Content Validity of the Lee Chronic Graft-versus-Host Disease Symptom Scale as Assessed by Cognitive Interviews

Abstract

The Lee Chronic Graft-Versus-Host Disease (cGVHD) Symptom Scale has been recommended for use by the 2005 and 2014 NIH Consensus Conferences to capture chronic GVHD symptoms. Although the cGVHD Symptom Scale was previously validated, this study aims to re-examine the instrument’s content validity by exploring the clarity, comprehensibility, relevance and ease of use in a contemporary chronic GVHD sample, toward FDA qualification of this patient-reported outcomes (PRO) instrument as a drug development tool. Attaining FDA qualification means that an instrument has been judged to be a reliable and valid measure of clinical benefit. Twenty adult patients with a median age of 58 (range 31–79) years participated. Median duration of chronic GVHD was 33 (range 0–134.4) months, and current NIH severity was mild (n=1), moderate (n=10) or severe (n=9) with a median of 5.5 (range 0–14) treatments ever used for chronic GVHD. The median summary score was 23 (range 8–51), and the median time to complete the scale was 2 minutes 7 seconds (range 01:08–04:00 minutes). Chronic GVHD symptoms were well captured on the Symptom Scale, although four additional symptoms/signs were mentioned by 15% of participants. Participants reported that item wording was clear, and they provided accurate definitions of specific terminologies. However, 7 (35%) participants indicated that they found one or more items in the skin domain unclear, reporting, for example, that rashes and itchy skin seemed synonymous. Two (10.5%) of 19 participants described how their answers would have changed if asked about their symptoms within the past month instead of within the past week owing to recently resolved symptoms. All participants were able to accurately explain the concept of “bother” in their own words and distinguish it from symptom severity or other related symptom attributes. In summary, participants found the tool to be a comprehensive and understandable way to report their chronic GVHD symptom experiences. Future work will focus on options for the recall period, the phrasing of skin items, and whether some very rare symptoms (e.g., feeding tube, use of oxygen) should continue to be a part of the scale.

Graft Versus Host Disease Clinical Trials: Is it Time for Patients Centered Outcomes to Be the Primary Objective?

“…Recently, further work has been done to re-examine the validity of the LSS in a contemporary patient cohort, towards FDA qualification of this PRO measure as a drug development tool. The results show very positive responses from participants, who reported that the scale is clear and captures almost all of their symptoms (30). Although future studies may be needed to expand the populations studied, this study strongly supports the FDA qualification of this PRO measure.…”

Patient-reported outcomes and health status associated with chronic graft-versus-host disease

“…The LSS is a 30-item measure with one summary score and seven domains: skin, mouth, eye, lung, psycho-emotional, vitality and nutrition. 23 , 24 Higher scores indicate greater symptom burden. Half of the cases received the LSS with a 1-month recall period and half received a 1-week version; results were combined for analysis because there was no statistical difference between the aggregate scores for the two versions ( data not shown ).…”

Coping and Modifiable Psychosocial Factors are Associated with Mood and Quality of Life in Patients with Chronic Graft-versus-Host Disease

“…This 30-item symptom assessment measures the negative effects of chronic GVHD on skin, vitality, lung, nutritional status, psychologic functioning, and eye and mouth symptoms, with higher scores indicating greater symptom burden. The Lee Symptom Assessment Scale is well validated [22] and frequently used in chronic GVHD research [23].…”