Individuals born with primary immune deficiency diseases (PIDD) have a dysfunctional immune system, and many are treated by lifelong injections of immunoglobulin therapy. Studies have shown that these patients have low health-related quality of life (HRQOL) and well-being (WB) and that these outcomes might be improved by the availability of therapy innovated according to preferences for fewer needle sticks or a shorter infusion time. Regulators at the U.S. Food and Drug Administration (FDA) have approved therapies innovated per these preferences. However, there is limited data demonstrating how these innovations impact HRQOL and WB. Using the biopsychosocial model, the purpose of this cross sectional quantitative study was to evaluate whether patients with PIDD using therapies innovated for fewer needle sticks or a shorter infusion time had a higher mean HRQOL and WB compared to those who were not. The study included 153 patients who completed the Patient Reported Outcomes Measurement Information System (PROMIS)-29 survey. The dependent variables were HRQOL and WB measured by PROMIS-29, and the independent variables were the medical product innovations. Independent samples t tests results showed mean PROMIS-29 scores were not statistically different (p > .05). This suggests patients were optimized according to their treatment preference. A subgroup of patients who had taken the PROMIS-29 survey more than once concurrent with switching to a therapy aligned with patient preferences showed improved HRQOL and WB. These findings have implications for positive social change in that seeking the patient's voice to inform medical product innovation and FDA regulatory decision-making has potential to improve biopsychosocial outcomes.
| Identifer | oai:union.ndltd.org:waldenu.edu/oai:scholarworks.waldenu.edu:dissertations-6068 |
| Date | 01 January 2018 |
| Creators | Heckman, Niedre |
| Publisher | ScholarWorks |
| Source Sets | Walden University |
| Language | English |
| Detected Language | English |
| Type | text |
| Format | application/pdf |
| Source | Walden Dissertations and Doctoral Studies |
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