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. 2020 May 15;2020(5):CD008602. doi: 10.1002/14651858.CD008602.pub4

Pittner 2008.

Study characteristics
Methods RCT. 2‐arm, parallel‐group design
Randomisation was done according to medical record number. Participants were randomised (not feet)
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
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
Outcomes Diméglio scale
Parent satisfaction questionnaire
Conflicts of interest None declared
Funding None declared
Notes Location: USA
Dates conducted: 15 month period (dates not stated)
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