Abstract:
Objective: The first objective was to identify common exclusion criteria used in clinical trials. The second objective was to quantify the degree to which these criteria exclude emergency psychiatry patients. Methods: Qualitative Content Analysis was used for the first objective, identifying common exclusion criteria used in recent high-impact substance use clinical trials. A retrospective record review was used for the second objective, which examined the frequency of these exclusion criteria in a 1-month sample of adults receiving psychiatric evaluation in an emergency department. Results: Most trials had exclusions for co-occurring psychiatric problems (76.6%), medical problems (74.0%), prior or current treatment (72.7%), motivation for change (61.1%), pregnancy or lactation (57.1%), or using other specified substances of abuse (54.6%). In the clinical sample, exclusions for co-occurring psychiatric problems would make 94.7% of patients ineligible. Other exclusions had a combined effect of making 76% of patients ineligible. Conclusions: Clinical trials using typical exclusion criteria exclude nearly all emergency psychiatry patients with substance use problems.
摘要:
目的:第一个目的是确定临床试验中使用的常见排除标准。第二个目标是量化这些标准排除急诊精神病患者的程度。方法:第一个目标采用定性内容分析法,确定近期高影响物质使用临床试验中使用的常见排除标准.第二个目标是回顾性记录回顾,该研究检查了在急诊科接受精神病学评估的1个月成人样本中这些排除标准的频率。结果:大多数试验排除了同时发生的精神病(76.6%),医疗问题(74.0%),先前或当前治疗(72.7%),变革动机(61.1%),怀孕或哺乳期(57.1%),或使用其他特定物质的滥用(54.6%)。在临床样本中,排除同时发生的精神问题将使94.7%的患者不符合资格.其他排除具有使76%的患者不合格的综合效果。结论:使用典型排除标准的临床试验排除了几乎所有存在物质使用问题的急诊精神病患者。