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研究网络对痴呆患者抗抑郁药临床试验的贡献。

Contribution of research networks to a clinical trial of antidepressants in people with dementia.

机构信息

Florence Nightingale School of Nursing & Midwifery, King's College London, Room 1.17, James Clerk Maxwell Building, London, UK.

出版信息

J Ment Health. 2012 Oct;21(5):439-47. doi: 10.3109/09638237.2012.664298. Epub 2012 May 1.

DOI:10.3109/09638237.2012.664298
PMID:22548261
Abstract

BACKGROUND

The Mental Health Research Network and Dementia and Neurodegenerative Diseases Research Network were established in the UK to increase research capacity and activity; the former in mental health generally, and the latter specifically in neurodegenerative disorders including dementia. Little evidence exists on the impact of these networks on research in mental health of older people.

AIMS

To examine research network support to a multi-centre randomised controlled trial of antidepressants in people with depression superimposed on dementia. Method Qualitative questionnaires were completed by principal investigators, trial-funded research workers and clinical study officers (CSOs) of the research networks.

RESULTS

Research network contribution was much valued by principal investigators and the nine research teams. CSOs boosted the recruitment campaign in a challenging environment and enhanced assessment processes. Some problems with consistency and staff turnover were raised.

CONCLUSION

Research network input can make an appreciable difference to the process and outcome of a multi-centre clinical trial.

摘要

背景

心理健康研究网络和神经退行性疾病与痴呆症研究网络在英国成立,旨在提高研究能力和活动;前者主要关注心理健康,后者则专门关注神经退行性疾病,包括痴呆症。关于这些网络对老年人心理健康研究的影响,证据很少。

目的

调查研究网络对一项在痴呆症患者中抗抑郁药的多中心随机对照试验的支持情况。

方法

采用定性问卷的方法,对主要研究者、试验资助的研究人员和研究网络的临床研究人员进行调查。

结果

研究网络的贡献得到了主要研究者和九个研究团队的高度重视。临床研究人员在充满挑战的环境中推动了招募活动,并增强了评估过程。但也提出了一些关于一致性和人员流动的问题。

结论

研究网络的投入可以对多中心临床试验的过程和结果产生显著影响。

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