多中心临床试验结果对临床实践的影响：退伍军人事务部全国范围内使用利培酮治疗 PTSD。

Impact of multi-site clinical trial results on clinical practice: Use of risperidone to treat PTSD nationally in the veterans health administration.

机构信息

VA New England Mental Illness, Research, Education and Clinical Center, West Haven, CT, USA; Department of Psychiatry, Yale Medical School, West Haven, CT, USA.

VA Boston Healthcare System, Boston, MA, USA.

出版信息

Psychiatry Res. 2023 Mar;321:115071. doi: 10.1016/j.psychres.2023.115071. Epub 2023 Jan 27.

DOI:10.1016/j.psychres.2023.115071

PMID:36720177

Abstract

Multi-site randomized effectiveness trials evaluate treatments under real-world conditions. Whether results change practice is under-studied. A 6-month 26-site Veterans Health Administration (VHA) cooperative study published in 2011 compared an oral second-generation antipsychotic, risperidone, to placebo for refractory PTSD with null results. National VHA administrative data compared new starts on risperidone during the 5 years before and after the year of publication. Among the 450,000-841,000 Veterans diagnosed with PTSD annually from 2006 to 2016 the proportion with new starts on risperidone declined every year before and after publication. No evidence of an effect of null study results on VHA clinical practice was observed.

摘要

多中心随机有效性试验在真实环境下评估治疗方法。但研究结果对实践的影响程度却鲜有涉及。2011 年发表的一项为期 6 个月、涉及 26 个地点的退伍军人健康管理局（VHA）合作研究，对比了口服第二代抗精神病药利培酮与安慰剂治疗难治性 PTSD 的效果，结果为阴性。利用国家退伍军人健康管理局行政数据，对比了在研究发表前后 5 年里，新开始使用利培酮治疗的情况。在 2006 年至 2016 年期间，每年约有 45 万至 84.1 万退伍军人被诊断患有 PTSD，在研究发表前后，新开始使用利培酮的比例每年都在下降。研究结果为阴性并没有对退伍军人健康管理局的临床实践产生影响。