Table 1.
Clinical activity outcomes and costs at day 28 of study by trial arm
| Mirtazapine n=30 | Placebo n=34 | |
| Clinical activity outcomes—mean (SD) | ||
| NRS worst (last 24 hours)* day 28 change from baseline to day 28 mean (95% CI) |
6.3 (1.8) –1.3 (–2.1 to −0.5) |
7.1 (2.3) –0.8 (–1.6 to 0.0) |
| NRS average (last 24 hours)* day 28 change from baseline to day 28 mean (95% CI) |
4.7 (2.0) –0.7 (–1.2 to −0.2) |
4.9 (1.8) 0.0 (–0.7 to 0.7) |
| IPOS total* day 28 | 17.2 (8.0) | 17.8 (7.6) |
| HADS anxiety* day 28 [HADS depression* day 28] | 4.3 (2.8) [6.1 (3.3)] | 5.3 (3.5) [6.5 (3.7)] |
| SPPB†‡ day 28 | 7.6 (2.1) | 7.4 (2.9) |
| CRQ dyspnoea†§¶ day 28 [CRQ emotion†§ day 28] | 3.1 (1.1) [5.0 (1.2)] | 2.8 (1.0) [4.9 (1.3)] |
| CRQ fatigue†§ day 28 [CRQ mastery†§ day 28] | 3.8 (1.3) [4.9 (1.2)] | 4.0 (1.2) [4.9 (1.3)] |
| GSES total score† day 28 | 31.4 (5.1) | 30.7 (4.8) |
| Economic measures—mean (SD) | ||
| EQ-5D† day 28 change from baseline to day 28 mean (95% CI) |
0.61 (0.26) 0.07 (0.00 to 0.15) |
0.63 (0.15) 0.03 (–0.04 to 0.09) |
| EQ-5D VAS† day 28 | 63.4 (21.2) | 60.8 (19.0) |
| Health and social care costs (£) in the previous 1 month* | 522 (773) | 412 (529) |
*Scale interpretation: high score worse.
†Scale interpretation: high score better.
‡Missing data were higher for SPPB than other measures (see online supplementary table S3)
§CRQ subdomains averaged on the 1–7 scale to give comparability across subscales.
¶Not all patients completed all five activity subscales. However, scores were similar, the data for those completing all five activity subscales are provided here.
CRQ, Chronic Respiratory Disease Questionnaire; EQ-5D, quality of life; GSES, General Self-Efficacy Scale; HADS, Hospital Anxiety and Depression Scale; HRQL, health-related quality of life; IPOS, Integrated Palliative care Outcome Scale; NRS, numerical rating scale/10; SPPB, Short Physical Performance Battery.