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临床科学中的注册连续性:透明实践指南。

The registration continuum in clinical science: A guide toward transparent practices.

机构信息

Department of Psychology, University of Nevada, Las Vegas.

Interdisciplinary Addiction Program for Education and Research, Center for Health Equity and Research Promotion, Mental Illness Research, Education and Clinical Center, VA Pittsburgh Healthcare System.

出版信息

J Abnorm Psychol. 2019 Aug;128(6):528-540. doi: 10.1037/abn0000451.

Abstract

Clinical scientists can use a continuum of registration efforts that vary in their disclosure and timing relative to data collection and analysis. Broadly speaking, registration benefits investigators by offering stronger, more powerful tests of theory with particular methods in tandem with better control of long-run false positive error rates. Registration helps clinical researchers in thinking through tensions between bandwidth and fidelity that surround recruiting participants, defining clinical phenotypes, handling comorbidity, treating missing data, and analyzing rich and complex data. In particular, registration helps record and justify the reasons behind specific study design decisions, though it also provides the opportunity to register entire decision trees with specific endpoints. Creating ever more faithful registrations and standard operating procedures may offer alternative methods of judging a clinical investigator's scientific skill and eminence because study registration increases the transparency of clinical researchers' work. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

摘要

临床科学家可以使用一系列注册方法,这些方法在披露和时间上相对于数据收集和分析而有所不同。从广义上讲,注册通过提供与特定方法相结合的更强有力、更强大的理论检验,以及更好地控制长期假阳性错误率,从而使研究人员受益。注册有助于临床研究人员在招募参与者、定义临床表型、处理合并症、处理缺失数据以及分析丰富而复杂的数据时,思考围绕带宽和保真度的紧张关系。特别是,注册有助于记录和证明特定研究设计决策背后的原因,尽管它也为注册整个具有特定终点的决策树提供了机会。创建越来越忠实的注册和标准操作程序可能为判断临床研究人员的科学技能和卓越性提供替代方法,因为研究注册提高了临床研究人员工作的透明度。

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