# Exploring patients’ experiences with wAIHA and the content validity of the FACIT-fatigue: a qualitative interview study

## TL;DR

This study explores how patients with warm Autoimmune Hemolytic Anemia (wAIHA) experience fatigue and validates a tool for measuring fatigue in these patients.

## Contribution

The study provides new evidence on the content validity of the FACIT-Fatigue scale for wAIHA patients and identifies meaningful changes in fatigue scores.

## Key findings

- Fatigue is the most common and bothersome symptom reported by all wAIHA patients.
- A conceptual disease model was developed linking symptoms to impacts on patients' lives.
- A 1-point change in FACIT-Fatigue item 1 was considered meaningful by most patients.

## Abstract

Warm Autoimmune Hemolytic Anemia (wAIHA) is a rare form of anemia caused by premature destruction of red cells. This qualitative study aimed to understand the patient experience with wAIHA and provide evidence of FACIT-Fatigue scale validity by interviewing adult wAIHA patients along with examining patients’ definitions of meaningful change for item 1 of the FACIT Fatigue.

Hybrid Concept Elicitation (CE) and Cognitive Debriefing (CD) interviews, lasting approximately 75 min, were conducted with US-based adults diagnosed with wAIHA. The CE part of the interview focused on understanding the patient's experiences with wAIHA, particularly the signs/symptoms, and impacts. The CD part evaluated patient’s feedback on clarity, relevance, and comprehensibility of the FACIT-Fatigue, and examined their interpretation of meaningful change for item 1.

Nineteen adult wAIHA patients (mean age 49.7 years) from the US were interviewed, 31 signs/symptoms were identified with fatigue being the most common (reported by all patients, 100%) and bothersome. In addition, many patients experienced shortness of breath (95%) and skin/eye color change (74%). Other common symptoms included headaches (63%), dark/brown urine (63%), heart palpitations (63%), and dizziness (53%). The study also found that wAIHA can have negative impact on patients’ emotional functioning, physical functioning, daily activities, social and professional life. The most frequently reported impacts included feeling anxious or scared (79%), difficulty climbing stairs (74%), needing help from others (74%), and reduced physical strength/mobility (74%). Patients also frequently reported feelings of anger/frustration (68%), needing frequent rests (68%), difficulty walking (68%), feeling worrisome (53%), and impacts on social activities (53%). A novel conceptual disease model was developed, highlighting the associations between symptoms and their impacts on patients’ lives. Patients indicated the FACIT-Fatigue was clear, relevant, and appropriate for measuring their wAIHA related fatigue. A 1-point score change in the item 1 was considered meaningful for both improvement and worsening of their fatigue by most patients.

The study offers insight into the patient experience with wAIHA, detailing common symptoms and impacts on daily life as part of wAIHA conceptual disease model. It also supports the content validity of the FACIT-Fatigue instrument for assessing fatigue in wAIHA patients.

The online version contains supplementary material available at 10.1186/s13023-025-03767-4.