Davidson 2001.
Methods | Quasi‐randomised controlled trial Study period: 6 month period, before June 2000 |
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Participants | Alder Hey Children’s Hospital, Liverpool, UK 201 children with torus fractures of the distal radius Exclusion: None described Sex: 107 male (53.2%) Age: mean 8.9 years (2 to 15) Fracture type: torus Assigned: 116 (splint) / 85 (cast) Analysed: 98 / 81 (ignores the 2 excluded, 1 of which was in the splint group) |
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Interventions | 1. Futura‐type wrist splint sized and fitted by doctor or nurse. Written instructions provided to participants and parents, including removal for bathing and reapplication of splint; advice for use with discharge after first visit; removal at follow‐up clinic 2. Standard full ‘Colles type’ (full below‐elbow) plaster of Paris cast applied by plaster technician; removal at follow‐up clinic Seen at A&E department, radiograph diagnosis. Fracture immobilised by a metal splint held in place by a crepe bandage and participant referred to fracture clinic. Follow‐up appointment at 3 weeks; discharged if no complications after removal of splint / cast and clinical examination and radiograph and questioning |
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Outcomes | Length of follow‐up: 3 weeks Function data: not reported, no formal data collection Non‐union or loss of position: 3 weeks Compliance Protocol violation Costs |
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Funding and declarations of interest | Funding source: authors stated that no benefits in any form were received from a commercial party related directly or indirectly to the subject of the article Declarations of interest: not stated |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: “They were randomised into two groups depending on the day on which they attended clinic, which was usually the day after injury.” Quasi‐randomised |
Allocation concealment (selection bias) | High risk | Quote: “They were randomised into two groups depending on the day on which they attended clinic, which was usually the day after injury.” No allocation concealment |
Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Not blinded |
Blinding of outcome assessment (detection bias) Objective outcomes | High risk | Not blinded |
Incomplete outcome data (attrition bias) Objective outcomes | High risk | Difference in losses between groups: 18/116 (15.5%) versus 4/85 (4.7%) |
Selective reporting (reporting bias) | High risk | No protocol or trial registration. Insufficient detail on outcome recording and reporting. No mention of function |
Other bias: major imbalance in baseline characteristics | Unclear risk | No data provided |
Other bias: performance bias | High risk | Insufficient details on care personnel to make a judgement. No mention of written instructions for plaster cast use |
Other bias | Low risk | None detected |