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Quality of Life Research

Erschienen in:

01.12.2009

Development and validation of a composite score based on clinically meaningful events for the opioid-related symptom distress scale

verfasst von: Kitty S. Chan, Wen-Hung Chen, T. J. Gan, Ray Hsieh, Connie Chen, Mani Lakshminarayanan, Dennis A. Revicki

Erschienen in: Quality of Life Research | Ausgabe 10/2009

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Abstract

Purpose

To develop and validate a composite score based on clinically meaningful events (CMEs) for the opioid-related symptom distress scale (OR-SDS) that would be appropriate for use in postoperative clinical trials.

Methods

Secondary analysis of data from 2 multi-site Phase III randomized clinical safety trials: a general surgery trial (N = 1,050) and a coronary artery bypass graft surgery trial (N = 1,636). Validating measures include daily opioid consumption and physician and patient global evaluations of study medication. We empirically defined CMEs for each symptom, using factor analysis and an area under the receiver-operating characteristic analysis of the severity and frequency items of the OR-SDS. Construct validity was examined by testing hypotheses of relationships between composite CME scores and opioid consumption and physician and patient evaluations of study medication.

Results

Hypotheses supporting the construct validity of the CME-based composite score were confirmed. Significant associations were found between higher numbers of CMEs with greater opioid consumption and lower likelihood of a positive evaluation of the study medication.

Conclusions

The OR-SDS CME-based composite score demonstrates evidence of construct validity and appears appropriate for use in evaluating patients’ opioid-related side effect burden in future postoperative clinical trials.

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Titel: Development and validation of a composite score based on clinically meaningful events for the opioid-related symptom distress scale
verfasst von: Kitty S. Chan
Wen-Hung Chen
T. J. Gan
Ray Hsieh
Connie Chen
Mani Lakshminarayanan
Dennis A. Revicki
Publikationsdatum: 01.12.2009
Verlag: Springer Netherlands
Erschienen in: Quality of Life Research / Ausgabe 10/2009
Print ISSN: 0962-9343
Elektronische ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-009-9547-2

Springer Medizin

Abstract

Purpose

Methods

Results

Conclusions

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