Table 2.
Outcomes at 12 Months.*
| Outcome | Overall (N = 100) | ETV–CPC Group (N = 51) | Ventriculoperitoneal-Shunt Group (N = 49) | Estimated Difference (95% CI)† | P Value‡ |
|---|---|---|---|---|---|
| Primary outcome | |||||
| Median BSID-3 cognitive score (IQR) | 3 (1 to 6) | 4 (1 to 7) | 2 (1 to 6) | 0 (−2 to 0) | 0.35 |
| Secondary outcomes | |||||
| Median BSID-3 expressive language score (IQR) | 2 (1 to 5) | 3 (2 to 4) | 2 (1 to 5) | 0 (−1 to 1) | 0.84 |
| Median BSID-3 receptive language score (IQR) | 4 (3 to 6) | 5 (3 to 6) | 4 (2 to 6) | 0 (−1 to 0) | 0.34 |
| Median BSID-3 general motor score (IQR) | 1 (1 to 3) | 1 (1 to 4) | 1 (1 to 2) | 0 (0 to 0) | 0.14 |
| Median BSID-3 fine motor score (IQR) | 4 (1 to 7) | 4 (1 to 7) | 3 (1 to 6) | 0 (−2 to 0) | 0.25 |
| Median CSF volume (IQR) — cm3 | 311 (97 to 526) | 410 (236 to 668) | 171 (80 to 366) | −221 (−325 to −131) | <0.001 |
| Median brain volume (IQR) — z score | −2.3 (−3.3 to −1.0) | −2.4 (−3.5 to −1.4) | −2.1 (−3.2 to −0.9) | 0.3 (−0.3 to 1.0) | 0.12 |
| Treatment failure — no. (%) | 30 (30) | 18 (35) | 12 (24) | −10.8 (−28.6 to 7.0) | 0.28 |
| Infection — no. (%) | 4 (4) | 2 (4) | 2 (4) | 0.2 (−7.5 to 7.8) | 1.00 |
| All-cause mortality — no. (%) | 6 (6) | 4 (8) | 2 (4) | −3.8 (−13.0 to 5.5) | 0.68 |
*
Data at 12 months for BSID-3 scores and volume measurements were available for 47 patients in each treatment group (94 patients in total).
†
Hodges–Lehmann estimates and 95% confidence intervals were used for differences in medians and normal approximation for differences in proportions. Because of the use of the Hodges–Lehmann estimator, the estimated difference is not the crude difference between the medians.
‡
P values were based on a Mann–Whitney test or Fisher’s exact test.