Table 2.
PRO Reporting in Heart Failure RCTs (N=226)
| PRO Reporting | |
|---|---|
| No. of PRO per trial, median (IQI) | 1 (1–2) |
| No. of CONSORT PRO items per trial, median (IQI) | 4 (3–6) |
| PRO reported in primary publication, n (%) RCTs | |
| Yes | 221 (97.8) |
| Analysis of PRO, n (%) RCTs | |
| Primary outcome | 17 (7.5) |
| coprimary, composite | 27 (11.9) |
| Secondary outcome | 182 (80.5) |
| No. of PRO instruments used, n (%) RCTs | |
| 1 | 137 (60.6) |
| 2–3 | 76 (33.6) |
| >3 | 13 (5.8) |
| No. of CONSORT PRO items reported, n (%) RCTs | |
| ≤4 | 123 (54.4) |
| 5–7 | 86 (38.1) |
| >7 | 17 (7.5) |
| Report minimal clinically important difference, n (%) RCTs | |
| Yes | 38 (16.8) |
| Type of PRO, n (%) RCTs | |
| HF specific | 98 (43.4) |
| Generic | 64 (28.3) |
| Both | 64 (28.3) |
CONSORT indicates Consolidated Standards of Reporting Trials; HF, heart failure; IQI, interquartile interval; PRO, patient‐reported outcome; and RCT, randomized controlled trial.