Πέμπτη 4 Οκτωβρίου 2018

Intra- and Interrater Reliability and Concurrent Validity of a New Tool for Assessment of Breast Cancer related Lymphedema of the Upper Extremity (CLUE)

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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