(1048) Patient-reported outcomes of iron-deficiency anemia treatment in pregnancy: a mixed methods analysis

Objective: Iron deficiency anemia (IDA) in pregnancy is common, yet patient-reported outcomes on IDA treatment are limited. Our objective is to determine whether intravenous iron, compared with oral iron, improves patient-reported outcomes in the treatment of iron-deficiency anemia (IDA) in pregnancy.

Study Design: We conducted a randomized controlled trial of pregnant patients with laboratory-confirmed IDA comparing IV ferumoxytol to oral ferrous sulfate. We assessed patient-reported outcomes with a modified short-form validated survey and free text feedback using a mixed methods approach. We compared the changes in survey domain scores (scale of 0-100) in general health, physical functioning, role limitations due to physical health, and energy/fatigue from study initiation to 4 weeks between treatment groups. We analyzed free-text responses with inductive thematic analysis and compared qualitative themes with quantitative results. Adverse side effects were monitored by survey and a Data Safety Monitoring Board.

Results: Among the 61/80 (76% of the total study) participants who responded to the 4-week survey, participants in the IV ferumoxytol group noted improvements in energy/fatigue, with a median increase of 10 points over 4 weeks compared to no change in the oral ferrous sulfate group (p=0.018) (Table 1). There were no changes in general health, physical functioning, or role limitations due to physical health at 4 weeks post-treatment in either study group. Thematic analysis of free text responses revealed that patients generally favored IV iron (preferred IV treatment despite randomization, more energy and effectiveness, and fewer side effects) and desired anemia management (follow-up of their hemoglobin levels) (Table 2). Analysis of quantitative and qualitative data reinforced patient preference for IV iron. There were no serious adverse events during the study period.

Conclusion: IV iron significantly improved patient-reported outcomes in quality of life, specifically more energy and less fatigue, compared to oral ferrous sulfate.