The aim of this trial was to assess the cost-effectiveness of a soft bandage and immediate discharge, compared with rigid immobilization, in children aged four to 15 years with a torus fracture of the distal radius. A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective, as well as a broader societal point of view. Health resources and quality of life (the youth version of the EuroQol five-dimension questionnaire (EQ-5D-Y)) data were collected, as part of the Forearm Recovery in Children Evaluation (FORCE) multicentre randomized controlled trial over a six-week period, using trial case report forms and patient-completed questionnaires. Costs and health gains (quality-adjusted life years (QALYs)) were estimated for the two trial treatment groups. Regression was used to estimate the probability of the new treatment being cost-effective at a range of ‘willingness-to-pay’ thresholds, which reflect a range of costs per QALY at which governments are typically prepared to reimburse for treatment.Aims
Methods
We undertook a randomised clinical trial to compare
treatment times and failure rates between above- and below-knee
Ponseti casting groups. Eligible children with idiopathic clubfoot,
treated using the Ponseti method, were randomised to either below-
or above-knee plaster of Paris casting. Outcome measures were total
treatment time and the occurrence of failure, defined as two slippages
or a treatment time above eight weeks. A total of 26 children (33 feet) were entered into the trial.
The above-knee group comprised 17 feet in 13 children (ten boys
and three girls, median age 13 days (1 to 40)) and the below-knee
group comprised 16 feet in 13 children (ten boys and three girls,
median age 13 days (5 to 20)). Because of six failures (37.5%) in
the below-knee group, the trial was stopped early for ethical reasons.
The rate of failure was significantly higher in the below-knee group
(p = 0.039). The median treatment times of six weeks in the below-knee
and four weeks in the above-knee group differed significantly (p
= 0.01). This study demonstrates that the use of a below-knee plaster
of Paris cast in conjunction with the Ponseti technique leads to
unacceptably high failure rates and significantly longer treatment
times. Therefore, this technique is not recommended. Cite this article:
The aim of this study was to explore clinicians’ experience of a paediatric randomized controlled trial (RCT) comparing surgical reduction with non-surgical casting for displaced distal radius fractures. Overall, 22 staff from 15 hospitals who participated in the RCT took part in an interview. Interviews were informed by phenomenology and analyzed using thematic analysis.Aims
Methods
