West 2005.
Methods | Randomised trial Study period: not stated (ethical approval July 1999) |
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Participants | Royal Gwent Hospital, Newport, South Wales, UK 42 children with buckle fractures of the distal radius Exclusion: not stated, no written consent Sex: not stated Age (< 5 / 5 to 10 / > 10 years): 1/26/12 (39 analysed) Fracture type: buckle fracture Assigned: 21 (bandage)/ 21 (cast) Analysed: 18 / 21 (according to the primary trial); 17 / 20 (as stated in 2 abstracts) |
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Interventions | 1. Bandage: a layer of orthopaedic wool was applied. This was then covered with a layer of ordinary commercial cotton crepe bandage, which was held with tape. Participants seen every week. Bandage was removed and then reapplied after measuring range of movement each week. Participants were encouraged to report adverse incidents and advised they could convert to a cast at any time 2. Plaster cast: initially, a below‐elbow back‐slab cast. At 1 week the cast was converted to a full below‐elbow polymer cast. Seen at 1 week and then at 4 weeks, when cast was removed At A&E on day of presentation, given an information booklet that set out in a question‐and‐answer format information on the 2 treatments provided prior to consent. Discharged at 4 weeks |
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Outcomes | Questionnaire at 4 weeks; also 1 week for both groups Function data: not reported, no formal data collection Adverse events or skin problems Cross‐over (protocol deviation; parents requested that a special‐needs child had bandage changed to a cast) Pain and comfort at 4 weeks Early bandage removal at first week or second week Convenience of treatment Range of movement: 1, 2, 3, 4 weeks in bandage group and 4 weeks in cast group |
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Funding and declarations of interest | Funding source: authors received no financial support for study Declarations of interest: not stated |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “Patients were randomised using a set of presealed envelopes, of which there were equal numbers to direct patients to either bandage or cast. Patients selected the envelope themselves.” Probably random |
Allocation concealment (selection bias) | Unclear risk | Quote: “Patients were randomised using a set of presealed envelopes, of which there were equal numbers to direct patients to either bandage or cast. Patients selected the envelope themselves.” Probable allocation concealment but not quite enough to stop meddling |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | No blinding |
Blinding of participants and personnel (performance bias) Objective outcomes | High risk | No blinding |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | No blinding |
Blinding of outcome assessment (detection bias) Objective outcomes | High risk | No blinding |
Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | 3 withdrawals from the bandage group; 2 confirmed to have no problems |
Incomplete outcome data (attrition bias) Objective outcomes | Low risk | 3 withdrawals from the bandage group; 2 confirmed to have no problems |
Selective reporting (reporting bias) | Unclear risk | No trial registration or protocol, outcomes insufficiently reported (e.g. pain and function). Also 2 conference abstracts refer to power calculations based on a difference of 5 º at 3 weeks (rather than 4 weeks) and target sample size of 46 participants |
Other bias: major imbalance in baseline characteristics | Unclear risk | No information. Only provided for age ranges for 39 or 42 participants |
Other bias: performance bias | High risk | The extra follow‐ups for the bandage group added an important co‐intervention. No details on clinician expertise |
Other bias | Low risk | None detected |