COGNITIVE TESTING OF A MODIFIED VERSION OF THE FACES PAIN SCALE-REVISED IN CHILDREN WITH SICKLE-CELL DISEASE
Author(s)
Naegeli AN1, Heath L2, Turner-Bowker DM3, Flood E4, Dampier C5, Happich M6
1Eli Lilly, Indianapolis, IN, USA, 2Eli Lilly and Company, Indianapolis, IN, USA, 3Adelphi Values (work conducted while at ERT, Pittsburgh, PA), Boston, MA, USA, 4ICON COA, Gaithersburg, MD, USA, 5Emory University School of Medicine, Atlanta, GA, USA, 6Lilly Deutschland GmbH, Bad Homburg, Germany
OBJECTIVES: Sickle-cell disease (SCD) manifests clinically as severe pain episodes in various locations of the body. Patients with SCD also experience chronic daily pain, which profoundly affects quality of life. Cognitive interviews were conducted to evaluate comprehension and usability of a modified version of the Faces Pain Scale-Revised (Modified FPS-R), which asks children to rate their worst pain today using an electronic device. METHODS: In-person interviews were conducted in the US with children aged 4-17 years with SCD and their parent/legal guardian. Children who were unable to read or needed guidance were assisted by their parent/legal guardian using written administration guidelines. Children were asked questions about their pain experience, understanding of the instrument, and ability to use the electronic device. Parents/legal guardians were debriefed on the administration guidelines, assisting their child, use of the electronic device, and their child’s pain experience. RESULTS: The sample included 22 African American children (13 females/9 males; 7=4-5 year-olds, 12=6-11 year-olds and 3=12-17 year-olds). Pain was most commonly reported to occur in the legs, back, arms, stomach, or head. Those aged ≥7 years were able to demonstrate good understanding of the Modified FPS-R item and response scale and ability to use the electronic device. Children 4-6 years were generally not familiar with “discomfort” and many did not know the meaning of “pain”. It was unclear whether these children were able to consider their worst pain over the course of the day and respond accordingly. Parents/legal guardians noted that the instrument instructions were clear and that the administration guidelines provided simplified, standardized direction for young children and those unable to read without assistance. CONCLUSIONS: The Modified FPS-R used with the administration guidelines where parental assistance is needed, is an appropriate measure of sickle-cell pain over the course of a day for children aged ≥7 years.
Conference/Value in Health Info
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PSY92
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Systemic Disorders/Conditions