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

Bryan Spinelli, PhD, Michael J. Kallan, MS, Xiaochen Zhang, MPH, Andrea Cheville, MD, MSCE, Andrea Troxel, PhD, Joy Cohn, MPT, Lorraine Dean, PhD, Kathleen Sturgeon, PhD, MTR, Margaret Evangelista, MS, Zi Zhang, MD, David Ebaugh, PhD, Kathryn H. Schmitz, PhD, MPH. ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION, 2018

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

Bryan Spinelli, PhD, Michael J. Kallan, MS, Xiaochen Zhang, MPH, Andrea Cheville, MD, MSCE, Andrea Troxel, PhD, Joy Cohn, MPT, Lorraine Dean, PhD, Kathleen Sturgeon, PhD, MTR, Margaret Evangelista, MS, Zi Zhang, MD, David Ebaugh, PhD, Kathryn H. Schmitz, PhD, MPH. ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION, 2018

Objective.  The goal of this study was to develop and assess intra and inter-rater 6 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.

Main findings

  • The Breast Cancer-related assessment of Lymphedema in the Upper Extremity (CLUE) is a standardized clinical, physical assessment tool for lymphoedema.
  • The inter-limb volume difference was derived from perometer measures. The limb dimensions and volumes of bilateral upper extremities were assessed using the Optoelectronic Perometery.
  • Self-report of lymphedema symptoms were assessed using the Norman Lymphedema Survey.
  • This was followed by the breast Cancer-related Lymphedema assessment of the Upper Extremity (CLUE)
    • CLUE involves assessing obscuration of anatomical architecture (e.g.; bony prominences, tendons), deviation from normal anatomical contour, change of soft tissue texture, and the presence of pitting or non-pitting oedema. These aspects of lymphedema evaluation were included because they are integral to clinical evaluations of BCRL. Measures included in the CLUE tool can be completed in approximately ten minutes, in the order noted below.   It potentially can be used as a teaching tool, clinical tool and in research. As a teaching and clinical tool it may need to be adapted.
  • Generally speaking, assessment of obscuration of anatomic architecture and anatomic contour change were more reliable and valid than assessments of tissue texture or oedema. This may reflect the extent to which the latter measures are more qualitative or subjective. It is noted that the pitting test as part of the oedema assessment was only for 5 second duration.