Bryan Spinelli1, Michael J Kallan2, Xiaochen Zhang3, Andrea Cheville4, Andrea Troxel5, Joy Cohn6, Lorraine Dean7, Kathleen Sturgeon8, Margaret Evangelista2, Zi Zhang9, David Ebaugh10, Kathryn H Schmitz11. 1. Department of Physical Therapy, Thomas Jefferson University, Philadelphia, PA. 2. Department of Epidemiology, Biostatistics, and Informatics, University of Pennsylvania, Philadelphia, PA. 3. The Ohio State University Comprehensive Cancer Center, Columbus, OH. 4. Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, MN. 5. Department of Biostatistics, New York University, New York, NY. 6. Good Shepherd Penn Partners, Philadelphia, PA. 7. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD. 8. Department of Public Health Sciences, Penn State Cancer Institute, Penn State College of Medicine, Hershey, PA. 9. Department of Radiology, Harlem Hospital Center, Columbia University, New York, NY. 10. Department of Physical Therapy, Drexel University, Philadelphia, PA. 11. Department of Public Health Sciences, Penn State Cancer Institute, Penn State College of Medicine, Hershey, PA. Electronic address: kschmitz@phs.psu.edu.
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.
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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