| Items |
Grades |
Notes |
| 1. Was the assigned treatment adequately concealed prior to allocation? |
Y = method did not allow disclosure of assignment.
? = small but possible chance of disclosure of assignment or unclear.
N = quasi‐randomised or open list/tables. |
Cochrane code: Clearly yes = A; Not sure = B; Clearly no = C |
| 2. Were the outcomes of participants who withdrew described and included in the analysis (intention to treat)? |
Y = withdrawals well described and accounted for in analysis.
? = withdrawals described and analysis not possible.
N = no mention, inadequate mention, or obvious differences and no adjustment. |
|
| 3. Were the outcome assessors blinded to treatment status? |
Y = effective action taken to blind assessors.
? = small or moderate chance of unblinding of assessors.
N = not mentioned or not possible. |
|
| 4. Were the treatment and control group comparable at entry? |
Y = good comparability of groups.
? = confounding small; mentioned.
N = large potential for confounding, or not discussed. |
The principle confounders were considered to be: age, sex, fracture location, pattern and displacement, and associated soft tissue injury. |
| 5. Were the participants blind to assignment status after allocation? |
Y = effective action taken to blind participants.
? = small or moderate chance of unblinding of participants.
N = not possible, or not mentioned (unless double‐blind), or possible but not done. |
|
| 6. Were the treatment providers blind to assignment status? |
Y = effective action taken to blind treatment providers.
? = small or moderate chance of unblinding of treatment providers.
N = not possible, or not mentioned (unless double‐blind), or possible but not done. |
|
| 7. Were care programmes, other than the trial options, identical? |
Y = care programmes clearly identical.
? = clear but trivial differences.
N = not mentioned or clear and important differences in care programmes. |
Examples of clinically important differences in other interventions which could act as active measures for treatment of ulna fractures were considered to be: advice on activity, exercises undertaken, timing of intervention etc. |
| 8. Were the inclusion and exclusion criteria clearly defined? |
Y = clearly defined.
? = inadequately defined.
N = not defined. |
|
| 9. Were the outcome measures used clearly defined? (by outcome measure) |
Y = clearly defined.
? = inadequately defined.
N = not defined. |
For fracture non‐union: Was the algorithm for detection clearly described? |
| 10. Were diagnostic tests used in outcome assessment clinically useful? (by outcome) |
Y = optimal.
N = adequate.
? = not defined, not adequate. |
For fracture union (non‐union):
2 = full bridging of external callus determined radiographically, and no pain on forearm movement.
1 = as above but no associated test for pain.
0 = no mention of criteria. |
| 11. Was the duration of surveillance clinically appropriate? (by outcome measure) |
Y = optimal.
? = adequate.
N = not defined, not adequate. |
For fracture union (non‐union):
2 = 26 weeks or more post injury.
1 = 10‐26 weeks.
0 = under 10 weeks. |
