4. Outcomes prespecified and data available.
| Primary outcomes pre‐specified in review protocol | Data available (and section reported in results) |
| 1.1 Quality of life | |
| Clinically important change in quality of life (as defined by individual studies) (Y/N, binary outcome) at 12 months | |
| 1.1 Quality of life: clinically important change (average endpoint in mental health component) ‐ 12 months | |
| 1.2 Mental state | |
| Clinically important change in mental state (as defined by individual studies) (Y/N, binary outcome) at 12 months | 1.2 Mental state: clinically important change (binary) ‐ 12 months |
| 1.3 Psychiatric admissions | |
| Number of participants admitted to hospital (psychiatric admissions) at 12 months | 1.3 Psychiatric hospital admissions: number of participants admitted to hospital (12 months) |
| Secondary outcomes pre‐specified in review protocol | |
| 2.1 Quality of life | |
| Clinically important change in quality of life (as defined by individual studies) (Y/N, binary outcome) (time points other than 12 months) | |
| Clinically important change in quality of life at 12 months (as defined by individual studies) (Y/N, binary outcome) | |
| Any change in quality of life | |
| Average endpoint quality of life score | 2.1.6 Quality of life: overall endpoint (WHOQOL‐BREF) ‐ 6 months 2.1.7 Quality of life: overall endpoint (WHOQOL‐BREF) ‐ 12 months |
| Average change in quality of life scores | |
| No clinically important change in specific aspects of quality of life (as defined by individual studies) | |
| Any change in specific aspects of quality of life | |
| Average endpoint in specific aspects of quality of life scores | 2.1.1 Quality of life: average endpoint in physical health ‐ up to 6 months 2.1.2 Quality of life: average endpoint in physical health ‐ 12 months 2.1.3 Quality of life: average endpoint in physical health ‐ more than 12 months 2.1.4 Quality of life: average endpoint in mental health ‐ up to 6 months 2.1.5 Quality of life: average endpoint in mental health ‐ more than 12 months |
| Average change in specific aspects of quality of life scores | |
|
2.2 Mental state General and specific (including positive and negative symptoms of psychosis, and mood (as defined by individual studies) |
|
| Any change in mental state Average endpoint mental state Average change in mental state No clinically important change in mental state (as defined by individual studies) Any change in specific aspects of mental state Average endpoint in specific aspects of mental state Average change in specific aspects of mental state |
2.2.1 Mental state (overall general score) up to 6 months 2.2.2 Mental state (general psychopathology) up to 6 months 2.2.3 Mental state (general psychopathology) at 12 months 2.2.4 Mental state (positive symptoms) up to 6 months 2.2.5 Mental state (positive symptoms) at 12 months 2.2.6 Mental state (negative symptoms) up to 6 months 2.2.7 Mental state (negative symptoms) at 12 months 2.2.8 Mental state (depressive symptoms) up to 6 months 2.2.9 Mental state (depressive symptoms) at 7 to 12 months 2.2.10 Mental state (depressive symptoms) at 24 months 2.2.11 Mental state (manic symptoms) up to 6 months 2.2.12 Mental state (manic symptoms) at 7 to 12 months 2.2.13 Mental state (manic symptoms) greater than 12 months |
| 2.3 Psychiatric admissions | |
| Number of participants admitted to hospital (psychiatric admissions) greater than 12 months | 2.3.1 Number of participants admitted to hospital (year 2) |
| 2.3.2 Number of participants admitted to hospital (year 3) | |
| Mean number of days in hospital for psychiatric admissions | |
| Length of time to readmission (psychiatric admissions) | |
| 2.4 Other hospital admissions | |
| Number of participants admitted to hospital (physical health admission) | 2.4.1 Number of participants admitted to hospital (up to 12 months) 2.4.2 Number of participants admitted to hospital (in year 2) 2.4.3 Number of participants admitted to hospital (in year 3) |
| Mean number of days in hospital for physical health admissions | |
| Length of time to readmission (physical health admissions) | |
| 2.5 Personal recovery | 2.5 No data available |
| Clinically important change in personal recovery (as defined by individual studies) (Y/N, binary outcome) | |
| Any change in personal recovery | |
| Average endpoint personal recovery score | |
| Average change in personal recovery scores | |
| No clinically important change in specific aspects of personal recovery (as defined by individual studies) | |
| Any change in specific aspects of personal recovery | |
| Average endpoint in specific aspects of personal recovery scores | |
| Average change in specific aspects of personal recovery scores | |
| 2.6 Physical health status (including specific measures of blood pressure, blood cholesterol, blood glucose ‐ HbA1c, body mass index (BMI) | |
| Clinically important change in physical health status (as defined by individual studies) Any change in physical health status score Average endpoint physical health status score Average change in physical health status score |
