Sensitivity (%) | Specificity (%) | Positive likelihood ratio | Negative likelihood ratio | |||||||
---|---|---|---|---|---|---|---|---|---|---|
ECR | Usual peer review | p value | ECR | Usual peer review | p value | ECR | Usual peer review | ECR | Usual peer review | |
All domains | 83.6 [79.7–87.0] | 19.0 [15.4–23.1] | < 0.001 | 62.9 [59.1–66.6] | 79.9 [76.6–82.9] | < 0.001 | 2.26 [2.02–2.51] | 0.94 [0.73–1.21] | 0.26 [0.21–0.33] | 1.01 [0.96–1.08] |
All CONSORT domains | 85.7 [81.8–89.1] | 19.7 [15.9–24.1] | < 0.001 | 60.9 [56.7–64.9] | 77.2 [73.6–80.6] | < 0.001 | 2.19 [1.96–2.44] | 0.87 [0.67–1.12] | 0.23 [0.18–0.30] | 1.04 [0.97–1.11] |
- Item 6a (Outcomes) | 94.8 [85.6–98.9] | 27.6 [16.7–40.9] | < 0.001 | 42.6 [30.0–55.9] | 57.4 [44.1–70.0] | 0.16 | 1.65 [1.32–2.07] | 0.65 [0.39–1.08] | 0.12 [0.04–0.38] | 1.26 [0.97–1.65] |
- Item 8a (Randomization/sequence generation) | 76.3 [59.8–88.6] | 34.2 [19.6–51.4] | < 0.001 | 85.2 [75.6–92.1] | 76.5 [65.8–85.2] | 0.21 | 5.15 [2.97–8.94] | 1.46 [0.81–2.63] | 0.28 [0.16–0.50] | 0.86 [0.66–1.11] |
- Item 9 (Allocation concealment mechanism) | 82.3 [70.5–90.8] | 8.1 [2.7–17.8] | < 0.001 | 71.9 [58.5–83.0] | 87.7 [76.3–94.9] | 0.05 | 2.93 [1.90–4.51] | 0.66 [0.22–1.95] | 0.25 [0.14–0.43] | 1.04 [0.93–1.18] |
- Items 11/1b (Blinding) | 56.9 [42.2–70.7] | 19.6 [9.8–33.1] | < 0.001 | 76.5 [64.6–85.9] | 83.8 [72.9–91.6] | 0.38 | 2.42 [1.48–3.95] | 1.21 [0.56–2.63] | 0.56 [0.40–0.79] | 0.96 [0.81–1.14] |
- Items 13a/13b (Participant flow) | 92.3 [79.1–98.3] | 17.9 [7.5–33.5] | < 0.001 | 21.3 [12.9–31.8] | 78.8 [68.2–87.1] | < 0.001 | 1.17 [1.01–1.36] | 0.84 [0.38–1.87] | 0.36 [0.11–1.16] | 1.04 [0.87–1.25] |
- Item 17a (Outcomes and estimation) | 93.8 [82.8–98.7] | 33.3 [20.4–48.4] | < 0.001 | 56.3 [44.0–68.1] | 64.8 [52.5–75.8] | 0.42 | 2.15 [1.63–2.82] | 0.95 [0.57–1.58] | 0.11 [0.04–0.34] | 1.03 [0.79–1.34] |
- Item 19 (Harms) | 97.2 [90.2–99.7] | 9.9 [4.1–19.3] | < 0.001 | 8.3 [2.3–20.0] | 75.0 [60.4–86.3] | < 0.001 | 1.06 [0.97–1.16] | 0.39 [0.17–0.93] | 0.34 [0.06–1.77] | 1.20 [1.00–1.44] |
- Item 23 (Trial registration) | 88.9 [65.3–98.6] | 11.1 [1.4–34.7] | < 0.001 | 95.1 [88.8–98.4] | 88.1 [80.2–93.7] | 0.09 | 17.96 [7.52–42.86] | 0.94 [0.23–3.83] | 0.12 [0.03–0.43] | 1.01 [0.84–1.21] |
Switched outcomes | 61.1 [43.4–76.9] | 11.1 [3.1–26.1] | < 0.001 | 77.1 [66.6–85.6] | 97.6 [91.6–99.7] | < 0.001 | 2.67 [1.66–4.28] | 4.61 [0.88–24.05] | 0.50 [0.33–0.77] | 0.91 [0.81–1.03] |