Table 3.
HGS Mean (SD), Patients with No Event | HGS Mean (SD), Patients with Event | HGS Decrease Cont (−10 kg) | HGS Decrease Cont (−10 kg) | |
---|---|---|---|---|
All patients | Unadjusted OR or Coef (95% CI), p-value | * Adjusted OR or Coef (95% CI), p-value | ||
Primary endpoint | ||||
180-day all-cause mortality | 24.42 (11.13) | 22.35 (9.99) | 1.2 (1.03 to 1.41) p = 0.019 | 1.52 (1.19 to 1.94), p = 0.001 |
Short-term endpoints (30 days) | ||||
All-cause mortality | 23.81 (10.65) | 22.15 (11.37) | 1.16 (0.92 to 1.48) p = 0.211 | 1.59 (1.13 to 2.22), p = 0.007 |
Adverse outcome | 23.82 (10.73) | 23.17 (10.76) | 1.06 (0.9 to 1.24) p = 0.481 | 1.23 (0.98 to 1.54), p = 0.077 |
Admission to the intensive care unit | 23.71 (10.8) | 19 (6.1) | 1.64 (0.89 to 3.01) p = 0.114 | 2.58 (1.08 to 6.16), p = 0.033 |
Non-elective hospital readmission | 23.42 (10.71) | 25.1 (10.92) | 0.87 (0.7 to 1.08) p = 0.211 | 0.84 (0.61 to 1.15), p = 0.283 |
Any major complication | 23.87 (10.85) | 20.53 (8.84) | 1.39 (1.02 to 1.89) p = 0.038 | 1.65 (1.09 to 2.51), p = 0.018 |
Decline in functional status of ≥10% * | 23.75 (10.5) | 22.93 (11.9) | 1.08 (0.88 to 1.31) p = 0.475 | 1.18 (0.89 to 1.58), p = 0.254 |
Mean length of stay (days) | - | - | 0.22 (−0.29 to 0.73) p = 0.398 | 0.65 (−0.08 to 1.37), p = 0.081 |
Mean Barthel Index score (points) | - | - | −1.69 (−2.48 to −0.9) p < 0.001 | −1.44 (−2.56 to −0.33), p = 0.011 |
Long-term endpoints (180 days) | ||||
Mean EQ-5D VAS (points) | - | - | −0.81 (−2.87 to 1.25) p = 0.442 | −1.2 (−4.14 to 1.75), p = 0.425 |
Mean EQ-5D index (points) | - | - | −0.02 (−0.03 to 0) p = 0.027 | −0.01 (−0.03 to 0.01), p = 0.363 |
Incidence of one or more falls | 23.84 (10.69) | 20.37 (10.53) | 1.41 (1.04 to 1.91) p = 0.027 | 1.58 (1.02 to 2.46), p = 0.04 |
Female patients | ||||
Primary endpoint | ||||
180-day all-cause mortality | 18.14 (7.08) | 15.9 (6.31) | 1.62 (1.11 to 2.37) p = 0.013 | 1.54 (0.89 to 2.65), p = 0.122 |
Short-term endpoints (30 days) | ||||
All-cause mortality | 17.68 (6.79) | 14.33 (7.17) | 2.05 (1.12 to 3.74) p = 0.02 | 2.26 (1.03 to 4.95), p = 0.041 |
Adverse outcome | 17.39 (6.77) | 17.24 (7.22) | 1.03 (0.7 to 1.52) p = 0.876 | 1.31 (0.8 to 2.15), p = 0.275 |
Admission to the intensive care unit | 17.32 (6.94) | 18.43 (4.83) | 0.79 (0.26 to 2.37) p = 0.673 | 1.33 (0.3 to 5.83), p = 0.704 |
Non-elective hospital readmission | 17.05 (6.89) | 19.63 (6.55) | 0.57 (0.32 to 1.01) p = 0.055 | 0.75 (0.37 to 1.55), p = 0.444 |
Any major complication | 17.4 (6.84) | 16.63 (7.59) | 1.18 (0.6 to 2.32) p = 0.638 | 1.55 (0.67 to 3.57), p = 0.304 |
