Table 2. Summary of Primary and Secondary Outcomes by Intention-to-Treat Analysis.
| Outcome | Indwelling Pleural Catheter (n = 73) |
Talc Pleurodesis (n = 71) |
Estimated Difference (95% CI)a |
P Value |
|---|---|---|---|---|
| Primary Outcome | ||||
| Total all-cause hospital stay duration, d | ||||
| Median (IQR) | 10 (3-17) | 12 (7-21) | 2.92 (0.43 to 5.84) | .03 |
| Mean (SD)b | 12.7 (13.4) | 16.3 (15.2) | ||
| Secondary Outcomes | ||||
| Effusion-related hospital stay duration, d | ||||
| Median (IQR) | 1 (1-3) | 4 (3-6) | 2.06 (1.53 to 2.58) | <.001 |
| Mean (SD)b | 3.1 (4.3) | 4.7 (3.1) | ||
| Non–effusion-related hospital stay duration, d | ||||
| Median (IQR) | 5 (1-13) | 7 (2-15) | 0.92 (−1.10 to 3.73) | .37 |
| Mean (SD)b | 9.6 (12.7) | 11.6 (14.7) | ||
| VAS dyspnea scores, estimated mean (95% CI), mm | ||||
| Baseline | 50.0 (37.2 to 62.7) | 52.2 (39.3 to 63.1) | 2.27 (−5.33 to 9.88) | .56 |
| 1 d after procedure | 64.5 (51.4 to 75.5) | 69.7 (56.5 to 82.9) | 5.25 (−3.21 to 13.71) | .22 |
| 30 d after procedure | 69.7 (56.7 to 82.6) | 72.2 (59.0 to 85.5) | 2.58 (−5.91 to 11.08) | .55 |
| 6 mo after procedure | 71.1 (57.8 to 84.5) | 71.2 (57.3 to 85.1) | 0.03 (−9.89 to 9.96) | .99 |
| 12 mo after procedure | 69.4 (55.4 to 83.4) | 59.0 (44.6 to 73.4) | −10.42 (−21.90 to 1.06) | .07 |
| VAS QoL scores, estimated mean (95% CI), mm | ||||
| Baseline | 52.4 (43.4 to 61.4) | 56.7 (47.5 to 65.9) | 4.24 (−3.76 to 12.25) | .27 |
| 2 d after procedure | 60.3 (50.9 to 69.7) | 58.5 (48.9 to 68.1) | −1.75 (−10.65 to 7.14) | .74 |
| 30 d after procedure | 61.5 (52.2 to 70.8) | 67.3 (57.6 to 77.0) | 5.79 (−3.11 to 14.69) | .17 |
| 6 mo after procedure | 67.4 (57.6 to 77.3) | 66.1 (55.5 to 76.7) | −1.27 (−11.64 to 9.09) | .89 |
| 12 mo after procedure | 61.7 (50.9 to 72.4) | 56.3 (45.0 to 67.6) | −5.34 (−17.30 to 6.62) | .43 |
| EQ5D QoL scores, estimated mean (95% CI) | ||||
| Baseline | 31.2 (26.7 to 35.7) | 32.3 (27.8 to 36.8) | 1.12 (−2.34 to 4.59) | .46 |
| 8 d after procedure | 34.1 (29.5 to 38.7) | 35.3 (30.6 to 40.0) | 1.18 (−2.73 to 5.10) | .48 |
| 30 d after procedure | 35.2 (30.6 to 39.8) | 34.5 (29.8 to 39.2) | −0.67 (−4.59 to 3.23) | .86 |
| 6 mo after procedure | 33.9 (29.1 to 38.7) | 33.1 (28.0 to 38.1) | −0.84 (−5.34 to 3.66) | .84 |
| 12 mo after procedure | 32.4 (27.3 to 37.5) | 31.5 (26.2 to 36.8) | −0.92 (−6.07 to 4.22) | .83 |
| Deaths at 12 mo, No. (%) | 44 (60) | 51 (72) | 0.12 (−0.05 to 0.28) | .20 |
| Further ipsilateral invasive pleural procedures required, No. (%) | 3 (4) | 16 (22) | 0.18 (0.08 to 0.29) | .001 |
Abbreviations: EQ5D, EuroQol 5 Dimensions; IQR, interquartile range; QoL, quality of life; VAS, visual analog scale.
a
Differences in VAS and EQ5D scores are differences in estimated means with 95% CIs and P values for the difference. Hodges-Lehmann location shift estimates and 95% CIs are presented for comparisons associated with differences in medians. Differences in proportions and 95% CIs for differences are provided for complications along with Fisher exact test P values.
b
Data not normally distributed but mean (SD) included to enable future economic calculations in savings of days in population cohorts.