Schizophrenia Trial Participation: Perceived Inclusion Barriers and Beliefs about Antipsychotics

 

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Abstract

Background: Patient recruitment is the universal rate-limiting factor for randomized controlled trials (RCTs) in all medical specialties. This study examined the opinions on perceived inclusion barriers and beliefs about antipsychotics of a group of psychiatrists participating in a pragmatic RCT on antipsychotic drugs in schizophrenia (the GiSAS trial).

Methods: A survey of all clinicians working in the trial recruiting centers was performed exploring factors associated to the respondents’ opinions.

Results: Of 465 clinicians, 278 (59.8%) responded to the questionnaire. Respondents (n=278) were mainly influenced by clinical and trial-related barriers (89%). Factors such as work setting and antipsychotic prescription choices appeared to be related to perceived inclusion barriers. Most respondents believed in the superiority of SGAs (62.9%), one-third indicating drug company representatives as the most important source of information; this was related to further optimism towards SGAs.

Conclusions: Respondents were affected mainly by system-related barriers, whereas personal barriers were given less weight. The influence of industry-mediated information could have affected opinions on SGAs and the lack of uncertainty about antipsychotics attitudes towards trial participation.

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Correspondence

Dr. A. Parabiaghi

Epidemiology and Social

Psychiatry Unit

‘Mario Negri’ Institute for

Pharmacological Research

Via La Masa 19

20156 Milan

Italy

Phone: +39/02/3901 4602

Fax: +39/02/3901 4300

Email: alberto.parabiaghi@marionegri.it