| Randomised controlled trials: number (95% confidence interval) | |||||||
|---|---|---|---|---|---|---|---|
| Characteristic | All trials | Study protocol available (full audit) | Study protocol not available (limited review) | P * | |||
| Trials included | 181 | 124 | 57 | ||||
| Trials with publicly available protocols | 46 | 25% (19–33%) | 46 | 37% (29–46%) | — | — | — |
| Intervention type | 0.34 | ||||||
| Treatment: drugs | 103 | 57% (49–64%) | 74 | 60% (50–68%) | 29 | 51% (37–64%) | |
| Treatment: devices | 8 | 4% (2–9%) | 7 | 6% (3–12%) | 1 | 2% (0–11%) | |
| Prevention | 12 | 7% (4–12%) | 9 | 7% (4–14%) | 3 | 5% (1–16%) | |
| Rehabilitation | 8 | 4% (2–9%) | 5 | 4% (2–10%) | 3 | 5% (1–16%) | |
| Other | 50 | 28% (21–35%) | 29 | 23% (16–32%) | 21 | 37% (25–51%) | |
| Primary indication | < 0.001 | ||||||
| Cancer | 32 | 18% (13–24%) | 27 | 22% (15–30%) | 5 | 9% (3–20%) | |
| Mental health | 18 | 10% (6–15%) | 7 | 6% (3–12%) | 11 | 19% (10–32%) | |
| Respiratory | 18 | 10% (6–15%) | 14 | 11% (7–19%) | 4 | 7% (2–18%) | |
| Musculoskeletal | 16 | 9% (5–14%) | 14 | 11% (7–19%) | 2 | 4% (1–13%) | |
| Cardiovascular | 12 | 7% (4–12%) | 7 | 6% (3–12%) | 5 | 9% (3–20%) | |
| Renal/urogenital | 11 | 6% (3–11%) | 8 | 6% (3–13%) | 3 | 5% (1–16%) | |
| Infection | 9 | 5% (2–10%) | 9 | 7% (4–14%) | 0 | 0% (0–8%) | |
| Oral/gastrointestinal | 9 | 5% (2–10%) | 8 | 6% (3–13%) | 1 | 2% (0–11%) | |
| Other | 56 | 31% (24–38%) | 30 | 24% (17–33%) | 26 | 46% (33–59%) | |
| Statistical hypothesis | 0.23 | ||||||
| Superiority | 168 | 93% (88–96%) | 113 | 91% (84–95%) | 55 | 96% (87–99%) | |
| Non‐inferior/equivalence | 13 | 7% (4–12%) | 11 | 9% (5–16%) | 2 | 4% (1–13%) | |
| Participants, assessors, statisticians, or investigators blinded to treatment allocation | 143 | 79% (72–85%) | 106 | 85% (78–91%) | 37 | 65% (51–77%) | 0.002 |
| Investigators blinded | 96 | 53% (46–60%) | 67 | 54% (45–63%) | 29 | 51% (37–64%) | 0.69 |
| Architecture | 0.10 | ||||||
| Parallel arms | 156 | 86% (80–91%) | 106 | 85% (78–91%) | 50 | 88% (76–95%) | |
| Crossover | 11 | 6% (3–11%) | 6 | 5% (2–11%) | 5 | 9% (3–20%) | |
| Factorial | 9 | 5% (2–10%) | 9 | 7% (4–14%) | 0 | 0% (0–8%) | |
| Cluster | 5 | 3% (1–7%) | 3 | 2% (1–7%) | 2 | 4% (1–13%) | |
| Setting | 0.020 | ||||||
| Hospital | 126 | 70% (62–76%) | 93 | 75% (66–82%) | 33 | 58% (44–71%) | |
| Other | 55 | 30% (24–38%) | 31 | 25% (18–34%) | 24 | 42% (29–56%) | |
| Significance level for primary outcome | 0.28 | ||||||
| P < 0.001 | 16 | 9% (5–14%) | 12 | 10% (5–17%) | 4 | 7% (2–18%) | |
| P = 0.001 to P < 0.05 | 44 | 24% (18–31%) | 25 | 20% (14–29%) | 19 | 33% (22–47%) | |
| P ≥ 0.05 | 101 | 56% (48–63%) | 72 | 58% (49–67%) | 29 | 51% (37–64%) | |
| Not reported | 20 | 11% (7–17%) | 15 | 12% (7–19%) | 5 | 9% (3–20%) | |
| Publication year | 0.09 | ||||||
| 2010 or earlier | 16 | 9% (5–14%) | 8 | 6% (3–13%) | 8 | 14% (7–26%) | |
| 2011–2015 | 83 | 46% (38–53%) | 54 | 44% (35–53%) | 29 | 51% (37–64%) | |
| 2016–2020 | 82 | 45% (38–53%) | 62 | 50% (41–59%) | 20 | 35% (23–49%) | |
*
Trials with protocols v trials without protocols.