Table 2.
Trial characteristics associated with use or no use of PROs
| PROQOPID PRO used (N = 321) | PROQOPID PRO not used (N = 352) | Relevance ratio (95% CI) | p-value (chi-square) | ||
|---|---|---|---|---|---|
| Status | 0.0113 | ||||
| Completed | 102 (31.8%) | 137 (38.9%) | 1.13 (0.79–1.61) | ||
| Recruiting | 136 (42.4%) | 105 (29.8%) | 1.50 (1.06–2.11) | ||
| Not recruiting | 45 (14.0%) | 50 (14.2%) | 1.26 (0.85–1.85) | ||
| Suspended, terminated or withdrawn | 15 (4.7%) | 22 (6.2%) | 1.08 (0.65–1.78) | ||
| Unknown | 23 (7.2%) | 38 (10.8%) | Reference | ||
| Funder | 0.2863 | ||||
| NIH | 80 (24.9%) | 86 (24.4%) | 0.99 (0.82–1.20) | ||
| Federal/Other government | 45 (14.0%) | 44 (12.5%) | 1.04 (0.82–1.31) | ||
| Industry | 30 (9.3%) | 47 (13.4%) | 0.80 (0.59–1.08) | ||
| Other | 166 (51.7%) | 175 (49.7%) | Reference | ||
| Numbers of collaborators | 0.5053 | ||||
| 1 | 162 (50.5%) | 177 (50.3%) | Reference | ||
| 2 | 82 (25.5%) | 91 (25.9%) | 0.99 (0.82–1.20) | ||
| 3 | 37 (11.5%) | 29 (8.2%) | 1.17 (0.92–1.49) | ||
| 4 | 16 (5.0%) | 25 (7.1%) | 0.82 (0.55–1.22) | ||
| >4 | 24 (7.5%) | 30 (8.5%) | 0.93 (0.68–1.28) | ||
| Sex | 0.8395 | ||||
| All | 305 (95.0%) | 331 (94.0%) | 0.96 (0.24–3.84) | ||
| Female | 15 (4.7%) | 20 (5.7%) | 0.86 (0.20–3.61) | ||
| Male | 1 (0.3%) | 1 (0.3%) | Reference | ||
| Phase | 0.4962 | ||||
| Early phase1 | 1 (0.3%) | 2 (0.6%) | 0.71 (0.14–3.51) | ||
| Phase2 | 6 (1.9%) | 4 (1.1%) | 1.27 (0.76–2.13) | ||
| Phase3 | 5 (1.6%) | 2 (0.6%) | 1.52 (0.94–2.44) | ||
| Phase4 | 4 (1.2%) | 2 (0.6%) | 1.41 (0.80–2.50) | ||
| Unknown | 305 (95.0%) | 342 (97.2%) | Reference | ||
| Intervention model | 0.4955 | ||||
| Sequential | 3 (0.9%) | 8 (2.3%) | Reference | ||
| Parallel | 290 (90.3%) | 311 (88.4%) | 1.77 (0.67–4.66) | ||
| Factorial | 15 (4.7%) | 15 (4.3%) | 1.83 (0.66–5.13) | ||
| Crossover | 13 (4.0%) | 18 (5.1%) | 1.54 (0.54–4.39) | ||
| Intervention type | 0.0194 | ||||
| Behavioral | 154 (48.0%) | 134 (38.1%) | 1.24 (1.04–1.48) | ||
| Device | 44 (13.7%) | 57 (16.2%) | 1.01 (0.78–1.31) | ||
| Diagnostic test | 2 (0.6%) | 5 (1.4%) | 0.66 (0.20–2.15) | ||
| Combination product | 6 (1.9%) | 1 (0.3%) | 1.99 (1.42–2.77) | ||
| Procedure | 2 (0.6%) | 6 (1.7%) | 0.58 (0.17–1.94) | ||
| Other or Mixture | 113 (35.2%) | 149 (42.3%) | Reference | ||
| Primary purpose | 0.0002 | ||||
| Prevention | 60 (18.7%) | 77 (21.9%) | 0.90 (0.66–1.23) | ||
| Diagnostic/Screening | 8 (2.5%) | 34 (9.7%) | 0.39 (0.20–0.77) | ||
| Health services research | 43 (13.4%) | 63 (17.9%) | 0.84 (0.60–1.17) | ||
| Treatment | 117 (36.4%) | 100 (28.4%) | 1.11 (0.84–1.47) | ||
