Pittner 2008.
Study characteristics | ||
Methods | RCT. 2‐arm, parallel‐group design Randomisation was done according to medical record number. Participants were randomised (not feet) |
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Participants | 34 participants with 42 CTEV feet who attended author's outpatient clinics Inclusion criteria: initial presentation of CTEV Exclusion criteria: none stated PARTICIPANT CHARACTERISTICS 3 participants excluded prior to data analysis. 1 lost to follow‐up, 1 had medical complications, and 1 switched groups during treatment Fibreglass Age mean (SD) weeks: 1.07 (0.57) Sex male:female: 9:4 Characteristics of feet: 13 participants. 16 feet (8 left, 8 right) Baseline severity: Diméglio scale score average: 13.1 Plaster Age mean (SD) weeks: 1.89 (1.88) Sex male:female: 18:0 Characteristics of feet: 18 participants. 23 feet: 9 left, 14 right Baseline severity: Diméglio scale average: 12.3 |
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Interventions | Semi‐rigid (fibreglass) casts versus plaster of Paris casts for Ponseti treatment of initial presentation of CTEV In the semi‐rigid (fibreglass) group, casting was done using Scotchcast Softcast (3M). In the control group, plaster of Paris was used Follow‐up: end of treatment |
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Outcomes | Diméglio scale Parent satisfaction questionnaire |
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Conflicts of interest | None declared | |
Funding | None declared | |
Notes | Location: USA Dates conducted: 15 month period (dates not stated) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Sequence generated by medical record number. Not stated how this was done |
Allocation concealment (selection bias) | High risk | Sequence generated by medical record number |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind intervention providers. Participant blinding unlikely to affect outcome |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Assessors not blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Several participants were excluded after randomisation or lost to follow‐up. Their data were removed from the study |
Selective reporting (reporting bias) | Unclear risk | Objective was to compare materials ‐ primary/secondary outcomes were not stated in Methods section. |
Other bias | Unclear risk | The trial report did not include sufficient detail to judge whether there could be other bias |