Items | Scores | Notes |
(1) Was the assigned treatment adequately concealed prior to allocation? | Yes = method did not allow disclosure of assignment. Unclear = small but possible chance of disclosure of assignment or unclear. No = 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)? | Yes = withdrawals well described and accounted for in analysis. Unclear = withdrawals described and analysis not possible, or probably no withdrawals. No = no mention, inadequate mention, or obvious differences and no adjustment. | |
(3) Were the outcome assessors blinded to treatment status? | Yes = effective action taken to blind assessors. Unclear = small or moderate chance of unblinding of assessors, or some blinding of outcomes attempted. No = not mentioned or not possible. | |
(4) Were important baseline characteristics reported and comparable? | Yes = good comparability of groups, or confounding adjusted for in analysis. Unclear = confounding small, mentioned but not adjusted for, or comparability reported in text without confirmatory data. No = 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 lesion (dislocation or subluxation). |
(5) Were the trial participants blind to assignment status after allocation? | Yes = effective action taken to blind participants. Unclear = small or moderate chance of unblinding of participants. No = not possible, or not mentioned (unless double‐blind), or possible but not done. | |
(6) Were the treatment providers blind to assignment status? | Yes = effective action taken to blind treatment providers. Unclear = small or moderate chance of unblinding of treatment providers. No = not possible, or not mentioned (unless double‐blind), or possible but not done. | |
(7) Were care programmes, other than the trial options, identical? | Yes = care programmes clearly identical. Unclear = clear but trivial differences, or some evidence of comparability. No = 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, difference in rehabilitation. |
(8) Were the inclusion and exclusion criteria for entry clearly defined? | Yes = clearly defined (including type of fracture). Unclear = inadequately defined. No = not defined. | |
(9) Were the outcome measures used clearly defined? | Yes = clearly defined. Unclear = inadequately defined. No = 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? | Yes = optimal. Unclear = adequate. No = not defined, not adequate. | |
(11) Was the timing (e.g. duration of surveillance) clinically appropriate? | Yes = optimal (> 1 year) Unclear = adequate (6 months ‐ 1 year) No = not defined, not adequate (< 6 months) | |