Abstract: FR-PO871
Conceptual Model of the Patient Experience of IgAN: A Qualitative Literature Review and Model Update
Session Information
- IgA Nephropathy: Clinical, Outcomes, and Therapeutics
October 25, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Knight, Sarah, Clarivate Analytics UK Limited, London, London, United Kingdom
- Davis, Greg, Clarivate Analytics UK Limited, London, London, United Kingdom
- Al-zubeidi, Tamara, Clarivate Analytics UK Limited, London, London, United Kingdom
- Nunna, Sasikiran, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, New Jersey, United States
- Gandhi, Hema Kannan, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, New Jersey, United States
- Ali, Sarah Naz, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, New Jersey, United States
- Richardson, Michelle M., Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, New Jersey, United States
- Oberdhan, Dorothee, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, New Jersey, United States
Background
A robust conceptual model (CM) is an essential foundation to inform clinical outcome assessments (COAs) for patient-centered trials in immunoglobulin A nephropathy (IgAN). This study updated a previous CM of adult and pediatric patient experiences of IgAN including disease manifestations, treatment side-effects and impact on functioning and well-being.
Methods
A targeted review of “A Summary of Survey Results and Call to Action from the IgA Nephropathy Foundation”, a 2021 IgAN Disease Burden Global Analysis (internal report) and an updated qualitative literature search was conducted to identify patient-reported concepts to update a previous CM. Semantic, qualitative and directed content analysis techniques, aided by ATLAS.tiv9, were used. Relevant concepts were coded and cross-checked against the previous CM and newly identified codes were flagged and evaluated for inclusion into the update. The domains were refined by grouping related concepts, where applicable.
Results
In addition to the two reports, three new studies were identified from the literature review, one of which was the development paper for the previous CM. A comparison of the previous and updated CM is detailed in Table 1. Data sources did not reveal the most salient/bothersome experiences, and a large portion of the new concepts were not reported by age groups.
Conclusion
This updated CM identified new symptoms and impacts of IgAN in adult and pediatric patients that can be used to inform the selection, development and/or amendment of COAs for future IgAN clinical trials. Patient and clinician input is needed to differentiate symptoms and impacts by age groups and to clarify relationships between concepts and domains.
Table 1: Comparison of existing to updated CM
| Domains | Previous CM | Updated CM |
| Disease manifestations | Swelling/puffiness (edema); pain/aches/discomfort; fatigue; weight gain; sleep problems; urinary problems; gastrointestinal problems | Edema locations; hematuria and proteinuria; swollen tonsils and respiratory problems; kidney discomfort and back/flank pain; disrupted sleep; vitamin D deficiency and frequent infections |
| Impact | Emotional/psychological wellbeing; physical functioning/activities of daily living; social functioning; work/school and relationships | Feeling unequipped to manage disease alone; school attendance; family and friend relationships; diagnosis delay; misdiagnosis or lack of clinician familiarity with IgAN, dietary restrictions, dialysis restrictions and length, shock and regret at prolonged diagnosis |
Funding
- Commercial Support – Otsuka Pharmaceutical Development and Commercialization, Inc