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Risk judgment justification basis
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Intervention
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|---|
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Domain I (random sequence generation)
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Categorization of supporting comments
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Non-surgical
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Surgical
|
|
Randomization not described
|
5317 (57.0%)
|
389 (50.0%)
|
|
Random number table
|
815 (8.7%)
|
68 (8.7%)
|
|
Computerized randomization
|
2597 (27.8%)
|
253 (32.5%)
|
|
Mechanical randomization
|
326 (3.5%)
|
33 (4.2%)
|
|
Inappropriate randomization
|
270 (2.9%)
|
35 (4.5%)
|
|
Domain II (allocation concealment)
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Type of allocation concealment
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Non-surgical
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Surgical
|
|
Central allocation
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506 (5.3%)
|
32 (4.1%)
|
|
Incomplete SNOSE
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1117 (11.8%)
|
147 (18.6%)
|
|
Not described/unclear
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7200 (76.1%)
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525 (66.5%)
|
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Open / predictable allocation
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386 (4.1%)
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34 (4.3%)
|
|
SNOSE
|
250 (2.6%)
|
51 (6.5%)
|
|
Domain III + a (blinding of participants and personnel)
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Blinding achieved
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Non-surgical
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Surgical
|
|
Achieved
|
1239 (12.1%)
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38 (4.0%)
|
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Not done or not possible
|
4318 (42.1%)
|
414 (43.8%)
|
|
Probably done
|
4709 (45.9%)
|
493 (52.2%)
|
|
Outcome influenced by lack of blinding
|
Non-surgical
|
Surgical
|
|
Influenced
|
472 (4.6%)
|
21 (2.2%)
|
|
Unknown
|
9340 (91.0%)
|
832 (88.0%)
|
|
Not influenced
|
454 (4.4%)
|
92 (9.7%)
|
|
Domain IV + a (blinding of outcome assessors)
|
Blinding achieved
|
Non-surgical
|
Surgical
|
|
Achieved
|
1722 (15.7%)
|
84 (9.1%)
|
|
Probably done
|
6695 (61.1%)
|
609 (65.9%)
|
|
Not done or not possible
|
2540 (23.2%)
|
231 (25.0%)
|
|
Outcome influenced by lack of blinding
|
Non-surgical
|
Surgical
|
|
Influenced
|
919 (8.4%)
|
31 (3.4%)
|
|
Unknown
|
9045 (82.5%)
|
839 (90.8%)
|
|
Not influenced
|
993 (9.1%)
|
54 (5.8%)
|
- aAlso includes data for joint domain of blinding of participants, personnel and outcome assessor; SNOSE = sequentially numbered sealed opaque envelopes
