Jan Weiss, PT, DHS, CLT-LANA Validation of a Lymphedema-Specific Functional Measure: The Lymphedema Life Impact Scale (LLIS) Jan Weiss, PT, DHS, CLT-LANA CoxHealth, Missouri State University Todd Daniel, PhD Missouri State University Introduction Results Results Results Content Validity Construct Validity Convergent Validity Lymphedema manifests as swelling resulting from lymphatic system failure to remove excess tissue interstitial fluid. Due to the specific impact of this disease, it is essential for practitioners to have a condition-specific measure with which to assess the effects of lymphedema, and upon which to base appropriate treatment. The few existing lymphedema instruments focus mostly on the impact of upper extremity lymphedema, use multiple forms, or not been available in English. The Lymphedema Life Impact Scale (LLIS) was developed as a comprehensive lymphedema-specific instrument that also addresses the 2013 Medicare requirement for documentation of functional outcomes for rehabilitation. The LLIS consists of 18 questions including physical, functional, and psychosocial domains. The purpose of this study was to investigate the reliability and validity of the LLIS in a mixed (upper and lower extremity) lymphedema patient population. Content validity was assessed by computing a content validity ratio (CVR; Lawshe, 1975) for each item, then calculating the average of the CVRs for a content validity index of the overall measure. Four subject matter experts rated the items. Limb symptoms, pain, and physical limitations have been demonstrated to correlate more closely with negative quality of life than amount of edema. Construct validity was measured through examination of six symptoms frequently associated with lymphedema. The LLIS correlated moderately to highly (r = .44 to r = .85) with all symptoms. This supports the use of the LLIS to provide additional information about the impact of lymphedema on the individual. Each of the domain scales of the LLIS were correlated with like domains from functional and quality of life outcome measures currently used in lymphedema research. The European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30; Aaronson et al., 1987) is a self-report measure used to assess quality of life among cancer patients. Although not specifically designed to be used with lymphedema patients, it is frequently used in lymphedema research. Not surprisingly, the LLIS correlations with the EORTC, although statistically significant, were weaker than with other lymphedema measures. This might indicate the limited suitability of using a cancer-specific measure with lymphedema patients. Both the Lymphedema Quality of Life (LYMQOL; Keeley et al., 2010) and the Disability of Arm, Shoulder, and Hand (DASH; Institute for Work and Health, 2006) correlated with their respective scales on the LLIS for UE participants at r = .73 to r = .80 (all statistically significant at the .01 level). The functional scale of the LLIS correlated reasonably well (r = .538, p < .01) with the Lower Extremity Functional Scale (LEFS; Binkley et al., 1999), and all three LLIS scales correlated with their respective scales on the LE LYMQOL between at r = .74 to r = .88 (all statistically significant at the .01 level). Summary Participants This research suggests that the LLIS works adequately to assess impairments, activity limitations, and participation restrictions in patients with either upper or lower extremity lymphedema. The LLIS demonstrates the following advantages: The LLIS is construct valid with established measures of lymphedema, making it useful to practitioners. The LLIS is lymphedema-specific: it discriminates between patients with lymphedema and without, even in those patients with risk factors for lymphedema. The LLIS provides a single measure for both upper and lower extremity lymphedema eliminating the need for multiple forms of a measure. The LLIS measures three types of lymphedema-specific impairment: physical, psychosocial, and functional. The LLIS can be used with an Excel worksheet allowing practitioners to calculate Medicare severity codes to comply with the 2013 Medicare requirements for the documentation of functional outcomes for rehabilitation. The LLIS is short and quick to administer. Participants were recruited from Lymphedema and Rehab Therapy Clinics across the U.S. The sample consisted of 93 patients; approximately one third of whom had been diagnosed with upper extremity (UE) lymphedema, one third had lower extremity (LE) lymphedema and the remaining third comprised of patients at risk for, but without lymphedema (MHx: obesity, cancer, DVT, CVI) who served as controls. Participants were an average of 58.19 years old, were 83.9% female, and almost exclusively white (98.9%). Roughly half of the sample (51.6%) were employed. The control group was selected because its members fit diagnostic categories associated with lymphedema, but had no swelling. More patients with UE lymphedema had a history of cancer compared to those with LE lymphedema or the control. Reliability All scales on the LLIS produce Cronbach’s alpha values above .80. Discriminant Validity Discriminant validity was assessed by comparing LLIS scale scores from patients diagnosed with lymphedema to LLIS scores of those in a control group. The control group was chosen because lymphedema occurs from a variety of etiologies. Using one-way ANOVAs, the LLIS was demonstrated to discriminate between patients with lymphedema and those without lymphedema on all three LLIS scales (Physical: F(2,90) = 42.10, p < .001; Psychosocial: F(2,90) = 24.33, p < .001; Functional: F(2,90) = 29.25, p < .001). Post hoc tests conducted with Tukey HSD showed that for all three scales, the lymphedema patients formed homogeneous subsets distinct from the control group. References Lawshe (1975). A quantitative approach to content validity. Personnel Psychology, 28, 563-575. doi:10.1111/j.1744-6570.1975.tb01393.x I wish to acknowledge and thank all of the lymphedema therapists and patients across the U.S. who assisted with survey submission. I would also like to thank Dr. Todd Daniel at Missouri State University RStats Institute for his invaluable assistance with statistical analysis and project design.