TY - JOUR
T1 - Intra- and Interrater Reliability and Concurrent Validity of a New Tool for Assessment of Breast Cancer–Related Lymphedema of the Upper Extremity
AU - Spinelli, Bryan
AU - Kallan, Michael J.
AU - Zhang, Xiaochen
AU - Cheville, Andrea
AU - Troxel, Andrea
AU - Cohn, Joy
AU - Dean, Lorraine
AU - Sturgeon, Kathleen
AU - Evangelista, Margaret
AU - Zhang, Zi
AU - Ebaugh, David
AU - Schmitz, Kathryn H.
N1 - Funding Information:
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 ).
Funding Information:
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).
Publisher Copyright:
© 2018
PY - 2019/2
Y1 - 2019/2
N2 - 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.
AB - 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.
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U2 - 10.1016/j.apmr.2018.08.185
DO - 10.1016/j.apmr.2018.08.185
M3 - Article
C2 - 30291828
AN - SCOPUS:85057820711
SN - 0003-9993
VL - 100
SP - 315
EP - 326
JO - Archives of Physical Medicine and Rehabilitation
JF - Archives of Physical Medicine and Rehabilitation
IS - 2
ER -
