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Table 3 Efficacy outcomes

From: Improving adherence in mental health service users with severe mental illness in South Africa: a pilot randomized controlled trial of a treatment partner and text message intervention vs. treatment as usual

Outcome n % Risk ratio (ITT) p value 95% CI
Unadjusted
(n = 77)
Adjusteda
(n = 77)
Intention-to-treat analysis (ITT): non-adherence to first clinic visit, re-admission over 9 months
 Non-adherence to first clinic appointment
  Intervention (n = 42) 14 33.3 0.72 0.79 0.419 0.44 to 1.39
  Treatment as usual (n = 35) 16 45.7
 Any re-admission over 9 months
  Intervention (n = 42) 5 11.9 0.83 0.86 0.713 0.39 to 1.87
  Treatment as usual (n = 35) 5 14.3
Outcome Complete case analysisc (intervention vs. TAU) ITT (intervention vs. TAU)
Mean differenced p value 95% CI Mean differencee (n = 77) p value 95% CI
Unadjusted Adjusted Unadjusted Adjusted
Complete case and intention to treat analysis (ITT) of other efficacy outcomes at 3 months
 PANSS score
  Total score − 9.4 − 14.7 0.052 − 29.71 to 0.16 − 13.4 − 13.1 0.062 − 27.00 to 0.73
  Positive subscale − 3.8 − 6.4 0.011 − 11.20 to 1.60 − 5.6 − 5.4 0.060 − 11.16 to 0.25
  Negative subscale − 2.6 −4.4 0.059 − 8.99 to 0.18 − 3.5 − 3.5 0.078 − 7.52 to 0.43
  General subscale − 2.8 − 3.9 0.350 − 12.6 1 to 4.68 − 4.4 − 4.2 0.248 − 11.67 to 3.19
 MARS − 0.21 − 0.75 0.425 − 2.68 to 1.17 0.36 0.49 0.603 − 1.44 to 2.43
 CGI − 0.8 − 0.58 0.346 − 1.84 to 0.67
 GAF 7.5 4.1 0.440 − 6.90 to 15.17
 CAN     
  Total needs
  Unmet needs − 3.2 − 3.6 0.029 − 6.74 to 0.49
  Met needs
EUROQUEL-VAS 16.1 15.2 0.124 − 4.59 to 34.99
  1. aLog-Poisson regression model with robust variance estimation, ITT; adjusted for age, sex, substance use disorder, baseline scores of PANSS total score, GAF score, MARS, EUROQUEL VAS scale, CAN unmet needs score
  2. bLog-Poisson regression model with robust variance estimation, ITT; sex dropped from model, adjusted for adjusted for age, substance use disorder, baseline scores of PANSS total score, GAF score, MARS, EUROQUEL VAS scale, CAN unmet needs score. Baseline data were imputed
  3. cMultiple linear regression models adjusted for age, sex, substance use disorders, baseline scores of PANSS total score, GAF, EUROQUEL, MARS, CAN unmet needs. Models with violation of linear regression assumptions omitted
  4. dSample size varied due to list-wise deletion
  5. eOnly models for which missing data < 55% are reported