Nachemson 1995.
Methods | Multicentre multinational prospective cohort trial. 8 centres enrolled; included only physicians who firmly believed in effectiveness of bracing or who firmly believed that bracing was ineffective. Each physician consecutively enrolled all participants who met the inclusion criteria and prescribed only 1 treatment | |
Participants | 240 girls with AIS; mean age 12.7 years; Cobb angle 30‐35°: 42% in the observation group and 65% in the brace group; Cobb angle 20‐29°: 58% in the observation group and 35% in the brace group; menarche at baseline: 57% in the observation group and 41% in the brace group; imbalance: 46% in the observational group and 25% in the brace group | |
Interventions |
Experimental: plastic brace worn for at least 16 hours per day (111 girls) Control: observation only (who received the electrical stimulation referred to in the text) (129 girls) |
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Outcomes | Failure of treatment as measured by an increase of the curve of ≥ 6°, noted on 2 consecutive roentgenograms performed every 4 months before menarche and every 6 months after menarche | |
Notes | Length of follow‐up: 16 years after maturity | |
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 | Unclear risk | No subjective outcomes measured |
Blinding of outcome assessment (detection bias) objective outcomes | Low risk | Roentgenograms read by providers, but objective outcomes unlikely to be influenced by lack of blinding |
Incomplete outcome data (attrition bias) were drop‐out reported and equal between groups? | High risk | 7% lost at follow‐up in the control group; 21% lost at follow‐up in the experimental group Comment: percentage unbalanced between groups, but worst‐case analysis performed |
Incomplete outcome data (attrition bias) were all randomized participants analyzed in the group to which they were allocated? | High risk | Quote: "the patients lost at follow‐up were included in the survivorship analysis for the time they were in the study" Quote: "the 23 patients who dropped out from the brace group were analysed in the worst‐case analysis and considered as treatment failure" Comment: only the participants who dropped out from the experimental group were included in the worst‐case analysis |
Selective reporting (reporting bias) | Low risk | Results from all pre‐specified outcomes have been adequately reported |
Groups similar at baseline | High risk | Comparability of cohorts on the basis of the design or analysis: more participants with severe scoliosis (30‐35° in the brace group (65% with brace vs. 42% with observation); fewer participants with imbalance in the brace group (25% with brace vs. 46% with observation); menarche at baseline: 41% with brace vs. 57% with observation No adjustment for most important confounding factors Comment: differences at the baseline were in favour of the control group |
Co‐interventions | Unclear risk | Not reported |
Compliance with intervention | Unclear risk | Not reported |
Similar outcome timing | Low risk | All participants received a roentgenogram every 4 months before menarche and every 6 months after menarche |
Representativeness of the exposed cohort | Low risk | Truly representative of the average adolescents with scoliosis |
Selection of the non‐exposed cohort | High risk | Drawn from a different source |
Ascertainment of exposure | Low risk | Secure record (e.g. clinical records) |