Table 3.

Summary of outcome measures

Outcome	Instrument
Psychiatric nurse-administered interview with patient
Symptom severity	Brief Psychiatric Rating Scale – Expanded version (BPRS- E) [62]. A 24-item instrument focussing on psychotic symptoms, but also covering somatic concerns, anxiety, depression and mania. Individual BPRS-E items and total score are sensitive to change in persons with persistent schizophrenia [63]. The scale has been previously used in Ethiopia [64] and has recently been shown to have good inter-rater reliability (>0.8 comparing psychiatric nurses and psychiatrists) in this setting (personal communication, Dr Charlotte Hanlon) [65]. As the scale is clinician-rated this allows for sociocultural sensitivity. Inter-rater and test-retest reliability as well as internal consistency are also high in high-income settings [66]
Clinical impression	Clinical Global Impression (CGI). A widely used assessment tool, comprising three scales, to determine overall illness severity and efficacy of intervention [67]
Relapse	Life Chart Schedule (LCS) including course type and relapses [68].
	Longitudinal Interval Follow-up Evaluation: DSM-IV version (LIFE). A semi-structured interview to determine the subject’s psychiatric course since the last interview [69]. Satisfactory validation has been conducted in Ethiopia and the reliability data is currently being analysed. Any necessary adjustments will be made on the basis of the inter-rater reliability assessments (personal communication, Dr Girmay Medhin)
Lay data collector-administered interview with the patient
Disability	Patient-reported 36-item WHODAS (Disability Assessment Schedule) 2.0 [55].
	A validated indigenous functioning scale, specific to the Ethiopian context [70]
Economic activity	Measure covering current employment, subsistence farming work, income, and hunger due to lack of resources
Discrimination	Section 1 of the Discrimination and Stigma Scale-12 (DISC-12) [71]
Medication adherence	Adapted Morisky Medication Adherence Scale (MMAS) [72]. This scale has previously been utilised for antipsychotic medication adherence [31, 73]. Good construct validity has been demonstrated in Ethiopia (personal communication, Dr Charlotte Hanlon) [65]).
	A 5-point nominal scale measuring frequency of adherence [31]
Health service use and costs including engagement with FBC for schizophrenia and physical health conditions	An adapted version of The Client Service Receipt Inventory (CSRI) will enquire systematically about the costs (direct and indirect) of help-seeking from biomedical, traditional and religious healers [74, 75]. The CSRI has been translated into Amharic and found to be acceptable and feasible [76]
Access to community interventions (including CBR components)	Including person administering the component, and satisfaction
Physical restraint	In the preceding 1 and 6 months. Includes assessment of duration, perpetrator, setting and reason for restraint
Nutritional status	Measurement of weight (kg) and height (m) will be carried out [77] and body mass index (weight in kg/(height in m)2) calculated
Depression	The Patient Health Questionnaire- 9 (PHQ-9). A 9-item scale which scores each of the 9 DSM-IV criteria for depressive disorders as ‘0’ (not at all) to ‘3’ (nearly every day) [78]. Shown to be valid in the Ethiopian setting [79]
Alcohol use disorder	The AUDIT (Alcohol Use Disorders Identification Test) is a ten-item tool to detect hazardous drinking [80]
Social support	Oslo-3 Social Support Scale [81]
Serious adverse events	Occurrence of serious adverse events (for example, suicide attempt and hospitalisation for medical emergency) in the last 6 months
Lay data collector interview with the primary caregiver
Patient disability	The 36-item WHODAS 2.0 proxy version will assess functional impairment from the caregiver’s perspective [82, 83]
Economic activity of caregiver	Employment, subsistence farming work, income, and hunger due to lack of resources
Caregiver burden	The Burden Section of the WHO ‘Family Interview Schedule’. This scale, covering financial strain and work difficulties has been previously used in Ethiopia for persons with schizophrenia [2].
	A scale developed for PRIME will quantify the time burden of caring for their relative with schizophrenia, the type of work that was stopped or reduced and the amount of money lost. The Involvement Engagement Questionnaire (IEQ) will be used as an additional measure to assess caregiver burden.
Caregiver depression	PHQ-9 [78, 79]
Stigma	Section of the WHO ‘Family Interview Schedule’; previously used in Ethiopia [8]
Patient medication adherence	The 5-point nominal scale developed for the COPSI study will be used [31]

CBR community-based rehabilitation, DSM-IV Diagnostic and Statistical Manual of Mental disorders, version four, FBC facility-based care