Content Validity of the Lee XXXX Symptom Scale as Assessed by Cognitive Interviews.

@entity1 @entity26 @entity2132
The Lee @entity2132 ( @entity2132 ) Symptom Scale has been recommended for use by the 2005 and 2014 National Institutes of Health (NIH) Consensus Conferences to capture @entity2132 symptoms. Although the @entity2132 Symptom Scale was previously validated, this study aims to reexamine the instrument's content validity by exploring the clarity, comprehensibility, relevance, and ease of use in a contemporary @entity2132 sample, toward Food and Drug Administration (FDA) qualification of this @entity1 -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 @entity1 with a median age of 58  year (range, 31 to 79  years) participated. The median duration of @entity2132 was 33  months (range, 0 to 134.4  months), and current NIH severity score was mild in 1 @entity1 , moderate in 10 @entity1 , and severe in 9 @entity1 , with a median of 5.5 treatments (range, 0 to 14) ever used for @entity2132 . The median summary score was 23 (range, 8 to 51), and the median time to complete the scale was 2  minutes, 7  seconds (range, 1  minute, 8  seconds to 4  minutes). Symptoms of @entity2132 were well captured on the Lee @entity2132 Symptom Scale, although 4 additional symptoms/signs were mentioned by 15% of the @entity1 . @entity1 mostly reported that item wording was clear and provided accurate definitions of specific terminologies; however, 7 @entity1 (35%) reported finding 1 or more items in the skin domain unclear, reporting, for example, that rashes and itchy skin seemed synonymous. Two of 19 @entity1 (10.5%) described how their answers would have changed had they been asked about their symptoms within the past month instead of within the past week, owing to recently resolved symptoms. All @entity1 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, @entity1 found the Lee GVHD Symptom Scale to be a comprehensive and understandable way to report their @entity2132 symptom experience. Future work will focus on options for the recall period, the phrasing of skin items, and whether some very rare symptoms (eg, feeding tube, use of @entity26 ) should continue to be a part of the scale.
