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. 2022 May 25;17(5):e0268948. doi: 10.1371/journal.pone.0268948

Table 3. Comparison of quality-adjusted life years by trial arm, across all participants and stratified by prognostic group (multiple imputed data).

All participants (n = 1,868) p-value Minimal/mild (n = 1,357) p-value Moderate (n = 288) p-value Severe (n = 223) p-value
3 months
Mean QALYs (SE) 1
Intervention arm 0.147 (0.0006) 0.164 (0.0008) 0.112 (0.002) 0.089 (0.002)
Control arm 0.145 (0.0006) 0.163 (0.0008) 0.108 (0.001) 0.085 (0.002)
Difference in mean QALYs between arms (95% CI)1 0.002 (-0.0002 to 0.003) 0.09 0.0008 (-0.001 to 0.003) 0.47 0.004 (-0.001 to 0.008) 0.13 0.003 (-0.002 to 0.008) 0.22
Sensitivity analysis2 0.001 (-0.0004 to 0.003) 0.15 0.0007 (-0.001 to 0.003) 0.52 0.003 (-0.001 to 0.008) 0.16 0.003 (-0.002 to 0.008) 0.19
Sensitivity analysis3 0.001 (-0.0009 to 0.003) 0.27 -0.0002 (-0.003 to 0.002) 0.85 0.004 (-0.0008 to 0.009) 0.10 0.004 (-0.001 to 0.010) 0.17
12 months
Mean QALYs (SE) 1
Intervention arm 0.607 (0.004) 0.669 (0.005) 0.482 (0.011) 0.392 (0.012)
Control arm 0.596 (0.004) 0.661 (0.004) 0.465 (0.010) 0.367 (0.011)
Difference in mean QALYs between arms (95% CI)1 0.011 (0.001 to 0.022) 0.049 0.008 (-0.005 to 0.021) 0.23 0.016 (-0.014 to 0.047) 0.29 0.024 (-0.011 to 0.059) 0.18
Sensitivity analysis2 0.010 (-0.001 to 0.021) 0.09 0.00 (-0.006 to 0.020) 0.29 0.016 (-0.015 to 0.046) 0.32 0.024 (-0.010 to 0.059) 0.16
Sensitivity analysis3 0.015 (0.00004 to 0.030) 0.049 0.009 (-0.008 to 0.027) 0.32 0.048 (0.002 to 0.095) 0.04 0.013 (-0.034 to 0.059) 0.59

Abbreviations: QALYs = quality-adjusted life years; SE = standard error; CI = confidence interval

1 Baseline mean and the difference between the mean for the intervention arm minus the mean for control arm estimated using a generalised linear model (family = Gaussian, link = identity) with random intercepts for individuals and adjusted for baseline AQoL-8D utility weight, baseline PHQ-9 score, general practice and prognostic group (the final covariate only applied to the analysis involving all participants);

2 Same as 1, adjusted for factors associated with non-response to the primary outcome measure, the PHQ-9 score, at 3 and 12 months (age, gender, highest level of education, current employment status, hold a health care card, long-term illness, live alone, number of times visited a psychiatrist or counsellor in past 12 months and current use of antidepressants)

3 Same as 1, for complete cases only (i.e., no multiple imputation of missing data)