Abstract T MP89: Development of Patient Reported Spasticity Symptom and Impact Assessment Measures
Objectives: To develop new patient-reported outcome (PRO) measures to assess symptoms and impacts of spasticity in accordance with the FDA Guidance on PRO development.
Methods: Six focus group interview sessions involving 51 patients and 21 individual face-to-face interviews were conducted among patients with upper and lower limb (UL and LL) post-stroke spasticity (PSS) to elicit the symptoms and health-related quality of life impacts that these patients experience. A coding scheme consisting of the root concepts was developed using an iterative process. Patient transcripts were coded in ATLAS.ti using a framework that allowed responses to be organized by limb attribution (i.e., UL, LL, or unspecific limbs). The coded concepts were evaluated for saturation. Items for the symptom and impact instruments were developed based on: 1) frequency with which a concept was expressed spontaneously, 2) whether the item evaluated a symptom or impact of spasticity, 3) represented a single concept and 4) is likely to change with treatment of the condition. The draft measures were cognitively debriefed among 24 PSS patients to ensure patients’ comprehension of the items and response options.
Results: The mean age of patients in this study was 65 years and more than 40% were female. The average time since stroke was approximately 4 years. Saturation of the symptom and impact concepts by limb category was achieved for all frequently reported items. Limited movement of the affected limb was the most frequently reported UL and LL PSS symptom (>70%) followed by limb curling (UL: 62%; LL: 38%), limb clenching (UL: 52%), spasms (UL: 52%, LL: 67%), pain (UL: 48%; LL: 52%) and stiffness (UL: 43%; LL: 62%). Specific UL impacts mentioned frequently were: difficulty getting dressed (86%), holding/gripping objects (71%), showering/bathing (62%), and other self-care activities (81%). Specific LL impacts mentioned frequently were: difficulty with mobility (100%), keeping balance (62%) and getting dressed (48%). A total of 32 impact and 21 symptom items across UL and LL categories were generated.
Conclusions: The spasticity symptom and impact PRO measures represent a systematic approach to assessing outcomes that are meaningful to patients with spasticity.
Author Disclosures: C. Evans: Consultant/Advisory Board; Significant; Allergan, Inc. S. Burgess: Employment; Significant; Adelphi Values LLC, Independent Consultant. R. Zorowitz: Honoraria; Modest; Allergan, Inc, Medergy HealthGroup. K. Dunning: Employment; Significant; University of Cincinnati. Research Grant; Modest; Bioness Inc FASTEST trial. A. Yaworsky: Employment; Significant; Adelphi Values LLC. V. Ganapathy: Employment; Significant; Allergan, Inc. P. Gillard: Employment; Significant; Allergan, Inc. B. Kissela: Research Grant; Significant; NIH R01. Consultant/Advisory Board; Modest; Consultant to Allergan, Inc..
- © 2014 by American Heart Association, Inc.