Date of Award

January 2021

Document Type

Thesis

Degree Name

Master of Public Health (MPH)

Department

School of Public Health

First Advisor

Andrew Heinrich

Second Advisor

Mark Schlesinger

Abstract

Abstract.Patient Reported Outcomes (PROs) have been defined by the Food and Drug Administration (FDA) as "any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else.” Similarly, the FDA defines Patient Preference Information (PPI) as a metric system which defines how important certain aspects of care are to patients, “and what tradeoffs [they] are willing to make between attributes.” In conjunction, these measures are powerful tools that help drive the medical device market to not only satisfy the basic survival needs of patients, but focus innovation on what patients want access to. Globally, the United States’ spending by far exceeds any other developed nation, yet their healthcare outcomes do not correlate with this trend. In order to improve patient morbidity, mortality, and quality of life, the U.S. must look at external successes in order to benefit from alternative strategies. This analysis compares the medical device approval processes and healthcare systems used in the United Kingdom and Israel to determine what methods can potentially be implemented in the United States. From this review, I determined that there are three key policy suggestions that the U.S. can potentially incorporate to improve healthcare outcomes. The first would be to integrate culturally adept “translators” who can collect and collate patient's PROs and PPI to ensure the collection of scientifically relevant data that reveals the meaning behind the feedback. The second proposition suggests that a portion of the taxes that go towards the U.S. public healthcare system, in part, be used to offset the burden of making PRO and PPI data available for all companies applying for medical device approval. The third suggestion would offer tax breaks or incentives to organizations who use PROs and PPIs in their medical device applications to the FDA. Patient preferences, even if they exchange length of life for quality of life must be integrated into medical decisions in a more complex manner than a life or death directive. Patient's rights to select therapeutics must be included into the device development process from the moment a product can be tested. Not only will devices be more profitable to industry because of higher patient acceptance, but more cost-effective to our shared healthcare system because of better compliance and therefore better allocation of resources.

Comments

This thesis is restricted to Yale network users only. This thesis is permanently embargoed from public release.

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