Abstract Number: PB0662
Meeting: ISTH 2021 Congress
Background: coreHEM Mental Health (coreHEM MH) builds on the coreHEM core outcome set for hemophilia gene therapy (Iorio Haemophilia 2018). coreHEM MH seeks to develop a content-validated, patient-reported outcome measure (PROM) to measure mental health (MH) outlook in patients who receive gene therapy, a coreHEM core outcome. Once fully developed, the coreHEM MH PROM can be used to measure changes in MH outlook in hemophilia gene therapy trials.
Aims: To compare the anxiety/depression domain of the EQ-5D-3L and the draft anxiety and depression items of the coreHEM MH PROM.
Methods: A conceptual framework and draft PROM were developed following a background literature review. The framework included living with/treating hemophilia and aspects of MH outlook that may change after gene therapy. Concepts were categorized into five domains: stigma, anxiety, depression, life interference, and identity. Thirty participants with severe or moderate hemophilia A or B participated in concept elicitation interviews and completed the PROM, a demographic survey, and the EQ-5D-3L.
Results: For EQ-5D-3L, 43% reported they were not anxious or depressed. 56% reported being moderately or extremely anxious or depressed (Table). Mean EQ-5D VAS score indicating participant “health today” was 68.5 (range 20-99). For the coreHEM MH PROM, those who reported they were not anxious or depressed on the EQ-5D-3L had higher mean scores in both the PROM anxiety (7 items) and depression domains (10 items) compared to those who reported they were “moderately” or “extremely” anxious or depressed in the EQ-5D-3L (Figure). For the coreHEM MH PROM a higher percent indicates a better MH outlook.
|Anxiety/Depression “Today”||Number (Percent)|
|I am not anxious or depressed||13 (43%)|
|I am moderately anxious or depressed||16 (53%)|
|I am extremely anxious or depressed||1 (3%)|
Conclusions: Domain scores for anxiety and depression on the coreHEM MH PROM follow the expected pattern aligning with the EQ-5D-3L levels. Thematic analysis will be performed on the qualitative interview data to refine the conceptual framework and PROM.
This work is funded by Bayer, BioMarin, Pfizer, Sanofi, Spark, Takeda, and uniQure.
To cite this abstract in AMA style:Clearfield E, Chang H-, Majid T, Skinner MW. Responses to Anxiety and Depression Items in People with Hemophilia who Tested a Patient Reported Outcome Measure: The coreHEM MH Study [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 1). https://abstracts.isth.org/abstract/responses-to-anxiety-and-depression-items-in-people-with-hemophilia-who-tested-a-patient-reported-outcome-measure-the-corehem-mh-study/. Accessed September 24, 2021.
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