Ersen 2015.
Methods |
Study design: RCT Duration of the study: August 2012 and September 2013 Protocol was published before recruitment of patients: not reported Details of trial registration: not reported Intention‐to‐treat analysis: Likely, but outcome data for participants who had withdrawn from the trial or were lost to follow‐up were not presented Funding sources: the authors reported that no benefits in any form were received or will be received from a commercial party related directly or indirectly to the subject of this article |
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Participants |
Location: Istanbul, Turkey Number of participants assigned: 60 (30 figure‐of‐eight bandage group; 30 arm sling group) Number of participants assessed: 51 (23 figure‐of‐eight bandage group; 28 arm sling group) Inclusion criteria:
Exclusion criteria:
Age (mean; range):
Gender (male/female):
Side of injury (dominant/non‐dominant):
Classification of injury (displaced/not displaced):
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Interventions |
Timing of intervention: All participants were assessed on the day of injury Intervention 1 (figure‐of‐eight bandage):
Intervention 2 (arm sling):
Rehabilitation: not reported Any co‐interventions: not reported |
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Outcomes |
Length of follow‐up:
Loss of follow‐up: nine participants lost to follow‐up: Figure‐of‐eight bandage group ‐ seven participants lost to follow‐up:
Arm sling group ‐ two participants lost to follow‐up:
Primary outcomes:
Secondary outcomes:
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Notes | We found some data discrepancies between text and tables of paper – all data were checked by authors’ via email. This confirmed the denominators at follow‐up were 23 figure‐of‐eight bandages and 28 arm slings | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | The authors employed non‐stratified randomisation in blocks of two using the sealed envelope method, so when one patient had chosen an envelope, the next patient would be allocated to a group according to the remaining envelope of the pair |
Allocation concealment (selection bias) | High risk | Allocation was not concealed |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcomes assessors were not blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Only 82% of participants completed the follow‐up. Missing outcome data were not balanced in numbers across intervention groups; more participants in the figure‐of‐eight group were lost to follow‐up at 12 months; (2/30 (6.7%) in sling group vs. 7/30 (23.3%) in figure‐of‐eight group). This may have overestimated the benefits of sling |
Selective reporting (reporting bias) | High risk | The study protocol was not available. Function or disability was measured by validated scores, however, only at the end of follow‐up that raged by 6 to 12 months ‐ the authors did not report functional outcomes at each time point |
Other bias | High risk | The results were published in imprecise format. We found some data discrepancies between text and tables of paper |