Statistical methods in randomised controlled trials for delirium.

Abstract:

OBJECTIVE:The analysis of clinical trials in delirium is typically complicated by treatment dropouts and by the fact that even untreated individuals may have a good prognosis. These features of delirium trials warrant special statistical attention; implications for each stage of a trial planning process are described. METHODS:Choice of outcome, patient sample, and data collection in delirium trials are discussed. Descriptions are given, together with examples, of time-to-event, imputation-based, linear and nonlinear models for the analysis of randomised controlled trials for delirium. RESULTS:Imputation allows evaluation of the plausibility of individual recovery trajectories, but some simple imputations are found to be unsuitable for delirium research. Time-to-event and nonlinear models encourage a global perspective on analysis, which is often preferable to cross-sectional end-of-trial assessments. It is suggested that nonlinear random effects models for longitudinal trajectories are particularly suitable in a delirium context. CONCLUSION:It is hoped that the methods described, and nonlinear models in particular, will play a part in convincing analyses of future delirium research.

journal_name

J Psychosom Res

authors

Farewell D,Tahir TA,Bisson J

doi

10.1016/j.jpsychores.2012.06.002

subject

Has Abstract

pub_date

2012-09-01 00:00:00

pages

197-204

issue

3

eissn

0022-3999

issn

1879-1360

pii

S0022-3999(12)00152-3

journal_volume

73

pub_type

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