Examples of different outcomes in pragmatic and traditional RCTs
| Study | Type | RWE used? | Indication | Total patients randomised, N | Primary outcome | Proportion of patients who dropped out, % |
| SLS COPD (NCT01551758)17 | Pragmatic RCT | Yes | COPD | 2802 | FF/VI cut the rate of moderate or severe exacerbations by 8.4% vs usual care | 7.0 |
| INTREPID (NCT03467425)31 | Pragmatic RCT | Yes | COPD | 3092 | Patients treated with FF/UMEC/VI had a significantly greater proportion of CAT responders at week 24 vs non-ELLIPTA MITT | 3.3 |
| SLS asthma (NCT01706198)18 | Pragmatic RCT | Yes | Asthma | 4233 | Patients were more likely to achieve an ACT score >20 or an increase of ≥3 in ACT score at week 24 if they initiated treatment with FF/VI rather than usual care | 9.0 |
| TORCH (NCT00268216)32 | Traditional RCT | No | COPD | 6184 | FP/SAL reduced the risk of death by 17.5% vs placebo | 34.0–44.0 |
| SUMMIT (NCT01313676)33 | Traditional RCT | No | COPD | 16 590 | Treatment with FF/VI or its components FF and VI did not affect the risk of all-cause mortality vs placebo | 23.0–29.0 |
| FLAME (NCT01782326)34 | Traditional RCT | No | COPD | 3362 | The annual rate of all COPD exacerbations was 11% lower with IND/GLY than FP/SAL | 16.6–19.0 |
ACT, Asthma Control Test; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; FF, fluticasone furoate; FLAME, Effect of Indacaterol Glycopyrronium vs Fluticasone Salmeterol on COPD Exacerbations; FP, fluticasone propionate; GLY, glycopyrronium; IND, indacaterol; INTREPID, INvestigation of TRELEGY Effectiveness: usual PractIce Design; MITT, multiple-inhaler triple therapy; RCT, randomised controlled trial; RWE, real-world evidence; SAL, salmeterol; SLS, Salford Lung Study; SUMMIT, Study to Understand Mortality and Morbidity In COPD; TORCH, TOwards a Revolution in COPD Health; UMEC, umeclidinium; VI, vilanterol.