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Clinical trials in psychiatry: should protocol deviation censor patient data?

Authors: P W, Lavori;

Clinical trials in psychiatry: should protocol deviation censor patient data?

Abstract

Clinical trials methodologists recommend counting all events regardless of adherence to protocol and comparing originally randomized groups. This strict "intent-to-treat" policy implies availability and use of outcome measures taken regardless of adherence to treatment protocol. However, outcome measurement in psychiatry requires the cooperation of the patient, and usually occurs in the context of treatment management. Consequently, the patient's or clinician's decision not to adhere to the treatment protocol may be design or default cause censorship of patient data by early truncation. This disables the analysis "by intent to treat" in the strict sense. Current methods applied to such nonrandomly truncated datasets are unsatisfactory ("last value" analysis, survival analysis) or worse (imputation by last value carried forward). I review the context of clinical experimentation in psychiatry, contrast the state of design and analysis with expert recommendations on general methods, review the current statistical strategies and propose that investigators should try to obtain complete follow-up data on all patients without regard to their adherence to treatment protocol.

Related Organizations
Keywords

Psychiatry, Clinical Trials as Topic, Research Design, Mental Disorders, Humans

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Powered by OpenAIRE graph
Found an issue? Give us feedback
selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
128
Top 10%
Top 0.1%
Top 10%
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