Publication date: Available online 4 October 2018
Source: Archives of Physical Medicine and Rehabilitation
Author(s): Bryan Spinelli, Michael J. Kallan, Xiaochen Zhang, Andrea Cheville, Andrea Troxel, Joy Cohn, Lorraine Dean, Kathleen Sturgeon, Margaret Evangelista, Zi Zhang, David Ebaugh, Kathryn H. Schmitz
Abstract
Objective
The goal of this study was to develop and assess intra and inter-rater reliability and validity of a clinical evaluation tool for breast cancer related lymphedema, for use in the context of outcome evaluation in clinical trials
Design
Blinded repeated measures observational study.
Setting
Outpatient research laboratory.
Participants
Breast cancer survivors with and without lymphedema (N=71).
Interventions
Not applicable.
Main outcome measure
The assessment of Intraclass Correlations (ICCs) for the Breast Cancer related Lymphedema in the Upper Extremity (CLUE) standardized clinical evaluation tool.
Results
Intra-rater reliability for the CLUE tool was ICC: 0.88 (95% CI: 0.71, 0.96). Inter-rater reliability for the CLUE tool was ICC: 0.90 (95% CI: 0.79, 0.95). Concurrent validity of the CLUE score (Pearson's r) was 0.79 with perometric inter-limb difference, and 0.53 with the Norman Lymphedema overall score.
Conclusions
The CLUE tool shows excellent inter- and intra-rater reliability. The overall CLUE score for the upper extremity also shows moderately strong concurrent validity with objective and subjective measures. This newly developed clinical, physical assessment of upper extremity lymphedema provides standardization and a single score that accounts for multiple constructs. Next steps include evaluation of sensitivity to change, which would establish usefulness to evaluate intervention efficacy.
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