1. Was there clear concealment of allocation? |
Score 3 if allocation was concealed (e.g. numbered sealed opaque envelopes drawn consecutively). Score 2 if there was a possible chance of disclosure before allocation. Score 1 if the method of allocation concealment or randomisation was not stated or was unclear. Score 0 if allocation concealment was clearly not concealed such as those trials using quasi‐randomisation (e.g. even or odd date of birth). |
2. Were the inclusion and exclusion criteria clearly defined? |
Score 1 if text states the type of fracture and which patients were included and/or excluded. Otherwise score 0. |
3. Were the outcomes of trial participants who withdrew or excluded after allocation described and included in an intention‐to‐treat analysis? |
Score 1 if yes or text states that no withdrawals occurred, or data are presented that, by clearly showing 'participant flow', allow this to be inferred. Otherwise score 0. |
4. Were the treatment and control groups adequately described at entry and if so were the groups well matched or appropriate co‐variate adjustment made? |
Score 1 if at least four admission details given (e.g. age, sex, mobility, function score, mental test score, fracture type) with no significant difference between groups or appropriate adjustment made. Otherwise score 0. |
5. Did the surgeons have prior experience of the operations they performed in the trial, prior to its commencement? |
Score 1 if text states there was an introductory period or that surgeons were experienced. Otherwise score 0. |
6. Were the care programmes other than trial options identical? |
Score 1 if text states they were or if this can be inferred. Otherwise score 0. |
7. Were the outcome measures clearly defined in the text with a definition of any ambiguous terms encountered? |
Score 1 if yes. Otherwise score 0. |
8. Were the outcome assessors blind to assignment status? |
Score 1 if assessors of pain and function at follow‐up were blinded to treatment outcome. Otherwise score 0. |
9. Was the timing of outcome measures appropriate? A minimum of 24 months active follow‐up for all surviving trial participants. |
Score 1 if yes. Otherwise score 0. |
10. Was loss to follow‐up reported and if so were less than 5% of trial participants lost to follow‐up? |
Score 1 if yes. Otherwise score 0. |