Lusini 2013.
| Methods | Prospective controlled cohort study | |
| Participants | 57 participants with AIS, at least 1 curve of ≥ 45°, Risser stage 0‐4, aged >above 10 years, first evaluation between 1 March 2003 and 31 December 2010, surgical intervention refused | |
| Interventions |
Experimental: full‐time brace treatment. Participants who arrived in the institute for the first time in 2003 and 2004 were treated with either a Risser cast followed by the Lyon brace, or only the Lyon brace if they refused a cast; from 2005, participants were treated with the Sforzesco brace. Braces had to be worn full‐time (24 hours per day for the Risser cast, 23 hours for the Lyon/Sforzesco brace for the first year, followed by a 1‐hour reduction for 6 months, and then a weaning of 2 hours every 6 months. Physiotherapy‐specific exercises were prescribed systematically to all participants, which were to be performed twice a week. Participants were prescribed Scientific Exercises Approach to Scoliosis exercises to be followed up and updated regularly in the institute (every 3 months ‐ exercised then performed autonomously at home or followed by a trainer) (39 participants) Control: treatment not accepted or came for a second opinion only (18 participants) |
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| Outcomes | Percentage of participants to have radiographically improved above the measurement error (5°). We considered the main curve (if there was > 1 curve, both were considered main curves if their difference was less than 11° Cobb) and the maximum curve. Treatment success (improvement of ≥ 5°) Treatment failure (either progression of ≥ 5°, or fusion) Clinical and radiographic results: TRACE for aesthetics, Cobb degrees, angle of trunk rotation, and plumb‐line distances for the sagittal plane Compliance |
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| Notes | Both per‐protocol (treatment completers) and ITT analysis (all participants enrolled, including drop‐outs) performed length of follow‐up: 2‐9 years | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Prospective cohort study |
| Allocation concealment (selection bias) | High risk | Prospective cohort study |
| Blinding of participants and personnel (performance bias) subjective outcomes | High risk | Blinding of participants not possible for the type of interventions compared (brace vs. no treatment) |
| Blinding of participants and personnel (performance bias) objective outcomes | Low risk | Blinding of participants not possible for the type of interventions compared (brace vs. no treatment) but outcomes unlikely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) subjective outcomes | High risk | Information about blinding of outcome assessor not reported but he was probably not blinded |
| Blinding of outcome assessment (detection bias) objective outcomes | Low risk | Information about blinding of outcome assessor not reported but he was probably not blinded; but outcomes unlikely to be influenced by lack of blinding |
| Incomplete outcome data (attrition bias) were drop‐out reported and equal between groups? | High risk | 11 participants lost at follow‐up (19.3%), unbalanced between groups: 7.7% in the experimental group, 44.4% in the control group |
| Incomplete outcome data (attrition bias) were all randomized participants analyzed in the group to which they were allocated? | Low risk | ITT analysis with worst‐case analysis considering lost at follow‐up as failure when the outcome "improvement" was addressed and as success when the outcome "scoliosis progression/fusion" was addressed |
| Selective reporting (reporting bias) | Low risk | Results from all pre‐specified outcomes have been adequately reported |
| Groups similar at baseline | Unclear risk | Data not reported |
| Co‐interventions | High risk | Physiotherapy prescribed only to the experimental group |
| Compliance with intervention | Unclear risk | Information not reported |
| Similar outcome timing | Unclear risk | Information not reported |
| Representativeness of the exposed cohort | Low risk | Sample representative of the mean population with scoliosis |
| Selection of the non‐exposed cohort | Low risk | Drawn from the same cohort |
| Ascertainment of exposure | Low risk | Clinical records |