Handling clinical comorbidity in randomized clinical trials in psychiatry

O'Hara, Ruth, Beaudreau, Sherry A., Gould, Christine E., Froehlich, Wendy and Kraemer, Helena C. (2017) Handling clinical comorbidity in randomized clinical trials in psychiatry. Journal of Psychiatric Research, 86 26-33. doi:10.1016/j.jpsychires.2016.11.006

Author O'Hara, Ruth
Beaudreau, Sherry A.
Gould, Christine E.
Froehlich, Wendy
Kraemer, Helena C.
Title Handling clinical comorbidity in randomized clinical trials in psychiatry
Journal name Journal of Psychiatric Research   Check publisher's open access policy
ISSN 1879-1379
Publication date 2017-03-01
Year available 2016
Sub-type Article (original research)
DOI 10.1016/j.jpsychires.2016.11.006
Open Access Status Not yet assessed
Volume 86
Start page 26
End page 33
Total pages 8
Place of publication Kidlington, Oxford, United Kingdom
Publisher Pergamon Press
Language eng
Subject 2738 Psychiatry and Mental health
2803 Biological Psychiatry
Abstract The purpose of this paper is to a) outline the importance of including patients with clinical comorbidities in Randomized Clinical Trials (RCTs) of psychiatric treatments; and b) to propose a specific approach for best handling, analyzing and interpreting the data on clinical comorbidities in terms of their impact on treatment outcomes. To do this we first define and describe clinical comorbidity and differentiate it from other forms of comorbidity. We then describe the methodological and analytical problems associated with excluding patients with clinically comorbid conditions from RCTs, including the impact on the outcomes of RCTs in psychiatry and the impact on evidence-based clinical decision-making. We then address the challenges inherent to including patients with clinical comorbidities in RCTs. Finally, we propose a methodological and analytic approach to deal with these issues in RCTs which aims to significantly improve the information yielded from RCTs in psychiatry, and thus improve clinical decision-making.
Keyword Clinical decision-making
Clinical trials
Psychiatric disorders
Randomized control trials
Q-Index Code C1
Q-Index Status Provisional Code
Grant ID IK2 RX001478
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: HERDC Pre-Audit
School of Psychology Publications
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