Content validity and meaningful change for the FACIT-Fatigue scale in warm autoimmune hemolytic anemia: results from qualitative interview studies with patients
Abstract Purpose Warm autoimmune hemolytic anemia (wAIHA) is a rare disorder characterized by premature destruction of red blood cells (hemolysis) and fatigue that affects patients’ health-related quality of life. This study aimed to identify fatigue concepts important to patients and evaluate the c...
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| Format: | Article |
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SpringerOpen
2025-07-01
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| Series: | Journal of Patient-Reported Outcomes |
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| Online Access: | https://doi.org/10.1186/s41687-025-00930-0 |
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| author | Sheryl Pease Rikki Mangrum Karolina Schantz Christina Slota Lindsey Rubin Susan Martin Cathye Shu Kayla Scippa |
| author_facet | Sheryl Pease Rikki Mangrum Karolina Schantz Christina Slota Lindsey Rubin Susan Martin Cathye Shu Kayla Scippa |
| author_sort | Sheryl Pease |
| collection | DOAJ |
| description | Abstract Purpose Warm autoimmune hemolytic anemia (wAIHA) is a rare disorder characterized by premature destruction of red blood cells (hemolysis) and fatigue that affects patients’ health-related quality of life. This study aimed to identify fatigue concepts important to patients and evaluate the content validity of the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) in the wAIHA patient population. Methodology Two observational studies collected data via 60-minute, individual interviews. Eligible participants were English-speaking, US-resident adults diagnosed with wAIHA by a physician. Both studies gathered data regarding fatigue experiences that mattered to patients and comprehension and relevance of the FACIT-Fatigue; one study also gathered data about patient perspectives on meaningful change in item-level response selection. Results Each study enrolled 10 individuals with wAIHA (n = 20). All participants described fatigue as the most prominent or most bothersome symptom, with substantial impacts on daily functioning, family and social life, and emotional well-being. The FACIT-Fatigue was well understood, comprehensive, and relevant to participants’ experiences with wAIHA. Data analysis indicated that at least a 3-point change in total score likely reflects a meaningful change in fatigue. Conclusions Fatigue is the primary patient-reported wAIHA symptom and important to measure from the patient perspective. Findings demonstrated that wAIHA patients found the FACIT-Fatigue understandable, comprehensive, and relevant, and the data indicated that the instrument can detect a meaningful change in fatigue symptoms and impacts. Study findings support the content validity of the FACIT-Fatigue and contribute to the evidence that the FACIT-Fatigue is fit-for-purpose to evaluate fatigue in adults with wAIHA. |
| format | Article |
| id | doaj-art-82244352f6ef4c86b93acd3d14621898 |
| institution | Kabale University |
| issn | 2509-8020 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Journal of Patient-Reported Outcomes |
| spelling | doaj-art-82244352f6ef4c86b93acd3d146218982025-08-20T03:43:22ZengSpringerOpenJournal of Patient-Reported Outcomes2509-80202025-07-01911910.1186/s41687-025-00930-0Content validity and meaningful change for the FACIT-Fatigue scale in warm autoimmune hemolytic anemia: results from qualitative interview studies with patientsSheryl Pease0Rikki Mangrum1Karolina Schantz2Christina Slota3Lindsey Rubin4Susan Martin5Cathye Shu6Kayla Scippa7Johnson & Johnson, Patient Reported OutcomesVector Psychometric Group, LLCVector Psychometric Group, LLCRTI Health Solutions, Patient-Centered Outcomes AssessmentVector Psychometric Group, LLCRTI Health Solutions, Patient-Centered Outcomes AssessmentJohnson & Johnson, ImmunologyJohnson & Johnson, Patient Reported OutcomesAbstract Purpose Warm autoimmune hemolytic anemia (wAIHA) is a rare disorder characterized by premature destruction of red blood cells (hemolysis) and fatigue that affects patients’ health-related quality of life. This study aimed to identify fatigue concepts important to patients and evaluate the content validity of the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) in the wAIHA patient population. Methodology Two observational studies collected data via 60-minute, individual interviews. Eligible participants were English-speaking, US-resident adults diagnosed with wAIHA by a physician. Both studies gathered data regarding fatigue experiences that mattered to patients and comprehension and relevance of the FACIT-Fatigue; one study also gathered data about patient perspectives on meaningful change in item-level response selection. Results Each study enrolled 10 individuals with wAIHA (n = 20). All participants described fatigue as the most prominent or most bothersome symptom, with substantial impacts on daily functioning, family and social life, and emotional well-being. The FACIT-Fatigue was well understood, comprehensive, and relevant to participants’ experiences with wAIHA. Data analysis indicated that at least a 3-point change in total score likely reflects a meaningful change in fatigue. Conclusions Fatigue is the primary patient-reported wAIHA symptom and important to measure from the patient perspective. Findings demonstrated that wAIHA patients found the FACIT-Fatigue understandable, comprehensive, and relevant, and the data indicated that the instrument can detect a meaningful change in fatigue symptoms and impacts. Study findings support the content validity of the FACIT-Fatigue and contribute to the evidence that the FACIT-Fatigue is fit-for-purpose to evaluate fatigue in adults with wAIHA.https://doi.org/10.1186/s41687-025-00930-0Warm autoimmune hemolytic anemiaFACIT-FatigueConcept elicitationCognitive debriefingRare diseasePatient-reported outcomes |
| spellingShingle | Sheryl Pease Rikki Mangrum Karolina Schantz Christina Slota Lindsey Rubin Susan Martin Cathye Shu Kayla Scippa Content validity and meaningful change for the FACIT-Fatigue scale in warm autoimmune hemolytic anemia: results from qualitative interview studies with patients Journal of Patient-Reported Outcomes Warm autoimmune hemolytic anemia FACIT-Fatigue Concept elicitation Cognitive debriefing Rare disease Patient-reported outcomes |
| title | Content validity and meaningful change for the FACIT-Fatigue scale in warm autoimmune hemolytic anemia: results from qualitative interview studies with patients |
| title_full | Content validity and meaningful change for the FACIT-Fatigue scale in warm autoimmune hemolytic anemia: results from qualitative interview studies with patients |
| title_fullStr | Content validity and meaningful change for the FACIT-Fatigue scale in warm autoimmune hemolytic anemia: results from qualitative interview studies with patients |
| title_full_unstemmed | Content validity and meaningful change for the FACIT-Fatigue scale in warm autoimmune hemolytic anemia: results from qualitative interview studies with patients |
| title_short | Content validity and meaningful change for the FACIT-Fatigue scale in warm autoimmune hemolytic anemia: results from qualitative interview studies with patients |
| title_sort | content validity and meaningful change for the facit fatigue scale in warm autoimmune hemolytic anemia results from qualitative interview studies with patients |
| topic | Warm autoimmune hemolytic anemia FACIT-Fatigue Concept elicitation Cognitive debriefing Rare disease Patient-reported outcomes |
| url | https://doi.org/10.1186/s41687-025-00930-0 |
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