Psychometric development of the Upper Limb Lymphoedema Questionnaire demonstrated the patient-reported outcome measure to be a robust measure for breast cancer-related lymphoedema
Angela E. Williams, Frances Rapport, Ian T. Russell, Hayley A. Hutchings. Journal of Clinical Epidemiology 2018
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Psychometric development of the Upper Limb Lymphoedema Questionnaire demonstrated the patient-reported outcome measure to be a robust measure for breast cancer-related lymphoedema
Angela E. Williams, Frances Rapport, Ian T. Russell, Hayley A. Hutchings. Journal of Clinical Epidemiology 2018
Objective:
To develop and undertake initial validation of a patient-reported outcome measure (PROM) to assess health-related quality of life in patients with breast cancer-related upper limb lymphedema (ULL).
Study Design and Setting:
We developed and validated the Upper Limb Lymphedema Quality of Life (ULLQoL) scale in two stages: devising the items and pre-testing with patients and clinicians; longitudinal validation to test its psychometric properties – underlying dimensions, internal consistency, test-retest reliability, construct validity, and responsiveness. Patients with ULL were recruited from two out-patient clinics.
Results:
We derived the ULLQoL scale from a pool of 98 items generated by patients. After further consultation we produced the draft ULLQoL scale. For validation 103 patients with ULL completed the draft scale and two generic health measures: SF-36 and ED-5D-3L. Psychometric analysis identified two components, physical and emotional well-being, with good internal consistency and test-retest reliability. Significant correlations with SF-36, EQ-5D-3L, and percentage excess limb volume confirmed construct validity. The ULLQoL scale showed good responsiveness to change reported by lymphedema patients and moderate to large effect sizes.
Conclusion:
The 14-item ULLQoL scale is a robust upper limb lymphedema-specific measure that is feasible and valid to use in both the clinical and research settings.
Main findings
For each of the following questions the participant had to choose from the following 5 point scale for the eight magnitude questions – “not at all”, “a little bit”, “moderately”, “quite a bit” and “extremely”; and for the four frequency questions: “none of the time”, “some of the time”, “a good bit of the time”, “most of the time” and “all of the time”.
- To what extent did your swollen arm interfere with your normal work activities?
- To what extent did your swollen arm interfere with your normal leisure activities?
- To what extent did your swollen arm interfere with your self-care?
- To what extent did your swollen arm interfere with dressing and undressing?
- To what extent did your swollen arm interfere with your sleep?
- To what extent did you feel your femininity or masculinity was influenced by your swollen arm?
- To what extent did your swollen arm interfere with lifting or carrying light objects?
- To what extent did your swollen arm interfere with reaching high objects?
- To what extent did you feel down because of your swollen arm?
- To what extent did you feel down because your swollen arm has restricted the clothing that you would like to wear?
- How much of the time did your swollen arm stop you wearing clothing that you would like to wear? 0.869
- How much of the time did your swollen arm cause you pain or discomfort?
- How much of the time were you aware of your swollen arm?
- How much of the time did your swollen arm cause you to feel self-conscious or embarrassed in public?
Of the 85 participants who completed the lymphoedema health transition question as well as the baseline and final questionnaires, 42 (49%) perceived their lymphedema as improved, and 33 (39%) perceived it as little changed, while ten (12%) perceived it as worse. Table 8 shows that the first group reported clearly improved ULLQoL scores (functional and emotional well-being) while the third group reported that all mean scores deteriorated. Furthermore, these changes reflected analogous changes in limb volume, with a decrease in limb volume when the patients reported improvement on the lymphoedema transition question, no change in limb volume when patients reported no change on the transition question, and increase in limb volume when they reported deterioration on the lymphedema transition question.
The final version 2 of the ULLQoL scale showed good item completion, wide ranges of responses and consistency between items.
The resulting upper limb lymphedema-specific QoL measure showed excellent internal consistency and test-retest reliability, and good construct validity, with the generic SF-36 and EQ-5D-3L as constructs.
Further analysis of the test-retest reliability using an objective measure for stability, and further larger studies of construct validity, particularly against more specific constructs, for example, a clinician’s global assessment of well-being, or severity of lymphedema using the International Society of Lymphology’s staging system. The vast majority of the patients in the validation study had developed ULL secondary to breast cancer. The authors consider that the ULLQoL may be appropriate for a broader target group with ULL, but this would have to be tested in further validation studies.
Though the assessment of limb size is important in clinical assessment of ULL, the ULLQoL scale now provides complementary, holistic assessment that takes full account of the wide range of morbidity.
It is short, takes less than five minutes to complete, and is easy to use in clinical practice and research.
