Development and Psychometric Validation of a Patient-Reported Outcome Measure for Arm Lymphedema: The LYMPH-Q Upper Extremity Module

Anne F. Klassen*, Elena Tsangaris, Manraj N. Kaur, Lotte Poulsen, Louise Beelen, Amalie Lind Jacobsen, Mads Gustaf Jørgensen, Jens Ahm Sørensen, Dalibor Vasilic, Joseph Dayan, Babak Mehrara, Andrea L. Pusic

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

6 Citations (Scopus)


Background: A multiphased mixed-methods study was performed to develop and validate a comprehensive patient-reported outcome measure (PROM) for arm lymphedema in women with breast cancer (i.e., the LYMPH-Q Upper Extremity Module). Methods: Qualitative interviews (January 2017 and June 2018) were performed with 15 women to elicit concepts specific to arm lymphedema after breast cancer treatment. Data were audio-recorded, transcribed, and coded. Scales were refined through cognitive interviews (October and Decemeber 2018) with 16 patients and input from 12 clinical experts. The scales were field-tested (October 2019 and January 2020) with an international sample of 3222 women in the United States and Denmark. Rasch measurement theory (RMT) analysis was used to examine reliability and validity. Results: The qualitative phase resulted in six independently functioning scales that measure arm symptoms, function, appearance, psychological function, and satisfaction with information and with arm sleeves. In the RMT analysis, all items in each scale had ordered thresholds and nonsignificant chi-square p values. For all the scales, the reliability statistics with and without extremes for the Person Separation Index were 0.80 or higher, Cronbach’s alpha was 0.89 or higher, and the Intraclass Correlation Coefficients were 0.92 or higher. Lower (worse) scores on the LYMPH-Q Upper Extremity scales were associated with reporting of more severe arm swelling, an arm problem caused by cancer and/or its treatment, and wearing of an arm sleeve in the past 12 months. Conclusions: The LYMPH-Q Upper Extremity Module can be used to measure outcomes that matter to women with upper extremity lymphedema. This new PROM was designed using a modern psychometric approach and, as such, can be used in research and in clinical care.

Original languageEnglish
Pages (from-to)5166-5182
Number of pages17
JournalAnnals of Surgical Oncology
Issue number9
Publication statusPublished - 5 Jul 2021

Bibliographical note

Funding Information:
Phase 1 of this study was supported by the Canadian Breast Cancer Foundation Project Grant (now integrated into Canadian Cancer Society) (Grant No. 319371. Phase 2 of this study was supported by the Canadian Cancer Society (Grant No. 706256). Manraj Kaur was supported by the Canadian Institute of Health Research Canada’s Best Graduate Scholarship Doctoral Award (2015–2019). Louise Marie Beelen was partially supported by ZonMw (Network Grant). Contributions from Memorial Sloan-Kettering were funded in part through the NIH/NCI Cancer Center Support Grant P30CA008748.

Publisher Copyright:
© 2021, The Author(s).


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