Baseline characteristics of randomized controlled trials and associations by PROs being a primary or secondary endpoint
| Characteristic | Total 29 (100) | Coefficient (SE) | t | P value |
| Region*, no (%) | ||||
| East Asia and Pacific | 3 (10.34) | 1 (ref) | – | – |
| Europe and Central Asia | 11 (37.93) | −0.61 (12.34) | −0.05 | 0.961 |
| Middle East and North Africa | 6 (20.69) | 5.56 (13.39) | 0.41 | 0.682 |
| Multiregion | 3 (10.34) | 9.52 (15.46) | 0.62 | 0.544 |
| North America | 6 (20.69) | −1.79 (13.39) | −0.13 | 0.895 |
| Year of publication, no (%) | ||||
| <2014 | 8 (27.59) | 1 (ref) | – | – |
| ≥2014 | 21 (72.41) | 15.89 (6.95) | 2.29 | 0.03 |
| Intervention of RCT, no (%) | ||||
| Device | 1 (3.45) | 1 (ref) | – | – |
| Diet | 1 (3.45) | 44.76 (22.18) | 2.02 | 0.054 |
| Drug | 24 (82.76) | 14.98 (16.01) | 0.94 | 0.358 |
| Therapy | 3 (10.34) | 41.19 (18.11) | 2.27 | 0.032 |
| Includes COI statement, no (%) | ||||
| No statement | 6 (20.69) | 1 (ref) | – | – |
| Reports COI | 9 (31.03) | −0.86 (9.38) | −0.09 | 0.928 |
| Reports no COI | 14 (48.28) | 9.9 (8.68) | 1.14 | 0.265 |
| Journal requirement of reporting guidelines, no (%) | ||||
| Not mentioned | 2 (6.9) | 1 (ref) | – | – |
| Recommended | 14 (48.28) | 1.94 (14.07) | 0.14 | 0.891 |
| Required | 13 (44.83) | 2.66 (14.14) | 0.19 | 0.852 |
| Mention of CONSORT or CONSORT-PRO within RCT, no (%) | ||||
| No | 29 (100) | 1 (ref) | – | – |
| Yes | 0 (0) | – | – | – |
| PRO as a primary or secondary outcome, no (%) | ||||
| Primary | 7 (24.14) | 1 (ref) | – | – |
| Secondary | 22 (75.86) | −15.55 (7.35) | −2.12 | 0.044 |
| Overall RoB, no (%) | ||||
| High | 5 (17.24) | 1 (ref) | – | – |
| Some concern | 16 (55.17) | −6.26 (9.09) | −0.69 | 0.497 |
| Low | 8 (27.59) | 6.18 (10.11) | 0.61 | 0.546 |
| Length of PRO follow-up | ||||
| 3 mo or less | 21 (72.41) | 1 (ref) | – | – |
| 3+–6 mo | 5 (17.24) | −11.29 (8.97) | −1.26 | 0.219 |
| 6+ mo–1 y | 3 (10.34) | 2.76 (11.12) | 0.25 | 0.806 |
| 1+ y | 0 (0) | – | – | – |
| Sample size | ||||
| Mean (SD) | 86.34 (63.09) | 0 (0.05) | −0.09 | 0.933 |
Bolded entries reflect values of statistical significance (p<0.05).
*Region based on 2021-2022 World Bank country classifications by income levels.
COI, conflict of interest; CONSORT, Consolidated Standards of Reporting Trials; PROs, patient-reported outcomes; RCT, randomized controlled trial; RoB, risk of bias.