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. 2016 Apr 14;2016(4):CD004161. doi: 10.1002/14651858.CD004161.pub2

Covell 2012.

Methods Allocation: random.
Blinding: open‐label, blinded clinical raters.
Duration: 6 months (+ 6 months naturalistic follow‐up).
Design: parallel.
Setting: National Institute of Mental Health Schizophrenia Trials Network and five sites in Conneticut's public mental health system, USA.
Participants Diagnosis: schizophrenia (DSM‐IV).
Age: ≥18 years, mean age 48 yrs (risperidone depot: 48.5 ± 12.2; haloperidol/fluphenazine depot: 47.3 ± 9.1).
N = 62.
Sex: 44 M (22 in each group), 18 F.
History: currently taking fluphenazine decanoate or haloperidol decanoate, "may benefit from changing medication" and "willing to change", able to afford own medication, at least one 3‐monthly clinic visit in past 6 months.
Included: eligible patients were those who might benefit from switching to risperidone microspheres (with sub‐optimal response to treatment because of persistent psychopathology or significant side effects); people where change in medical opinion was a reasonable clinical opinion, but not required; willingness to change antipsychotic medication; access to medication without financial burden; at least 1 clinic visit every 3 months for past 6 months.
Excluded: symptom severity indicating immediate change; exacerbation in previous 3/12; pregnancy; pending criminal charges; non‐independent living; antipsychotic polypharmacy.
Consent and ethics: written informed consent after thorough description of the study to participants and assessment of understanding consent materials.
Interventions 1. Risperidone depot: 25, 37.5 or 50 mg/ 2 weeks, n = 32.
2. Haloperidol decanoate OR fluphenazine*, n = 30.
*No data on dosages actually prescribed in this arm ‐ "clinician's judgement".
Outcomes Primary ‐ time to all‐cause treatment discontinuation.
Mental state: PANSS (completer‐only).
Hospitalisation by 6 months.
Adverse events: Arizona Sexual Experiences Scale; weight; prolactin (completer‐only, skew data).
Unable to use ‐
AIMS (adapted scale used).
Subjective Side‐effect Rating Scale (no data reported).
EPS (SAS); tardive dyskinesia (incomplete data for all participants ‐ only 44% accounted for).
Tardive dyskinesia (more than 50% participants did not complete assessment).
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised, quote, "stratified by gender and baseline decanoate. No exceptions were made to the predetermined randomisation streams" (p670).
Allocation concealment (selection bias) Unclear risk No details given of how this was achieved. Quote, "eligible patients were those who might benefit from a switch to risperidone microspheres" (p670).
Blinding (performance bias and detection bias) 
 All outcomes High risk Open‐label study with assessment by blinded clinical raters.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Data relating to loss to follow‐up are given and overall attrition is < 50%. Lost to follow‐up n = 8: reasons for discontinuation included increase in psychiatric symptoms (n = 4), EPS concerns (n = 1), participant preference (n = 2), hypertension and weight gain (n = 1). However, not all participants completed continuous outcome measures; LOCF carried forward used in primary study citation, completer‐only data provided with means and SD for additional requested information (unpublished).
Selective reporting (reporting bias) High risk Not all data reported, including means and SDs for most continuous outcomes.
Other bias Unclear risk Funding: quote, "research presented in this article was funded by the National Institute of Mental Health grant number MH71663 and MH59312." One author (Schooler) "has previously received grant/research support from... Janssen‐Cilag, and Johnson & Johnson."