临床儿科精神药理学中的传统及替代研究设计与方法
Traditional and alternative research designs and methods in clinical pediatric psychopharmacology.
作者信息
Fava M
机构信息
Clinical Psychopharmacology Unit, Massachusetts General Hospital, Boston 02114, USA.
出版信息
J Am Acad Child Adolesc Psychiatry. 1996 Oct;35(10):1292-303. doi: 10.1097/00004583-199610000-00016.
OBJECTIVE
To review both traditional and alternative research designs and methods in pediatric psychopharmacology.
METHOD
Study designs used in clinical trials in psychiatry were selected for review with the special considerations of pediatric psychopharmacological trials in mind. Where possible, a reference to a specific published trial in pediatric psychopharmacology was provided for each design.
RESULTS
It appears that pediatric psychopharmacology trials require a relatively greater flexibility in design to avoid significant study biases. Alternative research designs may be preferable to the traditional approaches, particularly when the use of the latter may raise important issues of feasibility.
CONCLUSIONS
Evolution of a clinical research hypothesis to a study protocol in pediatric psychopharmacology is a manageable task if one keeps in mind essential elements such as selection of study design, population, sample size, treatment duration, and efficacy assessments.
目的
回顾儿科精神药理学中传统和替代的研究设计及方法。
方法
选择精神病学临床试验中使用的研究设计进行回顾，并特别考虑儿科精神药理学试验。在可能的情况下，为每种设计提供了儿科精神药理学中一项具体已发表试验的参考文献。
结果
儿科精神药理学试验似乎在设计上需要相对更大的灵活性，以避免显著的研究偏差。替代研究设计可能比传统方法更可取，尤其是当使用传统方法可能引发重要的可行性问题时。
结论
如果牢记诸如研究设计、人群、样本量、治疗持续时间和疗效评估等基本要素，那么在儿科精神药理学中将临床研究假设转化为研究方案是一项可控的任务。
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