Melle 2008.
| Methods | Controlled clinical trial started on 1 January 1997 with patient recruitment continuing to 31 December 2000. Patients diagnosed in intervention areas were followed up at 3 months, 1 year and 2 years after diagnosis. Collaborating partners Lead agency: Mental health. Strategic involvement (policy making and service planning): Secondary health care. Commissioning (implementing strategy taking account of resources available): Secondary health care and the Local Education Authority. Operational (providing services directly): Secondary health care, social services and the Local Education Authority. Intervention set in Norway and control areas in Norway and Denmark. |
|
| Participants | Patients aged 18‐65 years from four catchment areas (total population of 665,000) in Norway and Denmark, diagnosed with first‐episode psychosis and meeting a range of inclusion criteria including DSM‐IV diagnosis of psychotic disorder and IQ higher than 70. 380 people met the inclusion criteria (186 from Early Detection (ED) intervention area and 194 from the control areas). 281 agreed to participate (74% of all eligible patients, 141 in ED area, 140 in non‐ED area). Male 69% (intervention), 66% (control) Mean age at study entry 26.4 (intervention) 30.7 (control). |
|
| Interventions | Mental health clinicians, nurses, psychologists, GPs, school staff and social workers delivered the Early Detection Programme, which consisted of two approaches. Two specialist teams integrated into the ordinary outpatient units, providing rapid assessment of first episode patients, and raising awareness through visiting schools, working with GPs and the media. Community information campaigns about mental health directed at schools and the general population and general practitioners. Use was made of postcards, flyers, and car stickers and a booklet was sent to all the households. |
|
| Outcomes | Primary outcome was to reduce the duration of untreated first episode psychosis. Secondary outcomes included assessment of symptom levels through the PANSS scores and level of functioning through the Global Assessment of Functioning scores. |
|
| Notes | Power calculations suggested they required 100 participants in each group, which they achieved. Joa paper in Schizophrenia Bulletin 34, 466 ‐ 472, 2008 looked at position after information campaign had ceased. Authors note possibility of assessment bias as clinical ratings of PANSS interviews were not masked. Additional resources would be required to replicate this service. Overall risk of bias was medium |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | High risk | Not clear if participants were aware at recruitment |
| Blinding (performance bias and detection bias) All outcomes | High risk | Clinical assessments for symptoms and function were not performed blind. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All available data appears to be presented. |
| Selective reporting (reporting bias) | High risk | There is full reporting of the outcomes they claimed to have measured but the study is due to run for up to 10 years. Data is reported for here only for the 2 year follow‐up. Joa paper reported on 2 cohorts1997‐2000 and 2000‐2004. |
| Other bias | High risk | Different reports of the same work have different age groups for the subjects (15 ‐ 65 in Johannessen, 16 ‐ 65 in Melle 2005, 18 ‐ 65 in Melle 2004). Also, there may be differences in disease severity between people identified early and people identified late with psychosis. Those identified early may have less severe underlying disease and be more likely to make good progress on treatment. |
| Randomisation adequately described/protected? | High risk | Not randomised |
| Protection against contamination? | Low risk | Intervention delivered in discrete geographical areas |
| Follow‐up rate adequate? | Low risk | Rate > 60% and balanced across both arms (Melle 2004 pg. 145 Table 2) |
| Reliable primary outcome measure? | Low risk | Stated in the Johannessen paper page 41, to reduce duration of untreated psychosis and therefore improve course and outcome of illness. |
| Groups measured at baseline? | Low risk | Groups approximately balanced |
| Appropriate choice of controls (CBA studies only)? | Unclear risk | Not applicable |
| Contemporaneous data collection (CBA studies only)? | Unclear risk | Not applicable |
| IS THE STUDY AT LOW RISK OF BIAS? | High risk | OVERALL RISK OF BIAS WAS MEDIUM |