Real-life decision making of Serious Mental Illness patients: Opt-in and opt-out research participation.

Background: Patients' decisions in relation to participation in clinical research depend on individual values and relevant outcomes. Presenting possible decisions by way of defaults (opt-in or opt-out) has been used to achieve desired outcomes. Our objective was to characterize patients willing to participate in clinical research and to assess the impact of defaults on patients with Serious Mental Illness (schizophrenia, schizoaffective disorder, major depression and bipolar disorder; SMI) during the decision process.

Methods: Patients with SMI were requested to accept or reject participation in a novel drug treatment study using either the (1) opt-in condition, wherein they were told that our center's policy is not to include them in drug studies; (2) the opt-out condition, wherein they were told that our center's policy is to include them in drug studies; and the (3) neutral condition that required patients to state their preference with no prior information.

Results: 311 patients with SMI completed the brief questionnaire within 48 hours of admission to a psychiatric ward. There were 227 (73%) patients suffering from schizophrenia and schizoaffective disorder, 40 (13%) suffering from bipolar disorder and 44 (14%) suffering from major depressive disorder. There were 156 men (50%) and 155 women in the sample, mean age 47.8±16.2 years. In the opt-in condition, 58% abstained, while 42% opted-in (p=0.003). In the opt-out condition, 58% participated, while 42% opted-out. In the neutral condition 51% indicated willingness to participate, 33% refused and 16% were undecided. The "willing" patient was characterized by younger age, previous hospitalizations, affective illness and more comorbid physical disorders.

Conclusion: Taken together these findings reveal the "profile" of patients with SMI willing to participate in clinical research and demonstrate an increase in participation preferences through the use of defaults.