Abstract
Objective
The goal of this study was to develop and assess intra- and interrater 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 correlation coefficients (ICCs) for the Breast Cancer–Related
Lymphedema of the Upper Extremity (CLUE) standardized clinical evaluation tool.
Results
Intrarater reliability for the CLUE tool was ICC: 0.88 (95% confidence interval [95%
CI], 0.71-0.96). Interrater reliability for the CLUE tool was ICC: 0.90 (95% CI, 0.79-0.95).
Concurrent validity of the CLUE score (Pearson r) was 0.79 with perometric interlimb difference and 0.53 with the Norman lymphedema
overall score.
Conclusions
The CLUE tool shows excellent inter- and intrarater 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.
Keywords
List of abbreviations:
BCRL (breast cancer–related lymphedema), BIS (bioimpedance spectroscopy), 95% CI (95% confidence interval), CLUE (Breast Cancer–related Lymphedema of the Upper Extremity), CTCAE (Common Terminology Criteria for Adverse Events), ICC (intraclass correlation coefficient)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: October 03, 2018
Footnotes
Supported by National Cancer Institute, United States, U54-CA155850. Lorraine Dean’s efforts were supported by the National Institute of Mental Health (R25MH083620), the National Cancer Institute (grant no. K01CA184288), the Sidney Kimmel Cancer Center (grant no. P30CA006973), and the Johns Hopkins University Center for AIDS Research (grant no. P30AI094189).
Disclosures: none.
Identification
Copyright
© 2018 Published by Elsevier Inc. on behalf of the American Congress of Rehabilitation Medicine
