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. 2018 Dec 19;2018(12):CD012470. doi: 10.1002/14651858.CD012470.pub2

West 2005.

Methods Randomised trial
Study period: not stated (ethical approval July 1999)
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)
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
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
Funding and declarations of interest Funding source: authors received no financial support for study
Declarations of interest: not stated
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