DEVELOPMENT OF A REPORT CARD FOR IDENTIFYING LOCAL SUBLINGUAL IMMUNOTHERAPY EVENTS IN CLINICAL TRIALS

Author(s)

Norquist JM1, Tanzosh T1, Flood E2, Li H1, Iskold B1, Ganser TR2, Marson-Smith HR2
1Merck & Co, Whitehouse Station, NJ, USA, 2ICON COA, Gaithersburg, MD, USA

OBJECTIVES: Develop the Sublingual Immunotherapy (SLIT) Report Card to capture patient-reported local reactions associated with the administration of sublingual immunotherapy, based on the World Allergy Organization’s (WAO) side effect grading system METHODS: Items were drafted based on the WAO grading system. Cognitive debriefing, usability testing interviews, and translatability assessment were conducted. Adults (aged 18+ y), adolescents (aged 12-17 y), and parents/caregivers and their children (aged 5-11 y) participated in two rounds of interviews. A paper version of the SLIT Report Card was tested in Round 1, and both paper and electronic versions were further evaluated in Round 2. Interviews were conducted to confirm appropriateness and comprehension of the instrument’s content and, for the electronic version, ease of completion using the electronic device. A translatability assessment enabled identification and mitigation of potential issues that might arise during future translation and linguistic validation RESULTS: Ten adults, 10 adolescents, and 10 parent/child dyads participated in interviews. In general, subjects interpreted the instrument and instructions as intended, and were able to demonstrate understanding by explaining the meaning of the instrument’s content. However, some adult, adolescent and parent/child subjects were uncertain of, or suggested clarifying, the meaning of certain terms, including tablet, ulcer, taste alteration, uvula, nausea, and itching in the ear. The translatability assessment also identified uvula and nausea as potentially problematic with respect to translation. Subjects were able to use the device and found navigation of the instrument ‘easy’, with only a few minor suggestions made to improve usability. Some wording and formatting changes were made based on subject feedback and the translatability assessment CONCLUSIONS: The SLIT Report Card was refined following best practices for instrument development. The refined SLIT Report Card is appropriate for systematically collecting data on SLIT-related local reactions directly from subjects in a clinical trial setting, based on the WAO grading system.

Conference/Value in Health Info

2016-05, ISPOR 2016, Washington DC, USA

Value in Health, Vol. 19, No. 3 (May 2016)

Code

PRS45

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Respiratory-Related Disorders

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×