Examining the Relevance of the SF-36v2 for Assessment in HDFN or FNAIT-Affected Pregnancies: Results of a Landscape Assessment and Clinician and Patient Interviews

OBJECTIVES: There are no disease specific patient-reported outcome (PRO) instruments available for use in Hemolytic Disease of the Infant and Newborn (HDFN) or Fetal/Neonatal Alloimmune Thrombocytopenia (FNAIT). The purpose of this study was to understand the patient perspective in HDFN and FNAIT and evaluate whether a general health-related quality of life (HRQoL) measure, the SF-36v2, is suitable to measure areas identified as meaningful in these populations.

METHODS: A targeted literature review and PRO landscape assessment was conducted to inform interview guide development. Qualitative interviews were conducted first with maternal-fetal specialists with experience treating HDFN and FNAIT pregnancies (n=4). Subsequent interviews were conducted with mothers who had at least one pregnancy diagnosed with either HDFN (n=10) or FNAIT (n=8). All participants were recruited from the United States via a research partner following IRB approval. Qualitative data were mapped to the items of the SF-36v2 to evaluate conceptual coverage.

RESULTS: Several concepts identified from clinician and patient interviews mapped either directly or indirectly to the item concepts in the SF-36v2. Emotional well-being, physical well-being, and impact on work mapped most directly to the SF-36v2. Items with the highest relevancy to patients included questions that evaluated how an individual feels mentally and physically. Clinicians reported that emotional well-being and impacts on work due to the diagnosis and treatment came up frequently in their conversations with patients.

CONCLUSIONS: This study provides important context in HDFN and FNAIT where very little patient experience data is available. Evidence collected from this study demonstrates that items within the SF-36v2 capture relevant impacts experienced by individuals with an affected pregnancy. Results of this study can be used to support the use of the SF-36v2 in future studies to evaluate the impacts of HDFN or FNAIT on HRQoL.