Decline in functional status of ≥10% | 17.66 (6.84) | 15.51 (6.98) | 1.58 (0.95 to 2.62) p = 0.076 | 1.23 (0.64 to 2.39), p = 0.532 |
Mean length of stay (days) | - | - | 0.33 (−0.88 to 1.53) p = 0.596 | 0.43 (−1.06 to 1.92), p = 0.569 |
Mean Barthel Index score (points) | - | - | −2.89 (−4.92 to −0.86) p = 0.005 | −2.44 (−4.94 to 0.06), p = 0.056 |
Long-term endpoints (180 days) | ||||
Mean EQ-5D VAS (points) | - | - | −2.91 (−7.42 to 1.6) p = 0.204 | −1.47 (−6.89 to 3.95), p = 0.592 |
Mean EQ-5D index (points) | - | - | −0.05 (−0.09 to −0.01) p = 0.013 | −0.04 (−0.09 to 0.01), p = 0.084 |
Incidence of one or more falls | 17.59 (6.84) | 13.56 (6.13) | 2.38 (1.14 to 4.95) p = 0.021 | 3.57 (1.36 to 9.41), p = 0.01 |
Male patients | ||||
Primary endpoint | ||||
180-day all-cause mortality | 29.33 (11.26) | 26.23 (9.79) | 1.32 (0.01 to 1.63) p = 2.69 | 1.59 (1.19 to 2.12), p = 0.002 |
Short-term endpoints (30 days) | ||||
All-cause mortality | 28.29 (10.73) | 26.38 (11.01) | 1.19 (0.25 to 1.61) p = 1.14 | 1.61 (1.09 to 2.38), p = 0.016 |
Adverse outcome | 28.54 (10.66) | 27 (10.96) | 1.15 (0.2 to 1.41) p = 1.28 | 1.18 (0.91 to 1.55), p = 0.218 |
Admission to the intensive care unit | 28.18 (10.77) | 19.67 (7.76) | 2.77 (0.05 to 7.73) p = 1.95 | 4.28 (0.83 to 22.16), p = 0.083 |
Non-elective hospital readmission | 27.92 (10.65) | 29.02 (11.78) | 0.91 (0.53 to 1.22) p = −0.62 | 0.79 (0.54 to 1.15), p = 0.217 |
Any major complication | 28.47 (10.83) | 23.09 (8.77) | 1.76 (0.01 to 2.71) p = 2.58 | 1.61 (0.95 to 2.73), p = 0.08 |
Decline in functional status of ≥10% * | 28.24 (10.47) | 27.14 (12.09) | 1.1 (0.45 to 1.42) p = 0.76 | 1.19 (0.86 to 1.66), p = 0.297 |
Mean length of stay (days) | - | - | 0.47 (0.17 to 1.15) p = 1.38 | 0.59 (−0.28 to 1.46), p = 0.182 |
Mean Barthel Index score (points) | - | - | −1.67 (0 to −0.69) p = −3.35 | −0.96 (−2.2 to 0.29), p = 0.132 |
Long-term endpoints (180 days) | ||||
Mean EQ-5D VAS (points) | - | - | −1.27 (0.39 to 1.63) p = −0.86 | −0.45 (−4.18 to 3.28), p = 0.813 |
Mean EQ-5D index (points) | - | - | −0.01 (0.47 to 0.01) p = −0.73 | 0 (−0.03 to 0.02), p = 0.810 |
Incidence of one or more falls | 28.42 (10.69) | 23.78 (10.67) | 1.61 (0.02 to 2.37) p = 2.4 | 1.29 (0.78 to 2.11), p = 0.32 |
Abbreviations: OR, odds ratio; Coef, coefficient; SD, standard deviation; EQ-5D, EuroQol Group 5-Dimension Self-Report Questionnaire; HGS, handgrip strength; VAS, visual analogue scale. * Adjusted for randomization, age, weight, height, NRS 2002, center, main diagnosis (cardiovascular, infection, renal disease, failure to thrive) and comorbidities (hypertension, chronic kidney failure, chronic heart failure, diabetes mellitus) and for randomization group.