Enhancing Methods to Explore Meaningful Change in Patient Interviews: A Case Study in Spinocerebellar Ataxia (SCA)
Author(s)
Naomi Suminski, MS1, Rinchen Doma, BA, BS, MPH2, Chris Buckley, MSc3, Katja Rudell, BSc, MSc, PhD3, Michele Potashman, PhD4, Gil L'Italien, PhD5;
1Parexel, COA Science, San Diego, CA, USA, 2Parexel, Durham, NC, USA, 3Parexel, COA Science, London, United Kingdom, 4Biohaven Pharmaceuticals, Inc., New Haven, CT, USA, 5Biohaven Pharmaceuticals Inc., New Haven, CT, USA
1Parexel, COA Science, San Diego, CA, USA, 2Parexel, Durham, NC, USA, 3Parexel, COA Science, London, United Kingdom, 4Biohaven Pharmaceuticals, Inc., New Haven, CT, USA, 5Biohaven Pharmaceuticals Inc., New Haven, CT, USA
OBJECTIVES: Asking patients to consider meaningful change (MC) within the context of a clinical outcome assessment (COA) score can be cognitively complex, especially for multi-item instruments. We assessed the effectiveness of enhanced interview methods, including visual aids and compounding questions, used to explore patients’ perceptions of MC for a composite instrument, the Spinocerebellar Ataxia Composite Score (SCACOMS).
METHODS: Qualitative interviews were conducted with SCA patients (N=24) located in the United States (US). To complement the interview guide, patient-friendly visual aids were developed to illustrate the concepts of MC. The aid included color-coded markers to represent changes in item score; markers were adjusted based on real-time responses, enabling the participant to visually track the discussion. A compounding question approach was used, starting with item review and exploring item relevance. Lay-person friendly questions were then used to assess MC concepts (stability, improvement, and worsening) and degrees of MC for each item. Once familiar, the overall instrument was reviewed including previous item responses and assessing which item(s) would need to change (and by how much) to be meaningful.
RESULTS: All patients understood, engaged with, and provided responses to the MC exercise (n=24). Using compounding questions and visual aids proved effective in collecting complex data on patient perceptions of MC, evidenced by their increasingly detailed response of score change and ability to describe how this translated into their daily life. Further, interviewers collectively assessed that the approach: (1) enhanced patient engagement, (2) allowed on-the-spot adjustments to patient responses for dynamic and accurate data capture, and (3) created a record for interpretation of patient-reported results during analysis.
CONCLUSIONS: Iteratively building patients’ understanding of the measure allowed for reliable patient reflections and discussions of how score changes would translate into their feelings, functioning, and impacts on daily life. Implementing an interactive visual allowed for enhanced recording of patients’ perspectives.
METHODS: Qualitative interviews were conducted with SCA patients (N=24) located in the United States (US). To complement the interview guide, patient-friendly visual aids were developed to illustrate the concepts of MC. The aid included color-coded markers to represent changes in item score; markers were adjusted based on real-time responses, enabling the participant to visually track the discussion. A compounding question approach was used, starting with item review and exploring item relevance. Lay-person friendly questions were then used to assess MC concepts (stability, improvement, and worsening) and degrees of MC for each item. Once familiar, the overall instrument was reviewed including previous item responses and assessing which item(s) would need to change (and by how much) to be meaningful.
RESULTS: All patients understood, engaged with, and provided responses to the MC exercise (n=24). Using compounding questions and visual aids proved effective in collecting complex data on patient perceptions of MC, evidenced by their increasingly detailed response of score change and ability to describe how this translated into their daily life. Further, interviewers collectively assessed that the approach: (1) enhanced patient engagement, (2) allowed on-the-spot adjustments to patient responses for dynamic and accurate data capture, and (3) created a record for interpretation of patient-reported results during analysis.
CONCLUSIONS: Iteratively building patients’ understanding of the measure allowed for reliable patient reflections and discussions of how score changes would translate into their feelings, functioning, and impacts on daily life. Implementing an interactive visual allowed for enhanced recording of patients’ perspectives.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR36
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Neurological Disorders, SDC: Rare & Orphan Diseases