Pharmacopsychiatry 2011; 44(4): 123-128
DOI: 10.1055/s-0031-1277147
Original Paper

© Georg Thieme Verlag KG Stuttgart · New York

Schizophrenia Trial Participation: Perceived Inclusion Barriers and Beliefs about Antipsychotics

L. Ghio1 , W. Natta1 , A. Barbato2 , M. Marcenaro1 , S. Gotelli1 , P. B. Jones3 , A. Parabiaghi1
  • 1Departments of Neuroscience Ophthalmology, and Genetics University of Genoa, Genoa, Italy
  • 2Epidemiology and Social Psychiatry Unit, ‘Mario Negri’ Institute for Pharmacological Research, Milan, Italy
  • 3Department of Psychiatry, University of Cambridge, Cambridge, UK
Further Information

Publication History

received 22.12.2010 revised 22.03.2011

accepted 23.03.2011

Publication Date:
27 June 2011 (online)

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.

References

  • 1 Campbell MK, Snowdon C, Francis D. et al . Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study.  Health technology assessment. 2007;  11 ((48))
  • 2 Ross S, Grant A, Counsell C. et al . Barriers to participation in randomised controlled trials: a systematic review.  J Clin Epidemiol. 1999;  52 1143-1156
  • 3 Fayter D, McDaid C, Eastwood A. A systematic review highlights threats to validity in studies of barriers to cancer trial participation.  J Clin Epidemiol. 2007;  60 990-1001
  • 4 McDaid C, Hodges Z, Fayter D. et al . Increasing participation of cancer patients in randomised controlled trials: a systematic review.  Trials. 2006;  7 16
  • 5 Barbato A, D’Avanzo B, Ferrannini L. et al . A chance for clinical research in Italy: The GiSAS study on aripirazole, olanzapine, and haloperidol in the treatment of schizophrenic disorders.  Psichiatria di Comunità. 2008;  7 46-54
  • 6 Spaar A, Frey M, Turk A. et al . Recruitment barriers in a randomized controlled trial from the physicians’ perspective: a postal survey.  BMC Medical Research Methodology. 2009;  9 14
  • 7 Arbuckle MR, Gameroff MJ, Marcus SC. et al . Psychiatric opinion and antipsychotic selection in the management of schizophrenia.  Psychiatric Services. 2008;  59 561-565
  • 8 OsMed Working Group . [The use of drugs in Italy. National report year 2008] [Italian].  Il Pensiero Scientifico Editore, 2009, Aavailable at: http://www.agenziafarmaco.it/it/content/rapporti-osmed-luso-dei-farmaci-italia accessed March 22, 2011

Zoom Image

Zoom Image

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