HFS 14- A SPECIFIC QUALITY OF LIFE INSTRUMENT FOR PATIENTS WITH HAND-FOOT SYNDROME
Author(s)
Taieb C1, Sibaud V21PFSA, Boulogne, France, 2Institut Claudius Regaud,, Toulouse, France
Presentation Documents
Hand-foot syndrome or palmar-plantar erythrodysesthesia is a common adverse effect of certain chemotherapy agents, such as capecitabine or pegylated doxorubicin, where it is estimated to occur in 50% of cases. However, there is no specific, validated clinical instrument to measure its intensity and its impact on patients, apart from NCI-CTC grading which is relatively insensitive and is not specific. OBJECTIVES: The aim of this study is to develop and validate a hand-foot syndrome-specific quality of life scale in order to be able to measure the impact of the condition on patients and secondly to be able to assess the value of certain specific treatments in this indication. METHODS: The questionnaire was developed after conducting a series of structured interviews with patients with forms of hand-foot syndrome of varying severity, which yielded a detailed and rigorous collection of verbatim transcripts. RESULTS: Thirty-one items were identified, and 14 items were selected as being relevant and non-overlapping after initial evaluation. The first question in the HFS14 addresses which member is affected (hand, foot or both). The second question addresses the pain with three possible responses (very, moderately or not painful). The 14 items can be organised in 2 modules: the first module more specifically assesses the handicap generated by involvement of the "feet" and the second assesses the handicap generated by involvement of the "hands". Six (6) items are considered common to both modules, 4 are hand-specific and 4 are foot-specific. Psychometric validation confirmed the internal consistency and very high reproducibility of the questionnaire. CONCLUSIONS: The hand-foot syndrome-specific HFS14 scale is easy to use and meets the requirements of a quality of life scale. This scale now needs to be tested in longitudinal studies (for example in clinical trials) to confirm its ability to measure a change in status.
Conference/Value in Health Info
2009-10, ISPOR Europe 2009, Paris, France
Value in Health, Vol. 12, No. 7 (October 2009)
Code
PMC53
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Multiple Diseases, Oncology