Table 2.
Primary and secondary outcomes, assessed 3.5 years after inclusion in the OPUS II trial and five years after initiation of SEI intervention treatment
| Imputed and register data | ||||||
|---|---|---|---|---|---|---|
| No of participants | OPUS treatment | Treatment as usual | Estimated mean difference (95% CI) | Odds ratio (95% CI) | Pdifference | |
| Primary outcome | ||||||
| Negative dimension (mean (SD)) | 400 | 1.72 | 1.81 | −0.10 (−0.33 to 0.13) | — | 0.39 |
| Secondary outcomes | ||||||
| Psychotic dimension (mean (SD)) | 400 | 1.72 | 1.94 | −0.23 (−0.52 to 0.06) | — | 0.12 |
| Remission | 400 | 44 (22.3) | 44 (21.7) | — | 1.08 (0.65 to 1.80) | 0.76 |
| Suicidal ideation | 400 | 58 (29.4) | 69 (34.0) | — | 0.80 (0.50 to 1.30) | 0.37 |
| Substance abuse* | 400 | 33 (16.8) | 35 (17.2) | — | 0.95 (0.53 to 1.72) | 0.87 |
| Compliance with medical treatment† | 229 | 89 (83) | 97 (79) | — | 1.34 (0.61 to 3.0) | 0.47 |
| Client satisfaction (mean (SD)) | 400 | 27.0 | 24.4 | 2.57 (1.36 to 3.79) | — | <0.001 |
| No of months employed (mean (SD))‡ | 400 | 8.8 (14.1) | 9.0 (14.0) | −0.11 (−2.67 to 2.44) | — | 0.93 |
| No of bed days (mean per year (SD))‡ | 400 | 9.1 (21.9) | 11.8 (34.1) | −2.79 (−8.40 to 2.82) | — | 0.33 |
| Adherence to treatment§ | 319 | 142 (90.4) | 90 (55.6) | — | 8.6 (4.5 to 16) | <0.001 |
Data are number (%) of participants unless stated otherwise. OPUS treatment=psychosocial treatment programme (specialised early intervention) provided to all patients diagnosed with a schizophrenia spectrum disorder in Denmark, column named OPUS show participants randomised to five years of OPUS treatment; SD=standard deviation.
*Fulfilling criteria for harmful use or dependency syndrome diagnosed, ICD-10 (F1x.1 and F1x.2).
†Only analysed for participants receiving treatment with antipsychotic drugs.
‡Data based on registers and therefore not imputed.
§Outcome was operationalised as participants were still in contact with specialised psychiatric services at the time of follow-up interview. Data were obtained with a combination of registers and medical files, and therefore not imputed and only analysed for participants from Copenhagen.