Schizophrenia Trial Participation: Perceived Inclusion Barriers and Beliefs about Antipsychotics

L. Ghio; W. Natta; A. Barbato; M. Marcenaro; S. Gotelli; P. B. Jones; A. Parabiaghi

doi:10.1055/s-0031-1277147

Pharmacopsychiatry, Inhaltsverzeichnis

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

Original Paper

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

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.

Volltext

Referenzen

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

Correspondence

Dr. A. Parabiaghi

Epidemiology and Social

Psychiatry Unit

‘Mario Negri’ Institute for

Pharmacological Research

Via La Masa 19

20156 Milan

Italy

Telefon: +39/02/3901 4602

Fax: +39/02/3901 4300

eMail: alberto.parabiaghi@marionegri.it