Table 3. Between-Group Differences for Secondary Outcome Measures.
Secondary analysis | Probiotic (n = 155) | Placebo (n = 155) | Absolute difference (95% CI) | Adjusted difference (95% CI)a | P value |
---|---|---|---|---|---|
3-mo EQ-5D index valueb,c | |||||
Self-report, mean (SD) [No.] | 0.6 (0.3) [49] | 0.6 (0.2) [43] | 0 (–0.1 to 0.2) | Mean, –0.1 (–0.1 to 0) | .13 |
Proxy, mean (SD) [No.] | 0.5 (0.3) [130] | 0.5 (0.3) [129] | 0 (–0.1 to 0.1) | Mean, 0 (–0.1 to 0) | .66 |
3-mo EQ-5D health statusb,c | |||||
Self-report, mean (SD) [No.] | 65 (18.3) [44] | 65 (20.6) [42] | 0.1 (–8.1 to 8.3) | Mean, –0.3 (–8.0 to 7.5) | .95 |
Proxy, mean (SD) [No.] | 71 (19.1) [128] | 70 (20.6) [130] | 0.4 (–4.4 to 5.2) | Mean, 0.4 (–4.1 to 4.8) | .87 |
Second follow-up EQ-5D index valueb,c | |||||
Self-report, mean (SD) [No.] | 0.6 (0.4) [38] | 0.6 (0.3) [31] | 0 (–0.2 to 0.2) | Mean, 0 (–0.1 to 0.1) | .92 |
Proxy, mean (SD) [No.] | 0.5 (0.3) [97] | 0.5 (0.3) [95] | 0 (0 to 0.1) | Mean, 0 (–0.1 to 0.1) | .79 |
Second follow-up EQ-5D health statusb,c | |||||
Self-report, mean (SD) [No.] | 65 (21.4) [34] | 66 (21.5) [29] | 0.5 (–10.1 to 11.1) | Mean, 24.4 (–1267.9 to 1316.6)d | .97 |
Proxy, mean (SD) [No.] | 65 (21.8) [98] | 64 (21.0) [96] | 0.6 (–5.4 to 6.6) | Mean, 0.6 (–4.9 to 6.2) | .82 |
3-mo ICECAP-O valuee | |||||
Self-report, mean (SD) [No.] | 0.7 (0.2) [47] | 0.7 (0.2) [40] | 0 (–0.1 to 0.1) | Mean, –0.1 (–0.1 to –0) | .05 |
Proxy, mean (SD) [No.] | 0.7 (0.2) [117] | 0.7 (0.2) [118] | 0 (0 to 0.1) | Mean, 0 (0 to 0) | .85 |
Second follow-up ICECAP-O valuee | |||||
Self-report, mean (SD) [No.] | 0.7 (0.3) [35] | 0.7 (0.2) [27] | 0.1 (–0.1 to 0.2) | Mean, –0.1 (–0.2 to 0) | .15 |
Proxy, mean (SD) [No.] | 0.7 (0.2) [84] | 0.7 (0.2) [90] | 0 (–0.1 to 0.1) | Mean, 0 (–0.1 to 0) | .69 |
No. ever hospitalized/total No. (%) | 42/152 (27.6) | 36/153 (23.5) | 0 (–0.1 to 0.1) | OR, 1.25 (0.74 to 2.11) | .41 |
Death, No. (%) | 33 (21.3) | 32 (20.6) | 0 (–0.1 to 0.1) | OR, 1.03 (0.59 to 1.80) | .90 |
No. of hospital stays, mean (SD)f | 0.4 (0.7) | 0.3 (0.6) | 0.08 (–0.06 to 0.22) | IRR, 1.17 (0.72 to 1.90) | .53 |
Cumulative No. of hospital days, mean (SD)f | 4.5 (12.5) | 5.4 (19.4) | 0.9 (–2.77 to 4.57) | IRR, 1.00 (0.43 to 2.29) | >.99 |
Incidence of antibiotic-associated diarrhea, mean (SD)f | 0.8 (2.0) | 0.6 (1.8) | 0.2 (–0.16 to 0.50) | IRR, 1.39 (0.79 to 2.46) | .25 |
Cumulative days of antibiotic-associated diarrhea, mean (SD)f | 6.8 (22.3) | 4.4 (16.1) | 2.4 (–2.00 to 6.71) | IRR, 1.83 (0.95 to 3.54) | .07 |
Incidence of all-cause diarrhea, mean (SD)f | 1.8 (3.9) | 1.6 (3.5) | 0.2 (–0.6 to 1.1) | IRR, 1.1 (0.7 to 1.6) | .80 |
Cumulative days of all-cause diarrhea, mean (SD)f | 4.4 (10.2) | 4.4 (10.8) | 0 (–2.3 to 2.4) | IRR, 1.2 (0.78 to 2.0) | .39 |
≥1 All-cause diarrhea episode, No./total No. (%) | 64/152 (42.1) | 61/153 (39.9) | 0 (–0.1 to 0.1) | OR, 1.0 (0.6 to 1.8) | .89 |
Mean duration of diarrhea episodes for those with ≥1 episode, mean (SD), No. of persons | 1.4 (0.6) [64] | 1.4 (0.6) [61] | 0.1 (–0.1 to 0.3) | Mean, 0.1 (–0.1 to 0.2) | .27 |
Abbreviations: EQ-5D-5L, EuroQol Group 5-Dimension Self-Report; ICECAP-O, Icepop Capability Measure for Older People; IRR, incidence rate ratio; OR, odds ratio.
Column includes adjusted mean difference, adjusted OR, and adjusted IRR values and 95% CIs (indicated as mean, OR, and IRR).
Column includes adjusted mean difference, adjusted OR, and adjusted IRR values and 95% CIs (indicated as mean, OR, and IRR).
Responses by proxy were completed by relatives, consultees, (or the legal representative or guardian) on behalf of participants without capacity to self-report.
EQ-5D index values range from −0.594 to 1 (higher score indicates better health utility), and EQ-5D health status values range from 0 to 100 (higher score indicates better overall health).
Indicates transformed outcome (power of 2).
ICECAP-O score ranges from 0 to 1 (higher score indicates higher capability).
Analysis for this category included 152 participants in the probiotic group and 153 in the placebo group.