2.6.1 Blood pressure, mmHg systolic ‐ up to 6 months 2.6.2 Blood pressure, mmHg systolic ‐ at 7 to 12 months 2.6.3 Blood pressure, mmHg systolic ‐ 24 months 2.6.4 Blood pressure, mmHg diastolic ‐ 6 months 2.6.5 Blood pressure, mmHg diastolic ‐ 7 to 12 months 2.6.6 Blood pressure, mmHg diastolic ‐ 24 months 2.6.7 Body mass index (BMI) ‐ 6 months 2.6.8 Body mass index (BMI) ‐ 12 months 2.6.9 Body mass index (BMI) ‐ 24 months 2.6.10 Total cholesterol ‐ 6 months 2.6.11 Total cholesterol ‐ 12 months 2.6.12 Total cholesterol ‐ 24 months 2.6.13 Triglycerides ‐ up to 6 months 2.6.14 High‐density lipoprotein (HDL) ‐ 6 months 2.6.15 High‐density lipoprotein (HDL) ‐ 12 months 2.6.16 High‐density lipoprotein (HDL) ‐ 24 months 2.6.17 Low‐density lipoprotein (LDL) ‐ 6 months 2.6.18 Low‐density lipoprotein (LDL) ‐ 12 months 2.6.19 Low‐density lipoprotein (LDL) ‐ 24 months 2.6.20 HbA1c ‐ up to 6 months 2.6.21 Waist circumference ‐ 6 months 2.6.22 Waist circumference ‐ 12 months 2.6.23 Waist circumference ‐ 24 months |
| 2.7 Global state | 2.7 No data available |
| Relapse (as defined by individual studies) | |
| Time to relapse | |
| Clinically important change in global state (as defined by individual studies) | |
| Any change in global state | |
| Average endpoint global state score | |
| Average change in global state score | |
| 2.8 ‐ 2.9 Medication adherence | |
| Clinically important change in compliance (patient‐reported) Any change in compliance (patient‐reported) Clinically important change in compliance (carer‐reported) Any change in compliance (carer‐reported) |
2.8 Medication adherence (patient‐reported) (DAI‐10) 2.8.1 Medication adherence (patient‐reported) at 6 months 2.8.2 Medication adherence (patient‐reported)at 12 months 2.9.1 Medication adherence (patient‐reported) ‐ up to 6 months |
| 2.10 ‐ 2.11 Social functioning | |
| Clinically important change in social functioning (as defined by individual studies) Any change in social functioning Average endpoint social functioning score Average change in social functioning scores |
2.10.1 Social functioning/disability (binary) ‐ 12 months 2.11.1 Social functioning/disability ‐ up to 6 months 2.11.2 Social functioning/disability ‐ 12 months 2.11.3 Social functioning/disability ‐ 24 months |
| Employment status | |
| Living tenure (number of participants homeless, in unstable housing or living independently) | |
| 2.12 Substance use (alcohol/illicit drugs/cigarettes/tobacco) | 2.12 No data available |
| Clinically important change in substance use (as defined by individual studies) | |
| Any change in substance use | |
| Average endpoint substance use | |
| Average change in substance use | |
| 2.13 Adverse effect/event(s) | 2.13 No data available |
| At least one adverse effect | |
| Incidence of specific effect (e.g. cardiovascular, metabolic, movement disorders) | |
| 2.14 Death | |
| Number of participants who died from suicide | 2.14.1 Number of participants that died from suicide (36 months) 2.12.3 Number of participants that died from suicide (12 months) |
| Number of participants who died from natural causes | 2.14.2 Number of participants that died from natural causes (36 months) 2.14.4 Number of participants that died from natural causes (6 months) |
| 2.14.5 Number of participants that died (all causes) (12 months) | |
| 2.15 Service use outside of mental health (i.e. primary care, emergency services, walk‐in centres, social services) | 2.15 No data available |
| Mean number of contacts per month | |
| Number of participants in contact with service | |
| Mean number of service hours per month | |
| 2.16 ‐ 2.17 Cost of treatment | |
| Direct cost of inpatient care | |
| Direct cost of health and social care (including the above, plus the costs of all other medical and psychiatric care, such as: outpatient care and specialist service, collaborative care and community‐based social services) | |
| Total costs, including types of costs above, plus the costs of accommodation and minus benefits, such as earnings where these are known | 2.16.1 Cost of treatment (USD 1000) ‐ at 36 months 2.17 Cost of treatment (international dollars (Int$)) up to 12 months |
| 2.18 Experience of care/satisfaction (participant/carer/staff) | 2.18 No data available |
| Clinically important change in experience of care/participant, carer and staff satisfaction (as defined by individual studies) | |
| Any change in experience of care/participant, carer and staff satisfaction | |
| Average endpoint experience of care/participant, carer and staff satisfaction score | |
| Average change in experience of care/participant, carer and staff satisfaction score | |
| 2.19 Leaving the study early (attrition) | |
| For any reason | 2.19.1 Attrition/leaving the study early (lost to follow‐up 6 months) 2.19.2 Attrition/leaving the study early (lost to follow‐up 12 months) 2.19.3 Attrition/leaving the study early (lost to follow‐up at 24 months) 2.19.4 Attrition/leaving the study early (lost to follow‐up at 36 months) |
| For specific reason |