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. 2020 Jul 7;324(1):47–56. doi: 10.1001/jama.2020.8556

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.

a

Column includes adjusted mean difference, adjusted OR, and adjusted IRR values and 95% CIs (indicated as mean, OR, and IRR).

a

Column includes adjusted mean difference, adjusted OR, and adjusted IRR values and 95% CIs (indicated as mean, OR, and IRR).

b

Responses by proxy were completed by relatives, consultees, (or the legal representative or guardian) on behalf of participants without capacity to self-report.

c

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).

d

Indicates transformed outcome (power of 2).

e

ICECAP-O score ranges from 0 to 1 (higher score indicates higher capability).

f

Analysis for this category included 152 participants in the probiotic group and 153 in the placebo group.