Departments of Neuroscience Ophthalmology, and Genetics University of Genoa, Genoa, Italy.
Pharmacopsychiatry. 2011 Jun;44(4):123-8. doi: 10.1055/s-0031-1277147. Epub 2011 Jun 27.
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).
A survey of all clinicians working in the trial recruiting centers was performed exploring factors associated to the respondents' opinions.
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.
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.
患者招募是所有医学专业随机对照试验(RCT)的普遍限速因素。本研究调查了参与精神分裂症抗精神病药物实用 RCT(GiSAS 试验)的一组精神科医生对感知纳入障碍的看法和对抗精神病药物的看法。
对参与试验招募中心的所有临床医生进行了一项调查,以探讨与受访者意见相关的因素。
在 465 名临床医生中,有 278 名(59.8%)回答了问卷。受访者(n=278)主要受到临床和试验相关障碍(89%)的影响。工作环境和抗精神病药物处方选择等因素似乎与感知的纳入障碍有关。大多数受访者相信 SGA 的优越性(62.9%),三分之一的人表示药物代表是最重要的信息来源;这与对 SGA 的进一步乐观态度有关。
受访者主要受到系统相关障碍的影响,而个人障碍的影响较小。行业介导信息的影响可能影响了对 SGA 的看法,以及对试验参与的抗精神病药物态度的不确定性。