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Assessing blinding in clinical trials

conference contribution
posted on 2012-01-01, 00:00 authored by Ognjen Arandjelovic
The interaction between the patient's expected outcome of an intervention and the inherent effects of that intervention can have extraordinary effects. Thus in clinical trials an effort is made to conceal the nature of the administered intervention from the participants in the trial i.e. to blind it. Yet, in practice perfect blinding is impossible to ensure or even verify. The current standard is follow up the trial with an auxiliary questionnaire, which allows trial participants to express their belief concerning the assigned intervention and which is used to compute a measure of the extent of blinding in the trial. If the estimated extent of blinding exceeds a threshold the trial is deemed sufficiently blinded; otherwise, the trial is deemed to have failed. In this paper we make several important contributions. Firstly, we identify a series of fundamental problems of the aforesaid practice and discuss them in context of the most commonly used blinding measures. Secondly, motivated by the highlighted problems, we formulate a novel method for handling imperfectly blinded trials. We too adopt a post-trial feedback questionnaire but interpret the collected data using an original approach, fundamentally different from those previously proposed. Unlike previous approaches, ours is void of any ad hoc free parameters, is robust to small changes in auxiliary data and is not predicated on any strong assumptions used to interpret participants' feedback.

History

Event

Neural Information Processing Systems. Conference (26th : 2012 : Lake Tahoe, Nev.)

Series

Neural information processing systems : annual conference

Pagination

521 - 529

Publisher

Curran Associates Inc.

Location

Lake Tahoe, Nev.

Place of publication

Red Hook, N. Y.

Start date

2012-12-03

End date

2012-12-06

ISSN

1049-5258

ISBN-13

9781627480031

Language

eng

Publication classification

E1 Full written paper - refereed

Copyright notice

2012, Curran Associates

Editor/Contributor(s)

P Bartlett, F Pereira, C Burges, L Bottou, K Weinberger

Title of proceedings

NIPS 2012 : Advances in neural information processing systems : proceedings of the 26th Annual Conference on Neural Information Processing Systems

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