| Items |
Scores |
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 or tables. |
Cochrane code (see Handbook): 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, or probably no withdrawals.
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, or some blinding of outcomes attempted.
N = not mentioned or not possible. |
|
| (4) Were important baseline characteristics reported and comparable? |
Y = good comparability of groups, or confounding adjusted for in analysis.
? = confounding small, mentioned but not adjusted for, or comparability reported in text without confirmatory data.
N = large potential for confounding, or not discussed. |
Although many characteristics including hand dominance are important, the principal confounders are considered to be age, gender, type of fracture. |
| (5) Were the trial 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, or some evidence of comparability.
N = not mentioned or clear and important differences in care programmes. |
Examples of clinically important differences in other interventions are: time of intervention, duration of intervention, anaesthetic used within broad categories, operator experience, difference in rehabilitation. |
| (8) Were the inclusion and exclusion criteria for entry clearly defined? |
Y = clearly defined (including type of fracture).
? = inadequately defined.
N = not defined. |
|
| (9) Were the outcome measures used clearly defined? |
Y = clearly defined.
? = inadequately defined.
N = not defined. |
|
| (10) Were the accuracy and precision, with consideration of observer variation, of the outcome measures adequate; and were these clinically useful and did they include active follow up? |
Y = optimal.
? = adequate.
N = not defined, not adequate. |
|
| (11) Was the timing (e.g. duration of surveillance) clinically appropriate? |
Y = optimal. (> 1 year)
? = adequate. (6 months ‐ 1 year)
N = not defined, not adequate. (< 6 months) |
|
