Table 6.
Comparison of evidence-based personalised approach (EBPA) with benchmarked Randomised Controlled Trials (RCTs): Plastic Brace (PB) and Elastic Brace (EB) subgroups with the BrAIST [8] and SpineCor [9] studies, respectively.
| Analysis | Groups | Relative Risk (RR) of Success | Number Needed to Treat (NNT) | ||||
|---|---|---|---|---|---|---|---|
| EBPA | RCT | RR | IC95 | p | NNT | IC95 | |
| Comparison with BrAIST Study | |||||||
| Efficacy | treated EBPA | controls BrAIST | 2.0 | 1.7–2.5 | chi2 = 307.4 p < 0.001 | 2.0 | 1.7–2.5 |
| treated EBPA | treated BrAIST | 1.4 | 1.2–1.5 | chi2 = 141.8 p < 0.001 | 3.8 | 2.9–5.3 | |
| Intent to Treat | treated EBPA | controls BrAIST | 1.8 | 1.5–2.3 | chi2 = 97.5 p < 0.001 | 2.5 | 2.0–3.3 |
| treated EBPA | treated BrAIST | 1.2 | 1.1–1.4 | chi2 = 24.46 p < 0.001 | 6.3 | 4.2–12.5 | |
| Comparison with SpineCor Study | |||||||
| Efficacy | treated EBPA | controls SpineCor | 1.7 | 1.2–2.5 | chi2 = 184.2 p < 0.001 | 2.4 | 1.6–4.8 |
| treated EBPA | treated SpineCor | 2.9 | 1.7–4.9 | chi2 = 377.0 p < 0.001 | 1.6 | 1.2–2.2 | |
| Intent to Treat | treated EBPA | controls SpineCor | 3.5 | 2.0–6.1 | chi2 = 103.1 p < 0.001 | 1.6 | 1.3–2.1 |
| treated EBPA | treated SpineCor | 1.2 | 0.97–1.5 | chi2 = 5.96 p = 0.05 NS | 6.7 | 3.2–100 | |
RR: Relative Risk; NNT: Number Needed to Treat; IC95: Interval of Confidence 95%. In EBPA, we considered the subgroups comparable to the populations of RCTs. We used the Relative Risk (RR) of success since all data in RCTs and EBPA were collected prospectively. A higher RR shows the probability for a patient to achieve better results with one treatment vs. the other. It was in this way also possible to compare our subgroups to the control groups of RCTs, showing the superiority of EBPA on natural history. Note that the relative risk of success is different for the two comparisons: in BrAIST RCT, it was defined as remaining below 50° [8], while in SpineCor one, it was remaining below 45° [9].