| Supportive care | 61 (19.0%) | 44 (12.5%) | 1.20 (0.89–1.61) | ||
| Other | 32 (10.0%) | 34 (9.7%) | Reference | ||
| Masking | 0.5480 | ||||
| Single | 97 (30.2%) | 92 (26.1%) | 1.15 (0.96–1.39) | ||
| Double | 47 (14.6%) | 44 (12.5%) | 1.16 (0.92–1.46) | ||
| Triple | 18 (5.6%) | 19 (5.4%) | 1.09 (0.77–1.56) | ||
| Quadruple | 7 (2.2%) | 7 (2.0%) | 1.12 (0.66–1.92) | ||
| None | 152 (47.4%) | 190 (54.0%) | Reference | ||
| Masking person | 0.4315 | ||||
| Investigator | 10 (3.1%) | 15 (4.3%) | 0.90 (0.55–1.48) | ||
| Outcomes assessor | 65 (20.2%) | 54 (15.3%) | 1.23 (1.00–1.50) | ||
| Participant | 20 (6.2%) | 21 (6.0%) | 1.10 (0.78–1.53) | ||
| Care provider | 2 (0.6%) | 2 (0.6%) | 1.12 (0.42–3.02) | ||
| Mixture | 72 (22.4%) | 70 (19.9%) | 1.14 (0.93–1.39) | ||
| Unknown | 152 (47.4%) | 190 (54.0%) | Reference | ||
| Reported results in ClinicalTrials.gov | 0.2515 | ||||
| Yes | 19 (5.9%) | 17 (4.8%) | 1.29 (0.91–1.83) | ||
| No | 83 (25.9%) | 120 (34.1%) | Reference | ||
| Has publications in PubMed after primary completion | 0.7118 | ||||
| Yes | 57 (17.8%) | 81 (23.0%) | 0.93 (0.69–1.24) | ||
| No | 45 (14.0%) | 56 (15.9%) | Reference | ||
| Age group | 0.0257 | ||||
| ≥65 years | 312 (97.2%) | 328 (93.2%) | 1.79 (1.02–3.14) | ||
| <65 years | 9 (2.8%) | 24 (6.8%) | Reference | ||
| Study size | 0.0072 | ||||
| ≤100 | 134 (41.7%) | 131 (37.2%) | Reference | ||
| 101–500 | 139 (43.3%) | 135 (38.4%) | 1.00 (0.85–1.19) | ||
| 501–1000 | 29 (9.0%) | 39 (11.1%) | 0.84 (0.62–1.14) | ||
| >1000 | 19 (5.9%) | 47 (13.4%) | 0.57 (0.38–0.85) | ||
| Number of centers | 0.8825 | ||||
| 1 | 240 (74.8%) | 261 (74.1%) | Reference | ||
| 2–5 | 58 (18.1%) | 63 (17.9%) | 1.00 (0.81–1.23) | ||
| 6–10 | 13 (4.0%) | 13 (3.7%) | 1.04 (0.70–1.55) | ||
| >10 | 10 (3.1%) | 15 (4.3%) | 0.84 (0.51–1.36) | ||
| Country of recruitment | 0.7182 | ||||
| HIC, UMIC or mixture | 310 (96.6%) | 337 (95.7%) | 1.13 (0.72–1.79) | ||
| LMIC or LIC only | 11 (3.4%) | 15 (4.3%) | Reference | ||
| Region of recruitment | 0.9275 | ||||
| North America only | 162 (50.5%) | 179 (50.9%) | 1.07 (0.79–1.44) | ||
| Europe and Central Asia only | 90 (28.0%) | 97 (27.6%) | 1.08 (0.79–1.48) | ||
| East and Pacific only | 41 (12.8%) | 41 (11.6%) | 1.12 (0.79–1.60) | ||
| Other or mixture | 28 (8.7%) | 35 (9.9%) | Reference | ||
| Year | 0.0003 | ||||
| 2012–2014 | 5 (1.6%) | 9 (2.6%) | Reference | ||
| 2015–2017 | 31 (9.7%) | 62 (17.6%) | 0.93 (0.44–1.99) | ||
| 2018–2020 | 102 (31.8%) | 120 (34.1%) | 1.29 (0.63–2.64) | ||
| 2021–2024 | 183 (57.0%) | 159 (45.2%) | 1.50 (0.74–3.05) |