to inclusion criteria constricting the upper age limit to 70 years. Fourteen patients were over 70 years evenly distributed across both arms.
†Antibiotics reported for ‘sore throat’ are included if prescribed within the 7-day trial period and were administered outside a secondary care setting. This deviates slightly from the clinical paper analysis classification of overall antibiotic use which included antibiotics administered in secondary care for one patient in the control group.
‡SAE’s included were categorised as ‘Suspected Serious Adverse Reaction’ in the clinical paper. Although three such events were reported, one was linked to a further SAE ultimately resulting in death and so was excluded from the economic analysis.
§Those aged 18–21 years reporting ‘yes’ to FT/PT work/education question in the baseline survey were all categorised into education for purposes of costing productivity losses in a scenario (see online supplementary appendix).
AE, adverse event; FT/PT, full time/part time; ITT, intention-to-treat; OTC, over-the-counter; SAE, serious adverse event; TOAST, Treatment Options without Antibiotics for Sore Throat.