Rosenheck 2011.

Methods	Allocation: random. Blinding: single (rater). Duration: 2 years. Design: parallel. Setting: multi‐centre, 14 Veteran Affairs (VA) medical centres, inpatient, USA.
Participants	Diagnosis: schizophrenia or schizoaffective disorder (DSM‐IV). N = 382. Age: ≥ 18 years of age. Sex: not stated. History: 64% participants reported problems with medication adherence in past (43% patient‐reported, and 60% physician‐reported); 37% participants reported active problems with alcohol or drug use (25% patient‐reported, and 36% physician‐reported). Included: at risk of hospitalisation as evidenced by current hospitalisation; hospitalisation in the previous 2 years, or increased use of services to prevent relapse. Excluded: detoxification in the previous month; past intolerance to risperidone or IM injections; current treatment with long‐acting injectable antipsychotics; oral clozapine, warfarin or a combination of those agents; serious medical conditions; unstable living arrangements; and a history of assault or suicidal behavior requiring urgent intervention. Consent: guardian or participant consent permitted; participants' decisional capacity assessed with MacArthur Competence Assessment Tool.
Interventions	1. Risperidone depot: 25 mg to 50 mg every 2 weeks; dosage increments of 12.5 mg permitted every 4 weeks at discretion of treating physician, n = 190. 2. Oral antipsychotics: as prescribed by treating physician, n = 192*.
Outcomes	Service utilisation: hospitalisation; outpatient care. Global state: use of benzodiazepines or sedative drugs. Adverse events: death; other specific events. Not receiving allocation study medication. Leaving the study early: any reason. Unable to use ‐ Global state: CGI (follow‐up rates less than 50%). Metal State: Total PANSS score and Positive, negative and general subscale (follow‐up rates less than 50%). Quality of life: Heinrichs‐Carpenter Quality of Life Scale, Personal and Social Performance scale (PSP), Quality of well being scale (follow‐up rates less than 50%). Adverse events: BARS; Abnormal involuntary movements rating scale; Simpson and Angus rating scale for extrapyramidal side effects (follow‐up rates less than 50%).
Notes	*Concomitant psychotropic medication (anti‐anxiety, anti‐depressants, oral antipsychotics and mood stabilisers, as well as anticholinergic medications were permitted.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomly permuted blocks of various size, centrally conducted and stratified according to site.
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding (performance bias and detection bias) All outcomes	High risk	Single blind (implied). Blinded video conference assessment for some measures, but others assessed in unblinded meetings.
Incomplete outcome data (attrition bias) All outcomes	High risk	Of n = 382 randomised, n = 237 completed the study; including n = 75 oral antipsychotic treatment (n = 7 declined participation and did not receive intervention; n = 65 'lost to follow‐up or discontinued'; n = 3 excluded because participant did not have a Social Security number or baseline data), and n = 74 in risperidone depot group (n = 2 declined participation and did not receive intervention; n = 71 'lost to follow‐up or discontinued'; n = 1 excluded because participant did not have a Social Security number or baseline data). ITT analysis used ‐ follow‐up rates in this analysis group included n = 223 (60%) at year 1; n = 170 (46%) at 18 months; n = 107 (29%) at 24 months. Of the deaths, in the risperidone group, n = 1 died in his sleep and n = 1 took his own life; in the oral antipsychotic group, n = 1 died from chronic obstructive pulmonary disease and n = 1 from accidental drowning.
Selective reporting (reporting bias)	Low risk	Supplemental pages cover all outcomes.
Other bias	Unclear risk	Industry funded study but stated that Janssen had no involvement beyond financial and intervention drug provision.

AIMS: Abnormal Involuntary Movement Scale
 BARS: Barnes Akathisia Rating Scale
 BMI: body mass index
 CGI: Clinical Global Impression
 CNS: central nervous system
 DSM‐IV: Diagnostic and Statistical Mannual version 1V
 EPS: extrapyramidal symptoms
 ESRS: Extrapyramidal Symptom Rating Scale
 GAF: Global Assessment of Functioning
 IM: intramuscular
 ITT: intention to‐treat
 LOCF: last observation carried forward
 N =: number of participants
 NMS: neuroleptic malignant syndrome
 PANSS: Positive And Negative Symptom Scale
 PP: paliperidone palmitate
 PSP: Personal and Social Performance Scale
 RIS‐LAI: risperidone long‐acting injectable
 SAFS: Social and Functioning Assessment Scale
 SAS: Simpson and Angus Rating scale
 SD: Standard Deviation
 SF36: short form 36
 SGA: Second‐generation antipsychotic
 SOFAS: Social and Occupational Functioning Assessment Scale
 UKU:Udvalg for Kliniske Undersgelser side effects rating scale