Table 3.
Primary and secondary outcome measures
| Intensive n=150 | Standard care n=158 | Difference* | |||
| Physical Component Summary measure of SF-36 | |||||
| Hospital discharge | n=76/116 | 34 (8.0) | n=76/113 | 34 (9.0) | −1.0 (−4.2 to 2.2) |
| 3 months | n=69/115 | 35 (10.8) | n=69/109 | 34 (9.0) | −1.4 (−5.9 to 3.0) |
| 6 months | n=62/107 | 37 (12.2) | n=54/102 | 37 (11.3) | −1.1 (−7.1 to 5.0) |
| Mental Component Summary measure of SF-36 | |||||
| Hospital discharge | n=76/113 | 40 (13.2) | n=76/113 | 39 (11.4) | 1.3 (−3.4 to 6.0) |
| 3 months | n=69/115 | 47 (11.8) | n=69/109 | 45 (12.3) | 4.2 (−1.2 to 9.5) |
| 6 months | n=62/107 | 47 (15.0) | n=54/102 | 48 (11.5) | −0.4 (−6.5 to 5.7) |
| Modified Rivermead Mobility Index† | |||||
| ICU discharge | n=112/124 | 19 (10) | n=104/118 | 16 (10) | 0.4 (−2.7 to 3.4) |
| ICU length of stay (median (IQR) days) | |||||
| Participants alive at ICU discharge | n=124 | 13 (8–21) | n=118 | 15 (8–23) | 0.3 (−4.0 to 4.8)‡ |
| Participants deceased at ICU discharge | n=26 | 10 (6–29) | n=40 | 9 (4–14) | 5.2 (−7.3 to 16.7)‡ |
| Hospital length of stay (median (IQR) days) | |||||
| Participants alive at hospital discharge | n=116 | 28 (19–56) | n=113 | 28 (20–43) | 4.1 (−6.5 to 15.3)‡ |
| Participants deceased at hospital discharge | n=34 | 14 (6–31) | n=45 | 9 (5–21) | −5.0 (−29.2 to 14.7)‡ |
| Six-minute walk test (median (IQR) in metres) | |||||
| Hospital discharge | n=49/116 | 195 (120–260) | n=34/113 | 173 (123–274) | −27.9 (−86.1 to 31.8)‡ |
| 3 months | n=32/115 | 293 (124–444) | n=27/109 | 255 (120–337) | −6.3 (−125.8 to 107.3)‡ |
| 6 months | n=28/107 | 374 (203–435) | n=25/102 | 321 (197–400) | 61.7 (−47.2 to 157.0)‡ |
| Functional Independence Measure§ | |||||
| ICU discharge | n=114/124 | 70 (27) | n=107/118 | 64 (25) | −0.6 (−7.1 to 8.3) |
| Hospital discharge | n=83/116 | 113 (17) | n=75/113 | 108 (20) | 1.2 (−5.2 to 7.7) |
| 3 months | n=71/115 | 116 (19) | n=67/109 | 111 (23) | 9.7 (0.9 to 18.5) |
| 6 months | n=64/107 | 118 (17) | n=51/102 | 117 (16) | 3.7 (−5.4 to 12.7) |
| Grip strength | |||||
| ICU discharge | n=95/124 | 14 (9) | n=89/118 | 15 (9) | −0.6 (−3.3 to 2.1) |
| Hospital discharge | n=60/116 | 19 (10) | n=54/113 | 22 (14) | −3.5 (−8.1 to 1.2) |
| 3 months | n=36/115 | 25 (16) | n=31/109 | 24 (14) | 1.8 (−6.7 to 10.3) |
| 6 months | n=31/107 | 29 (19) | n=31/102 | 24 (16) | −0.5 (−11.3 to 10.3) |
*Adjusted difference in means (95% CI). Multiple linear regression models included stratification variables (unit, admission type and preadmission Katz Index) and baseline variables sex, mode of ventilation, specialty, age in years, body mass index, randomisation lag (time between admission to ICU and participant randomisation), duration of ventilation and ICNARC Physiology Score.
†Distribution was positively skewed so bootstrap sampling was used to estimate 95% CIs for adjusted difference in means.
‡The Functional Independence Measure rates patients on a scale of 1 (<25% independence; total assistance required) to 7 (100% independence) against 18 activities, giving a maximum score of 126.
§The Modified Rivermead Mobility Index rates patients on a scale of 0 (unable to perform) to 5 (independent) against eight physical tasks, giving a maximum score of 40.
ICNARC, Intensive Care National Audit and Research Centre; ICU, intensive care unit.