title: The ethical challenges of a randomized controlled trial of involuntary outpatient commitment.
abstract: Involuntary outpatient commitment (OPC) is a civil justice procedure intended to enhance compliance with community mental health treatment, to improve functioning, and to reduce recurrent dangerousness and hospital recidivism. The research literature on OPC indicates that it appears to improve outcomes in rates of rehospitalization and length of stay. However, all studies to date have serious methodological limitations because of selection bias; lack of specification of target populations; unclear operationalization of OPC; unmeasured variability in type, frequency, and intensity of treatment; as well as other confounding factors. To address limitations in these studies, the authors designed a randomized controlled trial (RCT) of OPC, combined with community-based case management, which is now under way in North Carolina. This article describes ethical dilemmas in designing and implementing an RCT of a legally coercive intervention in community-based settings. These ethical dilemmas challenge the experimental validity of an RCT but can be successfully addressed with careful planning and negotiation.
authors.affiliation: Department of Psychiatry, Duke University Medical Center, Durham, NC 27710, USA.
authors.forename: M S
authors.initials: MS
authors.lastname: Swartz
authors.forename: B J
authors.initials: BJ
authors.lastname: Burns
authors.forename: L K
authors.initials: LK
authors.lastname: George
authors.forename: J
authors.initials: J
authors.lastname: Swanson
authors.forename: V A
authors.initials: VA
authors.lastname: Hiday
authors.forename: R
authors.initials: R
authors.lastname: Borum
authors.forename: H R
authors.initials: HR
authors.lastname: Wagner
mesh_terms: D000553:Ambulatory Care / Q000458:organization & administration; D035841:Behavioral Research; D015982:Bias; D019090:Case Management / Q000458:organization & administration; D003134:Commitment of Persons with Psychiatric Disorders; D003156:Community Mental Health Services / Q000458:organization & administration*; D015986:Confounding Factors, Epidemiologic; D004992:Ethics, Medical; D006302:Health Services Research / Q000379:methods / Q000592:standards; D006801:Humans; D028642:Persons with Psychiatric Disorders; D009657:North Carolina; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D015203:Reproducibility of Results; D035842:Research Subjects